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Judgment
Prathiba M. Singh, J. (Oral)
This hearing has been done through hybrid mode.
The present batch of petitions have been filed by the Petitioners who are mostly children suffering from Rare Diseases. The case of the Petitioners is that the medicines and therapies for the said Rare Diseases are exorbitantly expensive, and directions ought to be issued to the Respondents i.e., the Union of India and its Ministry of Health and Family Welfare, All India Institute of Medical Science (hereinafter, “AIIMS”), as well as, the GNCTD, to provide continuous and uninterrupted treatment to the Petitioners, free of cost.
These matters have been heard by the Court from time to time and various directions have been issued for enabling treatment and for making available medicines for the Petitioners.
Vide previous order dated 29th November, 2022, the Department of Biotechnology (hereinafter, “DBT”) and Dystrophy Annihilation Research Trust (hereinafter, “DART”), were impleaded as Respondent Nos. 3 and 4 respectively in W.P.(C) 5315/2020. Affidavit dated 28th November, 2022 on behalf of the Ministry of Health and Family Welfare, Union of India was also directed to be placed on record, along with the agreement between the DBT and DART in respect of the funding of clinical studies.
Today, submissions have been made in part in these matters, in respect of the following directions issued by this Court, vide order dated 23rd March, 2021:
“21.In view of the above, the following directions are issued by this Court:
i)The ‘National Policy for Rare Diseases’ shall be finalized and notified by the Government of India, on or before 31st March, 2021.
ii) As a part of the said policy, the ‘National Consortium for Research and Development on therapeutics for Rare Diseases’ shall also be set up.
iii) A Rare Diseases Committee shall be set up at AIIMS consisting of Prof. (Dr.) Madhulika Kabra and Prof. (Dr.) P. Ramesh Menon, who shall examine the applications for treatment and funding, received from any patient suffering from Rare Diseases. The said Committee can, depending upon the condition of the patient, also co-opt any one member from any specialized field into the said Committee. The Committee would, upon examination, recommend the kind of treatment which would be made available to the patients. Upon the approval of the Committee, the expenses for the treatment involved shall be drawn from the Rare Diseases Fund after approval by the Director, AIIMS.
iv) The entire unspent budget allocated for Rare Diseases, for the years 2018-19, 2019-20 and 2020-21, as per the amounts extracted above, shall be immediately moved into a fund called the ‘Rare Diseases Fund’, which shall be managed and utilized by AIIMS, which shall serve as a nodal agency for this fund. A separate bank account for the Rare Diseases Fund shall be opened by the Director, AIIMS for this purpose.
v)The digital platform that is created in the Policy, for the purposes of receiving crowdfunding and other kinds of funding, shall be linked to the Rare Diseases Fund. All individuals, organizations, companies etc., who wish to contribute to the said fund, shall make direct contributions. The Rare Diseases Fund shall be under the direct control and supervision of the Director, AIIMS. Periodic reports may be called for, by the Ministry of Health and Family Welfare, UOI, from AIIMS, in respect of the contributions that are received, as well as qua the utilization of the said fund.
vi) The other Institutes which shall be notified under the policy, as centres for excellence, for Rare Diseases shall also be entitled to receive applications from patients who need treatment, and shall forward the same to the Rare Diseases Committee based in AIIMS.
vii) In the case of direct applications being made to AIIMS, a decision shall be taken by the Rare Diseases Committee within a period of two weeks, in respect of the treatment and funding etc. In case, the application is routed through other institutes/ centres of excellence which are notified in the Health Policy for Rare Diseases, a decision upon the treatment and funding shall be taken by the Committee within a period of four weeks.
viii) In the context of Rare Diseases, the Government may consider increasing the budget for the year 2021-22 for the Rare Diseases Fund.
ix) The National Consortium for Research and Development on therapeutics for Rare Diseases shall be the nodal agency for supervising and monitoring the indigenization of treatments and therapies, manufacture of drugs, technology transfer, approvals, etc. for Rare Diseases. The said Consortium, as recommended in the report, shall consist of representatives from DBT, ICMR, DST, CSIR, DCGI, and other related Ministries and Departments. DBT and ICMR shall jointly take the lead.
x)The Consortium shall also make recommendations, if any, as to whether the patients suffering from Rare Diseases ought to be included in any of the clinical trials currently taking place.
xi) The Consortium, while monitoring Research and Development, shall also approve applications for funding of research projects in respect of treatment and therapies for Rare Diseases. The Amounts from the ‘Rare Diseases Fund’ may be utilised for the purpose of Research. All projects approved shall have specific deliverables and timelines. The amounts shall be released for this purpose only after the project is approved by the Chairperson of the Consortium or an official, not below the level of Joint Secretary, Ministry of Health and Family Welfare, until the consortium is fully operational. Upon a project being approved by the Chairperson of the Consortium/Joint Secretary, the amount from the Rare Diseases Fund shall be released for the said project.
xii) The National Policy for Rare Diseases shall also deal with any limits/ caps that are to be imposed for various categories of Rare Diseases, only if required.
xiii) Any financial incentives to be given for manufacturing/ Research and Development of therapies for Rare Diseases shall also be explored in the Policy.
xiv) The Policy shall also explore as to whether any financial incentives are to be given to the companies, who could contribute for the treatment/ Research and Development relating to Rare Diseases.”
National Policy for Rare Diseases & Consortium of Centres of Excellence
As recorded in the order dated 19th April, 2021, the Union of India has finalized and notified the National Policy for Rare Diseases (NPRD), 2021 on 30th March, 2021, for the treatment of patients suffering from rare diseases. The consortium of Centres of Excellence for the prevention and treatment of Rare Diseases, under the leadership of AIIMS, has also been made a part of the policy as per paragraph 12(a) of the policy. A ‘Rare Diseases Committee’ was also constituted within AIIMS.
Creation of Digital Crowdfunding Platform
Vide order dated 23rd March, 2021, a crowdfunding platform had been directed to be set up by the Government under the National Policy for Rare Diseases.
It is submitted that the said crowdfunding platform is now operational. However, it appears that the same requires to be publicized in order to attract funding from the general public and corporate entities, including Public Sector Undertakings (“PSUs”).
Accordingly, it is directed that the details of the crowdfunding platform be communicated by the Respondent No.1 to all the Navratna PSUs, as also, at least ten of the top business houses / private companies in India, so as to enable them to consider contribution to the said platform as part of CSR (corporate social responsibility) endeavours. There shall be proper follow up to this communication by the Respondent No.1. Any responses received to the said communication shall be placed on record.
Rare Diseases Fund
It is clarified by ld. CGSC that the ‘Rare Diseases Fund’ is currently being managed by the Ministry of Health and Family Welfare, Union of India.
Let a status report be filed, jointly by the Ministry of Health and Family Welfare and the Department of Biotechnology, on the following aspects:
Compliance of the directions issued under paragraph 21 of order dated 23rd March, 2021, which has been reproduced hereinabove.
Data shall be provided to the Court as to the number of patients in respect of whom Centres of Excellence have been granted the funding, as also, the number of patients in respect of whom the treatment has been commenced.
Timelines being followed by the Ministry of Health and Family Welfare in approving the recommendations for grant of funding and treatment.
Commencement of Treatment
This Court is informed that the treatment for patients of Gaucher Disease is stated to have commenced. However, despite repeated orders, the patients of Duchenne Muscular Dystrophy (“DMD”) have yet not started receiving treatment.
Mr. Oberoi, ld. Counsel for AIIMS submits that there is substantial development in this regard. The fund had been received qua few patients. Tenders have been called and the purchase orders have also been placed on the concerned manufacturers.
Let the expected timelines for receiving of the medicines and for the starting of administration of the medicines upon the DMD patients, be also provided by AIIMS, by way of affidavit on the next date of hearing. AIIMS to file a detailed status report of the working of the Rare Diseases Committee functioning in the hospital and the work done till date.
Indigenous Development of Treatment, Therapies & Medicines for Rare Diseases
Insofar as the indigenous development of treatment, therapies and medicines for rare diseases, especially DMD, is concerned, it has been pointed out that a Memorandum of Understanding dated 8th January, 2021 has been signed between the Biotechnology Industry Research Assistance Council (BIRAC) and M/s. Hanugen Therapeutics Private Limited (hereinafter, “Hanugen”). As per the said MoU, Hanugen was to conduct a multi-centric study for therapeutic evaluation in respect of DMD patients. In terms of the agreement, 50% of the fund for this study was to be contributed by the Government and the other 50% was to be contributed by Hanugen itself. The total approved amount was Rs.9.24 crores.
It is submitted by Ms. Trehan, the Ld. Amicus that the first tranche of Rs.1.41 crores was released. The same was matched by Hanugen. However, for the remaining tranches, there is shortage of funds.
The representatives of Hanugen have appeared before the Court virtually. They have stated that Phase 2-3 trials of the therapy have been approved by DCGI, and they have enrolled 54 patients for conducting the said trials. However, the commencement of the said trials has been delayed due to lack of funds.
In the opinion of this Court, DMD is a rare disease which is prevalent in a considerable number of patients in India. The indigenous development of therapies for DMD is extremely crucial in order to avoid import of expensive medication. The medication for DMD is currently not manufactured and also not easily available in India. The same is, in fact, imported from the USA. Thus, the trials, which have already been approved, ought to be allowed to be completed. If the same prove to be successful, there could be the possibility of a solution for patients suffering from DMD in India.
Under such circumstances, it is directed as under:
The officials from M/s. Hanugen Therapeutics Private Limited, who have joined the proceedings virtually today, shall place on record an affidavit giving the details of requirements of funding, patient enrolment, DCGI approval, and the manner in which the Phase 2-3 trials are to be conducted. The said affidavit shall be filed by M/s. Hanugen Therapeutics Private Limited, within one week.
Ld. CGSC shall seek instructions as to whether a sum of Rs.5 crores could be released from the Rare Diseases Fund in favour of M/s. Hanugen Therapeutics Private Limited, on an urgent basis, in order to enable the commencement of the clinical trials.
List on 22nd December, 2022.
Cont. Cas(C) 722/2022
In the present contempt case, the Petitioner is suffering from the Gaucher disease. The allegation of the Petitioner was that AIIMS had not commenced the treatment, pursuant to the orders dated 19th January, 2022 and 2nd February, 2022 passed by the Court in W.P. (C) No.1182/2022 titled “Insha (Minor) through her next friend and natural father Sh. Irshad Ahmad Sofi v. Union of India & Ors.”. As per the said two orders, the Petitioner has to be provided free of cost Enzyme Replacement Therapy treatment.
Mr. Oberoi, ld. Counsel for AIIMS, under instructions, submits that the first infusion has been administered on the Petitioner on 2nd December, 2022. He submits that he has filed an affidavit to this effect.
Let the said affidavit filed by AIIMS be brought on record in the present contempt case. Copy of the said affidavit shall also be filed and placed on record in the writ petition being W.P.(C) 1182/2022.
Since the writ petition being W.P.(C) 1182/2022 is already pending, and the treatment has commenced, Cont. Cas(C) 722/2022 is, disposed of.