U.K. politicians push for cooperation with EMA post-Brexit

The Palace of Westminster
The Palace of Westminster--Courtesy of Diliff [CC BY-SA 2.5]

Senior politicians in the British government have called for the country to work closely with the European Medicines Agency (EMA) after Brexit. The statement suggests the politicians are willing to stand up to colleagues pushing for a clean break from European regulation and want to reassure the industry they will minimize disruption.
 
Writing in the Financial Times, Jeremy Hunt, health secretary, and Greg Clark, business secretary, said they want “to continue to work closely” with the EMA when the U.K. leaves the European Union. 
 
The statement is in line with comments made by other members of the government since the U.K. voted to leave the EU last summer. Hunt himself has previously said the U.K. should seek the “closest possible regulatory equivalence” with the EMA after Brexit. And Prime Minister Theresa May has spoken more generally about the need to maintain “deep, broad and dynamic cooperation” with Europe.
 
But, while the topline message is familiar, Hunt and Clark’s letter is notable in that it is a rare unsolicited comment on the U.K.’s future relationship with the EMA. The letter appears designed to ease the jitters of industry. It is a rare example of two ministers seemingly holding the same position on the EMA. And, in the context of May’s weakening position after a disastrous general election, it suggests people with contrasting views inside and outside the government may now speak up.
 
The letter also goes into greater detail than previous comments. Hunt and Clark have created three principles to guide the U.K.’s decisions as it reshapes its regulatory relationship with the EU.
 
These principles are: “Patients should not be disadvantaged; innovators should be able to get their products into the UK market as quickly and simply as possible; and we continue to play a leading role promoting public health.”
 
The first two principles address concerns raised by the biopharma industry. Leaders including  AstraZeneca CEO Pascal Soriot have warned patients in the U.K. will wait longer and pay more for new drugs if the U.K. creates a drug approval system distinct from the EMA. 
 
Hunt and Clark are seeking to reassure Soriot and others that, however the negotiations with the EU go, the U.K. will retain an attractive regulatory environment. 
 
“We are clear that should we not achieve our desired relationship with the EU, we will set up a regulatory system that protects the best interests of patients and supports the U.K. life science industry to go from strength to strength. We will seek to process licences as quickly as possible, certainly no more slowly than at present. Our fee pricing will be competitive with current levels,” the ministers wrote.
 
The elephant in the room is that license processing times are only part of the problem. If winning approval in the U.K. requires a separate filing, companies will shunt the country down their lists of priorities. The sheer size of the U.S. and EU markets mean companies will seek approval there first, before then turning their attention to countries such as Australia, Canada and, potentially, the U.K.
 
One way to achieve the U.K.’s objectives would be to stay in the EMA. Hunt has previously said May’s refusal to remain under the jurisdiction of the European Court of Justice makes it impossible for the U.K. to stay in the EMA. Newly-emboldened opposition politicians are pressing May on that red line. But Hunt and Clark’s letter suggests the government still plans  to leave the EMA.