1. BIOSAFETY IN HEALTH RESEARCH Annah R. Takombwa – Acting Technical Affairs Manager, National Biotechnology Authority

2. National Biotechnology Authority of Zimbabwe WHO IS NBA? National Competent Authority on biotechnology and biosafety National Focal Point for Biosafety Clearing House. mandated to protect the public through management of potentially harmful technologies and undertakings (biotech, nanotech, nanobiotech, synthetic biotech products)

3. National Biotechnology Authority of Zimbabwe BACKGROUND Biotech is one of many technologies with potential to empower people to attain food and nutritional security, sustainable socioeconomic development. Opportunities presented by breakthroughs in biotech exists e.g Ebola vaccine from tobacco BUT taking into account public concerns being raised Biofortification is a biotech process e.g. of oils and other products. NBA was set up to protect the public: where Biosafety is concerned with protection of human, animal health & environment from possible effects of biotech products.

4. National Biotechnology Authority of Zimbabwe BACKGROUND CONT’’ In 1998, the Research Act was amended to provide for the management of potentially harmful technologies and undertakings.  In 2005, Zimbabwe ratified the Cartagena Protocol on Biosafety (CPB). National Biotechnology Policy was developed in 2005 with support from UNEP-GEF. In 2006, the National Biotechnology Authority Act [Chap.14:31] of 2006 was gazetted. This gave rise to the National Biotechnology Authority. National Biosafety Framework in place. NBA mandate further emphasised in the Second, Science, Technology and Innovation Policy of 2012.

5. National Biotechnology Authority of Zimbabwe CORE FUNCTIONS Regulatory Function Research & Development function Public Awareness, Education & Training Advisory function

6. National Biotechnology Authority of Zimbabwe BIOSAFETY IN HEALTH RESEARCH Use of biotech techniques has been on the rise within the medical sector E.g. many recombinant medicines are on the on market these include, hormones (insulin), vaccines (Hepatitis B. Vaccine), antibodies Therefore NBA works hand in hand with other regulators to assess biosafety aspects of these products. This helps to guide decision makers and educate the public and the media about key issues surrounding the safety of such products

7. National Biotechnology Authority of Zimbabwe VACCINES Vaccine development is centred on identifying suitable antigens, adjuvants and delivery methods Also include regulatory, technical and manufacturing hurdles in translating a vaccine candidate to the clinic.

8. National Biotechnology Authority of Zimbabwe VACCINE BIOSAFETY CONCERNS Depending on the type of vaccine, biosafety concerns include the possibility of – side effects – integration of the plasmid DNA into the host genome – adverse immunopathological effects – the formation of anti-DNA antibodies resulting in auto-immune diseases – use of novel molecular adjuvants Need for comprehensive regulatory and monitoring protocols to be in place.

9. National Biotechnology Authority of Zimbabwe FACILITY REGISTRATION All facilities used for biotech medical research should be registered with the NBA in accordance with Part III of the NBA Act [Chap. 14:31] of 2006. Requirements for registration include: – Establishment of an Institutional Biosafety Committee (IBC) – Election of an Institutional Biosafety Officer (IBO) – Development of Instructional Biosafety Manual (IBM) NBA audits facilities to ensure adherence to biosafety guidelines.

10. National Biotechnology Authority of Zimbabwe PROCEDURE FOR REGISTRATION OF MEDICAL BIOTECH PRODUCTS

11. National Biotechnology Authority of Zimbabwe ROLE OF NBA DURING TRIALS Throughout the clinical trial phases, NBA will be part of researchers and medical staff conducting regular follow-up to ensure adherence to biosafety procedures. Review progress reports as they come IBCs.

12. National Biotechnology Authority of Zimbabwe Thank you 21 Princess Drive, Newlands,harare +263 4 782856/9 Email: nba@nba.ac.zwnba@nba.ac.zw Website: www.nba.ac.zw