Regulating Biotechnology in Africa: Trends and Prospects

1. Regulating Biotechnology in Africa:Trends and Prospects By Francis Nang’ayo, Ph.D. AATF, Nairobi, Kenya

2. Outline Part I • Historical milestones • The Earth Summit in Rio, Brazil, 1992 Part II • Regulatory Landscape in African Countries • Policies, Laws, Regulations, Institutions, Projects

3. PART IRegulating GM Technology:Historical Perspectives

4. Genetic Modification: Early Breakthroughs Regulations for rDNA activities Asilomar Conference, USA • Transgenic plants created in early 1980s by four groups working independently: • Ghent, Belgium • Washington University, St. Louis, USA • Monsanto Company in St. Louis, USA • University of Wisconsin, USA NIH Guidelines, 1976 At the conference, scientists raised concerns about possible adverse effects of the nascent rDNA research activities; and voiced the need to proceed with appropriate safeguards OECD Ad hoc Expert Group, 1983 Safety focus was on contained laboratory research and production systems in the US and US-supported projects around the world Recombinant DNA Safety Considerations, Published in the ‘Blue Book’ - the basis for regulation of GMOs in the Western world

5. The Earth Summit • A landmark conference was held in Rio de Janerio, Brazil, in 1992 • Focused on Sustainable Development and is associated with following outcomes: • Rio Declaration (Principle 15*) • Agenda 21 (Chapter 16) • UNCBD (The Biosafety Protocol)

6. Convention on Biological Diversity • Objectives of CBD …are the conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of benefits arising out of utilization of genetic resources… via access to genetic resources and by appropriate transfer of relevant technologies … • Very simply, the Convention is about access to, transfer of technologies, equitable and sustainable utilization of biodiversity • CBD and the Protocol • Article 8(g) of the Convention obligates contracting parties to establish means to manage risks associated with use of LMOs resulting from biotechnology … • Article 19(3) … need for and modalities of a protocol setting out appropriate procedures … AIA… in the field of safe transfer, handling and use of living modified organisms resulting from biotechnology that may have adverse effect on conservation and sustainable use of biological diversity…”. Cartagena Protocol on Biosafety about …contributing to ensuring an adequate level of protection in the safe transfer, handling and use of LMOs resulting from modern biotechnology that may have adverse effects on biological diversity, taking also into account human health

7. Cartagena Protocol on Biosafety • The Protocol is about …contributing to ensuring an adequate level of protection in the safe transfer, handling and use of LMOs resulting from modern biotechnology that may have adverse effects on biological diversity, taking also into account human health … • Protocol focuses on transboundary movement of LMOs (…Scope) • Advanced Informed Agreement; • Premised on the precautionary approach; • Socio-economic considerations; • Decisions informed by the need to carry out Risk Assessment (Annex III)

8. Contracting Parties Convention on Biological Diversity

9. Contracting Parties to Cartagena Protocol on Biosafety

10. Key Obligations of Parties to CPB • Article 2 (1) … Each Party shall take necessary and appropriate legal, administrative and other measures to implement its obligations… A commitment to developing an NBF • A Policy on Biotechnology/Biosafety • A legislation on biosafety • A System for handling requests or notifications • A System for monitoring & enforcement • Mechanisms for Public Awareness, Education & Participation

11. Status of NBFs in SSA • Countries with developed NBFs, • Countries with interim NBFs • Countries whose NBF is ‘work-in-progress’ • Countries with little progress on NBFs.

12. Status of GM regulations Developed National Bio-safety Frameworks Interim National Bio-safety Frameworks Work in progress No significant progress

13. Status of GM regulations Developed National Bio-safety Frameworks Interim National Bio-safety Frameworks Work in progress No significant progress

14. Wrap up • Approaches to regulation for GM crops in Africa has its origins on the outcomes of the Earth Summit: • Principle 15 of the Rio Declaration (“Precautionary Approach”) • Agenda 21 (Chapter 16) • The Convention (CBD) • The Protocol (CPB) • cf South Africa (SAGENE)

15. Regulations for GM crops in African Countries: Policies, Laws, Regulations, Guidelines PART II

16. SUB SAHARAN AFRICA

17. Nearly all African countries are contracting parties to the CBD & CPB What factors influence Policy Approaches on GM technology in Africa? Trade with EU is a major influence on the kind of policytowards GM Miami Group Vs Like-minded Group • Concerns regarding threats to Biodiversity • Concerns regarding possible loss of markets • Regional positions at international forums • Novelty surrounding GM technology • Food safety scandals and disease epidemics • Level of anti-GM activism (NGOs) • Challenge of famine, hunger & poverty • Reactive “late comer” response approach! Mad Cow Disease (BSE); Ebola, Bird Flue

18. Policy Choices for GM Crops • “Promotional” policy approach Assumes GM crops to be as safe as conventional! • “Permissive” policy approach Approvals made on case-by-case risk assessment considerations e.g. South Africa, Burkina Faso, Kenya, Uganda, etc • “Precautionary” policy approach Approvals linked to ‘precautionary principle’ e.g. Mauritius, Malawi, Zambia,Tanzania, Ethiopia etc • “Preventive” policy approach Where GM technology is assumed inherently too risky; e.g. Benin, Angola Adapted from Paarlberg (2000)

19. Legislation • The Protocol , Art 2(1): Each Part shall take necessary and appropriate legal, administrative and other measures to implement its obligations under this Protocol • Interpretation • Promulgation of new law(s) (e.g. GMO Act, Biosafety Act) • Pronouncement of Decrees • Use of existing laws through appropriate amendments • Merits and demerits

20. Legislation ... • Most countries in Sub-Saharan Africa have tended towards developing new laws, thanks to UNEP/GEF program on Biosafety, PBS • Developing new laws is a time-consuming process with many “starts and stops” during which time product development may not take place • Examples: Kenya; 6 years, Ghana & Nigeria >8 years

21. Administrative System • The law is a necessary condition, but alone, it is not a sufficient condition for regulation • Thus, laws must be backed by an enabling institutional arrangement for implementation and enforcement (e.g. NBFP, NCA, Biosafety Secretariat*, Agencies, Guidelines, Regulations etc) • While some nations have done well in setting Admin. Systems; in most countries of SSA, regulatory institutions still grapple with ‘teething’ problems === thin staff, limited budgets that often delays decision-making!

22. Pilot Countries

23. Summary: Regulatory Landscape

24. Regulatory Landscape ...contd

25. Regulatory Landscape ...contd.

26. Regulatory Landscape ...contd.

27. Wrapping Up! Pilot Countries NBFs – Functional NBFs – Dysfunctional NBFs – Work-in-progress

28. Paradox of Risk Assessment • In ‘the US’ products are safe until proven risky • In ‘France’ products are risky until proven safe • In ‘India’ products are risky even when proven safe • In ‘Canada’ products are neither safe nor risky • In ‘Africa’ products are risky even if they do not exist Source: Prof CalestousJuma

29. FONDATION AFRICAINE POUR LES TECHNOLOGIES AGRICOLES Thank you for your attention