On 24 December 2020, the European Union and the United Kingdom concluded the anticipated Trade and Cooperation Agreement (TCA), which crystalizes the terms of the relationship between the EU and the UK. The TCA follows the end of the transition period formerly governed by a Withdrawal Agreement.
The focus of the TCA is the free trade area between the EU and the UK, ensuring no tariffs or quotas on trade in goods (in which are included healthcare products, such as medicinal products and medical devices) from 1 January 2021.
Annex TBT-2 of the TCA refers to Technical Barriers to Trade, specifically relating to trade and availability of medicinal products, namely (1) Marketed medicinal products for human or veterinary use, including biological and immunological products; (2) Advanced therapy medicinal products; (3) Active pharmaceutical ingredients for human or veterinary use; and (4) Investigational medicinal products.
The Guiding Principles contained in this Annex TBT-2 foresee the facilitation by the parties of the availability of medicines in each Party’s territory, the promotion of public health, the protection of high levels of consumer and environmental protection in respect of medicinal products and the determination of the conditions for the recognition of inspections and for the exchange and acceptance of official Good Manufacturing Practice (GMP) documents between the parties. The key aspects of the Annex TBT-2 are the following:
- The Parties shall recognise inspections carried out by the other Party and shall accept official GMP documents issued by the other Party. Notwithstanding, an authority of a Party may in specific circumstances opt not to accept an official GMP document issued by an authority of the other Party for manufacturing facilities located in the territory of the issuing authority;
- The Parties have the right to conduct their own inspections of manufacturing facilities that have been certified as compliant by the other Party;
- Each Party shall notify the other Party at least 60 days before adopting any new measures or changes relating to GMP rules;
- Each Party has the power to suspend in whole or in part the recognition of inspections and acceptance of official GMP documents.
In what concerns medical devices, and even though these are not specifically covered in the Agreement, in principle, they should benefit from the overreaching tariff-free and quota free trade on goods.
It should be noted that the TCA does not recognize CE marks and does not contemplate the cooperation of notified bodies and competent authorities. Therefore, each Party is free to apply its own rules. In this sense, the UK will have an autonomous “UKCA” mark (“UK Conformity Assessed”) and CE markings will be recognised in Great Britain and certificates issued by EU notified bodies will continue to be valid until 30 June 2023. As for UKCA marks and certificates from UK based notified bodies, these will not be recognised in the EU.
The new Medical Devices Regulation and the In Vitro Diagnostic Regulation will not be implemented by the UK, thus, UK regulatory regime will still be based on the existing Directives governing medical devices, active implantable medical devices and in vitro diagnostic medical devices.
Title V of the TCA intends to facilitate the production, provision and commercialization of innovative and creative products and services, ensuring the protection and enforcement of intellectual property rights.
In relation to patents and public health, the parties recognize the significance of the Declaration on the TRIPS Agreement and Public Health, adopted on 14 November 2001 (“Doha declaration”).
Moreover, the Parties recognize that, due to the possibility of medicinal products being subject to an administrative authorization procedure before being placed on the markets, additional patent protection will be provided.
The Parties commit to implementing Article 31bis of the TRIPS Agreement which governs compulsory licences necessary to produce pharmaceutical products and to protect the confidential data submitted to regulatory authorities in order to obtain a marketing authorisation for a medicinal product.
Even though the TCA does not cover all the matters related with the life sciences sector (for instance, pharmacovigilance), most likely these additional aspects will be subject of further discussion between the UK and the EU. In any case, it is undeniable that the TCA is a relevant step in the transformation of the relationship between the UK and the EU.