A letter from Health Secretary Jeremy Hunt and Business Secretary Greg Clark published in the Financial Times on 4 July has put the future relationship between the EU and the UK life sciences sectors, and collaboration between regulators, at the forefront of Brexit discussions. In their letter, the Secretaries of State stress three principles guiding the challenge of developing a new life sciences regulatory regime post-Brexit: (1) continuing to place patient safety at the heart of regulation; (2) providing certainty and long-term stability; (3) building on the UK's legacy as a leader in medical innovation, as part of the Industrial Strategy. The letter concludes in promising that, should the UK Government not achieve its desired relationship with the EU in relation to life sciences, it will set up a regulatory system which will protect patients' best interests and support the UK life sciences sector in its continued development.
The letter comes shortly after the EMA Management Board agreed a methodology for redistributing the EMA's workload on evaluation and monitoring of medicines and set up two working groups, and an agreement was reached by EU27 leaders on the criteria and process for deciding upon the new location of the EMA. A significant number of Member States are expected to vie to host the EMA headquarters with a decision to be made in November 2017: a complicating factor concerns liability for the rent payable on the London headquarters until 2039 (there being no break clause in the lease) and its relocation expenses.
The call for collaboration from the UK also comes a few months after the EMA issued a number of communications giving guidance to marketing authorisation holders of centrally authorised medicinal products for human and veterinary use. These state that Brexit will have certain legal repercussions that they will need to prepare for, given that:
- EU law requires marketing authorisation holders to be established in the EU (or EEA)
- Some activities must be performed in the EU (or EEA), related for example to pharmacovigilance, batch release etc.
In particular, on 31 May, the EMA and Commission issued a Q&A focusing on the establishment requirements in the context of centralised procedures and certain activities, which it says is intended as the first in a series of guidance notes on a dedicated Brexit EMA page.
Publication of the EMA/Commission guidance caused considerable concern across the industry, and an EMA spokesperson subsequently accepted that its guidance assumed 'the worst case scenario' of the UK becoming a third country as of 30 March 2019. The industry will be collectively hoping, of course, that this scenario will not come to fruition and will be following the ongoing political discussions and statements with interest.
The EMA/Commission Q&A should therefore be understood on the basis that it assumes the UK is a 'third country' as of 30 March 2019. It sets out what would need to happen in a number of post-Brexit scenarios under that assumption:
- Marketing authorisation holder established in the UK: For centrally authorised products, the MA holder would normally need to transfer its MA to a holder established in the EU (EEA).
- Orphan designation holder established in the UK: A UK holder of an orphan designation would need to transfer its designation to a holder established in the EU (EEA) or change its place of establishment to the EU (EEA) and submit relevant documentation.
- Qualified Person for Pharmacovigilance (QPPV) resides and carries out tasks in the UK: The QPPV would need to change its place of residence and carry out its tasks in the EU (EEA) or a new QPPV meeting the requirements must be appointed.
- Manufacturing site of active substance, manufacturing site of finished product and/or batch release site located in the UK: Active substances and medicinal products manufactured in the UK would be treated as imports, because the UK would be treated as a third country – raising the prospect of tariffs.
MA holders must use as starting materials only active substances that are manufactured in accordance with the detailed GMP guidance for starting materials. Further, active substances can only be imported into the EU (EEA) if, inter alia, they are accompanied by a written confirmation from the competent authority in the exporting third country confirming that the standards of good manufacturing practice and control of the plant are equivalent to those in the EU (EEA).
For medicinal products manufactured in the UK, the MA holder would therefore need to specify an authorised importer established in the EU (EEA) and submit the corresponding variation. They would also have to specify a site of batch control in the EU (EEA) (and change the location of its current UK based site of batch control to one in the EU (EEA)).
The MA holder would also need to transfer its current UK based site of batch release to a location established in the EU (EEA) and submit the necessary variation.
Separately, CMDh (which is responsible for Mutual Recognition and Decentralised Procedures) has issued its own Notice to holders of national authorised medicinal products and a related Q&A on establishment requirements.
The MHRA has recently also updated its statement ('Making a success of Brexit') to highlight the 4 July letter and also to refer to the recent notices issued by the EMA/EU-27 and CMDh. The MHRA stresses the continued full role it places in the network and that however the negotiations conclude, it will "continue to collaborate with all involved to deliver the current speed of authorisations, access to new and innovative medicines and devices and to continue to ensure the quality, safety and efficacy of all medicines and devices, to safeguard an uninterrupted level of public health protection".
Pharma companies from across the industry meanwhile are putting increased pressure on negotiators to indeed make a success of Brexit, with the publication of an open letter underlining the importance of ongoing co-operation between the UK and the EU in relation to medicines.