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UK Drugs Industry Forms Brexit Steering Group

12.07.2016 -

The UK pharmaceutical industry and government officials have established a task force to address regulatory concerns and other top issues facing the pharmaceutical sector as the country prepares to exit the EU (Brexit).

At an inaugural meeting held on Jul. 6, the 15-member EU Steering Group co-chaired by Andrew Witty, CEO of GlaxoSmithKline, Pascal Soriot, CEO of AstraZeneca and UK life science minister, George Freeman, agreed to review issues ranging from intellectual property and trade to market regulation and access to skilled workers.

The group, which is being supported by the two UK drugs industry organisations Association of the British Pharmaceutical Industry and the BioIndustry Association will guide the new Conservative-led government through its discussions with the EU. It will also look at opportunities for the UK life science sector outside the EU regulatory environment.

In a joint statement, GSK and AstraZeneca said the aim is to “secure outcomes that will “enable our industry to continue to make an important contribution to health and wealth.”

UK drugmakers, overwhelmingly supported remaining in the EU. While globally active companies such as GSK and AstraZeneca will not feel the impact of Brexit as much as smaller firms, industry groupings have warned that being based outside the EU could undermine future investment, research and jobs in the country.

According to figures recently published, the life science industries account for about a quarter of all business research spending in the UK, which is a major hub, and companies have warned that Brexit threatens uncertainty, adds complexity and has the potential to delay drug approvals.

The loss of the drug regulatory authority European Medicines Agency, EMA, which tests and approves new drugs sold throughout the EU, will be a major blow. Of necessity, following a British EU exit, the agency will be forced to relocate to the continent. Several countries including Germany and Sweden, Italy and Denmark can be expected to bid for the EMA headquarters, with Frankfurt beating the drum loudly in recent days.

In the run-up to the Brexit referendum, Steve Bates, CEO of the BioIndustry Association, said a British exit from the EMA “would lead to disruption, expense and significant regulatory burdens as a new system is developed.”

At a media briefing in London following the initial steering group meeting, life science minister Freeman sought to reassure the global investment community that the UK is still “the life science powerhouse it was before the EU referendum, ” and that at present the company is still a full voting member of the EU.

“No one needs to make immediate decisions on the basis of the referendum. We are at least two years away, if not more, from any new settlement being agreed,” he said.

The minister went on to say that, “the UK is and still intends to remain a very influential regulatory voice in the European life science sector.” Furthermore, he said the government intends to design an environment that is conducive to attracting international investment as a gateway to the European market.

Freeman noted that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), has done much to shape the European regulatory environment. “Just because we will be out of the formal EU does not mean we can’t be influential in shaping regulatory thinking in the next few years,” he added.