It’s been an important week for clinical research, with two important documents published, which should go a long way in helping to support clinical research as the UK leaves the EU.
Cancer Research UK has published a comprehensive report exploring the impact of Brexit on the future of clinical trials as a whole and cancer trials in particular in the UK and EU.
This comes shortly after the MHRA published an important notice regarding the Clinical Trials Regulation and its role in the UK during the implementation period under the terms set out in the draft Withdrawal Agreement.
The new Clinical Trials Regulation (CTR) is a major step forward. It will enable a streamlined application process, harmonised assessment procedure, single portal for all EU clinical trials and simplified reporting procedures, including multi-member state trials.
That’s why it’s good news that even if the new regulation does not come into force during the implementation period, the Government has confirmed UK law will remain aligned with parts of the CTR legislation. This will mean researchers conducting clinical trials can plan with greater certainty.
Today’s Cancer Research UK report details short and long-term issues, which need to be addressed to support clinical research and patients in the UK. At the ABPI we support these findings.
In 2017, there were 823 applications for commercial clinical trials of medicines in UK. It is in the interests of patients and medicines development for us to find a way to continue to work together in clinical trials.
The UK Government’s proposals for a new ‘Science and Innovation Pact’ with the EU say that collaboration enables researchers to work at greater scale than they can in their own countries and the proposals supports this spirit of future science collaboration.
Here is an analysis of some of the key points, which are particularly relevant to pharmaceutical companies.
- Participation in the forthcoming EU regulatory system for clinical trials. This will support the UK’s continued leadership in clinical research. It will allow UK patients to take part in developing new medicines. It is also aligned with the MHRA’s notice about the terms of the Brexit implementation period and would avoid longer term disruption in clinical research.
- Trade barriers should not impact on clinical trials. It is critical that the UK and EU ensure that trade barriers do not impact the availability or movement of investigational medicinal products (IMPs), clinical trial supplies and medicines after the UK leaves the EU. Seventy per cent of all IMPs in ongoing EU trials are QP (qualified person) released from the UK. It is important to make sure that patients who are participating in trials – both in the UK and the EU - at the time of Brexit are able to continue to get their trial medicines.
- UK Government should focus on long term funding initiatives. The UK Government should continue to develop long-term funding initiatives for clinical trials. Trials may be funded by industry, charities, the public sector - or a combination. Mechanisms must be in place for this to happen internationally. The Government’s commitment to increase investment in UK R&D to 2.4% of GDP by 2027 is welcome and must be complemented by funding of international collaborations. Implementation of the Life Sciences Industrial Strategy in full is also needed to support the ambitious goals for clinical trials set out within the Strategy.
- Getting the right talent. The UK and EU must continue to cooperate and develop new migration arrangements, which enable scientists and doctors working on clinical trials to continue to collaborate.
When patients take part in clinical trials, they are helping the patients of the future. We know from our own research this year that clinical research is important to people; two thirds (66%) of British people said they are willing to allow the NHS to use their healthcare data for medical research. This important report sets out just why we must take great care to safeguard the future of clinical research for patients not just in the UK, but across the whole of the EU.