All drug firms with UK-registered marketing authorisations will need to transfer them, along with batch release and pharmacovigilance activities, to an operation established in the EU or EEA after the UK withdraws from the European Union on March 29, 2019.
The rule - set out in According to Article 2 of Regulation (EC) No 726/2004 - applies to UK-registered manufacturers of orphan drugs (OD) according to a representative of the European Medicines Agency (EMA).
He told us “Marketing authorisation holders [for drugs for rare disease] will be required to adapt processes and to consider changes to the terms of the marketing authorisation in order to ensure its continuous validity, once the UK has left the EU.”
Developers have been able to seek orphan designation in the European Union (EU) since the year 2000 under regulations designed to encourage the development of medicines for smaller patient populations.
To date, the EMA has classified 1,900 candidate products as orphan drugs, 140 of which are commercially available.
According to the agency representative, “There are 52 products, authorised in the EU for the treatment of a rare disease, whose marketing authorisation holders are registered in the UK.”
Virginie Hivert from Eurodis, a non-governmental organisation representing patient groups and individuals active in the field of rare diseases, raised concerns that Brexit will change drug availability and impact future research spending.
“We are concerned that the consequences of Brexit may have an impact on patients’ access to rare disease treatments.
“Recent news that funding that would have been otherwise earmarked for therapeutic development will need to be diverted to the relocation of headquarters and manufacturing facilities is discouraging” she said.
Hivert added that while the outcome for patients is difficult to assess before Brexit negotiations are completed, any relocation or administrative costs incurred by drug developers are likely to impact prices.
“If the UK leaves the single market there will likely be an inflation in the costs of pharmaceutical products as, unless a special agreement is reached, industry will have to adopt costly measures to run regulatory affairs in the UK and also in the EU.