E-DRUG: Blocking of generics medicines in Guatemala
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[Cross posted from IP-Health/e-med. LL]
New blocking to generic medicines in Guatemala.
Dear all;
Guatemala is, again, victim of the greed of Big Pharma in a very dangerous way not only for Central America, but worldwide.
Constitutional court accepted a lawsuit from Big Pharma lobby which eliminated the exception for generics to present clinical trials demonstrating efficacy and safety. In a confuse decision, court ruled that it is not fair that generics do not present its own data since that means that the population could be exposed to insufficient 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 acquired right.
Guatemala was also victim of one of the most repudiable unethical trials around the 40s of the past century. In 2010 President Obama apologized for an experiment with humans who were inoculated with siphylis and did not receive treatment to "observe" the clinical evolution of the disease. In a 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 decision, and are asking for a revision. Our colleagues from CSOs, are collecting information to propose a global campaign to reject such a ruling. Some kind of "Drop the case" campaign oriented to reverse the decision.
We will be in touch to support our friends in this challenge
submitted to IP-Health by Francisco Rossi