The future of the biotech sector in Europe lies in the simplification of the regulatory process, said Commission executive vice president Margrethe Vestager.
ADVERTISEMENTThe European Commission presented a series of actions to boost biotechnology and biomanufacturing in the EU, confirming a leak published by Euronews earlier this week.
As previously reported, the Commission is planning to assess the current rules for biotech products market approval in a bid to make the EU regulatory framework and its implementation smoother.
“What we hear from industry is that there are indeed huge differences, in what time it takes to have a product that is finalised and tested from the side of the business to being able to market it,” Vestager explained presenting the proposal.
“The claim is that in the US you can do that in two to three years, but within the European Union, it will take you six to eight years,” she continued.
Vestager mentioned the approval process of COVID-19 vaccines as an example of what could also work for biotech products.
“The reason why we could do it in record time [the approval of the vaccines] was that instead of waiting for all the tests to be finalised, and then all of that data being sent to us, we asked the businesses to send us their results in real-time so that it could be assessed in real-time,” she said.
In this way, while companies are conducting final tests, regulatory authorities can prepare final approvals without compromising safety.
In reaction to the proposal, the EU’s largest biotech association EuropaBio stressed the importance of rapidly addressing regulatory challenges in a statement.
“If Europe is to succeed, this initiative has to rapidly transform ‘rhetoric’ into policy and legislative action for competitiveness, enabling innovators to thrive and grow, and creating long-term investment into infrastructures, employment and skills in Europe,” the statement said.
The European Federation of Pharmaceutical Industries (EFPIA) said that the commission’s strategy “should include coordinated and strategic governance to ensure policy coherence and to bridge existing silos between research, health, industry, and internal market policies”.
