NHS Partnerships Director, British Generic Manufacturers Association (BGMA)
While vaccines play a critical role in protecting society and getting us out of the grip of COVID-19, generic medicines are what have saved many thousands of lives.
The vast majority of medicines used to treat hospitalised COVID-19 patients – including those requiring ventilation – are generic drugs. Four out of every five NHS prescriptions are generic medicines. Despite the enormous challenges caused by COVID-19, generic medicine supply has been a success, with no patients going without treatment.
The first medicine found to help treat patients suffering from COVID-19 was a genericised corticosteroid product called dexamethasone. Previously, the medicine was used to treat a wide range of health conditions, including severe skin conditions, anaphylaxis and autoimmune conditions, such as Lupus.
Repurposing generic medicines
However, a clinical trial supported by the National Institute for Health Research (NIHR) found that dexamethasone could be repurposed. This generic medicine significantly reduced the risk of dying from COVID-19 for patients requiring respiratory intervention. It was a breakthrough. Not only was it the first drug found to treat COVID-19 sufferers, but as a generic, it was widely available in large quantities and affordably priced. Use of dexamethasone for COVID-19 has so far saved 22,000 lives in the UK and an estimated one million worldwide.
Repurposing existing generic medicines is an untapped but vital way of discovering new treatments. These treatments are inherently affordable because the drugs are off-patent. Generic manufacturers already have the requisite supply chains in place, well-established regulatory departments and pharmacovigilance systems to monitor safety.
Repurposing existing generic medicines is an untapped but vital way of discovering new treatments.
Policy interventions are needed
However, the NHS and patients will miss out on repurposed medicines without policy interventions. Generic manufacturers rarely conduct clinical research because they cannot afford it. It’s a low margin business. If one generic company is given a first-mover incentive to lead the way in licensing the new indication, the others in the market will quickly follow, with no change to generic prescribing and dispensing practices.
Finding an incentive for the first mover is essential. We believe solutions need to be transparent, simple to administer and avoid complexity. Recently, a NHS England repurposing report recommended creating a ‘catalyst’ fund solution for high-priority areas for the NHS. Over three years, NHS England needs just £10.5 million to support two to three repurposed medicines through the regulatory process.
Incentives for repurposing medicines
NIHR’s work has put the UK in a world-leading position for medicines repurposing. But, it’s a position that will be lost to other countries unless the Government makes a significant investment in repurposing drugs.
If we can get the incentives right, the NHS, industry and patients will benefit from innovative yet affordable treatments. Innovation doesn’t always mean expensive. Re-examining our existing drugs can bring affordable and substantial patient benefits.