[Ip-health] FW: New bloking to generic medicines in Guatemala.
francisco_rossi at hotmail.com
Wed Jan 20 13:00:52 PST 2016
From: francisco_rossi at hotmail.com
To: ip-health at lists.keionline.org
Subject: New bloking to generic medicines in Guatemala.
Date: Sat, 9 Jan 2016 03:24:39 +0000
Guatemala is, again, victim of the greed of Big Pharma in a very dangerous way not only for Central America, but worldwide.
Constitutional court acepted a lawsuit from Big Pharma lobby which eliminated the exception for generics to present clinical trials demonstrating efficacy and safety. In a confuse decission, court ruled that it is not fair that generics do not present its own data since that means that the population could be expossed to insufficent evaluates medicines.
Since for ethical reasons it is not possible to repeat clinical trials for known substances, in the future it will not be possible to obtain a registration for generics.
Guatemala was victim of an unparalleled data exclusivity in the past. Around 22 products obtained a 15 years of exclusivity (the largest in the world) which was maintained after the law was derogated, as an aquaired rigth.
Guatemala was also victim of one of the most repudiable unethical trial around the 40s of the past century. In 2010 Presidente Obama apologized for an experiment with humans whom were inoculated with siphylis and did not receive tratment to "observe" the clinical evolution of the disease. In certain way, the court is ruling to repeat the same disaster.
MOH, Pharmacists and gremial organizations expressed their concerns on the implications of such a decission, and are asking for a revission. Our colleagues from CSOs, are collecting information to propouse a global campaign to reject such a ruling. Some kind of "Drop the case" campaing oriented to reverse the decission.
We will be in touch to support our friends in this challenge
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