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A document on the National Vaccine Policy, 2011, released in August by the Union health ministry has come under the scrutiny of public health experts. The new policy, they say, is a one-man’s job and drafted in favour of private vaccine manufacturing companies.
The document lays down policy guidelines for evidence-based research and introduction of vaccines in the Universal Immunisation Programme (UIP) in India. N K Ganguly, former director general of Indian Council of Medical Research (ICMR), was asked to prepare a draft policy by National Technical Advisory Group on Immumisation (NTAGI)--a group of experts from vaccination and immunisation fields under the Union ministry for health in 2010. Once drafted, the policy was to be opened for comments from public health experts. But they were never consulted, they say.
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The minutes of the NTAGI meeting held with the health ministry on August 23, 2010, states that the task of drafting the national vaccine policy was handed to Ganguly. It committed that the policy document prepared by Ganguly will be circulated for comments before the final draft is discussed in the NTAGI meeting.
“The government took such an important policy decision, which involves huge funds, without the approval of the Cabinet or the Parliament,” says Jacob Puliyel, a Delhi-based paediatrician and member of NTAGI.
“There was no attempt to make it a collective exercise despite protests. The draft is a Ganguly draft,” say Y Madhavi and N Raghuram in a note to Down To Earth. Madhavi from National Institute of Science, Technology and Development Studies in New Delhi and Raghuram from School of Biotechnology, Indraprastha University, Delhi alongwith other experts had prepared a draft on the policy which was rejected by the health ministry. “The Ganguly draft was suddenly released in July (though dated April, 2011) as the official government policy in a five-star hotel function, without further validation through the NTAGI, ministry, Cabinet or the Parliament,” they add.
Ganguly refutes the claim. “The draft was reviewed by the government agencies involved. From there it went to the health ministry for approval and later sent to the UN bodies for their comments. It is definitely not drafted by one person.”
Ajay Khera, deputy commissioner, child health and immunisation at the health ministry clarifies that the expert team was consulted a number of times during the drafting procedure and the ministry tried to incorporate whatever comments were made. He adds there is no need to go to the Parliament for any approvals. “The health ministry has the expertise to take such decisions,” he says.
The work on the draft policy was initiated in response to a Supreme Court order in February 2009 asking for revival of the public sector vaccine units and formulation of a national vaccine policy based on scientific evidence.
Procurement under scanner
Other than lack of transparency in the drafting method, the policy also promotes certain contentious procedures for procurement. For one, the policy says it should be “mandatory for the government to support advance market commitments and honour the commitments”. It also adds that the government should have an “innovative funding mechanism”.
This means that the government will request a vaccine manufacturing company to produce vaccines needed for the country’s immunisation programme. Once committed, the country cannot withdraw from the deal and will have to purchase the vaccines from that company itself, no matter what. Global Alliance for Vaccines and Immunisation (GAVI), an organisation of vaccine manufacturers, the Bill and Melinda Gates Foundation and the World Health Organization, say on their website that “these commitments provide vaccine makers with incentives to invest in manufacturing plants needed to develop vaccines and produce them on a large scale. Developing countries can then purchase the vaccines at guaranteed prices they can afford.”
Puliyel, however, says this will be a financial burden on countries entering into such commitments. “If government enters into such commitments, it will have to first deposit the money to be given to the manufacturing companies in the World Bank even before the vaccine is manufactured. Once the vaccine is produced, the government will have to buy it even if it is not effective or if the country does not need it,” he notes.
Ganguly clarifies that the government will ask the manufacturers to make vaccines not easily available. “The government will commit to the manufacturers so that they invest in vaccine production. If governments do not commit, the company which will set up the plant exclusively for the need of the country, may sink because no one else would want that vaccine and the company would be producing it exclusively for the country which demanded it,” he says.
Both Khera and Ganguly say the government can get into such contracts with several companies at the same time and it will be flexible to move from one company to the other.
“Vaccines are not available over the counter. Their shelf life is also less. Large quantities of vaccines need to be procured for UIP and to make sure it is available, we have to make commitments so that we get the vaccine from the manufacturers,” says Khera. “This doesn’t mean we are tied up. This is just a concept. There can be several companies we can have commitments with. The shift over from one company to the other will be flexible. This is just one mechanism. The nitty-gritty of it will be worked out later,” Khera adds.
“One contract will last for a year for one programme. Once the programme is over, the government will revise the programme and select new companies. If the government wants to discontinue a particular vaccine after a year, it can easily do that,” Ganguly notes.
For placing large orders for vaccine production to the companies, the policy suggests that the government to go for innovative funding mechanism. This means that the country floats bonds and raises money from the public for paying the manufacturing companies.