For thousands of breast cancer patients in India and those fighting to ensure access to lifesaving drugs in the country, January 3 is set to be a crucial day.
The Kerala High Court is scheduled to pass the final order on a first-of-its-kind petition filed by a breast cancer patient seeking judicial intervention to nudge the government to help lower the cost of Ribociclib, a critical anti-cancer drug.
The petitioner, a retired bank employee, was diagnosed with HER2 negative, or Luminal A breast cancer, in July 2021 and had approached the court seeking government action to issue a compulsory licence for Ribociclib, a drug developed and marketed by Swiss-American multinational company Novartis Pharmaceuticals Corp. The petitioner died during the course of the case.
Ribociclib, available in India as Kryxana, costs Rs 58,140 per month and is among three drugs prescribed for late-stage Luminal A breast cancer. The other two drugs, one each by Pfizer and Eli Lilly, are also under patent and are prohibitively expensive.
Compulsory licence is a provision of Indian patent rules that may allow generic drug makers to produce a medicine, introduce competition, and lower costs.
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At the last hearing of the case in December 2022, the Union health ministry told the court there is an unmet medical need related to breast cancer drugs but added that the leading cause of cancer in Indian women does not qualify as a “national or extreme emergency”.
In India, a compulsory licence has been issued only once – in 2012 for Bayer’s Sorafenib Tosylate to treat late-stage lung cancer, which steeply brought the cost of the drug down from $5,000 or Rs 4,13,000 to Rs 8,800.
According to the National Cancer Registry Programme maintained by the Indian Council of Medical Research, almost 200,000 breast cancer cases are detected in India every year and while one in every 22 women develops the disease, one out of the two who gets it, dies.
Breast cancer, which is now the leading cause of cancer deaths among women in India, is divided into three subtypes depending on whether the tumour is driven through the estrogen receptor (ER+), the HER2 negative receptor or neither (triple negative).
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Currently, no cheap, generic medicines are available for HER2 negative breast cancer, considered among the most aggressive forms of breast cancer. For this reason, experts underline the need for affordable medicine to treat the disease.
“Breast cancer is certainly an emerging health problem of national relevance and its incidence is rising,” said Dr Aju Mathew, an oncologist and cancer researcher based in Kerala.
The treatment of cancer causes substantial “financial toxicity” and compulsory licensing for drugs that are widely needed will help reduce prices, he stressed.
“Ribociclib has a role in a subset of patients with late-stage breast cancer and soon studies may even show that it is relevant in early stages of the disease. Compulsory licensing for production of the drug would bring a huge relief for a large number of patients,” Mathew said.
Aashna Mehta, a health economist with the Public Health Foundation of India who specialises in drug pricing, said while there have been several instances of drugs making a strong case for compulsory licensing, it is largely an issue of political will.
Case for compulsory licensing
India’s patent laws permit any drug, patented or non-patented, to be produced and made available at an affordable price through a compulsory licence if the government is satisfied a large section of people needs the drug but are unable to access it, or if there is a national emergency or health crisis that the absence of the drug is precipitating.
However, the provision is rarely exercised.
“There has been a lot of pressure on India and other developing countries in terms of using flexibilities such as compulsory licensing to make generic versions of a patented drug,” Mehta said.
In its submission to the court, the health ministry said Ribociclib was among 42 cancer drugs on which the trade margin was capped at 30 percent and there also weren’t “claimants” who demanded that Ribociclib be domestically made.
According to Mehta, since the base price of drugs like Ribociclib itself is very high, trade margin rationalisation has not been effective and hasn’t benefitted patients.
The Centre also told the Kerala High Court that the Drug Controller General of India has allowed two companies to make the drug locally.
However, Chaitali Rao, a legal researcher with the Third World Network who has followed the case closely, pointed out that the two companies are under infringement suit in the US by innovator companies for violating patent norms. Therefore, the government should issue compulsory licences in the case as less than 10 percent of the women who may need the drug can afford it, she said.
In the US, 62 contracts under provisions of compulsory licence were issued to ensure accessibility and affordability of lifesaving drugs during the COVID-19 pandemic period so far, Rao said.
“If the US government can use the tool in case of a public health emergency, why can’t India do it to ensure the availability of a lifesaving drug?” asked Rao. “The provision of compulsory licence was actually made as a lever mechanism by the Indian Parliament when it amended the Patent Act so that the government has something in hand to undermine the power of the patent and monopoly.”
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A Novartis spokesperson told Moneycontrol it is unable to comment on the matter because the writ petition is sub judice.
“Moreover, Novartis is neither a party to the writ petition nor a party to the representation,” said the spokesperson. “Novartis remains committed to improving patient outcomes by providing quality innovative medicines such as Ribociclib.”