Debate on legality of organ donation and transplantation under new National Health Act, 2014

THE recent debate triggered by Mr. Femi Falana (SAN) on the legality of organ donation and transplantation in Nigeria has arisen in the wake of both the promulgation of the National Health Bill, 2014 into law by President Jonathan and the publication of our new book on health and medical law in Nigeria – which expert reviewers have described as “timely”, and “bold and path-breaking”, with chapters on organ donation and transplantation, euthanasia, informed consent, abortion and reproductive health, medical negligence, traditional and complementary medicine, research involving human participants and other topics on health law and policy in Nigeria which are yet to capture the imagination of the public (Iyioha & Nwabueze, Comparative Health Law & Policy: Critical Perspectives on Nigerian and Global Health Law, London & New York: Ashgate Publishing Limited, 2015). 

 While some of the views canvassed in the debate simply trench on the novelty of medical law in Nigeria, it is not altogether surprising that the first statutory and comprehensive legislation in the country to regulate and legitimate a medical procedure that is absolutely extraordinary should elicit mixed reactions from Nigerians, of relief and gratitude in some, and the polar responses of outright jubilation or condemnation by others. Developed countries like the United Kingdom and the USA, where organ donation and transplantation have become routine, passed through a similar phase about 60 years ago when organ donation and transplantation were still rudimentary in those countries, and their lawyers equally struggled to account for the legality of the procedure under their prevailing legal systems. At that time, it was strongly believed in some respectable legal circles that the extraction of an organ from a living donor for transplantation into a recipient would amount to a criminal offence since the extracted organ could not be said to be for the treatment of the donor. But all that is now legal history and there cannot be any doubt as to the legality of organ donation and transplantation carried out within the confines of law in all developed countries. Mr. Falana’s opposition to the Nigerian Act captures the need and timeliness of a comprehensive analysis of the legal and ethical aspects of medical practice in Nigeria, including the legal history of organ donation and transplantation and the statutory transplantation framework that has been established under the new Act. But for Mr. Falana’s challenge, one would have assumed that there was some awareness of the basic issues relating to organ donation and transplantation, such as the dual criminality and lawfulness of donation and transplantation in themselves, rather than the unfortunate recourse to untenable interpretations and arguments that ignite public misgivings about the new Act.

 Most trenchantly, Mr. Falana accuses the Act and its facilitators of violating the Nigerian Constitution and infringing various fundamental rights of Nigerian citizens, in that  section 51 of the Act, according to Mr. Falana, permits non-consensual organ extraction from a live donor. Mr. Falana equally contends that section 51 makes possible the trafficking in bodies of Nigerian citizens; but we give short shrift to this latter contention because of the unambiguous criminalisation of commercialisation of human organs by sections 48(3) and 53 of the Act. So we focus on section 51 which provides the sting of his argument, as well as section 48. 

 Although Mr. Falana should be applauded for the very fact of provoking this interesting public debate, we however think that his interpretation of section 51 does not capture the legislative intent that underlies the section. According to section 51:

 1.    A person shall not remove tissue from a living person for transplantation in another living person or carry out the transplantation of such tissue except:

(a) In a hospital authorized for that purpose; and

(b) On the written authority of;

(i) The medical practitioner in charge of clinical services in that hospital or any other medical practitioner authorized by him or her; or

(ii) In the case where there is no medical practitioner in charge of the clinical services at that hospital a medical practitioner authorized thereto by the person in charge of the hospital.

2. The medical practitioner stated in subsection (1)(b) shall not be the lead participant in a transplant for which he has granted authorization under that subsection.

3. For the purpose of transplantation, there shall be an independent tissue transplantation committee within any health establishment that engages in the act and practice of transplantation as prescribed.

 Based on the provisions of section 51 above, Mr. Falana argues that ‘since medical doctors have been empowered to decide when to remove organs from living persons Section 51 of the Act constitutes an infringement of the rights of citizens’. We contend that this view is incorrect. Section 51 of the Act does not deal with consent to organ donation as contended by Mr. Falana. Rather, a live donor’s consent is regulated by section 48 of the Act; and although Mr. Falana seemed to have recognized that fact, he quickly dismissed the impact of section 48. We shall come to that soon. In stark contrast to Mr. Falana’s rendition of section 51 of the Act, we argue that section 51 clearly deals only with the issue of licensing for the practice of transplantation. In other words, no hospital in Nigeria can undertake transplantation procedure unless it is duly authorized or licensed pursuant to regulations or criteria prescribed by the National Tertiary Health Institutions Standards Committee under section 54 of the Act. Thus, section 51 of the Act ensures that only authorized and specifically licensed hospitals can provide transplantation services, and even in such hospitals no transplantation procedure can take place without further internal controls, such as consent of the appropriate officer of the hospital (usually the doctor in charge of clinical services) and the permission of an ‘independent tissue transplantation committee’ of the hospital (section 51(3)). 

Under section 51, therefore, there can be no question of any ‘me too’ hospital carrying out a transplantation procedure. Nor can such (me too) hospital justify a transplantation procedure merely on the basis of consent given by both donor and donee. Recall that without section 51, the common law permits every hospital and qualified doctor to offer transplantation services, subject to the consents of the donor and recipient of an organ, as well as the use of medical negligence theory to ground the transplant surgeon’s liability. In essence, section 51 is wisely intended to obviate the application of common law which would have rendered the provision of transplantation procedures a free-for-all medical practice. As section 51 is basically a licensure provision, it does not have the effect attributed to it by Mr. Falana – non-consensual extraction of live donor organs. In contrast, the issue of donor’s consent to organ donation is dealt with in section 48 to which we turn. 

The section provides:

48. (1) Subject to the provision of section 53, a person shall not remove tissue, blood or blood product from the body of another living person for any purpose except;

(a) with the informed consent of the person from whom the tissue, blood or blood product is removed granted in prescribed manner;

(b) that the consent clause may be waived for medical investigations and treatment in emergency cases; and

(c) In accordance with prescribed protocols by the appropriate authority.

(2) A person shall not remove tissue which is not replaceable by natural processes from a

person younger than eighteen years.

(3) a person who contravenes the provisions of this section or fails to comply therewith is

guilty of an offence and liable on conviction as follows:

(a) in the case of tissue, a fine of Nl,000,000 or imprisonment of not less than two years or both fine and imprisonment; and

(b) in the case of blood or blood products, a fine of N100,000 or imprisonment for a term not exceeding one year or both fine and imprisonment.

 Clearly, section 48(1)(a) above provides the architecture of live organ donation in Nigeria and uses informed consent of a donor as the applicable regulatory model. Although Mr. Falana acknowledges this, he asserts that the exception for ‘medical investigations and treatment in emergency cases’ under section 48(1)(b) vaporizes the potency of the protection provided under section 48(1)(a). We do not think that this construction of the effect of section 48 is justifiable. A bit of introduction of the doctrine of informed consent is necessary, even at the risk of boring our professional readers. But we intend only a cursory review of the concept. Informed Consent is an ethical and legal doctrine that requires healthcare professionals to obtain the consent of their patients before treatment is administered or surgery performed. The principle of patient autonomy is foundational to the doctrine of informed consent: patient autonomy recognizes the right of every patient to decide what is to be done with his or her body as well as every patient’s right to bodily integrity. 

 Informed consent, which applies in both medical research and treatment, arose because of the Nuremberg trials in 1946 and the horrific inhuman experimentation carried out by medical physicians. Principle 1 of the Nuremberg Code established after the trials stipulates the requirement of voluntary consent as essential to the grant of consent for research purposes, accompanied by the individual’s knowledge and understanding of the nature of the subject matter involved. The new National Health Act (NHA) incorporates the informed consent doctrine in section 23, which provides for the right of every patient in Nigeria to informed consent in matters of diagnosis and treatment and the right of every patient to refuse health services. We have noted in our writings on the evolving field of health law and policy in Nigeria that informed consent has been a challenging subject for many health professionals. In fact, some have assumed that the concept is merely a tool for health professionals to get their patients to accept the professional’s own idea of what is best for the patient, rather than as a mechanism for facilitating a patient’s independent decision-making. As we have further noted in our work on health law and policy in Nigeria, demographic factors in Nigeria such as illiteracy and poverty and cultural and social dynamics can maintain an existing culture of submission to medical authority in medical decision-making without the patient fully grasping the implications of the decision. If these were the concerns of Mr. Falana, that would be understandable.

 The fact that the NHA does not define what constitutes ‘medical investigations and treatment in emergency cases’ under section 48(1)(b) of the Act further fuels Falana’s angst about his perceived displacement of the informed consent rights of Nigerians in emergency situations in the new Act. His argument on this point, however, is also not substantiated by the exceptions to the informed consent principle, of which the circumstance of emergency is one. It is particularly relevant that informed consent functions within certain constitutive elements or conditions, including whether the individual from whom consent is sought has the necessary competence to do so. To be competent to provide consent, the patient must have the mental capacity to consent and must have attained the age of majority, which is 18 in Nigeria, or if younger than 18, is able to appreciate the nature and consequences of the proposed treatment; the patient must also be conscious and mentally capable to provide consent. Indeed, the Code of Medical Ethics of the Medical and Dental Professions in Nigeria outlines this clearly. According to the Code, a competent patient in Nigeria is one who has attained the age of 18 and is not mentally impaired or unconscious. Where a patient is incompetent by virtue of age, mental impairment or being unconscious, a next-of-kin must provide the necessary informed consent for a procedure to be carried out. Where there is no next-of-kin, the highest-ranking physician in a hospital is given the power to give appropriate directives to preserve the life of the patient, and where necessary, a court order may be required to enable a life-saving procedure to be carried out by the physician. Of course – and as clearly stated in the Code – these safeguards are in place to protect the fundamental rights of every patient.  

From the discussion above, therefore, we argue that based on the Code of Medical Ethics, ‘emergency’ under the NHA involves a situation where a patient is in urgent need of life-sustaining medical attention and is either unconscious or unable to provide the necessary consent either explicitly or implicitly, nor is the patient’s next-of-kin, legal guardian or representative available to give proxy or substituted consent. This is consistent with common law’s approach to emergency treatment as evident in numerous cases on the topic, which recognize the legal rule that health professionals can, without risking legal repercussions, take measures to save the life of an ‘incompetent’ patient without the consent of the patient’s next-of-kin or legal representative due, of course, to an inability to reach the latter promptly before the performance of a time-sensitive life-saving medical procedure. Simply stated in legalese (with apologies to readers who are non-lawyers or experts), there is in law a presumption of consent to medical treatment in cases of incapacity where there is neither an advanced directive nor any of the other proxy or substitute decision-makers identified above. Thus, the common law on emergency treatment is fairly basic. 

Note, however, that instead of the simple characterization of the topic as ‘emergency treatment’ as is often the case in the medico-legal literature, the Act uses the cognomen of ‘medical investigation and treatment in emergency cases’. But this adds nothing to the standard acceptation and understanding of the medical emergency exception to the doctrine of consent. The ‘medical investigation’ part of the phrase simply means ‘medical diagnosis’, so that if the entire phrase is read together it means medical diagnosis and treatment provided in a period of emergency. This means that, at least, the removal of tissues, blood and blood products for non-therapeutic research involving human subjects or other purposes such as transplantation is not contemplated by section 48(1)(b). The emphasis is ‘treatment’ in the course of an emergency.

More to the point, Mr. Falana argues that the exception for medical emergency means that, during such a period, a doctor could harvest organ from the victim of an emergency for the purpose of transplantation into another person. Again, this view is incorrect. The emergency exception under section 48(1)(b) deals squarely and solely with ‘treatment’ (that is, therapy) given to the victim of an emergency, including the medical diagnosis (of the victim of emergency) done pursuant to such treatment, such as necessary blood tests or, where the victim is scheduled to receive a transplant, histo-compatibility tests. Extracting an organ from a victim of medical emergency for the purpose of transplantation into another person or for any other non-diagnostic or non-therapeutic purpose, does not qualify as the ‘treatment’ of that victim under section 48(1)(b). More poignantly, live organ donation, qua donation, whether the donor is a victim of medical emergency or absolutely healthy, does not amount to medical treatment of the donor, and as such consent must be obtained for such donation. That was why, as we stated at the beginning of this piece, many developed legal systems thought, at the dawn of transplantation technology, that it was criminal and unlawful to extract an organ from a live donor because the surgery could not be said to be for the treatment of the donor. Contrary to Mr. Falana’s argument, therefore, the emergency exception does not permit organ donation or non-consensual extraction of organs from sick persons by doctors.

As an epistemic matter every debate is arguably beneficial, so we praise Mr. Falana for triggering the extant debate on organ transplantation in Nigeria, though we have felt obliged to deconstruct his argument in order to highlight its errors, and to posit a more rigorous analysis of the relevant sections of the Act. Nevertheless, the Act falls short of clarity in a number of cases – cases we have carefully detailed in our work and new book on Nigerian health law and policy. Finally, it should not be forgotten that the National Health Act 2014, although comprehensive, should not be taken to have filled every gap and provided for every situation relating to the topics it dealt with. That is rarely done by any statute. Therefore, the common law is handy to fill any gap left behind by the Act. Not even the more comprehensive Human Tissue Act, 2004 in England and Wales dealt with every conceivable situation. The English and Welsh Act does not even regulate the extraction of organ from a live donor and only covers the storage and use of such organs; the legality of organ extraction from a live donor is still regulated by the English common law despite the comprehensiveness of the English and Welsh Human Tissue Act, 2004. 

• Policy Consultant; Assistant Adjunct Professor, University of Alberta, Canada; Barrister and Solicitor, Nigeria;

• Associate Professor of Law, University of Southampton, United Kingdom; Barrister and Solicitor, Nigeria.

• The authors (By Dr. Irehobhude O. Iyioha (Ireh Iyioha) and Dr. Remigius N. Nwabuezeare )co-editors of the book, Comparative Health Law and Policy: Critical Perspectives on Nigerian and Global Health Law (London & New York: Ashgate Publishing Limited, 2015) and enquiries may be directed to [email protected].