Pharma hopes for best, fears the worst, as Brexit vote nears

The deadline for Brexit is edging closer, and politicians in the UK are struggling to come to terms with the deal that prime minister Theresa May has negotiated with her European counterparts.

At the time of writing May is making the case to UK politicians for the deal thrashed out with 27 other EU leaders and approved at a summit over the weekend.

Whether the embattled prime minister can win over opposition from across the domestic political spectrum remains to be seen – but the message to politicians from pharma, an industry whose fortunes will be affected by any Brexit deal, is to accept what is on the table.

Nearly all pharma companies have been firmly in the Remain camp, as the industry has spent decades working with European officials to create a regulatory system that provides them with access to the 28 member states and an enormous market for drugs.

With more than a fifth of the world’s pharma sales occurring in the EU, it’s crucial for pharma that any disruption caused by Brexit is minimised.

And of course it is also vital from an ethical point of view that the political turmoil does not affect supplies of badly-needed drugs, both in the EU and in the UK.

Representing branded pharma, the European Federation of Pharmaceutical Industries and Associations (EFPIA) said it welcomed the European Council’s decision over the weekend to support the Brexit withdrawal agreement and political declaration of support.

EFPIA welcomed a reference to a “free trade area combining deep regulatory and customs cooperation”, and the possibility to explore cooperation of UK authorities with EU agencies such as the European Medicines Agency.

Pharma has welcomed the provisions during a transition period, when the UK will continue to recognise decisions made by the EMA – a period expected to last around 21 months, which could be extended if necessary.

The EMA has of course already been affected – it is in the process of moving from its old home in London to a new base in Amsterdam

‘Infinitely better than no deal’

Nevertheless, pharma continues to prepare for “no deal”, which is a distinct possibility given the political turmoil Brexit has caused.

EFPIA’s director general Nathalie Moll said in a blog last week ahead of the meeting that the deal on the table is “infinitely better” than the UK leaving the EU with no deal in place.

The transition period outlined in the plan gives EFPIA’s member companies from large pharma time to adapt to new regulatory requirements, manufacturing and supply issues, including customs arrangements, to ensure the medicines supply is not disrupted.

“The transition period also allows multi-national companies with international workforces in the UK and the EU to manage the implications for staff,” said Moll.

Some pharma companies are also having to invest millions in extra testing facilities either side of the border in case the UK and EU can’t agree on how to recognise each other’s quality control arrangements.

Moll said the scale of the medicines supply issue “should not be underestimated” – around 45 million packs of medicines leave the UK destined for patients in Europe every month and 37 million packs head the other way.

That is more than a billion packs of medicine crossing the border between the UK and EU each year, Moll pointed out.

Moll said: “Our hope is that the deal is accepted and then immediate and intense focus is given to regulation and supply of medicines in the post-Brexit relationship.”

When Brexit began there were concerns about whether any deal would be scuppered by disagreements among member states.

Infighting

But it’s mostly likely to be undone by the infighting and increasingly bitter divisions among UK politicians.

The much-awaited parliamentary vote on Brexit is due to go ahead on 12 December – but there are sure to be twists and turns ahead of this.

There is already talk among Northern Ireland’s Democratic Unionist Party saying that it will vote against the deal on the grounds that it could create a trade barrier between Northern Ireland and the rest of the UK.

Theresa May relies on support from the DUP to prop up her government after she failed to secure an overall majority in last year’s general election.

May also faces opposition from Brexiteers within her own party, who would rather see the UK walk away without a deal than the halfway house approach outlined in the document.

And the opposition Labour party, which also has a Brexiteer faction, is opposed to the deal.

As the politicians signed off the document, Theresa May hailed the end of freedom of movement between the EU and UK “once and for all”, and the UK’s ability to return to “laws being made in our country by our democratically elected politicians”.

But the tone from the EU’s chief negotiator Jean-Claude Juncker was rather more sombre, who said it was a “sad day” and that no-one should be “raising champagne glasses” at the prospect of the UK leaving.

The message for patients is that the best they can hope for is “business as usual” when it comes to medicines supply.

But the matter is now in the hands of politicians, and as the last period of history has shown, the outcome of the vote on 12 December is anything but predictable.