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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 children suffering from rare diseases. These matters have been heard by the Court from time to time and various directions have been issued for enabling treatment and making medicines available to the Petitioners.
Developments qua M/s. Sarepta Therapeutics and M/s Hanugen Therapeutics
On previous occasions, such as on 10th July 2023, this Court directed M/s. Hanugen Therapeutics/DART to proceed with clinical trials, as the arrangement with ICMR had not materialized, and they sought to proceed on their own through third-party investment as per the contract with BIRAC. Thereafter, on 7th December 2023, this Court directed the ld. Amicus to contact M/s. Hanugen Therapeutics and DART to inquire about the progress of trials of the indigenous therapies for DMD.
In relation to M/s. Sarepta Therapeutics, it appeared before the Court on 5th January 2024, and on the said date, Mr. Saurabh Kirpal, the ld. Senior Counsel, presented to the Court a communication/submission on behalf of M/s Sarepta Therapeutics, as forwarded by Mr. Charles Gerrits through its counsel, Mr. Anish Chawla. This Court directed that the said communications be present before the National Rare Diseases’ Committee (hereinafter, ‘NRDC’) and representatives from M/s. Sarepta Therapeutics were also permitted to attend the meeting. A positive development was also noted that M/s. Sarepta Therapeutics had agreed to provide free treatment for 14 patients.
On the previous date, i.e., 19th January 2024, it was submitted on behalf of AIIMS that, in terms of the order dated 5th January 2024, AIIMS had placed an order for therapies for 14 children, which M/s. Sarepta has assured would be supplied. Further, the final report of the NRDC was received by the Court. The quotation given by M/s. Sarepta Therapeutics to the NRDC has also been placed on record in a sealed cover. This Court directed as follows:
“8.Today, the final report of the NRDC has been received by the Court. The quotation given by M/s. Sarepta Therapeutics to the NRDC has also been placed on record in a sealed cover.
9.Thus, to facilitate the conclusion of submissions in these writ petitions, let the report of the NRDC, submitted on 5th January 2024, along with the addendum handed over to the Court today, be provided to the ld. Amicus, Ms. Trehan, and Mr. Anand Grover, ld. Sr. Counsel by the Court Master. The said documents shall be handed over so as to enable them to make submissions at the next date of hearing. The said report(s) shall be retained exclusively by these two counsels, and all parties may present their submissions on the next date, referencing the report and the addendum. The said reports shall not be shared by the said counsels with anyone else.
10.Ld. Counsels for the Petitioners, ld. Amicus and the counsels for all the companies, as also the Union of India may make their submissions on the next date of hearing. 11. For the purpose of carrying out the final hearing in these petitions in a smooth manner, it is directed that all parties shall submit electronic copies of their written submissions, along with the copies of any judgments on the email address of the Court Master. The said submissions should be filed at least two days before the next date of hearing.”
Ms. Trehan, ld. Amicus has commenced her final arguments.
Today, at the outset, two important issues have been raised:
Ms. Trehen, ld. Amicus, informs the Court that she has learned that M/s Hanugen Therapeutics has approached AIIMS for clinical trials in respect of three Exon Skipping Therapies, namely, Exon 51, Exon 53, and Exon 45. These are the three therapies which are made available even through M/s. Sarepta Therapeutics. Dr. Madhulika Kabra and Dr. Sheffali from AIIMS have confirmed that M/s. Hanugen Therapeutics has reached out to them last week, and the exact nature of the trial and the number of persons who can be enrolled has not yet been made clear. Mr. Oberoi, ld. Counsel for AIIMS also confirms this position, and stated that DART has reached out to take the trials forward. Thus, let AIIMS file an affidavit within one week, after meeting with M/s Hanugen Therapeutics Pvt. Ltd. as to the nature of the clinical trial. The details of the clinical trial, if any, being conducted either in AIIMS or in any other institute in the country, number of patients likely to be enrolled etc., shall also be mentioned in the said affidavit after ascertaining the same from M/s Hanugen Therapeutics Pvt. Ltd.
ii) Mr. Kirpal, ld. Senior Counsel appearing for M/s. Sarepta Therapeutics submits that though an offer was made by M/s. Sarepta Therapeutics to the NRDC, there has been no negotiation in respect of the same, as there was no counter offer from the Union of India. Further, M/s. Sarepta Therapeutics is willing to still explore the possibility of supplying the therapies for DMD patients as well.
In terms of the reports received from the NRDC and the submissions made by ld. Counsels, one of the most important outstanding issues in these petitions relates to the treatment of DMD. Considering the large number of DMD patients and the physical and mental health of the families involved in these cases, it is deemed appropriate to direct that the NRDC shall, within the next two weeks, meet with M/s. Sarepta Therapeutics. Mr. Kirtiman Singh, ld. CGSC shall arrange for the said meeting to take place between the NRDC and the representatives from M/s. Sarepta Therapeutics. Any information gained from M/s. Sarepta Therapeutics during these meetings shall be kept confidential and shall be submitted only to the Court. The NRDC, after its meetings with M/s. Sarepta Therapeutics, shall submit a report detailing the discussions and any further relevant details as also their recommendations. This report should be submitted to the Court by the next date of hearing.
Furthermore, during the hearing, it was further clarified that the report submitted by the NRDC on 5th January 2024, already addresses the concerns of SMA, with specific allocations made for SMA.
In terms of the previous orders dated 5th January, 2024 and 19th January, 2024, regarding the treatment for the 14 patients that needed to commence, Mr. Kirpal, ld. Senior Counsel, submits that the orders have been complied with and the medications are being procured for delivery to AIIMS. However, he expresses concern over the potential imposition of custom duties and other charges by the Union of India.
On 30th March, 2023, the Ministry of Finance published the following press release1:
“The Central Government has given full exemption from basic customs duty on all drugs and Food for Special Medical Purposes imported for personal use for treatment of all Rare Diseases listed under the National Policy for Rare Diseases 2021 through a general exemption notification.
In order to avail this exemption, the individual importer has to produce a certificate from Central or State Director Health Services or District Medical Officer/Civil Surgeon of the district. Drugs/Medicines generally attract basic customs duty of 10%, while some categories of lifesaving drugs/vaccines attract concessional rate of 5% or Nil.
While exemptions have already been provided to specified drugs for treatment of Spinal Muscular Atrophy or Duchenne Muscular Dystrophy, the Government has been receiving many representations seeking customs duty relief for drugs and medicines used in treatment of other Rare Diseases Drugs or Special Foods required for the treatment of these diseases are expensive and need to be imported. It is estimated that for a child weighing 10 kg, the annual cost of treatment for some rare diseases, may vary from ₹10 lakh to more than ₹1 crore per year with treatment being lifelong and drug dose and cost, increasing with age and weight.
This exemption will result in substantial cost savings and provide much needed relief to the patients.
The Government has also fully exempted Pembrolizumab (Keytruda) used in treatment of various cancers from basic customs duty.”
Further, the Ministry of Finance, Department of Revenue vide gazette notification bearing no. G.S.R. 235 (E) dated 29th March, 20232, issued under the Customs Act, 1962 notified as follows:
In terms of the said gazette notification, List 38 includes inter alia the following Rare Diseases:
Gaucher Disease Type I and III
Hunter syndrome (MPS II)
Pompe Disease
Duchenne Muscular Dystrophy
Spinal Muscular Atrophy
Thus, in addition to the above Press Release issued by the Ministry of Finance, and the gazette notification, it is hereby clarified that custom duties and charges shall not be levied on medicines, drugs and therapies for rare diseases.
Whenever medicines are brought in respect of rare diseases, the custom authorities shall ensure that the same are cleared expeditiously and no unnecessary impediments are caused in ensuring that the same reach the concerned hospital. Let the present order be communicated to Central Board of Indirect Taxes and Customs (‘CBIC’) for compliance by the Registry, as also through ld. CGSC Mr. Kirtiman Singh.
List on 22nd March, 2024.
These are part-heard matters.
Footnotes
- 1.Ministry of Finance, ‘Customs duty full exemption for all imported drugs & Food for Special Medical Purposes for personal use for treatment of all Rare Diseases’ https://www.pib.gov.in/PressReleasePage.aspx?PRID=1912095#:~:text=The%20Central%20Government %20has%20given,through%20a%20general%20exemption%20notification.
- 2.https://static.pib.gov.in/WriteReadData/specificdocs/documents/2023/mar/doc2023330177401.pdf