Establishing National Bioethics Committee: The case of Nigeria

The establishment of a National Bioethics Committee is a requirement for member states of UNESCO who are signatories to the UNESCO 2005 Universal Declaration on Bioethics and Human Rights. The Universal Declaration on Bioethics and Human Rights advocates for an independent, multidisciplinary, and pluralist National Bioethics Committee at the national, regional, local or institutional level. Therefore, the National Bioethics Committee is expected to conform to the guidelines of the Declaration. According to UNESCO’s Assisting Bioethics Committee project document, the National Bioethics Committee is to provide advice on ethical issues member states may encounter in research development, application of scientific knowledge, formulating recommendations regarding guidelines and legislation, develop tools for standard setting, strengthening coordination and contacts among experts and institutions, foster debates, education and public awareness and engagements in bioethics. The National Bioethics Committee is to reinforce the role of UNESCO as an international clearing house for ethical issues, as well as act as an intermediary body for the implementation of the normative instruments adopted by member states. As a member state of UNESCO and a signatory to the 2005 Universal Declaration on Bioethics and Human Rights, Nigeria is expected to establish a National Bioethics Committee that is independent, multidisciplinary, and pluralist. This paper highlights the several meetings and steps taken to establish the Nigerian National Bioethics Committee, as well as the challenges.


Background
Nigeria became a member state of UNESCO in 1960.In 2005, it joined the rest of the members to adopt and sign the UNESCO Declaration on Bioethics and Human Rights.Being a signatory to the 2005 UNESCO Declaration comes with the obligation to establish a National Bioethics Committee to implement the various instruments established and adopted by UNESCO.This is because the Declaration demands the establishment of an independent, multidisciplinary and pluralist bioethics committee at national levels, and further down to regional, local or institutional levels (UNESCO 2008).Since 2009, Nigeria as a member state of UNESCO has been struggling to establish its National Bioethics Committee.
A bioethics committee is a committee that systematically and continually addresses the ethical dimensions of (a) the health sciences, (b) the life sciences, and (c) innovative policies.The term "bioethics committee" means that a group of people with expertise in diverse disciplines headed by a chairperson meet regularly to address issues that are not simply factual, but are profoundly normative (Elgharib, 2015;UNESCO 2005).
The National Bioethics Committees of UNESCO member states operate under the aegis of the Universal Declaration on Bioethics and Human Rights (UDBHR, 2005).It enshrines bioethics in international human rights laws and links the ethical issues that may arise in member states with the need to respect human dignity, human rights, and fundamental freedom (UDBHR, 2005).
In the National Bioethics Committee, policymaking is done as a participatory, pluralistic process through deliberation and is influenced by the local and international social context (UDBHR, 2005).The National Bioethics Committee of member states is expected to work in line with the Universal Declaration on Bioethics and Human Rights and to pay attention to local customs, demands, histories, needs, and traditions, so as to safeguard the development of context-sensitive to public policies, as far as respect for cultural diversity is an important consideration.It must be in accordance with human dignity, human rights, fundamental freedoms, and principles (UDBHR, 2005).
Despite being a signatory to the 2005 UNESCO Declaration, Nigeria did not make any effort to execute the terms of the Declaration and was left without a National Bioethics Committee for a very long time.The consequences of the infamous drug trial of unapproved trovafloxacin drug (Trovan), on children in Kano, by Pfizer in 1996 were what triggered Nigeria to establish the National Health Research Ethics Committee (Ewuoso, 2016).The experiment which led to the death of so many children and left so many others with debilitating illnesses like blindness, deafness, paralysis, and neurological disorders, and which was neither authorized nor approved brought to the fore, the stack reality of the dangers of unethical practices (Ewuoso, 2016: Ezeome & Simon, 2010;Loewenberg, 2008;Raufu, 2003).An attempt to forestall such unethical and dubious enterprise in healthcare and medical research was the impetus for the establishment of the National Health Research Ethics Committee (NHREC) of Nigeria (Ewuoso, 2016).The NHREC is domiciled in the Ministry of Health; the Committee's mandate is limited to health research ethics (NHREC 2007;Yakubu & Adebamowo, 2012).
The established National Health Research Ethics Committee (NHREC) does not have the mandate of fulfilling the 2005 UNESCO Declaration on Bioethics and Human Rights (UDBHR), given that it was established specifically for just health research.The mandate of the National Health Research Ethics is therefore restricted to health research as the name implies.There is therefore a gap in addressing ethical issues that border around societal, agricultural, educational, security and defence and health ethics in the country.The NHREC does not have the mandate to stir up debates on these mentioned ethical issues.For example, ethical debates around artificial intelligence (AI) or agricultural use of genetically modified crops would not be addressed by NHREC, but the National Bioethics Committee.However, if a research proposal on artificial intelligence or the effect of the use of genetically modified crops on human life is to be done in Nigeria, the research proposal would be submitted to the NHREC for review and approval.The NHREC reviews protocols submitted to it, but not to The Global Health Network Collections • African Journal of Bioethics Establishing National Bioethics Committee: The case of Nigeria 4 stir up debates on ethical issues.This obvious limitation kept the commanding need for a National Bioethics Committee in Nigeria alive.Suffix it to say that the NHREC is a member of the National Bioethics Committee.
The NHREC would not only continue to handle every protocol review that relates to health research, it would also be present in every meeting and activity of the National Bioethics Committee.The author and her coworkers had discussed the local perspectives and the importance of having a National Bioethics Committee in Nigeria elsewhere.(Princewill et al, 2021).It is important to note that the National Bioethics Committee is neither to compete with nor replace the already existing National Health Research Ethics Committee (Princewill, et al, 2021).Rather the National Bioethics Committee would act as an advisory body to the government of the federation and relevant policy makers.The scope of the National Bioethics Committee is allencompassing and will continue to expand to accommodate changes in society and advancement in several disciplines and sectors of the country (Princewill, et al, 2021;2022).
In 2012, the author was appointed the Desk Officer for the Nigeria-UNESCO Bioethics by the Federal Government and was privileged to work in liaison with the Nigerian National Commission for UNESCO (NATCOM-UNESCO), and other major stakeholders including the Federal Ministry of Science, Technology and Innovation (FMSTI), as well as the NHREC to actualize the dream of establishing the National Bioethics Committee in Nigeria.
The aim of this paper is not only to highlight the process it took Nigeria to establish its National Bioethics Committee, but to serve as a guide to member states of UNESCO aspiring to establish a National Bioethics Committee.

Methodological processes
The birthing of a National Bioethics Committee in Nigeria systematically passed through four distinct steps: The timeline of these activities and their outcomes are subsequently documented.

(a). UNESCO Midwifing of the Drive for National Action Plan
The drive for the establishment of a National Bioethics Committee in Nigeria began in 2009.At the request of the Federal Government of Nigeria, the United Nations Educational, Scientific, and Cultural Organization (UNESCO) through its "Assisting Bioethics Committee" (ABC) Project sponsored and organized the first institutional arrangements in public and private sectors in a manner that can improve overall national ethos (Princewill et al, 2022).
Technical Working Groups (TWGs) were set up at the August 2019 meeting in line with the identified areas for the development of the respective sectorial frameworks and policies with particular attention to ethical principles and practices.Each technical working group was headed by a Chairperson.The groups were made up of experts in the relevant fields.They were drawn from Ministries, Agencies, Civil Society Organisations, Universities, and other Institutions.The meeting generated preliminary sketches and contents on the different areas for both the National Bioethics frameworks and the National Bioethics Policy Documents.Specifically, each TWG defined their areas of focus and critically deliberated on them to generate ethical issues to be addressed (Princewill et al, 2021).
From the 15th to the 16th of October 2019, the six TWG Chairpersons met in Abuja for two days to collate and fine-tune the Bioethics working documents produced by the Technical Working Groups (TWGs) in August 2019.Prior to this October meeting, the Chairpersons had taken time in consultation with team members to further develop the initial drafts of the National Bioethics Framework and Policy Documents in their respective areas raised at the Stakeholders meeting, to provide more robust and technical content with better differentiation.In the process, incremental drafts were drawn up.Following peer reviews and the technical support of senior staff of the National Biotechnology Development Agency (NABDA), a final draft was produced (Princewill et al, 2021).The full report of the transactions of the third National Bioethics Stakeholders Conference is published elsewhere (Princewill, 2022).

(d) Establishment and Inauguration of the Nigerian National Bioethics Committee
Following the Presidential approval, on the 18th of April, 2023, the Nigerian National Bioethics Committee was established and the members inaugurated.
In a nutshell, the breakdown of the methodological processes involved the following: Act as an umbrella body to all ethics committees in the country Act as an advisory body to the government and policy makers by providing recommendations and guidance to government and the public, thereby ensuring that public policies are informed by ethical concerns so as to ensure the Rights, Freedom, and Dignity of the citizens.
Facilitate public debates on bioethical issues, educate the public, review proposals, and set ethical standards which will ensure the Rights, Freedom and Dignity of all citizens.
Conform to the Universal Declaration on Bioethics and Human Rights by ensuring that science does not take preeminence over the lives of the citizens

Challenges
The process of establishing the Nigerian National Bioethics Committee was not an easy feat.
There were numerous impeding factors, ranging from lack of political will, ignorance, vested interests, lack of funding and bureaucratic bottlenecks.Typically, those occupying the commanding heights of policy drive in Nigeria lack the political will to do the needful.It becomes worse when it is complicated by ignorance.
Bioethics is new to the Nigerian lexicon, so apart from medical ethics, most people do not understand and appreciate the frontiers of bioethics.Consequently, there were doubts and questions as to what the Committee would be representing how it was different from the existing National Health Research Ethics Committee (NHREC).The doubts and questions were largely due to a lack of understanding.Nigeria seems to be lagging behind in understanding the workings and operations of the National Bioethics Committee.It took Nigeria fourteen (14) years to come to terms (if at all) with the difference between the Research Ethics Committee and the National Bioethics Committee (Princewill & Malomo, 2023).It took Nigeria fourteen years to understand that bioethics is much more than health or medical research.In fact, some people are still struggling to understand the holistic nature of bioethics.We were able to overcome the challenge of lack of understanding by being dogged and resilient, laced with patience and lots of explanations as to the difference between the National Bioethics Committee and the National Health Research Ethics Committee to the government, policymakers, the Federal Ministry of Health, and the NHREC, as well as the budget office to have a budget line for the process of Establishing a National Bioethics Committee.It was important to have them understand that there would not be overlapping functions between the NHREC and the National Bioethics Committee because the NHREC is a member of the National Bioethics Committee.
Further to the above, is the issue of vested interest.Everything in Nigeria is seen from the perspective of politics.People in power and even public servants show demonstrable vested interest in most things and try to frustrate well-meaning programmes except they are beneficiaries.These account for most bureaucratic bottlenecks and hiccups.As a consequence, little things such as the release of funds, movement of mails and reports, and feedback from the anticipated executor of assignment of projects take an unreasonably long time to be accomplished.It took the stern resolve of the current Director-General of NABDA to overcome a lot of Provide advice on ethical issues member states may encounter in; research development, application of scientific knowledge, formulate recommendation regarding guidelines and legislation, develop tools for standard setting, strengthen coordination and contacts among experts and institutions, foster debates, education and public awareness and engagements in bioethics.
Reinforce the role of UNESCO as an international clearing house for ethical issues, as well as act as intermediary body for the implementation of the normative instruments adopted by member states.
To implement various instruments (Declaration) established and adopted by UNESCO The Global Health Network Collections • African Journal of Bioethics Establishing National Bioethics Committee: The case of Nigeria 11 these obstacles.Lack of funding support from the government was and still remains a problem.There is insufficient budgetary allocation to accomplish this assignment and even now that the Committee has been established, there is no budgetary provision for it to take off.It is hoped that the government will give a budget line for the National Bioethics Committee so as to enable it to function optimally.

Conclusion
It is clear that Nigeria is lagging behind in appropriating the benefits of Bioethics.There is a need for vigorous awareness creation, advocacy and education of Bioethics in Nigeria for those in authority, as well as the citizens (Princewill et al, 2021).The importance of formal, systematic and continuous education, integration of those in government, policymakers, the media, and caregivers as well as the citizens cannot be overemphasised.
Nigeria has successfully established its National Bioethics Committee in line with the 2005 UNESCO Declaration on Bioethics and Human Rights.The methodological processes and activity footprints are presented.The timeline for accomplishing this assignment is unenviably long for the different reasons that have been adduced.For an effective and vibrant National Bioethics Committee, awareness creation is the key.
It is hoped that the National Bioethics Committee will receive the expected attention of the Nigerian government at the national level because Bioethics Committees are most effective when their incorporation into government is statutory.This will grant the Committee the stability and legitimacy to carry out its functions effectively and efficiently (UNESCO, 2005).
The criteria for measuring the effectiveness and efficiency of the Committee would be seen in policy creation and changes, as well as guideline formulations that are informed by ethical concerns so as to ensure the Rights, Freedom, and Dignity of the citizens.
of the National Bioethics Committee National Bioethics Stakeholders meeting in Abuja, Nigeria.The meeting which was held from 29th March to 1st April 2009 brought together about thirty (30) participants, representing relevant institutions and organizations.The objective of the meeting was to provide the Nigerian government with the information needed for the establishment of a National Bioethics Committee.At this maiden meeting, UNESCO explained that when the Committee is established, it would provide technical assistance to Nigeria after a Memorandum of Understanding has been signed between the Nigeria National Bioethics Committee and UNESCO.At the 2009 meeting, the National Biotechnology Development Agency (NABDA) was nominated to be the Focal Agency to drive the process of establishing the Nigerian National Bioethics Committee.Invariably, this made NABDA the Focal Point for the Nigeria-UNESCO Bioethics.It was also at this maiden meeting that the Federal Ministry of Science, Technology & Innovation was made the host Ministry because it is the mother ministry of the National Biotechnology Development Agency (Princewill et al, 2021).UNESCO again organized and sponsored the second National Bioethics Stakeholders meeting in Akwanga, Nasarawa State, Nigeria from 7th to 8th June 2017.The aim of this second meeting was to prepare and review drafts of the status of the proposed National Bioethics Committee, as well as prepare a Memorandum of Understanding to be signed with UNESCO.This second meeting was therefore a follow-up on the 2009 National Bioethics Stakeholders' Meeting.During this meeting, a road map was developed.In that Roadmap, NABDA, as the Focal Agency for Bioethics was mandated to produce the National Bioethics Framework and the National Bioethics Policy Documents needed for the establishment of a National Bioethics Committee.At this second meeting, it was also agreed that NABDA will be the Secretariat of the National Bioethics Committee(Princewill et al, 2021).(b).Development of the National Bioethics Framework and Policy DocumentFrom the 20th to the 22nd of August 2019, the Federal Government, through the National Biotechnology Development Agency (NABDA) in collaboration with the Nigerian National Commission for UNESCO (NATCOM-UNESCO) which is the clearing house for UNESCO in Nigeria, organized and sponsored the third National Bioethics Stakeholders meeting in Abuja, Nigeria.The main objective of the meeting which drew over a hundred persons from different institutions; civil society, government and private sectors from all over Nigeria was to develop the first draft of the National Bioethics Framework and the National Bioethics Policy Documents.Building on cumulative deliberations from the previous meetings, and broad-based consultations, bearing in mind the current national realities, six thematic areas were identified and agreed upon at the Abuja meeting for the development of the National Bioethics Documents: They are; agriculture, defence & security, education, environment, health, and society.These six areas demand special attention to learning, social dynamics, safety and protection of life and environment in the context of human dignity, human rights and fundamental freedoms.The initial prioritisation was to enable focused deployment of interventions to important areas that could bring about early results in terms of heightened moral standards, attitudes and practices.The development will facilitate systematic programming towards ethical evolution by the relevant The Global Health Network Collections • African Journal of Bioethics Establishing National Bioethics Committee: The case of Nigeria 6 Sometime in December 2019, the National Bioethics Framework and Policy Documents required for the establishment of a National Bioethics Committee were developed and sent to the Federal Ministry of Science, Technology & Innovation.Before the two National Bioethics Documents were sent to the Ministry; copies of the National Bioethics Framework and the National Bioethics Policy were sent to the Nigerian National Commission for UNESCO (NATCOM-UNESCO) and to the UNESCO Regional Office in Abuja, Nigeria for their necessary inputs.On the 4th and 11th of February, 2021, the National Bioethics Framework and the National Bioethics Policy Documents were ceremoniously handed over to the Ministers of the Federal Ministry of Education and the Federal Ministry of Science, Technology & Innovation respectively.This was done because the Federal Ministry of Education is the mother ministry of the Nigerian National Commission for UNESCO, and the Federal Ministry of Science, Technology & Innovation is the Host ministry for the National Bioethics Committee and the mother ministry for the National Biotechnology Development Agency (NABDA), which is the Focal Agency and the Secretariat for the National Bioethics Committee.These two ministries would jointly The Global Health Network Collections • African Journal of Bioethics Establishing National Bioethics Committee: The case of Nigeria 7 in a memorandum submit the National Bioethics Document to the Federal Executive Council for Presidential approval.Early in May 2022 the National Bioethics Documents were sent to the Federal Executive Secretariat for onward submission to the Federal Executive Council for Mr. President's approval.On the 11th of May, 2022 the President approved the National Bioethics Documents for the establishment of the National Bioethics Committee to ensure sectorial ethics for sustainable national development in line with international best practices.
state of UNESCO, the Nigerian National Bioethics Committee just like the National Bioethics Committee of all other member states of UNESCO and a signatory to the 2005 UNESCO Declaration on Bioethics and Human Rights is expected to do the following: