The European Commission is continuing discussions with the pharmaceutical industry to ensure rapid, safe and affordable access to future Covid-19 vaccines, said the Deputy Director General of DG Trade, Sandra Gallina, who is in charge of these negotiations. She was answering questions from MEPs on the Committee on Public Health who were very concerned that they were not more involved in the process.
Discussions again revolved around the obligations of the pharmaceutical industry. Sandra Gallina once again pointed out that no changes had been made to European product safety legislation, but that the advance purchase agreements did provide for a compensation mechanism for hidden effects.
Regarding the EPF’s request for a patient fund, made by Véronique Trillet-Lenoir (Renew Europe, French), Ms Gallina said that this idea could be discussed and analysed. “There are associations of patients that are asking to have a European fund for rapid indemnification. There are some Member States that have already have that, some bind the use of the fund to obligatory (future) vaccines”, she reiterated (see EUROPE 12547/7).
Who, when, where?
The Commission representative said the vaccine’s first doses should be available in December, or even November for the “number one”, she added. And while quantities will initially be limited (which will require directing doses to certain categories of the population), this problem should be resolved by April of next year.
The price of the doses will fluctuate between €5 and €15 to keep them affordable. Gallina, however, refused to indicate the price paid by the EU to build up these reserves (she spoke of a “percentage”, saying the issue could be further explored “in camera”) nor did she mention the names of the members of the negotiating committee.
Transparency of clinical trials
During the discussion, several MEPs also insisted on the need to give access to raw data from clinical trials. Ms Gallina said the European Medicines Agency would publish its analysis of these data, but did not provide any commitment on the raw data.
However, she suggested that the regulation on clinical trials - which came into force six years ago but which is still not implemented - is on track. She shared her hopes to see this regulation fully implemented “by the end of next year” (see EUROPE 12536/13). (Original version in French by Sophie Petitjean)