Review Of WHO Mechanism To Fight Substandard Medicines Postponed Until 2017

World Health Organization delegates today agreed in committee to postpone until 2017 the review of a mechanism that had been set up to help countries deal with substandard and fake medicines.

The third meeting the member state mechanism on substandard/spurious/falsely-labelled/falsified/counterfeit medical products (SSFFC), which met in Geneva from 29-31 October 2014, asked that the review of the mechanism be postponed by one year, until 2017.

The request had already been submitted to the WHO Executive Board meeting in January, which agreed on the principle of the postponement.

Established in 2012 by WHA decision 65.19, the mechanism was expected be reviewed by the WHA after three years of its operation.

The mechanism agreed on a list of prioritised activities for 2014-2015 (in Annex III) of the World Health Assembly document [pdf] and decided that certain countries would be led or supported by specific countries. For example, Brazil led Activity A, which is expected to develop recommendations for the health authorities engaged in the detection of SSFFC medical products and establish a strengthening and tool-generating programme to contribute to member states’ training.

Delegates agreed today to postpone the review of the impact of the mechanism to 2017 “both to allow more time for the review itself and for implementation of new policies to tackle the problem,” according to WHO.

The mechanism includes two outcome documents. One is laid out as Annex I of the World Health Assembly document [pdf], and states recommendations for health authorities to detect and deal with actions, activities and behaviours that result in SSFFC.

The second outcome document is in Annex II and is a proposal by India. It deals with activities and behaviours that fall outside the mandate of the mechanism, which were also reviewed by the mechanism (IPW, WHO, 30 January 2015). According to the WHO document, the mechanism revised the document in Annex II but did not reach consensus on the title, a paragraph in the introductory section, and elements 3 and 7 of the document.

Element 3 regards: “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 is: “[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.]]”

Countries taking the floor today underlined the importance of tackling substandard medical products. Sudan said SSFFC medical products represent a grave danger against public health around the world.

Colombia remarked on the fact that the fight against SSFFC products should not prevent the production of safe and effective generic medical products.

The United States said it was deeply concerned about being the only donor to the system, welcomed a new contribution from India and urged other member states to contribute. The US also said it was concerned about WHO not prioritise this member state priority in its own budget.

Algeria said SSFFC products are a major challenge for public health authorities in years to come but WHO needs to guarantee access to affordable medicines.

Industry Sees Growing Trade in SSFFC Goods

In its statement, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) said a recent study published in the American Journal of Tropical Medicine and Hygiene “found that 52.8% of all counterfeit medicines detected in the legitimate supply chain are lifesaving-related treatments.” The statement added, “The trade of fake medicines is growing,” the statement said, saying that IFPMA and other 28 partner organisations “have united under the Fight the Fakes campaign…”