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Synopsis

The Delhi High Court has sought an explanation from the All India Institute of Medical Sciences on the allegations of its grossly negligent behavior for not placing purchase orders of therapeutics for the treatment of rare diseases like Duchenne Muscular Dystrophy (DMD), Hunter's Syndrome, etc.

A single-judge bench comprising Justice Prathiba M Singh said, "The amount having been released by the Ministry of Health & Family Welfare way back in September 2022, the non-placing of purchase orders/supply orders on M/s Sarepta would be a grossly negligent attitude adopted by the concerned persons at AIIMS. There cannot be any justification for this attitude."

The bench was hearing a batch of petitions filed mostly by children suffering from rare diseases stating that the medicines and therapies for the said diseases are exorbitantly expensive. In view of the above, the batch has sought directions to the Union of India and its Ministry of Health and Family Welfare, All India Institute of Medical Science, as well as, the GNCTD, to provide continuous and uninterrupted treatment to the petitioners, free of cost.

Earlier, the High Court had directed the Centre to release Rs. 5.35 crore to fund clinical trials for the treatment of rare diseases like Duchenne Muscular Dystrophy (DMD), Hunter's Syndrome, etc.

Furthermore, the court had noted that Hanugen Therapeutics Private Limited, the company that had agreed to conduct the clinical trials with the Biotechnology Industry Research Assistance Council (BIRAC) last year, was unable to begin them due to a lack of funds.

In view of the above, the court opined that it appears that there is a complete stalemate between Hanugen and BIRAC as no effective meeting has taken place between BIRAC and Hanugen in terms of the earlier order.

The high court said that there are a large number of petitions filed by children suffering from DMD and the Government has agreed to release a maximum of Rs. 50 lakhs per patient. The intention was that the entire research for the indigenous therapy for DMD could be funded by BIRAC/Government, which would also own IP rights in the data and therapy/drug that may be developed, court said.

"The Government thus has an obligation to invest in this research to enable development of indigenous therapies," the court opined.

In view of the above, the court directed a meeting for negotiating an agreement for the development of indigenous therapies for DMD and vesting the intellectual property and other rights with the Government to be held on February 2, 2023, at 5:00 pm.

Case Title: Master Arnesh Shaw v. Union of India & Anr.