UK Parliamentary Committee Voices Concerns on Regulatory Divergence Post Brexit
The Business, Energy & Industrial Strategy Committee of the UK Parliament has released a report, The Impact of Brexit on the Pharmaceutical Sector, to highlight its concerns over the prospect of regulatory divergence between the UK and the European Medicines Agency (EMA) post the UK’s withdrawal from the European Union (EU) (i.e., Brexit), which it says would potentially impact the cost of drugs in the UK.
The committee says that regulatory divergence, referring to separate regulation of medicines in the UK and the EU, would mean that pharmaceutical companies would have to duplicate their facilities and roles across the UK and EU. “Drug costs could be significantly impacted,” the committee said in a May 17, 2018 statement. “A separate regime could impose extra costs of £45,000 [$60,000] for each new product released, making the UK an unattractive market for new and innovative medicines.”
The committee further highlighted the potential impact on pharmaceutical trade. “The impact of Brexit on the pharmaceutical sector finds that leaving the EU without an agreement for the industry would diminish access to markets, including £11.9 billion [$16.0 billion] of exports and to more than 446 million potential patients and consumers in the EU,” said the committee in its May statement. “British patients’ access to medicines would also be at risk, with nearly three-quarters of pharmaceutical imports coming from the EU.”
To address those issues, the committee is calling for continued membership of the UK in the EMA. “While the Government has indicated its desire for continued cooperation, the Committee calls for a continued form of membership of the EMA as a priority and recommends that the Government seek to retain a presence for the EMA in the UK after its relocation to Amsterdam,” according to the committee’s statement.
Rachel Reeves, Chair of the Business, Energy and Industrial Strategy Committee, says its time for the government to take action. “The Government’s own analysis identifies pharmaceuticals as the sector for which UK/EU market access is the most important given the industry is reliant on friction-free border movement for [its] products,” Reeves said in the committee’s May 17 statement. “Any delays at the border faced by short-life pharmaceuticals for emergency treatments would have a hugely detrimental impact on patients.”
Mike Thompson, Chief Executive of the Association of the British Pharmaceutical Industry (ABPI), which represents research-based, innovator pharmaceutical companies in the UK, and Steve Bates, Chief Executive Officer of the UK BioIndustry Association (BIA), which represents the biotechnology industry in the UK, concurred with the findings from the committee’s report. “Today’s Select Committee Report is right—a Brexit ‘no deal’ would significantly damage public health, patient access to medicines, and the UK’s leading pharmaceutical sector. This must be avoided at all costs,” ABPI and BIA said in a May 17, 2018 joint statement. “Securing cooperation on the regulation, trade and supply of medicines must be a priority for both the UK Government and the EU.” The groups estimate that 45 million packs of medicine move from the UK to the EU with 37 million packs of medicine moving from the EU to the UK.