Campaigners urge NHS to ignore patents on Vertex's CF drug

The fight to get Vertex’s cystic fibrosis drug Orkambi available on England’s NHS continues, after pressure groups called on the government to implement a little-known law allowing to set aside patents and provide drugs for the benefit of society at a much cheaper price.

A patient-led pressure group, Just Treatment, has joined with campaigners who want Vertex’s cystic fibrosis drug Orkambi to be funded by the NHS, and last night lobbied the government to implement the so-called “Crown use” law.

Under provisions in the 1977 Patents Act, the government could allow another manufacturer to make Orkambi and pay Vertex a royalty that would be much lower than the list price of around £104,000 per patient per year.

Orkambi is a combination of the drugs ivacaftor and lumacaftor that works in patients with two F508del mutations, around 4,000 patients in the UK.

NICE already rejected Orkambi in 2016, saying it was too expensive for the NHS, and since then Vertex has been deadlocked with representatives of the health service in confidential talks over pricing. Vertex has also refused an offer worth £500 million over five years for all its CF drugs.

Campaigners led by Christina Walker, whose eight-year-old son Luis has Cystic Fibrosis, have joined with Just Treatment to put further pressure on Vertex to drop its price.

Orkambi has the potential to change the lives of patients with the F508del mutation, stabilising the disease and preventing the steady decline in health caused by symptoms including a build-up of mucus in the lungs.

In an adjournment debate held in Parliament, Bill Wiggin, Conservative MP for North Herefordshire, asked the government to invoke “Crown use”.

The provision has already been used in the 1960s to obtain cheap generics of the antibiotic tetracycline for NHS hospitals, against the wishes of the patent holder Pfizer.

Its use has also been threatened over hepatitis C diagnostic tests and for treating kidney stones.

Diarmaid McDonald, lead organiser at Just Treatment, a charity funded by billionaire philanthropist George Soros’ Open Society Foundations, described Vertex’s behaviour as “pretty disgusting”, saying that it is a “company ruthless in its focus on maximising profit and maximising the price.”

Diarmaid McDonald

McDonald has written to the government calling on it to implement a "Plan B" for Orkambi, using Crown use to make it available to NHS patients.

He told pharmaphorum: “We are really pleased with how the campaign has gone. Significant numbers of them (MPs) understand there is a problem with the intellectual property system and how it affects the NHS.”

“Every avenue should be explored to get this medicine access. The quickest way is for Vertex to reengage with NICE and the NHS with a much-improved price.”

“We should be prepared to press ahead and prioritise the lives of UK citizens. It’s heartbreaking that parents have to turn into campaigners and fight for their kids to get access to medicines.”

Speaking on behalf of the government last night health minister Stephen Brine MP said in the debate that it was “looking at all options” and that Crown use could be used to ensure patients get access to Orkambi.

Rebecca Hunt, vice president, Corporate Affairs, International, Vertex Pharmaceuticals, said: "We are determined to find a solution that allows the NHS to provide patient access to our precision medicines across the UK with budget certainty and also allows Vertex to continue its research and focus on a cure for CF and other serious diseases.

"To invoke Crown use and provide third parties access to Vertex’s intellectual property would seriously undermine our ability to achieve these goals and would significantly weaken incentives for future innovation."