Uncertainty in the UK over Brexit is making the pharmaceutical industry very anxious, but could also put the lives of patients “at risk,” according to a new report, which seeks to persuade government officials to look beyond the usual warnings from drug makers about reduced investments in the country.
To be clear, the findings reiterate concerns that have been heard from companies for months — research funding may dwindle, regulatory approvals could be hindered, and scientific talent may be forced to go elsewhere, among other things. But the report also argues that Brexit may force UK patients to wait “years longer” for access to innovative new drugs and jeopardize their quality of life.
“Under a ‘hard’ Brexit, British patients face a perfect storm of lower health spending and a drug approval process that isn’t aligned with Europe,” according to the report from Public Policy Projects, which is run by LaingBuisson, a health care consulting firm. A “hard” Brexit generally refers to a quick exit from the European Union, coupled with a minimal free trade agreement.
It remains unclear exactly when a Brexit may occur, though. British Prime Minister Theresa May wants to proceed by March. But a UK court ruled this morning that the government cannot begin negotiations to leave the European Union without first obtaining a vote from Parliament. The government is expected to appeal, but a vote could slow or even derail the process.
Meanwhile, the pharmaceutical industry is gearing up to win commitments from the government, although the effort does not appear to be going well. Last month, government ministers pooh-poohed a different report describing what the life sciences sector would need to thrive outside the European Union. A meeting between industry executives and government officials is scheduled later this month.
Although some companies, such as GlaxoSmithKline, have committed to remain in the UK, industry watchers say they see gloomy images in their crystal balls. With Brexit, “the free movement of labor is going to end and the implication for industry is reduced productivity in R&D,” said Kurt Kessler, a managing principal at the ZS Associates consulting firm.
Like the previous report, the newest assessment discusses the need for a consistent regulatory framework, access to European talent, easy cross-border trade, and the loss of funding provided by the European Union. But it also seeks to shift the focus — instead of harping on concerns from drug makers about their ability to do business in the UK, the report emphasizes a Brexit effect on patients.
Predictions of a weaker UK economy could lead to reduced spending on health care, which might then result in added pressure on government spending on drugs or postponing initiatives designed to access new or costlier medicines. “The net result is that patients in the UK are likely to face delays and restrictions,” the report warns.
This also reflects concerns that the UK’s Medicines and Healthcare Products Regulatory Agency will hold less sway over approvals. “Simple commercial reality dictates that, if companies have to choose between launching drugs in the UK, which accounts for 2.5 per cent of the global market, and the European Union, which accounts for 16.6 per cent, then they will prioritize a European launch,” the report states.
“The $100 million question is what will the MHRA look like?,” said Lincoln Tsang, a partner at the Arnold & Porter law firm in London. “A passive player or an active player in a new relationship? MHRA has been instrumental in developing many impactful regulatory policies within the EU and globally… We can’t ignore the increasingly globalized regulatory environment and role played by MHRA.”
To what extent these dire predictions become reality remains to be seen, assuming Brexit does occur. For now, anyway, the industry is using this as an opportunity to extract more government support.
We should note, by the way, that the new report was funded by Quintiles/IMS, a newly merged company, which provides both clinical trial services and market research data to the pharmaceutical industry. In other words, the company also has a big stake in the outcome. For instance, the report notes that the UK may become a less attractive destination for running clinical studies of medicines.