Knowledge Ecology International (KEI) delivered the following statement on the WHO roadmap on access to medicines, vaccines and health products (agenda item 5.7.1) on Tuesday evening, 29 January 2019 during the 144th session of WHO’s Executive Board.
The WHO Roadmap should guide the organization’s assessment of incentives and funding mechanisms for research and development to stimulate the development of new drugs, vaccines, diagnostics and new gene and cell-based therapies.
In the current document (EB/144/17), we welcome the proposals to enhance the transparency of R&D costs and the development of incentive mechanisms that delink the costs of R&D from the prices of health technologies, and look forward to more concrete actions to achieve both.
It is time to re-evaluate the notion that governments can effectively regulate drug monopolies in the public interest. And if, and KEI suggests since, the contrary is true, we need to explore and then implement new incentives for R&D investments that are not tied to monopolies and high prices.
The reform of pricing and R&D incentives should be based upon accurate empirical evidence of the economics of drug development, including product-specific costs by stages of development, global resource flows for R&D by sources and targets, and pricing and revenues from sales of specific products and services.
We have been disappointed with the slow and unfocused implementation of the WHO R&D Observatory. The WHO should connect Observatory staff with members of the public working on reforms of biomedical innovation pricing and R&D incentives, to give this project more direction.
Finally, the WHO should develop a manual on the control of and remedies to excessive pricing by December 2020. The manual should describe the context-specific methodologies employed by Member States for determining if prices are excessive, and the mechanisms to remedy and control pricing abuses.
For an earlier analysis of the zero draft of the roadmap and member states’ responses, please see: Roadblocks ahead on the WHO Roadmap on Access to Medicines and Vaccines. For background on civil society perspectives on the roadmap, please see: 16 groups write open letter to WHO Director-General Dr Tedros: Roadmap on Access to Medicines and Vaccines 2019-2023.
On Thursday, 24 January 2019, Grover G. Norquist (Americans for Tax Reform) and Lorenzo Montanari (Property Rights Alliance) wrote a letter to Alex Azar, Secretary of United States Secretary of Health and Human Services, complaining about WHO’s provision of technical assistance (as described in the roadmap) to Member States in using the flexibilities afforded to them under the World Trade Organization’s Agreement for Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). In May 2001, Norquist, in an interview with National Public Radio’s (NPR) Morning Edition declared:
I don’t want to abolish government. I simply want to reduce it to the size where I can drag it into the bathroom and drown it in the bathtub.
The letter to Secretary Azar presented an uninformed reading of Article 31 of the TRIPS Agreement:
Americans for Tax Reform and Property Rights Alliance are deeply concerned that the policymaking process at the World Health Organization has been hijacked by radical members that advocate for policies that if put in place would undermine intellectual property rights, ultimately erode global health as a whole, and harm the free-exchange of goods and services.We encourage you, as you attend the conference to remind members that any policy which includes price controls or questioning the value of intellectual property rights will lead to nowhere.
With increasing frequency policy solutions for any health concern at the WHO includes advocating for “TRIPS flexibilities”and government interventions for price controls.The most recent examples, the WHO’s Roadmap on Access to Medicines and the WHO’s report on cancer medicines, will be discussed at the Executive Board meeting.
As you know,compulsory licenses strip innovators of their intellectual property rights and should only be used in extreme circumstances, if at all. Yet countries like Chile and Colombia have, encouraged by the WHO, recently considered issuing compulsory licenses for hepatitis C when they in fact do not have emergencies.Often countries invoke compulsory licenses as a method to reduce prices. The evidence refutes this claim. Instead prices for medicines, especially expensive hepatitis C drugs, are reduced when regulators approve of new competitors. Unfortunately, in many countries market-entry can be delayed for years due to burdensome approval processes.