The ABPI is working to ensure that the UK has the best relationship with the EU for patients, public health and the life sciences sector.
Both sides have agreed to explore medicines cooperation in the Political Declaration. This ambition remains both in the UK Government’s negotiating objectives and in the EU Commission’s negotiating mandate.
We believe this should be a priority and are optimistic that both sides will be pragmatic about the need to work together on some essential aspects of medicines regulation.
We also share the Government’s ambition of making the UK a leading global hub for life sciences and an internationally competitive trading partner with the EU and the world.
For us, securing our reputation as an attractive destination for global investment is key, but as an industry, our priority is a future trading relationship with the EU based on cooperation
What has the UK Government outlined?
The UK Government released an overview of its priorities for the UK-EU relationship in February 2020. The priorities published include:
- A Mutual Recognition Agreement (MRA) on batch testing and GMP.
- Commitment on Good Regulatory Practice and Regulatory Cooperation.
- Commitment to cooperate on pharmacovigilance.
- Explore participation in Horizon programme.
- No tariffs, fees, charges and quantitative restrictions on trade in manufactured and agricultural goods between the UK and the EU.
We have responded to these priorities here.
What do we think the Future Relationship should look like?
We believe that the relationship between the UK and the EU should be based around three objectives:What do we think a future relationship should look like?
- Ensuring UK and EU patients have uninterrupted supply of their current treatments and fast access to new medicines.
- Safeguarding the current high global regulatory standards and public health protections for medicines used to treat UK and EU patients.
- Retaining the UK’s position as a global leader in life sciences innovation and increasing its international influence in shaping life sciences policy.
To achieve this, there four key areas for negotiators on both sides to work within and reach a pragmatic and positive future relationship:
1. Medicines supply
It is essential that the new relationship between the UK and EU does not put unnecessary barriers to the supply of medicines to patients.
The ABPI is calling for:
- A Mutual Recognition Agreement on Good Manufacturing Practice and batch testing to avoid unnecessary disruptions to supply chains and delays to patient access to medicine.
- Clarification on the impact of the Northern Ireland Protocol to medicines and of the UK implementation of the Protocol in relation to medicines.
2. Patient safety
The UK must ensure that medicines are assessed and monitored according to robust, science-led, and globally harmonised regulatory standards that protect patient safety.
The ABPI is calling for:
- A Mutual Recognition Agreement on Good Manufacturing Practice and batch testing to avoid duplication of work, reduce the risk of misalignment of quality data between regulators and most importantly, avoid delays in patient access to medicines.
- Ongoing regulatory cooperation, such as input and access to patient safety databases, such as Eudravigilance and collaboration through established EU-3rd country regulatory authority clusters.
- UK connectivity and access to EU databases that protect the safety of patients, including the European Medicines Verification System.
3. Science, research and people
The UK should maintain scientific collaboration and cooperation with the EU, the movement of skilled people it requires, and reinforce incentives for innovation.
We believe the UK should:
- Fully participate in the Horizon Europe programme and continue to influence the EU research programmes as far as possible.
- Ensure a transparent and mutually beneficial system for exchange of scientific talent, maintaining current systems such as the Intra-company Transfer process.
- Maintain mutual recognition of professional qualifications.
- Ensure that the UK IP framework remain the minimum accepted standard.
- Seek continued free flow of personal data from the EU under both the General Data Protection Regulation and the Law Enforcement Directive.
4. Customs
Both sides should enable a system of zero tariffs for components of medicines production and research, along with simplified and precedent-based Rules of Origin requirements, to ensure the continuation of trade and manufacture of medicines.
We recommend the UK and EU:
- Guarantee tariff liberalisation for all finished medicines, APIs and intermediates used in the manufacturing of medicine, research and clinical trials.
- Establish rules of origin requirements simplified and based on common, defined chemical and pharmaceutical processing activities, similar to those agreed in EU and Canada
For media enquiries, contact the Press Office or call 0207 747 7147.
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.
Key documents
