Brexit has long been expected to disrupt the supply of medicines into the UK from European Union countries, but a less understood risk is the diminished supply to patients with the EU.
Manufacturers of up to 19 marketed pharmaceuticals have still not made the necessary regulatory changes to allow them to continue to supply to EU patients after Brexit, an expert has warned.
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Medicine shortage: supply chain problems
At the last count, 19 centrally authorised human medicinal products (CAPs) were considered “at risk” for supply problems to the EU if the UK exits the EU as planned on 30 March, said Marie-Helene Pinheiro, Industry Stakeholder Liaison within the European Medicines Agency (EMA).
Pinheiro was addressing delegates at the 18th Regulatory and Scientific Affairs Conference of the generics group Medicines for Europe in London.
All, or a major part of, the manufacturing steps for these 19 at-risk CAPs are currently carried out in the UK. To continue to sell these products in the EU after Brexit, pharma companies must switch some of these processes to EU locations, and submit amendments of their marketing authorisations to regulators.
For these 19 products, these changes are unlikely to be submitted in time, according to Marketing Authorisation Holders’ (MAH) own plans, said Pinheiro. Companies must act immediately if they wish to beat the Brexit deadline, she said.
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By GlobalDataPharmaceutical Brexit preparedness
The MAH of each CAP will need to be situated in the EU, or European Economic Area (EEA) and not the UK before Brexit. There are other changes MAHs must prepare for: some activities related to pharmacovigilance and batch release must be performed in the EU or EEA, such as certification of the product by a qualified person (QP).
CMOs offering QP release can be searched in the GlobalData Contract Service Providers database.
Other companies have already withdrawn, or plan to withdraw, a further six human CAPs before 30 March, instead of pursuing the regulatory amendments to allow continued supply to the EU, Pinheiro said.
She told the conference, which closed in early February, that only 199 of the 728 CAPs that will be affected by Brexit (27%) have completed all necessary changes so they will be available to EU patients.
Pinheiro said the agency is now engaging with specific member states and companies to provide alternative ways to mitigate supply problems for the 31 CAPs on the critical list.
Centrally authorised medicinal human medicines – Brexit preparedness status
Source: GlobalData
Pinheiro advised companies to submit changes as soon as possible and to avoid the week of 4-8 March, when EMA buildings will be shut between the closing of the agency’s London headquarters and the opening of its temporary Amsterdam office.
The staff will telework during this period and capacity may be reduced. MAHs have a legal obligation to warn the EMA of a potential risk to supply of medicines, she added.
Speakers at the conference, while preparing for the UK’s looming withdrawal, were generally critical of the departure, with Marc-Alexander Mahl, President of Medicines for Europe and Executive Vice-President of Generic Drugs for Fresenius Kabi (Bad Homburg, Germany), calling Brexit a “massive regulatory project that unfortunately brings little value to regulatory science.
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