Alarming No. Of Women Succumbing To Breast Cancer Due To Inability To Afford Treatment: Kerala HC Asks Centre To Consider Compulsory Licensing Of Drug Ribociclib

The Kerala High Court has directed the Department for Promotion of Industry and Internal Trade to consider compulsory licensing of Ribociclib, a life-saving breast cancer drug considering the alarming number of women who succumb to the disease merely because they could not afford treatment.  

Justice V.G. Arun found this issue to be demanding serious consideration at the hands of the concerned authorities and issued an interim direction to the Department to pass a reasoned order on this issue after consulting with the relevant authorities. 

"As per the available statistics an alarming number of women succumbing to Breast cancer by reason of their inability to afford expensive treatment and medication. The right to life guaranteed under the Constitution, coupled with the State's duty to improve public health, call for emergent and effective action in the matter."

The Court was adjudicating upon a plea moved through Advocate Maitreyi Sachidananda Hegde by a retired bank employee diagnosed with breast cancer and undergoing targeted therapy. According to the petitioner, her treatment involved three drugs, the monthly expense for which went over ₹63,000, out of which Ribocicilib alone costs ₹58,140.

The life-saving drug Ribociclib currently enjoys a patent monopoly which implies that its manufacturers are deterred from producing the drug without the approval of Novartis, the patent holder.

Alleging that she only draws a monthly pension of only ₹28,000, the petitioner submitted that Ribociclib is not manufactured in India yet. It was also submitted that if it was indeed manufactured in India, the cost would come down substantially and be affordable for all breast cancer patients.

The petitioner also highlighted that the Central government can invoke Section 92 of the Patents Act which provides for compulsory license and Section 100 which authorises the government to requisition life-saving medicines in cases of extreme necessity.

She further alleged that the dormancy by the Centre to provide access to this medication violates the right to health guaranteed under Article 21 of the Constitution of India and the Directive Principles of State Policy under which the Government is obliged to ensure public health.

Moreover, the petitioner argued that she had already submitted a representation on this issue before the department which was pending consideration.

The Court accordingly directed the Department to take up this representation and pass a reasoned order on said representation after consultation with the other authorities within four weeks. The matter will be taken up again on July 18.

Case Title: XXX v. Union of India

Citation: 2022 LiveLaw (Ker) 290

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