UK ministers call for 'special relationship' with EMA post Brexit
Cabinet ministers will be relying on the UK’s Medicines and Healthcare products Regulatory Agency to keep communication channels open with the European Medicines Agency.
A post-Brexit UK wants to continue to “work closely” with the European Medicines Agency (EMA) — the organisation responsible for drugs safety, it has emerged.
The UK health and business secretaries promised in a letter published this morning (4 July 2017) in the Financial Times that the door to the European Union (EU), and the EMA especially, will “remain open” in order for patients in the UK to access the best and most innovative medicines and to protect patient safety.
They write: “Our door will always be open to a deep and special relationship with the EU which remains the best way to promote improved patient outcomes both in Europe and globally.”
Health secretary Jeremy Hunt and business secretary Greg Clark reveal the government is relying on the UK’s own drug safety watchdog to continue a relationship with the EMA.
They say: “The Medicines and Healthcare products Regulatory Agency wants to work with all types of innovators, ensuring new medicines can reach patients quickly. Drug development is a global business — and we will look to continue to work closely with the EMA and our international partners.”
They confirm that whatever the outcome of the Brexit negotiations, the government plans to have a regulatory system that both protects patients and supports the development of the UK life science industry.
They promise that any future licensing system will match the current timescales and that the fees will remain competitive.
According to Mike Thomson, chief executive of the Association of the British Pharmaceutical Industry, the industry membership body, the letter confirms the government’s recognition that medicines regulation is a key priority for the Brexit talks and its desire to be “pragmatic.”
He said in a statement: “This is a great first step. If patients in Europe are to continue to get safe and effective medicines in a timely fashion, the focus must be on agreeing regulatory partnership between the UK and the EU. The time frames we need to meet to ensure no disruption or delay mean that confirmation of a reciprocal approach from the EU would provide welcome certainty to more than 500 million patients.”
The UK BioIndustry Association — the membership organisation for the life science industry — welcomed the commitments made in the letter describing them as “good news for patients, industry and investors” in the UK and EU.
Its chief executive officer Steve Bates, said: “It’s the first step to a sensible approach to Brexit for this key sector and recognises the negative impact in areas like falsified medicine, pharmacovigilance and infectious disease control that a cliff-edge Brexit would cause on both sides of the channel.”
The EMA said it was unable to comment on the content of the FT letter as the future of medicines regulation “is a matter of negotiations between the UK and the EU” and was the responsibility of the European Commission.
The agency confirmed that a decision about the post-Brexit headquarters of the EMA, currently based in London, will be taken at the November 14 to 15 meeting of the EU’s general affairs council.
A spokeswoman for the European Commission said that citizens’ rights, new borders and details of the financial settlement are the priorities for Brexit negotiations. Until those issues are decided all other matters - which include medicines regulation - are on hold, she said.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2017.20203107
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