Posted by Roger Bate
The World Health Organization just posted its new report on inferior medicines (http://apps.who.int/gb/ebwha/pdf_files/WHA68/A68_33-en.pdf). It is called the member state mechanism (MSM) report on Substandard/spurious/falsely-labelled/falsified/counterfeit medical products - SSFFC for short. This report is the culmination of multiple meetings of health bureaucrats to finalize how to combat inferior medicines. Or rather that is what one hoped for when the SSFFC process began a few years ago. But the reality is that this interim report does not advance the effort far and instead of reporting to, and demanding action at, the World Health Assembly this coming May, it has postponed doing so until 2017.
Perhaps worst still one can see the hands of the usual suspects in this interim report – notably India. It should be remembered that India was the reason that the anti-counterfeit IMPACT initiative of WHO was scuppered a few years ago. It’s not that the Indian government wants the world flooded with inferior medicines, but it doesn’t want anything that will undermine the rapid growth of its generic drug industry, some of whom play fast and loose with the rules on drug manufacturing.
On page 5 of the report the MSM says it will undertake “a study to increase understanding and knowledge on the links between accessibility and affordability and their impact on the emergence of SSFFC medical products and to recommend strategies to minimize their impact”. A balanced study on this topic of pricing and access to medicines as they relate to drug quality, would be useful, whereby one would examine how driving prices too low can lead to cutthroat competition and lower quality, as well as how high pricing can encourage counterfeiters to enter markets. However, one can tell from the MSM text that only the latter type of concern will actually be investigated.
More worrying still is Annex 2, which covers items not to be covered by MSM on SSFFC. Page 16 items 2 and 3 of this Annex covers “authorized” products and “minor” infractions of reporting requirements. Excluding such products may seem reasonable but many of the problems we encounter with substandard medicine are made by authorized firms, with minor deviations in products and reporting. After all a product with the right ingredients produced in a compliant plant by a legal firm, but that doesn’t work, is just as bad as a total fake
Take Femulan (mycophenolic acid), until recently made by Landsteiner, a Mexican manufacturer. Femulan is a generic immunosuppressant used post-transplant in patients to limit organ rejection. As such it is extremely important that it work properly, in order to ensure that the risk, suffering and expense of a transplant does not go to waste. Femulan was authorized by the Mexican government, and also several other Latin American nations. When tested it conformed to the content requirement for the medicine. It was used widely, but unfortunately it didn’t work properly.
To work it required that the tablet did not dissolve and release the active ingredient when in the acidic stomach (or it would have not functioned properly), but that it did dissolve afterwards in the more alkaline small intestine. The innovator product had an enteric coating that ensured that this occurred. Femulan’s coating did not release the product in the stomach as per the innovator, but it also did not release in the small intestine so that patients were barely receiving any active ingredient.
It wasn’t until a study was undertaken and published in 2010 in Transplantation Proceedings, that Femulan was exposed as a non-equivalent copy of the innovator, which ultimately led to its withdrawal. Although it was still available in several Latin American countries until very recently, according to Jose Santiago, a physician based in Bogota, Colombia. The minor infractions of this product meant it probably would not be combatted under WHO SSFFC, but the product was completely useless to patients.
It is ironic that the reason that WHO IMPACT was undermined was because health activists, claimed that it was more important to combat substandard medicine than counterfeit medicine, and IMPACT was too focused on intellectual property violations and counterfeiting. The direction the WHO MSM is taking means it is unlikely to combat any of the most widespread problems with substandard medicine.
The World Health Organization just posted its new report on inferior medicines (http://apps.who.int/gb/ebwha/pdf_files/WHA68/A68_33-en.pdf). It is called the member state mechanism (MSM) report on Substandard/spurious/falsely-labelled/falsified/counterfeit medical products - SSFFC for short. This report is the culmination of multiple meetings of health bureaucrats to finalize how to combat inferior medicines. Or rather that is what one hoped for when the SSFFC process began a few years ago. But the reality is that this interim report does not advance the effort far and instead of reporting to, and demanding action at, the World Health Assembly this coming May, it has postponed doing so until 2017.
Perhaps worst still one can see the hands of the usual suspects in this interim report – notably India. It should be remembered that India was the reason that the anti-counterfeit IMPACT initiative of WHO was scuppered a few years ago. It’s not that the Indian government wants the world flooded with inferior medicines, but it doesn’t want anything that will undermine the rapid growth of its generic drug industry, some of whom play fast and loose with the rules on drug manufacturing.
On page 5 of the report the MSM says it will undertake “a study to increase understanding and knowledge on the links between accessibility and affordability and their impact on the emergence of SSFFC medical products and to recommend strategies to minimize their impact”. A balanced study on this topic of pricing and access to medicines as they relate to drug quality, would be useful, whereby one would examine how driving prices too low can lead to cutthroat competition and lower quality, as well as how high pricing can encourage counterfeiters to enter markets. However, one can tell from the MSM text that only the latter type of concern will actually be investigated.
More worrying still is Annex 2, which covers items not to be covered by MSM on SSFFC. Page 16 items 2 and 3 of this Annex covers “authorized” products and “minor” infractions of reporting requirements. Excluding such products may seem reasonable but many of the problems we encounter with substandard medicine are made by authorized firms, with minor deviations in products and reporting. After all a product with the right ingredients produced in a compliant plant by a legal firm, but that doesn’t work, is just as bad as a total fake
Take Femulan (mycophenolic acid), until recently made by Landsteiner, a Mexican manufacturer. Femulan is a generic immunosuppressant used post-transplant in patients to limit organ rejection. As such it is extremely important that it work properly, in order to ensure that the risk, suffering and expense of a transplant does not go to waste. Femulan was authorized by the Mexican government, and also several other Latin American nations. When tested it conformed to the content requirement for the medicine. It was used widely, but unfortunately it didn’t work properly.
To work it required that the tablet did not dissolve and release the active ingredient when in the acidic stomach (or it would have not functioned properly), but that it did dissolve afterwards in the more alkaline small intestine. The innovator product had an enteric coating that ensured that this occurred. Femulan’s coating did not release the product in the stomach as per the innovator, but it also did not release in the small intestine so that patients were barely receiving any active ingredient.
It wasn’t until a study was undertaken and published in 2010 in Transplantation Proceedings, that Femulan was exposed as a non-equivalent copy of the innovator, which ultimately led to its withdrawal. Although it was still available in several Latin American countries until very recently, according to Jose Santiago, a physician based in Bogota, Colombia. The minor infractions of this product meant it probably would not be combatted under WHO SSFFC, but the product was completely useless to patients.
It is ironic that the reason that WHO IMPACT was undermined was because health activists, claimed that it was more important to combat substandard medicine than counterfeit medicine, and IMPACT was too focused on intellectual property violations and counterfeiting. The direction the WHO MSM is taking means it is unlikely to combat any of the most widespread problems with substandard medicine.
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