28 August 2018 - Authored by:Jacqueline Bore
The UK government has published a series of guidance documents setting out how it plans to regulate the Life Sciences sector if the UK leaves the European Union on 29 March 2019 without an agreement with the remaining EU-27 Member States. The UK government emphasizes that significant progress has been made in negotiations with the EU and remains confident that the UK will leave the EU with a good deal for both sides. But, as The Secretary of State for Health & Social Care, Matt Hancock, has also explained in an open letter to stakeholders, the government continues to prepare proportionately for all scenarios, including that the UK leaves the EU without any deal.
In an intriguing document “How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal” we learn that the MHRA is planning a consultation in early autumn, covering the regulation of medicines, medical devices and clinical trials. A more detailed technical note will follow after that consultation. In outline, the present proposals are that:
- The MHRA takes over all functions of the European medicines regulatory network;
- The UK will recognise CE marked medical devices approved for the EU market for a limited time and will comply with all key elements of the Medical Devices Regulations and the in vitro diagnostic Regulations which will apply in the EU from May 2020 and 2022;
- All centrally authorised product marketing authorisations will automatically be converted into UK marketing authorisations with an opt out provision for marketing authorisation holders;
- Post Brexit, applications for marketing authorisations will go through a national assessment by the MHRA, with the aim that patients have access to innovative medicines at the same time as the EU patients;
- Medicines approved through the mutual recognition and de-centralised procedures are unaffected as they already have a UK marketing authorisation;
- The UK will not recognise the outcomes of EU procedures that have been not been completed before Brexit but the MHRA will take EU decisions into account;
- Data and market exclusivity periods for UK marketing authorisations will be unchanged and will begin on the date of the authorisation in the EU or UK, whichever is earlier;
- New generic applications will need to be based on reference products authorised in the UK. Existing generic marketing authorisations would remain valid;
- Marketing authorisation holders and Qualified Persons for Pharmacovigilance will have to be established in the UK by the end of 2020;
- The UK will accept products that have been batch tested and released in accordance with EU rules https://www.gov.uk/government/publications/batch-testing-medicines-if-theres-no-brexit-deal
- Incentives for paediatric development will remain in line with EU legislation but, significantly, no such commitment is made for orphan incentives;
- Packs labelled in English designed to be marketed in the UK and Ireland will be accepted as complying with UK requirements;
- Marketing authorisation holders will be required to submit pharmacovigilance data directly to the MHRA;
- Parallel imports will continue temporarily, subject to a later consultation as the UK will unilaterally align to the EU/EEA exhaustion regime;
- Clinical trials will continue to be managed nationally by the MHRA, which is working towards a single application and national decision in the UK. Eventually a legal representative present in the UK may be required.
In addition to the proposals on regulation, there is a great deal of information to be absorbed by companies on how trade and tariffs between the EU and the UK will work. A further notice on intellectual property rights may also contain some interesting themes.
The Secretary of State’s letter asks pharmaceutical companies that supply medicines for NHS patients from, or via, the European Union or EEA to ensure that they have a minimum of six weeks additional supply in the UK, over and above usual operational buffer stocks. He asks suppliers to ensure that they have plans in place to air freight products with short shelf lives that cannot be stockpiled. The Department of Health & Social Care will be checking with suppliers individually that these preparations have been made.
The EU and UK negotiators have now progressed to a phase of “continuous negotiation”. The UK government believes the Brexit deal is 80% agreed. The Life Sciences sector will be hoping that the remaining 20% can be agreed soon so that it does not have to adapt to the new and separate regulatory regime unveiled in these Notices.