The year 2020 has been extraordinary. It would have been inconceivable 12 months ago that the process of developing and testing medicines would be a topic of intense political and public interest. The UK pharmaceutical sector has taken centre stage, with more support than ever before for Britain’s gold-standard regulatory framework.
After a difficult year, this winter has seen a steady drumbeat of positive news about Covid-19 vaccines, demonstrating that the pharmaceutical industry can deliver world-leading clinical research at pace and at scale within the UK’s regulatory system. As the crisis of the Covid-19 pandemic hopefully eases over the coming months and the transition period for Britain’s exit of the EU comes to an end, we must seize the opportunity to strengthen this framework.
The medicines approval regime we have in the UK is just over 50 years old. A series of unfortunate and tragic events related to drug safety in the 1960s catalysed the development of medicines regulation in the UK. The entire regulatory system was reshaped with patient safety at its core. Medicines are not consumer products; therefore, their regulation demands the application of sound medical, scientific and technical knowledge combined with the independent assessment of robust evidence. Regulation matters because its driving purpose is to protect patients.
The UK was one of the first countries in the world to properly recognise this and build a modern regulatory system for medicines, leading the world in establishing standards for evidence and a consistent assessment process. It is out of this regime that the Medicines and Healthcare products Regulatory Agency (MHRA), which regulates our medicines in the UK, was created. These regulations have enabled the UK’s pharmaceutical sector to thrive.
The UK’s approach to medicines assessment is the gold standard because it puts patients first. To protect them, the UK regulatory system insists that companies collect high-quality evidence on how safe and effective drugs are through randomised, controlled clinical trials. This regime also supports the NHS, ensuring public money is spent only on medicines that work and are proved to be well tolerated for patients. Every medicine paid for by the NHS has to be rigorously tested before it is used, with the requirement for safety monitoring after one is approved to ensure it continues to be safe and effective in the long term.
The process of assessing and developing new medicines is rightly complex and rigorous. In 1998, Dr Geoffrey Guy and Dr Brian Whittle took up the challenge of creating a tried and tested, regulatory-approved modern medicine from the cannabis plant. In direct response to the unmet medical need of a group of British patients, who at the time were facing prosecution for self-medication with street cannabis and following requests by the UK government to assess the medical use of cannabis through clinical trials, Guy and Whittle formed GW Pharmaceuticals. For over 20 years, GW has worked to unlock the potential of the cannabis plant through rigorous scientific investigations and extensive clinical trials.
UK medicines regulation places patient safety and robust clinical standards at its core. Rather than stifling innovation and investment, world-leading standards have enabled the UK’s pharmaceutical sector, including GW, to thrive. Around 25 per cent of the world’s top prescription medicines were discovered and developed in the UK. This is testimony to the strength of the UK research system and its ability to translate discoveries into treatments for patients.
GW is proof that the patient-driven approach works. Despite a perception that cannabis may not be suitable for clinical trials, over the past two decades GW has established extensive experience in researching, developing and delivering novel, breakthrough medicines, undertaking pioneering work to unlock the medical benefit of cannabis through rigorous scientific investigation, extensive clinical trials and regulatory approvals. We cannot, however, take our current regulatory system for granted. To ensure we keep finding new ways to help patients, the UK must continually strive to remain at the forefront of innovation in medicines regulation.
The Covid-19 pandemic has demonstrated the ability of the UK to innovate within our current regulatory framework. In early December, the UK became the first country in the world to approve the Pfizer/BioNTech Covid-19 vaccine. To achieve this at speed and scale, the MHRA delivered a streamlined approval and guidance process to ensure rapid deployment of much-needed vaccines without compromising on patient safety.
The MHRA has committed to streamlining its assessment procedures, prioritising access to new medicines that will benefit patients and reducing the time needed to gain approval for innovative medicines. However, we strongly believe that there is even more scope to enhance these reforms. This could be achieved through mechanisms such as incentivising innovation in medicines development, fostering the development of treatments for rare diseases and further enhancing the regulatory framework for medicines.
This is an important moment of introspection for the UK. We have left the EU, and the transition period will soon end. There is an opportunity to consider policy innovations to better meet the needs of patients by incentivising research and facilitating earlier access to innovative medicines. We must also ensure that our commitment to quality and safety is reaffirmed to safeguard the interests of the most vulnerable in our society.
The Covid-19 pandemic has demonstrated how policymakers, regulators and industry can work together to react quickly and responsibly to challenges without compromising on standards. As we emerge from the crisis, this continued collaboration is vital, as it facilitates a thriving UK life sciences sector with patient safety at its core.
Chris Tovey is chief operating officer at GW Pharmaceuticals.
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