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Focus on Regulation

Ministers Provide Insight on the UK’s Position on the Regulation of Medicines post-Brexit

With the negotiations for the UK’s withdrawal from the EU formally under way, the UK healthcare sector is calling on the UK Government to make patient safety and access to medicines a priority in negotiations – and it appears from a recent letter to the Financial Times (FT) that Government ministers are listening.

On 3 July 2017, the UK ministers for Health and Business, Jeremy Hunt and Greg Clark, wrote an open letter to the FT seeking to provide reassurance that the UK intends to seek close collaboration with the EU in relation to the regulation of medicines post-Brexit.

The letter sets out three principles for the development of the UK medicines regulatory system post-Brexit: patients should not be disadvantaged; innovators should be able to get their products into the UK market as quickly and simply as possible; and the UK should continue to play a leading role in promoting public health.

The letter also states that patient safety will be at the heart of the new regulatory system and recognises the positive impacts that close UK/EU collaboration and data sharing has had to date in areas such as product development for rare diseases. The ministers also emphasise the need to support medical research and scientific collaborations across Europe, as well as ensuring that the UK continues to play a leading role in medical innovation and promotion of public health, with support from the UK Medicines and Healthcare products Regulatory Agency (MHRA) and by working closely with the European Medicines Agency (EMA) and other international partners.

The ministers specifically state that under the post-Brexit regime, UK licences will be processed as quickly as possible and fees for doing so will be competitive. The majority of new, innovative medicines in the EU are currently authorised by the EMA and depending on the outcome of negotiations, companies may be required to apply for authorisation both in the EU and the UK in order to access the two markets. Establishing a quick and easy procedure in the UK will therefore be key in continuing to attract companies to obtain marketing authorisations for new medicines for the UK market.

The letter concludes that the UK is open to a “deep and special” relationship with the EU and that this is the best way to promote improved patient outcomes both in Europe and globally.

The Minister’s letter is the clearest indication to date that the UK Government envisages that, post-Brexit, the UK will have a separate medicines regulatory system from the EU, but that it should be closely aligned with the EU system. The emphasis in the letter on protecting patient’s interests and supporting the UK life sciences industry should help to reassure patients and industry that the Government is taking on board their concerns and that the regulation of medicines, and the life sciences industry more generally, are high on the Brexit agenda.

The EU Commission has also begun to publish its negotiating position on a number of issues. The Commission’s approach to continued collaboration with the UK is less clear. On the one hand, in one of its recent Brexit negotiating position papers (on Goods placed on the Market under Union law before the withdrawal date), the Commission stated that products lawfully placed on the market before Brexit should be permitted to remain in circulation, and the withdrawal agreement with the UK should establish mechanisms for the exchange of information and cooperation on market surveillance for such products. However, the paper also states that EU risk assessments, approvals and authorisations for medicinal products (and other products) currently being led by a UK authority (being the MHRA in the case of medicinal products) should be transferred to another national competent authority post-Brexit “where appropriate”. The European Medicines Agency (EMA) has also published its own Brexit Q&A for marketing authorisation holders of centrally authorised medicines. You can read more about this here. Further details of the EU’s position for the life sciences sector specifically have not yet been published.