WHO Board Debate: High Prices Sow Seeds Of Fake Medicines In Developing Countries

Fake and poor quality medicines are still a growing public health concern particularly in developing countries, according to some World Health Organization members, who said at last week’s WHO Board meeting that the problem comes from the unaffordability of medicines and the lack of a strong surveillance system.

The WHO Executive Board (EB), which met from 25-30 January, noted a report [pdf] presenting the results of the November meeting of the Member State Mechanism on Substandard/Spurious/Falsely-labelled/Falsified/Counterfeit (SSFFC) medical products. The long name reflects a compromise of past debates, and came under discussion again last week.

The mechanism is working on several activities to fight SSFFC medical products, in particular track and trace systems, and a proposed study on the public health and the socioeconomic impact of SSFFC medical products.

The November meeting established a global network of focal points for the exchange of information and consultation among member states, and established a virtual exchange forum.

Quality Medicine Unaffordable, Africa Says

The Democratic Republic of the Congo, on behalf of the WHO Regional Office for Africa (AFRO), blamed the high price of quality medicines for the spread of SSFFC medical products in Africa. Another factor is the weakness of monitoring mechanisms at the local level, the Congo representative said.

The WHO should help developing countries set up national procurement systems in high quality medicines, ensuring traceability, the AFRO representative said. The region called for strengthening of the capacities of the regional bureaus in Africa so that countries can provide their own response to the problem.

Obstacles to access should be removed, he added, by encouraging price reductions in partnership with other international actors, for example UNITAID or GAVI the vaccine alliance.

Support for local manufacturing of generic medicines should be provided by lifting obstacles on intellectual property, such as patents and licences, the AFRO group said. Developing countries also need financial and technical assistance so they can strengthen their monitoring and control systems and put in place resilient health systems.

Several countries praised the work on track and trace systems, such as Albania, Thailand and Brazil, which also underlined the need for affordability and accessibility to medicines. New Zealand remarked that for track and trace systems to be effective, they have to be global and transposable in countries.

SSFFC Tongue-twister, Needs Change, India Says

Indian said a significant step was taken in the November meeting, which decided to set up a Working Group on Definitions. “Early conclusion of this work will bring much needed clarity on different and often confusing terminologies that are currently in vogue and will hopefully allow us to do away with the rather tongue-twisting acronym of SSFFC.”

Most countries taking the floor on 29 January did struggle with the acronym.

Separately, the Indian representative said it was unfortunate that the November meeting did not find agreement on its proposal identifying issues relating in particular to medicines in transit.

“The transit issue is particularly relevant given the recent trend to include provisions related to in-transit scrutiny that risk conflating trademark infringements with substandard/spurious medicines and place barriers to access to legitimate generic medicines,” he said. “A proper discussion on the issue of transit under the MSM framework is required so that access to medicines is not hampered in the name of SSFFC medical products.”

Indonesia said the working definition of SSFFC medicines should focus more on public health than IP rights.

NGOs Call for Change in Acronym

Medicus Mundi International, speaking on behalf of the People’s Health Movement and Third World Network, in its statement said the acronym SSFFC “had been proposed by the Director General as a temporary terminology. However, even after six years passed, we are still using this terminology. In fact, ‘substandard’ refers to deviations from product specifications, ‘spurious’ stands for medicines without any or with wrong active ingredients, ‘counterfeit’ refers to products that imitate trademarks.”

The International Pharmaceutical Federation, speaking on behalf of the World Health Professions Alliance, said in its statement that a series of activities have been carried out by members of the alliance to fight SSFFC medical products. For example, the representative said, the alliance “developed last year training materials for health care professionals entitled, ‘All you need to know about spurious medicines’,” in cooperation with the Indian healthcare professions.

WHO: Over 1,000 Documented Cases

WHO Assistant Director-General Marie-Paule Kieny said through WHO surveillance and monitoring projects, almost 1,000 cases of SSFFC have been documented and the WHO has trained people in over 100 countries on surveillance tools.

The member state mechanism’s steering committee will meet again in March, she said, and will discuss the review of the mechanism, the definition question, and the possible study on the relation between lack of access and the emergence of SSFFC.

[Update: WHO posted an SSFFC fact sheet on 15 January, available here.]

Image Credits: William New