The future relationship between the UK and the EU
Pharmaceuticals | Regulatory
More clarity is now available regarding regulatory cooperation on medicines between the UK and the EU following the publication by the UK Government of the Brexit white paper
The Brexit white paper, produced by the UK Government, builds on previous communications and provides more public confirmation that British authorities would like the UK to retain regulatory cooperation on medicines with the EU as part of the desired future relationship.
For the last two years, BIA has consistently advocated that Government pursue a number of policies essential to members and industry as well as patients and public health. BIA commented that it is good to see much of this reflected in the white paper and it shows that the UK Government has listened to the needs of patients, public health and the UK life science ecosystem.
The BIA commented that the white paper is a statement of policy by Government. It’s not the final deal, but it does provide the basis for detailed future relationship discussions with the EU. Turning the policy into reality needs to be a priority now for UK Government in the negotiations.
Key Points from the white paper
As outlined in the Chequers Deal, the UK proposes a free trade area for goods. The goods arrangements would sit alongside new arrangements for services and digital, “recognising that the UK and the EU will not have current levels of access to eachother’s markets in the future”.
European Medicines Agency key points:
- participation in the EMA
- “accepting the rules”
- “active participant”
- contribution to costs
- no voting rights
- able to conduct technical work - including acting as a “leading authority”
- participation in other activities – including ongoing safety monitoring and the incoming clinical trials framework.
Transition/Implementation Period key points:
- all manufactured goods authorisations, approvals, certifications, and any agency activity undertaken under EU law, completed before the end of the implementation period, should continue to be recognised as valid in both the UK and the EU
- any processes underway as the UK and the EU transition from the implementation period should be completed under existing rules, with the outcomes respected in full.
Manufacturers should only need to undergo one series of tests in either market to place products in both. This would be supported by arrangements covering all relevant compliance activity, supplemented by continued UK participation in the agencies including for medicines and chemicals. Proposals cover all of the compliance activity necessary for products to be sold in the UK and EU markets, including the following:
- manufacturing and quality assurance processes – including Good Laboratory Practice and Good Manufacturing Practice
- role of nominated individuals – including “responsible persons”
- provisions for human and animal medicines - including the release of individual batches by a qualified person based in the UK or EU, and the role of the qualified person for pharmacovigilance, responsible for ongoing safety monitoring of potential side effects
- testing products to see if they conform to requirements – including labels and marks applied to show a good meets the regulatory requirements
- accreditation of conformity assessment bodies – testing the testers within a jointly agreed accreditation framework, to provide mutual reassurance that UK and EU conformity assessments are robust
- licensing regimes and arrangements - such as export licenses.
Intellectual Property / Unified Patent Court Agreement
The UK wants to explore staying in the court and unitary patent system after the UK leaves the EU. The Unified Patent Court has a unique structure as an international court that is a dispute forum for the EU’s unitary patent and for European patents, both of which will be administered by the European Patent Office.
The UK proposes:
- continuing close collaboration with the Health Security Committee and bodies such as the European Centre for Disease Prevention and Control (ECDC), including access to all associated alert systems, databases and networks
- ongoing cooperation with the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA)
- collaboration with the European laboratory surveillance networks to monitor the spread of diseases across Europe
- continued collaboration between the EU and the devolved administrations in these areas, including direct sharing of information with ECDC and the ability for Microbiology Reference Laboratories in Glasgow, and Public Health Wales, to provide European Public Health Microbiology (EUPHEM) training.
Trade: Facilitated Customs Agreement
The UK proposes a Facilitated Customs Agreement (FCA), which aims to maintain current frictionless trade between the UK and EU. The proposal aims to maintain the integrity of the EU Customs Union, while also allowing the UK to pursue an independent trade policy.
Tariffs and Rules of Origin
- zero tariffs across goods (including manufactured goods, agricultural, food and fisheries products), with no quotas
- no routine requirements for rules of origin between the UK and EU
- arrangements that facilitate cumulation with current and future Free Trade Agreement (FTA) partners with a view to preserving existing global supply chains. This would allow EU content to count as local content in UK exports to its FTA partners for rules of origin purposes, and UK content to count as local content in EU exports to its FTA partners. Diagonal cumulation would allow UK, EU and FTA partner content to be considered interchangeable in trilateral trade.
R&D / Funding: Science and Innovation
The UK proposes a “science and innovation accord” that:
- provides for UK participation in EU research funding programmes – including Horizon Europe and Euratom Research and Training Programme
- enables continued cooperation through joint participation in networks, infrastructure, policies and agencies which are to the UK’s and the EU’s joint benefit
The Brexit white paper produced by the Government can be read in full here.