The State of Biosafety and Biosecurity in South Africa

Abstract

This consensus study report presents the findings of a systematic assessment of the state of biosafety and biosecurity in South Africa, including an evaluation of legislation, regulations and practices at both national and institutional levels. The findings report on strengths, weaknesses and gaps in the laws and in their implementation, and the practices relating to biosafety and biosecurity at laboratory level. Recommendations are made to address the weaknesses and gaps identified.

Research and development in the life sciences are important elements of South African growth and development and are essential to address the needs of the country. It was thus imperative that ASSAf contributes towards ensuring that life science research in South Africa is conducted safely, securely and ethically. This is in the interests of all South Africans and in the interests of the life science community.

With this broad objective, ASSAf constituted a Biosafety and Biosecurity panel of experts to assess and comment on the relationship between science and security in South Africa. While it is deemed important to extend an assessment of biosafety and biosecurity to the greater southern African region, this was not possible in the timeframe permitted for the study, but remains an important objective in the long term.

The research conducted for this consensus study included: 1. An investigation into the applicability and balance of relevant ethical principles through a review of literature in order to establish a context for biosafety and biosecurity considerations. 2. An assessment of existing, relevant legislation and regulations in relation to biosafety and biosecurity in order to identify strengths, weaknesses and gaps in laws and in their implementation. 3. A critical overview of the implementation of biosafety and biosecurity measures in laboratories in South Africa and an assessment of the extent to which laboratory practices address safety and security concerns. 4. An evaluation of existing measures and capacity to detect, identify, control and prevent the natural, accidental or deliberate spread of infectious agents.

The panel used a variety of methods to conduct the research, including but not limited to: 1. Convening a series of panel discussions on biosafety and biosecurity. 2. Assessing existing legislation and regulations in relation to biosafety and biosecurity to identify strengths, weaknesses and gaps in laws and in their implementation. 3. Conducting a survey of life scientists’ experience and perceptions of biosafety and biosecurity measures in laboratories in South Africa. 4. Evaluating existing measures and capacity to detect, identify, control, and prevent the natural, accidental, or deliberate spread of infectious agents. 5. Consultation with experts from a variety of disciplines (including experts with proven biosecurity expertise).

Ultimately, the goal of the study was to: 1. Make sustainable and evidence-based recommendations to the South African government and the scientific community to address the identified weaknesses in: existing legislation; the implementation of biosafety and biosecurity in laboratories; existing measures and capacity to detect and control spread of infectious diseases; and to raise awareness about existing measures (including practices and legislation) to reduce the risks associated with dual-use research and to engage the life science community in a dialogue about biosafety and biosecurity. 2. Make recommendations to remove weaknesses and gaps in existing legislation and in the implementation of such legislation.