E-DRUG: New IOM report on substandard and falsified medicines
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Dear e-druggers,
I would like to draw your attention to a recent report of the USA Institute of Medicine (part of the American Academies of Science) on substandard and falsified medicines. The very careful development and review process of IOM reports is comparable to that of WHO Expert Committee reports.
The full prepublication report or an executive summary can be downloaded, free of charge, from the following web site:
http://www.iom.edu/Reports/2013/Countering-the-Problem-of-Falsified-and-Substandard-Drugs.aspx
[the site requires free registration; downloading the full PDF is free for developing countries; WB moderator]
These are some of the most important points:
1) The report makes a clear distinction between substandard, falsified and counterfeit medicines, but without getting stuck in an endless debate on definitions. This is a very helpful approach to enabling a meaningful discussion. The report then focuses on the public health impact of substandard and falsified medicines. The term counterfeit medicines is reserved for trade-mark infringements, which are considered outside the scope of the report.
2) Chapter 3 of the contains the most comprehensive overview of the extent of the problem of substandard and falsified medicines I know of.
3) The report makes a number of good recommendations for the FDA (who commissioned the report) and for national authorities, covering various ways and means to strengthen regulatory oversight and to promote supply chain security. For example, a three-step approach is recommended, starting with registration/licensing of all medicine importers in a country, followed by registration/licensing of all national institutions that buy/sell medicines (secondary wholesalers, pharmacies, etc); and ultimately the use of unique identifiers of individual packages as a final step. This approach is in line with recent EU directives coming into force.
4) The report also proposes the development of an international code of practice. This type of non-binding international "soft law" would identify and promote regulatory and other governance measures that have proven to be effective in containing substandard and falsified medicines, and could serve as a action guide to an international "coalition of the willing".
There is much more in the report, which I can recommend to all e-drug readers interested in the subject.
With best regards,
Hans V Hogerzeil
Professor of Global Health
University of Groningen
Netherlands
h.v.hogerzeil@umcg.nl