Nothing about Brexit is certain.
Prime Minister Teresa May has said she wants to trigger the two-year process during which the UK will negotiate the terms of its withdrawal from the EU by the end of March; however, various ongoing legal challenges could force her to seek parliamentary approval.
Whether Brexit even happens if May tables an article 50 bill is anyone’s guess.
Right leaning UK newspapers suggest parliament would not reject last June’s referendum result, while left wing publications speculate that ministers would tie the legislation up with amendments or even try to force a second vote.
Brexit-related uncertainty is not good for the pharmaceutical industry or patients according to European Federation of Pharmaceutical Industries and Associations (EFPIA), a Brussels trade association that represents drug manufacturers.
Spokesman Faraz Kermani told us “it is difficult to prejudge anything as we do not know what Brexit will actually look like at this point."
Nevertheless, EFPIA is making Brexit contingency plans according to Kermani, who said: “Our main focus hitherto has been to ensure regulatory continuity across Europe.”
ABPI seeks consistency
In London, the Association of the British Pharmaceutical Industry (ABPI) – an EFPIA member association –also wants the MHRA and the Government to keep regulations consistent with those in the EU.
CEO Mike Thompson told us “Securing continued regulatory cooperation and alignment with the EU for medicines will be in the best interests of the UK Government, EU member states and patients.”
He added that: “We continue to work with Government and partners across Europe to make sure a workable solution is in place from day one of the UK leaving the EU.”
Prior to the referendum vote Thompson warned that changes to medicines regulation resulting from the UK’s withdrawal from the EU - including the need to win separate clearance from the MHRA - would likely change how drug firms prioritize their efforts to win approval.
“Our members have confirmed that the applications for UK license would come after the European license due to the smaller patient population in the UK.”
The ABPI view echoes comments by UK-headquartered drug manufacturer AstraZeneca. In August the Anglo-Swedish drug manufacturer raised concerns about any changes to the current mutual recognition procedure.
MHRA on Brexit
The MHRA has not discussed what impact Brexit would have on its regulation of drugs.
Its most recent statement on the subject - issued in August - made clear that "playing a full, active role in European regulatory procedures for medicines remains a priority.
"We contribute significantly in both the centralised and decentralised regulatory procedures, including new rapporteur and reference member state (RMS) appointments, and maintain our programmes for implementing EU legislation as required by our obligations as a Member State. We are also fully engaged in European and national scientific advice services and in delivering our EU inspection-related duties."