The number one priority of countries around the world at the moment is developing a vaccine for Covid-19. According to WHO, more than 170 teams of researchers are currently working on vaccines. Among them, 139 are yet to begin human trials, 25 are conducting small-scale safety trials (Phase 1), 17 are conducting expanded safety trials (Phase 2), 7 are conducting large-scale efficacy trials (Phase 3) and 0 of them have developed a vaccine that is approved for general use.
What does this mean to law firms and businesses?
While researchers and scientists are continuously experimenting to create a vaccine, governments and politicians are working on regulations and policies to speed up the approval and distribution of vaccines. For example, last month, the European Parliament and the Council adopted Regulation (EU) 2020/1043, which temporarily relaxed some of the rules regarding clinical trials. It will be the role of law firms to advise clients, particularly the life sciences companies, of the changing regulatory environment to ensure that they can benefit from relaxed regulations. Also, recently, the HM Government decided to invest £100 million for the acquisition of a facility in Braintree, Essex, and improvement of it into a Cell and Gene Therapy Catapult Manufacturing Innovation Centre that will have the capacity to mass-produce vaccines. Clifford Chance was the firm that advised the government on this deal and the deal engaged the firm’s real estate, corporate, construction and environment teams.
Before vaccines can be successfully distributed around the world, it not only needs to go through numerous regulatory steps but also numerous deals with other companies or organisations to make the manufacturing and distribution possible. For example, Arnold & Porter, a firm with renowned life sciences practice, has been advising AstraZeneca on various agreements with other companies and organisations for the global distribution of the University of Oxford’s potential Covid-19 vaccine. This includes an agreement with Serum Institute of India, the largest vaccine manufacturer in the world by volume, and an agreement with Coalition for Epidemic Preparedness Innovations (CEPI), a foundation that takes donations from both public and private to fund research projects on vaccines, to support the manufacturing and distribution of the Oxford vaccine.