UK on Brexit Implications: ‘Significant Benefits’ to Remain Part of EMA

Posted 14 March 2017 By Zachary Brennan

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The UK government’s EU External Affairs Subcommittee on Tuesday published a report on the implications of Brexit on trade, noting that there may be “significant benefits” in continuing UK participation in the European Medicines Agency (EMA).

However, the report also notes that it “is unclear how the UK could co-operate with the EMA after Brexit, and whether the UK would be able to influence decisions taken by the EMA.”

How the UK is able to maintain its influence at the EMA will be crucial for the EU-wide agency and  the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), which the report notes has “contributed heavily” to developing EMA standards.

Dr. Virginia Acha, Executive Director of Research, Medical and Innovation of the Association of the British Pharmaceutical Industry, noted that while “having predictable funding” mattered, collaboration is just as important: “It is not just about the money; it is about the networks in which these researchers are able to participate.”

Acha also said there would be the opportunity for the UK to continue participating in the EMA after Brexit, if it chose to remain part of the European Economic Area (EEA) as non-EU EEA countries “can participate under the EEA arrangements, but they do not have voting rights and they do not lead on policy.”

If the UK were to retain membership of the EMA, it would probably have to comply with EU law in the areas covered by the EMA. The Court of Justice of the European Union (CJEU) has jurisdiction over proceedings against any EU agency

Three Options

The consulting firm Deloitte, meanwhile, told the subcommittee that the UK has three options: “It could either continue to align with the EMA (particularly given the ‘potential disadvantages of losing mutual recognition with the EU’), align with another regulatory framework (such as the US Food and Drug Administration (FDA), or ‘create a new/enhanced UK regulatory body’. Aligning with another regulatory body such as the FDA might be ‘time-consuming and costly’, while the ‘size and complexity’ of the task of creating a new regulatory body and supporting a new regulatory framework meant that this was ‘unlikely to be feasible in the time available.’

Acha added that the ABPI “would like the role the MHRA plays”—as a voice in the EMA and in international groups on harmonization—“in the future to be no smaller than in the past.”

She also called on the government “to ensure that … we are directly represented at the ICH [International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use] and other relevant bodies” as the UK is currently represented at ICH only as a member of the EU, and the government will need to establish itself as an independent member.

In the concluding remarks, the report adds: “The Government’s decision to rule out membership of the Single Market means that the UK may be unable to maintain its membership of this body [the EMA]. We regret this, and urge the Government to bring forward proposals for future collaboration with the EMA.”

HOUSE OF LORDS European Union Committee 16th Report of Session 2016–17; Brexit: trade in goods

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Categories: Biologics and biotechnology, Drugs, News, Europe, EMA, EC, MHRA, NICE

Tags: Brexit, UK in EMA, House of Lords

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