Brexit Could Lead to New Regulatory Burdens

29 February 2016

Brexit Could Lead to New Regulatory Burdens

February 29, 2016

More than 50 leaders of the British biopharmaceutical industry have warned of the regulatory and business upheaval that could result from the United Kingdom leaving the European Union, an event dubbed “Brexit.” In a letter in The Financial Times, the executives argue leaving the EU would result in “significant regulatory burdens” and diminish the status of U.K. medicine institutions within the region.

The 55 executives, who include AstraZeneca CEO Pascal Soriot and GlaxoSmithKline Pharmaceuticals R&D President Patrick Vallance, released the letter days after UK Prime Minister David Cameron set the date for a referendum on EU membership. Polls suggest the public is fairly evenly split between those who want to stay in the EU and those who want to leave, but the biopharmaceutical industry is overwhelmingly against exiting the union. This viewpoint, which has been expressed several times in recent months, is underpinned by worries about the effect of Brexit on drug regulation.

“Over a generation, regulators and legislators have built up an integrated European regulatory framework for clinical research and development of new, innovative medicines. It is cornerstoned in the UK, and has significant UK input,” the executives wrote. “If the UK were to leave the EU it would risk unpicking all of that successful work. It would affect regulatory frameworks, the leadership role of the UK’s Medicines Healthcare Products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) in the EU ... and most importantly patient access to medicines.”

If the UK cuts itself off from the Europe-wide regulatory machinery, the authors of the letter foresee “disruption, expense and significant regulatory burdens for a new authorization system.” As with all aspects of the UK’s relationship to the EU, details of how its regulatory system will interact with the rest of Europe in the event it leaves the union are yet to be established. Norway, which is outside the EU but in the European Economic Area, is covered by the centralized authorization procedure. Switzerland, another non-EU country, has mutual recognition and sharing agreements with Europe.

A variation on these types of relationships could await the UK if it leaves the EU, although its situation is complicated by the fact that it is has spent decades forging ever-tighter bonds to its neighbors. If the UK now severs these bonds, the European Medicines Agency (EMA) is expected to relocate from its current base in London. Similarly, plans to use London as the location of the court at the heart of the incoming EU-wide patent system would likely change, as would the UK’s involvement in the initiative itself. 

Euroskeptics claim the UK will be better off once it no longer has to comply with such EU regulatory programs, but the argument has found little favor in life sciences. George Freeman, the UK minister for life sciences and a vocal critic of aspects of the EU, has joined the industry he represents in calling for the UK to vote to stay in the union.

Source: RAPS