LONDON - The U.K. government has given the industry formal notice that it aims to keep the Medicines and Healthcare products Regulatory Agency (MHRA) involved in and aligned with the EMA when the U.K. leaves the EU.

Speaking at the Bioindustry Association/MHRA joint annual conference in London Friday, junior health minister James O'Shaughnessy said no matter what the outcome of the overall negotiations, the aim in pharmaceuticals is to maintain a "deep and close working relationship with EMA after Brexit."

It is "incumbent on both sides of the negotiating table" to make sure patients are never put at a disadvantage and that the U.K. is in a position to continue to play a leading role in medicines innovation, O'Shaughnessy told delegates.

"It is necessary to ensure the integrity of the pan-European public health system no matter what the outcome," said O'Shaughnessy. "Industry must be able to get their products into the U.K. market as quickly and as simply as possible."

O'Shaughnessy was speaking just over a week after two senior members of the government, health minister Jeremy Hunt and business minister Greg Clark, said they wanted to secure cooperation on the regulation of drugs as part of Brexit negotiations. (See BioWorld, July 6, 2017.)

Given that, there were no surprises in what O'Shaughnessy had to say. However, it was the first time a minister had addressed the industry in public on the subject. And with the government split into various factions on Brexit negotiating tactics and objectives, it was significant that O'Shaughnessy told attendees of the meeting the stance articulated by Hunt, Clark and himself "is supported across government."

In addition, the U.K. government will negotiate to maintain zero tariffs on drugs and medical devices traded within Europe. "We want a new customs agreement with the EU to support this, so medicines and devices reach patients and there is product integrity," O'Shaughnessy said.

But with O'Shaughnessy reiterating the position set out in January that the U.K. will leave the EU single market, it is far from clear how the objectives of regulatory cooperation and zero tariffs will be secured.

"We want a close working partnership [with the EMA], but it needs to be on new terms," O'Shaughnessy said, adding he has been reassured by the industry in Europe and by EU member state governments that MHRA's contribution to the EMA's work is valued.

While aiming to remain part of the European regulatory system, it also is the case that the U.K. government is working on the worst-case scenario in the event that an agreement for MHRA and EMA to continue to cooperate cannot be reached.

O'Shaughnessy declined to elaborate, but said if there was no deal the U.K would stick to the principles that treatments would not be slower reaching the market, and approval and licensing "is no worse than now."

Following on from the Clark/Hunt letter, industry groups from across Europe in turn wrote an open letter to the two ministers to underline that companies in the EU-27 want the EMA and MHRA to continue to cooperate. (See BioWorld, July 13, 2017.)

The BIA and the Association of the British Pharmaceutical Industries (ABPI) have been active for a year in setting options for minimizing disruption for the industry and patients. But it was an EMA edict on April 28, telling companies to start preparing for the U.K. leaving the EU in March 2019 with no agreement on future cooperation, that allowed the ABPI and BIA to press the case for the government to make a statement on its objectives.

"We needed to make sure there is an alternative, so we worked behind the scenes to say, put the U.K. intentions in the public domain," said Steve Bates, chief executive of BIA. The arguments the industry has been making are at the core of the government's position, he said.

'Nested in a big market'

The U.K. government may have a clear objective, but the industry is still left juggling alternative scenarios. Andrew Gregory, deputy director in the Policy Division of MHRA, said, "We do understand the dilemma a lot of you are facing at the moment. You don't know what the future regulatory framework is going to look like. You need to plan, but you don't know what for."

The EMA edict to prepare to relocate marketing authorizations to outside the U.K. is predicated on the bleakest version of a no-deal scenario, Gregory said. "Even if the U.K. is a third party, you wouldn't have to take all the actions set out in EMA's notices, so wait a while."

The chief regulatory officer of Glaxosmithkline plc, Paul Huckle, said he was heartened by O'Shaughnessy's speech. It is not a trade issue, but rather about making sure patients in the U.K. and EU get access to medicines. "We've come a long way in the past few months; I hope we can land in an appropriate place," Huckle said.

But even while putting access forward as the first principle underpinning negotiations, it is clear that trade plays a big part in ensuring that happens. The U.K. represents 3 percent of the global pharmaceuticals market; the EU represents 24 percent. "We are nested in a big market and that's why people come here," said Bates.

Pharma companies have to launch their products sequentially and the simple reality is that the U.K. will go from being a natural launch market to being at the back of the queue, Bates said. "That's how global companies operate; there are many markets where not all products are launched."