The agreement between the European Union and AstraZeneca to supply 300 million doses of the future vaccine (developed by the manufacturer together with Oxford University) is now official. The European Commission announced on Thursday 27 August that it had signed the advance purchase agreement concluded on 14 August and which is now effective (see EUROPE 12544/6).
Despite this ‘officialisation’, only the main lines of the agreement are known, as it is still classified as confidential. It should give all Member States the possibility of purchasing 300 million doses of the vaccine, with an option for a further 100 million doses.
While the European Patients’ Forum (EPF) welcomed the efforts of industry and regulators to promote the rapid emergence of a vaccine against Covid-19, the organisation called on the European institutions to provide more information on the terms of contracts with pharmaceutical companies, including their liability provisions.
Risk indemnification
The Vaccines Europe lobby, a division of the European Federation of Pharmaceutical Industries and Associations (EFPIA), has indeed lobbied extensively, according to a note seen by the Financial Times, for these agreements to contain a “comprehensive no-fault, no-charge compensation system and a civil liability waiver”.
When presenting the agreement with AstraZeneca to the press, a Commission spokesman said that it was in no way intended to weaken the existing liability rules. However, Tim McPhie has confirmed that the agreement does contain ‘risk insurance’. In order to compensate for the high risks taken by manufacturers, the advance purchase agreements provide that Member States compensate the manufacturer for liabilities incurred under certain conditions.
“This is a pandemic, the circumstances are extraordinary and we need to act quickly”, said Tim McPhie. “ Citizens’ rights will remain strong. But Member States are prepared to financially cover some of the risks taken by the company to ensure that these vaccines are available to EU citizens”, he added, before recalling that, to be marketed, a vaccine must be positively evaluated by the Commission, on the basis of a recommendation from the European Medicines Agency (EMA).
EPF calls for insurance
For its part, the European Patients’ Forum has called for greater transparency in the negotiations, in view of the doubts and rumours circulating.
The organisation is seeking reinsurance from the Commission on the maintenance, as it stands, of the provisions of the European directive on product liability (85/374). “It is not appropriate, at this stage, to grant exemptions from civil liability and from the European regulation on product liability”, the statement said.
Instead, the organisation calls for a mechanism such as a common fund at EU level that will ensure appropriate and prompt compensation to patients in the event of serious adverse reactions.
Controversy around the negotiating team
But the lack of transparency is not just about the terms of the contracts. On Wednesday, the Flemish newspaper Het Laatste Nieuws revealed that one of the members of the negotiating committee is a former member of the EFPIA pharmaceutical lobby. Richard Bergström served as Managing Director of the organisation from 2011 to 2016. He is also a partner in a consulting firm whose clients are pharmaceutical companies, and he owns the software company PharmaCCX, a start-up active in the sector, the newspaper points out.
The other six members of the team negotiating EU advance purchase contracts with manufacturers are not known. (Original version in French by Sophie Petitjean)