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Regulating Biotechnology in Africa: Trends and Prospects . By Francis Nang’ayo, Ph.D. AATF, Nairobi, Kenya. Outline. Part I Historical milestones The Earth Summit in Rio, Brazil, 1992 Part II Regulatory Landscape in African Countries Policies, Laws, Regulations, Institutions, Projects.

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Regulating biotechnology in africa trends and prospects

Regulating Biotechnology in Africa:Trends and Prospects

By

Francis Nang’ayo, Ph.D.

AATF, Nairobi, Kenya


Outline
Outline

Part I

  • Historical milestones

  • The Earth Summit in Rio, Brazil, 1992

    Part II

  • Regulatory Landscape in African Countries

  • Policies, Laws, Regulations, Institutions, Projects


Part i regulating gm technology historical perspectives
PART IRegulating GM Technology:Historical Perspectives


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


The earth summit
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)


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


Cartagena protocol on biosafety
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)


Contracting Parties

Convention on Biological Diversity



Key obligations of parties to cpb
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


Status of nbfs in ssa
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.


Status of GM regulations

Developed National Bio-safety Frameworks

Interim National Bio-safety Frameworks

Work in progress

No significant progress


Status of GM regulations

Developed National Bio-safety Frameworks

Interim National Bio-safety Frameworks

Work in progress

No significant progress


Wrap up
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)


  • Regulations for gm crops in african countries policies laws regulations guidelines

    Regulations for GM crops in African Countries: Policies, Laws, Regulations, Guidelines

    PART II


    SUB

    SAHARAN

    AFRICA


    What factors influence policy approaches on gm technology in africa

    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


    Policy choices for gm crops
    Policy Choices for GM Crops CBD & CPB

    • “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)


    Legislation
    Legislation CBD & CPB

    • 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


    Legislation1
    Legislation ... CBD & CPB

    • 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


    Administrative system
    Administrative System CBD & CPB

    • 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!


    Pilot Countries CBD & CPB


    Summary regulatory landscape
    Summary: CBD & CPBRegulatory Landscape


    Regulatory landscape contd
    Regulatory Landscape ... CBD & CPBcontd




    Wrapping Up! CBD & CPB

    Pilot Countries

    NBFs – Functional

    NBFs – Dysfunctional

    NBFs – Work-in-progress


    Paradox of risk assessment
    Paradox of Risk Assessment CBD & CPB

    • 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


    FONDATION AFRICAINE POUR LES TECHNOLOGIES AGRICOLES CBD & CPB

    Thank you for your attention


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