UK Government Prepares Brexit Scenarios for Pharma RegulationBy
The UK government has outlined various recommendations for pharmaceutical regulation and trade in the UK post the UK’s withdrawal from the European Union (EU) (i.e., Brexit). The recommendations, which depend on various scenarios of a final UK–EU agreement, include the UK remaining part of the European Medicines Agency, having a seat on the International Council on Harmonization of Technical Requirements of Pharmaceuticals for Human Use (ICH), and continuing industry practices, such as good manufacturing practices (GMP) and good distribution practices (GDP).
The UK’s government report, which was presented to the Parliament by the Secretary of State for Health and Social Care, was in response to a report issued in March 2018 by the Health and Social Care Committee of the House of Commons of the UK Parliament. That report, Brexit: Medicines, Medical Devices and Substances of Human Origin, examined the regulatory arrangements needed to guarantee the safe and effective supply of medicines, medical devices, and products post-Brexit and offered 34 conclusions and recommendations.
Overall, the UK government emphasized that it will continue to work toward and take into account different scenarios of a UK-EU agreement as it relates to the supply of medicines. “We want to retain a close working partnership with the EU in the interest of ensuring patients continue to have timely access to safe medicines and medical innovations,” said the UK government report. “However, while negotiations are ongoing, it is important that we understand the implications of different scenarios in full. As a result, we are exploring a range of options for the future regulation of medicines and medical devices in the UK. We will discuss with the EU and Member States how best to continue cooperation in the field of medicines regulation in the best interests of business, citizens and patients in both the UK and the EU as part of the future partnership negotiations.”
As part of that process, the UK government supported the committee’s recommendations that the UK remain aligned with the EU and other international organizations on pharmaceutical regulation. “The safety of patients is of paramount importance to the Government’s exit negotiations for medicines, medical devices and substances of human origin and that is why the UK wants to explore with the EU the terms on which we could remain part of EU agencies, including the European Medicines Agency (EMA),” said the government in its report.
This cooperation will begin during the implementation period of Brexit. UK and EU negotiating teams have reached agreement on the terms of an implementation period for Brexit that will start on March 30, 2019 and last until December 31, 2020. During the implementation period, the UK will no longer be a member state of the EU, but market access will continue on current terms. During this implementation time, the EU will continue to accept UK batch testing, release and inspections, UK-based marketing authorization holders and other regulatory actions in the UK, including Qualified Person certification, according to the UK government report. During the implementation period, the UK said it will remain in step with the EU, including with respect to good manufacturing practices (GMP) and good distribution practices (GDP). The UK will also still be able to discuss issues with EU counterparts, such as between the EMA and the Medicines and Healthcare products Regulatory Agency (MHRA), the UK pharmaceutical regulatory authority.
The UK government also said it will continue to seek opportunities to influence through collaborations such as the ICH and similar international organizations, such as the Pharmaceutical Inspection and Co-operation Scheme (PIC/S) and the International Medical Device Regulators Forum (IMDRF). “Applications to become a full member of such organizations can take some time, and work is underway to clarify the timelines involved in these processes, said the UK government in its report. “The form that UK membership will take will depend on the outcome of the Future Economic Partnership negotiations with the EU.”
Additionally, the UK government said it is also working with its Department of Health and Social Care (DHSC) to produce a comprehensive list of all the issues relating to the supply of medicines, medical devices, and substances of human origin, which require contingency planning for the UK leaving the EU. It said that teams within the DHSC are working to assess the impact of exiting the EU on the supply chain for all medicines and medical devices used in the National Health Services, the publicly funded national healthcare system in the UK. A cross-government steering group, which includes the MHRA, NHS England (NHSE), and Public Health England (PHE), was formed to oversee and contribute to this work. The management-consulting firm, Ernst and Young, was appointed to carry out this work with the initial phase expected to be concluded in late spring 2018.
Other stakeholders highlight post-Brexit concerns
Concerns over how the UK would handle pharmaceutical regulation and trade post-Brexit were addressed by other stakeholders. Earlier this month (May 2018), the Business, Energy & Industrial Strategy Committee of the House of Commons of the UK Parliament 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 Brexit, which it says would potentially impact the cost of drugs in the UK. Like the Health and Social Care Select Committee, the Business, Energy & Industrial Strategy Committee also called for continued membership of the UK in the EMA.
The Business, Energy & Industrial Strategy 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.”
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 [the Business, Energy & Industrial Strategy Committee Report issued on May 17, 2018[ 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.