Manufacturers to be insulated from ‘certain liabilities’ under advance purchase agreements
Agreements to secure doses of Covid-19 vaccines for the EU will protect the manufacturers from some potential legal claims and damage payments they could face if the vaccines cause harms—potentially as a result of the speed with which they are being developed—the European Commission has said.
“In the race against time, vaccine manufacturers have to produce vaccine a lot quicker than under normal circumstances,” a Commission spokesperson said. “To compensate for such high risks taken by manufacturers, the advance purchase agreements provide for member states to indemnify the manufacturer for certain liabilities incurred.”
“This means that…member states are ready to financially cover certain of the companies’ risks to ensure that vaccines are actually available for EU citizens to protect public health.”
The spokesperson insisted that the EU and member states “are taking all necessary measures to protect citizens”, and that a strict safety assessment must be carried out before a vaccine is approved.
On 25 August, the Financial Times reported that the pharmaceutical industry lobby group Vaccines Europe had pushed the EU to provide such protections.
The newspaper said it had seen an internal Vaccines Europe memo that said: “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”, and that this creates “inevitable” risks.
Vaccines Europe confirmed the existence of the memo, but said in a statement that safety was the “top priority” and that, although work that would normally be carried out sequentially is being carried out in parallel for Covid-19, this is “never at the expense of safety or quality”.
The lobby group admitted that harms from use of Covid-19 vaccines were a possibility, saying: “Deploying billions of doses of vaccines around the world means it is possible that some people receiving a Covid-19 vaccine will experience medical events.”
But it said this is “not unique to Covid-19 vaccines, as all medicines and vaccines can give rise to side-effects in some individuals”.
The group confirmed it is seeking “to work with governments to develop a system of compensation that works for any individuals affected”, and said that “any system should aim to get the right level of compensation to the right patient when they need it”.
It said its members are discussing with authorities how such a system could work, based on best-practice examples from several European countries.
On 24 August, the Commission said it had concluded exploratory talks with the United States-based company Moderna to buy doses of the Covid-19 vaccine it is working on, and that Moderna was the fifth company with which it had concluded such talks. The other four are Sanofi-GSK, Johnson & Johnson, CureVac and AstraZeneca.