The rollout of COVID-19 vaccinations has been largely successful in Israel, UAE, UK, US, and Chile. Lawyers have played an imperative role in ensuring that the UK government and big pharmaceuticals administer vaccinations to the public on a large-scale. This includes the negotiation and drafting of contracts, assisting with government investments, and advising on supply, distribution, and IP-related matters. This article briefly explores the involvement of lawyers throughout these processes, particularly concerning the Pfizer-BioNTech and Oxford-AstraZeneca vaccines.
Collaboration Agreements
The renowned Pfizer-BioNTech vaccine resulted from a definitive agreement between the two companies in April 2020 to develop and distribute a potential vaccine for COVID-19. Clifford Chance advised Pfizer on the collaboration agreement along with its in-house legal counsels, while Freshfields Bruckhaus Deringer and Covington & Burling advised BioNTech.
Similarly, AstraZeneca became the University of Oxford’s partner for the development of its vaccine for COVID-19 earlier this year. Gowling WLG led AstraZeneca on the development and distribution of the vaccine, and Bristows led for the University of Oxford.
Regulatory Approval
For the Pfizer-BioNTech vaccine, clinical testing started imminently in research and development sites across the US and Germany. The role of lawyers was to assist with the regulatory approval of these clinical trials in both jurisdictions i.e., ensuring it complies with legal, ethical, and professional standards is scientifically sound, and is free from discrimination.
Simultaneously, there were challenges presented by Brexit at the time of the clinical trials and questions around how it will affect the regulatory framework between Europe and the UK. Lawyers at Clifford Chance were mindful of this regulatory complexity, but at the same time, did not have the luxury of waiting until the transition period was over. According to Stephen Reese, the partner who received instructions from Pfizer, “…the firm was dealing with unprecedented times and had a fairly tight time pressure on anticipating the specifics of the deal that addressed different eventualities on both development and approval of the vaccine. These types of deals normally take three to six months to put together but doing it in a few weeks entailed reconciling regulatory clinical trial aspects with commercial imperatives.”
Intellectual Property
Regarding intellectual property, the Pfizer-BioNTech vaccine deployed novel technology that introduces mRNA genetic material into the human organism, sparking an immune response by replicating the spike proteins contained in the coronavirus. The role of lawyers was to counsel Pfizer on patent issues arising from the unprecedentedly large-scale distribution of the vaccine is developed in conjunction with German biotech company BioNTech, amidst big uncertainty.
Contract Negotiation
Apart from collaboration, licensing, and research agreements, lawyers assisted pharmaceutical companies in drafting contracts and negotiating with the UK government concerning production, supply, and distribution agreements. For example, Baker McKenzie advised a multinational pharmaceutical company in structuring contracts for local production of its COVID-19 vaccine.
Government Investment
The UK Government made investments in the development of an infrastructure for a COVID-19 vaccine from AstraZeneca and the University of Oxford. The investment was aimed at making sure the UK has infrastructure capable enough to capture other vaccine companies if they needed manufacturing capabilities.
Clifford Chance, Eversheds Sutherland, and Travers Smith were involved in the Government’s investment in the Cell and Gene Therapy Catapult’ to accelerate such production of a COVID-19 vaccine at scale in the UK, including advanced therapy and vaccine manufacturing for potential future pandemics. The lawyers advised on all aspects of the transaction including the facility acquisition and funding arrangements, the acquisition of the existing facility and related business, real estate, construction, and administrative and public law aspects.
Government Contracts
In December 2020, the United Kingdom became the first country to approve the use of the Pfizer-BioNTech vaccine after it was authorized for emergency use by the Medicines and Healthcare products Regulatory Authority (MHRA). One month later, the Oxford-AstraZeneca vaccine was also approved for emergency supply in the UK.
Subsequently, lawyers advised the Department for Business, Energy and Industrial Strategy and the Government’s vaccine task force, which was set up last November, on the drafting and negotiations of contracts relating to the manufacture and procurement of vaccines for Covid-19. Negotiation points may include the duration of the contract, precise quantities, delivery dates, and penalties such as price reductions for non-compliance.
In summary, the various legal considerations discussed above had to be taken into account before COVID-19 vaccinations could be administered to the public. This required advice from lawyers on a wide range of issues involving various departments, including competition, corporate, litigation, and real estate.
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