Future of the European Medicines Agency

Background

The debate on the Future of the European Medicines Agency will take place on Wednesday 12 October at 2.30pm in Westminster Hall. The member in charge is Daniel Zeichner MP.

The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of human and veterinary medicines developed by pharmaceutical companies for use in the EU.

Founded in 1995, the European Medicines Agency (EMA) works across the European Union (EU) to protect public and animal health by assessing medicines and by providing independent, science-based information on medicines. Its activities include, assessing medicines for marketing authorisations, monitoring the safety of medicines and working to improve access to innovative medical products.

The Medicines and Healthcare Products Regulatory Agency (MHRA) is the Department of Health executive agency responsible for licencing and regulating medicines and medical devices in the UK.

Leaving the EU and the EMA

The EMA is based in London and the vote to leave the EU on 23 June 2016 has led to speculation that it is likely to move when the UK leaves the EU. Following the referendum, it has been reported that a number of other countries have expressed interest as potential new sites for the agency.[1] According to reports in the Guardian and the Financial Times a number of EU states, including Ireland and Spain, have expressed an interest in hosting the EMA.[2]

Following the referendum result, a statement from the EMA explained that its work will continue as normal; as there is no precedent for a Member State leaving the EU, the implications for the location and operation of the EMA are unknown. The EMA also stated that any decision about the location of the agency’s headquarters will be decided by common agreement by Member States:

• EMA welcomes the interest expressed by some Member States to host the Agency in future. The decision on the seat of the Agency will however not be taken by EMA, but will be decided by common agreement among the representatives of the Member States. We are confident that the Member States will take the most appropriate decision on EMA's location and arrangements in due course, taking also into account the complex political and legal environment generated by the outcome of the UK referendum.
• The European Regulatory Network as a whole is a very strong and flexible system that is able to adapt to changes without jeopardising the quality and effectiveness of its work. The Agency is in close contact with the EU institutions. As soon as concrete information will become available, EMA will share it with its stakeholders.[3]

In response to a Parliamentary question in September, the Under-Secretary of State for Health, David Mowat, reported that the location of the EMA will be decided once the UK has left the EU, and that it is too early to speculate on this.

According to the Financial Times the EMA outsources up to a third of its work to the MHRA and this work is responsible for a third of the MHRA’s income.[4] A report in the British Medical Journal states that this work by the MHRA also makes the UK an attractive location to carry out clinical trials.[5]

The MHRA has responded to the EU referendum result. It has said that it will continue to make a global contribution to improving public health through effective regulation of medicines and medical devices:

Following the result of the referendum on the UK’s membership of the European Union, the focus of the Medicines and Healthcare products Regulatory Agency continues to be on our public health role. We will continue to work to the highest levels of excellence and quality, working with and supporting our customers, partners and stakeholders to protect health and improve lives. [6]

Beyond the future of the EMA and its location, there are wider issues relating to how medicines will be regulated following leaving the EU.

Countries that are members of the EEA, are covered by the EMA, and have access to the centralised marketing authorisation procedure. This may mean that the UK could continue to do so after leaving the EU but this will depend on the negotiations that take place and the resulting position of the UK in the single market. However, EEA countries do not play a role in decision making and the operation of the EMA.

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

2016

[2] The Guardian, Ireland calls for EU drug agency to be moved from London to Dublin, 1 August 2016; Financial Times, Brexit Briefing: Bitter medicine, 4 August 2016

[3] EMA, Statement on the outcome of the UK referendum, 6 July 2016

[4] Financial Times, Brexit Briefing: Bitter medicine, 4 August 2016

[5] BMJ, How “Brexit” might affect the pharmaceutical industry, 10 May 2016

[6] MHRA, Medicines and Healthcare products Regulatory Agency statement on the outcome of the EU referendum, updated 11 August 2016