NOTE TO READERS: This relatively new section as  compared to the rest of the site, which dates back many years, will be devoted to publishing articles that the largest proportion of this website called "Medical Law". They are selected for their interest and / or effect or because of new unpublished author's own design and the author of this site (Rafael, Aguiar-Guevara) has created, and usually presented at World Congress, National Conference and / or written works and books . For the purpose of citation it is placed at the end of each article to the date of first publication. However, as long as in this section, the date last reviewed and updated, shall be the date of last update of this website in its entirety, which date appears on the home page of the portal. It is clear that the concepts here are cast by the author of his own authorship, and accountability and protected by Copyright under the law. Rafael, Aguiar-Guevara

 

 

 

 

 

 

Oncoplastic surgery in breast cancer: legal approximationNew



Oncoplastic surgery in breast cancer, a concept attributed to Werner Audretsch [1] in Germany, in 1994, proposed the use of procedures that allow tumor resection and immediate breast reconstruction with restoration techniques that apply the principles of cosmetic surgery and they change with the location of tumors in different quadrants and the relationship between breast volume and size of the tumor. [2]

The development and tuning of cancer treatment associated to aesthetic correction  represents a great achievement in the treatment of breast cancer, mainly on the issue of rehabilitation of women.

The Oncoplastic surgery is presented as a legitimate option for women and which, in our country, has real legal bases, if perhaps not oblige, the conjunction of mastologist, with the pathologist and plastic surgeon in order to compensate as far as possible the health of women in their comprehensive holistic concept.

Our Constitution of the Bolivarian Republic of Venezuela, Article 83, teaches us that health is a fundamental social right and therefore is inalienable, indispensable; and every person has a duty to actively participate in their defense and promotion, which does not exclude the physician in his practice, on the contrary, requires more emphasis and considers Article in comment that health as a right, guaranteed as part of the right to life, so we can not speak simply and purely, life in general, but we're talking about quality of life rather poorly as the right to live.

This right to health as an inherent part of the right of life should be interpreted as a comprehensive holistic right, of the the project of life, the health of each individual project that involves not only a state of physical welfare, or merely the absence of disease , but also considers the personal dignity, social and personal welfare, self-esteem, biodiversity, the workplace, health care, and in our case, of women with breast cancer, involves legitimate option of integrated treatment that offer her the purposes of a full state of well-being, offering a better quality of life, emotional, social, and personal being.

But how can a woman attending the consultation with the mastologist achieve these objectives which are their rights and that appears themselves as a legitimate option if she, as a patient, do not know?

The answer is simple. Every physician is required to obtain from his patients a legitimately declared consent at the moment when women   exercises their right to a timely (prior to treatment), true (full) and impartially information, in accordance, inter alia, Article 58 of our Constitution of the Bolivarian Republic of Venezuela.

This right of everyone to a timely, accurate, and unbiased information, as an expression of constitutional principle mentioned, is the essential foundation of the full exercise of the most sacred and beautiful gift that every person has from beginning of life, which is the principle of self-determination and autonomy of will . Exercise of this right is met in the modern concept of a physician-patient relationship completely horizontal in which the patient decides, according to her health project, project life, what to do with her ​​own body, and it being so far from the old relationship and hated old concept of protectionist vertical model of doctor-patient relationship, of a paternalistic order, where was the doctor who, in his opinion, decided for himself that it was better to "their" patient.

And it is this timely, accurate, and unbiased information required by Article 46, paragraph 3 of the Constitution of the Bolivarian Republic of Venezuela, whose language reflects the principle of bodily integrity by which any person has the right to be respected on their physical, mental and moral integrity, therefore ... no person shall be subjected without his/her free consent to medical examinations; and consequently derived, if it can not be subjected to medical tests much less would be deemed legitimate without prior information and consent can a person be subject to therapeutic procedures; which, in our particular case, involves the need and obligation of the mastologist of informing the patient about the existence of oncoplasty .

But is there any rule that requires the physician to inform the patient of any option or alternative treatment? Definitely yes.

Let's see:

We mentioned the right to timely, truthful and impartial information contained in Article 58 of the Constitution. Article that allows the exercise of another constitutional right contained in Article 20 of the Constitution itself: everyone has the right to the free development of personality. Concept that in its teleological development involves many aspects within which we can assume to include the right of women to complete a valid alternative to surgery allows greater range of personal esteem and well-being.

But beyond the constitutional principles we find laws and codes that includes but these concepts but, inclusive, more specific to medical practice.

Article 69 of the Health Law, in its paragraph 3, stipulates that the patient has the right to receive an explanation in understandable terms with respect to his/her health and the treatment of their disease, so that they can give consent reported to the diagnostic and therapeutic options ... omissis

Clearly oncoplasty is presented as a legitimate therapeutic option that woman, as a patient, has the right to know, ergo, the doctor is obliged to report. Otherwise the doctor did not fulfill its obligation to inform and obtain  legitimately declared consent [3] and will be exposed to legal claims, merely by omitting the consent of the patient, and that, far from mentioning the existence of sufficient jurisprudence of other countries that we can not mention now for the brevity of this commentary, apart from jurisprudence in this country.

In greater abundance is presented in Article 72, paragraphs 3 and 4 of the Code of Medical Ethics states clearly that the patient's right to be informed of the nature of the proceeding and to receive timely information necessary to give valid consent (free) prior to application of any diagnostic or therapeutic procedure.

Again, the consent can not be free, legitimate if it does not contain accurate information, and can not be truthful if the information is not complete, hence understand the obligation of all mastologist to inform, or at least refer your patient to a specialist who will talk about oncoplasty, and understanding that all mastologist is required to know about the existence of oncoplasty, mandated by Article 13 of the Law Practice of Medicine that forces him to keep informed of the progress of medical knowledge.

I must emphasize that, according to the current horizontal model of the doctor-patient relationship, it does not matter whether or not the mastologist agrees with oncoplasty because ultimately who must exercise their autonomy of will and self-determination is the patient who has the right to be informed in a truthful, complete, timely and fairly.

There can not be, from a legal point of view, another option. The doctor is obliged to inform and gather, their patient  legitimately declared consent; and being truthful information it must be complete and therefore should include everything on the oncoplasty. Except that mastologist integrating team with a plastic surgeon, refers the patient to the latter for the purpose of it and  he is who finally informed of the therapeutic options that best fit with the type of tumor and surgical raised as each particular case.

But could the mastologist apply therapeutics techniques to his patient without the help of a plastic surgeon? I believe not. According to Article 14 of the Law on the Practice of Medicine to practice any medical or surgical medical specialty it is required to have approved graduate course or specialty training directed at an Institute duly accredited by the governing bodies of health ministry.

On the other hand, constitute a prohibited practice conceptualized as a true intrusion in our Code of Medical Ethics in Article 23, paragraph 1, 1.1 and 1.2 and considered as academic intrusion and intrusion into the medical practice by stipulating:"Medical intrusion is the doctor who seeks academic exercise without being trained and recognized for it; and intrusion into the medical practice is the doctor who tries to exert a specialty for which you are not properly prepared or recognized". Both situations are punished in the Code of Medical Ethics by Disciplinary Tribunals of Medical Colleges of the country; subject to civil and / or criminal claims arising as mentioned above.

Hence, these very short courses on oncoplasty to which can attend the mastologist do not really credit  for the various techniques oncoplasty, and thus be exposed, personally, to any legal action (civil and / or criminal)   when a patient discomfort or obvious damage as a product of the process applied by recklessly mastologist.

This is why the recommendation is the integration of teams that have both specialists: the mastologist and the plastic surgeon. But not any plastic surgeon. It should also be a plastic surgeon with sufficient education and training in breast surgery.

The oncoplasty is focused on plastic surgery breast reconstruction as an immediate removal of benign or malignant process, becoming a true derivative of plastic surgery for breast reconstruction has currently allowed to provide women, quality emotional and social life much better than in previous times.

It is presented as a true scientific legitimate option to be offered to every patient to be subjected to surgery as a result of breast tumor, benign or malignant pathology. The final decision to accept it or not, is an exclusive decision of the patient leaving the surgeon mastologist the obligation to offer his patient all information on this matter in conjunction with the oncoplastic surgeon that together with him form an integrated team to benefit the patient.

The development and tuning of cancer treatment associated with the aesthetic correction represents a great achievement in the treatment of breast cancer, especially on the issue of rehabilitation of women. Thus, oncoplastic surgery highlights the health, general welfare and rehabilitation, in harmony with body image and social and family reintegration of the patient. Thus, breast reconstruction, must be inserted, if possible, in the overall treatment in any breast surgery.

  [1] Audretsch W, et al. Oncoplastic Surgery: "Target" volume reduction (BCT mastopexy) lumpectomy reconstruction (reconstruction BCT) supported operability and flap in breast cancer. Proceedings of the Second European Congress on Senology, Vienna, Austria. October; Bologna, Italy: Monduzzi,: 139-157, 1994.

Quoted by: National Inter-Society Consensus on Oncoplastic Breast Cancer Surgery - April 2012 - Posted by Cancer Society of Argentina. http://www.socargcancer.org.ar/consensos/2012_consenso_oncoplastica.pdf Last Visit: Oct 12, 2013

[2] Audrestch W et al. Tumor-specific immediate reconstruction in breast cancer patients. Perspect Plast Surg. 1998, 11: 71-106. Quoted by Nora Sánchez-Jaime Rubiano. Oncoplastic surgery in breast cancer. Colom Cir Rev 2008; 23 (4): 217-229. In http://www.ascolcirugia.org/revista/revistaoctubrediciembre2008/217-229.pdf last visited October 12, 2013

[3] Aguiar-Guevara, Rafael. Declared consent legitimately. Medical Law Treaty. 2nd Edition. Editors Legis. 2008


Aguiar Guevara, Rafael. Medical Doctor - Lawyer. raguiarg@gmail.com Published September 29th, 2014

 

 

 

 

The tax "forced donation" in organ transplantsNew

 

We have started a (unilateral) debate (?) on presumed consent on organ transplants. The various agencies such as ONTV (National Transplant Organization of Venezuela), the Ministry  for Health, transplant teams, and even the Commission to study the reform of the Law on Organ and Human Anatomical Material Transplant   in Venezuela (dated 1992), say that  it is necessary to impose what is known as presumed consent, ie: everyone in Venezuela is considered an organ donor unless otherwise stated.

What is not said is that we are all donors since 1992! That already exists .... ever since 1992 Law: and in the Law on Organ and Human Anatomical Material Transplant   in Venezuela, it is considered that we are all donors. What reformists  do not say   (ONTV, deputies, transplantation professionals, etc.) is that the (real) intention of the reform is to advance to the point of presumed consent in the case of brain death .... And this is so because it already exists presumed consent in current law in cases of biological death. (Complete cessation of vital functions).
No wonder, I was then said by the President of the ONTV, in an interview from El Nacional on 21 June 2000: .. (I quote): "We want the government to force all medical doctors in Emergency Rooms, in  the Intensive Care Unit, so that if someone is admitted with gunshot wounds, head trauma or hemorrhagic cerebrovascular accident, understand that that person is a (potential) donor. " (I could read or understand: You doctor does not treat these patients ... not waste time ... saving them and prepare themn  to extract the organs ....)

 

Presumed consent is a "legal monstrosity," is a contradiction, absurd, illogical and unfounded, or is informed and express consent, or it is presumed, but there can be no consent if no prior information and a real consensus, or conformity of wills between two subjects of law to establish, modify, regulate, and establish a legal link between them. It is set in the 1131 of our Civil Code, in other words, it is a contract between two people to form a legal bond between them.
In the specific case of the donation, which is set by the 1431 Civil Code, the civil law doctrine, as a perfect contract between two people or a bilateral contract when a person (identified person as donor) gives a specific (particular) thing, not general nor abstract, to a (identified) person who receives, which is also specific (identified), and placed on perfection that contract when the person who is donating learns acceptance of the thing given receptor. And by way of 1,439 of the Civil Code, requires that donation to be via certified so you can improve the contract. That is the civilian current and that is not being met or fulfilled, or it may be enforced based on what is being called presumed consent in terms of "donations", because I think the term is poorly implemented in the field of transplantation For the purposes of organ transplantation or donation, or for ablation and implantation, which are modern concepts that are managed today.

 

Criminal doctrine, which is the one that more or less offers paths to the understanding of presumed consent to us we established three fundamental requirements:


First one is that there is a trial value of a qualified probability, a good and qualified sense to substantiate the likelihood that the person, in full possession of his(her) knowledge, and  with legal and mental capacity, might have expressed his (her) will on a particular issue. This is one of the requirements. As explained Mezger, from who is due the progress of the doctrine of presumed consent because it was him to formulate and develop the concept on this ground of justification as "a trial of probability, judicial objectivity, in which if the affected had obtained full knowledge of things and from their point of his (her)view, he (she) would have consented the   conduct. " Roxin explains: Someone intervenes on behalf of another in the legal field of the patient and trust with his (her) approval. ".  it can be referred as presumed consent who has in mind with objective assessment, unequivocal overriding interests of the owner's legal of the protected right affected.


Second, that the attack is made to the legally protected by law is for the benefit of the injured person and not of any third party, in other words,  the interest of others are not the own bewnefit. In criminal doctrine Presumed Consent is rejected when the specific circumstances of individual case does not allow a goal that is  consistent with the legal owner of the right concerned. For this can not be  a (presumed) approval of donation from a person when the agent (transplantist) does not know anything close on the opinion of the holder (presumed donor) of the legal question (health, life, physical integrity) . For others, like Rieger, valuation of affected assets is only clue to the presumed intention, but not the basis for justification for it. So there is, in principle, space for interventions in the interests of third parties. For its part Jakobs points: even when an action might be allegedly (presumed beneficial) intentional action this action  can not be justified solely on the overriding interest of auditor or a third person. The application of such an approach would be very risky.


Third: subsidiarity. Principle by which state that presumed consent as the only intended to replace the lack of real consent, this, presumed consent, may be raised only when it is impossible to obtain real consent. There is no reason to allow the risk of wrongly interpreting the real intention of the legal owner, if it is possible to ask the person whose legal interests will be intervened.

If we understand these three conditions as grounds for justification or exemption from responsibility for understanding the presumed consent, we would understand   the situation of a patient who arrives at a hospital in a situation of no conscience, arrived unconscious to a hospital to better a need for amputation of a leg to save his life and there is no way to obtain a formal consent for the establishment of the doctor-patient relationship and for the approval of the removal or amputation of that leg. Only through a trial value of certain qualified probability that this individual being live would have consented to the amputation of a leg in terms of saving his (her) live and in terms of protecting the legal right, (life or health) in this case of the potential donor, is that you may understand then presumed consent.

But beyond the criteria of civil or criminal doctrine is the certain existence that presumed consent violates at least 4 constitutional principles. (Personal integrity and autonomy of will and self-determination, conscientious objection, the free development of personality, freedom of worship and religion), not to mention those items, such as Article 22 which provides for the defense of the escalation of human rights: the case in question: Every citizen, every person has the right to demonstrate, to orally express if he (she) wants to be or not to be an organ donor .... I understand that in 1992, under the concepts of that time it was imposed as obligatory (alleged) intent to donate, but understand the same in this actual process of our country is something I have to be explained it slowly because otherwise I do not understand it.

What has happened? In some countries, because not all, if we see the international comparative law, we know that presumed consent does not dominate, it is not the majority concept;  is the concept minority, that has been established in countries as a way to tax, because they want and must increase the need to fill the waiting lists of people who needs an organ  transplantation.
The index that measures and with which we compare ourselves with other countries in the world is called Index of Donors per million population. Venezuela last year concluded at 3.47 persons per million inhabitants. Spain is the country that has more donors, is at 34.3 donors per million inhabitants, is a very high number is well above other countries. But Latin America is, on average, in 8 donors per million inhabitants.

In USA the donor rate is 26.3 per million. The difference in USA and Spain (34.3 per million) is only 8 donors per million which is a negligible 0.8% difference between the two countries with completely opposite patterns, with presumed consent in Spain. In USA the number of donors is higher compared to Argentina, according to figures from INCUCAI (Unique Central National Institute of Ablation and Implant Coordinator) reports to the 14.54 per million (2010), and considering that we started in Argentina, the opposed imposition of presumed consent.
Another country is Greece, which maintain the presumed consent comes just a figure of 8 per million.

That is, evidence that the illegal presumed consent "duty to donate" does not appear as a real solution to the problem of transplants. Not the panacea of XXI century. Which brings us to our conclusion that it should be through: 1 .- true education campaigns, from school level, and diversified basic education and university education, and through the media that can reach real awareness to the issue of donation, and 2 .- We understand that many of the organ failure that warrant transplantation of organs or anatomical materials,   from the beginning, probably preventable disease which is justified campaigns prevention of these diseases, cardiovascular, and kidney, among others, may be preventable, consequentially lead to functional organ failure and hence the need for transplantation.
That is why I clarify that, even when I totally agree with organ transplants and understanding the problem of insufficient number of donors, also concluded that there is a fault, negligence, breach of duty by the State and / or organizations (such as ONTV) involved nationally in the field of transplants to raise awareness, to sensitize the population, then they promote the adoption of the concept of organ donation for transplantation. These ONTV managers have recognized on TV interview that (quote): "... we accept that there are gaps of information ..." Just ONTV management (same interview VTV) has been said that the most important is the view the family, that family is the cornerstone of the conversation and that if the family says no, but there is consent by the person (donor) is then not satisfied with the donation and transplantation.

The most beautiful and sacred gift that is the human being since his arrival in this world is the principle of freedom of will and self-determination. If through such awareness education campaigns I manage the problem and express my willingness to donate an organ, my question is: Who could, even family, to revoke my express donor status? It is another contradiction that emerges from the said ONTV. Of course, if there is informed and express consent, and you want to apply the theory of presumed consent, then yes, the advice and consent of family members is prevalent.


But there are two concepts that I wanted to clarify also because it confuses people. It has been stated  Spain as a model to follow with the thesis of presumed consent. Matezan Raphael himself, President of the ONT (National Transplant Organization) of Spain, speaking, and has advertised in various medical journals and scientific journals in Spain, which presumed consent does not increase the donations and that (quote): "There is belief that changing the express consent to presumed consent it will increase consequently the donations, but it is not. In countries that it has been implemented there has not been a steady increase.. " (Medical Journal, September 25, 2009, Spain).

That is, where it is said that the mother of donation presumed consent is ruling the world, the national transplant co-ordinator in newspapers from Spain says that there is no increase in rates, and that we have seen in countries like Greece where there is presumed consent and the rate of donors per million is extremely low.
However, we can make comparative stages, Spain has a number of figures as presumed consent, the alleged weak, because it allows the family to revoke the consent that a person has expressed. If I consciously want to donate my organs, I would donate my organs, why should I explain this desire, that I can even provide an authenticated document to respect my will, why not be respected by the family if that is and it obviously is  my desire that I have informed my family?
But it's very interesting to consider such other information carrying Regional Transplant Coordination of the Autonomous Community of Murcia, Spain, and publicized in a medical journal indexed (Med Clin (Barc) 2004; 122 (2): 67-9.) , which provides a survey which  was done and the studied selecte population was 2,000 people, which means a significant percentage shown for the purposes of statistics and which established that 75% of people were against compulsory donation or of presumed consent, and the total majority against (75%)  spoke it was considered as an abuse of authority and the other 25% as a lack of respect for the family. Is it because it is feared, in this debate, to openly ask the public?

Brain death: all the current campaign to impose presumed consent is based on legislative change that you want done. Thesis imposes presumed consent in brain death, which in the current legislation is not allowed. (Article 16, paragraph b).
It refers to countries like Spain and Colombia, but what is not said is that in those countries there are other demands on our legislation, so ingeniously facile, do not appear. One of them is outdated criteria of brain death that exist in our current legislation. As the number of doctors and specialists who must intervene in order to certify brain death and the time between the certification of brain death and organ harvesting is doubled in those countries against just the three (3) hours needed,  normatively, in our country. (Articles 16 paragraph c Article 10 paragraph 2, letter c of the second paragraph.)

The worst thing is trying to apply criteria such as those expressed by ONTV we refer in the beginning of this article, whereby a great donor support would come from patients entering the hospital for emergencies: accidents, any stroke, injured by firearms, or all brain damage occurs.

It is worth noting that the current legislation, Article 26 requires that documentation of national identification issued by the national body must include an expression of willingness of the person with respect to whether or not to be an organ donor. This obligation of law has not been accomplished during the past 19 years. We would like to impose with so much strength as you want to impose the criteria required to donate or presumed consent.

It is totally unacceptable that a minority concept like this, of presumed consent,  a violation of constitutional principles may be imposed by force, with a law, not with moral or ethical criteria to continue what so far is a reality in our country and others: we will continue to have  80% of donor population from the lower income classes who can not  (via certified or other legally valid enough way)  opt for the exercise of their rights: to express out loud whether to be or not be an organ donor.
Aguiar Guevara, Rafael. Doctor - Lawyer. ragaso@cantv.net. Published June 09th, 2011

 

 

 

 

 

 

World Right to Die Day

 

On November 2nd, 2010 we celebrate, worldwide, Right To Die Day; better known as the day for the Right to Die With Dignity Day.
We obey  the announcement made by the Board of the World Federation of Right to Die Societies, and with honor, our Venezuelan Association Right To Die With Dignity join, all over the world societies in the commemoration of this day.

This  celebration began, for the first time, on 02 November 2008, the day on which significant events took place in the city of Paris. The World Federation of Right to Die With Dignity (World Federation of Right to Die Societies), of which the Venezuelan Association Right to Die With Dignity is a member, declared on 02 November as World Day of the Right to Die With Dignity . The first memorial service was held in Paris, France on Sunday, November 2, 2008, in the vicinity of Le Mur pour la Paix (Peace Wall) which is a fairly recent monument is located in the Parc Champ de Mars in Paris since 2000. The event brought together members of various associations worldwide, including Venezuela, under the direction and coordination of the directors of the World Federation of Right to Die Societies, and in the context of the completion of the 17th World Congress of the Federation. It was so declared on 02 November as World Day to Die With Dignity law.
All of us in this globalized world we are united by our belief in the autonomy of will and self determination and the possibility to determine the moment worthy of end of our life process, when the critical moment has arrived. Many are the ways and procedures that are part of our belief, from the guidelines of a mere living will for a palliative medicine, the refuse of medical treatment and until the determination of going through a euthanasia procedure, when life and unnecessary suffering, is shameful for us.
The Venezuelan Association Right to Die With Dignity, is pleased and honored to join this international celebration with the sincere desire for the approval of a legislative alternative that allows us to fully develop and exercise our right to die with dignity and in this sense we announce our best commitment to fight for passage of the decriminalization of euthanasia, referred to in the last draft of the reform of our Penal Code.

 

Rafael, Aguiar-Guevara
Founder Chairman of the Venezuelan Association Right to Die With Dignity

ragaso@cantv.net ;  www.ragaso.com

 

 

 

 

 

Nuclear magnetic resonance (NMR) studies, and medical malpractice
Author: Prof. Rafael, Aguiar-Guevara MD - JD


During the long years dedicated to research and teaching Medical Law it has always worried me the indifference with which, on some relevant aspects of daily medical practice, health professionals insist on disposing of the guidance and advice on this delicate subject, has always insisted on transmit, not only from the legal doctrinal approach of the legal implications on the damage caused as a result of NMR studies, but also about the need of health professionals to understand and accept that they need to deepen on the update on the necessary techniques and anesthesia sedation outside the operating room. Unfortunately, today I could know, by reading a newspaper on the death of a patient who underwent an NMR scan on her right shoulder for rotator cuff problems.
Subject to traditional concepts of medical fault, enshrined in Articles 409 and 411 of the Penal Code, relating to negligent homicide (manslaughter ) and injury, to name: negligence, imprudence (recklessness), incompetence and disregard of orders and regulations, which apply well in these cases by the special "blameworthiness of the conduct"; there are several Postmodern principles of criminal law applicable in such cases, and even, responsibly, I dare to think in qualifying crime of intent (homicide) by way of possible willfully crime intended as eventual will. We do need to understand why a patient to undergo a NMR study of this nature should be subjected to sedation or anesthesia. No escape from reality that an adult patient, who might suffer from anxiety or claustrophobia, being introduced into these chambers, needed to complete its review, a degree of sedation. Another typical case is the need for an NMR in a child, girl, from the earliest stages of life until old enough to understand and accept the procedure without sedation. It becomes necessary then the application of techniques and / or procedures that might help the realization of this test. Hence there arises the idea of applying sedatives, by an anesthesiologist or other doctor, even the same radiologist, and even reckless (but routine) use of true anesthetics that, in minute doses, called "deep sedation or light anesthesia.”
The first complication in the use of these drugs is precisely the depression on cardiovascular and respiratory system, produced by such drugs. And the first question that disturbs us is: Was the doctor really qualified for the use of these drugs? "Being accredited, ie being an anesthesiologist, has the doctor used, before, during and after the NMR and the  use of these drugs some type of respiratory monitoring, capnograph, cardiac monitoring, blood pressure, status and level of consciousness, etc? At the time of a complication, was the Center equipped  of necessary inputs, equipment, drugs, medicines and trained medical qualified specialists  to offer the patient some degree of assurance in fulfilling their duty of care towards the patient´s life?
I have found such a large majority of day care surgery units do not have the equipment and infrastructure needed for surgeries, and with much greater reason, I have seen as in any clinics perform NMR scans under "sedation" as also in endoscopic procedures, without counting or even meet with the requirements that government, through the Health Ministry has published over many years in the Official Gazette and that are mandatory for all staff working in these centers, from the resident of emergency until the owners, principals or directors.
Generally in these cases, once appeared the foreseeable and avoidable complication of cardiorespiratory depression, doctors, in their attempt to prevent the spread of information and feeling confident they could win on the situation, wasting valuable time prior to referral the patient to more specialized center which does have the legal infrastructure and qualified and trained doctors to solve the problem. It gives us, according to our penal code, a truly negligence, and it is what modern doctrine known as "loss of opportunity." We may argue: if the patient had been transferred earlier would it have been a reasonable and qualified best chance of survival? The general answer is "YES" and thus are automatically pointed to the guilt and the causal link necessary to impute criminal liability. I think if I had the unpleasant opportunity to know today, the patient was transferred to another facility better equipped after approximately 6-7 hours after the cardiorespiratory depression came up.
But the case is not whether there was a reasonable and qualified probability of better chance of survival once the complication appeared. Our greatest consideration is the factor that we need to know whether complication was foreseeable and predictable, and whether it was avoidable. I am fully convinced that in all these cases, the use of anesthetic drugs and sedatives without proper and legal infrastructure are not only predictable complications (specific to these drugs) but completely avoidable.
We wonder if these patients are met with respect to the sacred principle of free will and self-determination? Is the principle of physical integrity, contained in Article 46, paragraph 3 of the Constitution of the Bolivarian Republic of Venezuela  duly accomplish? No one shall be subjected to medical examinations, or laboratory, ergo, nor may they be subjected to diagnosis or treatment, without their free and full consent.
And this consent, called by the Anglo-Saxons "Informed Consent" should be, forgive the repetition, fully informed as required by Article 58 of the Constitution of the Bolivarian Republic of Venezuela and in accordance with Article 69 of the Health Act and Article 74 of the Medical  Code of Ethics, and also subject to other laws. It is the right to a timely, truthful and objective information. But this information, and therefore consent is usually omitted. Let's see. If a patient was informed that, for the misuse of a sedative or anesthetic is likely to suffer a cardiorespiratory depression and   being the patient without monitoring or surveillance, which is involved in a "tube" , and consequently could die because no one has the necessary qualification nor infrastructure to save him, would the patient   submit him/her self to this risk? Surely not!.
This patient, to be subjected to the action of depressant drugs (sedatives or anesthetics) Do you have practiced the cardiovascular and laboratory tests required by law prior to the procedure?. Have you met the mandatory pre-anesthetic consultation? Surely the answer is no, and then learned the following dictum of Roman law: res ipsa Loquitor ... things speak for themselves.
So, it is inevitable to mention another principle that guides us into the criminal liability  of the physician in these cases. The “disproportionate harm principle” under which can logically be concluded of the presence of medical malpractice if the damage suffered by the patient (death, for example) is totally disproportionate to the purpose of the consultation (in this case a simple examination of the cuff rotator).
The necessary complicity is also seen  in the pharmaceutical industries, to the reckless use of these anesthetic drugs by imprudent professionals, allegedly in small doses, these companies come to place their ads and to avoid detriment to their market, that these drugs can be safely  used in diagnostic procedures, leading to its erroneous use.
There are medical procedures which, by their nature, warrant the presence of an anesthesiologist. And this specialist practice real patient anesthesia in places far from an operating room. But not be neglected safety parameters. For this, science has developed anesthetic protocols and anesthesia outside the operating room which are very distant to those used by non-anesthesiologists in medical procedures such as NMR. Just to understand the situation let us ask: if the patient is introduced into a closed chamber (“resonator tube ") and which is closed, how can monitor directly into the patient to continue with caution and due care, to make the diagnosis of any alteration of cardiorespiratory patient?
That is why, except in cases of emergency, and in full compliance with a number of formalities and procedures, use of sedatives, hypnotics, anesthetics, and the like, is, in these cases, a veritable folly. This is true, especially when the unit is not an in-hospital resonance unit, ie when you do not have the proper infrastructure to cope reasonably foreseeable and preventable complications.
The standard elements of manslaughter and negligent injury in the aforementioned articles of the Penal Code are always present in these cases: negligence, imprudence, incompetence and disregard of orders and regulations. Subject to the Criminal Law postmodern criteria in terms of objective accountability and the legal definition of crime of intent to eventually willfully title.
Most especially when they can be objectively attributed the realization of the final result of damage by the conduct of the physician as an producer agent, led to an unreasonable risk, legally disapproved by a non-consent, constitutes the charging of its behavior in the objective assessment of his work, and not simply the result brought about by chance, bad luck or fate, especially considering the violation of the principle of proportionality by comparing the outcome of death in a procedure that, by saying and judge of the lex medical arts, so they did not entail great risk.
The doctor would have performed a procedure, having produced a disproportionate result, [the doctor] may not ever prove that the cause of it (the damage), is unrelated to his performance. The cause has been within the sphere of his/her action. It was the doctor who, quid divinum decided to recklessly run the unlawful action.
There are actions whose danger is so high that can not be undertaken without damaging the objective duty of care, as would, for example: conducting diagnostic procedures without proper permission; without accreditation and qualification; omitting the detailed evaluation of the procedure, leave the patient to die, unnecessarily subjecting the patient to a procedure without the necessary infrastructure to ensure, at least, proper patient care, and many other behaviors that, in perfect competition, join in creating an unjustified risk unnecessary for the elective nature of the proceedings and which was submitted to the injured patient ..
Guilt is the reprehensible attitude of the conscious will which determines the verification of a typical wrongful fact, omission of duty of care that was required of the agent according to their personal conditions and circumstances under which he acted, and by which he unduly infringe the protected legal interest, in this case life.
The legislative intent is clear in its positive legislation, and through his wise legislative activity aims to ensure that the conduct of human beings, in this case of doctors in particular for her (his conduct) meets the standards expected within patterns that correspond to the lex artis ad hoc Medicine, based on protecting a legal right, not wealth, not available, not repairable, as is the life (quality) and health.
Among the preset objective obligations of care, based on the general and specific substantive rules, doctrine and jurisprudence, the doctor is obliged, inter alia:
1. Duty of care and mandatory pre adequate assistance to the patient.
2. Do not subject your patient to undue risk.
3. Always obtain proper informed consent validly and lawfully held for each patient's specific procedure to try with his patient.
4. Keeping abreast of advances in medical science.
5. Provide timely, fair, truthful to his patient so that it can exercise freely and without vices, their right of self determination and autonomy.
6. Acting within the parameters required by the lex artis of Medicine, within the prevailing scientific criteria.
7. Refrain from activities for which no jurisdiction.
8. Put sufficient and thorough surveillance on individuals or patients under their care.
9. Always act with due diligence, prudence, diligence and promptness.

These obligations, standards of medical care to the patient, are estimated as objective duties of the physician. The duty of care is objective as long as interested in the consideration of all consequences of action that, according to an objective opinion, were expected in the production of a specific damage.
The objective duty of care purchased, without waiver of their legal and axiological content, a particular profile in terms of medical fault, and becomes strong factor in the incidence awakening, even mistakenly, the initial confidence that puts the patient in his physician.
The unfairness of the criminal conduct is, in itself, in the divergence between the action performed by the doctor and what the doctor should have done under the obedience of the duty of care, totally objective, it was necessary to observe, and more while emphasizing the positive rules of law and medical duties imposed on the objectives and conduct enforceable in certain situations.
The end result of death occurring due to a medical diagnosis made against multiple laws speak for recklessly creating an unnecessary risk that materialized in the final damage death by negligence, incompetence, and failure of orders and regulations can infer who is responsible for the damage caused, and that, depending on the analysis of each particular case, one might even conclude with the presence of genuine intentional action to bring the accused to the limits of the crime of intentional injury any degree of malice.
Similarly, as to the factual allegation is concerned, if a person dies or is injured as a result of surgery, death or injury that is objectively attributable to him if the surgeon has performed the operation conforming to the lex artis, that is: if you have done foolishly.
These concepts and principles are equally applicable, latus sensu, in diagnostic procedures videoscopes (eg colonoscopy, sigmoidoscopy, gastroscopy, etc.). Which are usually performed by gastroenterologists, and they themselves unwisely administered drugs such sedatives, and even low-dose anesthetic. Then focusing on the completion of their study and being negligent when leaving patient care. The patient goes into respiratory depression and / or cardiopulmonary sudden death happens, and then they want to explain the death by an "anaphylactic shock" when in fact the death has occurred due to the incorrect and imprudent use of these drugs. I have always recommended that these procedures must be done with the parameters of ambulatory surgery in an operating theater with the presence of an anesthesiologist. This will ensure patient care and the infrastructure needed to sustain life of the patient. The excuse is that then increase costs. And I wonder if the doctor if necessary to sacrifice the security of your patient for a purely economic concept.
A large academic consideration on this subject is  impossible, on this sensitive issue of guilt NMR medical procedures, especially considering the purpose and scope of these brief articles in this website. However, I could not  end it without warning on a reasonable conclusion, based on experience, and it is that the use of sedative drugs, hypnotic, anesthetic, and the like, for an NMR procedure without complying with the expected protocols of the art of Medicine, as usually happens, usually in the hands of untrained personnel or accredited, are real and unambiguous medical malpractice and criminal and civil liability on the part of doctors acting, not forgetting the institutional civil liability.
The patient puts his/her full confidence in both health professionals and in the institutions to which they derive their patients. This legitimate expectation is disappointed. Hence the medical fault in such cases, and legal liability of doctors and the institutions which, in undertaking activities for which they are unprepared, and sometimes not authorized by the governing body of health (Ministry).
Unfortunately, we could not provide assurance of the necessary and appropriate action by the Ministry representatives and respected judges who, in the vast majority of cases, are engaged in research of this type without the necessary skills that truly meets the fundamental purpose of criminal proceedings: fair compensation for damage to the victim, is the very person who suffers injury (direct victim, a victim of its own), or whether those who, in case of death, are considered legal victims, to Under Article 119 of the Code of Criminal Procedure (such as spouse, parents, children, and relatives within the fourth degree of consanguinity or second of affinity). Subject to those cases in which the false medical fraternity is reinforced by the cloak of impunity that the judicial system itself (public prosecutors, judges) offers.
PROF. RAFAEL, Aguiar-Guevara. (published 01-Jan-2010)

 

 

 

 

Medical Law in VenezuelaNew

 Author: Prof. Rafael, Aguiar-Guevara MD - JD

1.- Brief  introduction to Venezuela

Bolivarian Republic of Venezuela is a federal republic in the north of South America, constituted as a democratic, social, Law and justice, autonomous and sovereign, as enshrined in the Act of Independence signed on July 5-1811 and established in the newest Constitution dated December-1999.  The capital and seat of the federal powers of the Nation is Caracas; and our official idiom is Spanish. (It includes official Castellano (Castillian) as main language and the constitution recognizes more than thirty indigenous languages).

As reference our minimum wage is BsF 967 (US $ 450 aprox) which added to BsF 639 (due to feeding tickets as labor benefit) gets a total of BsF 1606 ( US $ 747) as real legal impact; it being one of the highest of all Latin American (US $ 37 by 1997) .

Infant mortality rates have fallen to 13.7 per thousand born babies (21 in 1999); rates of unemployment has also fallen to 7, 7 % in past April-2009.

On 28th of October-2009 Venezuela was declared, by UNESCO, as a country free of illiteracy. Approximately 1,482,000 adults learned to read and write in the last two years and less than two percent of the population remains illiterate. Among the 70,000 indigenous people are literate in dozens of communities in bilingual mode. There were also special programs for the blind and dumb, and for 2,000 prisoners (who constitute 10 percent of the prison population), while the visually impaired were assisted consultations with more than 200,000 eye and corrective lenses. The Bolivarian Republic of Venezuela, with the illiteracy of 0.10% exceeding the target required by UNESCO, which is 4% for the declaration of a territory free of illiteracy.

This in term of Health Concept as an integrity unit of welfare: social, physical, mental, labor, family, and so on is, in fact, of great importance to consider.

2.- Medical Care system: updating

Our Constitution establishes the right of Health as a fundamental, social, human right. Also determines that the medical care shall function under a Public Health Unique System which means that the State shall take all the decisions and directives regarding the right of health and also the right for medical attention. This is accomplished through a system called Mision Barrio Adentro; and divided into: a) Barrio Adentro 1: many little two floors houses has been built through all the country; especially in ghettos and where the poorest people live. These houses allow offering living media to medical doctors (second floor) and for Primary Medical care (first floor). Medical doctors shall live in the same area, and he/she takes the opportunity to share directly and permanently with the community; b) Barrio Adentro 2: the Government has built several bigger institutes for medical care of second level and for ordinary and specialized diagnosis procedures; c) Barrio Adentro 3: There has been an increase of budget to enhance all the existent hospitals which offers more specialized and advanced medical attention; and  d) Barrio Adentro 4 which means the building of very specialized centers such as Cardiology Hospital for Children, the biggest in all Latin American even capable up to cardiac transplant. Many similar advanced Hospitals are being put in motion such as Oncology for Adults, Ophthalmology, and so on.

Also, a new program has been established to accomplish Telesurgery and Telemedicine thanks to our own new Communications Satellite placed in space thanks to a Venezuelan-China operational agreement.  Also Robotic Surgery, since 10th of March-2009 in the Central University of Venezuela Hospital which put in motion a Da Vinci Robotic system.

Just now a new Institute has been opened by Government to attend all population and to offer, free of charge, , all those so called  high costs medicines (HIV/SIDA, Cancer, etc..). Our critical poverty has fallen to 7% as compared with over 20% in 1999.

These concepts are related directly to Public Health System as we also have several Private Medical Institutions which consumer use especially through Insurance Company System.  

3.- Medical Malpractice  Historic reference:

In previous opportunities I have sustained that the concept of Medical Law has been either neglected or taken by granted. Therefore, I am convinced of the necessity to explain these concepts which seem to be of great relevance.

I am not spending words to describe the medical care system in our country as the important, main, subject to discuss is about the existence (if any) of Medical Law and its evolution in each country.  Following this objective I may express:
We do have our first steps towards Medical Law in the normative ruling during the colony period. Our Penal (Criminal) law is based upon some different sources: one coming from Spain and the Spaniards colonizers who imposed over our autochthonous inhabitants a foreign code of law.  Nevertheless, there was, at that time, an autochthonous Indian Criminal Law that while regulating the behavior of the Indians (in general sense) it had strong regulatory rules that, for example,
 criminalized and punished the “misbehavior” of the “Piache” (witch doctor of the tribe) who had to face a death penalty when failing to cure the chief of the tribe; in other words, we are talking about first traces of medical care regulation (Medical Law) in Venezuela. These facts would historically place us in the XV century and before.

A big gap filled in our history in this field; but its evolution is just more o less the same as any other country.   At the beginning of time, we only had the mere application of criminal law doctrine in the field of medical malpraxis litigation. Then, we started talking about Forensic Sciences, which is no different to the Medicine applied to the service of justice and Law.  However, any science becomes forensic science at the time that it serves the judicial proceeding.  Still by the by the end of 20th century, there was no explicit criterion in Law which clearly defined, in terms of content, the concept of Medical Law.

Venezuela, different to other countries in the world, serves more the criminal aspect of medical litigation or the so called medical malpraxis than the civil aspect of the obligation to repair (economically) any damage caused by medical doctors in their medical practice.

Following this criterion the first authors to talk about penalties in medical practice and confusing the doctrinaire aspects of it were attracted by the idea to talk on how to apply the penal (criminal) regulations on medical malpractice. Thus, although we do not have a precise and typical crime of malpractice, the prosecutors use the two articles of Penal Law that have to do with it: non intentional death and non intentional lesions. Under the parameters of these crimes they judge the medical doctor in Venezuela, who causes, without intention, just by negligence or imprudence, or by disobeying the Law, any damage to a patient during medical care attention. Penalty would be imprisonment of 1 up to 5 years (case of involuntary death) or 1 up to 12 months (case of involuntary lesions)

Our (adjective) Organic Code of Penal Procedure contemplates the possibility to the victim (of lesions) or relatives (in case of death), to claim to the Criminal Judge that the defendant doctor, once condemned, pay an economical compensation.

As compared to the criminal regulations we also have the civil regulation which is followed by victims or relatives, after a medical doctor is condemned, to sue (Civil Courts) the Public or Private Medical Institution for an economical repair or compensation, all of which end in very high economical condemns. 

It has been calculated that branches of Medicine more suitable for medical malpractice litigation are:  Obstetrics (26%), Surgery (25%), Orthopedics and Traumatology (14%), y Pediatrics (10%). Also, a new project on Medical Malpractice Law has been presented for consideration of National Assembly (Parliament) which intends to sanction, not just   medical doctors as persons, but also against medical Institutions.  It has been calculated that at present time a bit more of 20% of cases end with a condemning sentence to the medical doctors. It seems very low but it really is very high as compared to the past when never a criminal prosecution in Criminal Court or economical compensation for damage in Civil courts, as a result of medical malpractice,  were seen.

4.-Medical Law Concept:
There was not a real concept of Medical Law regulating all of our subjects in this field until 1995 when I had the opportunity to define, in Venezuela, a new (never published before) concept of Medical Law define as:
The set of legal norms and ethical and moral precepts, of Public and Private nature, that regulate the activity of medical doctors in connection with the practice of their medical profession, regulates the juridical doctor-patient relationship and its consequences; thereby establishing the general principles of medical liability .

 5.- Medical Law legislation:
In Venezuela we have some specific regulations, which are born such as: Law of Medical Practice (1983); Code of Medical Deontology (2004); Organic Health Law (1992); Law on Organ Transplantation (1992); Forensic Medicine Code (1783-1992); Social Security Law; Law that regulates Medicines and therapeutic products; Law on Blood Transfusion; Immunizations Law; Law to Protect from Venereal Diseases. Other regulations come from the Ministry of Health as Resolutions (but still are compulsory) and they have to do with: By-Laws of Surgical Units; Acts on Day Care Units; Act on requirements of buildings to become medical care institutions and so on.

Nevertheless, we do not have express regulations on: Informed Consent (although some articles are define within the above mentioned laws); Clinical History; Assisted Reproduction; Telemedicine or Telesurgery.

There is now a discussion on parliament (National Assembly) to have an amendment of criminal law and it is important to mention that either abortion (all types) or Euthanasia (all types) are considered for decriminalization. Results of these two articles are uncertain. Also, a new project on Medical Malpractice has been presented for consideration of National Assembly (Parliament).

6.-  Associations-Academics: In 2000 I had the opportunity to call another colleagues and to Found of our Venezuelan Association of Medical Law (of which I still am its Founder President).

The 10th of March -2006 and obeying a necessity to impulse a very delicate issue I had the opportunity, with some friends and colleagues to found the Venezuelan Association Right to Die with Dignity; which is affiliated to the International Federation of Right To Die Societies.

In January 2002 I founded the first Cathedra on Medical Law at the “Andrés Bello Catholic University” in Caracas. Nowadays,  I and other colleagues are professors at several Universities on Medical Law around the country.

There at least three well recognized Association on Bioethics. Many more in Human Rights.  We have about 4-5 recognized cathedras of Medical Law around the country and it has become, more than a tradition, an obligation, that medical societies of all branches of Medicine include Medical Law issues in their scientist Congress despite the specialty which organizes the Congress (Surgery, Anesthesiology, Obstetrics and so on).

At this moment, an amendment of the Organic Law on Health is conducted by the National Assembly (Parliament) and there is one article which establish the obligation to any medical care worker (professional or technician) to know all the legal regulations on Health Area which, in due time, shall conduce, compulsory, to have more official Medical Law training sites in our Universities.

7.- Conclusion:  In Venezuela we have been advancing in Medical Law with a great force  since 1988. At present time it is not strange in Lawyers or Medical environments to talk about Medical Law. There are many Lectures, Conferences, Seminars, and Workshops in these fields around the country every day. We still lack, on my opinion, of much different legislation but we are working on that.

A major fact has been that our capital city of Caracas, according to article 2 of World Association of Medical Law, was the official office of the World Association for Medical Law between 2004 through 2008 as the Secretary General (author of these comments) had the honor to serve as its Secretary General during the mentioned period.

Prof. Rafael, Aguiar-Guevara. MD - JD

References:     

·         Agencia Bolivariana de Noticias. http://www.abn.info.ve/go_news5.php?articulo=90437&lee=4

·         Aguiar-Guevara, Rafael. Tratado de Derecho Médico. Legis Editores.  2008

·         Asamblea Nacional. www.asambleanacional.gob.ve

·         Hospital Cardiológico Infantil. www.cardiologicoinfantil.gob.ve

·         Instituto Nacional de Estadísticas www.ine.gov.ve

·         Ministerio del Poder Popular para la Salud. www.msds.gov.ve

·         Ministerio del Poder Popular para la Ciencia, Tecnología e Industrias Intermedias. http://www.cnti.gob.ve/

·         Ministerio del Poder Popular para la Comunicación e Información. Pobreza crítica. http://www.minci.gob.ve/noticias-_prensa/28/177776/gobiernoenezolano_disminuye_pobreza.html

·         Ministerio Público. www.fiscalia.gov.ve

.     UNESCO http://www.unesco.org
 

 

 

 

 

Organ Transplants: presumed or explicit consent? New

 

In Venezuela we have an actual average of 3.8 donors per million inhabitants. Figures quite low compared to other countries and the standard sought by international bodies. However, compared to other Latin American countries are: Uruguay at the highest rate of 18.2 p / m, followed closely with 12.4 in Argentina, Cuba with 11.2, 10.4 with Colombia, Peru, Bolivia Ecuador and 1 per million. Countries such as Finland have 21 donors per million. This is the actual figure for those who have donated. In comparison with the figures of potential donors and significantly increased in Venezuela is considered that there are approximately 105 registered volunteer donors per million inhabitants (2007 figures), i.e. people who have positive expressed their willingness to be potential donors.
Our legislation suffers greatly from a series of concepts and situations that are not specifically covered by the Law of Transplant of Organ and Anatomical Material in Human Beings dated December 1992, and that on the contrary, it is well structured in the laws of other countries . Still, the transplant, for the purposes of the law mentioned above, is still seen as a simple replacement, for therapeutic purposes, of organs, anatomical or materials derived by others from a human donor, living or dead (sic). It also defines body as the remains of an integrated human being, which has led to the death.
This consideration of human being living or dead seemed not to have any connotations   but at the time of discussion of the controversial   presumed consent of a dead person, , it has been argued, unjustified and illegitimate, that a dead person is no longer a human being and therefore devoid of rights.


Regarding the legal nature of the dead body has been endless discussions, depending on the final approach and the objective sought, the answer will lead us in one direction or another. Some authors argue that the body itself is a remnant of the personnel subject to the decision of the bereaved. The body, for that they believe that is one thing, is not likely to be appropriate, which removes the strict quality thing, not estimable value is outside the trade, which together diminishes the possibility of being considered only thing. In the Italian literature, it is considered that the body is something to be extra trade, and while not subject to private property rights itself is a subject of private law, which determines the power to determine the mode and manner of his fate and that morality corresponding to a family law, family members decide to play, because of the feeling that unites them with the deceased.

The body and the remains of a deceased person find protection in our Penal Code to criminalize offenses against the remains, and the desecration of tombs, coffins, chapels, and property of the things that the body is put there by their bereaved. Found in the Civil Law  there are sections protecting the honor, even of the dead person, the legacy of the moral rights of authors and some others.

 
The person is the entity capable of holding rights and obligations and the personality is the quality of that person or his/her ability to have rights. Is well known and accepted that the fundamental rights of personality are: the right to identity, rights over the body, on the moral character and personal or moral rights of authors. Rights related to the body are: the right to life (and now also accepts the right to dignified death), the right to physical integrity, and the one we are concerned about it: the right to dispose of the body.
The person has the right to dispose of his/her body and that right continues, extends even after death. Only the person may dispose of his body, and in his/her absence, by the feeling that unites them, their family members. In Venezuela more than 68% of the relatives have expressed their refusal to allow the removal of organs for transplants of their deceased relatives.
Therefore one can conclude that no third party to these family ties, over the right of the person and personality, and in violation of the right to integrity unified body-soul of this deceased person, no third party can not as yet therapeutic purposes, if you decide that this person had no life in it we can now assume, infer, presume, that his wish was to donate their organs or body part, and this will continue discussing throughout this chapter.
Thus, I insist on the need to eliminate, once and for all, the alleged possibility of presumed consent, which under the focus of the principles of self-determination and respect for the human person, can not impose a rule requiring to prove the  true of the negative (of what does not exist) to replace the deficiency of a express consent  because of the  negligence of institutions to educate and seek for the awareness of the community, or because, in spite of educational campaigns aimed at the community, it is not decided yet in the majority, for the donation of organs, materials and byproducts. Respect for human rights of persons, freedom of religion, belief, should be understood to extend those closest to the person who dies, and not abuse the opportunity to not get a letter   as it is proposed, in showing how the undoubted desire not to donate in order to disregard the wishes of the family is drawn irrationally and bodies who had died.

The donation of  organs, tissues and body material is very personal act, raised by the gesture of generosity and solidarity of those who expressed the benefit of his neighbor, even without knowing who he is.  But it certainly involves more than one person. The donor with the premium expressed intention to donate, sell, deliver, bequeath, to test their bodies, but in one way or another, after the deceased person and no a clear indication of his wishes should always view their families, who must respect the right to their beliefs, religions, customs or feelings.

I am a firm believer and advocate relentlessly of the express consent, and then be able to require the State an opportunity to speak freely regarding this matter. The Law on Organ Transplants and Anatomical Materials in Human Beings 1992, article 26 clearly states that any document of identification issued by a national body should include: whether the person has accepted or not being willing donors of organs, tissues, derivatives or anatomical materials. Similarly all institutions of secondary and higher education shall, at the time of registration, which is expressed the willingness to donate organs, or failing that, his refusal.

This article is clear about my right to express freely and without coercion, which would be my choice in the field of transplants. Do I want to be a donor or not?
But:
1. The State institutions have failed to comply with these regulations.
2.  The institutions involved in transplantation have failed to make real educational programs and awareness campaigns to educate the general population in the area of transplantation.
3. Ergo, agencies and institutions are in the need to manipulate the alleged pretended consent, which is aberrant, with the sole aim to supplant, via the presumed consent what has been a negligent behavior in their duties to population education.
It does not escape for transplants   my defense of express consent, because I do believe aberrant intention, contrary to altruism, which is the interest of those who performed the transplants under presumed intention of the donor just because he/she does not carry on him/her a prove that he/she does not want to be a donor.

Can never be accepted the rejected position of the presusmed consent. Neither from an ethical or moral, much less legal, that provision can not be accepted, however much we agree with organ transplants nor can the use after death be made with the body of a deceased.
The consent is just that: consensus, conformity of wills, exteriorization determined by the willingness of an individual internal negotiation, there can be no presumption of consensus or agreement of wills.

Such a position, presumed consent,   is unacceptable and even less in the light of international conventions, the doctrine and comparative   international law, which clearly shows the legislative updates from the various communities, to enforce, ever, the express consent, not only for medical act which you want but in the field of organ transplants. (Recently, the users of credit cards, we received a charge to account for the recruitment of a Life Insurance and Medical Care with a particular company and the state of mind to read a note saying:  as you has not expressed an opinion to the contrary and if you do not come to our offices in the space of so many days it is presumed his acceptance of and compliance with payment of the same; Is this fair and legal?

Indeed, only those countries which still retained (presumed consent), do have legislation on human rights for 10 years or more overdue (had not developed the contemporary concepts of human rights progressive), and request because, in addition, compliance with other requirements: declaration of brain death and non-opposition from relatives in the span of more than 6 hours (not mandatory 3 hours in the words of our law) require that the declaration of death is carried out by a medical team that includes specialists in clinical neurology, neurosurgery, and cardiology and intensive (and not our law, which only requires two doctors "strangers" to the transplant team). (Can we imagine an ophthalmologist, a geriatrician, a dermatologist, deciding the criteria for a neurological patient to establish legally brain dead and thus opening the possibility for the extraction of their bodies?).

In greatest abundance in countries that accept the so-called presumed consent it is required, in addition to, and complied with the foregoing, consent of the close relatives, where they express their wish or not inconsistent with the extraction bodies of deceased patients (or comatose patient, as appropriate) and other countries are required to consent to court (a judge) if the above fails.

Comparative law teaches us: "... the human body is a  legal good protected by Law and it is individual property, which it is available only to the person who possessed  in natural way while he/she was living…."

This matter of consent, is widely discussed and is looking for a uniform approach that can only join up to the vast majority of countries that have finally established the express, because by the way, even in some communities in which accepts the presumed consent, even if the person has died in a demonstration of willingness to express their wishes to donate their organs after death, just that this is a familiar object is to stop the transplant procedure.
For me, rather than a legislative issue is an educational problem. Must be taught to the general population to raise awareness the problem of transplants, only through an educational campaign can try to achieve. But an education campaign for truth. Our legislation in transplants in its Article 25, inter alia: mandatory to include in the curriculum of primary and media education, materials relating to transplants, also the Ministry of People's Power for Health had to provide spaces in the medias (TV, radio, press) to promote educational campaigns for a better culture in terms of donation and transplantation. It is now almost 17 years since the Law was promoted and it still has not been accomplished. Even private institutions interested in transplantation have failed to focus on the education. What's more, the new Health Act goes back to the same promise. The only guarantee of respect is through the general express consent.
Finally, I should clarify that what has been  explained above is my personal view on the matter based on research and scientific and legal analysis, especially comparative legislation.
For the researches in other countries to investigate the issue can be clarified that:
1. Venezuela has a special law on transplants since December 1992.
2.  The Law accepts the transplant either as inter vivos act in  organ transplants as well as from dead donors.

3. That for the purposes of transplantation and organ donation inter vivos the law requires the express consent of the donor.

4. The law accepts the presumed consent only in cases of clinical (biological)  death  when the patient or relatives  fails to show the contrary will of the deceased.

5. Presumed Consent is not accepted in cases of suspected brain death unless it obtains permission from relatives according to the Civil Law.

6. There may be opposition from relatives in the order of precedence in the law.

 

Prof. Rafael Aguiar-Guevara  (published july 01th-2009

 

 

Concepturus and protection. Juridical status of the embryoNew

By way of exception, referring to the number of writers, lawyers, scientists, bioethicists, and so on, who have advanced various opinions over this issue, I am convinced to defend, not just the nasciturus (conceived but not born yet), but also, through the especial State tutelage, it mist be promoted a special legislation for a worldwide protection of the concepturus (the not even yet conceived).

I was explaining in a conference that the health professional, especially doctors, has been given, ad libitum, a pseudo right to clinical research to try to place themselves over the rights of individuals, of their patients, and above all things, alike a deity or divinity. Louis Pasteur said that science, in obedience to the laws of humanity, shouls always work to expand the frontiers of life. But science has developed by leaps and bounds and the Law has lagged behind in its attempt to regulate it. Pasteur never imagined, expressing the above sentence, the aberrations that, in the name of this pseudo scientific right, humanity would have been facing this worldwide aberrant practice, 100 years later, and which is the busilis of the issue before us in this brief space, the which, for short, keeps us away from a broad and deep discussion, but nevertheless, I will articulate those deviations that may encourage our analysis and study of the topic under discussion.

 
On the one hand, the great discussion on the embryo at all stages, even from the blastcyst stage and agreed to its fetal form, and by means of a simple and illogical, illegitimate, legal fiction that the fetus is say, the nasciturus, are not “person”. Are arbitrarily denied the quality of person in their rights but the law relates, or the professionals who interpret it in his way, sparing no efforts to do debt load, even before being conceived, and proof of this is in genetic manipulation, selection of embryos in assisted reproduction in order to bring the embryo to birth and that have been "created" with a debit, charge of a credit obligation, to serve as donors of organs and / or anatomical materials themselves and their siblings were born, i.e. embryos to the letter, or as I called Babies chiveras or mere replacements.   
In this regard Lionel Penrose explained that it is better to live in a society of genetically imperfection, which retains humanitarian living principles that living in a society in which technological bases shall be declared paragon of   inherited perfection.

 
To define, to establish and to defend the rights of individuals when these individuals have already been: conceived, designed; taken human form, separate from the mother's body, they are autonomous, viable and / or vitality, independent individual, or otherwise already been born and born alive, and they are given by way of legal fiction, character of “person”, with own personality, and defined as subjects of rights and obligations, it is extremely easy.
The problem has been presented to us at the moment when we  must  define when, such individuals, as persons and when we should be bound to recognize their right of ownership of the most sacred fundamental right: the life, and inherent to it (right to life): the right to health, ergo , to a quality of life in order, then, already recognized their potential for life, be covered then and protected by international declarations, constitutions, national laws of each country to protect the interests of those who, even without being conceived (concepturus) have neither been able to, being perhaps the most important (obviously), to express their preferences, anxieties, preferences, beliefs, and why not: rights. But the question immediately emerges: Could it be that we can establish or recognize rights of  "something-cell-group" that has not even yet been conceived? (“conceived" refers to the semantic debate that today, scientists use in this area to escape the legal regulations, moral, ethical fertilized created groups cell embryos pre-embryos, blastocysts, conceptus, and so on)


International law, I refer to the declarations and international conventions, have embraced the formula to recognize that the protection of human beings should be given since the beginning of life and that this, the beginning of life, is recognized as soon of conception or fertilization (by any route or way that it is achieved). Hence, together with other writers and lawyers, at the international level, we have dedicated ourselves to work and proposed a legal status of regulation, not a mere status, perhaps preferably international in scope, which can provide the necessary protection, not only to embryos but long before them, the embryonic potential to be conceived, and why not: created! Legal status of the embryo that, by its very nature, is always rejected by the groups, eternally existing, scientists from the more liberal advocates of scientific research and medical practice, but it definitely has to be well received by those physicians, biologists and scientists who work hard, within the ethical standards and conduct, sufficient to prevent the aberrations that we see today are still producing in the highest degree of impunity, both scientifically and legally.

Our work within the space limitations of this site may not engage in a thorough and comprehensive legal approach as it is not the intention of this presentation, which is treated legally in extenso in my writings (see publications in this site); by contrast, guides us, only to raise the physicians, biologists, scientists in general, some concerns, and examples that can serve the reader of these lines as an incentive for analysis. It is up to the reader to reach an analysis of the scientific foundations and principles of law raised for the purpose of seeking, in its analysis of bioethics and introspective, their own answers and conclusions. Scientific and legal considerations of highest amplitude are those raised in another independent work of mine entirely devoted to this subject.

 
We discuss whether the right to life gives a woman the pseudo so called
subjective right to procreation. To accept this thesis (which we do not), not far from achieving many adherents to it, we could think logically, the acceptance of other individual rights that give rise to such right. To accept as valid the approach of the right to life as a generator of other rights that depend on the original, then we could infer that the right of procreation would be a subjective element inherent right to life. Perhaps for this reason we see in clinical assisted reproduction responds to this' right'and provides scientific support to limit women coming in search of the assisted reproduction procedure.

 
Accepting, (which I do not) the existence of the subjective right of procreation, at least in the sense that some have tried to give, we would be faced with the problem in short term, perhaps structural or substantive, that we should accept as a consequence an individual right to not to procreate, in which case we would be opening a gate to the dangerous indiscriminate and irresponsible right to abortion; in other words, towards an irresponsible motherhood.
In fact, it is actually happening. Nuances and variations that might, prima facie, take us to delusion with subtle appearance of legitimacy to discover the veil of the exercise of this pseudo-right. The woman was subjected to processes of hyper stimulation was achieved a very variable number of embryos were re two or three, and the rest are discarded or ruthlessly and without regard, or are kept in extremely cold temperatures (cryopreservation) for up to a variable period of time, according to the techniques and the country, but that varies from two to five years, after which time the embryo should be discarded if it has not previously been reintroduced. (some have already begun experimenting with the use cryopreservated embryos of 10 years)

Eugenic practices aimed at selective genetic breeding and care of assisted reproduction with gamete and embryo selection, feed traits fearful of a scientific breakthrough that needs to be controlled by the legal rule. The only rule that we find in our legislation, it is regarding pre implantation diagnosis, contained in Article 222 of the amended Code of Medical Ethics:
Predictive analysis of genetic diseases or capable of identifying the genetic predisposition of an individual, may be carried out only for reasons of health or scientific research related to them.

Subject to Sentence 1456 (Constitutional Court) which later commented that opens a dangerous door to defend, quid  divinum, the thesis contained in the famous aphorism: ubi lex non show, we distinguish debemus nec (what the law does not distinguish is not to us to distinguish), which explained in other words, left some as "absolute truth" that criticized the ruling when it expresses that what is not expressly prohibited by law it must be presumed, inferred as approved, accepted, approved.

In my opinion it would be contradictory to maintain the semantics of the terminology involved in assisted reproduction, for the vested interest of classifying egg, blastocyst, pre-embryo, embryo, fetus and finally, especially when that classification was caused more scientific interests and conveniences of law. But to mention the Constitution of the Bolivarian Republic of Venezuela is due to mention timely and accurate, of Article 76 when the state guarantees, according to international conventions and declarations, assistance and protection of motherhood, in general, from the moment of conception. If that egg, blastocyst, pre-embryo, embryo or fetus is not a legal person, simply because the writers and legislators have not liked, "yet," given that classification terminology, even when our Civil Code contains standards of protection, even for not even conceived (concepturus) (articles 1443 of the Code: the unborn child of a living person can receive certain donations, even when he/she has not yet been conceived), not because it does not mean that this cell group, which contains all the genetic information of an individual of the human race, singular, particular, and even differences of the parents does not mean that it should not be protected.

When we think of the international protection of the unborn and concepturus, based on "potential and dignity of being' that little zygote fused, as glad to see more and more scientists, lawyers, geneticists, biologists, with trajectory is continue to respond to support the idea of the need for such protection.

 
That is why we defend the interests, above this potential to be formed by the union of gametes, and which must, at its maximum protection, the State in achieving its highest and best protector. It can not be allowed to breed or be able to create embryos just to bring the interest burden to donate, or bring them to the fold of the extramarital union of two lesbians violating the right to be created within the family, or deny its sacred right to know the biological identity (and genetic) of their parents, or born of parents without a higher life expectancy with the probability of this  concepturus to be orphan within 5 years of its existence, described as alike that women (Ms. Rajo Davi) considered world's oldest mother (India, November 2008) to whom an embryo is implanted at the age of 70 years, or those coming from surrogate motherhood, and the worst cases of postmortem insemination bringing the world to a child without father and with genetic diseases that do not allow you to live more than 20 years (which is why the father died) and you stop to count the many aberrations that are being practiced.


The same semantic game, academic, full of sophistry, that is to maintain that the gametes are one thing, or property and can order any type of contract, free of charge or not, once these are obtained and separated from the human body given source. Authors who are aligned in this thesis believe that the sperm and / or eggs, once separated from the body become merely 'things', ergo, subject to any contract provision, (sale or donation, for example) simply because the property owner (male or female) can assign a convenience, and treated, mistakenly, in my opinion, nails, hair and any body part that, once separated may be res (thing) in trade.

 
For all the above and more, lawyers and writers who, at the international level, shall not rest peacefully until we  achieve an alternate route that does   allow us , without transgressing the basic legal concepts, without imposing restrictions on the notorious scientific progress, achieving an international agreement protection on this non-material entity, named concepturus, i.e. not even designed yet, to establish an adequate level of protection to enable him, in future, a decent life, as it deserves the unborn (conceived but not born) and whose history allow us to positively that we need to consolidate a system that allows the concepturus such a protection. Consequently, this leads us to the consideration of the respect for the human person from the beginning, which led to the conclusion that we must protect the dignity and potentiality of being. We must to protect the potentiality of the gametes to form an embryo, autonomous and distinct from their parents, and their proven potential to become a human being. You can not eliminate  the potential of the embryo, their dignity and inherent rights of human beings.
The embryo may not be legally protected person but for the dignity, there can be no separation between the (born) in the different embryonic stages because there is no conceptual break between them. (Judge Alvaro Cienfuegos-2001)
There should be a minimum common denominator in the protection of the fetus and which leads to the necessity of protecting the
potentiality of being and their ability to become a person, although this does not mean  that it automatically becomes in a human being with the very right to life,   not at least from the point of view of law:   lege data. We believe that the problem is of social approach:  lege ferenda criterium. And that protection of the nasciturus must, in pure justice, apply also to the concepturus with interest on the supreme and superior interest of the embryo to be formed, according to then same principles applied in international conventions and local laws of protection of children. Facing with the discussion of the scientific or technical nature of legal dogmatic, the problem arises from the policy variable, like a spear against a Byzantine discussion that we deviated from the fund to focus our attention to matters of form. We must focus on what is socially necessary in terms of protection. Not radical in search of purified exegetical and legal limbo in a semantic just as the particular interests of each of the parties involved (parents, doctors, biologists) who need this or that defensive argument in its favor.


That is why I advocate the position of an alternative route that, legally, we can protect those who, ˂person˃ or not, it does not matter to define, is in itself physically unable to express him/her self, and it  is here where the State should play a protecting role in their interests and rights. Only for the purpose of proving our thesis we see as our Civil Code has defended those  who had not yet been conceived: the concepturus. Illustrating some particular situations: Article 1443 of the Civil Code is clear in stipulating that: "The unborn child of a living person can receive  donations," although he/she has not been conceived yet. " For acceptance, of an inheritance the children "not yet conceived" shall be    represented by the father or mother specified by the donor”. omissis .... "For its part, Article 840 (ejusdem) complements:" ... can receive will the immediate descendants,    i.e. the children of a given person living in the moment of death of the testator, although "not conceived yet"(the quotation marks added)

 
It's easy to understand, therefore, that if the State, through the substantive rules of Law imposed by the legislature is   inclined to protect the no conceived yet  (concepturus), in matters purely heritage (gift, inheritance) why do not in the case of non-economic issues, not available, such as the right to health, life, quality of life, free development of his personality, the right to family and so on?.

Referring to the dignity and significance of the negative aspect of the right to health and quality of life they imply, by the State or individuals, an obligation to refrain from exercising any conduct that may hinder the gradual development of dignity towards a state of full development and quality of life, understood in a holistic and integrated   and holistic point of view. There is the busilis of the question. If there was no conduct by a third party intervener, the fusion of gametes from the moment of union, set the potential of being and the dignity of being. You call it fusion of gametes, fertilization, fertilization, conception, and then renamed as interested blastocyst of "x" or "and" days, pre-embryo, embryo, fetus, person, that does not matter. That potential and dignity of being is manifested even well before the fusion of gametes. Each one carries a load which, if permitted, without interference, shall set the man known to all. Therefore, in this understanding of things, we must consider how and in what conditions leave the potential to be developed. Because if, knowing that the means and conditions to enable this potential to reach this world, i.e. we allow born, and become (legally) in person, are adverse to him/her it will be late to defend rights that were violated and we know that we could have prevented and avoided. The cases presented in this study demonstrate these issues with fervor that now pose.


The
proposal for the third track that is being proposed is to: Recognize the duty of the State to accept that, from the moment of conception, and even before, it must safeguard and protect the potential of being and dignity by developing and or being born, simply because that concepturus and / or nasciturus   has not found its way to express their preferences, birth or being born, and in any case, not being born into the conditions under which it brings, even to with credit costs, i.e. obligations (for example those designed for potential donors of their siblings). That is why the State is obliged to safeguard and protect it.
So it is worth recalling the words that the ruling of the European Court of Human Rights, based in the city of Strasbourg, that on 08 July 2004 led by saying that "the fetus is not (yet)a human being and therefore rejects "grant”   legal status of the person to a fetus, but there is a need to protect the potential of this being and their ability to become a person, without this becomes him/her a human being with a right to life" The embryo may not be (yet) a person, legally speaking, and therefore there is a tendency not to recognize their rights. But to quote Roca Trías neither is right to grand him/her the category of a “thing” (it is not a subject nor object,) because it is a not-subject of law-recognized, by its evolutionary process, to become a subject of law.


Just to list some of the aberrations in this area which scientist are practicing under the shield of impunity and the pseudo right to scientific research:

1. Menu baby: a la carte, chivera (spare parts)baby

2. Postmortem insemination

3. Parenting proxy and / or surrogate uterus. Woman gives birth to their grandchildren.

4. Lesbian couple have 4 children (California, USA, 07-August-2008)

5. Thomas Beaty (now a man, transsexual surgery while preserving the uterus) now called Tracy Lagondino of 34 years old, accepted the implantation of an embryo that his partner could not keep as a women; becoming the first man pregnant.

6. Genetic manipulation and sex selection.

7. England: an unmarried woman was a virgin (willing to keep that way) and she was inseminated by doctors to have a child without losing their virginity, the couple had the opportunity to choose the color of the skin and the eyes of the baby.
8. Conflicts of identity, affiliation and nationality.

9. Alava province in Spain: the doctors, through artificial insemination with sperm from a donor to one of the women, had given a child to a lesbian couple.

10. Incestuous relationships and related problems.

11. Pre-implantation diagnosis and selective eugenics.


Our question is: Have you considered the supreme interest of the higher-concepturus, then nasciturus (unborn), and then born alive and consequently grown to be borne who have to put up living within a environment that he/she does not desire but could not express him/her self? Or by contrast, has prevailed ego centrist interest of scientists who wish to manipulate the reproduction of any person, under any conditions, to allow these aberrations that the law does not protect?

Hence the need that I have raised and supported in all possible scenarios of an explicit provision in this very delicate and that can be geared to meet the protection of one who has not yet been conceived.

I refer the reader to the 1456 ruling dated July 27, 2006, the Constitutional Chamber of the Supreme Court (http://www.tsj.gov.ve/decisiones/scon/Julio/1456-270706-05-1471.htm)  to find the most absurd sentence ever produced by this Chamber, which opens a dangerous gates to be, in the country, performing any act or intervention simply because they were not expressly prohibited by law. In my lectures, and with views of this ruling, which lacks any legal basis, full of adefesios; sophistry, biased approaches, misrepresentations, consultation of  imaginary websites and intentional violation of law principles and legal norms, and of which I doubt, not even the judges have spent as little time reading the file, proved  changes that are set forth in the ruling itself, and which constitutes a grave violation of the judiciary from their posts, I have referred that this sentence ( with the reservation of excellent dissenting opinion of Judge Pedro Rondón Haaz) makes me remember the words attributed to one of the most heinous being of the French Revolution: worse than a crime, an brutality.

Prof. Rafael Aguiar-Guevara  (published july 01th-2009

 

 

In memoriam: to Raphaël Dierkens: Founder of World Association for Medical Law

 06-nov-1925  --  06-may-2009

In memoriam

 

Raphael, the “tocayo” as I used to name him (because of our equal name) was born in   Belgium, November 6th of 1925. He died in May 6th 2009.

He graduated on Law and in the early  1960s,  from the Faculty of Law at the Ghent State University and focused his study on multicultural issues related to Medical Law.

Louis Pasteur (1888) said: Science, obeying the law of humanity shall struggle to enhance the frontiers of life.

Nevertheless, we do know by experience that science, especially medical science, is going far beyond and faster than Law and we lack of real and actual regulations in all fields of medical practice. Prof. Dierkens knew this fact. To do it just nowadays is too easy; but we have to think of 40 years ago when practically nothing was written about it around the world and when so many advances in medical sciences were invented, created, developed.  He could recognize that Pasteur’s though was not being accomplished and that progress of science was running to fast while Law was staying behind; especially in medical fields and practice.  That is why it is easy to understand that the seed of Medical Law was already inside him as he truly believed in gathering, bringing together, Medical Science and Law.

Alike Julius Verne on his several novels, Prof. Dierkens had this vision to establish a worldwide organization and bring together experts from around the world and wait no time to start thinking of building  the platform to establish the legal structure which allows accomplishing his objective.

He received the support of many friends and colleagues; more specifically from the same Gent State University. To try to name all of them would be an injustice fact as we might neglect and forget some of them;  and on the other hand, we might shade the real visionary of Medical Law: Prof.  Raphael Dierkens.

He dedicated to write some books in the early 60´s when he also was appointed   as Associate Professor at the Faculty of Law, Ghent State University and he had meetings with colleagues and friends working on this idea to create such an international organization.

The World Association for Medical Law was established in 1967 at its center in the University of Gent in Belgium. The first international conference on medical law was convened by Prof. Dierkens at the Ghent University, Belgium, in August 1967.   This first World Congress on Medical Law was such a successful meeting counting hundreds of attendees that the same format used for this Congress served as framework  for future Congresses. Ever since, the main purposes and objectives of this organization have been to encourage the study and discussion of problems concerning Medical Law.

Afterwards, many Congresses were held: Washington (1970), Philippines, Prague, Ghent (five different occasions: 1973, 1979, 1982, 1985 and 1991), Israel, South Africa, Hungary, Helsinki (Finland-2000), Maastricht (The Neetherlands-2002), Sidney (Australia-2004), Toulouse (France-2006) and Beijing (China-2008). Next 18th World Congress will be held in Zagreb, Croatia, during first week of August-2010.

Prof. Dierkens was (shall I say is?) the valuable and pioneering leader on Medical Law at the global level and he has won this legitimate world historical recognition as the creator and founder of the World Association for Medical Law, existing since 1967, and having now near 42 years of permanent work.

Among all this large time Prof. Dierkens was not just his founder but he humbly and indefatigable served as its Secretary General for consecutive 35 years, until the meeting of the Board of Governors gathered in Sidney (Australia) in 2004 when the undesirable, but needed decision, was taken by Governors to accept the change of Secretary General, giving in this way the  necessary opportunity to Raphael Dierkens to take care of himself and giving him the most valuable recognition for all of his work accomplished.

During a wonderful Gala Dinner, at closing of World Congress in Maastricht (The Netherlands) in 2002 he was bestowed with the highest award of WAML: the Dierkens´ Medallion. This Medallion is the highest award of the association, carries his name and it was presented for the first time ever to its founder: Prof. Raphael Dierkens. This Medallion has got his face and name on one of the sides.  Thus, one face of this Medallion is presenting the Dierkens’ image and on the bottom of it the title as Founder with the name of the World Association for Medical Law along the edge.  

The Association owes a great deal of thanks to its Founder Prof. Raphael Dierkens for his foresight in starting this worldwide   organization.   He was also presented the recognition of Founder and Honorary Secretary General of World Association for Medical Law in 2004 by the unanimous decision of the Board of Governors.

We have lost a most valuable friend, leader, teacher, who was the visionary founder of the World Association for Medical Law and its Secretary General for 35 consecutive years. Sadness seizes deep in our hearts not only by the loss of a friend but
also by the disappearance of the valuable and pioneering leader on Medical Law at the global level.

Thanks “tocayo” for your valuable advises and example, and your sincere friendship.

Rafael,  Aguiar-Guevara (Former Secretary General of World Association for Medical Law 2004-2008)  Caracas. Venezuela.- June 11th 2009


 

 

 

 

 

 

 

 

MEDICAL LAW AND HEALTH LAW CONCEPT: PAST, PRESENT AND FUTURE

Prof. Rafael, Aguiar-Guevara (Caracas-Venezuela)
ragaso@cantv.net

 

During the process of evaluation of papers presented to this Congress, there was a particular doubt regarding whether to accept or to reject some of them because, although they had an excellent clinical content, they were not really related to Medical Law. The question emerged among members of Scientific Committee; and even more, some were categorical to express that there was not a concept of Medical Law as to refuse a paper on these basis.  To talk about the benefits of a new medical procedure is pure clinical content; it is not Medical Law. However, to discuss the possible damage caused to a patient and to evaluate the legal implications for performing such  a   therapeutic method is to refer to Medical Law.  The concept  of Medical Law has been either neglected or taken by granted.  

Therefore, I am convinced of the necessity to explain these concepts which seem to be of great relevance to this Congress.   

At the beginning of time, we only had the mere application of criminal law doctrine in the field of medical malpraxis litigation. Then, we started talking about Forensic Sciences, which is no different to the Medicine applied to the service of justice and Law.  However, any science becomes forensic science at the time that it serves the judicial proceeding. There again, it is not Medical Law.

It was here in China, 3.000 years ago, when it was used, for first time ever, the fingerprints as evidence of personal identity. The historians agree to conclude that it was here, in China, during the Tang Dynasty where Forensic Science was born.  

 

here is a vitiated and polluted misconstruction, a sophism, to believe that Forensic or Legal Medicine might be referred to as Medical Law.  Clearly, Forensic Science, Legal Medicine, or the mere application of Criminal  Law to   medical malpraxis litigation  is merely one chapter within the great book of Medical Law. By the end of 20th century, there was no explicit  criterion in Law which clearly defined, in terms of content,  the concept of Medical Law. Thus, after a wide research and assisted by the analogy, similar matters and general principles of Law,   I dared to propose formally, in 1996, with the publication of my first book , a personal concept of Medical Law which has account, ever since, with widespread acceptance.

I concluded that, by that time, that the best approach to define Medical Law wasThe set of legal norms and ethical and moral precepts, of Public and Private nature, that regulate the activity of medical doctors in connection with the practice of their medical profession, regulates the juridical doctor-patient relationship and its consequences; thereby establishing the general principles of medical liability .

Despite the simplicity, this concept encompasses the fundamental principles that this branch of Law proposed in the explanation of the regulation of the conduct of medical doctors in their professional practice.  The basic legal standards remain under uniform criteria for medical behavior regardless of the location, specialty, timing, conditions and circumstances; hence the generality of the concept.  

It establishes clear and fundamentally, the legal nature of the doctor-patient relationship, and once well established, offers a broad understanding of the fundamental principles of medical liability, specially referred to the obligation of reparation, restitution, or compensation for those damages suffered by patients as a consequence of the medical care service.

It also is very dynamic and always developing; with a mixture of substantive and adjective (proceeding) norms of Law. It has its own specific legislated sources.  Moreover, it is imperative, with norms of public nature that can not be disobeyed neither relaxed by particular individual agreements.  Medical Law is an autonomous and primary Law because it has its own method and sources; it does not depend on any other type of Law for its existence.  However, this fact does not preclude to have, as indeed it has, a relationship with other areas and disciplines of Law and it uses them when necessary, to solve specific problems.

Medical Law is essentially pragmatic.  It just interprets the law, and find its applicability adapted to every specific case.    However, it   recognizes the valuable contribution that nowadays Bioethics is achieving within Medical Law, and it accepts unconditionally, that those bioethical values, currently under discussion at present time, must, eventually, be initiators or starting point for future standards of legal norms regarding the professional activity in the area of health.  Medical Law, as any other branch of Law, must have its own sources of law.  These rules of legislated formal written law consist of a set of specific laws, directly or indirectly, related to medical issues.     

In Venezuela,  and it is  the same in many other countries, we find the legal sources of Medical Law in specific and special laws with as many names as they are related to the field they directly regulate. Surely, in other countries we find more examples of sources of Medical.    Nevertheless, as Medical Law is very dynamic, we have to consider this set of laws also as variable and in permanent movement.  For example, in Venezuela, just now, a new Organic Law on Women's Right to a Life Free of Violence was sanctioned, which includes the so-called crime of "obstetric violence' and imposes a high economical fine but also it is subject to disciplinary process.  

Years later, in 1999, in Buenos Aires (Argentina) another concept of Medical Law was published in a juridical dictionary.    

In this Congress many professionals are presenting papers approaching medical care and Public Health policies from different points of views. The question is: are these issues included in the merely doctor-patient relationship? And the obvious answer is no, they belong to a wider scope of legal study which the orthodox Medical Law concept does not include. We also find, including in these Congresses on Medical Law, many professionals different to medical doctors and who are fully employed and profoundly interested in Medical Law. Again, the question arises: Do they belong strictly to the fundamental concept of Medical Law? And the answer again is negative; they are not medical doctors so the approach we used to have needs a change.

Thus, in our present time we have to consider another different type of approach as compared to the regular Medical Law. We explained that Medical Law is very dynamic.  Ergo, its title and concept must also be dynamic. In this process of evolution, we feel that a change is needed. That is why we started talking about Health Law instead of Medical Law. We started looking for a more comprehensive concept. We looked for a concept that had to be inclusive of all sciences and all professionals different to the regular medical doctors.

Among the more than 3.140.000 of entries in Internet (Google) under the complete name of “Health Law”, and as long as I could have checked upon many of them, there are two common characteristics:

1.     Neither one of these websites, define what Health Law is.  

2.     All of them come to the same error: confusing Medical Law with Health Law.  

 

Perhaps it is the time, here in China, for us to try to define Health Law.  I would, humbly, dare to present, now, my personal proposal:
The set of legal norms and ethical and moral precepts, of Public and Private nature, that regulate not just the activity of health care providers(workers and Institutions)  in connection with the right of society for health and medical care, but also related to the regulation of Public Health through the necessary policies, and the universal  control of disseminating diseases that might compromise the individual welfare of members of society; without discrimination, and where the health of community prevails over the individual interest.

 

However, our happiness of our present gift is too good to be true and too difficult to last forever. The President of our World Association for Medical Law, Prof. Amnon Carmi, is  always looking to the future; he has foreseen the initiation of a new change, of a new era.  He is teaching us that both concepts should be kept in the past. Now he is trying to introduce  the futuristic concept of Biolexology.

 

Quoting Professor Carmi:

The Biolexology deals with the legal implications relating to health and lives of human beings and its institutions, including their rights, duties and authorities. Similarly, to other fields, Biolexology emerge from its own sources upon which meets its foundation. Its first layers are in Law of Contracts and Law of Damages, which has been created, for convenience through habit, custom and developed in this way across generations.

According to the proposition of this new concept, Biolexology must find its fundaments in the quest for social criteria; in other words, it is a matter of  - lege ferenda   As explained by Prof. Carmi, Biolexology may never be solely a simple set of laws, not even a legal approach to science, not even a new school of thought, nor a mere response of society to scientific progress.

It begins from a truly scientific field and concludes with the presentation of a true history and legal exegesis  and the truly understanding of the concept of Health as a human fundamental social right, where we need to rescue the values and bioethical principles of health care profession in general.

 However, hundreds of years that have passed before accepting the designation of Medical Law, and now having to accept the term of Health Law, lead us to believe that  Biolexology must wait a little longer yet.

Finally, Medical Law, Health Law, Biolexology, shall fight against the dynamics of scientific advances (under egocentric control by scientists) and its social acceptance (always dependent on the interest of each group -juridical socialization). This would allow us to fill the voids or gaps of normative nature that may exist between the fast progress of science and the regulation that is required  for the sake of the society that finally takes it. Example of this  is the discussion of assisted reproduction techniques and how the absence of legal rules has allowed the greatest atrocities in this medical field.

Biolexology must also accept the challenge to offer, for example, the necessary legal protection, not only to the nasciturus (conceived but not born yet), but also to the concepturus (not even yet conceived). We must defend its potential to be, the dignity of  being.  Scientists in this area, have imposed an artificial border of 14 days arguing that the pre-embryo is neither life nor a person. Then, we come through the fetal stage in which lawyers maintain, capriciously, denying the quality of legal person.

I do believe that it is one of the major social injustice and discrimination act. If a   fetus,   under the new procedures of intrauterine surgery, suffers any damage he/she cannot claim liability against doctors or medical institutions simply because the lawyers do not consider this developing life as a subject of legal rights, namely denying the quality of person by not being born (yet).         

 

We talk about health as a fundamental social right of human being. We defend the right to medical care and the existence of Health Law.  But we seem to overlook  that we are in an evolutionary process towards a dark future where food prices increases because the worldwide lack of products, while the interest of few is to obtain biofuel or biocombustible from the potential food of the community.

We are in a world process of evolution where the interest of power prevails over the environment protection; where it does not matter to produce diseases that might be spread across the frontiers; where economical profit of international enterprises are of far more importance than the welfare of the community; where the great transnational pharmacological enterprises forbid developing countries to produce generic (no trade registered) medicines, which are cheaper, and reachable to all the individuals of the community just because it damages their own economical interest.  

 

That is why the importance of this Congress.

That is why the need to produce real policies in the interest of our societies. Medical Law had to move aside to let Health Law to enter and rule all of these processes.

The principles of Biolexology will have, in due time, to overcome and undertake this important role.    

 

We must review our past; we must learn from our present…we must rectify.

We ought to understand the great future to come, of which we all are responsible to guard, with our bioethical dedication, to the right of people for a better quality of longstanding life.

 

Prof. Rafael Aguiar-Guevara  (published november 30th-2009

 

 

 

 

 

 

Obstetric Violence:

the protection of Women’s Rights through Criminal Law

Rafael, Aguiar-Guevara

Caracas – Venezuela

ragaso@cantv.net

  

In contemporary doctrinal criminal law, the so-called Criminal Law of Enemy is being developed in some countries. Without entering into a doctrinal discussion (favor or against) of this new type of criminal regulation, I would like to present what could be considered, within the above mentioned premises, as special sort of these crime regulation but oriented to protect women’s right. It has been established in Venezuela with the promulgation of a new law named: Organic Law of Defense of Women’s Right to Live a Life without Violence, in force since its publication in April of 2007

Within the described crimes and offenses of this law, the State (Government) look into the special legal guardianship to protect certain modern women’s right through creation of new Courts and Special Commissions to endeavor in the defense of women’s rights.

Among all topics of this new Law I am specific interested in presenting three new delineations of standard typical crime which are directly related to the practice of medical care fields; therefore of interest of Medical Law; namely: obstetric violence; forced sterilization, and sexual harassment.

The struggle of women in the world to gain recognition of their human, social and political rights, and the respect for their dignity has been developed over centuries and had one of its highest expressions in the Declaration of the Rights of Women and Citizenship in 1789. Some other international declarations and Conventions have also been declared . Latin America also has legislated in this area, in recent years. Bolivia, Colombia, Peru, Mexico (1998), Nicaragua (1996), Panama (1995), Paraguay, The Bahamas and the Dominican Republic (1997), have adopted laws or they have amended some articles of    their respective penal codes to punish violence against women.
This Venezuelan new Law seeks to create awareness in all sectors of society in the country on what constitutes a serious problem for the Venezuelan society, which violate the human rights of half of its population.

Hence, it provides a wide range of actions of a preventive nature and education that are in charge of the institutions of the executive branch of Public Organs as they have the responsibility to educate the entire population against this serious problem of deep cultural roots. At the same time, to educate its entire people to build up a new society, which truly respect the fundamental Human Rights of women. Similarly, the new law attaches great importance to the actions of training for personnel who must deal with the victims of gender violence and the perpetrators, ensuring timely care to preserve the human rights of the victims; but at the same time, offering adequate treatment and simultaneous protection of human rights of victimizer, to whom it has to be guaranteed the right to defense and the possibility of re-education on the gender issue.

 Considering the new definitions and standards on new criminal conducts or behaviors that might constitutes an criminal offense to women and their rights, there are three that specifically I present specially because they are related to medical care, more specifically to Gynecology and Obstetrics assistance.

The most innovating one is defined as Obstetric Violence and it might be presented in five different types:

 It is considered an act of obstetric violence carried out by the obstetric health personnel:

      1.     When not responding timely and effectively the obstetric emergencies.
2.
     When forcing a woman to give birth in the supine position and with legs up, if there were the necessary means for the realization of childbirth in vertical position.
3.
     When obstructing the early fondness (attachment) of the child with her mother, without justifiable medical cause, denying the possibility of holding the baby and breastfeed him/her   immediately after birth.
4.
     When altering the natural process of low risk childbirth, by using acceleration techniques, without the voluntary informed and specific consent of the woman.
5.
     When practicing birth through caesarean section, when exist conditions for natural delivery without the voluntary ,  express and informed consent of the woman.

In such cases, the court will impose to the responsible or liable to a fine equivalent to 37.450 up to 74.900 

At the beginning of this paper, we mentioned how the so-called Criminal Law of Enemy is being developed in some countries. In colloquial words, you want to stop your enemy from doing something that you do not like, and to stop such an action you criminalize it by amending in purpose the penal law and allow that legislation creates a special standard typical crime, which is directly related to the practice you want to punish.

it is a real fact that in Venezuela, perhaps in many other countries, medical doctors prefer, for many reason, other than obstetrics ones, to perform a cesarean section that to assist a woman in normal labor for delivery of  a baby. One of the main reasons is the economical one. 

The obstetrician who works in private clinics would earn more “fees” by performing a cesarean section than for a normal birth labor. There was no other way that to criminalize this misbehavior to try to stop the exaggerated number of cesareans being performed in private clinics as compared  with the number of normal child delivery obtained in public hospital.  That was the main reason of paragraph 4 and 5 of this article. Number 2 and 3 of this article obeys more to the defense of normal consideration to the right of a woman to deliver the baby by other than regular or traditional supine position and to defend the right of the woman to bear affection and love with the baby as natural expression of motherhood.

Forced  (constrained) sterilization

This article does not need any explanation. Simply it was not right to sterilize a woman without her permission.  This happened to much in popular areas more than in high society class, where the women does not have, usually, a steady marriage, or perhaps enough economical income to maintain the number of children she would like to have. Regulation comes to put an end to the opportunity of the obstetrician to decide by himself and to put an end to the reproductive health of women without her freely, informed consent and with a justifiable medical reason. Let us see the content of article 52 of the new law. 

Sexual harassment

This article has been  in penal law in most countries. The National Assembly, obeying the clamor of women introduce the sexual harassment into the specific law to defend, most specifically and with more vigor the principle of integrity of a woman, who deserves to leave free a life free of violence, in whatever form this violence adopts its shape.

It is very well known the advantage that usually medical doctors want to exercise to the subordinate nurse, for example; or the teacher above the student whose qualifications depends on how good is his/her relationship with the professor; or what is even worse: the sexual harassment over a patient.

Although the violence conduct is based upon the superiority of one (active subject of crime)  above the other one (passive subject o crime) and despite the fact that this misbehavior might happens in any relationship, I call upon the attention of medical doctors who, at any time, perhaps without knowing it, may incur in this felony during medical care. 

 Conclusions

I think that these new types of criminal conducts, or felonies, bring to medical care more respect from the obstetrician to his/her patients, and appear evidently, the commitment for a new medical-patient relationship.
We may recognize that academically orientated lectures to medical doctors, specially obstetricians, and teaching of Bioethical aspects of  medical care was not enough as to avoid these misbehaviors and it was necessary now to include new types of delinquently conducts in law to try to avoid these felonies against women human rights continue being violated.  Now the teachings change from the ethical or bioethical field to the field of Medical Law.

Prof. Rafael, Aguiar-Guevara  (published April 30-2007)

 

 

 

Euthanasia: Venezuelan Tendency.  Second Report

Prof. Rafael,  Aguiar-Guevara  

 

 

During the 15th World Congress on Medical Law  (Sidney-Australia, 2004) I presented the First Report of Venezuelan Tendency on Euthanasia. That First Report contained the major doctrinaire and bioethical principles that we thought prevailed in Venezuela, either in favor or opposite to the idea of Euthanasia in our country.  

Self-determination, own will and the principle of individual autonomy is the most important aspect of them. It forces us to care about the right to life in a very different way.

According to the Venezuelan Constitution, each individual has the right to health. Two major aspects are the basis of this right.  First of all, the right of health is established as a fundamental social right. Secondly, the right of health is immanent to the right of life. There are so closely related to each other, that it is impossible to look at the right to life without considering at the right to a minimum quality of standard of life. This, in turn, is related to an optimum condition of health—not merely understood as a physical, social and mental well-being, but an optimum condition of health based on such other important facts as family, work, spirituality, ecology and biological environment, peace, among others.

 

In Venezuela, as in majority of countries, the subject of euthanasia has been sequestered for a long time. Traditional and orthodox doctrinaires, jurists, politicians and healthcare professionals, under the evidently authoritative influence of the catholic doctrine, have done their best to obstruct the access of the community   to fulfill their right of free speech and discussion of this special topic. Even the media, especially the press, refused to write on the subject and, according to information that I have had from several journalists, the orders came from editorial management and media owners; so that it has been the private sector itself,  and not the government, who incurred in a violation of the right to free speech and information.   

Another major proof was a poll conducted in internet by the biggest communication company in Venezuela which, by that time, was private.  This poll was in internet until the preliminary results showed that approximately 80% of population was on favor of euthanasia. The poll suddenly disappeared from internet without accomplishing the lapse of time it was announced to be available for internet visitors.

 

Beginning with Congress of the World Association for Medical Law in Maastricht, in 2002,   I decided to open a discussion on the topic in Venezuela. That is what prompted me to visit, on my trip back, the Netherlands Society of Voluntary Euthanasia (NVVE), headquartered in Amsterdam, where I had the opportunity to meet its President, Dr. Rob Jonquiere. He very kindly agreed to an interview in which he explained with great detail the problems that the Netherlands had in legalizing euthanasia.    Ever since I have been including the subject of euthanasia in my conference programs, also adding a nationwide survey in each one of the scenarios in which I have worked. In August of 2003, I had my book published: EUTHANASIA: MYTHS AND REALITIES , where I projected my conclusions. It might be considered as the first major step in publications regarding this subject in Venezuela.

 

One of the most important facts, within this issue, is that for the first time the Supreme Court of Justice of Venezuela presented a project to the National Assembly (Parliament) constitutive of special Amendment of Criminal Law . Within the articles to be added there is one numbered 217, which considered, for first time ever in Venezuela, the decriminalization of euthanasia in Venezuela.

"It is not an offense and will be not punished who cease medical treatment to avoid sufferinfg from an unbearable pain as result of a terminal desease knowing that by doing so it will terminate person’s life. Neither will be punished who gives masive doses of analgesics to eliminate  pain but knowing that it could shorten life as a result of such adninistration. Nor be punished who for mercy  and direct action cause person´s death in order to avoid ain or suffering. In all cases it will be necesary conscious, express, voluntary, carefully and undoubtfully request from a competent  patient. Such request might be given by vital living will  or any public document  where it is clearly stated persons´s will of refusing medical tratment o having letal inyection in case of terminal desease" 

 

It has got a long statement which I am not discussing in this short comments but it is good to report the fact that the highest Court was the one to advance the promotion of this amendment.

I have attended twice to the National Assembly to meet the Commission on charge of the Criminal Law Amendment. In those opportunities, I could explain to them my point of views about euthanasia and presented to them my proposal of amendment.  My proposal was to simplify the all article and to state just the decriminalization of the act of euthanasia in the criminal law but leaving some regulations to a special law. As it is in other countries such as The Netherlands and  Belgium.

 

My proposal to the National Assembly has been a shorter version:

It will be not considered a criminal offense nor will be punished the physician who, fulfilling the due criteria stablished in Termination of Life on Request Law, intentionally terminates the  life of a person who, voluntary, has thus requested. 

  

Despite the fact that we still do not have a legal approval for euthanasia I would like to call the attention over a real fact.  The Venezuelan Medical Federation has promulgated a new Deontological Medical Code in 2004. This Code is compulsory to any medical doctor to practice legally Medicine in Venezuela. Its article 83 (newly included) approved:  …. the gradual increase in the dose of powerful analgesics even though it can shorten the life process by the depression of the nerve centers that regulate breathing

This fact constitutes an advance within the orthodox, traditional and conservative medical care and although it still does not approve direct and active euthanasia, it has been approved, by this deontological code, the so-called indirect euthanasia.

 

Other advance that we must include in this Second Report of the Venezuelan tendency in euthanasia is the foundation of the Venezuelan Association Right to Die with Dignity   in March, 06-2006.   I have been honored as Founder of the Association and actual President. The Association constitutes a civil non-profit organization with the main objective of educate, orientate, inform, people regarding euthanasia. However, none of its members would officially, as organization, to take care and conduct any euthanasia procedure.

We have a website  which gives as much as possible information about its activities and also publish articles and news regarding euthanasia. Our Association is official affiliated member of the World Federation of Societies Right to Die with Dignity  and it organizes workshops, conferences, lectures, not just for professionals but also for general population.  Our major objective is to struggle for the approval of a special law that, as in The Netherlands, Belgium, Luxemburg, allow a person to freely decide when to die with dignity.

 

In order to educate lawyers, judges, district attorney deputies, forensic, medical doctors, nurses, and any other professional involved with medical care I have included a complete new Chapter in my latest book that has been published this  April -2008.  This publication includes major aspects of the former book (ut supra) and many new facts and tendencies in this issue. Thus, we expect to help professional people to understand much better the main topics of euthanasia and how this concept is developed around the world.

Conclusions:

We must remember that euthanasia is not an act of medical procedure; it should not depend on medical technical decision neither in juridical sentences.   We have to understand that it is an active exercise of a person (no patient) right; it is a voluntary act of self-determination, which depends only on the decision of the affected person.

 

Finally, we celebrate the inedited fact that the World Federation of Right to Die Societies is holding its next World Congress in Paris next November. On Sunday, the 2nd day of November, from the Mur de la Paix (Wall of Peace on the Cham de Mars),  it will be held a ceremony declaring that day as the World Day for the Right to Die with Dignity.

Another big step in the evolution of euthanasia.

  

Prof. Rafael, Aguiar-Guevara   (published August  30st-2006)

        

 

 

 

 

 

M@TIC

Medicine Assisted by Information and Communication Technology

Conflicts, responsibility, Liability
Prof. Rafael, Aguiar-Guevara  

 

I shall refer to the name M@TIC, as a term that encompasses all Medicine Assisted by Technology on Information and Communication. The development of these techniques brings up many ethical and legal conflicts, mainly because medical science has developed much faster than the Law.  Justice cannot be properly served if we do not have the regulations to help mankind to avoid aberrant behavior by medical practitioners in this field.  M@TIC is still regarded as experimental research procedures. Not all that is technically feasible is ethically acceptable. There are many potential risks associated with M@TIC and it is largely considered, and so it is understood by doctors, that any damage to the patient would be the fault of the system, never the responsibility of the doctor.  It frightens me to think that this fact may be used, in the future, as a shield to protect negligent medical doctors from malpractice suits.

Since the beginning of life and humanity, perhaps even before, science and its evolution have offered mankind access to areas that were absolutely unimaginable at the time of its origin. The e-Health industry continues to revolutionize healthcare all over the world.  The main objective of scientists is to expand human knowledge through the development of research. Remembering the words of Louis Pasteur at the opening of the Institute that bears his name, we get a look at the reality of a major principle: …of this we may be sure: that science, in obeying the law of humanity, will always labor to enlarge the frontiers of life

At present time, when we talk about different modern ways of health care; we surely consider that our horizontal doctor-patient relationship model is being put aside. The right to an autonomous will and self determination as expressed in the principle of informed consent is in danger and in conflict with the recent development of a new medical trend in which an indirect relationship can be established even if the doctor is absent or, at best, just making a virtual appearance through a video camera.

Basic and general concepts regarding medical practice and informatics have been, or will be, dealt with for qualified lecturers. At this point I will just review and analyze other aspects of this complex issue.

Many definitions have been used to define the subject related to health care and  distant medical practice via informatics and communication, all of them trying  to include  every  aspect of clinical care as it relates to health management, accomplished through computers and finally referred to as the applied informatics and communication technology on health care.

Some of these names, such as eHealth, TeleHealth, TeleHealthcare, TeleMedicine, or other terms yet to be invented have failed to cover the wide scope of services that might be obtained through this technology. I shall refer to the name M@TIC, which appeared for the first time in Venezuela on September 20, 2002, during a workshop held at the Metropolitan Medical College in Caracas.

We thought it was more convenient to apply M@TIC, as a term that encompasses all Medicine Assisted by Technology on Information and Communication. In this way,  from the simple consultation in any portal related to health care, through   the  surgical assistance using automatic and robotic arms; and as simple as an EKG taken from the astronauts and being sent from outer space to the physician’s office on earth, and eventually the use of real robots capable of providing surgical assistance, such as the one used by Dr. Marescaux when performing  a laparoscopic cholecystectomy manipulating  a robotic system placed next to the patient, an achievement accomplished from New York (USA)  to Strasbourg (France)  on September 9, 2001.

The development of these techniques brings up many ethical and legal conflicts, mainly because, in most countries, medical science has developed much faster than the Law.  Justice cannot be properly served if we do not have the regulations to help mankind to avoid aberrant behavior by medical practitioners in this field. This is where we encounter our first conflict with M@TIC, still regarded in most cases as experimental research procedures.

 

Therefore, our first concern is to understand the urgent need for ethical consideration and   legal regulation regarding the development and application of healthcare information and communication technologies.

For example--and here we face our second conflict: a patient is suffering from symptoms that worries him. This person goes into internet and start looking for information. Very shortly, he will find a portal. The question might be: how can a patient be sure that the person who is giving him/her an answer, found in this medical portal consultation is really a certified medical doctor with a specialization in the related field he/she is looking for?

A portal is a web site that purports to be a gateway to the Internet and the Web. Users will click through the portal to get to other sites. Portals will add other sites and services and market their brand heavily to drive traffic. High traffic or clicks-per-thousand (CPM) will impact their revenue model by charging advertisers and sponsors high fees. Over the past few years, healthcare portals have attracted much attention due to the high number of health information seekers who may be directed to other sites via portal strategy.

Consequently, we must ask: who will regulate these portals, when and how will it be done?  Providers should be forced by regulation to offer to the consumer a certain degree of guarantee of services. So far, most of these portals provide incredible offerings to users (no longer called patients!) and the information can turn into advertising, and advertising is no longer reliable because it guarantees the results offered in these portals in order to insure business, thus converting the informed consent into a consent that has been vitiated and results in liability when the contract is not fulfilled or the outcome is different from that initially offered by the system.

Information should be factual, verifiable, reliable, objective, true and integral so that the patient may be guaranteed relevant information that will allow him/her to express a valid legitimately declared consent. 

Then we come to the fact of accreditation and certification. The issue here is: How we assure users to find truly medical doctors, or specialist in health care and not just operators that through a phone line gives you certain factual answers to foreseen questions? 

We know that an independent organization should guarantees the identity of the person in encrypted electronic communication and act like a virtual notary public, verifying the identity of the user and storing the user’s public and private encryption key, issuing the necessary license called   “Digital Certificate” as a seal of authenticity for the recipient. The American Medical Association (AMA) and many other medical societies around the world are active in this field. Digital certificates can be carried in a smart card or stored in one’s computer as a software program. However, we must consider that a doctor certified in Venezuela may not be considered certified in the USA for medical practice. Or perhaps one doctor from one state in USA is not a qualified one to practice in another state within USA.  This might give way to a legal fraud in which a non-certified doctor could still practice in another state or country by proctoring or performing TeleSurgery.  In these cases, ¿shall we apply one country regulation and practice or shall we apply the one that for our convenience is the most favorable country?

This would result on the bitter prevention method of criminal sanctioning. One may ask: how did this happen?

 

Faulty communication is another is another aspect of this controversy.  If there is no direct and proper doctor-patient communication, how can a doctor (assuming that he/she is even a doctor) reach the answer that is right for a specific patient in a distant consultation?  In the event of damage to this patient, how can we determine responsibility and legal liability if even the patient ignores the real doctor’s name? If surgery is being performed between two countries with the assistance of M@TIC and an atmospheric condition leads to equipment malfunction, who is responsible for damage caused by delayed transmission of orders or data? When a risk like this one might be foreseen, who is responsible of informing the patient?  How far can we go with the issue of technical development maintaining the balance with a patient’s rights?

One of the major conflicts in this area is that of Informed Consent when medical assistance is performed through the use of these techniques in distant healthcare and remote manipulation. We have doubts regarding whose regulations and legal practices do we follow in the matter of Informed Consent. Who will be responsible for insuring that the patient has the integral information that he/she needs?  In the event of foreseeable damage, who is responsible for informing the patient? In the TeleSurgical context, patients should be told that surgery will be performed through TeleMedicine, the patient should be told the differences between conventional treatment and TeleSurgery/Medicine, which staff member is participating, and even,  how qualified and skilled the team members are, so that he/she can sign a valid informed consent.

 

Many systems, including the evolution through ESOPO, D´Vinci, HERMES, OTELO, and lately ZEUS equipments and technology, have allowed scientists to develop what is called Clever Operating Theatre or Intelligent Surgical Room. With the use of the voice the surgeon may give some commands to the robotic arms and/or hands and the robot is supposed to performs its task. However, what might happen if, for example, there is a subtle stress-related voice change and the robot does not recognize it? What if the surgeon is suddenly incapacitated and unable to continue the operation? Will the voice of other members of the team be recognized?  If, simultaneous commands are given to the robotic system by voices that are all recognized and authorized, how will the robotic system recognize each voice and its order of priority?

On the other hand, security has become one of the hot buttons of concern for consumers, legislators and healthcare professionals. Insuring that data transmitted—especially sensitive patient records—is safe and secure is a priority for anyone in e-Health today. Physical security refers to protecting access to computers; logical security refers to other software or hardware solutions to protect access to programs.

A firewall system must be secured and operative. The firewall system will allow, deny or limit the access to the private network, depending on the rules of the system.  These are very important measures for guaranteeing that patient confidentiality is not violated.

Then we come to the issue of considering how we are going to deal with the constitutional right to health and the right to medical care and assistance. Almost all of our Latin-American, African and Asian countries fail to provide an integral medical care system for the overall population. When a country faces the reality of more than 2/3 of its population at poverty levels, we need to ask how this population can have access to the benefits of M@TIC.

In addition to it, for the most part, private insurance companies and de facto standard-setting government programs remain selective (discriminating) about the remote health-care services that they will pay for.

For instance, some private insurance companies will cover various real-time video-conferencing consultations. But in general they will not yet pay for store-and-forward types of TeleMedicine services that would, for example, transmit an image of a patient's skin lesion to a remote dermatologist for future examination. Private insurance companies are reluctant to cover various TeleMedicine services for a variety of reasons, but a big obstacle is fear that services rendered remotely could fuel new types of fraud or billing abuses.  

 

One more conflict with M@TIC is that medical assistance performed by these methods is largely considered throughout the world as experimental research procedures. Therefore, if they are still considered as experimental research procedures, it would seem appropriate to apply national and international Acts and/or Declarations, and any other regulations on research on human beings, which would indeed put a limit on the scope of application of these methods, or at least not leaving the door open for violating rights of the patients nor to absolve medical practitioners and health institutions from malpractice suits. However, there is still room for legal fraud when we see that it is possible for researchers and doctors to willingly “shop” for  states or countries where minimum (if any) regulations are imposed, posing a threat to the rights of the patients.

When crossing the borderline of legal practice, we may find situations in which qualified doctors are not the ones to actually treat the patients. In the Boston area, home health-care nurses use digital cameras to take photos of patients' skin wounds and surgery incisions. The nurses transmit those images miles away over phone lines to wound-care specialists who compare the lesions with images taken a few days earlier and, if necessary, recommend a change in care to prevent more-serious conditions and even order this technical staff to perform some procedures that, in some countries like mine, would be considered illegal practice of Medicine, in yet another violation of the patient’s right to be assisted by qualified and certified professionals.

One final word about genetic research and M@TIC. Genome is waiting for micro- and nanotechnology, and I wonder how far science can go before ethical issues come up and question the real benefit for medical practice and the patient’s welfare. In Venezuela,    Dr. Medina Dagger informed us, on June 15th-2005, that he and his team at IVIC (Venezuelan Institute for Scientific Research) are ready for nanotechnology and expect that science will solve any challenge brought to them. This technology is expected to be applied, mainly,  in genetic research.

Concluding, we must insist that first line limitations to M@TIC are oriented to allow these procedures only for: 

1.      Imaging exchange:  such in education; teleconference, teleprocting (when really needed); teleconsulting and performing triage in battle field, or in cases of disasters.

2.    Telemanipulation:   Such as in laparoscopy - robot

3.    Telesurgery:  applied to rural areas; and other  areas that mean danger and risk  for the  medical team: like fire, radiations, endemic areas.


Thus, a briefing of major conflicts and problems of  M@TIC  will be, mainly,  related to:

1.      Accreditation and certification of personnel.

2.      Truly and objective information avoiding misleading information, fraud propaganda.

3.      Informed consent.

4.      Confidentiality. Privacy.

5.      Satellite communication failures.

6.      Liability

7.      unifying legislative criteria

 

There is also a conflict concerning legal liability when accepting the risks of virtual reality and cybernetics. The potential risks associated with M@TIC will be mostly in the area of technical risks due to equipment deficiency or failure related to the performance of the equipment per se, or due to hardware or software associated with the equipment, or due to the time lag in the signal transmission between the surgeon’s console and the operating room. It is largely considered, and so it is understood by doctors, that any damage to the patient would be the fault of the system, never the responsibility of the doctor. Thus, it frightens me to think that this fact may be used, in the future, as a shield to protect negligent medical doctors from malpractice suits. Not to mention the very hot discussion on whether we may consider M@TIC procedures purely as media obligation or, on the contrary, whether it fulfills the requirements for an opus, in other words: obligation of results. 

Regulation should be fundamentally and mostly geared to:

1.      Transparency: meaning honesty that shall include: name, physical address and electronic address of the person or organization responsible for the site;

2.       Authority: showing beyond any doubt the qualifications, credentials, and certification of team members;

3.      Privacy: offering clearly defined security and confidentiality policies and systems,  with respect for patient’s right to confidentiality;  

4.      Prudent and diligent behavior: doctors should recognize the limitations of the benefits of the procedures, as well as the limitations and boundaries of their capabilities.

 

In Venezuela, like in many other countries, we do not have specific regulations on M@TIC. However some legal bodies are present and regulate, mostly, indirectly some of these practices, such as:  Law on Data Messages and Electronic Signatures; Special Law for Protection against Informatics Crime; Consumer Protection Law; Organic Health Law; Medical Practice Law; and last but no least, our Medical Deontology Code that differs from other ethical codes in that it constitutes a real law of full obedience and obligation for any medical doctor.

Although we lack of specific regulations and obviously there is not a specific criminal type defined by the Penal Code, we could take some principles from these regulations and we may, analogically,  apply some concepts in the issue of M@TIC,  as follow:

  1. (Civil Code): Whoever causes any harm or damage to another as consequence of negligent or imprudent behavior is obligated to (economically) repair it. This obligation for compensation includes all physical as well as moral damage.
  2. (Penal Code) Whoever causes the death or injury to another, in negligence, carelessness, imprudence, lack of skill or disregard for orders or regulations, will be sentenced to a prison term of 6 months to 5 years.
  3. (Law on the Practice of Medicine): The physician will not expose his/her patients to unjustified risks, adjusting his/her behavior at all times to the prevailing scientific criterion in force.

Beyond these regulations, additional criteria learned from the doctrine of contemporary Penal Law advises us, (and I quote): in a situation of imprudent crime, that if a person dies from a surgical procedure, this death is objectively imputable to the surgeon if he/she has performed the operation disregarding the medical lex artis; this is if he /she has performed the operation imprudently (Prof. Günther Jakobs. Estudios de Derecho Penal; Ediciones Civitas. MADRID-1997). In the same line of thought, and again I quote: anyone who attempts to initiate an action that will probably jeopardize the property or rights of another and is unable to face and solve the resulting risk and danger due to a  physical (material-equipment) disability or lack of practice or skill,  should refrain from this action. The action itself presupposes negligent behavior and makes him/her objectively liable for any damage caused to another as a result of his/her negligent action. (Prof. Carlos María Romeo Casabona. Modernas Tendencias del Derecho Penal. Ediciones Facultad de Derecho. Madrid – 2002)

There is, as yet, no complete legal guidelines nor a full legal framework to be applied and so, I must conclude with a valuable general principle of bioethics that may be applied to any situation that intend to expand the frontiers of life. In order to do that, I would like to quote this time the words of Prof. Pedro Laín Entralgo when he said: (quote): “… man can do more than he must do; in consequence, man must not do everything that technically he can do.

In other, more colloquial, words I would dare to express: not all that is technically feasible is ethically acceptable.

These comments shall make us feel in the reasonable need of profound analysis, in order to seek for the necessary regulation on M@TIC, for the patients welfare and the dignity of medical practice.  

Prof. Rafael Aguiar Guevara.  (published September 01st-2005)

 

 

Defendant Medical Syndrome
 


After many presentations, and one special referred to a Lecture on the special day of the XXXII Aniversario Coro Hospital, I decided to publish for the first time, the product of my experience as professional litigation lawyer, an advocate of health professionals, and as a consequence of the scientific and legal oppoprtunity I have  to introduce a group a series of events that are common to all these professionals who have been sued for medical malpractice. I decided to call this concept of my own creation: the "syndrome of the physician defendant."
Over all these years, devoted to legal analysis in the health field, I was able to observe that almost all  defendants clinicians that I have had the opportunity to   assist  or to represent, from a legal point of view, show a set of events which, by their similarity between each one of them, well worth the grouping into a single entity, in this case called "syndrome" with the explanations presented later. Almost all of these defendant doctors in court proceedings present a base of common factors or common denominator.
Usually doctors start their "syndrome" with a primary stage of  "guilt" The doctor feels that "something" must have happened that has caused harm to the patient. Also believes that this "something" has been under its control. Which corresponds to an action or omission attributable to himself, ergo, he has  been "guilty" in the production of the damage. We see then he/she begins a long and winding road called the "investigative phase", which begin with bibliographic consultations, also by internet, in books, or by talking to colleagues (or who he/she thinks they are) friends, including those who, also,  directly or indirectly, might be linked with the trial and still he/she will be asking for answers to his/her question: What is it that I stopped doing that has not prevented the damage in this patient? What did I do wrong to cause this damage? Was my action consistent with the lex artis of medical care? Have I really been myself to blame for all this? How can I get rid of this  bitter feeling and this bad experience because I think I could I be guilty of damage to the patient? One of the mistakes that the defendant doctor (and I name  the defendant doctor that one who has got a civil suite supine  of the Civil Court or the first summons and complaint (the famous interview technique) of the Public Prosecutor in the criminal) is committed to talk and talk everywhere. My first recommendation has always been the utmost confidentiality, especially in these early stages of the judicial process. You never know who  make comments  repeatedly. The famous "medical fraternity" does not exist. It is a popular myth to say (in slang) that "among firefighters not step on the hose." Nothing more false than this. I remember, and I keep a certified copy of the part of the dossier, in which the president of a private clinic in his testimonial act, he said to the the judge:  Sure ... these doctors are negligent and ignorant ... .. . and have produced a damaged because of being negligent ...obviously they are guilty... but   Judge   the private institution is not responsible for the acts of these physicians as they are   in free medical practice  ... and there emerges another saying of the popular tells: "When the ship is sinking the first to leave are the rats." That is why we always warn the doctors to be very careful  about too much talking the case. Especially in this first phase of this "syndrome" when the doctor is eager shedding their guilt, and do not realize, really, that the comments made in public and certainly no measuring how much these comments might be used, usually misleading or biased these comments that he, without noticing, performs to  his "friends" by profession.
They began this syndrome. Attacks with more or less force depending on the doctor's personality and their own perception of the degree of "guilt" (negligence, recklessness) he could be attributed to his/her actions. The signs, symptoms, situations are common for all doctors sued, but the strength, the degree of subjective perception and the degree of deep emotional and / or hanger varies from doctor to doctor. Generally, the best trained and  the more dedicated and carefully are, the greater awareness of their own subjective feelings: why me? is the question that never get a response. And in my opinion, the course of my career and as a product of my experience in these disputes, I can say that the more immune  have always been those accused withy justified reason by the victim or patient. I have always considered it unfair that the most serious professional, capable and dedicated, are the most affected by these complaints, often unsubstantiated by patients, while recognizing a large number of cases of physicians practicing the profession but who cheerfully have a special way that makes them immune before the accusations.
Then, as a result of their discomfort and inconvenience caused by the idea of the possibility that yes, the damage to the patient, could have been the result of his performance, but also because the process itself, is a step away from your query professional and even withdrawal of its clinical activities and / or surgery, whether the doctor belongs to this area. I see doctors as those who fall from a horse and are afraid to ride again. Feels fear before each visit. He feels drawn by his colleagues and other staff members of health workers who regularly surround it. Avoid attend medical meetings. Without realizing, he begins to abandon his/her medical practice. If, by chance, he/she is a surgeon, he/she began to find reasons to justify the fact to postpone surgery. Do not feel safe. It is part of the syndrome.
It is not easy to hide all signs and symptoms of the depressive phase in which they enter and it is not easy to  leave. This produces a clear result as manifested in dysfunctional interpersonal relationships, friendship, family, work and even a couple disfunctionality. I have known of cases in which even the divorce is present. I have also known cases in which diseases and syndromes such as hypertension, cardiac arrhythmias crisis, insomnia, etc.. are present. I have seen doctors mourn during hearings in the criminal courts. I remember one case where the husband (also physician) of a good medical employee who was plunged into a criminal trial, had come to such a degree of personal neglect, which after several consultations and a precise orientation, demonstrating that neither scientifically nor legally, she could have been sentenced as guilty achieve of the alleged damage done to the patient, the husband, puzzled, and said, the great change that his wife had taken: she had returned to their hairdresser, changed her personal appearance and had returned to shine again. And that is precisely what I mean. The physician enters a state of neglect even without realizing it. The doctor,      (man) stop shaving daily. They neglects their dressing. These facts seems sumptuous but these things appear to form an integral part of the syndrome. The same neglect is manifested and reflected in their couple relationships in their family relationships, even professionals.
Depending on the degree of readiness of the physician, and greater degree of "injustice" (Why me?) they shows a greater or lesser rate of occurrence of these symptoms as well as the greater depth of clinical manifestation of the same . Deficiency, expense and lack of self-esteem is evident, and neglect of personal hygiene up, you see.
But to the extent that the case progresses and the truth of their proper performance is evident during the various phases of the trial, all these facts and symptoms begin to disappear and the health professional begins, at last, climbing to its successful recovery overall. Generally I have seen the doctor recovers and exceeds the initial status that was presented to launch the application.
One factor common denominator has been presented in all cases. From the very fist day, the doctors ask me that at the end of the trial, we shall sue the patient (I've called it the reactive demand)  or victim for all moral damages suffered. They always say: I mean: yes doctor, once this trial is finished I want you to help me to tke this patient to court and  sue for the moral damage that  I've experienced ... this patient is not getting away so easy... he/she has to pay dearly everything that this process has caused to me. For this purpose I have, mostly, made them to sign a sheet showing the request and I have kept them all. After the long years that these trials usually last, and once achieved the dismissal of the case or the verdict, and when the doctor comes and  tries to say goodbye to our final reunion, sack him and teach his original request of counterclaim. The response has been "unanimous: "... do not let that doctor ... well ... I'm tired of so many courts and judicial ... forget it ..." Demand reactive drowns itself. All what doctors wants is to relax and forget they ever had a legal problem. I remember even a good doctor whom I had the honor to defend, and despite having to explain to him his right to seek court's explicit pronouncement by the costs of the trial against the representative of the Public Ministry had actually hits him, I had to ask to be left on record that Judge would waiv his right to apply for such costs once heard the sentence of acquittal of that instance. The (excellent) Judge of the case by referring to its decision in the audience practically scolding the representative of the Public Prosecutor who, in conscience, did not file any appeal subsequently be definitively sign the acquittal of a doctor, who once heard it, he was so happy and wanted to know nothing more about the case.
There are other signs, symptoms and situations. I would rather preferred not to include in this syndrome as it is not, nor the most frequent, nor presented in a sufficient amount of cases to classify them in this syndrome. That does not mean that there may be no more demonstrations. Simply not worthwhile to include them.
However, one might ask What is this syndrome? Why this name? To be fair to the reader I have included a few lines in this regard. Obeying the medical terminology and be that "syndrome" means a whole characteristic of pathognomonic signs and symptoms of disease ... a set of phenomena that characterize a given situation is ... so I decided to call, to create this personal like "medical defendant Syndrome." Where in the many opportunities that I had to present this personal concept of conferences, or to my students, in different scenarios, as they advance in the explanation of it, supported by graphics that this space does not permit me to teach, I have seen the faces of participants at these conferences and could almost point out, even without knowing, but because their expression, and as I explain the syndrome, the most of the participants who have already gone through a similar situation.
The personal creation of this concept has been the result of my dual status. I am a medical doctor and without this I  would ever understand how to manage a syndrome similar to that set of circumstances I could see in the health professionals to whom I could lend my support as a professional lawyer, which also I am.. And had it not been because of my active legal professional as litigant as I am, it would have not had the opportunity to verify the accuracy of what led me to conclude with the contributions to Medical Law of  a concept that, surely, the readers have been able to compare to their personal experiences. (Rafael, Aguiar-Guevara. Published June 23 2005)

 

 

LEGITIMATELY DECLARED CONSENT

The doctrine of (informed) consent  may go as far as the history of ancient Greece; it has been strengthened with the establishment of Human Rights in Contemporary History. It's really in 1957 when, by U.S. court ruling, it specifically recognizes that physicians had a positive duty of disclosure of information to enable patients to give 'informed consent'. Since SLATER against Baker and Stapleton in the United Kingdom in 1767, it has been extensive discussion that has been presented in the international literature on the patient's right to be informed to show their acceptance of treatment suggested by the doctor.
The former "vertical model of doctor-patient relationship ', whereby the doctor, in his role as God, divinity, protector, being only him/her who knows the whole nature of the condition of the patient, and therefore, the one who may decide what is good and bad to the patient, without notice and without reservation of any legal liability, we have already passed to the time in which, obeying to civil society that imposed upon us by its voice, we have the need to shift to a bioethical "horizontal model"  of   doctor-patient relationship, in which two subjects of rights protected and safeguarded by law, freely express their opinions and willingness to internal bargaining for its consent, not only in establishing the legal relationship obligational contract itself but also to express their consent in a number of facts and circumstances, some relatives  and as consequences others, of the object and cause of that legal relationship involved in medical practice and health in general.
Consent is the action and effect of consent (Latin: consentire) which is given by allowing, condescend, approve, accept, tolerate, abide, that is one thing.
The consent or agreement defines a consent or conformity of wills between the contracting parties, between the offered and accepted, so that there is a deliberate connection to an external event that is desired, freely and spontaneously, by the contracting parties, no vices that nullify or destroy the will of one of the contractors. It is a declaration of will of a subject of law that congenia with the declaration of will of another subject of law, proven by the existence of manifestations of will, which must be communicated between the parties and to be adjusted in relation to each other or combined the only purpose for which the will is declared. Must then be considered, in its manifesto, the real genuine, internal, individual bargaining, without confusing, in contrast with that desire expressed or communicated declared.
Under the substantive civil law in Venezuela, consent is essential to the validity and existence of any contract, and for the purposes of Medical Assistance Contract, such consent can not be affected by any defect, error of law, or identification or the quality of the person hired, the object must always be possible to determine, lawful. For our purposes, the consent to the medical act has become a constitutional standard to be imposed and must balance the need for patient consent for any examination or laboratory testing, and therefore diagnosis and / or medical treatments as an extension of the principle of personality development and personal integrity.
The fundamental pillars of consent in the doctor-patient relationship, and not merely the ever proper medical treatment, are supported by international legal principles that are inherent to the human person, even before birth (nasciturus the fetus person feels towards his right, just who is born alive) and even, before conception (concepturus: protecting the confidentiality of information obtained from the study of protein chains in the genome). These principles are embodied in the autonomy and self determination, according to which each person can do what they see fit and society can not abrogate that right, unless  the order or public health  and protection of the rights of others (harm principle)are concerned .
But in order to achieve such an agreement, it is necessary to the fulfillment of a previous step, which is information, and there has been sustained by the settled doctrine of informed consent, being the analysis and discussion of the criteria of timeliness and relevance of information at the core of informed consent. They say that to talk of "informed consent" is wrong because, conceptually, there can be no consent without information. The information is inherent to consent.
Some believe that there is an imbalance in the doctor-patient relationship that primarily affect this consent, to the point that they prefer to call "acquiescence" rather than consent, because the doctor has a deep scientific preparation that the patient does not possess; and therefore, the patient can not sufficiently understand the criteria and alternatives explained, in which the patient has no choice but to join-the-discretion strongly suggested by the doctor, what membership contract or agree to the principles expressed. I do disagree with the ultimate criterion and to me is sufficient to recall the example of that consent, not mere acquiescence is a condition sine qua non for the application of conductive anesthesia: epidural or subdural; still absolute contraindication for this technique the desire or willingness of the patient not subjected to anesthesia and that in preferring instead a general anesthetic, which also discuss with your doctor anesthesiologist at the time of preoperative consultation performed.
In the same vein, and while I think that legitimately declared consent   unlike the traditional informed consent helds other aspects that go beyond the mere medical treatment; the patient actually enters into an agreement of wills, consensus, agreed, when choosing, for example, which of the two sites or institutions in which he was hired the doctor wants the patient to be operated; which approach may be based from the basic principle of economy, comfort, proximity to your home, to the maximum criterion of availability of supplies and instruments to enable the patient consents, to feel more assured in the protection and care of their life and health. Furthermore, we learn that if consent is a term denoting a thing or letting condescend to take, tolerate, accept something, while nodding in agreement to the same source, would be to show agreement or under what someone said or suggested, we can conclude that, as expressed by the legal dictionaries, the "acquiescence" is merely a prior necessary and inherent phase of consent or acceptance.
Thus, it is easy to understand, that having enough time devoted to the existence of questions and answers, we can not conclude with a simple "acquiescence"-required- at a pre-established contractual formula. The patient in the horizontal model of the doctor-patient relationship, takes an active role, with duties but also rights, with a need for care that must be satisfied by the obligation to be informed by the physician. And so we come to the convergence of two manifestations of will; revalidated line obtained by a real consensus among those who want to diagnose and cure and one that needs to be diagnosed and cured.
Two subjects of law, through the expression of their bargaining, with extensive and comprehensive information, put into play one of the most beautiful  fundamental principle of the  human being: self-determination, autonomy of will, and then they take the decision to close the legal relationship between the doctor and the capable patient, establishing between the two parties the conditions in this contractual obligation, which was born under the protection of a real consensus, an agreement. The patient's right to make their own decisions, from the beginning, is what determines the extent of the physician's duty to inform. There is a great truth concerning this matter: the self is the only justification and goal of informed consent, and to affect self-determination by the lack of information provided by the physician responsible for the consequences arising from their speech, even when that has been technically correct and the injury was the risk of any current medical intervention.
The criterion of timeliness of the information does not entail major considerations as it always must be timely and prior to the act or process to be consented, but the relevance of information has led to countless theories and doctrinal comments  reaching promote, within a certain logic, -- principle of beneficence, in the recital of the complete information that rendered to the patient could, under certain conditions, further aggravate his/her distress, discomfort and concern of the patient, thus leading inevitably to a breakdown of the concept of health, on the understanding a complete state of well-being, physical, mental and social health of an individual. I firmly believe that the fact that the doctor, once again, must be the one who have to decide what is good and what is bad to inform his patient would be a setback to the already rejected vertical model  with a protectionist physician-patient relationship and therefore the patient need, must have the right to be fully informed, and as required by a norm of our brand new Organic Law on the Protection of Children and Adolescents, even the minor must be informed in understandable terms for its development. Because the adult also must learn everything about the act consented, without further limitations resulting from the projection of a patient and understandable conversation and sufficient explanation that the patient needs to exercise their sacred right of self determination and autonomy . In the same way, today is considered absolutely valid the patient's right to be informed, but which must be settled and signed either in the form of consent or on the medical history.
However, based on personal experience and analysis necessary in obedience to the international literature, I am deeply convinced that mere information does not satisfy in a practical concept, the criteria required for a valid consent. The consent has been insufficiently understood and accepted just from the viewpoint of medical treatment only, and not, as it should be, from a broad range from the start of the doctor-patient relationship to the expression of the will as being competent (patient) to another (medical) meets at the time of my own incompetence; beyond life itself, even when I have to meet with my passage to death, and hence necessary to include advanced orders, as for example: Do Not Resucitate, or do not resuscitate order.
The doctor-patient relationship is and should be discretionary, except where unavoidable duty of care under the various international laws. From here starts the expression of will by the patient, to choose, freely and spontaneously, his attending physician and the dispensing of health institution to which you wish to attend.
Then you need a real consensus, an agreement of wills, expressing the will of the patient internal bargaining, to discuss, analyze and make decisions jointly with their doctor about the alternative diagnoses that arise in relation to the disease, what alternative therapies, and surgical clinics, and most importantly, what are the risks compared to the benefits of the procedure, what are the consequences of those alternatives, what's so great about half traditional surgery (cholecystectomy by laparotomy) against the benefits and risks of new alternatives (laparoscopic cholecystectomy), cost analysis, to assume the risks, establish responsibilities, and all those conditions, circumstances and contingencies that might arise considering not only the typical risks, but also including non-standard risks, which their rarity and low likelihood not question the physician's duty to warn on time.
The legitimacy of consent is referred to as genuine, certain and truly in any line, legal, lawful, on its component expresional. Therefore, consensus must be adjusted to the law, duly declared and set in its entirety of elements;  hence, the implicitly of its purpose and must also be legal, lawful, legitimate. Impossible to obtain consent to carry out a legitimate non-therapeutic abortion, to euthanasia, or extraction of a single live for a transplant. But this legitimacy is expressed in the content of information provided by the physician, which also must be accurate, complete, set the rules, true in its entirety. Is unlawful, for example, the incomplete information knowingly provided by physician anesthesiologist to the patient when only for purposes of ensuring the recruitment, hides the fact that he lacks of  the neccesary equipment  to ensure good care during anesthesia, ie, hidden the lack of an oximeter and capnograph, or perhaps the error of the quality of the thing hired the doctor advised his patient who is not himself who practice rhinoplasty, which is hiding another aesthetic surgeon who performed the operation. Vicious obtained   consent and can not ever considered legitimate.
For such consent, the information accurate, full, complete, is strictly necessary. It seeks to protect not only the health of the patient but also their right to self-determination principle, so a real assault on the constitutional right to bodily integrity and patient when it is not obtained legitimately expressed consent, to fulfill the requirement of full information to make the patient to decide what risks they're willing to face in view of their personal health and wellness.
The doctor must know, through their professional experience and a clinical trial, the most humane way to deliver this information, you must manage the technical reaffirming of conduct 'or reassure reassurance' of the English: calm, clear doubts, remove fears; ultimately give the patient confidence in this man that is there, with a health problem, with information on your condition and make a decision.
There is a dispute between two fundamental principles that revolve around the patient's right to information. On the one hand, the "principle of charity" serves almost exclusive interest of the patient seen from the viewpoint of the physician and the practice pursued by him, and addresses the need not to damage unnecessarily inducing patients to a higher state anxiety to the information provided, on the contrary, the principle of autonomy "interprets the patient's best interest from their own point of view, as he (the patient) understands it. Obviously that information badly managed can be very damaging to the patient. But every time you speak of-information-is done in the general sense that when we have already criticized the idea of consent-ie, in a general, abstract, generic.
Some authors have even considered the idea of setting up a division between "typical risks", as frequent or probable and those  "atypical risks", unusual, possible but not probable. The typical, in turn, can be understood by most statistical probability of happening at any given time, or  on the contrary, be typical in relation to the nature of the intervention or medical procedure in question (it would be a typical risk the wound infection in a colostomy). Expressed then that the doctor is obliged to disclose and to inform his patient only the typical risks because they are a typical consequence of the procedure safely. But those atypical risks do not require the phisician to inform as they are unusual or infrequent or should not be reported because of its minimal impact statistics, eg risk of injury and facial nerve paralysis in a tympanoplasty reaches the order of 0.05% of cases. But certainly  again, who decides the typical or atypical of a complication? The doctor;  then the doctor is still performing the rejected vertical model and decides how often a harmful event may occur as a complication of a procedure, and there comes the issue of medical school and training and updating, because it is known in professional medical association, while an American author reports some statistics on the occurrence of a certain complication of surgery, another European country can raise awareness of different figures. Even within the same United States figures, methods, techniques, complications can vary from state to state.
The legitimacy is inherent to paient´s respect for his/her own and fre will to decide. If you stand on the one hand, for the need to change the traditional and rejected vertical model as archaic, protectionist, endian, unilateral, of the physician-patient relationship, and stand to change it for the horizontal model, dynamic, bond, contract, participatory exercises in which there is discretion in both respects,  appropriateness of the relationship in both directions, and know and respect the rights and duties of each person's legal relationship desired, and on the other hand, stand the test of necessity that the patient be informed the purpose of obtaining a consensus, consent, not only of the doctor-patient relationship but also of all those parameters already discussed, and ultimately defend the principle of self determination for people, autonomy of will, human rights, progressive inherent to human beings, we must accept that the information should be given to the patient must be thorough, relevant, comprehensive, complete, understandable language, covering all possible aspects of this relationship and the diagnostic or therapeutic procedures to their risks (typical or atypical, infrequent or unusual, probable or possible), for the patient to exercise their right to self determination and an autonomous is he who will decide whether or not the circumstance presented .
It is logical to assume that consent is legally valid and declared in its conception, the information provided by the physician must be free from any defect or fraudulent machination or pressure that attempts to confuse the patient. We explained that there can be flaws in the consent and it is flawed in medical error either by the quality of things or persons involved in the medical act, either by plotting or deceit, artifice, capable of inducing error in the patient. We have seen patients go to a doctor because he had references from other patients in terms of the wonderful qualities that this doctor has given to proceedings, and that is not in this particular doctor who will really work ultimately to the patient. Illegitimacy demonstration in ensuring that the physician has allegedly offered in relation to the results of the procedure. Vices relating to the ease-of-procedure offered and which, supposedly, is risk-free when we know that there is no single medical-surgical risk-free. Machinations and economic arrangements with the promise of false information to the insurer to achieve a larger coverage that allows the procedure and then ends the company will not indemnify the insured as the doctor had promised.
I also think that, as an intrinsic element of the information, it, information must be continuous compliance thereafter not exhausted in the first interview, but that weighs on the doctor throughout their performance with the patient and there should be and as soon as the doctor-patient relationship still persists and the patient under the care of their treating physician.
I endorse the view that consent must be express, never suspected or presumed.  In some special substantive rules, as in the field of transplants, some countries, including Venezuela, in an illegitimate manner, they want to assert that if a person does not explicitly expressed a contrary desire to donate their organs after death, is considered by via a presumed consent, which is a volunteer donor or giver and therefore subject to their organs are extracted.
Likewise, it is erroneously thought that, under an informed consent, the surgeon may extralimit his/her action far beyond from what has been authiorized;  for example, the removal of an ovarian cyst, and to take a prophylactic appendix removed easily found in the surgery. Hence, the consent must also be legitimate solemnly expressed. This statement corresponds essentially to the action of exposing the truth in all its senses, demonstrate, discover, in a state notorious, obvious, and unquestionable reliability, showing the true animus, intention or affection, the patient will exhibit the desired internal negotiation, in a clear, written report or in the public or external makes his declaration of intent and purposes of general interest regarding the medical act and the circumstances are concerned. This solemn event validates the need for external voluntariness of the act desired by the patient as a positive expression of free will, spontaneous, self-informed and accurate and timely, as the fulfillment of the obligation of the contracted physician.
These three pillars that we have been discussing leads me to conclude that a conceptual principle, beyond the simple informed consent form must be completed clearly the inherent characteristics such consent carries in itself.
Then I do define as "Legitimately Declared Consent":  the express  act of will, freely expressed, and identified specific, timely and fully informed, documented, and valid, by which a patient (physically and legally) capable, accepts the diagnostic procedures and / or therapy to be performed by a physician who, in advance, has agreed to establish a doctor-patient relationship, as defined in the Act and in any manner or circumstance means the resignation of the patient to relieve their rights nor per - is-legal liability or subjective individual medical institution in an objective manner.
Conforms necessarily an act of will, which makes explicit, he never suspected there was a consensus or concurrence of wills between two subjects of law, both physical and full legal capacity to accept in terms of the law not just a doctor-patient relationship, but also all acts and procedures, diagnostic or therapeutic, clinical or surgical options, complications and risks, all of which, properly defined, clearly identified, as the patient expresses its consent to the realization of a certain behavior and nothing more, the doctor can not exceed the power conferred, such consent not to run beyond the limits set by the good faith or for the purpose in view of which has been given that right. This manifestation of free will is preceded by a relevant, timely, accurate and comprehensive information, which necessarily must be in documentary form finally signed by the contracting parties, ie, the consent must be legitimately expressed in writing and provided sustained duly signed by parties involved in the legal relationship doctor-patient contract: doctor, patient and / or their family's legal representatives in minor cases of doubt, and so on. and any other person as a witness to the event, as in the case of a relative of the patient, the nurse of the doctor, any administrative or scientific institution, and so on. It is clear that in this report must explain the specific procedure accepted and a note which indicates that the patient has understood all the explanations and the doctor has been willing to respond, and has responded to All questions asked by the patient, and, leaving clear evidence of a general understanding of the agreement, does not mean, nor can it ever mean, as is often claimed that the fact that the patient can take the risks explained, must also give a kind of immunity to the doctor or institution to claim a total exemption, general, generic and absolute liability for any damage that may result from the contractual obligation agreed, unaware that it could harm those in a given time against the doctor as subjectively or objectively to blame the institution.
Rafael Aguiar-Guevara. Paper presented for the first time at the XIII World Congress on Medical Law, Helsinki, Finland, 06 August 2000 and published in the Book of Proceedings of the Congress. Subsequently published in the book "Treatise of Medical Law", in August 2001 and ratified and extended the work of the same name, second edition, in May 2008. See "Publications".

 

 

Incidental  (contingent) Deceit: possible sentence in medical malpraxis 

In the study of the elements of the crime and more as we enter the analysis of guilt, we know the two major camps: the willful or intentional (deceit) crime, and the fault (negligence) itself.
We can easily understand that the health practitioner, apart from  the fact to be subject of intention (deceit)  strictly related to medical practice (false certification, non-therapeutic abortion, to swindle insurance companies, obstetric violence in all its forms; rape or lascivious acts patients, abandom, etc), these professionals, would be guilty of harming a patient simply by way of guilt, without intention, the product of a reckless action, or omission of appropriate conduct (negligence) or practice without proper preparation (inability) or disregard laws, ordinances and regulations. Obviously, all this, the mere consideration of the subjective analysis of the conduct of the professional but subject to liability and its various objective criteria, and other prevailing doctrines that are not subject of our consideration at this time. We will restrict ourselves to the elements that still are appearing in our Penal Code.

This error of conduct, or behavior, because of which there is an injury to another person, which involves the failure of an objective duty of care, and that only occurs in the person recklessly (vencible error) leads to the consideration of the definition of culpable homicide or injury blame, and it is clear that at no time, the health professional wanted no harm to the patient, and has never had the intention to produce it. Hence, the damage was not desired, but due to his/her  improper conduct is treated less severely than homicide or intentional injury (malice aforethought). It must be understood that, although there is no intent to produce damage, this does not mean that the conduct (reckless, negligent) did so involuntarily. No, the execution of behavior is always voluntary, but the active subject of crime is not even that his conduct caused harm can be attributed to him.
I try to be precise and clear in ideas because these lines are read by physicians in addition to lawyers, the last being clearly understood with the topic but not the former. Hence the need to repeat, once more, the old but still prevailing,  concept  of Antolisei: voluntary disregard of those rules of conduct that society imposes on men the obligation to act with prudence, diligence, with the due caution to prevent certain outcomes of harm or danger to the legally protected interests.

In this vein, we must clarify, for those who have never entered this field, there is a range, variety, grade, as to guilt is concerned. Since the pure intent, willful or intentional   up to the fault without representation (we call it the mother of fault or guilt).  It is voluntary, but the actual conduct reckless or negligent, is not represented by any damage. But between these two figures, there are two other, perhaps purely academic, they are confusing, with no limits, both are mixed in a legal limbo, which could assist the judge to convenience. The
Incidental  (contingent) Deceit and guilt (negligence) with representation of damage.
We can then note the sequence: direct malice --->   eventual deceit---> fault representation ---> guilty without representation.

The so-called fault is represented, also misnamed aware fault because as already explained in connection with the guilt, blame that, unlike the fraud, the conduct of the staff is always conscious and voluntary, yet, the subject (medical doctor) does not want the final results obtained or arising from his/her conduct. But in this case, the subject clearly represents the outcome that might result from his/her conduct, but within its sound logic thinks that such results are not only possible but probable, and that perhaps made him the unwanted situation overly confident in themselves and their expertise to prevent and eventually correct the result of damage, to prevent the gullible in updating the unlawful result. The subject has been expected and represented the injurious consequences of his/her act, but despite this he/she continues execution, hoping that no damage will occur, but in case of that presented the event, he can correct it based on your luck and skill.
This is the case of a plastic surgeon who recklessly omitted practice exams and general cardiovascular examination to the patient who is going to practice a ritidectomía or liposculpture, claiming that the surgery performed under is done  under local anesthesia, but knowing that the anesthetic used with adrenaline combined with the anesthetic, to avoid further bleeding and prolong the time of the anesthetic also have direct cardiovascular action. At the suggestion that a practicing anesthesiologist in preoperative examinations to the patient, the surgeon assures that nothing will or have  happened and never will anything happen that he hoped his luck, skill and fame. Momentarily he thinks of the damage that could happens as be   the result of his/her conduct negligent by failing exams and unwise to decide finally operate without them, but think that, although the result is possible, it is not all that likely to happen since it has never happened to him/her and was sure that this is not the time that it woulod  happen any eventuality.
In any case, for any irregularity he hoped his/her luck and skill and the blessing of all saints in time to correct the problem and avoid the results. The patient made a massive uptake of the anesthetic and adrenaline infiltrated wrongly, and has a sudden cardiac arrhythmia compounded by the presence of a mitral valve prolapse that was not previously diagnosed in time by the lack of preoperative examinations, followed by ventricular fibrillation and death. Fault representation.

For its part, the
Incidental  (contingent) Deceit (dolus eventualis) is very similar to the previous one. In fact they are so similar that there are authors who deny this position, simply stating that there is or there is not wrongdoing or guilt. The agent acts consciously and voluntarily, and although they do not really want a harmful finalist result, he/she represents the possibility of illegal conduct, but this time the set is not only possible but also probable, and yet, despite everything, no waiver of its execution, under the outcome no matter the consequences of his/her behavior that eventually concluded with the result of damage represented. The agent expected damage, represents a typical result is unlawful, in principle, he/she  did not want to do or achieve, but remains indifferent to the legal system, and continues to develop its initial activity, even though they know and therefore do not trust good luck in his or her expertise to prevent the update of this result is typically illegal. The agent thinks and says, "Whatever happens I will continue on implementation of my action and I shall accept the results". " What seems likely, almost certainly, is that I will not stop my behavior, I know that damage could be possible to result but still I act as have decided.
 
Incidental  (contingent) Deceit  (Dolo eventual) structure corresponds to that of culpable offense. While there was no intention to affect a legally protected right, which is the basis for the legislature to punish, the fact remains that there is more than mere neglect of the agent in the production of damage, and that is why punishes failure of duty to care. But beyond this mere breach of care there is a high probability, degree of certainty to cause damage in the legal guardianship, which the agent is really indifferent.
 

In a case dealt by Supreme Court, December 21-2000; final sentence stated:

Criminal Law refers to 
Incidental  (contingent) Deceit (Dolo eventual)  when the agent   represents him/her self a damage as  as possible or probable consequence of its execution, yet the process remains the same: he/she accepts his/her behavior, despite the serious dangers involved and therefore can be said that also want to agree with the result. There is talk of guilt, as to negligence is concerned, with respect to typical cases such as the one who cleans gun recklessly and accidentally hurts another, but when recklessness is so extreme that reflects a disregard for the coasociateds, caused the deaths should be punished as intentional homicide as a possible fraud: Incidental  (contingent) Deceit  (Dolo eventual) . The German criminal Günther Kaiser, Professor, University of Freiburg, express that Incidental  (contingent) Deceit  (Dolo eventual) is used in increasingly mode and more than willful misconduct of any endangerment. It concludes that a high percentage of traffic violations are committed intentionally, that is, Incidental  (contingent) Deceit  (Dolo eventual)  And the criminal Middendorff, also German in Freiburg and Professor, says that driving intoxicated, (under the influence of alcohol or drugs) fled in the event of serious commited acciden are willingly  traffic offenses, even simple, to qualify for criminal intentional offense. Therefore it should often traffic offenses reflect the existence of any deceit.
In cases of deaths in traffic, takes on great importance to discern the level between "the occidendi animus or intent to kill, on the one hand, and simply unpredictable behavior without intent to kill but that was cause of death, on the other part. I want to describe the situation of someone who had no direct and perfect malice murder, ie clear intent to kill and that his conduct, on the other hand, was much more serious than the simple cases taking the blame. In other words, the status of a person whose conduct is (in range of severity) a level lower than the direct fraud and perfect, and a higher degree than the simple absolute guilt and involuntariness. This intermediate state between dolus (intention) and culpa (negligence), this mixture of malice and guilt, blame or this informed malice or fraud, in short, this possible fraud, is keen to traffic offenses, and might be considered as Incidental  (contingent) Deceit) (
Dolo eventual)  (bold by the author)

This is true of the general surgeon, anesthesiologist, cardiologist and OB / GYN, who played a guard in a hospital emergency a given night. Learn that it has been declared a nationwide medical strike, and that unlike other strikes, the authorities in this union called the non emergency care and neglect of the hospital. All these doctors talk among themselves, remember their obligation to assist with emergencies, it does not represent the only feasible but also very likely that it reaches a patient with a serious injury by firearm and severe hemorrhagic shock, or a patient with a hypertensive crisis and myocardial infarction, or a patient at term pregnancy with a transverse position in labor and who required a caesarean section, and that led to its abandonment and non-hospital emergency care of these people will inevitably to die for failing to give anesthesia anesthesia, the surgeon who operated, OB / GYN practice that caesarean, or cardiologist who administered the drugs needed for the survival of heart attack.
They foresaw the possible, probable, almost certain damage, the results are represented proceeds of illegal conduct, they remained indifferent to the rules and their obligation as doctors to respond to emergencies, do not really want the result harmful finalist, but sympathized with continue the strike during its action, leaving the patients, creating a dangerous situation which is exacerbated by the fatal outcome of the product caused distress.
The patient dies: no doubt about 
Incidental  (contingent) Deceit (Dolo eventual)

Since the publication of my first book, Medical Law in Venezuela, in 1995, and lectures at national level, I introduced the concept of the applicability of
Incidental  (contingent) Deceit (Dolo eventual) in medical malpractice. In time there was criticism in this regard, both the medical and the legal environment, noting that, with medical practice, as a medical obligation of means and not ends, and considering that the doctor always looking for the good works of the patient, and that, in addition, in case of any crime in the area of health we always present a case of culpable offense, how could I speak of the crime of fraudulent intent as possible, within the profession of health? The discussions resulted in my account of the famous medical strike called as "zero hour" in which it called on all doctors who had to leave their places of work and presented in the respective College of Physicians. At that time, I defended the thesis by which it arose, a doctor who was on duty, as guardian of the institution, for patients to come and those already entered, and left their work site by going to appeal to medical strike known as "zero hour" represented (not just possible but probable) damage which, by its absence could lead to patients (including death, as really happened), and still be welcomed to results leaving hospital, just missing a court to consider seriously the possibility of prosecution for crimes of such physician intention as possible fraud; as Incidental  (contingent) Deceit) (Dolo eventual) . We were in 1995 when it was still in force under the inquisitorial system of law repealed Criminal Procedure Code (since repealed).
Incidental  (contingent) Deceit (Dolo eventual)  achieves this maximum expression of the following elements:
1.- The typical fact of crime is not really pursued by the active subject of it (the doctor in this case), but the alternative in the production of damage and its likely realization, it is simply indifferent to him/her.
2.- The agent (doctor) assumes the risk so called risk typical: he knows them;  they are represented in his/her mind but  yet acts with disinterest as the damage would not occur.
3.- The active agent producer of harm (doctor) does not have the certainty that the harm would not occur.
4.- His behavior is beyond, commonly, the limits of imprudence. But he/she simply does not care. Despite all these considerations, the staff is not abandoning its behavior, there is a total lack of interest because there is no damage.

As explained above, the first time I spoke of the possibility of any fraud or
Incidental  (contingent) Deceit (Dolo eventual) in the medical profession received strong criticism in two areas: the medical and legal fields. Despite criticism, held firm my position. Unfortunately we know, 9 years later (November 11, 2004) and for the duration of the Code of Criminal Procedure, which would be the first prosecution admitted with custodial measure, two doctors from Maracaibo, Zulia, on the crime of murder, for any fraud, and reported in local media (Panorama).
This was a patient who, at the suggestion of a Caesarean section was performed GYN: Both physicians and then charged defendants were partners. The patient experienced during the intervention, cerebral hypoxia that left her quadriplegic as the report details the judiciary. The doctors refused to identify the anesthesiologist. The newborn was also affected by problems of language today. The clinic had no ambulance or meet minimum standards of operation. The professionals were indicted for the crime of "intentional serious injury as possible malice" under Article 416 of the Penal Code punishable with 3 to 6 years. The interim measure requested by the Prosecutor before the Appeals Court of Zulia, because both (Campos and Gonzalez) had given them the benefit of the scheme of presentation.
Conveyed the news: "In effect the Code of Criminal Procedure (CCP), first in the country agreed to a custodial measure to two doctors for alleged medical malpractice during the investigation and further development of the trial." After a court process that began three years ago, was issued a proxy measure of deprivation of liberty for the Third Division of the Court of Appeals for the Zulia two doctors accused of malpractice. After one visit, it was determined that it does not comply with the Official Gazette number 36595, because it has no veterinary license operation. In addition, "was not carried out any formalities for the approval of the draft before the Committee on Physician Health Programs Building." The report also says that "offer emergency service and does not comply with the requirements of architectural and equipment service. There are no doctors on duty or nurse, despite the offer 24 hours service. Has no entry or indoor waiting room, no emergency power plant, there are no spaces fatigues clean and dirty and do not have ambulances. "

Subsequently, in 2006, in a case handled personally, before an injury to a patient, subject to liposculpture, and whom the treating physician, without consent of the patient, injecting fat taken from other parts of the body, through the nostrils to clear the grooves naso-genianos that in the immediate postoperative period were infected, leading to sepsis patients with a starting point the dermograsa facial necrosis and infection with 17 days of stay in intensive care, who was near death due to multiorgan failure and eventually became, among others, with serious injuries in a face and facial paralysis, is also accused the city of Barquisimeto, the crime of intentional injury as a possible fraud. The indictment was admitted even though the trial was never held for death of the doctor before the trial hearing.
Recently, February 22, 2007, we know, also reported in national newspapers, another physician who is blamed for the crime of murder as a possible fraud, for what happened in a cardiac surgery in Caracas and he gives custodial measure.
At present also maintain the representation of a victim in this case, according to prosecutor, and speaks of accuse of murder as a possible fraud, which would be the fourth case, which indicates that initial assumptions that I make many years ago is beginning to materialize.

These cases, which unfortunately will not be very unique, we show that the thesis presented by the author in 1995 was not far from reality. That is why we are convinced of the need to make some explanation on this occasion and on this particular.
In the area of prosecutions for health and medical malpractice dolus eventual actually starts, in most cases, the omission of the patient's informed consent for the conduct of diagnostic procedures and / or therapeutic, clinical or surgical. We have argued that informed consent, legitimately raised, not only moves the patient to accept unwanted risks, it is also an objective duty of the physician in response to a fundamental human right.
In the
Incidental  (contingent) Deceit (Dolo eventual) , the typical crime or action typically defined in the substantive criminal standard is not the objective of the agent, in this case the doctor who did not really want, is not his intention to cause death or injury to her patient. But the end, death or injury, is presented as an alternative, possible and probable, that he is simply indifferent. The agent, who represents the possibility and probability of harm (cognitive element) is not certain that it, the damage does not occur. However, the staff is not abandoning its behavior (volitional element). There is a total indifference and lack of interest in which the injury does not occur. Apparent activity, and the result is typical, although not prosecuted, it is discarded. Simply accepting the consequence that, by the exaggerated and unfounded confidence, he thinks that will never happen. The active subject in this case the doctor assumes the typical risks, which clearly knows, accepts, assumes and goes beyond recklessness. The lethal outcome of their action, although not certain, it was very likely, and nevertheless, despite the damage represented the agent acted simply accepting the possibility of the occurrence of damage. Unlawful acted without accepting the risk and secure the conviction that such damage would not occur, however, acted to accept the risk of their production. His performance was far from what the lex artis of their profession. Worse, these cases most often occur in day surgery units, without permits, without infrastructure and where the animus lucrandi not far from the real engine of these reckless actions.
It is precisely the behavior of the agent (doctor) after abandonment of no wrong behavior and their lack of interest because there is the tort and that a person (doctor) was able to anticipate and in fact it represents, where criminal liability arises as a possible fraud.

A major criticism is based on existing theory to say that any fraud is very imprecise in practice, considering that to be very difficult for the judge to admit ex post what might be possible or probable and how this agent was prepared to accept, accept, reject or not, it is more difficult for a person to determine, ex ante, whether the result of damage is likely or possible.
However, when we think about the applicability of the theory of possible fraud in a trial for medical malpractice, if we can be more secure, without fear of error, given the circumstances of the scientific methodology of evidence-based medicine, which The doctor not only can but should know about the risks typical and atypical of a particular procedure, diagnostic or therapeutic, clinical or surgical, which allow you to anticipate the complications and damage that may arise by their conduct, and yet indifferent to display them.
In the sentence above mentioned, when explaining the possible fraud, emphasizes: but when recklessness is so extreme that reflects a disregard for the coasociados, caused the deaths as murder should be punished as a possible fraud.
For all the above, I am fully convinced that there are many cases in which recklessness is so extreme that it reflects disdain for the so-called coasociados (ie patients), the characterization of intentional crime (homicide or injury) as possibility of
fraud, Incidental  (contingent) Deceit (Dolo eventual)  is not so ridiculous to mention it in the trials of medical malpractice, and I'm sure, unfortunately, that will continue to listen to such a classification. Just as we have been concerned about the increased demands, civil and criminal, medical, also concerned about the possibility of an increase in ratings of intentional crime as any willful misconduct, especially when we find many pseudo outpatient surgery units, operating without permits, remodeled into apartments without complying with the regulations of the governing body of health, intrusive interventions by staff because without training, multiple operations, lack of diligent care to patients, contempt and indifference by the results, including staff not qualified or trained, or training in emergency of private health.
As explained at the beginning, because the difference between representation and possible fraud is minimal, but the major difference lies in the procedure, the deprivation of liberty and the consequences when setting sentence, subject to substantial claims for damages Materials and expatrimoniales (damage). Hence its important to know about this matter. Dolus eventual is fully applicable in the trial of health professionals, and this is actually a growing concern. (Rafael, Aguiar-Guevara. Published June 15 - 2008)