Blog: European Medicines Agency — Ireland’s Brexit opportunity?

Gillian Rea
Gillian Rea

Gillian Rea, solicitor at Dublin firm Baily Homan Smyth McVeigh, writes on the opportunities for Ireland from the relocation of the European Medicines Agency away from Britain following the UK’s exit from the EU.

The European Medicines Agency, currently headquartered in London, has the important role of protecting public and animal health in the EU through the scientific evaluation, safety monitoring and regulation of human and veterinary medicines. It works closely with member state national regulators to authorise new medicines for use throughout the EU.

The Agency employs approximately 890 staff and has an annual budget in excess of €300 million. It is therefore unsurprising that virtually every member state has put in a bid to become the new home for the Agency, which will move its headquarters once the UK leaves the EU. The criteria to be considered by EU ministers when making the decision on the location of the new headquarters were recently circulated to member states. Emphasis has been placed on the need for business continuity, adequate office and archive space and the “desirability of geographical spread” of EU agency seats.

Impact of Brexit and relocation for the EMA

The uncertainty created by Brexit and the relocation has already been felt in the EMA. An EMA task force set up to deal with the relocation recently reported that up to 50% of employees may decide not to relocate, and that this decision is largely dependent on the future location of the Agency. The EMA has lost seven senior executives since the Brexit referendum. Furthermore, the Agency is finding it harder to attract recruits: the number of applicants for its trainee program has fallen to 700 this year, down from a usual level of around 2,000.

The EMA has made it clear that a long-term solution needs to be agreed as soon as possible. At stake is not only the smooth-running of the EU drug approval process but public safety: the disruption caused by the relocation could mean that national regulators may not be able to react to a side-effect problem, or quality issue in a timely fashion.

Impact of Brexit and relocation for the UK

The impact on the pharmaceutical industry was not often discussed in the media in the run up to the Brexit vote, despite the fact that it generates over 10% of the country’s gross domestic product, and the fact that current UK legal framework governing medicines (including clinical trials) derives largely from EU legislation.

The UK government is now tasked with the unenviable job of reconstructing a framework for the monitoring, evaluation and regulation of medicines in the UK. The options open to the UK post-Brexit regarding the regulation of medicines are outlined later in this article.

The relocation of the EMA may create a knock-on effect for future pharmaceutical industry investment in the UK. The Japanese government has already formally warned Britain that many Japanese pharmaceutical companies may follow the EMA out of London.

Furthermore, losing the EMA could lead to a significant brain drain. Not only will the UK lose the 890 people currently employed by the Agency, but they could also lose experienced personnel working elsewhere in the British pharmaceutical industry.

What will happen to the Medicines and Healthcare Products Regulatory Authority?

The full implications of Brexit on the relationship between the EMA and the UK’s Medicines and Healthcare Products Regulatory Authority Agency are, as yet, not fully known.

The EMA centralised marketing procedure allows pharmaceutical companies to submit a single application for automatic market authorisation for new medicines in all EU/EEA states. The UK will drop out of this system as a consequence of Brexit, and, unless an alternative is found, pharmaceutical companies will have to separately apply to the MHRA for approval to sell drugs in the UK. If this happens it could see delays in access to new medicines for UK citizens, as pharmaceutical companies will likely seek regulatory approval for new drugs from the biggest regulators first (the EMA and the US Food and Drug Administration).

In Canada and Australia, where drugs are regulated nationally, new medicines come to market between six months and a year later than in the EU/EEA. There is also a legitimate concern that this would mean an increase in drug prices in the UK.

The UK government’s EU External Affairs Sub-Committee has been advised that the UK has three main options:

  1. Align the MHRA with the EMA (particularly given the potential disadvantages of losing mutual recognition with the EU). This is the model adopted by regulators in Norway, Iceland and Liechtenstein;
  2. Align the MHRA with another regulatory framework, such as the FDA. This may prove to be time consuming and costly; or
  3. Create a new/enhanced UK regulatory body – the size and complexity of this task makes it unlikely to be a feasible solution.
  4. A further possible solution would be for the MHRA to function like Switzerland’s regulator, Swissmedic, where medical products are independently authorised but work with the FDA/EMA is conducted under a combination of mutual recognition and sharing agreements. Swissmedic conducts independent assessments of innovative medicines; however, for non-innovative medicinal products, for example, generics/known active substances, they consider assessments of other well-recognised regulatory authorities such as the FDA and EMA.

    Ireland’s Opportunity

    Ireland was one of the first countries to offer the EMA a new home in the wake of Brexit.

    A major advantage in the bid to secure the Agency is Ireland’s close proximity to the current headquarters. This may assist in minimising disruption to the Agency’s work and potential staff turnover. Other contributing factors is our excellent air connectivity with both EU capital cities and global destinations.

    The Food and Veterinary Office, another EU agency, is headquartered in Ireland and some commentators have noted that this body would have existing synergies with the EMA. Ireland of course also claims the advantage of being the only continuing member state to have English as an official language, the current working language of the EMA.

    Ireland’s highly-regarded national medicines agency, the Health Products Regulatory Authority, already provides significant support to the EMA and the Irish government has stated that this can be rapidly scaled up in the event of relocation.

    Undoubtedly, an exciting opportunity awaits the member state who is successful in its bid to provide new headquarters to the EMA. European drug makers came together on 24 April 2017 to issue a statement, putting pressure on the European Council to make a decision on the new headquarters as soon as possible.Now that the criteria have been circulated, it seems likely that a decision will be made by October of this year. However the full impact of Brexit on the pharmaceuticals and medical devices market, both in the UK and internationally, will not be fully known for many years to come.

    Blog: European Medicines Agency — Ireland's Brexit opportunity?

    • Gillian Rea is a solicitor in the corporate department at Baily Homan Smyth McVeigh. You can view her profile here.
    • Share icon
      Share this article: