We continue to assess the impact of the COVID-19 pandemic on the life sciences industry and in this update we consider the EU response to supply chain disruption, vaccine R&D and antibody testing kits.
EU response to supply chain disruption
Some EU member states have reported shortages (or anticipated shortages) of medicines used to treat COVID-19 patients. These include anaesthetics, antibiotics, muscle relaxants and other medicines used off-label i.e. medicines used for a purpose or in a manner which is not authorised. As a result, the recently established EU Executive Steering Group on Shortages of Medicines Caused by Major Events (the EU Executive Steering Group), comprising of various EU representatives is putting measures in place to mitigate supply shortages of medicines during this pandemic. These include:
- Collaboration with the pharmaceutical industry via a system, the i-SPOC (industry single point of contact), to fast-track communications between pharmaceutical companies and the EU Executive Steering Group on current or anticipated shortages. Testing of the system is due to start imminently.
- Regulatory actions to support increased manufacturing capacities, e.g. accelerating the approval of a new manufacturing line or site.
- Discussions with the pharmaceutical industry to increase production capacity for all medicines used in the context of COVID-19, particularly those potentially at risk of supply shortages.
The European Commission, the Heads of Medicines Agencies and the European Medicines Agency have also published guidance to industry stakeholders on adaptations to the regulatory framework to address challenges arising from the pandemic, with a particular focus on crucial medicines for use in COVID-19 patients. In particular, it provides guidance to marketing authorisation holders of medicinal products for human use. A market authorisation holder is a company or entity that has authorisation to market a medicinal product in one or more EU member states. Generally, marketing authorisation is required before a medicinal product can be marketed in the EU.
The guidance sets out flexibility in the regulations that can be applied to help pharmaceutical companies manage the consequences of the pandemic and reduce the risk of shortages or supply chain disruption whilst ensuring the availability of high quality and safe medicinal products to patients in EU member states. These includes mechanisms that permit market authorisation holders to swiftly source starting materials, reagents, intermediates or active substances from alternative suppliers where necessary and adding new manufacturing sites.
Manufacturers of medicinal products should note that these measures only apply to crucial medicines used for treating COVID-19 patients and a number of criteria need to be met before accessing the measures.
Research and development funding and vaccines
Research and development in the life sciences industry is continuing at a rapid rate in response to COVID-19. Globally, significant funding announcements have been made, including:
- In the UK, the Health Secretary announced that £13.4 billion of NHS debt will be written off with the stated intention of allowing NHS hospitals to plan for the future and invest in vital services.
- Pharma giants Sanofi and GSK announced their collaboration to develop a vaccine using technology from both companies, with the intention of conducting phase 1 clinical trials in the second half of 2020.
- In the US, Johnson & Johnson announced a US $1 billion partnership with Biomedical Advanced Research and Development Authority (BARDA) for COVID-19 vaccine research and development, with the intention of conducting phase 1 clinical trials by September 2020.
In addition to the human impact, the severe global economic impact has created significant pressure on governments and companies to develop a vaccine. The race to develop a vaccine is moving at unprecedented speed, with a number of phase 1 clinical trials now underway.
Vaccine development timelines are difficult to predict, and although the pace of the development of a COVID-19 vaccine is unprecedented, a vaccine may not be brought to market until next year, if not later.
Fast track development of diagnostic and antibody testing kits
The UK government has announced a five pillar plan to boost diagnostic testing, with the intention of conducting 100,000 diagnostic tests per day by the end of April 2020. Following the UK government’s announcement, GSK, AstraZeneca and the University of Cambridge have formed a joint collaboration including setting up a testing laboratory in Cambridge.
The UK government (as well as many others) is working on making home diagnostic testing available for the population. However, issues are still being raised as to their accuracy. In the US, the Association for Public Health Laboratories has raised concern over the reliability of the tests which are becoming available. Adding to the concern is the fact that home testing would be performed without professional assistance and therefore without a clinical eye on performance accuracy.
Although there is currently no proven reliable antibody test available to assess whether someone has already had COVID-19, both the UK and Germany have suggested the idea of immunity certificates. Some epidemiologists and other scientists have criticised this approach for fear it could lead to false reassurance and an increase in risky behaviours.
The regulatory landscape for stakeholders in the life sciences industry is changing in response to the unprecedented demands of the COVID-19 pandemic. Companies must be aware of, and adhere to, their regulatory obligations in this evolving landscape.
In addition to these regulatory changes, stakeholders subject to UK law must also operate on the basis of the UK government’s position that the transition period for the UK’s withdrawal from EU will end on 31 December 2020.
Companies operating in this environment should consider whether their insurance cover is worded in a way that will respond fully if they take advantage of the relaxation in regulations. While the COVID-19 pandemic risks causing significant supply chain disruption, it is also presenting industry stakeholders with an opportunity to capitalise on rapid research and product development.