Yesterday, the UK Government finally published its White Paper setting out its position on the UK’s continued relationship with the EU post-Brexit. Theresa May has said it “delivers on the Brexit people voted for”, although others in Parliament disagree. While at a very early stage of the negotiations, and with no real indication of how the European Commission has received the White Paper, other than that it represents important progress for focusing the further discussions, we set out below the key points for the supply and manufacture of medicinal products and medical devices after Brexit.
- A EU-UK free trade area should be in place for medicinal products and medical devices, to protect integrated supply chains and the interests of EU and UK patients. This is said to avoid the need for customs and regulatory checks at the border between the UK and EU.
- No tariff will be charged on medicinal products or medical devices when they move across the EU-UK border.
- All centralised approvals (including marketing authorisations and CE marks) completed before the end of the implementation period (to the end of 2020) will be valid in the EU and UK.
- There will be a “common rulebook” for medicinal products and medical devices, allowing “frictionless trade” across the EU-UK border. As such, the UK will commit to harmonisation with the EU rules. However, the rules will be set out in UK law as a result of legislation passed by the UK Parliament.
- The UK will seek participation, but without voting rights, in the EU committees that have a role in designing and implementing rules that will form the common rulebook.
- Only one set of approvals will be necessary to place medicinal products and medical devices on the market in the UK and EU, ensuring all current routes to market will remain available.
- The common arrangements would cover all levels of compliance activity, including clinical trials/investigations, conformity assessments, batch release, good manufacturing practice and the role of responsible persons, such as the qualified person for pharmacovigilance or authorised representative.
- The UK will participate in the activities of the European Medicines Agency (and other key agencies), accepting the rules of the EMA, with no voting rights, but with “appropriate financial contribution”.
- The MHRA can continue to conduct “technical work”, so can serve as rapporteur or reference member state in the assessment of individual products, and participate in other activities such as pharmacovigilance and clinical trials.
- There will be a jointly agreed accreditation framework for notified bodies, meaning assessments by UK notified bodies will allow products to be placed on the market in the EU and vice versa.
- Global standards will remain, and BSI standards will retain their ability to evidence compliance with the “common rulebook”.
- There should be consistent interpretation of the “common rulebook”, and the UK Courts will pay due regard to the decisions of the European Court, as it does to the decisions of other non-UK Courts on questions of relevance to the UK and other jurisdictions.
- A Joint Committee will be set up to establish a regular and structured dialogue between the UK and EU. This is intended to prevent disputes from arising, facilitate the resolution of any disputes that do arise, manage and monitor the implementation of the future relationship, and share information and views.
- The UK Courts will not automatically be able to make preliminary references to the European Court, but the White Paper also says there should be an option of making a referral to the European Court with the consent of the Joint Committee.
The UK seeks a bespoke arrangement that goes beyond the scope of what has been agreed to date with EEA Member States such as Norway, or as a result of bilateral treaties such as with Canada. While close ties in this area will be welcomed by the industry, whether this can be agreed to by the EU remains to be seen.
Further, the concept of a “common rulebook” between the UK and EU for highly regulated products, like medicines and devices, will need some development in the context of the UK’s stated desire also to be free to negotiate separate trade deals with countries outside the EU. The CEO of BritishAmerican Business commented today that it “is a mystery” how such an agreement could be achieved with the US “if the UK is tied into the EU regulatory rule book”.