Whilst we wait for the outcome of the UK general election, we thought it would be interesting to provide an update on the latest developments regarding Brexit and its possible implications on the regulatory framework for the approval of medicines in the EU.

Following the latest extension to January 31, the UK government announced that it will continue to work and plan for all eventualities, including a no-deal Brexit, and requested industry to maintain its readiness for a no-deal scenario.

There is of course the chance that the withdrawal agreement negotiated by Boris Johnson with the EU is ratified by the UK Parliament. The Conservative Party is leading the polls and Boris Johnson has promised to pass his Brexit deal before Christmas if he wins the election. Under this scenario, Northern Ireland would be treated differently from the rest of the UK and would have to align with specific EU rules, including EU rules on the authorisation and supervision of medicines.

In practice this would mean that the Medicines and Healthcare products Regulatory Agency (MHRA) would have to apply a different set of rules and standards in Northern Ireland from the rest of the UK. Undoubtedly, this situation would give rise to many interesting questions from a legal and regulatory point of view. Steve Bates, CEO of the UK Bioindustry Association (BIA), recently mentioned that under these circumstances it would be hard to see the UK as a pure third country to the EU in the context of the regulation of medicines. In his opinion, there should be technical detailed discussions on this matter. We are not aware of these discussions having taken place.

The harm that all this uncertainty is causing to the UK industry is known by all and cannot be underestimated. It also has had an impact on the UK civil service. After the latest Brexit deadline of October 31 passed, there were reports warning of Brexit-fatigue amongst UK Top civil servants. 

Meanwhile, in Amsterdam, the Dutch authorities have handed over to the European Medicines Agency its new permanent premises. From 9 December to 10 January most EMA staff will work remotely while equipment is transferred to the new premises and there will be a reduced number of meetings taking place during this period of time. EMA has also announced the hiring of new staff to make up for the staff losses that followed from its relocation to Amsterdam. (For further background on EMA relocation see here) And in Brussels the newly elected European Commission headed by Ursula von der Leyen has been approved and started working with no UK Commissioner appointed. Stella Kyriakides is the new Commissioner for Health and Food Safety and has already selected her cabinet. As a former president of a large cancer patient group, her nomination has been welcomed by EU patient organisations.

Author

Magda Tovar joined Baker McKenzie in September 2019 as a Knowledge Lawyer for the Global Healthcare and Life Sciences Industry Group, covering healthcare and life sciences legal issues for the EMEA region. She also supports the Industry Group at a global level on many knowledge management matters including thought leadership projects and global surveys. Before joining Baker McKenzie, Magda was a senior legal adviser at the European Medicines Agency (EMA) for 16 years where she advised on a broad spectrum of matters related to EU pharmaceutical law, covering medicines for human and veterinary use. She represented the EMA in cases before the General Court and the Court of Justice of the European Union.

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