WHO Members Agree On Roadmap To Fight Poor Quality Medicines

The first meeting of the World Health Organization mechanism intended to promote the prevention and control of “substandard/spurious/falsely-labelled/falsified/counterfeit” (SSFFC) medical products is being called a success. Member states agreed on a work plan that focuses on strengthening regulatory capacities and decided to form a steering committee to monitor country compliance to the plan.

Over 200 delegates from 76 countries, according to organisers, gathered in Buenos Aires, Argentina for the SSFFC member state mechanism meeting from 19-21 November. The meeting documents, which include a provisional list of participants, are available here.

Co-organised by the WHO and the Argentine Ministry of Health, the meeting’s top priorities included establishing a work plan, the scope of the mechanism, its structure and governance.

The final press release of the meeting in English is here.

According to a Pan American Health Organization and WHO joint press release (Spanish), the mechanism will focus on strengthening regulatory capacities and increasing cooperation between drug authorities in order to prevent and control poor quality medicines. Additionally, the mechanism will seek to identify the activities and behaviours that drive the propagation of poor quality medicines across the globe.

For Ambassador Umunna Humphrey Orjiako, permanent representative of Nigeria to the United Nations Office in Geneva and meeting chair, this was a particularly positive outcome.

“Every delegation thinks that the meeting was a success because they came with low expectations given the very difficult technical issues that deeply affect many countries. Countries were able to agree on setting up the parameters for future work, the methodology of work, an agenda, and other working platforms,” Orjiako told Intellectual Property Watch.

The resolution to establish the mechanism was adopted during the 65th World Health Assembly (WHA) in May 2012, available here [pdf], calls for an approach strictly from a public health perspective, excluding trade and intellectual property considerations. Nonetheless, these issues seemed to make their way into the conversation.

“Of course they were brought up,” Orjiako said. “One of the most contentious issues involved the work plan’s economic and financial implications. Some countries wanted to inject IP into the conversation, but we refused to go down that path. Everything we decided focused on public health issues, especially ensuring that countries public health systems are secure.”

Other key items of the plan include the importance of educating consumers, healthcare professionals and industry to avoid counterfeit products. Meeting participants also called for the development of tools to access accurate information on the issue and reaffirmed the importance of promoting the transfer of technologies for safe and effective products. Additionally, they established a need to strengthen medicines supply chains to prevent the infiltration of poor quality products.

In terms of governance, member states decided to form a steering committee comprised of representatives from each WHO region. Its role will be to monitor compliance with the plan, which includes the strengthening of national regulatory agencies, their capacity and quality control laboratories.

WHO Director General Margaret Chan was present during the three-day meeting, making an intervention during the opening session. She urged participants to produce a roadmap and an appropriate plan for the work ahead. Chan also emphasised that access to health services must be tied to safe and affordable products.

The WHO/PAHO media release from the opening day of the meeting is available here.

The report on the first meeting of the member state mechanism on SSFFC will be submitted for the WHO Executive Board’s consideration in January.

Related Intellectual Property Watch article here.