The Need for Biosafety Regulatory Systems

In order to advance the science of biotechnology in Africa effectively, while at the same time safeguarding human health and the environment, the African Ministerial Council on Science and Technology (AMCOST) resolved to develop a 20 year biotechnology strategy which guides the development of effective biosafety regulatory systems within the Member States. ABNE responds to the AMCOST biotechnology strategy.

Biosafety regulatory systems aim to provide a balance between promoting learning and innovation in biotechnology, while protecting public interests. Most countries in Africa confirmed this aim by ratifying the Cartagena Protocol on Biosafety.

A key element is the development of effective National Biosafety Frameworks (NBFs) and regulatory systems that foster the safe use of biotechnology. The major components of a functional NBF generally include:

  • A policy on biotechnology
  • Laws and regulations on biosafety constituting a regulatory regime for biotechnology
  • An administrative system for handling applications and issuance of permits e.g. functional NBCs, IBCs and PQs
  • A mechanism for public participation in biosafety decision-making.

There are four major elements of effective biosafety regulatory systems: (1) written guidelines that clearly define the structure of the system, the roles and responsibilities of those involved, and the review process; (2) regulatory authorities who are well trained in relevant disciplines and prepared to make informed decisions; (3) an information system that enables the biosafety evaluation process to be based on up-to-date and relevant scientific information, and the concerns of the community; and (4) feedback mechanisms for incorporating new information and revising the regulatory system as needed.

As signatories to the Cartagena Protocol on Biosafety, governments are committed to have in place functional NBFs and regulatory systems. As indicated by a recent review on agricultural biotechnology and biosafety conducted by the Forum for Agricultural Research in Africa (FARA), different countries are at different stages with respect to capacity building in environmental and food safety risk assessment. The ABNE will help provide information, experience and methodology to assist regulators in the decision-making process.