Merely Because Of Exorbitant Price Of Drug Or Treatment, Children Suffering From A Rare Disease Cannot Be Deprived Of Treatment: Delhi High Court

The Court, through a common judgment in the two petitions, issued directions on Union of India, Ministry of Health and Family Welfare to finalize the implementation of Draft Health Policy for Rare Diseases, 2020 at the earliest.

The petitioners contended that due to the exorbitant prices involved in the treatment, the government must provide free treatment to them as the disease fall well within the draft policy which is at the consultation stage at present.

The Court directed the Union of India to implement and notify the draft policy and also consider crowd funding option in the meantime for the successful treatment of the petitioners.

BACKGROUND OF PETITIONS

Petitions were filed by natural guardians of two children suffering from a rare disease known as Duchenne Muscular Dystrophy (DMD). According to the petitioners, due to the rarity of the disease, its drug was being manufactured by a USA company called Sarepta Therapeutics, because in India, the drug was presently in its experimental stage.

The petitioners, being aggrieved by the exorbitantly expensive prices of the drug, filed petitions in the High Court seeking directions on the Union of India, Ministry of Health and Family Welfare to ensure that the petitioners are given free treatment for the disorder as they could not afford the heavy prices at which the drug was being sold.

In one of the petitions (Master Arnesh Shaw), the Union of India had placed an affidavit which provided that a Draft Health Policy for Rare Diseases has been released by the government in 2020 which is still at the stage of consultation. It also provided that the earlier policy of 2017 was not implemented by the government.

Therefore, in view of this, the High Court vide order dated 07.08.2020 had directed AIIMS to submit a detailed report considering the health conditions of the petitioner. According to the report, it was suggested that the child was unlikely to show any improvement with the treatment being given to him with Exondys 51 therapy.

However, the report specified that the final recommendation in the case will be taken by the Central Technical Committee for Rare Diseases, Ministry of Health and Family Welfare.

OBSERVATION OF THE COURT

The bench while taking into account the seriousness of the health conditions of children observed that:

"Just because of the exorbitant price of the drug or treatment, patients, especially children, suffering from a rare disease ought not to be deprived of treatment for their condition."

In observing so, the Court also took note of the fact that Right to Health and Healthcare is a fundamental right under Art. 21 of the Constitution and that it is incumbent on society in general and authorities in particular to ensure that the life of such children is not compromised, even if there is a small window of improving their chances of survival or even providing a better quality of life.

The Court then went ahead to analyze the Draft Health Policy for Rare Diseases 2020 wherein it observed that the Duchenne Muscular Dystrophy (DMD) is recognized as one of the rare diseases which involves high cost of treatment. The Court also analyzed Group 3 of the Policy which specifically provides that the cost of treatment for DMD is very high and either long term follow up literature is awaited or has been done on small number of patients.

According to the policy, for diseases falling under Group 3, it was proposed that a digital platform must be created in order to bring together the patients receiving treatment and the potential donors willing to support such treatment. It was also recommended that through this online system, "Donors will be able to view the details of patients and donate funds to a particular hospital. This will enable donors from various sections of the society to donate funds, which will be utilized for treatment of patients suffering from rare diseases, especially those under category III."

Therefore, the Court observed that the finalization of the said policy cannot be kept pending indefinitely as done with the earlier policy of 2017, especially in cases where common human lives are at stake.

DIRECTIONS OF THE COURT

The Court therefore directed the Union of India that:

1. A specific timeline shall be created by the Secretary, Ministry of Health and Family Welfare for finalization and notification of Draft Health Policy for Rare Diseases, 2020.
2. The Ministry shall explore the crowd funding option through prospective individuals, corporate donors and independent foundations in order to fund the treatment of the petitioners.
3. The Ministry shall contact the USA Company, Sarepta Therapeutics which advertises that it provides financial support/medicines to deserving cases.
4. The Ministry shall come up with a proposal within the next 10 days.

The matter will now be heard on 28^th January 2021.

Case Name: Master Arnesh Shaw v. Union of India & Anr. and Keshav Sharma v. Union of India & Anr.

Judgment dated: 12.01.2021