The future of the European Medicines Agency (EMA)

A Westminster Hall debate was held on Wednesday 12 October 2016 on the topic of the future of the European Medicines Agency (EMA). The EMA is the regulator for medicines in the EU and works out of London, but in the light of the vote by the British people to leave the EU the future of the UK’s relationship with the EMA is uncertain. Parliamentarians gathered to discuss this in Westminster Hall. 

Main arguments and points of interest:

Keeping institutions such as the European Medicines Agency is key to the future of British science and medicine, and to accelerated access to treatments for patients in the UK, as well as to a number of other sectors due to the connectivity between the university sector, the clinical trials sector, the pharmaceutical sector and beyond.

If the UK did not become a member of the EEA (‘Hard Brexit’), pharmaceutical companies would need to apply separately for marketing authorisations from the Medicines and Healthcare Products Regulatory Agency for a medicine they wished to supply in the UK.

Parallel processes of regulation will cause delay for pharmaceutical companies, forcing them to jump through UK and EU law hoops to make the drugs available, which in turn will create longer delays in patient access to the drugs.

  • The EMA and rare diseases

It was recognised that the EMA helps to direct research into health challenges that the population of the EU faces including research into rare diseases. One pharmaceutical firm or one academic unit would not access enough patients to produce an answer, however, across a population of 500 million, there is real potential to find answers.

The EU has allowed for the development of harmonisation in the regulation that has led to the development of a single agency, which speeds up the path of drugs from the research bench to patients.

The EMA is not just a body that tells Britain what to do; it is an example of Europe coming together, streamlining itself and finding solutions. There was consensus over the fact that we should try to preserve this collaboration as we enter into Brexit negotiations.

  • A number of questions from Muscular Dystrophy UK were presented by Jim Shannon MP:

Will the Government ensure that there is a parallel approval system for new​treatments, so that after the UK exits the EU, EMA approvals that are granted apply to the UK at the same time?

Will the Government increase the capacity of the MHRA and the National Institute for Health and Care Excellence so that the regulatory and approval processes are faster and can cope with the growing number of emerging treatments for rare diseases in forthcoming years?

David Mowat MP said he would ensure that a written answer to these questions on muscular dystrophy would be given.

  • Contribution from the chair of The All-party Parliamentary Group on Medical Research, Liz McInnes MP:

The proposed great repeal Bill should ensure that all existing aspects are preserved in UK law and harmonised with EU legislation and directives.

We have a duty to give reassurance immediately to the staff of the EMA — “Science knows no country”.

  • Justin Madders MP suggested widening the scope of the discussion to include not only the future of the European Medicines Agency, but that of pharmaceutical research, development and regulation more widely:

Key questions remain unanswered: “of the potential effect on workforce numbers in the NHS of the UK withdrawing from the EU” and “on the immigration status of NHS employees from other EU countries when the UK leaves the EU.”

Sense of the urgency of this debate: ‘we run risks with respect to decisions about investment, future co-operation and, indeed, staff retention, if we do not begin to make our position clear’.

  • Response from the Minister – The Parliamentary Under-Secretary of State for Health (David Mowat)

The science and health industries are of great strategic importance, however, it is a global industry as opposed to a European one.

Delays in drug delivery are a question of regulation – there are alternative options that could circumvent copious bureaucracy.

What is being done at the moment:

Activity of the Veterinary Medicines Directorate and the MHRA: These agencies have set up groups looking at the opportunities and at how regulation might carry on into the future.

Activity of the Government: The Government intend to underwrite EU payments to academic projects even after leaving the EU, to protect the important activity of research programmes. Through the Office for Life Sciences, a steering group has been set up charged with informing on the transition.

  • Conclusion (Daniel Zeichner): ‘Today’s debate has shown a realistic understanding of the challenges and options that lie ahead. I am encouraged by the suggestion that the European economic area option is the best one for this sector. Many of us will be making that case, and I suspect that the debate will continue. It is right to highlight the importance of the sector, and I am thankful for the opportunity to do so today’.

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