Biotechnology and biosafety regulation in Zimbabwe

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Biotechnology and biosafety regulation in Zimbabwe

Overview Of Presentation Definition of Biosafety The National Biosafety Framework The Mandate of the NBA Biosafety Milestones in Zimbabwe The Cartagena Protocol on Biosafety Constraints in assimilation of Biotechnology.

Definition of Biosafety Biosafety is the protection of human and animal health and the environment from the possible effects of products of biotechnology. Biosafety entails risk assessment. In Zimbabwe risk assessment is an obligation under international agreements (e.g. Cartagena Protocol on Biosafety) and national laws which include the National Biotechnology Authority Act [Chap.14.31] of 2006 - section 25.

The National Biotechnology Framework Zimbabwe s regulatory framework on biosafety dates back to the early 1990s when the country s scientists approached the then Scientific Liaison Office in the Office of the President and Cabinet requesting that Government put in place legal measures to manage breakthroughs in modern biotechnology. The local scientists appreciated the critical role on cutting edge sciences like modern biotechnology, they however realized the human health, environmental, national security and socio economic challenges that usually come with such breakthroughs.

The National Biotechnology Framework cont. They felt that a standard code of practice without a legal framework would not provide the necessary safeguards in modern biotechnology practice. To fast track the regulatory process it was agreed to amend the Research Act, which was being administered by the Scientific Liaison Office, and allow it to provide for the regulation of modern biotechnology. Consequently, the Research Act was amended in 1998 so as to provide for the management of potentially harmful technologies and undertakings through Safety Boards.

The National Biotechnology Framework cont. To implement the new law, the Vice President developed and gazetted supporting regulations in 2000 the Research (Biosafety) Regulations. By the end of 2000 institutional arrangements to manage the research, development, application, import, export, sale and use of modern biotechnology (genetic modification) and its products were in place. These interim arrangements allowed Zimbabwean scientists to undertake laboratory and field trials with genetically modified organisms. This framework was also used to manage the import of food and feed containing GMOs.

The National Biotechnology Framework cont. When the UNEP/GEF project for building capacity for developing biosafety frameworks came on line, Zimbabwe applied for support with a view to revisit the interim national biosafety arrangements to come up with a more comprehensive and standalone regime. Using UNEP/GEF and Government support, a comprehensive national policy on biotechnology and its safe use was developed (2005) and a new Act of Parliament the National Biotechnology Authority Act passed into law in 2006.

The National Biotechnology Framework cont. The current national biotechnology regulatory regime (National Biotechnology Authority Act of 2006 and its supporting guidelines, regulations and standards) was developed as a means to implement the biotechnology and biosafety provisions contained in the National Biotechnology Policy and other national policy documents, and also to repeal earlier biosafety legal arrangements (The Research (Biosafety) Regulations of 2000). This Act transformed the Biosafety Board into the National Biotechnology Authority

The Mandate Of The NBA To regulate biotechnology research and development in Zimbabwe. To enforce standards and any regulations pertaining to biotechnology and its safe use. To champion all national efforts towards biotechnology research, development and management. To administer the Biotechnology Fund. To manage the National Biosafety Clearing House.

Biosafety Milestones in Zimbabwe Legal framework and supporting guidelines (NBA Act [Chap. 14:31] of 2006) Organisational structures (NBA as the major regulator) Public awareness & capacity building programmes (Policy Makers Awareness Workshop on Biotechnology, CAMSEC, The Official Launch of the OFAB Zimbabwe Chapter, Oral Evidence Session on Bt cotton in Parliament) Effective regulation and promotion of biotechnology in Zimbabwe

The Cartagena Protocol on Biosafety The Biosafety Protocol was one of the basis for improvements made in Zimbabwe s National Biosafety Framework in 2006. Zimbabwe has been a party to the Cartagena Protocol on Biosafety since 2005. The country actively participates in Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety (COP-MOP) and Biosafety Clearing House (BCH) activities.

Challenges Limited resources Brain drain Trade issues Intellectual property protection Public perception on biotechnoologies

NBA`s Prospects Promote a clear understanding on the potential of biotechnology. Increase biosafety and biotechnology capacity building programmes. Encourage more biotechnology and biosafety research programmes.

THANK YOU