On Thursday, June 23, U.K. voters will head to the poles for the European Union (EU) referendum, deciding whether Britain should leave or remain in the EU.
The referendum is being held after Prime Minister David Cameron promised to hold one should he win the 2015 general election, which was “in response to growing calls from his own Conservative MPs and the UK Independence Party (UKIP), who argued that Britain had not had a say since 1975, when it voted to stay in the EU in a referendum,” according to an article in BBC News.
The referendum for this vote is a rather straightforward question, but one with countless implications:
“Should the United Kingdom remain a member of the European Union or leave the European Union?”
According to an article in Fierce Biotech, “[t]he question over whether the U.K. should stay in Europe has in fact been asked before—back in 1975, just a few years after it joined, where voters said 2:1 that yes, the U.K. should remain.” But, as we know, a lot has changed over the past 41 years.
For those heading to the polls tomorrow, the pharmaceutical industry isn’t a high-level concern. However, the National Health Service (NHS), which is linked to the pharmaceutical industry, is a larger concern for many voters.
The BIA, representing the biotech industry in the U.K., is in support of the U.K. remaining with the EU. BIA Chief Executive, Steve Bates, said: “If the U.K. were to leave the EU, it would risk unpicking all of that successful work. The EMA would have to relocate because EU institutions cannot be located outside the Union’s borders. There would also likely be political pressure from other Member States to move the UPC court out of London.”
“Over a generation, regulators and legislators have built up an integrated European regulatory framework for clinical research and development of new, innovative medicines,” Bates continued. “It is cornerstoned in the U.K., and has significant U.K. input.”
A “Brexit” (or British exit) puts the regulatory framework and central authorization process at risk, Bates said, adding that the harmonized system in place is a “component of the U.K.’s successful life sciences sector.”
“In the event of a ‘Brexit,’ it is our view that the U.K. would either have to accept European legislation that it cannot influence (which is the model available under membership of the European Economic Area) or develop new U.K.-specific rules at cost,” said Bates. “Even if the latter option were pursued, in order for the U.K. to remain an attractive place to do business in for mobile, global companies, similar (if not identical) regulatory systems would need to be established.
“In either scenario, the U.K. would be mirroring a system that it cannot influence. This would paralyze the influence of our world leading national regulator, the Medicines & Healthcare products Regulatory Agency (MHRA). The MHRA has been highly influential in a number of successful and innovative European regulatory initiatives, including the PRIME and adaptive pathways schemes and the regulations concerning orphan medicines and advanced therapies. The MHRA also handles the largest number of scientific evaluations of new medicines for the EMA, a task for which it is remunerated.”
On the flipside, those voting for the U.K. to leave the EU believe the decision would restore the nation’s full sovereignty, enabling the country to be more pro-science than it is presently.
“This is an amiable aspiration, but it simply isn’t one grounded in reality,” said Bates. “The business voice for U.K. bioscience is strong and united on this issue—they see the future of our sector in Europe, are supportive of effective reform in Europe, ambitious for the U.K.’s future in Europe. and are ambitious for the EU in the world.”
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Filed Under: Drug Discovery
