WHA71: KEI intervention on Addressing the global shortage of, and access to, medicines and vaccines

21 May 2018

Knowledge Ecology International (KEI) intends to deliver the following statement on Addressing the global shortage of, and access to, medicines and vaccines.

    • 11.5 Addressing the global shortage of, and access to, medicines and vaccines
    Documents A71/12 and EB142/2018/REC/1, decision EB142(3)
    The Road Map report is WHO’s work program on access to medicines and vaccines which deals with issues that have several dimensions, including at the center, the global set of incentives and funding mechanisms for research and development to stimulate the development of new drugs, vaccines, diagnostics and new cell and gene therapies.

To evaluate the impact of the current system and any proposed reforms, both incremental and transformative, on innovation and access, the twin and currently conflicting objectives, it is important to have better evidence regarding the costs of R&D of specific products and services, in a level of disaggregation sufficient to adequately analyze the risks associated with development. It is also important to have better and more transparent information on resource flows by research targets, data on actual access by country, the annual and cumulative revenue from sales, as well as greater transparency and better information on a host of other issues, such as prices, patent and registration landscapes, the use of exceptions and limitations to intellectual property rights, the texts of proposed trade agreements that are relevant to innovation and access to medical technologies.

There is a need to fix the current failures to obtain competition for biologic drugs. Recent data in the US show that biologic drugs first registered between 1995 and 2005 faced competition for products with the same pharmaceutical active agreement only 17 percent of the time, compared to 61 percent for small molecules, and when competition did occur, it happened 6 years later, and only resulted in an average of 1.5 competitors.

Finally, we must admit that we cannot effectively regulate big drug monopolies in the public interest, and it is time to advance work on the delinkage of R&D funding including incentives from the prices of goods and services.