Accused of not playing the democratic game, the European Commission is trying to respond to civil society concerns about the purchase of vaccines against Covid-19. It authorised MEPs to partially consult, from Tuesday 12 January, one of the six advance purchase agreements concluded so far, that of CureVac.
It also announced that it is well on track to conclude two others, respectively with Novavax, for 100 million doses, and Valneva, for 60 million doses. Preliminary discussions with the latter have indeed just been finalised this Tuesday.
In addition, the European Medicines Agency (EMA) has indicated that it has received a marketing authorisation application from AstraZeneca. According to Sandra Gallina, the EU’s head of negotiations, the European Commission could make its decision on the vaccine on 29 January. Delivery could start “two weeks later”, at the rate of two deliveries per month.
The Commission also acknowledged at its midday briefing that the European Medicines Agency was in discussions with the developers of the Russian vaccine Sputnik, which is used only in Hungary at this stage.
EU negotiator to be heard by MEPs
On Tuesday 12 January, Sandra Gallina was heard by the European Parliament’s Environment Committee. Far from having answered all the MEPs’ questions, she nevertheless provided some new information, including the fact that the vaccine delivery schedule was only fixed in the contracts for the short-term vaccines. “In the contracts, we have a quarterly calendar: only when the company receives a purchase order from a Member State does it provide a more precise calendar”, she said, suggesting that this more precise calendar was then broken down into months or weeks.
However, she indicated that the Commission would be informed about the status of vaccination and the number of vaccines used through the European Surveillance System (TESSy) of the European Centre for Disease Prevention and Control (ECDC). Commissioner Stella Kyriakides has asked Member States to report to her twice a week (see EUROPE B12633A6).
On the question of contracts concluded on the fringes of the European procedure, Ms Gallina said that she had “never seen any before” and “I don't think I’ll ever see any. In my opinion, they don’t exist, according to what I've been told”, she continued, recalling that European orders were in any case a priority and that the surpluses (which a Member State can normally claim in relation to its population, but which it would have refused) would also be redistributed in proportion to the population.
Finally, on the subject of possible reimbursements in the event of failure of clinical trials, Ms Gallina indicated that the Commission had managed to include in some contracts a partial or total reimbursement of European funds (the Emergency Support Instrument). “However, this was never the objective. The aim is to take the risk on this money rather than on the money of the Member States and to have a down payment for companies that have vaccines that look promising”, she said.
Limited access to the contract with CureVac
Following this exchange of views, several MEPs were able to consult, in a reading room, the European Commission’s advance purchase agreement with CureVac (405 million doses in total). The German laboratory is the only one, for the moment, to have accepted the exercise.
However, this is disappointing, in the opinion of the chairman of the European Parliament Environment Committee, Pascal Canfin (Renew Europe, France) who told a small group of journalists that he came out of the reading room “with more questions than answers”.
He regretted that a number of important provisions, such as price, places of production and a third of the paragraphs relating to legal liability, were deleted. “There is nothing about intellectual property. There is also nothing about a mechanism to ensure that we continue to pay the right price over time, nothing about controlling margins”, he laments.
He also indicates that the way the calendar is presented in the contracts does not make it possible to say whether there are shortages in the short term.
On the issue of legal liability, the European Commission has always maintained that compliance with European rules in this area is a red line. During the debate with MEPs, Sandra Gallina did not deny rumours that Pfizer had tried to negotiate and exonerate itself from legal liability rules, but she reiterated that this was a European red line. Mr Canfin stated that it is too early at this stage to say that this is the case in the contract with CureVac, given that two of the seven paragraphs dealing with liability are deleted.
Tuesday also saw the revival of an old debate, that of a vaccination passport. According to Reuters, Greek Prime Minister Kyriákos Mitsotákis has written to the President of the European Commission, Ursula von der Leyen, suggesting that the Greek health certificate - which proves that a person has been vaccinated against Covid-19 - should be used as a model at European level. Such a European certificate could, according to the Prime Minister, be used for boarding, regardless of the mode of transport.
At the midday meeting, the Commission’s communication service indicated that “this subject, along with all the other issues relating to the deployment of vaccination campaigns, will be discussed at the summit of heads of state and government” on 21 January.
For his part, Mr Canfin stated that it was too early to consider the establishment of such a mandatory mechanism. For him, given that vaccination cannot be guaranteed to everyone who wants it, this debate is premature, even absurd. According to him, the issue will have to be reassessed in June 2021 in the light of the vaccination campaigns and the health situation at that time. (Original version in French by Sophie Petitjean)