Can't we have an oral vaccine?
Photo: dpa/Lukas Schulze

BerlinCosts for potential damages caused by a new coronavirus vaccine may be shouldered by European taxpayers, rather than the pharma industry, as politicians push for a quick solution to the current crisis.

"The preliminary contracts with the companies include compensation clauses in case a manufacturer is sentenced to pay damages,” a European Commission (EC) spokesperson told the Berliner Zeitung. The reason for this measure, he said, was "that in the race against time, vaccine manufacturers have to produce a vaccine much faster than under normal circumstances".

A vaccine would have to be developed in "12 to 18 months instead of a decade or more".

The EU wants to free manufacturers of the risk of damages should patients sue pharmaceutical companies because of the short development time. "In order to compensate for such high risks taken by the manufacturers, the preliminary agreements provide that the member states compensate the manufacturer for possible liabilities under certain conditions,” the spokesperson said.

The pharmaceutical industry has been lobbying hard in past months for a general exemption from liability for any damage caused by the new corona vaccine, the Financial Times reported on a memo from "Vaccines Europe", a division of the European Federation of Pharmaceutical Industries and Associations (EFPIA).

"The speed and scale of development and rollout do mean that it is impossible to generate the same amount of underlying evidence that normally would be available through extensive clinical trials and healthcare providers building experience," the memo said.

Manufacturers should be exempt from the incalculable risk of damages related to any potential vaccine. The association wants the EU and member states to offer "compensation and civil liability indemnification" for all damages that a new vaccine might cause.

However, pharmaceutical companies have so far been unable to win the exemptions. The compensation in the preliminary contract does not mean "that we will compromise on the safety of a future vaccine,” the spokesperson said. The EC is not prepared to alter liability regulations, he said.

The EC and the member states are negotiating with individual pharmaceutical manufacturers to purchase vaccines. An initial contract has already been completed with AstraZeneca, though it was hammered out under great secrecy at the highest level, according to information seen by the Berliner Zeitung.

Breathtaking amount of secrecy

Yannis Natsis

The talks even bypassed lower governmental departments, a person familiar with the negotiations said, requesting anonymity because of the sensitivity of the matter.

The European Medicines Agency (EMA), the European counterpart to the Food and Drug Authority (FDA) in the US, will make the final decision on the approval of any new corona vaccine. Yannis Natsis, one of the two EMA board members elected by patient associations, said during an interview with the Berliner Zeitung that he was concerned about the lack of transparency in the negotiations.

"There is a breathtaking amount of secrecy in the process of negotiations with the pharmaceutical industry. We need and demand that the negotiations be scrutinized by the public," he said.

Natsis said that the negotiations have  been "accelerated because governments want to get a vaccine as quickly as possible". He said the public sector is already essentially paying for "research and development, production and distribution of a vaccine we don’t even know about.” It is "unacceptable" that "taxpayers have to pay for possible damages".

The patient representative is concerned that the contract with AstraZeneca will be used as a blueprint for other Covid vaccine contracts in the EU: "We need to know every detail about the AstraZeneca agreement. We must not create a model solution for the industry here."

The EC spokesman said corona agreements will not undermine current EU rules.

"In the search for a vaccine against Covid-19, the rules of the product liability directive will remain in force. Any vaccine that is brought to market must meet the necessary safety requirements and be approved by the European Medicines Agency as part of the EU market authorisation procedure. The rights of citizens will continue to be fully protected. Companies can still be legally prosecuted," the EC spokesperson said.

Allegations that "the contracts negotiated by the Commission would not respect the Product Liability Directive are false," he said.

The German Medical Association is also calling for more transparency.

"All admission and liability issues must be solved with the highest degree of transparency. The public must be involved in such a way that a non-transparent debate does not play into the hands of the vaccination opponents," association president Klaus Reinhardt told this newspaper.

Yannis Natsis also sees a potential risk. His first priority is not to weaken confidence in vaccines: "If we leave this matter in the dark, people will become suspicious. This would encourage those who reject vaccination in principle. Such a development would create a real health emergency when people start to reject vaccination."

Germany specifically needs to step up, the EMA board member says: "The German EU presidency has a decisive say here and must play this role. It should promote the dialogue on such sensitive issues between the EU member states and must not bury its head in the sand."

Germany has been criticised by a number of EU countries as being too friendly with the pharmaceutical industry. An insider in charge of the negotiations told the Berliner Zeitung that many countries are angry with Germany because "the doors are wide open for the pharmaceutical industry in Germany".