Brexit uncertainty remains a fact of life for business. Next week’s Parliamentary vote on the Withdrawal Agreement is unlikely to resolve matters. For the time being, planning for no-deal is set to stay with us as a time-consuming and costly distraction from other priorities.
Clearly the regulatory issues for life sciences businesses are substantial, with most regulation based on EU law and much of it implemented through EU institutions. New guidance from Government addresses a number of areas, and helps to put some of the issues in context.
Medicines regulator, the MHRA brings together relevant Government guidance and communications with industry on its website – Making a success of Brexit. The latest addition to this collection is a Further guidance note produced as a response to the consultation on draft legislation, and giving more detail on the arrangements in the event of no deal. We highlight below a few points from that guidance:
The MHRA will take on regulation for the UK market. The guidance puts forward a package of measures largely replicating the European system, and offering some attractive features to maintain the UK’s competitiveness as a research and development location. The proposals include:
- Grandfathering of Centrally Authorised Products: Transitional legislation will ensure that Centrally Authorised Products will benefit from an automatic UK marketing authorisation for a limited period. Marketing authorisation holders can opt out of this “grandfathering” process. If they wish to retain the UK MA, MAHs will have to provide baseline data for grandfathered UK MAs by 29 March 2020. Processing of variations will require at least basic baseline data to have been submitted.
- MA assessment routes: new assessment procedures for products containing new active substances and biosimilars are planned. These will include a 67-day review for products benefiting from a positive EU CHMP opinion, a full accelerated assessment for new active substances taking no more than 150 days and a “rolling review” process for new active substances and biosimilars still in development.
- Abridged applications would need to reference UK authorised products. However, this would include Centrally Authorised Products that had been converted to UK MAs and also unconverted Centrally Authorised Products granted before Brexit.
- Incentives for orphan medicines will be offered, including fee refunds and waivers, and a 10-year exclusivity period. The EU’s pre-marketing orphan designation will not be replicated, as a separate UK designation is not seen as providing a substantial additional incentive for developers.
- Data exclusivity and incentives for paediatric investigation plans and data exclusivity will largely replicate the current EU legislation, at least initially.
- New UK-specific legal presence requirements will be introduced for holders of marketing authorisations and Qualified Persons (QPs).
- Arrangements for recognition of QP certification from EU countries are planned. Wholesalers will need to familiarise themselves with the details of this system as there are specific requirements designed to ensure public safety.
- Some elements of the Falsified Medicines regime will fall away, as the UK is unlikely to have access to the central EU data hub recording dealings with individual packs of medicines. The future of this regime in the UK will be evaluated.
- The UK plans to permit ongoing parallel importation of medicines authorised elsewhere in the EU where the MHRA can satisfy itself that the imports are essentially similar to a UK-authorised product. Parallel import licence holders will have to comply with new requirements such as establishing a UK base.
Plans for the future regulation of medical devices are less well developed. A further consultation will be carried out before changes are made. Importantly, the UK intends to track the implementation of the new EU laws on medical devices and in vitro diagnostic medical devices due to apply from May 2020 and May 2022.
The guidance recognises that UK Notified Bodies will lose their status under EU legislation in the event of no-deal. Products they have certified will no longer be validly marketed.
The UK will take steps to minimise short term disruption by continuing to allow marketing of devices in conformity with the EU legislation and also those certified by UK Notified Bodies. It will continue to recognise existing clinical investigation approvals and will not require labelling changes. New medical devices will need to be registered with the MHRA, although grace periods of up to 12 months after Brexit day are provided to give manufacturers time to comply.
Much of the clinical trials system operates nationally and can continue, and the UK will continue to recognise all existing approvals. For new trials, a sponsor or legal representative could be based in the UK or in country on an approved list – initially including all EU and EEA countries.
The UK would no longer have access to the European regulatory network for clinical trials, and pan-EU trials will presumably require an EU-based sponsor or legal representative.
The UK intends to align with the new EU Clinical Trials Regulation to the extent that it can. This is unlikely to include access to the EU clinical trials portal, but a new UK clinical trials hub will be introduced to provide a similar central information resource for UK trials.
Scenario planning for your business
These regulatory changes form just part of the picture for life science businesses, many of whom must also contend with a range of other issues. A number of our clients are already planning for different scenarios. Our experience indicates that the issues needing consideration fall into the following categories:
For an expanded view of this infographic click here.
Please get in touch if you would like to discuss your arrangements with us.
 Centrally Authorised Products are those which have been through the European Medicines Agency’s approval process resulting in a single approval for the whole EU.
 A Qualified Person is an experienced professional responsible for certifying that medicines comply with applicable legal requirements.