Last month, the European Medicines Agency (EMA) published its Brexit Preparedness Business Continuity Plan and has announced this week that it is getting ready for its relocation decision. The impact of the UK’s prospective withdrawal from the EU is not only significant for the EMA, but for the other EEA regulatory authorities and industry alike. This week, the European Federation of Pharmaceutical Industries and Associations (EFPIA) published the results of its survey into Brexit and the impact, if no special deal is reached to achieve concerted legislation and processes between the UK and EU in relation to the regulation of medicines, appears substantial. For example:
- Over 2,600 final products have some stage of manufacture within in the UK
- 45 million patient packs are supplied from the UK to other EU-27/EEA countries each month
- Over 37million patient packs are supplied from the EU-27/EEA to the UK each month
- Over 12,000 centrally authorised Marketing Authorisations (MAs) for medicines will require a separate MA in the UK in order for the medicine to be prescribed to patients.
- Approximately 17% of centralised MAs are held in the UK.
- There are over 1500 clinical trials on-going with UK as sponsor and over half of these trials are predicted to be continuing at the time when the UK is due to withdraw from the EU, in March 2019.
Against this backdrop, it is no surprise that there is a call for the EU and UK to arrive at a comprehensive agreement that ensures maximum alignment between EU and UK pharmaceutical laws. The possibility of such alignment was also subject of the lively debate, in which key representatives from PharmaLex participated, that took place at the recent annual TOPRA Symposium in London. In spite of such suggestions having very clear attractions, many pharmaceutical companies are already planning for the starkest of eventualities of a “hard Brexit” and no such alignment, with some big pharma names joining those who are publically declaring their prudence in this regard. At PharmaLex, with the public health stakes being so high, we continue to take a stance that there is value in companies acting now, to assess the potential business and operational implications for sustained regulatory compliance and prepare mitigation plans in readiness for the planned implementation of the UK’s prospective withdrawal.
With our experience and expertise across all pharmaceutical areas potentially affected by the UK’s withdrawal, including Quality and Supply Chain Management, Regulatory Affairs and Pharmacovigilance, we are perfectly positioned to partner with clients in undertaking a systematic evaluation of their Company’s pharmaceutical distribution, development, regulatory and pharmacovigilance operational status with respect to Brexit. Under our continued guidance, the outcome of that objective analysis can then be translated into a formal plan for implementation in preparation for Brexit, which can be further attenuated as the political environment becomes clearer over time. As such, organisations can be confident that they are taking constructive steps and assure their stakeholders that they are prepared and acting in a measured and timely manner. If you would like to discuss your requirements in relation to Brexit-planning, please contact us on firstname.lastname@example.org.