World Health Assembly: WHO To Member States: Support Our Efforts Vs. Substandard, Fake Medicines

World Health Organization members this week will decide on approval of a work plan on poor quality medicines, and the WHO secretariat is hoping members will follow with financial support to carry out the plan.

The issue, referred to as SSFFC (substandard/spurious/falsely labelled/falsified/counterfeit), is on the agenda at the 67th World Health Assembly taking place from 19-24 May.

This week’s Assembly has before it document A67/29 [pdf], the report of the second meeting on member state mechanism on SSFFC, which took place in November 2013. The document contains the proposed work plan as appendix 2.

The work plan adopted by the WHO SSFFC Mechanism in November, includes actions such as regulatory systems strengthening, and supply chain integrity, cooperation and collaboration, awareness-raising and surveillance and monitoring.

Now it has to be implemented.

“The surveillance and monitoring is a vital step in thoroughly and accurately understanding the scope, scale and harm caused by SSFFC medical products” said Michael Deats, group lead, SSFFC medical products, safety and vigilance, in the WHO Essential Medicines and Health Products department. “You can start to take some evidence-based decisions.”

There have been hundreds of reports of “SSFFC” activity sent to the WHO, which then validates them with the countries reporting to the system. By the end of this month, 80 countries will be participating in the system, according to WHO.

The operational benefits include good linkage between countries, and WHO can provide support emergency situations, Deats said.

They also are accumulating a validated body of evidence on this problem, he said.

“We are encouraging member states to provide reports,” he said.

Then someone needs to fund it.

The plan drafted by member states is budgeted at US$ 13 million per year. Currently, the SSFFC unit has $1 million for this year to develop the surveillance and monitoring system, officials said. The proposed budget is detailed in Appendix 3 of the Assembly document (linked above).

“We’re hoping that member states will reaffirm the importance of the mechanism and the work it should be doing,” said Kees de Joncheere, director of the Essential Medicines and Health Products at WHO. If that is the case, then they hope members will step up with funding.

WHO’s SSFFC activities are no longer linked to Interpol, officials said, an issue that had stirred concern among developing countries a few years ago.

In the 2012 World Health Assembly resolution launching the mechanism, member states explicitly declared that it does not include intellectual property rights, not an area of primary expertise for the health agency.

But the issue is critical to every member state, Deats said.

“There isn’t a country that isn’t touched by this issue,” he said. “Made it abundantly clear that it is a health issue, and not IP protection, is important.”

The mechanism chair is now rotating. Current chair Nigeria will serve until the end of this Assembly, then a chair from the Americas will be chosen until the end of the 2015 WHA. There are two countries in the group from the Americas, according to sources: Argentina and the United States.

The report also includes a non-exhaustive list of behaviours, activities and actions that lead to SSFFC medical products.

The next meeting of the SSFFC mechanism is proposed for the week of 27 October 2014, followed by a steering committee meeting.