PharmacoEconomics & Outcomes News 423 - 2 Aug 2003 Promoting access to vaccines in the developing world Although the cost effectiveness of immunisation is agreed by health economists, there remains a major need for advocacy to increase the supply of funding for development and delivery of innovative vaccines of public health importance, particularly for the developing world, say Drs Julie Milstien from the University of Maryland School of Medicine, US, and Roy Widdus from the Initiative on Public-Private Partnerships for Health, Geneva, Switzerland. They highlight the following legal/regulatory approaches designed to expand access to new vaccines, which have been put forward by the vaccine production industry and considered from a public health point of view. • Tiered or differential pricing of vaccines: the challenge is to achieve policy-maker and public acceptance for the humanitarian value of such pricing, so that supplying the needs of low-income countries at lower prices does not undermine the profitability and research and development (R&D) of manufacturers for further new products. • Enhanced product liability protection for manufacturers against vaccine-associated adverse reactions. • Extended market exclusivity for orphan products, although financial incentives are usually based in industrialised countries. • The establishment of high-income country subsidies for lower-income countries to improve access to vaccines. • Dedicated health insurance, which explicitly covers vaccination. • Development of regulatory pathways to enable legislation for vaccines in some developing countries. • Promotion of investment in R&D, particularly public-private partnership sharing of R&D investment. • Stockpiles using project management techniques, the use of which could have a major impact on vaccine access. Milstien JB, et al. Facilitating access to vaccines: an overview of legal and political issues. Pharmaceutical Development and Regulation 1: 101-116, No. 2, 2003 800927481 1 PharmacoEconomics & Outcomes News 2 Aug 2003 No. 423 1173-5503/10/0423-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

Promoting access to vaccines in the developing world

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PharmacoEconomics & Outcomes News 423 - 2 Aug 2003

Promoting access to vaccines inthe developing world

Although the cost effectiveness of immunisation isagreed by health economists, there remains a majorneed for advocacy to increase the supply of funding fordevelopment and delivery of innovative vaccines ofpublic health importance, particularly for the developingworld, say Drs Julie Milstien from the University ofMaryland School of Medicine, US, and Roy Widdus fromthe Initiative on Public-Private Partnerships for Health,Geneva, Switzerland.

They highlight the following legal/regulatoryapproaches designed to expand access to new vaccines,which have been put forward by the vaccine productionindustry and considered from a public health point ofview.• Tiered or differential pricing of vaccines: the

challenge is to achieve policy-maker and publicacceptance for the humanitarian value of suchpricing, so that supplying the needs of low-incomecountries at lower prices does not undermine theprofitability and research and development (R&D) ofmanufacturers for further new products.

• Enhanced product liability protection formanufacturers against vaccine-associated adversereactions.

• Extended market exclusivity for orphan products,although financial incentives are usually based inindustrialised countries.

• The establishment of high-income country subsidiesfor lower-income countries to improve access tovaccines.

• Dedicated health insurance, which explicitly coversvaccination.

• Development of regulatory pathways to enablelegislation for vaccines in some developingcountries.

• Promotion of investment in R&D, particularlypublic-private partnership sharing of R&Dinvestment.

• Stockpiles using project management techniques,the use of which could have a major impact onvaccine access.

Milstien JB, et al. Facilitating access to vaccines: an overview of legal andpolitical issues. Pharmaceutical Development and Regulation 1: 101-116, No. 2,2003 800927481