Fast and Flexible? – Regulating Access to COVID-19 Vaccines and Medicines | Max-Planck-Institut für Sozialrecht und Sozialpolitik - MPISOC
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Fast and Flexible? – Regulating Access to COVID-19 Vaccines and Medicines

Vaccines are needed to overcome the COVID-19 pandemic, but also drugs to effectively treat COVID-19. This project examines the key regulatory thresholds that determine whether a COVID-19 vaccine or therapeutic treatment will reach marketing authorisation and will be made routinely available to patients. For this purpose, it explores the relevant regulations in two of the leading global pharmaceutical markets in terms of development, production and sale: the US and the EU respectively. The EU operates a harmonised regime for the regulation of medicines. The research focuses on how the respective regimes regulating access to vaccines and medicines are adapting to the current crisis and whether their emergency regulatory mechanisms are fit for purpose. This is done on the basis of an analysis of the regulation of clinical trials, marketing authorisation, reimbursement of medicines and post-market surveillance.

Contact Person(s)
Wilman-Nikola-3

Nikola Wilman, LL.M., MJur (Durham, UK)