The European Commission is to present, on Wednesday 17 June, an EU strategy for the development of a vaccine against Covid-19 based on Advance Purchase Agreements (see EUROPE 12499/5). But, before that, it must have the political support of the European Health Ministers, who are meeting by videoconference on Friday 12 June.
This step will be a real test for the European solidarity that was undermined at the beginning of the pandemic.
Advance Purchase Agreements
According to a draft text seen by EUROPE, the European Commission proposes to negotiate, with pharmaceutical companies, privileged conditions of access to a future vaccine. Overall, the institution proposes to enter into a number of Advance Purchase Agreements (APAs) for the most promising vaccines.
“Under these agreements, a financial package would be agreed with individual vaccine producers in exchange for the right to purchase a specific number of doses of vaccine over a given period of time and at a certain price”, says the document. “This upstream financing will be considered as a down payment on the vaccines that will actually be purchased by Member States if a vaccine proves effective”, it continues, proposing to use the Emergency Support Instrument (€2.7 billion) to a “large extent”, or even to replenish it.
Prudent Commission on the respect of competences
In its presentation, the Commission details the centralised procedure. It suggests setting up a small team of experts from the Member States with experience in this field. This team would be responsible for assisting the Commission in negotiations with manufacturers. Operating as a single unit, it would report on a weekly basis to a steering committee of national experts chaired by the Commission.
Aware that the TFEU Treaty gives it only limited powers in the health field, the European institution stresses that its proposal respects the principle of subsidiarity.
“The actual purchase and subsequent use of the vaccine product under the subsequent framework contract would remain the responsibility of each Member State”, as well as “vaccination policies”, it said.
Between security of supply and universal access
In concrete terms, the Commission intends to give priority to manufacturers who have already started clinical trials or are planning to do so in 2020, with a view to producing on a large scale already in 2021. And to decide between them, it would use criteria such as risk sharing, diversification of technologies, a commitment to submit a marketing authorisation application to the European Medicines Agency and a commitment to supply developing countries.
Faced with an US President who is working hard to get his hands on a potential vaccine, the Commission is seeking to resolve two almost contradictory objectives, namely to ensure that its citizens have rapid access to a potential antidote without penalising other countries, particularly developing countries.
But the balance is precarious. The Commission foresees that “vaccines, which would be available for purchase through the Advance Purchase Agreements, but which would not be needed (...) could be made available for the global solidarity effort in addition to the support already provided”.
Lastly, in order to avoid a race between Member States, it indicates that participants will be able to access doses according to a distribution key for their population. (Original version in French by Sophie Petitjean)