Since the UK left the EU at the start of this year, the two regions have had separate markets and two distinct regulatory and legal processes for life sciences. The life science industry has expressed support for a mutual recognition agreement (MRA) between the European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA) and for the previously strong relationship to be re-established.
The UK is no longer part of the EMA procedures for the licensing of medicines through the centralised procedure (compulsory for orphan medicines and biotechnology products in the EU), mutual recognition or decentralised procedures. Instead, the UK has its own regulatory system governed by the MHRA.
Given that the EU accounts for approximately 25% of global pharmaceutical sales, and the UK just 3%, this situation is of enormous importance to life science companies when deciding where and when to invest and apply for marketing authorisation for a product.
In March 2018, Theresa May called for UK associate membership of the EMA as it “would mean investment in new innovative medicines continuing in the UK, and it would mean these medicines getting to patients faster as firms prioritise larger markets when they start the lengthy process of seeking authorisations. But it would also be good for the EU because the UK regulator assesses more new medicines than any other member state.”
This was ambitious, as no non-EU nations are included in the work of the EMA. The European Council in the same month excluded the UK from participation in EU institutions. It was possible that some form of observer status could have been pursued, however, this approach was dropped under the new government led by Boris Johnson.
In advance of the final agreement with the EU, the Life Science Industry Coalition and many others called for mutual recognition of regulatory activities with the EMA. In practice, this would involve an MRA, like the one the EMA has negotiated with seven other third-country authorities including Australia, Canada, Switzerland and the USA. Such agreements involve mutual recognition of good manufacturing practice (GMP) inspections and batch certification of human and veterinary medicines.
The UK/EU Trade and Cooperation Agreement of 24 December 2020 had an Annex (TBT-2) on medicinal products. Benefits included no tariffs or quotas on trade in medicinal products and medical devices. Each side will recognise GMP by the other and accept official GMP documents issued by the other party. However, there is a reasonable caveat inserted that if one party adopts new measures in respect of GMP, then the other party has the right to refuse to continue to recognise GMP inspections.
More importantly, no MRA was agreed. There is no mutual recognition of batch testing or of batch certification and release of medical products. Each batch of a finalised product must be certified by a Qualified Person in the European Economic Area (EEA) before being released on the EEA market. This poses a substantial commercial impediment.
Medical devices are not covered by the Agreement other than being excluded from tariffs and quotas.
Up to 1 January 2023 the UK will accept:
EMA marketing authorisations under the centralised procedure (account may also be taken of mutual recognition and decentralised procedures)
batch testing in EAA countries
CE marking and certificates issued by EU-recognised bodies.
These measures are not reciprocated by the EU. This is a temporarily beneficial position for the UK, involving no upheaval in these areas for almost two years. Some commentators note that there is a strong case for extending the deadline indefinitely to provide continued stability for the life science industry and to build up goodwill with the EU and EMA.
The December 2020 Trade Agreement created the Working Group on Medicinal Products to monitor and review the Annex, assisting the Trade Specialised Committee on Technical Barriers to Trade. The membership is yet to be decided, although given that it was part of a joint UK/EU agreement and that it is likely to become a forum for exchange of information between UK and EU regulators, UK involvement is very likely. This should provide a means of maintaining contact, acting as an opportunity for discussions and facilitating cooperation.
The European Commission has granted the UK preliminary data access on the basis that its data protection rules are essentially equivalent to the EU’s General Data Protection Regulation and Law Enforcement Directive. This will improve the transfer of data, which is particularly pertinent for the operation and delivery of clinical trials involving UK and EU sites.
The Working Group should be able to ensure that GMP practices do not diverge in any critical manner. Details of how the UK will participate in the Horizon 2020 research collaboration need to be ironed out and, although not set out in the Annex, this is an issue that could be raised within the Working Group.
An MRA between the EMA and MHRA would greatly benefit the future of the life sciences industry in the UK, especially if it can be used as a step towards closer relations with the EMA. The fact that the EMA was previously based in London, with its staff heavily drawn from the MHRA, points to a previously good relationship that could be re-established.
The Working Group on Medicinal Products is the obvious forum in which the UK representatives can raise this matter, referring to the current UK adoption of EU rules as a good basis from which to build up consensus.
The Association of the British Pharmaceutical Industry (ABPI) has called for “A Mutual Recognition Agreement on Good Manufacturing Practice and batch testing to avoid unnecessary disruptions to supply chains and delays to patient access to medicines” (16 March 2021). This approach is in line with those of other industry organisations.
MAP is considering whether there would be interest from our members in supporting an MRA. Given that it was not agreed in the 2020 Agreement, despite strong support from the industry, and the example of other countries having such an MRA, there are fears that it may not happen now that negotiations have been completed. This explains why the ABPI and others are so concerned. MAP has the agility and flexibility to act quickly and could draw up a detailed plan on how to achieve this aim, liaising with the ABPI, Bioindustry Association (BIA), European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and others to demonstrate the wide degree of support.
MAP would be pleased to hear from members interested in supporting this approach or who would like to share their thoughts: please contact Grace Jennings, Associate Director, at email@example.com.
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