Kerala HC Asks Centre To Consider Compulsory Licensing Of Drug Ribociclib

Sonal Bhargava | Prabhat Bandhulya

The Kerala High Court has ordered the Union Ministry of Commerce and Industry's Department for Promotion of Industry and Internal Trade (DPIIT) to explore mandatory licencing of the life-saving breast cancer medicine Ribociclib. Justice VG Arun asked for immediate action, stressing that an alarming number of breast cancer patients are dying as a result of their inability to purchase the prohibitively expensive treatment. The Court was debating a petition filed by a woman diagnosed with HER2- Negative Metastatic Breast Cancer and receiving targeted therapy. The treatment entailed taking three drugs with a monthly cost of nearly Rs 63,000, with one life-saving drug, Ribocicilib, costing RS 58,140. The petitioner claimed to be a former bank employee who received only a Rs 28,000 monthly pension. Ribociclib is not manufactured in India, and the petitioner claims that if it were, the cost of the medicine would drop dramatically, making it more affordable to her and other breast cancer sufferers. Ribociclib currently has a patent monopoly, preventing manufacturers from making the drug without the patent holder's permission, Novartis. The petitioner's lawyer, Maitreyi Sachidananda Hegde, pointed out that the government can use Section 92 of the Patents Act, 1970, which allows for compulsory licencing, and Section 100, which allows the government to requisition life-saving drugs in extreme instances. It was further argued that the government's failure to provide access to medication breaches the right to health given by Article 21 of the Indian Constitution and the basic principles of state policy, which require the government to maintain public health. It was pointed out that the petitioner had already filed a submission in this regard, which the DPIIT is currently considering. The Court issued an interim order directing the DPIIT to review and issue a reasoned order on the submission within four weeks. The subject will be discussed again on July 18.

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