Glenys Thornton on the need, post-Brexit, to ensure mutual recognition of medicines and clinical devices licensed in both the UK and EU
For some time now, it has not been possible to develop a new medicine in one country. It is a global industry and you need to run your clinical trials everywhere. Patients in the UK can currently access EU‑wide trials for a new treatment, particularly for rare diseases and in relation to children. Should the UK find itself unable to get access to this network, there will be an impact on the high‑quality research in which we get involved. To say nothing of the funding of that research at UK institutions.
From the clinician’s point of view, participating in trials means they get to know and experience the use of medicines under development. A lack of engagement however, means they can miss out and will only know about the advantages and disadvantages once approval has been given.
At present, gene therapies, cell therapies and all of the oncology therapies are all regulated at a European level. This is the cutting edge of drug therapy. For example, around 70-80% of the drugs currently under development are biologically based. And for many of those, the work is often initiated here in the UK.
We really are at the forefront of this work. Antibodies and DNA were discovered here but we cannot just do clinical trials in the UK because they require a larger pool of patients, particularly with rare diseases. It is important therefore, that we have a wider network and the funding to keep those trials moving. As we negotiation our exit from the EU, all of this is in jeopardy.
Accepting the UK’s strong science, world leading universities and an NHS which provides a huge patient data base and source for trials, means we could try to go it alone. But even if we develop and produce on our own approved medicines, it will be difficult from a regulatory point of view for us to break into an EU market. And because we are not the largest market in terms of sales and if we can’t ensure we are running trials, we will slip down the list of where companies want to do their work.
So, as the UK negotiates a new relationship with the EU, significant challenges must be overcome. Not only just to ensure the stability and continued growth of the UK’s pharmaceutical industry. But also to ensure that patients can continue to access the medicines they need. Ensuring close cooperation on medicines and continued collaboration on clinical trials is crucial.
The Clinical Trials Regulation (CTR), of which the UK was heavily involved in developing, will harmonise the assessment and supervision process for clinical trials via a central EU portal and database, currently being set up by the European Medicines Agency. Implementation however, has been pushed back because of delays in the establishment of the EU portal and database – meaning it will be applied in 2019 rather than this year.
The CTR therefore, will no longer be automatically captured by the EU (Withdrawal) Bill and the government’s planned response remains unclear. That is why Labour has tabled a frontbench amendment to the Bill calling on Ministers to set out a strategy that ensure the mutual recognition of medicines and clinical devices licensed in both the UK and EU.
Baroness Glenys Thornton is Shadow Health Minister in the House of Lords. She tweets @GlenysThornton
Published 21st February 2018