The EU has provided much of the scientific, regulatory and trade infrastructure for the pharmaceutical industry in the UK through the European Medicines Agency (EMA). This ensures all medicines available on the EU market are safe, effective and of high quality.
Securing co-operation between the EU and UK on the regulation of medicines will be critical to providing certainty to the pharmaceutical industry in the UK and ensuring EU and UK patients are able to continue to access the medicines they need from day 1 of the UK leaving the EU. Our sector has worked together with government since 24 June 2016 to establish consensus on the following issues:
For the mutual benefit of patients and industry in the UK and the EU, the UK should seek to negotiate alignment and commonality with the EU for the regulation of medicines, through:
- Seeking a regulatory cooperation agreement, or a mutual recognition agreement with the European Medicines Agency
- Agreeing continued alignment of current and future regulations
- Ensuring continued UK participation in EU regulatory and medicines safety processes
The UK should seek to negotiate continued access to long-term European funding and collaboration programmes for science, through:
- Reaching an agreement to maintain access to Horizon 2020 and its successor
- Seeking continued participation in the European Investment Bank and EIF, including shareholding, financial contributions and, as a result, a seat at the Board
Access to talent
The UK should seek to negotiate an agreement with the EU that facilitates the ease of movement for highly-skilled talent in Life Sciences, through:
- Delivering a UK immigration system that is needs-based, straightforward and rapid
- Agreeing a reciprocal arrangement with the EU that facilitates ease of movement forscientists, researchers and highly-skilled workers, maintaining current systems such as the Intra-company Transfer process
- Guaranteeing the rights of scientists, researchers and highly-skilled workers EU citizens already in the UK, alongside securing the rights of UK citizens working and operating in the EU
Due to the complexity of import/export declarations and inspections, and the existing integrated nature of supply chains, the UK should seek to negotiate the ability to trade and move goods and capital across borders with the EU for pharmaceuticals and medical supplies, through:
- Maintaining trading terms for Life Sciences goods and services that are equivalent to those of a full member of the EU Customs Union and EC common system of VAT
- Continued alignment of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards with the EU, and reach an agreement that allows UK-based Qualified Persons (QP) decisions and inspections to be recognised between the EU and UK
- Reaching an agreement with the EU to maintain the benefits of the Parent-Subsidiary and Interest & Royalties Directives
EFPIA Brexit Taskforce
Given the integrated nature the research, regulation and supply of medicines across Europe, The ABPI is working closely with the European Federation of Pharmaceutical Industries and Associations (EFPIA), who have established a Brexit Taskforce.
Read our latest media statements on Brexit here. For media enquiries, contact the press office or call 0207 747 7147.