Europe’s ability to manage big public health crises related to the use of medicines, such as the Zika virus, could be at risk if the UK were excluded from cross-EU incident management planning © Bloomberg

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UK pharma industry leaders have warned of the potential impact of Brexit on Europe’s capacity to respond to a continent-wide public-health emergency, as they step up their drive to ensure the sector’s interests are addressed when the next phase of negotiations begins.

The Association of the British Pharmaceutical Industry and the BioIndustry Association said that Europe’s ability to manage big public-health crises related to the use of medicines, such as the Zika virus, could be at risk if the UK were excluded from cross-EU incident management planning.

A report commissioned by the associations suggested that “delays in communication around crisis management or divergence in standards and procedures” between Europe and the UK “are likely to lead to delays in action”.

It noted that the EU’s incident management plan was used on average nine to 10 times a year and cited how, in 2015, the UK and the rest of Europe contributed their shared expertise to the global response to the Zika threat, and gave advice on scientific and regulatory issues related to research and development of medicines or vaccines against the virus.

Another striking finding in the research, carried out by OHE Consulting, was that if co-operation between the EU and the UK came to an end, there could be a delay of several months in sharing information about drug safety or adverse medical events.

The associations said that if the UK’s expertise were lost, “the detection of ‘signals’ — information relating to a possible causal relationship between an adverse event and a drug — could be delayed by up to five months, and the publication of safety recommendations relating to these ‘signals’ could also be delayed by the same amount of time”.

The report also highlighted the key role played by the UK in reporting and evaluating the safety of medicines on a population-wide basis, saying that the country hosted the highest number of centres for monitoring and scrutinising the safety and effectiveness of medicines of any European country.

Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, added: “A swift co-operation agreement between the EU and the UK on medicines is the only way to ensure that there is no disruption to 500m patients accessing the best possible healthcare and getting the medicines they need.”

The report also found that changes to trade and the medicines supply chain as a result of Brexit “could contribute to an increased frequency of medicines shortages in the EU27/EEA and the UK”.

It pointed to a recent survey by the European Federation of Pharmaceutical Industries and Associations that found that 45m packs of medicine went from the UK to the rest of Europe each month, with more than 37m packs coming back the other way.

The impact of any change would be felt most on vaccines and advanced therapies that use human blood or plasma, “as these products are disproportionately manufactured or imported via the UK”, it said.

Giving evidence to the Commons health select committee on Tuesday, Steve Bates, chief executive of the BioIndustry Association, said that the governments of the UK and the other 27 member states should “safeguard public health in the UK and Europe by making the regulation and supply of medicines the first priority in phase two of Brexit talks”.

Separately, following an appeal from the chemical and pharmaceutical industries to be allowed to remain within EU rules post-Brexit, Michael Gove, the environment secretary, told a Commons committee that a key regulatory standard, known as Reach, is “a single market measure so any company wanting to place products on the EU market after the UK’s exit will still have to follow Reach, whatever our future relationship with the EU”.

In his letter to the environmental audit committee, he added that Reach would continue to apply until Britain leaves the EU “and we are urging UK companies to still meet the final Reach registration deadline in 2018 to ensure they are compliant with regulatory requirements in the EU while we remain a member, and recognising that the EU Withdrawal Bill will bring Reach, with this registration requirement, into UK law”.

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