Brexit drug supply concerns ease within industry

A survey by the EMA earlier this year identified "serious concerns that there might be potential supply shortages" with more than one in seven of the human and veterinary medicines that the EMA has authorised to be sold in Europe – in total, 108 different medicines.

The EMA has now said that most of the manufacturers of those drugs had taken action to address those concerns, and that its focus is now on addressing potential Brexit-related supply disruptions for 39 medicines.

"Marketing authorisation holders for over half of the 108 medicines have either taken steps to transfer their marketing authorisation to an EU27 country, change their qualified person for pharmacovigilance (QPPV), relocate their pharmacovigilance system master file (PSMF), adapt their logistics, supply chains and contracts, or relocate some manufacturing sites," the EMA said.

"According to EU law, the marketing authorisation holder, the QPPV, the PSMF and certain manufacturing sites need to be based in the European Economic Area (EEA) in order for a company to be able to market a medicine in the EU," it said.

The EMA said it will "work directly" with the businesses behind the 39 remaining products "to address the outstanding issues on an ongoing basis". It said it would also "discuss with its scientific committees relevant mitigation measures, including recommendations on possible therapeutic alternatives to which patients could be switched if necessary".

Earlier this year, the EMA, together with the European Commission, issued Brexit guidance that confirmed that UK-based pharmaceutical companies will be unable to rely on marketing authorisations (MAs) issued by the Medicines and Healthcare products Regulatory Agency (MHRA) to sell their products across the EU after Brexit unless this is agreed by the UK and EU27 as part of an EU withdrawal agreement.

However, the UK government said in August that European pharmaceutical companies will be able to supply their medicines in the UK on the basis of approved batch testing carried out in the EU for at least two years from the point the UK leaves the EU in the event of a 'no deal' Brexit.

At the time, life sciences expert Catherine Drew of Pinsent Masons, the law firm behind Out-Law.com, said: "The approach advocated by the UK government would allow pharmaceutical companies based in and operating primarily in the EU to continue to supply products into the UK. However, the same does not appear to be the case for UK companies seeking to import their products into the EU."

"The EMA has made it plain for some time that it is proceeding on the basis that the UK would become a third country post 30 March 2019 and as such companies must ensure that those obligations set out in the EU's directives on medicinal products which must be carried out in EU member states, continue to be done so post-Brexit. In effect this means that companies with test and release activities in the UK, hoping to sell their product in EU markets, will need to move those activities to another EU member state post 30 March 2019," she said.