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Pharma fears “lack of focus” on no-deal Brexit preparations

As Brexit is delayed, pharma suggests new measures to avoid no-deal drugs shortages

May Juncker

Theresa May with European leaders yesterday in Brussels: Brexit is delayed, but no-deal remains a possibility

The short Brexit extension granted to the UK by the European Council last night averts a no-deal exit next week, but urgent action is still needed to safeguard the medicines supply.

That is the view of Merck KGaA chief executive and President of European pharma's EFPIA, Stefan Oschmann, who says that the pharma industry has “been concerned by a certain lack of focus, outside of our industry, on protecting medicines supply,” as well as the EU’s stance of leaving some critical issues to be resolved by the EU member states.


EFPIA president Stefan Oschmann 

He suggests in a blog post on the European Federation of Pharmaceutical Industries & Associations (EFPIA) website that there has been positive action in areas such as fisheries, transport and financial services, but “more needs to be done to protect public health and the supply of medicines to patients.”

The comments came ahead of the pivotal deliberations in Brussels yesterday where the Council agreed to extend the Article 50 deadline from 29 March to 22 May – assuming MPs approved Prime Minister Theresa May’s withdrawal agreement next week at the third time of asking – or to 12 April if they do not.

In the latter scenario, the UK will have to set out its proposed path forward or leave the EU without a deal, threatening the timely delivery of an estimated 1 billion packs of medicines that cross the UK-EU border each year. May’s request for an extension to 30 June was denied.

Oschmann says that despite strenuous efforts by industry to prepare for no-deal, more needs to be done by other parties, “from regulatory bodies to transport companies, wholesalers to governments.”

Industry has been making changes to supply chains, duplicating drug testing in the UK and EU27, transferring licenses and making plans to ship medicines to and from the UK on the government’s new ferry services or via air freight in the case of short half-life drugs.

As a matter of urgency, it is important that EU member states allow the use of medicines that have been quality tested in the UK where companies have been unable to transfer testing to an EU27 country by the time the UK leaves the bloc, says Oschmann.

Medical devices used alongside medicines that currently hold UK certified CE marks, should also be made available to use in the EU in the short term, he adds.

“While the situation at the EU-UK border remains unclear, two-thirds of the pharma companies indicated that border disruption remained their biggest concern,” says Merck’s CEO. “As a consequence steps should be taken to prioritise medicines, active pharmaceutical ingredients, raw and clinical trial materials.”

The blog also notes that the European Commission and European Medicines Agency have said that any action to resolve these issues is a matter for the member states, but they have differing approaches and what is needed is unified – and immediate – action.

Back in the political sphere, Theresa May incensed many MPs in a statement ahead of the European Council meeting where she laid the blame for the current situation on the Commons, and pitched herself as the guardian of the UK public’s desire for Brexit. This came even as a petition to revoke Article 50 and cancel the Brexit process sped above the 1m signatures mark (and was approaching 3m this morning).

She took a more conciliatory tone yesterday – mindful of the mountain still to climb in persuading MPs to back her deal, but there is still little confidence of success given the scale of the previous two defeats.

The big concern now is what happens if the third vote on the deal is defeated, and reports coming out of Brussels suggest there was little substance from May on that eventuality, and there is also still the question of whether Commons Speaker John Bercow will allow the vote to take place.

Article by
Phil Taylor

22nd March 2019

From: Healthcare



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