An Appraisal Of The Regulatory Framework For Genome Editing In Nigeria
By Oyetola Muyiwa Atoyebi, SAN
INTRODUCTION
Technological advancement, as a major tool for remoulding the human world, has taken a dynamic approach in recent times. Recent breakthroughs have made it possible for the natural genetic compositions of biological organisms to be alterable or manipulable by some scientific procedure with an unprecedented level of accuracy, ease, and precision. Often referred to as genome editing, gene editing, or genome engineering, this science allows for the alteration of the genome[1] or gene[2] of a living organism by the insertion, modification, deletion, or replacement of DNA in the organism. While this has been applauded for its prospective benefits in several spheres of human endeavours such as plant and animal agriculture,[3] human medicine,[4] environmental conservation etc., its potential risks[5] have also made it a slippery slope, one through which cautionary steps must be taken. This has made governments of nations, who have exhibited keen interest in the technology, to put in place legal and regulatory frameworks for the control, transfer, usage and disposal of the technology.
Nigeria is not left behind in the journey of the discovery of the benefits biotechnology has to offer the nation, and more particularly its potential effect of improving and unlocking new partnerships with other more advanced countries of the world.[6] As a signatory to the Cartagena Protocol on Biosafety (CPB) of the Convention on Biological Diversity of 2000 which was ratified in 2003, Nigeria has gone ahead to make laws for the regulation of biotechnological research, production, usage transfer etc., and in recent times gene editing as a form of biotechnology. In 2015, Nigeria passed the National Biosafety Management Agency Act which established the National Biosafety Management Agency as a regulatory body to ensure and enhance the safe practice of biotechnological research.[7] Amended in 2019 to include as part of the powers and functions of the Agency the provision of measures to ensure bio-security[8] and the prohibition of scientific research on gene drive, gene editing and synthetic biology without the prior approval of the Agency,[9] the Act further makes provisions to guide the process of request and approval for the importation, exportation, transit, the contained usage, confined field trial, multi-locational trial etc., of a genetically modified organism[10] as well as the procedure for approval for carrying out gene drive, gene editing and synthetic biology.[11] Furthermore, in 2020 the Agency issued a biosafety guideline[12] providing a step-by-step procedure for the application for approval to carry out any form of gene editing in the country as a means to ensure that scientific researches in this regard take into cognizance the health and safety of the people, the environment, etc.
This article seeks to examine the concept of genome editing and to appraise the regulations put in place by the Nigerian government to guide the practice of genome or gene editing.
WHAT IS GENOME EDITING
Genome editing is the scientific process that allows the genetic composition of an organism to be altered either by the introduction of DNA from a different source or some form of modification or deletion of a DNA of a host source. The practice of genome editing allows for the gene of an organism to be modified either by the insertion, deletion, or other forms of alteration targeted at a specific location in the genome. This technology has been applauded as possessing potentials which are beneficial to human society in several ways including the possibility of curing some genetic diseases or improving certain genetic traits in a person, improving agriculture by boosting crop yield through genetic modification of plants, etc.
Nigeria among the league of nations has signaled interest in the technology but has evinced an intention to ensure the safety of its citizens before seeking to harness the benefits of the technology. As a signatory to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity 2000, Article 2 of which enjoins parties to “take necessary and appropriate legal, administrative and other measures to implement its obligations,” Nigeria has made several provisions to protect biosafety in the use and research on biotechnology.
THE REGULATORY FRAMEWORK FOR GENOME EDITING IN NIGERIA
As stated earlier, Nigeria has actively indicated its interest among the comity of nations in embracing this technology. It has also taken into cognizance the safety concerns the technology is likely to generate. Hence in accordance with the obligations imposed by the provisions of the Convention of Biodiversity as well as the provisions of Article 2 of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, the Nigerian legal terrain has since changed to accommodate rules on biosafety in relation to biotechnology and in very recent times specifically on gene editing.
THE NATIONAL BIOSAFETY MANAGEMENT AGENCY ACT 2015 (AS AMENDED IN 2019)
Section 1 of the Act establishes the National Biosafety Management Agency and bestows it with power to, among others:
- Ensure the effective management of all components of the Nation’s Biosafety,[13]
- Propose the overall policy guidance on issues of Biosafety in Nigeria, subject to the approval of the Governing Board of the Agency,
- Accept and take samples from and undertake experimental analysis of crops, products or materials to determine whether they contain a recombinant DNA and to ensure compliance with the provisions of the Act,
- Receive and verify applications from such persons whether natural or artificial in respect of genetically modified organisms (GMOs) and keep records of all approvals and unapproved applications as required by the Act,
- Take such steps as are necessary to ensure compliance with the legal obligations imposed by the Act including, the conduct of research activities with GMOs under the Act, inspection of facilities, the collection and analysis of such materials as are allowed under the Act, the monitoring of human health and the environment to establish the effects of GMOs,
- Create measures to ensure bio-security,
- Take and maintain an inventory of laboratories with the necessary physical and human capacities to conduct research in modern biotechnology,
- Collaborate with other relevant national and international bodies for the effective realization of the Agency’s mandate, etc.[14]
The Act made provisions to bar any person or authority from engaging in the importation, exportation, a confined field or multi-locational trial, a commercial release or transfer of a GMO without the approval of the Agency. [15] It also barred the import, export, commercialisation, etc. of a GMO or its product intended for food or processing,[16] or carrying out gene editing, gene drive or synthetic biology without the prior approval of the Agency.[17]
Moreover, the Act provided extensive guidelines for the request and approval of such activities earlier stated.[18] Of particular importance is the fact that the emphasis placed on the risk level of any of such activities on the health and safety of humans, animals, and the environment as a whole. An applicant is mandated before the submission of any application for approval to carry out a risk assessment report which will indicate “the potential risk, if any, that the GMO may pose to human health including food safety, biological diversity or the environment including the consequence of unintentional releases.”[19]
The Act is carefully detailed on the procedure for application as well as the review and approval of such application, having a special interest in the health and safety of persons and life generally, which the Act seeks to protect.
THE NATIONAL BIOSAFETY POLICY 2017
The Policy was made pursuant to the powers conferred on the Agency in the establishing law. The Policy provides a framework to protect the natural resources of the country as well as the health and safety of the people from the risks posed by the “development and application of GMOs and its derived products.” The policy provides as its scope, the regulation, evaluation and monitoring of the development and use of GMOs in Nigeria, the establishment of the criteria for assessing potential risks associated with the use of GMOs, the development of capacity in Nigeria for the effective management and mitigation of the potential risks, etc.
THE NIGERIAN NATIONAL BIOSAFETY GUIDELINES ON GENE EDITING
The Guidelines were issued by the National Biosafety Management Agency to guide the safe use, transfer, and general research on gene drive, gene editing, and other related scientific procedures. It makes general provisions for applicants who wish to carry out gene editing as well as the release of gene-edited products in Nigeria. It is noteworthy that the provisions of the guideline do not apply to such pharmaceutical processes and products which are not covered by the provisions of the National Biosafety Management Agency Act. [20]
Part 3 of the Guidelines goes further to provide for the procedure for application. A person(s) or company intending to carry out any form of genetic engineering, editing, or research or otherwise deal with a genetically modified organism (GMO) in any manner including confined field trial, multi-locational trial, import, export, etc., shall submit an application to the Agency using the prescribed Form.
The Agency shall acknowledge the said application in writing within 21 days and upon an internal review of the application, may request additional information where necessary and shall convey its decision from the internal review to the applicant.
It is noteworthy to state that the Nigerian approach to the regulation of gene editing as well as the products of the process entails that “where the gene editing requires the use of recombinant DNA sequences[21] or the gene-edited product has a novel combination of genetic material (e.g. uses a recombinant DNA which remains in the final product), the product will be classified as a GMO and will be regulated as such. However, where the gene editing or the product thereof does not lead to or does not have a new combination of genetic material (e.g., does not use a recombinant DNA or uses a recombinant DNA which is removed in the final product), a non-GMO regulatory classification” will be applied.[22] Hence the decision of the internal review conducted by the Agency will depend on whether or not the product contains a recombinant DNA capable of being classified as a GMO. Where the product does not contain a recombinant DNA, a Biosafety Approval will be granted but where such product is found to contain a recombinant DNA, a further review of the Application shall be made in accordance with the provisions of the Act and the 2017 Guidelines discussed above.
Some other laws exist which though do not directly touch on gene editing, may become of necessary reference in determining the extent of certain actions which may be taken on the subject of genetic modification. Such laws include the Customs and Excise Management Act,[23] the National Agricultural Seeds Act,[24] the National Agency for Food and Drug Administration and Control (NAFDAC) Act,[25] etc.
CONCLUSION
Technological advancement no doubt impacts positively on the human society. Gene editing as an emerging technology no doubt will help combat genetic diseases and improve other aspects of human medicine, agriculture and other aspects of human endeavours. This technology, however, must be approached with caution as it poses biosafety risks. Nigeria, taking cognizance of these biosafety concerns, has gone to make extensive rules on the procedure for application for biotechnological research and particularly gene editing in a bid to ensure that biotechnological research in Nigeria is carried out with regard to human safety and biological resources preservation.
SNIPPET
Gene editing has overwhelming benefits but the potential adverse effects make the technology one to be approached with legal caution.
KEYWORDS
Genome editing, biosafety, biotechnology, genetic engineering, Nigerian legal framework.
AUTHOR: Oyetola Muyiwa Atoyebi, SAN
Mr Oyetola Muyiwa Atoyebi, SAN is the Managing Partner of O. M. Atoyebi, S.A.N & Partners (OMAPLEX Law Firm).
Mr. Atoyebi has expertise in and a broad knowledge of Technology Law and this has seen him advise and represent his vast clientele in a myriad of high-level transactions. He holds the honour of being the youngest lawyer in Nigeria’s history to be conferred with the rank of Senior Advocate of Nigeria.
He can be reached via [email protected]
CONTRIBUTOR: Bibiana A. Adeniji
Bibiana is a member of the Dispute Resolution Team at OMAPLEX Law Firm. She also holds a commendable legal expertise in Technology Law.
She can be reached via [email protected]
[1] The complete genetic information (either DNA or in some viruses, RNA) of an organism.
[2] A unit or segment of a cell or an organism’s DNA or RNA. A basic component of a genome.
[3] Tripathi, L., Dhugga, K.S., Ntui, V.O., Runo, S., Syombua, E.D., Muiruri, S., Wen, Z. and Tripathi, J.N., 2022. Genome editing for sustainable agriculture in Africa. Frontiers in Genome Editing, 4. Accessed at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9133388/ on the 15th of June 2023.
[4] See the Committee on Science, Technology, and Law; Policy and Global Affairs; National Academies of Sciences, Engineering, and Medicine; Olson S, editor. International Summit on Human Gene Editing: A Global Discussion. Washington (DC): National Academies Press (US); 2016 Jan 1. International Summit on Human Gene Editing: A Global Discussion: MEETING IN BRIEF. Accessed at https://www.ncbi.nlm.nih.gov/sites/books/NBK343651/ on the 15th of June, 2023.
[5] Ibid.
[6] Kyei, F., Puobi, R. E., Gadu, S., Dokurugu, E. W., Djimador, T. K and Laryea, E. N. 2017. The science, acceptance and support of modern biotechnology in Africa. J. Adv. Biol. Biotechnol. 12: 1-14.
[7] Section 1 of the National Biosafety Management Agency Act, 2015
[8] Section 2 of the National Biosafety Management Agency (Amendment) Act, 2019
[9] Ibid, Section 3.
[10] See Sections 22-30 of the 2015 Act.
[11] See Section 3 of the National Biosafety Management Agency (Amendment) Act, 2019
[12] The National Biosafety Guidelines on Gene Editing, 2020
[13] Section 1 (a) NBMA Act 2015 (as amended in 2019)
[14] See generally Section 3 of the Act.
[15] Section 22 of the Act.
[16] Section 24 of the Act.
[17] Section 25A of the NBMA Act 2015 (as amended in 2019)
[18] See sections 23-30 of the Act.
[19] See section 23(2)(b) of the Act.
[20] See Part 2 of the Guidelines.
[21] A recombinant DNA is a DNA engineered by the assemblage of fragments of the DNA from multiple species introduced into the cells of a host organism.
[22] Part 1 of the Guidelines.
[23] Cap C45 Laws of the Federation of Nigeria (LFN), 2004.
[24] Part N5 LFN 2004.
[25] Part N1 LFN 2004.
