The Kerala High Court has issued a judgement that leaves thousands of breast cancer patients in India without immediate access to the affordable medication Ribociclib. According to The Hindu BusinessLine, the court examined a writ petition filed in 2022 by a retired bank employee from Ernakulam who struggled to afford the drug. The petitioner, who had HR+/HER2- metastatic breast cancer, sought directions under the Patents Act, 1970, to make the targeted therapy reasonably affordable for patients with limited pensions.
The legal case experienced significant delays, with the Supreme Court taking suo motu cognisance in July of this year after the matter was listed 57 times and adjourned 40 times since January 2023. The apex court asked the head of the Kerala High Court to expedite the resolution of the petition. In its September 28 judgement, the high court determined that an alternative drug, Palbociclib, was not interchangeable with Ribociclib because the two are used for different stages of the disease.
The core of the ruling involves Section 100 of the Patents Act, which allows government intervention when a medicine is unaffordable due to its exorbitant price. The court held that this provision should be invoked in such circumstances but did not order its immediate use. Instead, the government was directed to collate data to decide if the medicine is affordable before proceeding under Section 100. The Hindu BusinessLine notes that no specific timeline was set for this data collection or the subsequent decision.
This open-ended direction has raised concerns among patient advocacy groups who fear further delays in treatment access. The judgement does not require the government to report its decision back to the court, meaning a rejection of Section 100 would necessitate a fresh writ petition. For patients like the original petitioner, who succumbed to her illness while the petition was pending, each postponed ruling represents a potential loss of time. The ruling effectively shifts the burden to the executive branch without a fixed deadline, maintaining the status quo for those battling the disease and its financial aftermath.