by Peter O'Donnell
BRUSSELS, Dec 8 (APM) - The overnight drama of the May-Juncker agreement on UK progress in Brexit preparations has brought new urgency within the European pharmaceutical sector regarding its chances of maintaining pre-Brexit activity in a post-Brexit world.
Steve Bates, CEO of the British Bioindustry Association, welcomed the terms on market access revealed within the outline agreement that the UK prime minister and the president of the European Commission signed off on early Friday morning.
In a statement, Bates said his "initial reading" of the ‘goods on the market’ proposals was that they should enable medicines that have been tested and released prior to Brexit to be freely available in the EU, even if that testing and release is carried out in the UK and the goods are shipped to other EU countries after the UK withdraws.
"This is an important detail for global companies deciding how, and crucially when, to progress existing Brexit contingency plans," he said.
However, at a meeting in London on Brexit and pharma on Friday morning, Bates admitted to the audience that on this issue he was "not yet certain".
The form of wording in the official joint document is as follows: "Goods placed on the market under Union law before withdrawal may freely circulate on the markets of the United Kingdom and the Union. There should be no need for product modifications or re-labelling. Goods may be put into service where provided in Union law. And goods concerned should be subject to continued oversight."
However, the document - which is a summary of what has been agreed so far between the UK and EU negotiators - continues: " Substantial work is still necessary to agree on the key notion of ‘placing on the market’."
It also goes on, in a passage about governance of the withdrawal arrangements agreed: "While some discussions have taken place on dispute resolution and the monitoring of the functioning of the Withdrawal Agreement, including the possibility of setting up a joint committee, significant divergences remain."
Elizabeth Kuiper, director of European affairs at European Federation of Pharmaceutical Industries (EFPIA), also told the London meeting that in the face of repeated reluctance by negotiators to take account in the talks so far of detailed submissions on technical issues such as health and pharma, the European industry had had to become more political in its approach.
Alert to suspicions in Brussels that EFPIA - in its repeated calls for a Brexit deal on drugs - was acting as a spokesman for the UK government, the federation was quick to move to develop a united voice across the life science sector involving a wide range of UK and European representatives.
"We were one of the first joint positions in Brussels to make clear what's at stake. We know that collaboration is vital across the whole network if we are to achieve our goals of minimum disruption," she said.
But despite its expressions of confidence, EFPIA is also making contingency plans for a no-deal scenario.
Alan Morrison, a vice-president of MSD and head of the EFPIA task force on Brexit, admitted to uncertainty in the wake of the last-minute agreement now likely on moving on to trade talks between the EU and the UK.
"I'm a 'glass-half-full' person", he said, but he confessed he was unable to parse the impact of the overnight deal.
And he expressed clear concern at the continuing delays in bringing certainty. "Companies cannot wait indefinitely. They need to make alternative arrangements if no deal is going to meet their needs", he said.
Meanwhile, in its own Friday statement
on Brexit progress, the Association of the British Pharmaceutical Industry (ABPI) welcomed the joint agreement to protect the rights of EU citizens living in the UK and UK citizens living in the European Union.
"The progress made on citizens' rights is particularly welcome news for pharmaceutical companies and our employees. To provide certainty to everyone, we hope this is swiftly agreed,” it said.
ABPI also reiterated its own previous calls - as well as those from EFPIA and other trade organisations (APMHE 55947
) - to prioritise regulatory and supply cooperation over medicines between Europe and the UK.
The leaders of the EU27 will decide next week whether to accept the recommendation that the Commission will now make to move to talks on trade and transition arrangements.
A Withdrawal Agreement will be drafted on the basis of the joint report and the outcome of the negotiations on other separation issues.
The Commission says that negotiations will need to be completed by autumn 2018 to allow good time for the Withdrawal Agreement to receive assent from the European Parliament and to be concluded by the EU Council, before 29 March 2019.
The next phase of negotiations may discuss transitional arrangements, during which time the full corpus of EU law would, according to the EU, continue to apply in the United Kingdom.