Almost six months after the start of the Covid-19 pandemic, the European Commission communication on a common strategy for research, development and marketing of a coronavirus vaccine has finally been launched.
The proposal aims to achieve three main objectives: 1) to ensure the safety, effectiveness and quality of vaccines by supporting research at EU level in compliance with the existing regulatory framework; 2) to ensure the earliest and widest possible access to vaccines for all Member States and their citizens, while pursuing efforts in international cooperation and solidarity; and 3) to ensure equitable access within the single market, especially with regard to price-related aspects.
The strategy will be based on two principles. On the one hand, to guarantee the production of vaccines and sufficient supply to meet demand at the EU level and, on the other, to adopt a regulatory framework that adapts to the current emergency and accelerates the introducing of this drug onto the market, in line with the EU standards.
Where the first point is concerned, the Emergency Support Instrument, created to support Member States’ actions with a view to coordination and cooperation, will play a key role. With a budget of € 2.7 billion, it complements all the initiatives put in place to respond to the Covid-19 emergency, including the EU Civil Protection Mechanism and RescEU, the Coronavirus Response Investment Initiative and the European Structural and Investment Funds. Within this framework, the Commission will proceed to conclude agreements with individual vaccine manufacturers, financing part of the initial costs through so-called Advance Purchase Agreements, a kind of pre-payment on those that will then actually be purchased by Member States. It would therefore be a means of transferring part of the producers’ risks to public authorities, thus stimulating production and ensuring fair access throughout the Single Market.
The second principle entails the creation of a regulatory framework that provides stability but, at the same time, remains flexible enough to cope with the evolution of the current crisis. The purpose is to speed up authorisation procedures, increase flexibility in labelling and packaging, streamline and provide derogations from the relevant provisions in order to speed up clinical trials.
The whole strategy will be put in place in cooperation with the European Medicines Agency, which has set up a Task Force (ETF) to interact with Covid-19 vaccine developers and provide scientific support from the start-up phase. This will be done in full cooperation with other relevant European and international organisations, primarily the World Health Organisation.
At the international level, the European Strategy is part of the framework provided by the Access to Covid-19 Tools (ACT) promoted by WHO and other initiatives such as the Global Coronavirus Response, through which more than €9.8 billion has been raised to ensure that access to therapies and vaccines is guaranteed globally, particularly in the most vulnerable countries.
