Government says breast cancer not a matter of ‘national’ or ‘extreme’ urgency

Centre makes the submission to a petition in Kerala High Court on high cost of breast cancer drug Ribociclib; says the medicine did not fulfil conditions for a ‘compulsory licence’, given to emergency drugs, which will make it cheaper

December 17, 2022 05:03 am | Updated 10:08 pm IST - NEW DELHI

The Indian Council of Medical Research has said in a report that 100.5 per 1,00,000 women were being diagnosed with breast cancer. File

The Indian Council of Medical Research has said in a report that 100.5 per 1,00,000 women were being diagnosed with breast cancer. File | Photo Credit: The Hindu

Breast cancer, by the government’s estimate, is the leading cause of cancer in women in India however it doesn’t qualify as a matter of “national” or “extreme” urgency in the Health Ministry’s reckoning, suggest court filings as part of an ongoing case in the Kerala High Court.

The case involves Saroja Radhakrishnan (now deceased), and diagnosed with a type of breast cancer called ‘Luminal A,’ which is among the most invasive and comprises the bulk of invasive breast cancer cases. In her petition, in January this year, she argued that one of the drugs prescribed for her condition, Ribociclib, was “too expensive and unavailable at an affordable price” because it was patented and therefore India’s generic drug makers, who routinely manufacture cheaper versions, were legally prohibited from making a version of the drug. Ribociclib is manufactured by multinational pharmaceutical company Novartis.

The Indian Council of Medical Research (ICMR) in a report this month said that 100.5 per 1,00,000 women were being diagnosed with breast cancer. From the approximately 1,82,000 cases of breast cancer at present, the report has projected cases to rise to 250,000 by 2030. There was no break-up of how many of these were Luminal A cancer.

According to the World Health Organisation, there were 23 lakh women diagnosed with breast cancer and 6,85,000 deaths globally. At the end of 2020, there were 78 lakh women alive who were diagnosed with breast cancer in the past five years, making it the world’s most prevalent cancer.

The petitioner said that she and her husband had a joint income of ₹74,400 a month whereas expense on Ribociclib cost her ₹58,140. Adding other medications, the cost of medication was well above what she could afford and therefore the “unaffordable price of the medicine” impacted her right to health, which is a fundamental right under Article 21.

India’s patent laws permit any drug, patented or non-patented, to be manufactured and made available at an affordable price, via a ‘compulsory licence,’ if the government is satisfied that a large section of people need the drug but are unable to access it, or if there is a “national emergency” or a health crisis that the absence of the drug is precipitating.

In 2012, India issued such a compulsory license for Sorafenib Tosylate, a medicine to treat lung cancer which brought the cost of drug down to ₹8,800 from $5,000 (around ₹4,13,000).

In June this year, the Kerala High Court directed the Department for Promotion of Industry and Internal Trade (DPIIT), a Commerce Ministry body and one of the respondents in the case, to “consider compulsory licensing” of Ribociclib.

The DPIIT decides on the pricing of drugs and following a meeting, that included experts from the National Cancer Institute, Drug Controller General of India and the Ministry of Health decided that conditions that were necessary to issue a compulsory licence “were not fulfilled”.

The DPIIT drew on comments from the Health Ministry which said that Ribociclib was among 42 drugs on which the “trade margin” was capped at 30% and there also weren’t “claimants” who were demanding that Ribociclib be domestically manufactured. The Hindu has viewed documents submitted to the High Court that contain the government’s submissions.

The High Court has listed the matter to January for further hearing on the case.

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