NHS patients could have quicker access to cutting-edge medical treatments as the UK teams up with international collaborators to fast-track the approval process.
Following the UK’s exit from the EU, the country has the autonomy to streamline approval processes for medicines. The UK will now be joining countries such as the US, Canada, Australia, Switzerland, Singapore, and Brazil to speed up the approval of innovative medicines, including cancer treatments.
The country will join two initiatives which are bringing together some of the world’s leading regulators to allow pharmaceutical companies to submit medicines to be reviewed by several countries at the same time, pooling resources, and allowing patients to benefit from earlier access.
Health and Social Care Secretary Matt Hancock said: “I will stop at nothing to make sure NHS patients can access life-saving treatments as quickly as possible and now we have left the EU, we have an opportunity to speed up the time it takes to get new medicines from bench to bedside.
“With the ground-breaking work on dexamethasone and other COVID-19 treatments, it is clear the UK continues to lead the way with research into the most transformative treatments. I’m delighted the UK will be teaming up with some of the world’s best regulators to put patients first by fast-tracking cutting-edge medicines after the transition period. The aim of both groups will be to ensure that patient safety and scientific integrity is upheld to the highest possible standards, while removing red tape and working together to get medicines onto the market quicker.”
Approval initiatives
The two approval initiatives include:
Project Orbis
Project Orbis is a programme co-ordinated by the US Food and Drug Administration involving Canada, Australia, Switzerland, Singapore, and Brazil to review and approve promising cancer treatments. The scheme has already given the green light to many life-saving treatments for patients suffering from conditions such as breast cancer, lung cancer, liver cancer, endometrial cancer, and chronic lymphocytic leukaemia.
Access consortium
Access consortium is a programme involving Australia, Canada, Switzerland, and Singapore to help secure improved patient access to high-quality, safe, and effective medicines. The consortium has previously approved nine innovative prescription medicines, including five new cancer treatments.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will participate as an observer of both groups before the end of 2020 and will be a full participant as of 1 January 2021 after the EU transition period.
MHRA will have the authority to make the final decision to authorise medicines onto the UK market and will have complete autonomy to streamline the approval processes even further if needed outside of both schemes.
Dr June Raine, MHRA Chief Executive, said: “We are committed to working together to ensure that UK patients are among the first to benefit from promising life-saving treatments. Through our commitment to international cooperation and innovation in regulation, the MHRA continues to be at the forefront of new developments as a global hub for life sciences.”
Richard Pazdur, MD, Director, FDA Oncology Center of Excellence, said: “Project Orbis stemmed from a monthly teleconference FDA held with other regulators for about 15 years, which indicated that the US often receives applications first ‒ sometimes months or even years before other countries.
“We decided to address this by partnering with other countries and asking the pharmaceutical companies to submit applications to several regulators at about the same time, to provide early entry of these applications into their regulatory systems. To date, our partners include Australia, Canada, Singapore, Switzerland, and Brazil. We are pleased to welcome the UK’s MHRA to this collaborative programme.”
