Covid-19: Guarding against the misuse of highly pathogenic agents. By Talkmore Maruta

There is a need to consolidate global efforts to control and manage highly pathogenic agents like SARS-CoV-2 (Covid-19). The legal framework under development by Africa-CDC will address this by assigning government agencies to regulate research activities that include high-consequence pathogens, and to ensure ethical boundaries are not breached.

Talkmore Maruta
September 08, 2020

When SARS-CoV-2 hit the shores of Africa on 14 February 2020 in Egypt, many questions arose, yet there was little scientific knowledge with which to answer them. This knowledge gap spurred researchers into action to determine what type of virus it was, its origins, method of transmission, and how to treat it. It soon became apparent that this was not an epidemic that was just passing by, and questions about vaccines became prominent.

All these issues pointed towards the need for urgent research to guide a response to the epidemic that turned into a global pandemic within four months of the first reported case in China. Ongoing research has been instrumental in generating evidence to inform public health measures like lockdowns, physical distancing, and clinical management of patients infected with SARS-CoV-2.

Research does not always lead to positive results or outcomes, as we would wish; it sometimes gives results that could easily be misapplied and cause harm – intentionally or unintentionally. For example, 2011 research on the genetic transmissibility of the H5N1 influenza strain (avian flu) resulted in creation of a highly infectious, laboratory-modified H5N1 virus. Concerns were raised on how the modified viruses would be managed and how information on its transmissibility would be disseminated. This scenario is known as Dual Use Research of Concern (DURC) – life sciences research intended for benefit, with results that could easily be misapplied to produce harm.

The World Health Organisation’s Joint External Evaluations (JEE) conducted between 2016 and 2019 revealed significant gaps in African countries’ ability to manage DURC. Of the 19 co-capacities evaluated by the JEE, biosafety and biosecurity were among the weakest, with an average performance capacity of 32%. Research conducted on pathogens with pandemic potential, such as SARS-COV-2, has potential to enhance their pathogenicity and transmissibility. This raises the question of how our biosafety and biosecurity capacities are prepared to deal with emerging threats.

It is with this background of weak biosafety and biosecurity systems that the Africa Centres for Disease Control and Prevention (Africa-CDC) and its partners, including the Nuclear Threat Initiative (NTI) biosecurity programme, Global Affairs Canada’s Weapons Threat Reduction Programme, Open Philanthropy Project, US Centers for Disease Control and Prevention, and US Defense Threat Reduction Agency, launched the 2019 regional biosafety and biosecurity initiative to strengthen the biosecurity and biosafety systems of African Union member states.

This initiative is designed to enable them to comply with international regulations such as the International Health Regulations (IHR) (2005), the Biological Weapons Convention (BWC), and United Nations Security Council Resolution (UNSCR) 1540. There are three key outputs from this initiative that relate to the management of pathogens that can potentially cause pandemics. They are: (i) development of a model biosafety and biosecurity legal framework; (ii) creating and implementing a certification framework for institutions handling high consequence pathogens and toxins; and (iii) creating a consensus list of High-Consequence Agents and Toxins (HCAT) list.

The model framework will be developed through the coordination of the five Africa-CDC regional technical working groups from Central, East, North, South and West Africa which will conduct meetings to provide an overview of risk assessment and risk-based decision-making to guide the development of a standardised process to support the establishment of an African Union bio-risk management legislative framework.

These technical working groups will also, in turn, advocate and support its adoption into country-specific legislation that supports a national biosafety and biosecurity programme. This will allow for the establishment of an existing government agency to administer and enforce biosafety and biosecurity oversight systems, and create mechanisms for accountability in the production, use, storage, and transportation of high-risk pathogens.

More importantly, the legal framework will define the physical protection measures for workers, the community, and the environment.

Second, Africa-CDC will work with member states to create a framework for the certification of laboratories and institutions handling high-consequence pathogens and toxins. These institutions will be selected based on a set of minimum pre-existing biosafety and biosecurity requirements. The primary objective of this effort is to centralise the storage and to track the use and transport of high-risk pathogens and toxic agents.

Third, the initiative will also create a consensus list of HCAT of concern for African Union member states through a consultative process coordinated by the regional technical working groups. This list will assist member states in the control of, possession, use, transportation, importation, exportation, and safe and secure research activities involving these pathogens. Key considerations will include the pathogen’s ability to be genetically manipulated, vaccine status of a population, history of prior misuse, its potential impact on the economy, and whether it exists in the laboratory, environment, or animal reservoirs.

Fourth, the initiative will catalyse the development of priority actions required to fill biosecurity and biosafety gaps, leveraging national and regional resources and informed by existing health security-related assessments’ strategic implementation plans to promote measurable progress toward achievement of WHO Joint External Evaluation biosafety and biosecurity targets, and to meet obligations under the Biological Weapons Convention and UN Security Council Resolution 1540.

Implementation of the Africa-CDC’s regional biosafety and biosecurity initiative will ensure that ongoing and future research for high-risk pathogens with pandemic potential, such as SARS-CoV-2 and H5N1, does not result in unintended consequences of misapplication of results and misuse of pathogenic agents leading to harm to the frontline workers, communities, and the environment.

Going forward, there is a need to consolidate global efforts to control and manage highly pathogenic agents. The Africa-CDC concurs with recommendations made during the 2013 World Health Organisation informal consultation on DURC – local, regional, and global research oversight mechanisms should be established to monitor ongoing research activities.

The legal framework under development by Africa-CDC will address this by assigning government agencies to regulate research activities that include high-consequence pathogens. The WHO also recommended that there be policies to guide agencies that fund research on these high-risk pathogens to ensure ethical boundaries are not breached.

Countries need to be supported to strengthen their systems to comply with international and national regulations like the IHR (2005), Biological Weapons Convention, and Global Health Security Agenda action packages. It is also raising awareness and education for a range of audiences that include civil society as gatekeepers of safety for our communities.