What exactly do the advance purchase agreements between the European Union and the pharmaceutical industry on future Covid-19 vaccines contain? After gleaning information from the European Commission (see EUROPE 12554/4), MEPs were hoping to get more details from industry at a public hearing on Tuesday 22 September. But not surprisingly, it invoked the sacrosanct principle of business secrecy.
Refusal to publish agreements
As a reminder, the EU is negotiating with the pharmaceutical industry to pre-reserve doses of several candidate vaccines. At this stage, the Commission has concluded two agreements, one with AstraZeneca and the other with Sanofi-GSK (see EUROPE 12547/7, 12563/8). It has also completed exploratory discussions with Johnson & Johnson, CureVac, Moderna and BioNTech (see EUROPE 12556/7). However, it revealed only very few details of these talks.
“The GUE/NGL group was outraged by the fact that this is public money”, said Belgian MEP Marc Botenga, a member of the European Parliament.
“I don’t think it’s a good idea to publish these agreements before all the negotiations are complete”, said Sue Middleton, chairman of the Vaccines Europe board of directors, “as this would undermine ‘commercial confidentiality’”. Sanofi’s executive vice-president added that these agreements had followed “normal procedure”, while the representative of CureVac, Jean Stéphenne, insisted on the need for European industry to remain competitive, citing the “3 to 4 months” lead of other companies.
A few small details
The representative of the European Medicines Agency (EMA) was the most vocal. Commenting on the issue of access to data, he said that the EMA would publish all clinical data submitted by a company (with the exception of personal data and certain confidential business information) once the Commission had issued a positive/negative marketing authorisation decision or the application had been withdrawn.
“The European public assessment report will be published within three days of the Commission granting authorisation and the full risk management plan will be made public”, he said. He also indicated that an ongoing review would begin in the coming weeks.
Sue Middleton, on the other hand, returned to the issue of accountability. According to her, the industry will remain liable in the event of malpractice, but will benefit from a compensation system if the vaccine gives rise to unexpected adverse effects and to cover legal costs. She called on MEPs to debate “a no-fault compensation system” for patient compensation.
With regard to the price of future vaccines, Mrs Middleton mentioned a price of between €5 and €15 per dose.
The representative of CureVac, for his part, indicated that his product would most certainly require two doses, or even three.
MEPs regret the opacity of talks
At the end of the 3-hour hearing, Industry Committee Chair Cristian Bușoi (EPP, Romania) listed points “still to be clarified”, including the production and distribution of future vaccines, transparency of agreements, risks, and situations where the virus would mutate.
For his part, the Chairman of the Committee on Public Health, who co-organised the hearing, was also disappointed. But Pascal Canfin (Renew Europe, France) nevertheless welcomed the presence of representatives from Sanofi and CureVac, while AstraZeneca, for its part, had simply refused the invitation.
This hearing comes the day after the publication of a report denouncing the lobbying of the pharmaceutical industry during the pandemic. This document, published on 21 September by Corporate Europe Observatory (CEO), shows in particular how the main pharmaceutical lobby (EFPIA) has opposed the joint procurement of medical countermeasures. It also points to the way Merck put pressure on the Commission just before the crisis to obtain unitary supplementary protection certificates.
See the CEO’s report: https://bit.ly/3hXiwoG (Original version in French by Sophie Petitjean)