The UK government published its long awaited White Paper, “The Future Relationship between the United Kingdom and Europe”, on 12 July 2018. The White Paper details the UK government’s comprehensive vision for the future relationship between the UK and the EU-27, which it describes as the “Future Framework”. The proposals that affect the Life Sciences industries in the UK and the EU have received a cautious welcome.
The UK proposes the establishment of a free trade area for manufactured goods, including medicinal products and medical devices. The UK and the EU would maintain a common rulebook for manufactured goods, with the UK making an upfront choice to commit by treaty to on-going harmonisation with EU rules on goods. A new Facilitated Customs Arrangement would remove the need for customs checks and controls between the UK and the EU as if in a combined customs territory. Tariffs, quotas and routine requirements for rules of origin for goods traded between the UK and the EU would be eliminated. The UK believes that this would ensure interoperability between UK and EU supply chains, removing the need for regulatory checks at the border.
The UK’s proposal would cover all of the compliance activity necessary for products to be sold in the UK and EU markets. Post Brexit, manufacturers would only need to undergo one series of tests in order to place products on the markets of the UK and the EU. In order to achieve this, the UK proposal would cover all of the compliance activity necessary for products to be sold in both markets. This would include conformity assessments, the accreditation of conformity assessment bodies, manufacturing and quality assurance processes such as Good Laboratory Practice and Good Manufacturing Practice, the role of “responsible persons” who interact with the authorities during and after production, provisions for batch release by a qualified person and the role of the qualified person for pharmacovigilance.
The UK seeks participation in the European Medicines Agency (EMA) as an active participant without voting rights, acknowledging that this would involve making an appropriate financial contribution. The UK would like to ensure that all current routes to market for human and animal medicines remain available, with UK regulators still able to conduct technical work, including acting as “leading authority” on the assessment of medicines, and participating in other activities such as on-going safety monitoring and the incoming clinical trials framework. To support this endeavour, the UK would want to secure access to relevant IT systems, ensuring timely transfer of data between the UK and EU authorities.
In order to ensure continued alignment of the common rule book between the UK and the EU, the UK envisages a Joint Committee that would consider rule changes proposed by either the UK or the EU. Agreed rule changes would become a binding obligation on both parties in international law preventing unintended regulatory drift. The Joint Committee would keep under review the case law of the senior courts of the UK and of the Court of Justice of the European Union (CJEU) and would be empowered to act to preserve a consistent interpretation of the common rule book. The UK would respect the remit of the CJEU such that if there was a challenge to a decision made by an agency such as the EMA that affected the UK, this could be resolved by the CJEU. In practice, if the UK continues to participate in all routes to the grant of a marketing authorisation then all decisions of the CJEU relating to the EMA will affect the UK. References to the CJEU from the UK courts would no longer be possible but references could be made by the Joint Committee.
An implementation or transition period has been provisionally agreed to run until the end of December 2020. This will become operational if, and only if, the terms of the Withdrawal Agreement are agreed between the UK and the EU. The White Paper suggests that the terms of neither the Withdrawal Agreement nor the Future Framework can be considered final until the terms of both can be considered final. UK proposes that all manufactured goods authorisations, approvals and 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 at the end of the implementation period should be completed under existing rules and the outcomes respected in full.
If all of the UK’s proposals were to be agreed to by the EU the future landscape for the regulation of medicines and medical devices would look from the point of view of manufacturers and importers little different from the way it looks today. But this is a big if. Will the EU agree to these proposals? They look very much like a customs union and single market but without free movement of people, which so far has been a red line that the EU refuses to cross. And will the UK Parliament even allow the government to make the offer? The present political turbulence in the UK means that this is not automatic. Only four days after the publication of the White Paper, the UK government has been forced by Parliament to accept that full participation in the European medicines regulatory framework must be a negotiating objective for the Future Framework. Although this amendment seems to reflect the proposals already in the White Paper, it will have some statutory force if it is not overturned in the House of Lords. This could reduce the UK government’s room for manoeuvre in the negotiations with the EU yet to come.
As the Prime Minister, Theresa May, says in her foreword to the White Paper, an agreement on a future partnership requires pragmatism and compromise from both sides. On past form, commentators predict that both sides will be negotiating right up to the eleventh hour. Meanwhile, the Life Sciences industries are unlikely to cease their contingency planning for a no deal, “hard” Brexit on Exit Day, and will continue to push the UK government, including the Medicines and Healthcare products Regulatory Agency (MHRA), for clarity on how it can continue to get vital medicines and medical devices to patients in the UK and the EU if the necessary compromise and pragmatism proves to be in short supply.