Sounding a note of optimism, the UK government released a report Wednesday calling again for the nation to remain a part of the European Medicines Agency (EMA) in some form, adding that “the prospect of a ‘no deal’ scenario is highly unlikely and therefore we are in a strong position from which to seek to agree a mutually beneficial way forward.”
“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),” the policy paper says.
While recognizing the importance of setting standards for the regulation of pharmaceuticals for human use on a global basis, the paper also says the UK will continue to seek opportunities with the International Council on Harmonisation (ICH), Pharmaceutical Inspection and Co-operation Scheme (PIC/S) and the International Medical Device Regulators Forum (IMDRF).
“Applications to become a full member of such organisations can take some time, and work is underway to clarify the timelines involved in these processes. The form that UK membership will take will depend on the outcome of the Future Economic Partnership negotiations with the EU,” the report says.
The report also says the recently agreed to implementation period – from 30 March 2019 to 31 December 2020 – “marks a positive step in maintaining a close relationship with the EU. During this time, the EU will continue to accept UK batch testing, release and inspections, UK-based Marketing Authorisation Holders (MAH) and other regulatory actions in the UK. We will also still be able to discuss issues with EU counterparts; this is important to ensure patient and public health is maintained.”
The UK also recently committed
to adopting the EU Clinical Trial Regulation despite Brexit.
“We are clear that should we be unable to achieve our desired relationship with the EU, we will establish a regulatory system that continues to protect the interests of patients and strengthens the UK life sciences industry,” the paper adds, noting the government is preparing for “all potential outcomes, including the unlikely scenario in which no mutually satisfactory agreement can be reached.”
Teams within the Department of Health and Social Care are progressing work to assess the impact of Brexit on the medicines and device supply chains used in the NHS.
And a cross-government steering group, including the Medicines and Healthcare products Regulatory Agency (MHRA), NHS England (NHSE) and Public Health England (PHE), has been established to oversee and contribute to this work. Ernst and Young also have been appointed to carry out this work and the government said it expects the initial phase to be concluded in late spring 2018.
Government response to report on Brexit and medicines, medical devices and substances of human origin