Brexit – Implications for Regulations and Research

Please find below a message from Guido Rasi, EMA’s Executive Director on the implications of the outcome of the UK referendum on EU membership for the pharmaceutical industry as well some additional information on possible implications for the life-sciences industry.

Dear Industry Stakeholders,

As you already know, the results of the referendum on the UK’s membership of the European Union announced this morning indicate that a majority of the citizens of this country are not in favour of the UK remaining a part of the European Union. The EMA respects the UK citizens’ decision and it is now up to the UK government to decide how to act upon the outcome of the referendum.

Article 50 of the Treaty on the EU foresees the procedure to be followed in case a Member State notifies the European Council of its decision to withdraw from the Union. As no country has ever decided to leave the EU, there is no precedent for this situation.

 I am writing to inform you that although it is too early to foresee the implications of this decision, we are in close contact with the EU institutions.

 Until the implications of this decision are formally communicated to us by the EU institutions, all of the Agency’s operations and procedures will continue as before.  EMA will continue with its work to protect human and animal health, and ensure access to medicines that are safe, effective and of good quality.

I would like to assure you that maintaining the strong relations that we have built with all of our stakeholders is very important to us.  

We will keep you regularly updated as new information emerges.

With kind regards,

 Guido

 
As mentioned in Gudio Rasi’s e-mail, the UK has to follow the procedure foreseen in Article 50 of the Treaty on European Union. The general deadline for the exit is two years, once the UK has notified the European Council of its intention to withdraw from the Union. This notification has not been sent yet.

1. Regulatory Implications

Apart from the fact that the London based EMA is likely to relocate, it is clear that the role of the UK’s regulatory agency, the Medicines and Healthcare products Regulatory Agency (MHRA) will change after Brexit, as would the way new medicines are approved in the UK. The MHRA currently account for approximately 15 per cent of applications via the centralised procedure, meaning this would have to be redistributed amongst the remaining EU countries.

The EMA has close ties with other world regulators such as the US FDA and Health Canada. Agreements with the FDA include parallel processes for giving scientific advice to companies and assessing quality by design. The MHRA will therefore have to rethink its regulations and agreements with these other regulators. However, market access is primarily determined by national rules and European regulation has had relatively little impact on the UK. Nonetheless, a separate marketing authorisation process in the UK post Brexit could translate into delayed market access for some products.

Considering that new EU Regulations on Clinical Trials, Medical Devices and IVDs are due to take effect in the coming months and years, the question is to what extent these new rules will apply to companies operating in the UK. For instance, the new Clinical Trials Regulation introduces a single portal for submitting applications to begin clinical trials in the EU. It also provides an EU-wide trials database and new requirements for trial data disclosure. It is unclear whether UK based companies still have access to this register. There is a risk that the UK could become an isolated clinical research island in which companies may find it easier and cheaper to conduct clinical research elsewhere.

The withdrawal of the UK from the EU will also have implications on the EMA Policy 0070 on the proactive publication of clinical data for medicinal products since the Terms of Use to access this data and any dispute or claim arising out of or in connection with them shall currently be governed by and construed in accordance with the laws of England and Wales. We expect that these provisions will be changed in the course of the negotiations on the UK’s withdrawal.

2. Research and Development

The EU currently runs the world’s biggest public/private partnership when it comes to R&D development. The Innovative Medicines Initiative and Horizon 2020 provide public funding to attract investment in developing new medicines and products. These collaborations are not only about the money but also encourage the sharing of knowledge and expertise between industry, academia and government to boost pharmaceutical innovation within the EU.

Evidence suggests that the UK has been successful in applying and winning funding through FP7 (The EU’s research and innovation funding programme for 2007-13) and through Horizon 2020 (the EU’s current research funding programme). As part of FP7 the UK received approximately € 7 billion, representing 15.5 per cent of total funding, second only to Germany. As the UK leaves the EU there will be a lengthy period of uncertainty also in relation to R&D funding as the UK negotiates its exit and new regulations and legislation are decided.

 

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Published 27. June 2016 in News UK