Unless the British government does a major about-face, the UK will leave the European Union (EU) on March 30th 2019. This decision is already making itself felt in the British life science community. Life science professionals are worried about how Brexit will affect product development timelines and research collaborations with European partners.
The European Pharmaceutical Review recently published an article by Katheryn Shea, Global Biobanking Lead at Azenta Life Sciences discussing the impact that Brexit will potentially have on the British and European life science industry1.
As Katheryn explained in that article, no Member State has ever left the EU, therefore it is not clear how the regulation and marketing of pharmaceuticals and other life science products will change after Brexit.
However, the European Medicines Agency (EMA), which oversees pharmaceutical regulation in the UK and Europe, has made several statements about how life science companies can continue to comply with regulatory guidelines during the Brexit transition period. In summary:
New regulatory rules
The UK will remain part of the EMA during the transition period. This means that until Brexit occurs, the EMA and national regulatory bodies will continue to regulate all pharmaceutical manufacturing, clinical research and marketing authorization of medicines in both the EU and the UK.
After Brexit, the EMA will consider the UK to be a ‘third country’2. Therefore, the UK will be solely responsible for regulating the British life science industry and the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK will no longer be involved in regulating drug development and marketing in European countries.
Post-Brexit, there will most likely be one set of regulatory rules for the UK and another for Europe. Any life science researchers sharing reagents or conducting research in both the UK and Europe will have to navigate both sets of guidelines, which could be a source of increased costs and time delays.
The EU and the UK are still negotiating their future trade and regulatory relationships. This means that life science organizations must continue to operate in an uncertain regulatory environment during the transition period.
No free trade between the UK and the EU
If the British government cannot negotiate for free trade of pharmaceutical products between the UK and the EU, any active substances or finished medicines manufactured in the UK will have to be imported into the EU, and vice versa. Only authorized importers within the EU or the European Economic Area (EEA) can import products into the EU. All products must comply with EU Good Manufacturing Practice requirements and each batch must be tested at an EU/EEA site of batch control3.
These new regulations will likely add to the cost and time required to move reagents and medicines between the UK and Europe, which is a significant source of concern for life science stakeholders.
Managing supply chain issues
In October 2016, the EMA held a stakeholder meeting to better understand the concerns that life science professionals have about Brexit and the transition period.
Manufacturing supply issues was one of the biggest concerns highlighted by life science stakeholders4. Finished pharmaceutical products, active ingredients and biological samples used in research all require temperature-specific and secure shipping and storage conditions. Failure to adhere to these conditions can result in sample degradation and make medicines unfit for sale.
Azenta Life Sciences is actively working with our clients to avoid any cold chain, transport and sample handling issues during the transition period. We have recently opened a best-in-class bioprocessing and biostorage facility near Frankfurt, Germany to accommodate our clients’ growing needs for safe, secure and reliable handling of valuable pharmaceutical and biological samples.
What happens next?
Negotiations between the UK and the EU will continue throughout the transition period. The EMA will regularly update regulatory guidelines on its website5. British and European trade organizations and the EMA are conducting industry surveys to identify potential problems caused by Brexit-related regulatory, legal and trading changes.
Brexit means that life science companies will face additional logistical hurdles when storing, transporting and supplying reagents and medicines between the UK and Europe.
Azenta Life Sciences is working hard to make the Brexit transition easier for our clients. We will continue to share any regulatory and legal updates from the EMA and the MHRA to help you plan your research, product development, shipping and marketing both before and after Brexit.
We have also developed a comprehensive suite of solutions to ensure we meet the evolving storage, transport and supply needs of the British and European life science community. Contact us to learn more about how we can help you maintain the integrity of your samples, reagents and medicines throughout the transition period and in the post-Brexit world.
References
- The impact of Brexit on life sciences. European Pharmaceutical Review. (Online) Available at: https://www.europeanpharmaceuticalreview.com/article/70708/impact-brexit-life-sciences/
- Notice to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use. (Online) Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/05/WC500226603.pdf (Accessed 23/11/17)
- Questions and Answers related to the United Kingdom's withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the framework of the Centralised Procedure. (Online) Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/05/WC500228739.pdf (Accessed 23/11/17)
- Report from Industry Stakeholder Meeting on ‘Brexit’: http://www.ema.europa.eu/docs/en_GB/document_library/Report/2017/10/WC500237768.pdf
- United Kingdom’s withdrawal from the European Union (‘Brexit’). (Online) Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/general/general_content_001707.jsp&mid=WC0b01ac0580a809a7 (Accessed 23/11/17)