The UK life science sector contributed over £30bn to the UK economy in 2015. UK pharma invests £11.5m per day on research and development, which represents 25% of total research and development expenditure across all UK businesses. The UK has launched more medicines than any other country (behind the US and Germany) and has had more drug approvals for speciality medicines to treat rare diseases than any other country (behind Germany and France). I have worked in this industry my entire career and I remain as proud of it as ever.
Will Brexit arrive with a worrying dose of reality?
I was one of the 48.1% of the 33.6 million people who voted to remain in the European Union (EU) last June. Leaving politics aside, I voted to remain because I believed it was impossible to make such a monumentally risky decision to exit the EU, based on supposition and no real facts. So, what do we know?
The future of the European Medicines Agency (EMA). The EU regulatory framework is the most complex issue we will face when the UK exits the EU. The EMA and thousands of its employees will be forced to move from London to another EU member country.
Replacement of the UK as a reference member state. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is a world-class regulator and completes about 30% of the work of the EMA. In that context, to replace the work that the MHRA does on behalf of the EMA will be a significant challenge.
Marketing authorisations. With no access to the single market, UK pharmaceutical companies will be forced to make two separate regulatory submissions – one to the EU and one to the UK. We will have no choice, but our international partners will and they are likely to choose the EU submission route because that will mean instant access to 27 member states (not the UK). This may well position the UK as a secondary or tertiary launch country.
Research funding. Between 2007 and 2013 the UK received EU grants for scientific research worth €7bn; UK research institutions will now be excluded from competing for this money. We are already seeing research collaborations halted.
People. The UK pharmaceutical industry runs the risk of a ‘brain drain’ as clinical research opportunities in the UK diminish. As well as not being able to attract the best specialist skills to the UK, we may well lose home-grown talent to markets that will leave the UK behind.
Can the UK pharma industry work Brexit to its advantage?
In a recent conversation with Leslie Galloway (Chair, Ethical Medicines Industry Group) he persuaded me that there could actually be a silver lining to this cloud by making the UK as attractive as possible to launch new medicines. Hear us out…
1. The UK has the opportunity to streamline and speed up regulatory processes, potentially enabling the approval of the latest technologies and treatments for use even earlier than EU countries. By working with the National Institute for Health and Care Excellence (NICE), the MHRA and the government, we can look at leveraging the UK’s valuable experience with real-world evidence data.
2. The Clinical Trials Directive is currently detailed and complex. This could be simplified to encourage greater participation and faster recruitment.
3. The regulation of medicines and devices in combination is complex. We have the regulation in place for medicines and devices, but this is not adequate when a device is used to deliver a medicine, and it is much easier to secure funding for stem cell research for developing advanced therapies in the UK compared to the US. These are major opportunities that could allow us to bring more exciting innovations to market more quickly than elsewhere in the world.
4. The Early Access to Medicine Scheme (EAMS) could be adopted more quickly by the NHS, to achieve patient access to new medicines more rapidly.
5. Finally, the value of NICE Guidance in supporting the international use of medicines is very important indeed to the role of the UK in global pharmaceuticals.
So what should we do?
As Leslie says, “We are a highly regulated industry, with specialist, complex needs compared to other industries. We have to make the UK environment attractive to global decision-makers and that involves reducing the time between regulatory approvals (MA), NICE Guidance and adoption by the NHS. That will involve decision-makers not thinking in silos, but working with each other in the best interests of the UK. We certainly need to make our voices heard throughout the negotiation process.”
It’s critical that the government understands the implications of Brexit on the UK life science industry and is motivated to make positive and ultimately attractive adaptions to the UK pharma operating environment to ensure the long-term health of our world-renowned industry.
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