When you are working with vaccines of any kind, you need to navigate many challenges. These include IP protection, clinical trials, authorization, pharmacovigilance, EU joint and advance procurement agreements, domestic price and reimbursement proceedings, liability and large-scale manufacture and distribution.
Whatever stage of that journey you are on, we can provide you with tailored advice, going way beyond the typical law firm experience. Our global Life Sciences and Healthcare sector team includes many attorneys with in-house experience in pharmaceutical companies, who have worked as scientists in the biotech sector, as pharmacists, or for the regulatory bodies and who have advanced university degrees in such areas as biochemistry, molecular biology, immunology, biotechnology, chemistry, physics, and other sciences.
We know that at any given time you could be experiencing issues with your supply chain, license or fundraising/finance or regulatory/compliance issues. You could also be seeking advice about what role vaccination can play in returning your workforce to workplaces around the world. Whatever challenges you are facing, our global team is here to help you achieve your goals.
Our recent work with vaccine law includes advising:
- various multinational pharmaceutical companies in relation to the local distribution, financing and pricing of COVID-19 medicines to COVID-19 purchased by emergency EU procedures or by pan-European purchasing legal mechanisms
- a leading international vaccine manufacturer on data protection issues and the actions to be taken to comply with the Data Protection Code of Ethics
- a leading international pharmaceutical group in defense of patent infringement proceedings, including damages compensation controversies
- a biotechnology company on a UK government investment of more than £100m to produce millions of doses of a COVID-19 vaccine, enabling these to be made available as soon as possible
- a leading US-based biopharma company on the development of an EMEA-wide product incident plan to include pharmacovigilance and regulatory notifications
- an international pharmaceutical company on public procurement matters relating to medicines and the application of national protectionist rules by the public customer, receiving a clarification from the FAS and Ministry of Trade of Russia that limits restrictive application of protective regulations
“Combination of real litigation expertise with practical assessment of what really matters and what the underlying dynamics and risks of the case actually are.”
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