After the end of the transition period, the UK will join two global initiatives which aim to allow international regulators to work together in order to authorise promising treatments.
The two initiatives are: Project Orbis; and Access consortium.
Project Orbis is a programme run by the US Food and Drug Administration involving Canada, Australia, Switzerland, Singapore and Brazil. It aims to allow regulators in various countries to review and approve promising cancer treatments at the same time. The project was set up in order to address the problem that the US often receives applications from pharmaceuticals years before other countries.
Access consortium is a programme involving Australia, Canada, Switzerland and Singapore to help accelerate patient access to high-quality, safe and effective medicines. To date, it has 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 until it becomes a full participant from 1 January 2021. As a result of these collaborations, NHS patients could benefit from faster access to new and innovative treatments.
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.”
There are significant benefits to sharing the evaluation of medicines across regulators in different countries. For example, the reduced duplication of work can lead to more efficient and effective regulatory reviews, also resulting in a more cost-effective approach. Furthermore, the regulators can learn from each other, and benefit from the knowledge and approaches of other partners.
MAP will monitor these developments. For further information read the UK Government press release.