Life sciences industry calls for Brexit transition period
The EU and UK must make progress in Brexit negotiations “as soon as possible”, according to the associations that represent the European and British life sciences industry.
In a joint statement published yesterday, November 28, nine associations called for a transition period “that adequately reflects the time needed by companies, as well as all relevant authorities at EU and national level, to adapt to changes in view of the UK exiting the EU”.
The associations include the European Federation of Pharmaceutical Industries and Associations (EFPIA), Medicines for Europe and EuropaBio.
They added that medicines are “different” from other industry sectors that are also seeking clarity on Brexit. Particular challenges include regulatory procedures, quality testing of medicines, supply chain, trade and intellectual property.
“Clarity and certainty are needed as early as possible to enable our industry to make the necessary changes and to transition smoothly into the new framework. This is key to ensure that there is no disruption in the supply of medicines to patients after March 2019,” said the statement.
According to a recent EFPIA survey, 45 million patients’ packs are supplied from the UK to the EU and 37 million from the EU to the UK every month.
The joint statement noted that medicines companies may need to submit applications to transfer marketing authorisations for many products, move batch release sites and duplicate quality testing for products, all of which will take time.
Other issues of specific concern to the industry in Brexit negotiations include supplementary protection certificates, which are governed by EU regulations; the planned unitary patent and Unified Patent Court; and regulatory data protection.
It is not yet clear what procedures the UK will have for regulating and approving medicines after 2019. The European Medicines Agency, which will move from London to Amsterdam, recently published guidance on Brexit.
