Brexit and Brain Tumours
As the UK and the remaining 27 EU member states begin to focus on trade talks, the brain tumour community turns its attention to how Brexit could affect the lives of brain tumour patients and their families.
In late November 2017, the All-Party Parliamentary Group on Brain Tumours (APPGBT) held a meeting entitled ‘Securing brain tumour researchers’ and patients’ needs as we leave the European Union’. On the same day a group of leading brain tumour clinicians and researchers co-signed a letter the to The Times detailing their concerns about Brexit and brain tumours.
There were four common themes in both the letter and the APPGBT:
1. Funds for research
There was apprehension about the possibility of a decrease in funding available for research. Brain tumour research gains investment from a number of sources, and one of these is Horizon 2020, the EU’s current Framework Programme for science and research. The UK has received approximately €240 million (around £215 million) from health-related Horizon 2020 projects so far – around 18% of the total awarded across EU Member States. The proportion of UK spending on scientific research that comes from the EU is somewhere between 3% - 10%, based on estimates from The Royal Society and The London School of Economics. This proportion may not seem high, but research into brain tumours is underfunded, so any decrease in money available is concerning.
The bad news is that the EU has confirmed that, in the absence of a replacement deal, UK researchers will lose their Horizon 2020 funding at the end of 2020. The good news is that the UK Government has underwritten all current Horizon 2020 projects involving participating UK universities. However, how this source of funding will be accounted for beyond this is not currently clear.
2. The health workforce
This specialist field of research has historically attracted promising researchers from the EU. The UK Government has promised a stress-free registration process for ‘settled status’ for EU nationals. It is vital that any new immigration rules and formal processes are clarified quickly as current uncertainties will make it even more difficult to recruit European brain tumour researchers.
Having invested so much in their training, the UK should do everything possible to ensure these specialists remain in the UK. This has been the case so far, of the 5,475 biomedical students from other EU countries that graduated in 2014/15 in the UK, only 18% took up positions in EU nations outside the UK.
Indeed, two of Brain Tumour Research’s Centres of Excellence are led by EU-nationals. Professor Silvia Marino heads up our team at Queen Mary University of London and Professor Oliver Hanemann is in charge of our facility at Plymouth University.
Furthermore, there are 150,000 EU workers in the health and care system that work to deliver clinical services that brain tumour patients depend upon daily.
3. Accessing EU-wide clinical trials
Clinical trials are vital in finding the safest and most effective treatments to fight the many types of brain tumours. Access to cross-border patient populations and regulations to facilitate multi-national studies are key in verifying the efficacy of potentially innovative drugs and therapies.
As a member of the EU, clinical trials in the UK are conducted in accordance with the European Clinical Trials Regulation, which establishes common procedures between member states that can reduce delay, bureaucracy and maximise the impact of investment from medical research charities. Cancer Research UK claims that a quarter of the clinical trials funded by the charity involve EU collaboration and that this was particularly true for less common cancers such as brain tumours.
Co-ordination can enable the engagement of sufficient cohorts of both brain tumour researchers and disparate patient groups such as those with a specific type of brain tumour or Children, Teenagers and Young Adults (CTYA). As the UK’s membership of the European Medicines Agency (EMA) – which regulates clinical trials – will cease when it leaves the EU, questions are raised about how to ensure future co-ordination of cross-border clinical trials.
4. Accessing new brain tumour drugs
Should a new drug be found to work, it must first be licenced by a regulator and this is currently the EMA. Under the centralised authorisation procedure, pharmaceutical companies submit and pay for a single marketing-authorisation application to the EMA (which is based in London, although is in the process of moving to Amsterdam as a result of Brexit). The benefit of this process is that medicines are authorised for all EU citizens at the same time.
If there is a clean break with the EMA, companies will have to apply to two different bodies and through two potentially different schemes for product approval. Drug manufacturers will almost certainly submit their new medicines to the EMA before the UK, as the EU is a market of approximately 500 million people, whereas the UK only has a potential customer base of 65 million. Pharmaceutical companies would also not want to risk a rejection from a smaller country, like the UK, influencing larger global medicines regulators (e.g. the EMA or the US Food & Drug Administration), thereby jeopardising the large profit margins that could be achieved in these larger markets.
This will all mean that UK patient access to new drugs could be delayed by between 6 and 12 months. The UK would become like Australia, whose small population and regulatory isolation mean that cancer medicines are submitted to Australia’s drugs regulator on average 9 months after they are submitted to the EMA.
As the functions of the EMA are translated into a new domestic framework, it will be important to ensure that promising new drugs become available to patients in the UK as soon as possible.
None of the topics discussed above are insurmountable and, indeed, the UK Government is making some positive noises about the need to maintain regulatory alignment with the EU post-Brexit – which would go some way in alleviating the clinical trials and drugs access issues. The UK has also stated that it wants a research deal with the EU and mooted the possibility of skilled scientists being awarded Tier 1 (Exceptional Talent) visas so they have a right to reside in the UK.
Similarly, the UK pledged more research funding in the recent Budget.
Although these are welcome signs of intent, the usual Brexit problem, namely uncertainty, rears its head once again. The problem is that there are too many “ifs”: if the UK and EU can strike a research funding deal, if the UK can change its immigration rules, if European research framework programme can be modified to allow non-EU participation.
This devastating disease already throws enough uncertainty the way of brain tumour patients and their families, the last thing they need are more questions arising from Brexit.