LONDON, 3 May (APM) - The head of the UK pharma trade body has called out EU officials for not being engaged in a dialogue on the impact of Brexit on medicines in the region.
Mike Thompson used his opening speech at the conference of the Association of the British Pharmaceutical Industry (ABPI) on Thursday to warn on the lack of action by the EU 27 to ensure a continuous supply of healthcare products and protect the public health.
Nearly three years on since the UK public voted to leave the EU, Thompson said the pharma industry in the UK has remained committed to inform officials about the importance of four key areas: trade, regulation, access to talent and scientific cooperation.
The Brexit date has since been pushed back twice - the first time until 12 April and the second occasion until 31 October - after the UK government was unable to reach a consensus over the withdrawal agreement.
Despite this, Thompson said Prime Minister Theresa May and her government has engaged with the industry, with trade and regulation plans in place in her withdrawal agreement.
"So we know the UK's preferred position, and to be absolutely clear we support this ambition," he said at the conference in London.
However, he said: "We have not made the same progress in the EU. The simple reason is that their approach of not discussing the future until the UK's terms of leaving have been agreed means that the same dialogue has just not been known."
This lack of dialogue could influence the future of regulation and research in the UK, he said.
"Across Europe the industry has no certainty as to the EU's long-term intent. The impact of this phased approach is now becoming clear. If the future relationship looks like UK being shut out from meaningful collaboration and medicines regulation, unable to be a rapporteur with a similar status for EU countries, then the voices here for the UK to have a standalone regulator will grow.
"Similarly if the UK cannot contribute to the design of scientific research programmes as part of Horizon Europe this will not be acceptable in the country with three out of the top ten universities in the global rankings."
These comments follow criticism from Thompson on the EU's lack of desire to accept batch release testing processes carried out in the UK if the country leaves the EU without a deal (APMMA 60098).
Thompson also said in his speech that the Brexit process has "fast forwarded" the global assessment of Europe as a region at the time of the lenses focused on the growth of China, pointing out that there are more CAR-T trials in China than in the U.S.
He added that Brexit has given the UK industry the "largest logistical challenge" it has ever faced in planning for a no deal.
"While some sectors can settle on an 80% solution for us only a 100% solution where every patient gets their medicines will do.
"With over three-quarters of the medicines we use here coming from or by the EU and 90% of those coming through Dover or Folkestone, delays at the border could be catastrophic.
He said the recent extension to October gives industry time to revisit its plans with a greater understanding of the potential impact of a no deal Brexit.
"We believe that we are the best prepared sector and we intend to stay with the best prepared sector."
MHRA view
Close cooperation with the EU remains the preferred option for UK regulator the MHRA, said its chief executive Ian Hudson at the same conference."Patients should not be disadvantaged, innovators should be able to get their products to market as quickly and simply as possible and we should continue to play a leading role in promoting public health," he said.
However, the regulator has also made plans to act as a standalone agency if the UK exits without a deal, he said (APMMA 62233).
"We've developed a range of offers for standalone if that's where we end up and included some novel approaches."
These include rolling reviews of data and accelerated review, said Hudson.
No matter the outcome, Hudson said it was important that regulators continue to evolve.
"Regulation must follow the science and we must evolve the regulatory pathways to meet the technologies of the future. So inevitably we are going to have move things along."
He said if the UK remained part of the European system it would continue to work with European colleagues to achieve that but if it was standalone, people must remember that the UK is a "relatively small market" and cannot apply different regulatory standards to the rest of the world or it would not see drug launches.
"Regardless of Brexit, supporting life sciences, supporting innovation, supporting development of new products is key. We are keen to ensure that we continue to support innovation and enable new products to be safely brought to the market for the benefit of public health."
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