For vaccine security and equity by creating fiscal and legislative provisions aided by external donors

Warning of the risks involved in totally depending on external sources for funding the country's Universal Immunisation Programme (UIP), the draft National Vaccine Policy has recommended that the government take ownership of the programme for ensuring vaccine security and equity by creating fiscal and legislative provisions with appropriate support from external donors.

The draft policy says that as such funding depends heavily upon donor countries and the UIP has yet to recoup from the impact of the recent global financial crisis. It is important that India creates and strengthens its own mechanisms and systems for long-term sustenance of programmes for vaccine-preventable diseases.

Besides giving guidance for maximising the use of vaccines available globally as a public health tool for improving the health of the population, the draft policy also recommends creation of a National Immunisation Authority that could be supported by several cells responsible for different functions, and a similar set up right up to the district level.

“The ideal situation for any government is to assume ownership of their national immunisation programmes to the fullest possible extent and accordingly create fiscal and legislative space. Meeting benchmarks and enacting protective legislation are both essential conditions for sustainability,” it says.

Need for corpus

Advocating need for creating a corpus (vaccine fund) through innovative financing mechanism, the policy calls for setting up an inter-agency task force to assess the legal and administrative barriers to make such a fund operational. This fund could also be used for introduction of new vaccines and development of vaccines for emergency. It calls for flexible governing and funding mechanisms to support development in the public-private partnership mode.

The draft policy was commissioned in September last to address issues such as strengthening of the institutional framework, processes, evidence base and framework required for decision-making for new vaccine introduction, vaccine security, and regulatory guidelines.

The nine-member team was chaired by the former Director-General of the Indian Council of Medical Research, N.K. Ganguly.

The UIP targets 2.7 crore infants and 3 crore pregnant women annually. It is one of the largest programmes in the world. The country also has a vaccine industry that caters to 43 per cent of the Expanded Programme for Immunisation vaccines as well as some of the new vaccines purchased by Global alliance for Vaccines and Immunisation. Thirty-five per cent of the country's population buys the vaccines through the private market.

Recommending changes in the existing immunisation schedule to accommodate new vaccines and for broader utilisation of some vaccines or changing the number of doses, the proposed policy draws attention towards the shortage of trained manpower to manage the UIP at the Centre and State levels, disease surveillance and procurement and effective vaccine management.

Disease burden

However, N. Raguram of the Society for Scientific Values has criticised the policy, saying it is not clear if this model has taken disease burden into account. When disease burden is lower than 2 per cent prevalence (and when the disease is treatable or preventable by other means), the quality of evidence emerging out of a clinical trial, in terms of the safety and efficacy of a vaccine, has no relevance in deciding whether to introduce the vaccine.

“The moot policy question is not whether the vaccine works, but whether the vaccine is necessary for all in India, and how many cases/deaths can be prevented by vaccinating how many people. This basic logic is missing throughout this policy document,” he says.