The UK’s chief executive of its medicines regulator is trying to combat the perception that the country has become “isolationist” following Brexit. He is building an alliance with other watchdogs around to make sure British patients don’t fall behind in the line to access new drugs.
Dame June Raine is the head of Medicines and Healthcare products Regulatory Agency. She said that she was working with counterparts from Australia, Canada and Singapore to establish a regulatory partnership which would allow access to a combined population totalling 160mn.
Raine stated that the alliance represented a “very important global opportunity” and would address concerns about Britain’s exit from the EU. He also said that it would reduce some of the benefits of being part the EU’s larger regulatory system. US and EU markets allow drugmakers to access potential patient populations of 350mn and 450mn, respectively.
She said that there are times when we might be seen as an isolationist or merely want to be omnipotent. However, it’s not uncommon for us to be seen as wanting to be independent. Collaboration is key to our success.
The European Medicines Agency approved drugs for use in the UK before Brexit. Some manufacturers had suggested that submitting an application for the small British market could delay access new treatments.
The government attempted to address the problem in the budget last Wednesday, when it declared that the MHRA would now be able to follow other “trusted regulators” such as the EMA, its US counterparts and Japanese counterparts. This will allow the government to spend more time and resources on innovative products and free up its time.
The plans to grant what the chancellor called “rapid and often near-automatic sign-off” for drugs that have been approved elsewhere were welcomed by drugmakers.
Raine stated that the MHRA was the western regulator that licensed vaccines and drugs for Covid-19. This achievement, he said before the Budget, would serve as a model for other transformative medicine rather than a “flash-in-the pan” approach.
The UK is “moving back towards being the best of all possible worlds”, she said. The so-called Windsor Framework places Northern Ireland under the MHRA rules, just like the rest of the UK. It is amazing that common sense prevails. . . She said that “She has prevailed.”
After a sharp rise in the clawback that drugmakers must pay to government, which has risen to 26.5 percent of total revenues, became increasingly frustrated by pressure from the UK government to limit how much it spends. It is a threat to the UK’s ambitions of becoming a superpower in life science.
Raine rebutted this claim, pointing out how the close relationship between regulator and NHS, which she described as “a living incubator for innovation”, had contributed to rapid approval of Covid vaccines.
She stated that this cooperation, together with the Office for Life Sciences played by the government, was a “jewel of the crown” that allowed the UK to move faster than other nations. She added, “I am certain there is no other ecosystem with this capability.”