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UK and EU’s future relationship ‘must protect patients’

UK coalition concerned about regulation, data sharing, infectious disease controls

Brexit

After the draft Brexit withdrawal agreement, Theresa May’s hard-fought exit deal is still looking precarious, but in the meantime attention is shifting to the future relationship between the UK and EU27 – and the impact on patients on both sides of the divide.

A slim document drawing out the broad strokes of a future relationship after the transition period that ends on 31 December 2020 (but may be extended) has been drawn up, and work is afoot to flesh that out with a declaration due to be finalised at an EU summit next Sunday.

The language of that early document is vague, however, and a coalition of UK health sector players want to make sure that patients and public health are placed front and centre as it is fleshed out, saying Brexit negotiators “have a responsibility to protect 500 million patients on both sides of the Channel”.

Failure to do so could make it easier for falsified medicines to enter the supply chain, interrupt the sharing of data that could signal problems with medicines, and weaken controls on the spread of infectious diseases, according to the coalition, which includes representatives of the NHS and UK pharma's ABPI and biotech association the BIA. They also want to ensure there will be no blockages on the supply of the billion or so medicine packs that ship between the UK and EU every year.

They want the Declaration to include specific references to the importance of cooperating on the regulation of medicines, the protection of EU and UK citizens from infectious diseases and falsified medicines, and maintaining close collaboration on science and innovation.

Niall Dickson, the chairman of the NHS Confederation, said: “We understand that there is still much detail to be worked out on the future relationship between the UK and the EU, and we are pleased that the withdrawal agreement preserves key safeguards for patients during the implementation period.

“But we need assurances from the UK and the EU authorities that they will put patients first as they negotiate details of the long-term relationship.”

Dickson added that it should be possible to include “specific but non-controversial commitments” in the Declaration to make sure these important functions are retained in future.

ABPI Chief Executive Mike Thompson said: “Brexit negotiators have an opportunity to take decisions today which will protect patients in the future.

While there are positives in the political declaration, the detail is missing.  We are asking Government to give explicit commitments on issues of public health and medicines safety which we think is the minimum that patients across Europe should expect.”

Steve Bates

The BIA's Steve Bates

The BIA's chief executive, Steve Bates, added: “The draft Political Declaration has missed an opportunity to prioritise patients across Europe and the UK.  It is vital that patients are included in the next Political Declaration and are a priority for discussions to ensure public health and patient safety are not negatively affected by Brexit – both day 1 post-Brexit and in the future.”

As it stands, the assumption is that medicines will still be able to move freely between the UK and the EU during the transition period if May’s Brexit deal is implemented, and that should alleviate near-term concerns about shortages that have led companies to start stockpiling supplies.

There will also be reciprocal arrangements on drug licensing dossiers, but the future role of the MHRA remains under a cloud as it can no long take the lead on marketing applications and it seems likely that new regulatory reviews will be made by EU27 agencies – at least during the transition phase.

The transition deal does provide some degree of regulatory certainty for the health sector, but support in the UK Parliament is looking increasingly shaky– thanks to opposition from Brexiteers in the Conservative party, the supposed allies in the Democratic Unionist Party and the opposition benches. And there are now reports that some EU27 countries are lobbying to harden the Brexit conditions further, which could further jeopardise the process.

The BBC says France and Spain are lobbying the EU over fishing rights in UK waters and the status of Gibraltar, respectively, to the consternation on EU Brexit negotiator Michel Barnier who has said there will be no adjustment to the agreement on the table at this late stage.

Faced with possible defeat in the UK Parliament, the prospect of a no-deal scenario is looming ever larger, and voices calling for the final decision to be returned to the UK electorate with three choices on the ballot – May’s deal, no deal, or no Brexit – are getting louder.

Article by
Phil Taylor

20th November 2018

From: Healthcare

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