On January 21, the WHO 130th WHO Executive Board (EB) adopted a resolution for agenda item 6.13 “substandard/spurious/falsely-labelled/falsified/counterfeit medical products” [SFFC]. The resolution is intended to address the growing prevalence of and the health risks associated with “deliberately and fraudulently mislabelled” pharmaceuticals.

The problem of SFFCs has been recognized by WHO as having a broad international impact. All varieties of medication are at risk of being counterfeited and this concern applies to both brand name and generic drugs. The results of fake packaging and improper ingredients include unsuccessful treatment as well as accidental consumption of toxic substances.

While it is difficult to paint an accurate statistical picture of the SFFC problem due to the constant evolution of illegal techniques and distribution methods, the WHO notes that the problem is most prevalent in developing nations in Africa, Asia, and Latin America and that less than 1% of the market value is from industrialized countries.  This dichotomy is evidenced by a number of the contributory factors cited by WHO. First of all, the high costs of medication often drive consumers to seek cheaper illegal sources. Similarly, in many developing nations, supplies at regular health facilities are often limited and illegal suppliers may be the only alternative option. Further, many jurisdictions lack legislation to combat SFFCs and are unable to address the increasing issues arising from the growth of international trade.

The WHO resolution aims to promote the “fundamental role of WHO in ensuring the availability of quality, safe and efficacious medical products.” Thus, the goal of the resolution is effectively to target the contributory factors and recognize how these factors shape the situation in developing countries. The resolution advocates for a “global strategy” involving public health, innovation and intellectual property. Part of this strategy is intended to address the lack of sufficient financing which is presently hindering WHO’s progress in combating SFFCs.

The resolution also outlines a mechanism through which all member states may take part in combating SFFCs. This mechanism reflects the contribution of international trade to the increasing prevalence of counterfeit medicine by stressing the importance of international collaboration regarding sharing of information and best practices. The intended result is to strengthen both regional and national supply chains, particularly in developing nations. In order to achieve this, existing WHO structures will be incorporated, as well as regional and subsidiary groups. The overarching perspective is to be that of a public health initiative, however, as opposed to being one of trade or intellectual property.

The resolution will be submitted for approval to the 65th World Health Assembly scheduled to meet in Geneva next May.

Nora Sleeth is a JD candidate at Osgoode Hall Law School. 

Posted in IP, Pharmaceutical Drugs