Kerala HC seeks data on patented cancer drug affordability

The Kerala High Court has asked the Centre to collect nationwide data on the affordability of patented life-saving medicines and assess whether existing price-control and subsidy measures are actually helping patients, even as it held that the government has the legal power to intervene when patented drugs become prohibitively expensive.

The Court, however, stopped short of directing the Union government to immediately invoke that power or prescribing a timeline for doing so, leaving the question of when patients could actually see cheaper access unresolved.

The ruling came in the High Court’s suo motu proceedings on the exorbitant pricing of life-saving patented medicines, a case that began with a breast cancer patient struggling to afford the patented drug ribociclib, a drug marketed in India as Kryxana by Swiss pharma giant Novartis, that costs Rs 7.68 lakh per year currently.

After being diagnosed with Luminal A breast cancer, a very aggressive form of HER2-negative breast cancer, in July 2021, the petitioner, Saroja Radhakrishnan, had asked the court to direct the government to issue a compulsory licence for producing a generic version of the drug.

The drug, which is highly effective in treating the specific breast cancer and is indicated even in early stages of the disease, will be under patent in India till 2029, which means its generics, which can make cheaper versions available, cannot be manufactured and commercialised.

The patient subsequently died during the proceedings, but the court continued the matter as a broader public-health issue and also included Eli Lilly’s abemaciclib and Pfizer’s palbociclib – also indicated for breast cancer treatment – under its ambit.

The patent on palbociclib, however, ended in 2023, leading to its cheaper version arriving and the Court continued to hear the matter on what can be done to make the other two exorbitantly expensive drugs affordable and accessible.

It has now said the government needs to establish, with ground-level evidence, whether medicines at the centre of the dispute are genuinely affordable.

It has called for data from hospitals across the country on the number of patients affected by the relevant cancers, the number actually using the medicines, and cases in which patients do not take them because of their prices.

Additionally, it also wants the Union health ministry to assess how many patients have benefited from government schemes providing medicines at subsidised prices, how effective those schemes have been and whether they need to be expanded.

India reports over 15 lakh new cancer cases every year and delay in diagnosis, coupled with lack of proper care, mainly due to affordability issues, remain major challenges for the majority of the patients, leading to very high mortalities.

An important study by Tata Memorial Centre (TMC) had shown that only about 1.5-3 percent of patients indicated for new cancer therapies, immunotherapies and targeted therapies that substantially improve survival and quality of life, can access them.PATENT POWER, NOT ORDER

As part of the proceeding, the Court had been deliberating on Section 100 of the Patents Act, 1970. The provision allows the Central Government, in specified circumstances, to authorise the use of a patented invention for government purposes.

The HIgh Court held that this power can extend to manufacturing and supplying life-saving patented medicines on a non-commercial basis, including for free or subsidised distribution to needy patients.

The significance is that the existence of a patent does not, by itself, prevent the government from using the statutory mechanism when public-health considerations warrant intervention.

The court linked this power to the constitutional framework around the right to life under Article 21 and the state's duty to improve public health under Article 47.

But it also made clear that deciding whether Section 100 should actually be invoked, and in which cases, remains a policy decision for the Union government.

“While the judgment recognises a potentially powerful legal route to make patented medicines cheaper, it does not itself order the Centre to use that route for ribociclib or any other particular drug,” said K M Gopakumar, a legal researcher with Third World Network, a group which works for improving access to life-saving crtical drugs in developing countries.

The Court's demand for data is therefore now central to what happens next.

It has specifically pointed out that adequate evidence about affordability had not been placed before it and said the government should collect the required information from hospitals across India.

This includes examining the extent to which existing price controls have worked, an issue that has become increasingly contentious amid demands for stronger regulation of margins and greater transparency in cancer-drug pricing.A CASE BORN FROM COST

The case originated with a breast cancer patient who challenged the price of ribociclib and sought government intervention under the Patents Act.

Ribociclib cost about Rs 58,140 for a course of 21 days at the time of the filing of the petition in 2021. The petitioner had argued that domestic manufacturers could substantially reduce the price and sought government action under provisions including Sections 92 and 100 of the Patents Act.

The Court considered whether cheaper drugs could simply be substituted for the patented medicines.

Palbociclib, which is no longer under patent and is manufactured by multiple drugmakers in India, was cited by the government as a possible alternative to ribociclib and abemaciclib, another drug for breast cancer.

The court sought expert medical opinion on the issue.

The latest judgement, based on the evidence cited, declared that these drugs are not automatically interchangeable.

n particular, medical evidence before the court indicated that treatment choices depend on the stage and clinical circumstances of breast cancer, meaning that the availability of a cheaper drug does not necessarily mean it can replace another drug for every patient.INDIA'S BREAST CANCER BURDEN

The affordability question comes against a substantial breast cancer burden in India.

The latest GLOBOCAN data by the World Health Organisation- International Agency for Research in Cancer (WHO-IARC) showed that India registered over 2.37 lakh new breast cancer cases in 2024, comprising 15.2 % of all malignancies and this cancer also claimed more than 96,000 lives that year.

Against this background, the price of newer targeted therapies becomes a particularly important access issue.

Ribociclib, abemaciclib and palbociclib belong to the CDK4/6 inhibitor class and are used in hormone receptor-positive breast cancers, but their clinical use depends on the patient's disease stage and treatment setting.

“Many of these breast cancer deaths can be prevented if patients have timely access to these drugs,” said Gopakumar.

But patients' rights advocates are also worried that while the Court’s interpretation of the provision could have implications beyond the two cancer medicines before it, extending the policy question to other life-saving drugs, the lack of direct order could lead to a rigmarole.

“We just hope that the wait for thousands of patients is not endless and the Centre takes the matter up in a time-bound manner,” said Chetali Rao, another legal researcher with TWN.- Ends

Sumi Sukanya Dutta writes on health and pharma for India Today - Health and Wellness. With over 17 years of experience in journalism, she has extensively covered a wide spectrum of issues-from pandemics and public health crises to the growing obesity epidemic and advancements in medical science.

Prior to her current role, Sumi held reporting positions at ThePrint, Moneycontrol, The New Indian Express, The Telegraph, and The Times of India, where she focused on governance and public policy at both state and national levels. She has also contributed to The British Medical Journal (BMJ).