Brexit has stunned the world and shaken the foundation of many industries, including the pharmaceutical industry. The decision for the United Kingdom (UK) to leave the European Union (EU) is creating more questions than answers. There are many details that will be ironed out in the coming days, months, and possibly even years, but pharma should be paying particular attention to how the Brexit will affect drug development, regulatory and health technology assessment (HTA) processes, and drug pricing.
Following are some of the most critical questions that will need to be answered.
- Will the UK’s separation hinder scientific collaboration across Europe?
- With one of the big five EU member states gone, will the EU remain a strong market for research?
- Will the UK and Europe be less attractive to R&D funding and clinical trial site selection?
The European Medicines Agency (EMA) is currently housed in London. Will the EMA have to relocate to a EU member state? If this is the case, how will this administrative burden affect drug approvals?
Will the UK continue to follow the EMA or will they develop their own regulatory approval process? If they develop their own regulatory process, will this add an additional burden to the manufacturer and delay patient access to innovative therapies in the UK?
Health Technology Assessment
There has been a significant amount of research on adaptive licensing and does the Brexit allow an opportunity for NICE and the NHS to move forward on streamlining the regulatory approval and reimbursement assessment of drugs?
Will NICE’s timeline to a reimbursement decision be affected if there is an upheaval to the regulatory approval process involving the EMA?
- How will the Brexit and the volatility of the pound affect the export/import of drugs?
- Will the UK remain a common reference price country for other EU member states?
These questions and the pending changes will have significant implications for patient access to medicines and for the global pharmaceutical industry. These questions are especially critical to drugs currently in development. Drugs currently in development may face a completely different landscape in the near future as the Brexit shakes up drug development, regulatory approval, HTA and drug pricing processes. As a result, consistent monitoring of these agencies will be critical. At Context Matters we are closely watching how the Brexit will affect the pharmaceutical industry and are prepared for how these changes will impact clinical trials, regulatory and HTA data.