Kerala High Court allows breast cancer patient to join case over expensive drug Ribociclib

The Kerala High Court has permitted a breast cancer patient from Malappuram to be impleaded in a pending petition that examines the issue of the exorbitant price of the life-saving breast cancer medication Ribociclib. The decision was made by Justice Harishankar V. Menon, who found that the applicant, also undergoing treatment for breast cancer and taking the drug, had a direct interest in the matter.

The case originated from a petition filed by another patient diagnosed with HR Positive HER2-Negative Metastatic Breast Cancer, who was taking Ribociclib. She had sought directions to the government to take over the patent of the medication and make it available at the lowest possible price. The court subsequently took up the matter suo motu, recognising the larger public interest involved. The original petitioner passed away while the case was pending.

Ribociclib, a targeted therapy used in the treatment of certain types of breast cancer, is produced primarily by pharmaceutical companies Eli Lilly and Company and Novartis AG. The cost of the drug has been a major concern for patients, often placing it beyond the reach of ordinary individuals. The petition aims to address these affordability issues.

During the proceedings, the court issued a directive to the National Cancer Institute (NCI), Jhajjar; Chittaranjan National Cancer Institute (CNCI), Kolkata; Regional Cancer Centre (RCC), Thiruvananthapuram; and the Drug Controller General of India (DCGI) to verify whether Palbociclib, a cheaper alternative suggested by the pharma companies, could be used in place of Ribociclib. The manufacturers had earlier opposed declaring Ribociclib an essential product, arguing that Palbociclib was already being used as a more affordable substitute across the country.

The DCGI reported to the court that according to records available with the Central Drugs Standard Organisation (CDSCO), Palbociclib and Ribociclib had been approved for similar purposes. However, the DCGI clarified that only a doctor or oncologist could determine whether the two medications were interchangeable in a particular patient's treatment plan. This left the question of substitutability open, depending on clinical judgment.

The amicus curiae appointed in the case, however, pointed out that the DCGI's report had not conclusively established that Palbociclib was a substitute for Ribociclib. She argued that the data from the CDSCO indicated that the two drugs were not approved for the same stages of the disease. Further, she contended that the clinical and toxicological profiles of the drugs are different, and therefore they should not be substituted without proper medical evaluation.

The court's decision to allow the new patient to be impleaded is significant because it ensures that the voice of an affected patient is heard in the proceedings. The matter raises important questions about access to essential medicines, the role of patents in pricing, and the obligations of the state to ensure affordable healthcare. The court's directive to the cancer institutes and the DCGI to examine the interchangeability of the drugs could have far-reaching implications for the treatment protocols and cost management for breast cancer patients in India.

The case is being closely watched by patient advocacy groups and the pharmaceutical industry alike. While the pharma companies maintain that Ribociclib's price reflects its research and development costs, patient groups argue that life-saving drugs must be made accessible to all, particularly in a country with significant economic disparities. The Kerala High Court's involvement underscores the judiciary's role in safeguarding the right to health and ensuring that public interest is prioritised in matters of drug pricing and availability.

As the case proceeds, the medical and legal communities await the responses from the cancer institutes and the DCGI on the crucial issue of drug substitution. The outcome could influence similar debates on the affordability of cancer treatments across the country.