Developing and marketing health products across the EU/UK

As the EU-UK Trade and Cooperation Agreement concluded on 24 December 2020 has now been made public, a few initial points can be identified as key for the health products industry operating on both sides of the Channel.

1. The Agreement does not provide a full final set of rules for trade and cooperation between the EU and the UK. It will be for the parties to apply the text, interpret it with the assistance of a bilateral Partnership Council and, where needed, supplement it by way of specific side agreements ('Supplementing agreements'). The text creates a number of Working Groups, including a Working Group on Medicinal Products, under the supervision of the Trade Specialised Committee on Technical Barriers to Trade. As other Working Groups established by the Agreement, it will be co-chaired by a representative of the European Union and a representative of the United Kingdom. Companies processing or marketing products in Northern Ireland should bear in mind that Northern Ireland is covered by special mechanisms - see, for example, the Unilateral declarations in the Withdrawal Agreement Joint Committee on human and veterinary medicines and the dedicated MHRA guidance.

2. The Agreement does not contain a Mutual Recognition Agreement, which would have allowed, for example, a marketing authorisation (medicinal products) or a CE-marking (medical devices) obtained in the EU to be recognised in the UK, or the other way round. Thus, duplication of regulatory work will be inevitable for companies marketing products on both sides. Specifically, operators should bear in mind the following consequences of the withdrawal of the UK, which should not be directly affected by the Agreement:
   a. Separate regulatory authorities means separate reviews. The UK's regulatory authority, MHRA, no longer participates in European regulatory network - it has joined the ACSS consortium, which brings together the competent authorities from Australia, Canada, Singapore, Switzerland. Efforts will be deployed to minimise disruption in capacity and expertise for the review, surveillance and safety supervision of heath products.
   b. Medicinal products Operators should pay special attention to activities including manufacturing and marketing authorisations, clinical trials (clinical trial in EU requires sponsor to be established or have 'legal representative' in EU) and pharmacovigilance, amongst other important issues. The essential of the EMA's Brexit-related guidance for companies remains relevant. On clinical trials, further guidance can be found in the EC's Notice to stakeholders - Withdrawal of the UK and EU rules in the field of clinical trials, or in the EC/EMA/HMA's Technical notice to sponsors regarding continuous compliance with the EU legislation for clinical trials. On the UK side, see the MHRA post-transition period information, and for more specific examples, the Government's updated guidance on Registration of clinical trials for investigational medicinal products and publication of summary results from 1 January 2021 and pharmacovigilance procedures.
   c. Medical devices The Trade and Cooperation is silent on medical devices. There is thus no mutual recognition of notified bodies, or of the certificates that they issue. In the EU, a EU CE conformity certificate must be issued by an EU-based Notified Body. In the UK, a new system will be in place 1 January 2021, providing for a 'UKCA' mark - but EU (MDD/MDR) CE stickers will be valid until 30 June 2023. EU-based companies who want to sell medical in the UK need to register a Responsible Person in the UK (by 1 January 2021), and to register products in the UK, within 4 months (Class III), 8 months (Classes IIa/IIb) or 12 months (Class I). See the UK Government's page on Regulating medical devices from 1 January 2021.

3. Some 'facilitation arrangements' are however provided in relation to medicinal products.
   A specific Annex TBT-2 on medicinal products, is provided with a view:
   '(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.'

   The Annex sets out an agreement on mutual recognition of inspections and good manufacturing practices. It states that with regard to medicinal products, the UK and EU will 'endeavour to consult one another, as permitted by their respective law, on proposals to introduce significant changes to technical regulations or inspection procedures.' (Article 10, Regulatory Cooperation). The Annex also provides that the parties will 'endeavour to cooperate with a view to strengthening, developing and promoting the adoption and implementation of internationally agreed scientific or technical guidelines' (same Article).
   Transport of medicinal products counts amongst the exemptions from licensing requirements (Article ROAD.6).

   The text also agrees to share information on health risks, such as pandemics, and allows for ad hoc access to the EU's Early Warning and Response System, a tool that allows member countries to share information on public health threats (Article HS.1, Cooperation on health security).

4. The Agreement contains foundations for protection of intellectual property. A specific Intellectual Property section addresses the 'Extension of the period of protection conferred by a patent on medicinal products and on plant protection products' (Article IP.33) - but the rules for certificates for supplementary protection certificates 'SPCs' will no longer necessarily be common, as 'The terms and conditions for the provision of such further protection, including its length, shall be determined in accordance with the laws and regulations of the Parties'. This section also addresses the 'Protection of data submitted to obtain an authorisation to put a medicinal product on the market' (data and market exclusivity), but such provisions (Article IP.35) also very much refers to domestic laws to set the rules. These are very light provisions that do not commit either side to maintaining current supplementary protection certificate or data and market exclusivity standards. We can therefore only hope that the Working Group on Medicinal Products will achieve further EU/UK cooperation on these subjects, in the bests interests of the industry and, ultimately, patients, on both sides of the Channel.