Expert Panel Recommends That The WHO Move Forward On Transparency And Delinkage

On Monday, 27 November 2017, the WHO published the recommendations of the overall programme review of the global strategy and plan of action on public, health innovation and intellectual property (EB142/14).  The full report of the overall programme review (OPR) will be published on Tuesday, 28 November 2017 [Note: the full report is now available here]. The mandate for this work is provided resolution WHA68.18 (2015) which requested the Director-General to establish a “panel of 18 experts” to conduct an OPR of the global strategy and plan of action on public health, innovation and intellectual property. (Source: EB142/14).  The composition of this expert panel can be found here:  http://www.who.int/medicines/innovation/gspa-review/members-list/en/

The expert panel provided 33 recommendations which included 17 forward looking ”high-priority actions” including on transparency and delinkage.

WHO headquarters

With respect to the budgetary implications of the recommendations for the Organization, the expert panel noted:

Having considered that the number of priority actions recommended by the expert review panel is only 33, compared with the original 108, the Secretariat estimates that the budget for full implementation of the review panel’s recommended actions will be US$ 31.5 million over the period 2018–2022. In addition, the estimated budget for implementation of the high-priority actions identified by the review panel would be US$ 16.3 million. This indicative budget would allow the Secretariat to ensure implementation and monitoring of the global strategy and plan of action and provide technical guidance and support to Member States in the implementation of the review panel’s recommendations for the period 2018–2022. (Source: Global strategy and plan of action on public health, innovation and intellectual property, EB142/14, 27 November 2017).

The high-priority actions on transparency include the following recommendations:

Member States to support the WHO Secretariat in promoting transparency in, and understanding of, the costs of research and development. (Indicator: Reports on the costs of research and development for health products prepared in 2019 and 2021.)

The WHO Secretariat to provide guidance to Member States on promoting and monitoring transparency in medicine prices and on implementation of pricing and reimbursement policies. (Indicator: Guidance developed and disseminated in countries by 2020.)

The high-priority action on delinkage includes the following recommendation:

Member States to encourage the implementation of schemes which partially or wholly delink product prices from research and development costs, including actions recommended by the Consultative Expert Working Group on Research and Development: Financing and Coordination. (Indicator: New schemes to partially or wholly delink product prices from research and development costs developed, approved and implemented by 2022.)

With respect to the management of IPRs to “contribute to innovation and public health, the high-priority action includes the following recommendation.

The WHO Secretariat, in collaboration with other international organizations working in intellectual property, to advocate for the development of national legislation to fully reflect the flexibilities provided in the TRIPS Agreement, including those recognized in the Doha Declaration on the TRIPS Agreement and Public Health and in Articles 27, 30 (including the research exception and “Bolar” provision), 31 and 31bis of the TRIPS Agreement. (Indicator: Inter-organizational report on national legislation and patenting guidelines that include the flexibilities provided in the TRIPS Agreement prepared by 2021.)

The full report and  the expert panel’s recommendations will be discussed at the WHO Executive Board in January 2018 under agenda item, “3.7 Global strategy and plan of action on public health, innovation and intellectual property”. (Source: Provisional agenda (annotated), EB142/1 (annotated), 8 November 2017).