Health ministry keeps information on HPV vaccines–Gardasil, Cervarix–a trade secret

PharmaBiz

India

Monday, August 16, 2010 08:00 IST
Ramesh Shankar, Mumbai

The information regarding the marketing approval granted to two HPV vaccines–Gardasil and Cervarix–is shrouded in secrecy as the union health ministry is not disclosing any information regarding this even through the Right to Information (RTI) Act.

Besides this, the ministry is not disclosing details about the HPV vaccine ‘demonstration projects’, under which thousands of uninformed girls in Andhra Pradesh and Gujarat were alleged to have been vaccinated with the two HPV vaccines – Gardasil and Cervarix- in gross violation of ethical protocols and human rights. All the efforts made by the NGOs to get details on these issues through the RTI Act have so far proved futile as the ministry says that such information have been exempted from public disclosure under Section 8 of the Right to Information Act, 2005.

The drug controller general of India (DCGI) Dr Surinder Singh had granted permission to two multinational pharma companies–Merck and GSK–to import, sell and market the HPV vaccine Gardasil and Cervarix in India in 2008.

Recently, an NGO working in the field of women’s health Sama had filed an RTI with union health ministry seeking information on the status and basis of approval granted to Merck Sharp and Dohme (MSD) Corp. and GlaxoSmithKline (GSK) to import, sell and market Gardasil and Cervarix in India, and the status, design and intent of the trials conducted by MSD and the Indian Council of Medical Research (ICMR). Sama also sought information on the protocols adopted for granting permission to PATH, a non-governmental organisation, and the ICMR to conduct the ‘demonstration project’.

But, the ministry refused to reveal the details on the plea that this information is a “trade secret and commercial confidence of third party and exempted from disclosure under Section 8 (1) (d) of RTI Act”.

Expressing surprise over the ministry’s response, Sama said that it is unclear how and where this clause comes into play in this context as both these vaccines are already approved for the private markets and are easily available therein. Moreover, it cannot be claimed to be a third party case since the vaccine is being sold in India and hence any buyer can seek such information and every customer has the right to know if the vaccine is safe and effective and seek documentary evidence in this regard beyond the mere approval of the DCGI.

Such a non-disclosure also raises the crucial question; why is the study design or a protocol of a demonstration project that sought to gain experience and build evidence for the future introduction of HPV vaccination into the public health system in India considered a “trade secret”?

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Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.