WHO Member State Mechanism On Fake Medicines Meeting This Week

This week the World Health Organization member state mechanism on falsified medicines is meeting in Geneva with a long agenda. In particular, the meeting is expected to consider a process for the mechanism review, the participation of the WHO in a global committee on the quality of health products, and several proposals including tracking systems and awareness campaigns.

The fourth meeting of the member state mechanism (MSM) on substandard/spurious/falsely-labelled/falsified/counterfeit medical products (SSFFC) is taking place on 19-20 November, just after a closed informal meeting on 16-17 November.

Review of WHO’s Work on SFFC

The document prepared by the WHO secretariat comments on WHO’s work on access to essential medicines and its support to countries in their effort towards universal health coverage. The document notes that “low- and low-to-middle-income countries continue to face problems with essential medicines that are in short supply and/or prohibitively expensive.”

In particular, the document remarks that “intersections between intellectual property rights, innovation and public health need to be dealt with, if market failure in respect of medicine development for unmet needs in developing countries is to be resolved.”

WHO works with the World Intellectual Property Organization and the World Trade Organisations on these research and development issues in the context of the Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property, the document says.

WHO’s current work in the area of public health and innovation includes the facilitation of “sustainable alternative ways to finance and coordinate the research and development of priority health technologies for developing countries in response to market failures,” according to the document. It also includes “policy guidance and provision of technical assistance to countries in support of the management and application of intellectual property, with a view to promoting needs-based innovation and access to patent-protected essential medicines and health products.”

SSFFC Not IP-Related

Member states are also expected to discuss a document [pdf] which has already been under discussion for some time.

It was a proposal by India and lists activities that fall outside of the mandate of the MSM and on which no agreement was found at the third meeting of the MSM on the title and elements 3 and 7 (IPW, WHO, 22 May 2015).

Element 3 of the document states: “Actions, activities and behaviours of licensee/authorization holders involving minor deviations, as determined by national and/or regional regulatory authorities, which do not compromise the quality or which do not pose a health risk, [such as minor [unintentional] deviations in good manufacturing practice.]”

Element 7 says: “[Actions, activities and behaviours] [in case of medical products in transit, which are in compliance with the regulatory requirements of the country of export and the country of final destination.][which may not be in compliance with the regulatory requirements of the country of transit [while preserving the integrity of the medical product in transit.][and except if there are grounds for suspecting the existence of SSFFC medical products.]]

Discussions have been ongoing for years on how to characterise falsified medical products in the context of WHO. They used to be referred to as counterfeit products but this implies that there is an infringement of a trademark, which is an IP right and has nothing to do with the quality of the product. This is how the denomination SSFFC was adopted by WHO member states.

WHO Participation In Global Committee

Also on the agenda is the question of WHO’s participation in the global steering committee for quality assurance of health products, which follows a presentation made to the steering committee of the MSM by the Global Fund to Fight AIDS, Tuberculosis and Malaria, in September.

The document [pdf] states that the Global Fund has established a global steering committee for quality assurance of health products. The committee, according to the document, “is a voluntary coalition of international institutions whose objective is to work together to reduce the public health risk posed by falsified medicines.”

Core members of the coalition include: The World Bank, the GAVI Alliance, the United Nations Development Programme, USAID, UNITAID, and INTERPOL.

The WHO currently has observer status until a decision is reached by the MSM as to further collaboration, according to the document.

Review of the MSM in 2017

The MSM was established in 2012 and was to be reviewed after three years. In May 2015, the World Health Assembly decided to postpone the review until 2017 (IPW, WIPO, 22 May 2015).

A meeting document [pdf] drafted by the secretariat presents the proposed process of the review, which would involve a review of the mechanism in terms of its success in achieving its objectives, and in particular to “document achievements, gaps and remaining challenges, and to make recommendations on the way forward.”

Focal Point Network for SSFFC

In October 2014, according to the meeting document [pdf], the third meeting of the MSM agreed on the establishment of a global network of focal points for the exchange of information and consultation among member states.

The meeting document introduces draft terms of reference for a focal point network for SSFFC. This focal point network would improve the flow and exchange of information and would improve the reporting and the alerts on SSFFC medical products, and learn from the experience of other member states.

According to the document, networks exist in many regions and the proposed focal point network does not attempt to replace any of those networks but facilitate global coordination and consistency.

“The WHO global surveillance and monitoring system for SSFFC medical products has established focal points within national regulatory authorities within over 90 Member States, and these terms of reference would apply to those focal points,” the document said.

Tracking SSFFC

A document [pdf] submitted by Argentina maps out existing technologies and “track and trace” models in use and to be developed by member states.

According to the document, national and regional regulatory authorities have identified traceability systems and mechanisms as useful to fight against “the falsification and illicit distribution of medical products.”

Some member states have issued traceability regulations currently implemented, said the document. The MSM decided to establish a working group to assess and report on “track and trace” technologies, methodologies and models currently in use or under development, and analyse their advantages and disadvantages.

For example, the document states that Mexico and Switzerland do not have a track and trace system in place yet, but the European Union is in the process of developing a unique identifier system for medicinal products.

Working Group, Study

A meeting document [pdf] submitted by the United Kingdom is proposing to create a working group to develop and leverage existing recommendations for effective risk communication and recommendations for awareness campaigns on SFFFC.

Also on the agenda [pdf] is a proposal [pdf] for a study on the public health and socioeconomic impact of SSFFC submitted by the technical group established to conduct the study.