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BIOSAFETY IN HEALTH RESEARCH

BIOSAFETY IN HEALTH RESEARCH. Annah R. Takombwa – Acting Technical Affairs Manager, National Biotechnology Authority. WHO IS NBA?. National Competent Authority on biotechnology and biosafety National Focal Point for Biosafety Clearing House.

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BIOSAFETY IN HEALTH RESEARCH

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

  2. 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. 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.gEbola 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. 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. CORE FUNCTIONS • Regulatory Function • Research & Development function • Public Awareness , Education & Training • Advisory function

  6. 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. 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. 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. 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. PROCEDURE FOR REGISTRATION OF MEDICAL BIOTECH PRODUCTS

  11. 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. Thank you 21 Princess Drive, Newlands,harare +263 4 782856/9 Email: nba@nba.ac.zw Website: www.nba.ac.zw

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