Facilitating Access to Vaccines

Abstract

The cost effectiveness of immunization is widely agreed. Thus, efforts to promote access to vaccines against diseases of public health importance have been a global goal. Vaccines differ from therapeutic drugs (usually small chemical molecules) in a number of ways, which means that market approaches for other pharmaceutical products may not be relevant for vaccines, and vice versa. This article considers ways of facilitating wider global access through legal and regulatory approaches, particularly for low-income countries. The following areas were considered for action: globalization of trade and the impact of Trade-Related Intellectual Property Rights (TRIPS), differential pricing strategies, regulatory considerations, product liability provisions, stockpiles and emergency rationing activities, and orphan vaccine legislation. Analysis of the options, proposed from the point of view of public health, resulted in the suggestion that the following approaches might be most useful: (i) institutionalizing differential pricing strategies while assuring that segregation of markets is maintained; (ii) development of regulatory pathways for developing market vaccines; (iii) ensuring that stockpiles, where used, are under rigorous project management; (iv) better liability protection for manufacturers; and (v) increasing the funds available for investment in vaccine R&D through public-private partnerships. Approaches relating to more investment in R&D, regulatory harmonization, liability protection, and differential pricing are also supported by representatives of the vaccine production industry. A basic condition is that more funds are needed for development and delivery of vaccines.