By Stephen Thompson, Director of Regulatory Affairs

The UK government has now published its Policy Paper on “The future relationship between the United Kingdom and the European Union”.

And while the document itself has been the subject of much controversy, it does provide a “detailed proposal for a principled and practical Brexit”.  The paper seeks to explain “how the relationship would work, what benefits it would deliver for both sides, and why it would respect the sovereignty of the UK as well as the autonomy of the EU.”

In terms of pharmaceuticals and medical devices, it seems that the UK government’s intentions are for processes and procedures to remain broadly similar to those current in place, with key messages including:

  • “the UK government seeking an economic partnership that includes participation by the UK in the European Medicines Agency, accepting its rules, while recognizing that the UK is no longer an EU Member State.  The UK is seeking participation, as an active participant, albeit without voting rights, which would involve making an appropriate financial contribution. The UK would want to secure access to relevant IT systems, ensuring the timely transfer of data between UK and EU authorities. The UK is also seeking to ensure that all the current routes to market for human and animal medicines remain available, with UK regulators still able to conduct technical work, including acting as a ‘leading authority’ for the assessment of medicines, and participating in other activities like ongoing safety monitoring and the incoming clinical trials framework.
  • In the context of a common rulebook, the UK believes that manufacturers should only need to undergo one series of tests in either market, in order to place products in both markets.  The UK proposal covers all of the compliance activity necessary for products to be sold in the UK and EU markets.
    • testing products to see if they conform to requirements, including conformity assessments and type approval for vehicles, as well as other tests and declarations. It would also apply to labels and marks applied to show they meet the regulatory requirements;
    • accreditation of conformity assessment bodies – testing the testers within a jointly agreed accreditation framework, to provide mutual reassurance that UK and EU conformity assessments are robust;
    • manufacturing and quality assurance processes, such as Good Laboratory Practice and Good Manufacturing Practice, which ensure production methods are being respected, and that declarations are made during manufacturing;
    • the role of nominated individuals, such as the “responsible persons” for certain high-risk products, who interact with authorities or perform a specific role during and after production;
    • bespoke provisions for human and animal medicines which reflect their unique status, including the release of individual batches by a qualified person based in the UK or EU, and the role of the qualified person for pharmacovigilance, responsible for ongoing safety monitoring of potential side effects;
    • licensing regimes and arrangements, such as export licenses, for the movement of restricted products.
  • To ensure that there is no market disruption as the UK and the EU transition from the implementation period to this new free trade area, the UK proposes that all manufactured goods authorisations, approvals, certifications, and any agency activity undertaken under EU law (for example, to register a chemical), completed before the end of the implementation period, should continue to be recognised as valid in both the UK and the EU. Moreover, any such processes underway as the UK and the EU transition from the implementation period should be completed under existing rules, with the outcomes respected in full.”

The next key step in negotiations is the European Council meeting on 18 October 2018, where the final outline of relations should be agreed.

What do Marketing Authorisation Holders (MAHs) need to do and by when:

It is important to note, that while the UK has now published these proposals, the document also makes clear that ‘nothing is agreed until everything is agreed’.

Until now, the European Commission (EC) and EMA’s position is that, as of 00:00h (CET) on 30 March 2019, the UK will become a ‘third country’, and the EU legislation and guidance on medicinal products will no longer apply to the UK.  In the Questions and Answers documents published by the EC/EMA and CMD(h), the advice to marketing authorization holders is that all relevant tasks and responsibilities currently conducted in the UK should be transferred to within the EEA by 30 March 2019, for example:

  • The marketing authorisation holder of centrally authorized medicinal products
  • The marketing authorisation holder of nationally authorized medicinal products in countries other than the UK
  • The sponsor of an orphan medicinal product designation
  • Qualified person responsible for pharmacovigilance
  • Batch release and analytical testing for centrally authorized medicinal products and nationally authorized medicinal products in countries other than the UK

It will also impact the choice and sourcing of reference products for bioequivalence testing for generic, hybrid and biosimilar MAAs

The European Medicines Agency has very recently published the results of their survey of Brexit Preparedness – they noted more than half of centrally authorised products (CAP) with an important step in their regulatory processes in the United Kingdom (UK), are on track to ensure that their marketing authorisation remains valid once the UK leaves the European Union (EU).  However, for 108 (88 human products and 20 veterinary products), or 16%, of centrally authorised medicines with manufacturing sites located in the UK only, there are serious concerns that the necessary actions will not be carried out in time.  EMA continue to urge companies to put in place the appropriate steps to ensure everything is completed in time, and therefore mitigate any risks to the continuous supply of medicines within the EU.

At S-cubed, we are working with our clients to navigate the challenges of Brexit. If you require further support or information, please do not hesitate to get in touch with our experienced Regulatory Affairs team in the UK or Denmark.