The pandemic has compressed into months of vaccine research and development which can take years. Some potential vaccines are already in phase three testing – the last step before they are submitted to regulatory authorities for approval. At the same time, governments around the world have invested money in research and development to try to save lives and avoid economically crippling lockdowns.
“The speed and scale of development and deployment means that it is impossible to generate the same amount of underlying evidence that would normally be available through extensive clinical trials and the strengthening experience of healthcare providers.” ”, Reads a note distributed to members by Vaccines Europe, a division of the European Federation of Pharmaceutical Industries and Associations.
The document says this creates “unavoidable” risks.
For this reason, Vaccines Europe said in its memo that it called for a “comprehensive system of no-fault and non-adversarial compensation, and exemption from civil liability”.
Responding to questions from the FT, the European Commission said that due to the pandemic it must act as quickly as possible while maintaining patient safety.
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She added that any suggestion that the contracts she was negotiating did not follow the rules of her product liability directive was “categorically false”.
But he also said he planned for the 27 EU member states to compensate vaccine companies for “certain liabilities” through advance purchase agreements he had made and sought to make on their behalf.
He said he was doing this “in order to offset these high risks taken by the manufacturers”.
Vaccines Europe represents drug makers including AstraZeneca, GlaxoSmithKline, Janssen (owned by Johnson & Johnson), Merck, Novavax, Pfizer, Sanofi, Takeda, Abbott and CureVac. Several of these companies are in advanced talks with the EU on the supply of vaccines, while some have already concluded agreements with the US or the EU.
Nathalie Moll, the director of Efpia, said that it and its members were in talks with the authorities on a compensation framework in the event of a vaccine problem “to obtain the right level of compensation for the right patient when there is one. requires”.
According to the Vaccines Europe memo, some people are likely to experience “adverse events” after vaccination. “While such events may in fact not be related to vaccines, such events, combined with the sheer scale of the vaccination program and the public attention on Covid-19, could lead to numerous damage claims .
Yannis Natsis, who sits as an elected member responsible for patient representation on the board of the European Medicines Agency, told the Financial Times that a liability exemption would set “a dangerous precedent” that could have ramifications beyond the pandemic.
“Such discrepancies will undermine people’s confidence in vaccines,” he said. “Governments must resist pharmaceutical pressure and be transparent.”
Efforts by drug makers to push for a blanket exemption from liability have been partially successful, according to people familiar with the discussions. While liability exemptions are common in the United States, this is not the case in Europe.
Last month, Reuters reported that AstraZeneca had secured an exemption from future product liability claims over its vaccine candidate, which it is developing in partnership with the University of Oxford, citing a company executive who would not name the countries. AstraZeneca has entered into a supply agreement with the EU and with other countries. The company declined to comment.
Separately, on Monday, the European Commission said it had concluded exploratory talks with Moderna on the supply of its vaccine.
The FT reported last month that Moderna pitched its vaccine in the $ 50 to $ 60 range for a two-dose course. According to a person close to the discussions, he is asking the EU for around € 20 a dose. The agreed price for the AstraZeneca vaccine is approximately $ 3 per dose.
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