The importance of government policy in supporting off-patent medicines

By Clara Carter , Accord UK Country Manager, Generics

During the recent "Generics, Branded Generics, and Biosimilars: NHS Update" panel hosted by Life Science Access Academy , we had the opportunity to discuss a pressing issue that often goes under the radar—the absence of a dedicated government policy for the off-patent sector. This topic is particularly important as we look towards the next five years, during which 255 medicines are expected to come off patent.[i] This represents a potential saving of over £18 billion for the NHS,[i] but these savings won’t materialise without the right support.

Approximately 60% of these savings could come from the introduction of generic treatments, while the remaining 40%, around £7 billion,[ii] is dependent on the successful uptake of biosimilars. The challenge, however, is that biosimilars are currently brand prescribed, making it difficult for them to gain the necessary traction in the market. If we don’t act, we risk losing out on these significant savings.

In the panel discussion, we highlighted the need for an NHS biosimilar strategy that actively promotes the use of these treatments. Clinicians need clear information and incentives to prescribe the most cost-effective biologic treatments, particularly in areas where these options are newly available. Additionally, NICE should have the capacity to re-evaluate biologics and high-value generics after their patents expire, especially those that were previously deemed too expensive. This would ensure that patients have access to the most effective treatments as soon as they become available.

Another important point raised was the necessity of making the MHRA’s 180-day biosimilar licensing pathway as efficient as possible. This could enable NHS patients to be among the first in the world to benefit from these treatments. However, this will only happen if the licensing process is both swift and reliable. Such efficiency would not only provide patients with earlier access to important treatments but also help the NHS make the most of these new opportunities.

The lack of a dedicated government policy for the off-patent sector is a significant obstacle to achieving these benefits. It’s crucial that we, as part of the healthcare industry, continue to push for the support needed to help the NHS fully realise the savings and improvements that patent expiries can bring, and we are now engaging directly with the new Labour government on this matter.

From the discussions at the panel, it’s clear that while the challenges are substantial, so too are the opportunities. With the right policies in place, we can unlock billions in savings and elevate patient care across the NHS. But to realise this potential, we must act with urgency, ensuring that generics and biosimilars not only reach the market but become a trusted choice for treatment.

[i] BGMA. ‘NEW: Manifesto for building a resilient UK medicines industry’ March 2024. Last accessed: September 2024

[ii] BGMA.