BGMA ‘Astonished’ By UK Government Snub

Source : 'Generics Bulletin'

Mark Samuels, CEO of the British Generic Manufacturers Association, has slammed the UK government after an extensive “Life Sciences Vision” strategy document published today contained no measures geared towards the off-patent sector.

“A key theme from the government’s vision for life sciences is that it addresses and supports the diversity of the sector,” Samuels observed. “Yet it entirely ignores our industry, which ultimately supplies four out of five National Health Service medicines.”

While the BGMA is listed as one of the many organizations to have engaged with the development of the Life Sciences Vision strategy, off-patent drugs are conspicuously absent from the document, with generics and biosimilars not even mentioned by name.

“I find it astonishing that we are both relied upon as a critical element of medicines supply, yet side-lined and taken for granted when it comes to these forward-looking funding initiatives,” Samuels commented.

“Of course it is critical to invest across the life sciences sector, particularly in light of what has been achieved via the COVID-19 vaccines,” Samuels acknowledged. “But the pandemic has also taught us that innovation is not just to be found in new and untried areas.”

“I find it astonishing that we are both relied upon as a critical element of medicines supply, yet side-lined and taken for granted when it comes to these forward-looking funding initiatives.”

Pointing out that “the first medicine approved to effectively treat patients suffering with COVID-19 was a repurposed generic in dexamethasone” – following the UK’s “RECOVERY” trial ("Dexamethasone Shows Potential Of Repurposed Generics Against COVID-19" "Generics Bulletin" ) – Samuels said “we believe there are scores of existing generic medicines which – with just a fraction of the funding talked about in the Office for Life Sciences Vision – could be used to treat unmet patient need.”

The Vision document does indicate an intention to “support the innovative use of off-patent drugs and technologies where no approved treatment exists, to address unmet patient need, as, for example, was done with dexamethasone during the pandemic.” However, it emphasizes that this must be done “without undermining the regulatory system and incentives to innovate.”

Moreover, Samuels said the BGMA had “grave concerns that the Vision also places more work and onus on the Medicines and Healthcare products Regulatory Agency at a time when it is also facing significant budget cuts which will ultimately impact patient access to medicines.”

The central focus of the Vision document is a “10-year strategy for the sector to build on the successes of the COVID-19 response and accelerate delivery of innovations to patients,” taking a “mission-led approach to solve some of the biggest healthcare problems of our generation, including cancer and dementia.”

It says it aims to “ensure scientific excellence, partnered with the dynamism of industry, is replicated to assist the NHS in solving the most pressing health challenges of our generation now and in the future.”

The seven “critical healthcare missions” outlined by the Vision document are:

Accelerating the pace of studies into novel dementia treatment;

Enabling early diagnosis and treatments, including immune therapies such as cancer vaccines;

Sustaining the UK’s position in vaccine discovery, development and manufacturing;

Treatment and prevention of cardiovascular diseases and its major risk factors, including obesity;

Reducing mortality and morbidity from respiratory disease in the UK and globally;

Addressing the underlying biology of ageing; and

Increasing the understanding of mental health conditions, including work to redefine diseases and develop tools to address them.

In a recent interview with Generics Bulletin, Samuels had set out his concerns that the UK government did not have a cohesive policy approach to the off-patent sector, suggesting that this was in part because the industry had succeeded so well in meeting the recent challenges of the COVID-19 pandemic and Brexit (see sidebar).

“Because the generics industry has managed to step up on the last successive occasions, however close a call it’s been, I think there is a real risk that the government misses a trick and misses the opportunity to have a strategy for our sector,” Samuels said.

“And that, I think, would be remiss. Because there will be another pandemic – this is unlikely to be the last. And who’s to say that we’re going to pull it off again next time?”

Suggesting that the UK government was “a step behind” the public perception and media appreciation of the sector, he emphasized that “even if you set aside the interests of the industry and look at the interests of the UK, the generics sector supports over 26,000 jobs in the UK, we supply four out of five medicines – those are reasons why any government ought to have a policy for our sector and a strategy for our sector.”

“I think it’s deeply ingrained in Whitehall that the pharmaceutical sector is the branded pharmaceutical sector, and people haven’t cottoned-on yet to the significance of generic manufacturing,” he suggested. “That’s obviously a task for the BGMA to provide that education.”

By David Wallace