Plea In Kerala High Court By Spinal Muscular Atrophy Patient Seeks Access To Life-Saving Medicine Risdiplam At Affordable Prices

A plea has been moved in the Kerala High Court by a 24-year old suffering from Spinal Muscular Atrophy (SMA), against the overpricing of the life-saving medicine, Risdiplam. 

Justice Devan Ramachandran issued notice to the concerned Government authorities in the matter yesterday. 

The petitioner averred that the medicine she had been adviced to take, namely, Risdiplam, costs around Rupees Six Lakhs per bottle. She added that for a patient weighing more than 20 kg, a bottle of Risdiplam would last only for 12 days and that the said person would require 31 bottles per year.

With the above estimates, the petitioner submitted that she would require 3 bottles a month which would cost around Rupees 18 lakhs per month, which she is unable to afford. 

She stated that the medicine had been overpriced due to the patent monopoly which prevented other manufacturers from producing the same, without the permission of the owner of the patent, which thereby resulted in lack of competition. 

"This unaffordable price directly affects the right to health, a fundamental right under Article 21 of the Constitution, of the petitioner," she says. 

She submitted that the respondents could invoke the provisions of the Patents Act, 1970 to ensure availability of Risdiplam at affordable prices by permitting other manufactures to produce Risdiplam, and that Section 83 of the Act laid down the guiding principles for granting compulsory license of articles. 

The petitioner added that as per Section 100 of the Act, 1970, the Government is vested with wider powers to use the patented invention for 'government use', and that the 'right to sell on non-commercial basis' was also included within the provision. 

She thus averred that the government is duty-bound to take steps under Section 100 to ensure the enjoyment of fundamental rights guaranteed under Article 21 of the Constitution. 

The plea thus seeks the issuance of directions to the Central and Stat Goverments for formulation of a a scheme to provide treatment for SMA patients including the petitioner, to provide Risdiplam at free of cost under National Policy for Rare Diseases. 

It further seeks directions to the concerned respondent authorities for initiation of steps under Section 92 or 100 of the Act, 1970 for ensuring availability and access to Risdiplam at reasonably affordable prices.

In the interim, the petitioner seeks the issuance of an Order to the competent respondent authorities directing them to initiate entire treatment for SMA including administration of Risdiplam at Government Medical College, Ernakulam within a time frame to be fixed by the Court. 

The matter has been posted for further consideration on Friday, December 22, 2023. 

The present plea has been moved through Advocates Maitreyi Sachidananda Hegde, Anjali Anil A., and Ashish Antony Francis. 

Case Title: Seba P.A. v. Union of India & Ors. 

Case Number: WP(C) 43275 of 2023