UK Industry Urges Labour To Go Further With Life Sciences Plan

BGMA Urges Consideration Of Generic Competition, Biosimilar Savings And IP Costs

A life sciences plan unveiled by the UK’s Labour party – which polls indicate is likely to take power after the country’s imminent general election – could “go further in considering the role of off-patent medicines,” the BGMA believes.

Labour party leader Sir Keir Starmer
The UK’s Labour party has unveiled a life sciences plan

A life sciences plan announced by the UK’s Labour party could “go further in considering the role of off-patent medicines,” according to the British Generic Manufacturers Association.

With Labour seen by many as a future government in waiting – based on polling that indicates a significant lead over the current Conservative government – the party has in recent months been increasingly cementing relations with leaders across various industries. And now, it has published a life sciences strategy that includes a promise to increase R&D in the UK’s pharmaceutical industry by £10bn ($12.7bn) a year, provided it wins power after the general election that is expected in the UK later in 2024.

Reacting to the strategy, BGMA chief executive Mark Samuels said the association was “pleased that the Labour party will set and monitor targets for regulatory approval timelines.” However, he said, “it will be necessary not just to prioritize new medicines and trials but also where new versions of off-patent medicines are being launched, as a healthy competitive market can save the National Health Service hundreds of millions and provide for a more resilient drug supply that mitigates the impact of shortages.”

Meanwhile, “it is also good to see Labour’s call for the UK to push for mutual recognition where the UK and other drug regulators are working to internationally recognized standards,” Samuels said. “Key to this is working with the EU to get it to recognize batch testing done on UK soil.”

“Any government’s life science strategy must ensure it reflects the full breadth of the UK’s medicines industry.”

Acknowledging that “it is right that there is a comprehensive innovation and adoption strategy,” Samuels emphasized that “this must not exclude biosimilar medicines.”

Biosimilars offered “an exceptional opportunity for the NHS to widen patient access to the best treatments while saving the NHS billions,” he underlined. “Ensuring that the NHS takes full advantage of this is essential for a sustainable NHS.”

“Finally, the Labour Party has committed to aligning its intellectual property stance in future trade agreements against TRIPS [Trade-Related Aspects of Intellectual Property Rights]. However, any future trade deals must not create an IP regime that pushes up the cost of medicines for the NHS,” Samuels cautioned.

Highlighting the current lack of consideration for the off-patent sector in the UK, he said that “any government’s life science strategy must ensure it reflects the full breadth of the UK’s medicines industry,” especially given that generics represented “four out of five drugs used by the NHS.”

Despite this, “incredibly, they have been entirely overlooked by the current government’s strategy,” Samuels observed. “This has to change to sustain the resilience of generic and biosimilar medicines – drugs that save the NHS £15bn annually and allow more patients to be treated.”

“Excluding generic drugs from the current government’s life sciences vision is why we have so many medicine shortages,” Samuels argued. “We look forward to engaging with the Labour Party as it continues its policy development up to the general election.”

A ‘More Strategic Approach’ Needed

Separately, Diane DiGangi Trench – the Sandoz UK country head who became BGMA chair late last year after previously serving as vice-chair (see sidebar) – said that Labour’s plan “signals welcome prioritization, including the shifting of responsibility for life sciences to the secretary of state and the political empowerment of the Office for Life Sciences.”

BGMA Lines Up New Leadership With Change Of Vice-Chair
UK generics and biosimilars industry association the BGMA is laying the groundwork for new leadership after appointing Sandoz UK head Diane DiGangi Trench as its vice-chair, ahead of her moving up to chair next year.
Discover the full story

However, she said, “there is potential for the plan to go further in considering the role of off-patent medicines in the delivery of Labour’s health mission.”

“A more strategic approach to how the NHS uses generic and biosimilar medicines could help drive forward this agenda while solving some of the major health challenges facing any future government,” DiGangi Trench suggested.

“Crucial to reducing health inequalities is ensuring equitable access to treatments for as many patients as possible,” she argued. “We can’t tackle these inequalities by focusing exclusively on novel, high-cost therapies.”

For example, she noted, “widespread use of certain cost-effective generic medicines such as statins have been one of the biggest preventative health interventions ever in the NHS’s history. Similarly, opening up access to biosimilars when patents have expired could mean many more patients with moderate illness could have their disease progression limited.”

“Delivering on its plan for life sciences will take time, so it is encouraging that Labour is setting out its vision at this stage,” DiGangi Trench concluded. “There is a huge opportunity to not only think about the life sciences sector as an engine for economic growth, but also as mission critical to a healthier nation as part of an NHS fit for the future.”

ABPI Welcomes Labour Strategy

Meanwhile, UK brand industry association the ABPI gave the Labour life sciences strategy a warm welcome, recognizing that it “emphasizes the need to encourage investment in the pharmaceutical sector.”

“This strategy reflects the extensive and thoughtful engagement with stakeholders that the Labour party has undertaken,” commented ABPI chief executive Richard Torbett.

“With its focus on the long-term, practical measures to boost investment in research, and the emphasis on quality data to underpin future strategy, this plan will help our industry to deliver the cutting-edge treatments NHS patients need and deserve and help the UK to better compete on the global stage.”

More from Policy & Regulation

Pulling Together: Global Regulators Discuss Convergence On Biosimilars

 
• By 

While the biosimilars industry has welcomed individual pockets of progress around regulatory streamlining, it is essential that approaches from global authorities move forward together if they are to have a meaningful impact on biosimilar development. At Medicines for Europe’s annual biosimilars conference, regulators from around the world talked about how their thinking is converging.

Medicines For Europe Sets Out Vision For Biosimilars Reforms

 
• By 

Four key areas for policy reform were identified by industry association Medicines for Europe at its biosimilars conference in early April, as sector chair Isabell Remus set out the importance of removing barriers to biosimilar competition.

Biosimilars Industry Buoyed By EMA Paper On Reducing Clinical Trials

 
• By 

The EMA’s latest move towards a more streamlined process for biosimilar registration in Europe was the hottest topic at last week’s annual biosimilars conference held by Medicines for Europe in Amsterdam. Generics Bulletin discusses the new draft reflection paper and its significance for industry, reports on reactions from the event, and reveals the next steps unveiled by EMA officials.

Key FDA Officials From Generics And Biosimilars User Fee Programs Laid Off, Said AAM

 

Off-patent drug trade groups expressed their concerns that personnel and expertise cuts will affect the agency’s ability to review and approve generics and biosimilars.

More from Generics Bulletin

Despite Multiple Headwinds, Formycon Remains Positive For Its Biosimilars Growth

 

Partnering opportunities, paused marketing, approvals, litigations, and many more. Formycon sets out the agenda for 2025, after seeing a bumpy start to the year.

Medicines For Europe Sets Out Vision For Biosimilars Reforms

 
• By 

Four key areas for policy reform were identified by industry association Medicines for Europe at its biosimilars conference in early April, as sector chair Isabell Remus set out the importance of removing barriers to biosimilar competition.

Celltrion Unveils Strategy Amid Series Of Milestones

 
• By 

South Korea’s Celltrion has doubled down on its efforts in further building its pipeline, eyeing a target of 22 commercialized products by 2030 while also aiming to submit INDs for 13 novel compounds.