As the coronavirus (SARS-CoV-2) pandemic sweeps the world, many organisations – particularly those with existing biotechnological expertise – are seeking to develop effective treatments for the disease caused by the virus, COVID-19. This raises the question of how, given the serious health risks associated with SARS-CoV-2, those organisations in England can lawfully conduct such work.
The relevant legal framework is the Control of Substances Hazardous to Health Regulations 2002 (COSHH) – this is a set of regulations produced under the UK’s general health and safety law, the Health and Safety at Work etc Act 1974 implementing in the UK the European Union Directive 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work. That Directive requires EU Member States to classify biological agents that are or which may be a hazard to human health.
Human pathogens are classified by COSHH into four Hazard Groups (1 - 4) according to specified criteria:
- their ability to cause infection;
- the severity of the disease that may result;
- the risk that infection will spread to the community; and
- the availability of vaccines and effective treatment.
The Health and Safety Executive (HSE), the workplace health and safety regulator in England and the competent authority under COSHH, maintains an “Approved List” of classifications. At present, there is no approved classification for SARS-CoV-2.
However, the UK’s Advisory Committee on Dangerous Pathogens (ACDP), an expert committee of the Department of Health and Social Care which provides scientific advice on the risks of exposure to various pathogens, met in early 2020 to consider a proposed Hazard Group for SARS-CoV-2.
As a group, coronaviruses are common across the world. COVID-19 is a new strain of coronavirus first identified in China in January 2020. Based on current information, and an expectation that measures appropriate for other strains of coronavirus could be appropriate SARS-CoV-2, the ACDP agreed on a provisional classification of SARS-CoV-2 as a HG3 pathogen. As more information becomes available, this classification will be reviewed.
Any organisation doing a risk assessment for work with SARS-CoV-2 (as is required under COSHH) should use this classification information to guide their approach. The COSHH Approved Code of Practice produced by the HSE gives further guidance on assessing the risks of working with hazardous substances and sets out the other elements of COSHH compliance.
One important consequence (but by no means the only one) of SARS-CoV-2 being placed in Hazard Group 3 is that it falls within COSHH’s prior notification requirement before any “research, development, teaching or diagnostic work” can be undertaken. Such notification must be made at least 20 working days in advance.
At present, the HSE has not promulgated detailed guidance on the actual practical measures which should be taken when working with SARS-CoV-2. However, given that SARS-CoV-2 falls within the same Hazard Group as another strain of coronavirus, the Severe Acute Respiratory Syndrome (SARS) that emerged from South-East Asia in 2003, it seems likely that the HSE’s detailed guidance on SARS will be, at least in part, relevant to working with SARS-CoV-2.
However, the situation relating to SARS-CoV-2 is developing rapidly. As a result, it would be prudent to consult with the HSE at all stages of work relating to SARS-CoV-2.
For more information and updates on the developing situation, visit GT’s Health Emergency Preparedness Task Force: Coronavirus Disease 2019.