As part of an attempt to ensure patients understand how drug shortages have been and will be managed when the UK leaves the EU, the European Medicines Agency (EMA) on Tuesday published a question and answer document related to the work the agency is undertaking.
The nine questions and answers cover everything from what happens if companies cannot make certain regulatory changes in time to whether Brexit will impact the safety or review of medicines in the EU and European Economic Area (EEA).
On whether regulators can force companies to make the necessary regulatory changes, the Q&A says: “EMA, EC [European Commission] and EU/EEA Member States have been monitoring the situation and advising companies on the necessary steps to take and urging them to make these changes on time in order to allow continued availability of medicines once the UK has withdrawn from the EU. However, ultimately the responsibility to transfer relevant activities and to continue marketing a medicine in the EU/EEA lies with the company holding its licence.”
And even if all regulatory changes are made on time, there might still be medicine supply issues at the borders if the UK leaves the EU without a deal, EMA adds.
“Companies are still making the necessary changes and it is difficult to indicate at the moment which medicines are at risk of a shortage. If at any point in time a specific shortage is confirmed for a medicine, medicines authorities will make this information public according to their regular practice. This may include recommendations for patients, healthcare professionals, farmers and pet owners, including recommendations to switch to a suitable alternative. Such communication will be published on the websites of EMA and/or national authorities,” EMA says.
The agency also tells patients not to ask for more than a usual supply of medicine.
“It is important that you only get your usual supply and that healthcare professionals do not prescribe or purchase additional supplies in order to prevent unnecessary strain to the supply system,” EMA said.
EMA also has said recently that companies need to continue to prepare for the UK’s withdrawal, even though the deadline for such a withdrawal has been pushed back. In addition, the UK’s MHRA has published a series of Brexit-related guidance documents
on various topics.
Biopharma companies, meanwhile, are spending tens of millions of dollars
to prepare for Brexit and to stockpile medicines so that shortages do not occur.
Pfizer said that its Brexit preparations are set to cost about $100 million, while GlaxoSmithKline has said it’s spending up to £70 million ($92.6 million) over the next two to three years. Novartis said it’s stockpiling medicines “to ensure continuity of supply to UK patients of the over 120 million packs of medicines we import to the UK from Europe each year.”
European authorities working to avoid shortages of medicines due to Brexit – Questions and answers