UK: The Government has awarded an extra £10mn (US$12mn) to the Medicines & Healthcare products Regulatory Agency to help bring innovative new medicines and medical technologies to patients quickly. In the Spring Budget 2023, Chancellor of the Exchequer Jeremy Hunt said: “From 2024 [the MHRA] will move to a different model, which will allow rapid, often near automatic sign-off for medicines and technologies already approved by trusted regulators in other parts of the world such as USA, Europe or Japan. From next year, a swift new approval process will be set up for the most cutting-edge medicines and devices to ensure the UK becomes a global centre for their development. And with an extra £10mn of funding over the next two years, [the MHRA] will put in place the quickest, simplest, regulatory approval in the world for companies seeking rapid market access. We are proud of our life sciences sector, which received more inward investment than any in Europe last year.”
Nicholas Hall Writes: The UK is without doubt the most liberal regulatory environment in the world – although sometimes it doesn’t feel like it on the ground. The UK is predominant in Rx-to-OTC switch: HRT and the daily oral contraceptive have been switched as global or regional firsts. Last week, we announced that Cialis had been approved in the UK as a global pioneer (although the ingredient tadalafil is already available OTC in Poland), and the UK is home to the topical ED treatment, MED3000, which has the potential to challenge sildenafil and tadalafil as it claims comparable efficacy without side-effects. There are blind spots, of course, including melatonin and CBD, but the good news continues to roll.
The switch of Gina, the first HRT treatment, is especially important, although Novo Nordisk seems an unlikely OTC pioneer. Perhaps that is why the company has run into difficulties in the weight loss sector. In recent editions of Newsflash, we’ve commented on the growing incidence of obesity and excess weight, now of almost stratospheric proportions; but new treatments have failed to take off. That is why the launch of Novo’s Wegovy is so important, and at some stage could be a switch candidate. Let’s hope that the suspension of Novo Nordisk by the Association of the British Pharmaceutical Industry is just a slap on the wrist and doesn’t dent the reputation of this interesting new product or lessen Novo Nordisk’s enthusiasm to invest in the UK.
And the latest news from the British government is that it is looking for an even faster route to market for innovative new products, piggybacking on approvals given by trusted regulatory authorities in other jurisdictions. This is a sure sign that the UK government continues to be amongst the most progressive in healthcare and has been since 1985.
ED treatments is one of the categories explored in our recent Sexual Health & Fertility report. Other categories reviewed include daily OCs, male & feminine intimate care and menstrual products. To order your copy, or for more information, contact melissa.lee@NicholasHall.com.