Indian Journal of Medical Ethics

CORRESPONDENCE


Consumer rights as applied to vaccine usage in India

The eight consumers’ rights as defined by the International Organization of Consumers’ Union are as follows :

The right to safety

This means the right to be protected against products, production processes and services which are hazardous to health or life. The right to safety has been broadened to include the concern for consumers’ long-term interests, not only their immediate desires. Vaccines introduced in this country are cleared on the basis of foreign trials and data. Safety and efficacy trials on Indian subjects are done in a hurry just before licensing. These trials merely test antibody responses and very few trials monitor adverse reactions over a prolonged period of time

There are virtually no guidelines on what training personnel administering vaccines should undergo. Camps are organised where ignorant people administer vaccines. Most fatalities related to mass vaccination are due to ignorance by the staff. Storage of vaccines is woefully inadequate; most centres administering vaccines do not have the appropriate facilities to handle serious reactions to vaccines. Dangerous vaccines are still available and are used on vulnerable segments of our population — such as the whole brain rabies vaccine.

Vaccine adverse reaction monitoring systems are not available freely and very few physicians, consumers or pharmaceutical companies use them.

The right to be informed

This means the right to be given the facts needed to make an informed choice or decision. This goes beyond avoiding deception and protection against misleading advertising, labeling or other practices. Consumers should be provided with adequate information, enabling them to act wisely and responsibly. This is a right which has been abused with regards to immunisation. On the one hand we have a large populace of illiterate people whose children are subject to a paternalistic system where they are not given information on any vaccine given to their children. On the other hand, a barrage of half-baked truths is fed to the educated, illiterate, urban rich, inducing them to immunise their children against diseases for which we know neither the incidence nor the efficacy of the vaccine in our population.

The right to choose

This refers to access to a variety of products and services at competitive prices and, in the case of monopolies, to have an assurance of satisfactory quality and service at a fair price. The right to choose has been reformulated to read: the right to basic goods and services. This is because the unrestrained right of a minority to choose can mean for the majority a denial of its fair share.

Here again we have a populace who is utterly ignorant of its choices. Not only are there a number of vaccines against various diseases, there are also a number of brands within each vaccine, and with different combinations. Their costs vary, leaving the medical profession and public confused. The assurance of the availability of essential vaccines rests with the government. The government has taken excellent initiative in making essential vaccines available. It is also a credit to the government that the cost of importing vaccines is entirely borne by the state and is not dependent on foreign aid.

The right to be heard

This means the right to be represented so that consumers’ interest receives full and sympathetic consideration in the formulation and execution of economic policy. This right is being broadened to include the right to be heard and represented in the development of products and services before they are produced or set up. It also implies a representation, not only in government policies, but also in those of other economic powers. This right should be invoked in the recent controversy over the inclusion of the Hepatitis B vaccine in the national immunisation programme. A thorough cost-benefit and risk benefit analysis should be undertaken before introducing this vaccine. Just because the vaccine’s cost is coming down and it is being indigenously manufactured does not automatically mean that it should be introduced in the national programme.

The right to redressal

This means the right to a fair settlement of just claims. This right has been generally accepted since the early 1970s. It involves the right to receive compensation for misrepresentation or shoddy goods or services. Where needed, free legal aid or an accepted form of redress for small claims should be available. This right unfortunately is not available to most of our population. There is no vaccine injury compensation programme. The legal rights are also not very clear. With the passage of the CPA, this may change.

The right to consumer education

This means the right to acquire the knowledge and skills to be an informed consumer throughout one’s life. The right to consumer education incorporates the right to the knowledge and skills needed for taking action to influence factors which affect consumer decisions.

Very little is done to educate the populace on vaccines and their effects or adverse reactions. With a large population, differing literacy levels and a multiplicity of languages, mass communication is a challenging task

The right to a healthy environment

This means the right to a physical environment that will enhance the quality of life. This right involves protection against environmental problems over which the individual consumer has control. It acknowledges the need to protect and improve the environment for present and future generations. Provision of clean drinking water is probably more important than immunising the entire population against typhoid or hepatitis A.

The right to basic needs

The right to basic needs means that availability of articles which are the basic need of every consumer must be ensured. Vaccines should be classified as a basic need and exempt from taxes. The government must pass laws to compel essential vaccines and provide for compensation for defined adverse reactions.

There should also be a political will to manufacture essential vaccines indigenously.

Jagdish Chinnappa, Manipal Hospital, Airport Road, Bangalore 560 017.