Patent

RTI application regarding CL/VL status for bedaquiline gets transferred 3 times with no information provided


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On March 4, 2018 the Hindu published a frontpage news report on bedaquiline, the new drug that has shown promise in treating multi-drug resistant tuberculosis (MDR-TB). While we have written extensively on other aspects of bedaquiline, the one issue that we have not commented on so far is the reporting in the Hindu on the compulsory licensing/voluntary licensing for the patents covering bedaquiline.

The Hindu’s report made two assertions.

The first assertion was that a panel headed by Dr. Soumya Swaminathan, then the Director General of the Indian Council for Medical Research (ICMR) and currently the Deputy Director General of the World Health Organisation (WHO), had recommended to the Ministry of Health that it should negotiate with Janssen (which owns the patents for Bedaquiline) and Otsuka (which owns the patents for Delaminid) to get them to issue voluntary licences for the drugs and if that failed to issue compulsory licensing.

The second assertion was that the Union Health Ministry had requested Janssen and Otsuka to issue voluntary licences to Indian manufacturers and that both companies had turned down the request.

I wanted more information on both aspects and decided to file a RTI application with the Ministry of Health asking the following questions:

“1. In the attached report, the Hindu reported the following: On September 19, 2017, a panel chaired by Dr. Soumya Swaminathan, then Director-General of the Indian Council of Medical Research and currently the Deputy Director-General of the World Health Organisation (WHO) recommended, among other steps, that the Health Ministry consider issuing a compulsory licence (CL) for the two TB drugs.

Please provide a copy of the panel report that was sent to the Health Ministry recommending the issuance of a CL for bedaquiline and delaminid along with notings of the Ministry in relation to the panel report.

2.In the attached report, the Hindu reported the following: The Union Health Ministry told The Hindu that it had requested Janssen and Otsuka, to grant Voluntary Licenses (VL) to Indian manufacturers.

Please provide a copy of the letters/communication from the Health Ministry to Janssen and Otsuka requesting them to issue VLs. Please also provide copies of their response.”

The Ministry of Health transferred this application to the Director General of Health Services (DGHS) which then transferred the application to the Central Drug Standards Control Organisation (CDSCO) which then transferred my application to the Indian Council of Medical Research (ICMR) with the following noting:

“Reply:- For point no 1 & 2: Your application has been transferred u/s 6 (3) to the CPIO, Indian Council of Medical Research to provide available information, if any directly to you. CDSCO regulates safety, efficacy and quality of the drugs including vaccines as per Drugs & Cosmetic Act, 1940 and Rules made there under and hence no comments and information to offer in respect of grant of voluntary licenses.” I am yet to hear from ICMR.

Under Section 6(3) of the RTI Act, public authorities are allowed to transfer RTI applications if the information requested from them does not fall within their purview. A transfer of application by a public authority usually means they do not have the information required. The transfer of the application to the CDSCO is rather odd since the only conclusion from the Hindu’s report is that the panel report by Dr. Swaminathan was communicated to the Ministry of Health and that the Ministry had written to Janssen and Otsuka for voluntary licensing which both companies declined. In such a scenario, the Ministry should have a record of the panel report and of its communications with Janssen and Otsuka. So why then were the RTI applications transferred to the CDSCO, which has nothing to do with either compulsory licensing or voluntary licensing? If the Ministry of Health doesn’t have any of the information reported by the Hindu it should simply say so, on the record. Why get into this game of passing the parcel?

Prashant Reddy

Prashant Reddy

T. Prashant Reddy graduated from the National Law School of India University, Bangalore, with a B.A.LLB (Hons.) degree in 2008. He later graduated with a LLM degree (Law, Science & Technology) from the Stanford Law School in 2013. Prashant has worked with law firms in Delhi and in academia in India and Singapore. He is also co-author of the book Create, Copy, Disrupt: India's Intellectual Property Dilemmas (OUP).

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