Patients to receive new cancer drugs faster under Brexit rules shake-up
Patients will receive new cancer drugs more quickly following post-Brexit changes to the regulatory oversight of pharmaceuticals.
The change of policy has already slashed approval times by as much as a month. The MHRA, Britain's regulator, has approved seven cancer treatments under the Project Orbis scheme, which it entered into last year after licensing decisions were no longer made by the European Medicines Agency.
Four of the newly approved treatments are for lung cancer and breast cancer. Another three are extensions of existing treatments.
Project Orbis links the UK to the US, Canada, Australia, Switzerland, Singapore and Brazil, harmonising the regulatory process so trial data can be submitted to all the regulators at the same time, where it can be reviewed and treatments approved.
Government officials have said the scheme is a Brexit benefit which will "speed up the time it takes to get these new medicines to patients".
European medical agency the EMA says it takes around a year for it to evaluate a medicine, after which it makes a recommendation to the European Commission, which can take another two months to approve.
The first drug the MHRA approved under Project Orbis last May - AstraZeneca's lung cancer treatment Tagrisso - took the EMA almost a month longer to approve.
AstraZeneca's executive vice president of oncology Dave Fredrickson praised Project Orbis as a "welcome initiative that has already shown it can help accelerate the speed of getting innovative cancer medicines to patients in the UK and across the globe".
He added: "It is vital for industry, regulators and health bodies to continue working closely together to make sure many more medicines can get to patients in the shortest possible time.”
The UK is among the countries facing a cancer treatment backlog as NHS resources have been diverted to tackling Covid, with experts saying it could take a decade to clear.
However, Project Orbis has attracted criticism from cancer specialists who warn that speeding up approvals risks cutting corners.
Richard Sullivan, a director for the Institute for Cancer Policy, said: "The concern is we're going to start aping some of what we see as the poor practices of the FDA in terms of accelerated approval.
"If this is about just lowering the bar even more and more, then this is a disaster, because what this is going to do is actually harm British cancer patients, not improve their outcomes."
