UK-EU trade and cooperation agreement – medicines regulation
The UK and EU negotiators reached agreement on the future relationship just days before the end of the Brexit transition period, ending UK’s participation in the EU’s Single Market and Customs Union. The UK-EU Trade and Cooperation Agreement concluded on 24 December 2020, was ratified by the UK Parliament on 30 December, provisionally applicable since 1 January 2021, as agreed with the European Commission and EU Member States pending European Parliament consent and Council decision by end of February.
The trade deal met one of the life sciences industry’s big demands – the UK and EU have agreed to ensuring mutual recognition of Good Manufacturing Practice (GMP) inspections and acceptance of official GMP documents, as provided in Article 5 of the Annex TBT-2 on medicinal products to the Agreement. This will allow both UK and EU countries to save on inspection resources and avoid unnecessary duplication of site inspections of manufacturing facilities. The EU will continue to recognise GMP certificates issued by MHRA for UK sites as well as for third countries.
Annex on medicinal products
(a) to facilitate the availability of medicines in each Party’s territory;
(b) to set out the conditions for the recognition of inspections and for the exchange and acceptance of official GMP documents between the Parties;
(c) to promote public health by safeguarding patient safety and animal health and welfare, as well as to protect high levels of consumer and environmental protection, where relevant, by promoting regulatory approaches in line with the relevant international standards.
This Annex applies to medicinal products as listed in Appendix C, i.e., marketed medicinal products for human or veterinary use, including biological and immunological products; advanced therapy medicinal products; active pharmaceutical ingredients; and investigational medicinal products.
The Annex also provides a basis for regulatory cooperation, stating that the UK and EU will “endeavour to cooperate with a view to strengthening, developing and promoting the adoption and implementation of internationally agreed scientific or technical guidelines”, and creates a Working Group on Medicinal Products to assist the Trade Specialised Committee on Technical Barriers to Trade in monitoring the implementation and ensuring the proper functioning of this Annex. This Working Group will likely become a forum for exchange of information between UK and EU regulators.
What changes on 1 January 2021?
There will be changes, even though this Agreement brings “some stability and relief” to life sciences companies. The UK and the EU now form two separate markets, with two distinct regulatory and legal regimes. It’s worth noting that new customs and border processes apply with implications for supply chains.
The Agreement does not cover the mutual recognition of batch testing and release certification of medicines. The UK will continue to accept batch testing conducted in EEA countries until 1 January 2023, but the EU hasn’t reciprocated. Companies have prepared for this by ensuring that all batch testing can take place in the EU, but there are concerns about the capacity for this.
The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK’s standalone medicines and medical devices regulator, and issued a large number of guidance to industry to follow for a period of two years from 1 January 2021 in areas including clinical trials, medicines licensing, importing and exporting, and pharmacovigilance.
The Innovative Licensing and Access Pathway announced at our joint BIA-MHRA Conference in September has started, readying the MHRA for a new era in medicines approvals in the UK. The BIA supports a joined-up life sciences ecosystem which would make the UK more attractive for research and development of innovative medicines to the benefits of patients.
It should be noted that the UK is no longer covered by the EU’s mutual recognition agreements for medicines and other international agreements which facilitate market access. The UK has signed a number of agreements that rollover agreements which the EU has with key countries including Australia, New Zealand, Switzerland, United States, Israel and Japan- more information here.
Northern Ireland Protocol
The Protocol on Ireland and Northern Ireland of the Withdrawal Agreement came into force on 1 January 2021. Under the Northern Ireland Protocol, all medicinal products placed in Northern Ireland will continue to comply with EU regulatory requirements. This causes a number of complications in relation to management of the supply of medicines entering Northern Ireland from Great Britain.
The European Commission published a notice on 22 December 2020 that gives companies further time to put in place appropriate authorisations and testing facilities in Northern Ireland, as well as ensuring there are no medicine shortages in these small markets, namely Northern Ireland, Ireland, Cyprus and Malta, that have historically relied on the supply of hundreds of medicinal products from Great Britain. This acknowledges that Northern Ireland is dependent on medicines supplied through Great Britain.
Trade Associations, including the BIA raised industry concerns with government which subsequently put together a case to the Commission that led to the agreement of a phased-in approach for certain aspects of medicines regulation in Northern Ireland for a 12-month period after the end of the Brexit transition period.
Dr Christiane Abouzeid
Christiane has been with the BIA since May 2004. She is a lawyer responsible for regulatory issues concerning the research and development of novel technology products and has been involved in influencing legislative and policy developments affecting the life sciences industry in the EU.
Christiane is the Clinical Trials Topic Leader for EuropaBio, the European Association for Bioindustries.
Previously, Christiane was part of the Biosciences Group at Eversheds, joining shortly after qualification at Llewellyn Zeitman (now Shook Hardy & Bacon LLP). She worked at the European Commission for one year.
Prior to her legal career, Christiane was a research scientist at University College London and Imperial College School of Medicine for over 12 years. She holds a PhD in microbiology and biochemistry from the University of Louvain (Belgium).