UK government urged to issue compulsory licence for breast cancer drug

The UK health secretary has been urged by a health campaigning group to issue a compulsory licence for a breast cancer patent owned by Swiss pharmaceutical company Roche.

In a letter dated today, October 1, The Coalition for Affordable T-DM1 requested that Jeremy Hunt use powers outlined in section 55 of the UK Patents Act 1977 to “permit third parties to supply the government with inexpensive biosimilar versions of T-DM1, under an open non-discriminatory and non-exclusive licence, subject to the payment of remuneration to patent holders”.

Under UK law, a member of the government can compel a drugs company to issue a licence “without the consent of the proprietor of the patent ... to sell the drug or medicine”.

T-DM1 is a drug used to treat breast cancer and is marketed under the trade name Kadcyla by the Swiss pharmaceutical company. The cost is £5,908 ($8,950) for each three-week cycle of treatment for an individual weighing 75kg. Over a year, the total cost is £102,405—a price that the coalition said is unaffordable.

Last year, UK public body NICE criticised the pricing of the Kadcycla drug and recommended that the NHS did not pay for the drug, despite “evidence of its benefits to patients”.

On September 3, the NHS announced it had stopped prescribing the drug to patients as part of a clampdown on costs within the service.

But according to the coalition, one drug company has said it will market its own version of the T-DM1 if a compulsory licence is issued. The drug company was not named in the letter.

The coalition noted that the move “will not directly address the current crisis in access to T-DM1”, but said a change in approach by the government to using biosimilar versions of the drug is likely to “change the reaction by Roche to longstanding requests for lower prices for T-DM1”.