The United Kingdom (UK) government has released a report which calls for the nation to remain part of the European Medicine Agency (EMA) in some way. Further to recent progress in negotiations, the government states 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 policy states that “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 European Union (EU) the terms on which we could remain part of EU agencies, including the European Medicines Agency (EMA)”.
The policy recognises the importance of setting standards for the regulation of pharmaceuticals for human use on a global basis, and how 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). Work is underway to clarify the timelines involved in the process of applications to become a full member of such organisations as it may take some time. The form the UK membership may take will depend on the outcome of the Future Economic Partnership negotiations with the EU.
The recently agreed implementation period from 30th March 2019 to 31st December 2020 “marks a positive step in maintaining a close relationship with the EU”. During the implementation period, 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”. Furthermore, despite Brexit, the UK has recently committed to adopting the EU Clinical Trial Regulation.
If the UK is unable to achieve the desired relationship with the EU, then a regulatory system that continues to protect the interests of patients and strengthens the UK life sciences industry will be established. The government is preparing for “all potential outcomes, including the unlikely scenario in which no mutually satisfactory agreement can be reached.”
To view the government response to the recommendations of the Health and Social Care Committee’s inquiry into Brexit: medicines, medical devices and substances of human origin, please click here.