Unlocking the biosafety regulatory deadlocks in Africa: Trends, challenges and opportunities

Transcription

1 Unlocking the biosafety regulatory deadlocks in Africa: Trends, challenges and opportunities Diran Makinde NEPAD Planning and Coordinating Agency/ABNE Ouagadougou, Burkina Faso. Presentation at the OFAB 2013 Annual Review and Planning Meeting. Dar es Salaam May 8-10, 2013 NEPAD Planning and Coordinating Agency

2 Africa 2012 On-going biotech/gm crops research activities by October 1st 2012

3 Biotechnology Solutions in Africa South Africa total acreage in 2012 reached 2.9 million hectares.(james 2013) 4 African countries that commercialized biotech crops: South Africa, Burkina Faso, Egypt & Sudan. 6 countries conducting field trials: Cameroon, Ghana, Kenya, Malawi, Nigeria and Uganda. Bt-cotton field trials in Burkina Faso (Vitale et al., 2008) 15% higher yield Insecticide sprays were reduced by two-thirds Promoting farmers health, reducing labor costs and environmental degradation. The lack of appropriate, science-based and cost/timeeffective regulatory systems continue to be the major constraint to adoption

4 Biosafety Involves GMOs GMOs (LMOs) are defined internationally in Cartagena Protocol Living e.g. seeds, propagative plant material, animals, microorganisms rdna techniques Products derived from GMOs Not living Don t pose environmental risks Food safety issue if they have new DNA and/or protein

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6 What is required from Governments? Successful agricultural biotech countries have the following features: strong biotech policy & regulatory legislation 1st priority: National biotech policy 2 nd priority: Regulation, a supportive safety role rather than a restrictive role

7 International Regulation: Cartagena Protocol on Biosafety Legally binding framework for international movement of LMOs- Does not dictate national regulations; Provides strong incentive for harmonisation. Objective of CPB based on the Precautionary Principle which states: Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation. Most of the existing biosafety laws in Africa were triggered by the need to take precautionary measures to protect biodiversity, human/animal health & the environment in anticipation of GMOs.

8 The Precautionary Principle It is adopted in the EU Charter. The European Commission made it clear in their first publication of the new millenium that the the PP was not intended to be used as a barrier (EC, 2000): It should be proportional to the chosen level of protection, non-discriminatory in their application, consistent with similar measures already taken, based on an examination of the potential benefits and costs of action or lack of action (including, where appropriate and feasible, an economic cost/benefit analysis), subject to review, in the light of new scientific data, and capable of assigning responsibility for producing the scientific evidence necessary for a more comprehensive risk assessment. NEPAD Planning and Coordinating Agency

9 The PP in action The PP has been distorted by activist groups and certain governments The PP is being used to block adoption of GMOs in the EU, and elsewhere, in a manner inconsistent with commonly accepted definitions and principles. The PP was never intended to be an excuse to do nothing or to not adopt a technology NEPAD Planning and Coordinating Agency

10 The PP in action II When applied correctly PP is an imp principle in assessing the risks arising from technology Used to identify gaps in knowledge, issues that need further study & the scope for potential risks. Application has to be contextualized & based on an analysis of data & evidence available, potential harm if the proposed measure is undertaken NEPAD Planning and Coordinating Agency

11 National Regulation: Generic Steps National Biosafety Focal Points Operational Biosafety Decrees Biosafety Laws & Implementing Guidelines Confined Field Trials Multi-locational Trials Deregulated status & Commercial Release NEPAD Planning and Coordinating Agency

12 Definition of a Biosafety Regulatory System A national biosafety regulatory system is a regulatory regime responsible for assessing and managing the full range of potential risks that could be posed from GMOs. A biosafety regulatory system addresses potential risks to the environment and biological diversity as well as any food/feed risks or other safety related issues involving GMOs (e.g. worker health, drug safety, etc ). Ensures safety to humans and animals Ensures safety to environment and agriculture Provide public confidence in a new technology

13 Principles of Regulation Regulation is an evolving process. Need to compare domestic regulations with best practices elsewhere & enhance the capacity to regulate. Regulation cannot be determined by a single principle but would need the application of more than one principle depending on the need & context e.g. environmental regulation cannot be based solely on the precautionary principle or the polluter pays principle NEPAD Planlning and Coordinating Agency

14 Principles for Regulation II What is required is a carefully developed regulatory policy based on various relevant principles & their application in specific contexts. Biotech regulation has been with us for a long time now with a lot of changes at the global & national regulatory policies on account of various factors but no harmonization at the global level. NEPAD Planning and Coordinating Agency

15 Principles of Regulation III As many as 15 institutions are relevant for biotech regulation while many conventions/treaties/protocols are available e.g. the CPB has many provisions relevant for biotech regulation. Of these Art 26, is imp. as it enables countries to take into account SEC in decision making. No consensus in putting this to practice; the saga of US-EU divide; wide variance on position among developing countries. NEPAD Planning and Coordinating Agency

16 Characteristics of a Good Biosafety Regulatory Regime Adequate legal authority Comprehensive Certain but also flexible Consistent, equitable and fair Easily understandable Case-by-case scientific reviews Proportionate based on risk Workable and enforceable Transparent and participatory

17 Transparency in Regulatory Procedures Transparency is critical Government regulators Applicants Interested stakeholders and public Who does what and when? Responsibilities Requirements Timelines

18 Establishing a Functional Biosafety Regulatory System (Jaffe, 2013)

19 Implementing Regulations Consistent with Biosafety Law Use existing definitions (GMO, contained use, confined field trial, etc.) Don t change scope (don t add products of GMOs if not called for in law) Address ambiguities Tend to be more legal and procedural/guidelines are more technical Details not included in the law Additional definitions Details about how decisions will be made

20 Enabling legislative and regulatory frameworks in 1 st six biotech adopter nations in Africa (Okeno et al. New Biotechnol. 30, 2013) Country Regulatory Framework Biosafety act/bill Biosafety regulations/guidelines South Africa Biosafety Act No GMO Regulations 1999 Draft GMO Regulations 2008 Biotech policy/strategy National Biotechnology Strategy 2001 Burkina Faso Biosafety Act 2006 GMO Regulations and guidelines 2004 Egypt Draft Biosafety Bill 2006 Ministerial Decree No. 136 of 1995 No stand-alone Biotech Policy No stand-alone Biotech Policy Ministerial Decree No 1648 of 1998 Kenya Biosafety Act No Biosafety Regulations 2011 National Biotechnology Policy 2006 Uganda Draft National CFT Guidelines 2006 National Biotechnology and Biotechnology Safety Bill Biosafety Policy Nigeria Biosafety Act 2011 Biosafety Guidelines 2001 National Biosafety Policy 2006

21 The 4 Biosafety Constraints Policy Capacity Too focused on risks; not reflect global experience. Non-science elements- socioeconomic considerations Strict liability clausesdisincentive RA requirements out of sync with product dev. Regulations are typically unaffordable & unenforceable. National vs regional conflicts Poor critical mass of expertsopportunity for loud voices & influencers Opposing views of development partners Process Inter-ministerial turf-lack of harmonization. Limited operational budget Biosafety law not reconciled with existing laws Practice NEPAD Planning and Trade Coordinating issues Expensive infrastructure for CFTs

22 Constraints in developing Regulatory Framework Limited institutional capacity- human, financial & institutional Lack of domestic regulatory policy for testing, release and commercialisatn. The complexity of the decisions required within a specific time-frame The problems of public involvement in countries with high levels of illiteracy.

23 Observations Regulations drafted by national lawyers with very limited knowledge and understanding of biotechnology and biosafety. The language had been informed by examples from countries with unworkable provisions. Implementing reg. must first be improved in terms of technical content before being casted in legal language. Some provisions would be better placed in NEPAD Planning and Coordinating Agency guidelines rather than in the regulations.

24 Observations II: Spielman et al., 2006 Regulatory environment slowing the forward movt. of research into later stages of product development Non-use of available info from other countries on efficacy & safety Public researchers in developing countries working in isolation from the private firms that lead the industry Studies show that despite similar starting dates for regulatory development, countries are arriving at different pts in terms of their laws, regulations, & guidelines & achieving diff outcomes field trials, no of events, crops approved for planting.

25 Research needs Very limited research is ongoing to examine food, feed and environment safety related to GMOs This is a priority area to develop capacity and methodologies for risk assessment and risk management on a case-by-case basis of GMOs. R&D programmes are also required for developing standardized methods for GMO detection.

26 Risk of backsliding Challenges Govt. decisions that are not supportive: labeling regulations; GM import ban No coherent position among govt. agencies; or within key govt. entities such as Public Health, NBA (Executive office vs Board) International biotech projects and privatesector efforts on Bt cotton Elections: a challenge and an opportunity

27 Challenges Facing Africa on Biotechnology and Biosafety Lack of fund Loss of technical expertise Quality seeds and inputs(fertilisers &agrochemicals) Slow development of a biotechnology sector Inadequate IPR infrastructure Government not taking a more active political role in promoting the technology Public acceptance

28 Other Challenges-(Field observations) Training of producers Technology fee Seed production Establishment of refuge zones Co-existence between GM & non-gm Building research capacity New pests NEPAD Planning and Coordinating Agency

29 Quo vadis (Where do we go from here?) Operational funding by governments for national biosafety functions; Donors: funding for regulatory capacity, not just for R&D. Strategic, coordinated approach to outreach & communication; Reposition the Biosafety Protocol for what it was intended to be- not the de facto regulatory framework it has become. NEPAD Planning and Coordinating Agency

30 Opportunities The challenges and opportunities enumerated are being met by dedicated biosafety service providers: ABNE, ABSF, AATF, ICGEB, IFPRI/PBS, ISAAA, AfricaBio, FARA/SABIMA, etc. RECs: COMESA, ECOWAS, SADC, etc. SROs: ASARECA, CILSS, CORAF/WECARD, UEMOA, etc., UNEP-GEF, UNIDO, UNECA, FAO, etc NEPAD Planning and Coordinating Agency

31 Opportunities II Capacity strengthening for African regulators. Access and assessment for African scientists and policy makers for transgenic crops. OFAB role in all these & to learn from experience rather than theory. Opportunity to compliment existing technologies and help Africa advance faster towards food security and poverty eradication NEPAD Planning and Coordinating Agency

32 Conclusion Experience has shown that in many cases countries have a Policy on paper but no Practice. Regulatory systems are expensive, time consuming, locally unaffordable; unpredictable, not science/evidence-based. Countries lack capacity, access to accurate info. & political will to move forward. NEPAD Planning and Coordinating Agency

33 Conclusion II Effective communication between natural & social scientists Questions on socio-economic relevance of biotech need to be amplified Application of PP should meet policy objectives & help in the understanding of risks, benefits, uncertainties in & gaps in knowledge. NEPAD Planning and Coordinating Agency

34 Implementation of APPROPRIATE REGULATION is a MUST to spur adoption of biotech crops in AFRICA Source :Compiled by Clive James, 2012 EGYPT EGYPT BURKINA FASO KENYA UGANDA MALI KENYA UGANDA GHANA NIGERIA SOUTH AFRICA 2011 (3 countries) South Africa, Burkina Faso and Egypt Ongoing Biotech Crop Field Testing BURKINA FASO TOGO NIGERIA SOUTH AFRICA MALAWI 2015 (up to 10 countries) South Africa, Burkina Faso, Egypt, Mali, Togo, Nigeria, Kenya, Uganda, Ghana and Malawi

35 Remember this The past is where you learned the lesson. The future is where you apply the lesson. Don t give up in the middle. (Anonymous) NEPAD Planning and Coordinating Agency

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