MPP Statement at the World Health Organization on 1 October 2018:

The Medicines Patent Pool (MPP) would like to thank the tripartite (the WHO, the FAO and the OIE) for the opportunity to provide inputs to the global framework for development and stewardship to combat antimicrobial resistance (AMR).

We would like to welcome that the framework, in line with the mandate of the Political Declaration of the United Nations High-Level Meeting on AMR, includes a number of basic principles for needs-driven research and development (R&D) that foster access to new products.  These principles should contribute to guiding the design of appropriate incentives to strengthen the current antibiotic pipeline. As stated in the declaration and the framework, those incentives should be designed in a manner that de-link the financing of R&D from the price and volume of sales of new antibiotics to facilitate equitable and affordable access and to avoid perverse incentives that lead to excessive use. And we agree to the need to consider innovation, access and conservation holistically.

The MPP believes public-health oriented patent pooling can contribute to implementing these principles by supporting efforts to manage intellectual property on new antibiotics in a public health-oriented manner. A manner that promotes innovation and facilitates both access and stewardship.

The MPP is already implementing, monitoring, and enforcing certain stewardship-related obligations in its current licenses with drug manufacturers in the fields of HIV, hepatitis C and tuberculosis. These could be further enhanced in relation to AMR.  Through its licensing agreements and careful monitoring of compliance, the MPP can ensure that there are binding obligations in a number of areas in which manufacturers would be expected to contribute to the stewardship of new antibiotics.  These could include, for example, licensing provisions that ensure that products comply with quality assurance standards, that there are appropriate controls on the release of active ingredient into the environment, that marketing practices are appropriate and contribute to rational use, or that new antibiotics are sold through appropriate channels to decrease the risk of resistance.  The licences can also contribute to ensuring that people in low- and middle-income countries who need them get access.

However, in relation to many of these areas, there is a need to develop appropriate standards that can be expected from manufacturers.  We would therefore like to propose that as part of the next steps, Member States, together with the WHO, the FAO and the OIE, further develop such norms and standards.  This would support the efforts of many stakeholders so that those norms and standards can be used as a benchmark for responsible behaviour from all parties.