The UK Pharma Industry Faces Regulatory Shake-Up Amid Brexit Fallout. The UK pursued a sovereignty-first Bretix. Having emphasized regulatory autonomy over market access to the EU and a frictionless border between Great Britain and Northern Ireland, the UK government is now trying to make sense of its newly gained autonomy. Brexit is creating the most significant change to the UK regulatory system in a generation. Keep reading the article to learn more about the UK pharma industry facing regulatory shake-up amid Brexit fallout.
UK Pharma Industry Faces Regulatory Shake-Up Amid Brexit Fallout
The UK’s pharmaceutical regulator would forfeit control over the European Medicines Agency (EMA) if Britons vote to quit the EU in a June referendum. This means that it could well look into aligning itself with its US equivalent, sector advisors have told EURACTIV.com. Experts say it is looking growing clear that the UK would fail the now London-based EMA if Britons vote to quit the EU in the looming 23 June referendum. Sweden and Denmark have both shown their desire to host the regulator if the UK cannot keep it.
Another big post-Brexit challenge is funding and investment, as Britain’s The Telegraph reported. It stated that UK institutions and researchers receive a huge amount of European funding via grants, including Horizon 2020 and the European Investment Fund. Up to £8.5 billion of funding and investment in UK science could be wasted over the next four years, possibly separating UK research and development and decreasing its impact within the worldwide scientific community.
Jo Pisani, pharmaceutical and life science consulting leader at PwC in the UK, told EURACTIV, “The pharmaceutical industry benefits from very harmonized regulation in Europe.” He added, “We could still benefit from this regulation under the EEA model, but we’d have less influence over it. In case of a full exit, we’d be put in a difficult position where we might be in the EMA but not have a say.”
If this happens, the UK could potentially try to join the US Foods and Drugs Agency (FDA), she said. “There’s been a lot of talk of a superpower global regulatory body,” Pisani said. This was echoed by another pharmaceutical and life science consultant who declined to be named because of the firm’s decision not to comment on the referendum. He stated, “There’s no reason why we couldn’t work with the FDA in the US rather than the EU. This could benefit the market more generally as more and more countries are beginning to follow [the regulation of] the FDA.”
Paul Fleming was asked a question by Akosua Mireku: Are there any other measures that could further protect the industry? On which Paul said, “One is probably looking at things like R&D tax credits, whereby companies who invest in their manufacturing facilities in the UK should be eligible for tax relief. That would give more encouragement to UK-based companies who invest in their manufacturing facilities and level up the playing field with other European markets.”
He added, “Separately, there are initiatives for critical products, for example with antibiotics, that are also being discussed within the EU. There is a risk that the UK gets left behind because the EU and individual European countries are recognizing the benefits of local manufacturing and the UK does not. There is a risk of investment drifting away from the UK and going to other countries within Europe. And we see examples of that happening already.”
“We have a fantastic asset, which is the NHS, and a fantastic science base. We need to connect those two so the industry can see that, as well as investing in our science base at the early stage of research, we have the potential for those medications to flow through the system [into commercialization],” said Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, to The Telegraph.
A spokesperson for the FDA would not comment particularly on a potential linkage with MHRA but said the two regulators already have a “strong relationship” and that the FDA “would work with MHRA as it does with them today [in case of a Brexit], but also as it does with regulators such as Swissmedic, which is not part of the EU or EMA.”
The spokesperson further added, “It is important to be aware that the EMA model is not identical to ours for medical product regulation, with the FDA’s remit being much broader.”