UK ministers commit to post-Brexit cooperation with the EU on medicines regulation
Earlier this month, the Health Secretary Jeremy Hunt and Business Secretary Greg Clark wrote a letter to the FT to express their commitment to continue close co-operation with the EU and European Medicines Agency after Brexit, in order to ensure that patients in the UK and EU continue to have access to the "best and most innovative medicines" and to protect their safety through the "strongest regulatory framework and sharing of data". They have set out three key principles which will inform the development of a new post-Brexit regulatory system:
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Patients should not be disadvantaged
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Companies should be able to bring products to the UK market as quickly and simply as possible
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The government should continue to play a leading role in promoting public health
The letter was published just over a month after the European Commission released a Q&A document concerning the impact of Brexit on medicinal products. This Q&A document suggests, amongst other things, that UK holders of marketing authorisations (MAs) will need to transfer their MAs to an entity established in the EEA and that medicinal products manufactured in the UK will be treated as imports to the EEA, meaning MA holders will need to specify an authorised importer established in the EEA in order to import such medicines. The assumption of the European Commission in publishing their Q&A is that the UK will be completely outside the EU regulatory regime on 30 March 2019 for medicinal products and that there will be neither a transitional period nor any form of mutual recognition or similar as between the EU and the UK.
Hunt and Clark's letter will be regarded by some as a move to reassure members of the public and the health profession, who may be concerned by the European Commission's stance, that the government is willing to compromise in negotiations regarding medicines regulation in order to protect public health and safety. It will also provide a degree of reassurance to businesses and investors in the UK life sciences industry, which generates over £60 billion a year and supports around 220,000 jobs. Indeed many in the industry, including the UK BioIndustry Association (BIA) and the Association of the British Pharmaceutical Industry (ABPI), have responded positively to the letter, and on 13 July the BIA was a signatory of a joint letter from UK and European bioscience trade bodies to the Brexit Secretary David Davis and the Chief EU Negotiator Michel Barnier, highlighting the importance of ongoing co-operation between the UK and the EU on medicines post-Brexit.
While it remains to be seen whether EU negotiators will pay heed to the government's latest position on post-Brexit medicines regulation, they will be aware that many would look askance at any attempt to use the health and safety of UK and EU nationals as a bargaining chip in Brexit negotiations. It will also be interesting to see whether Hunt and Clark's letter will be followed by further statements by the government which may suggest a general "softening" of its stance on Brexit.