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Orphan Drugs In Mexico: An Interview With Shire’s Markus Krenzlin

September 28, 2012

       Markus Krenzlin, Shire’s Country Manager in Mexico, is interviewed by about the status of orphan drugs in Mexico.

        Following are some interesting points about the status of orphan drugs in Mexico, per the interview :

  1. A change to a general health law in Mexico at the beginning of 2012, Article 224, which was amended to recognize both orphan diseases & the orphan drugs to treat them
  2. Over the past 2 years, Shire has been able to bring 4 products onto the market, 3 of which are available in the public health system for the following orphan diseases:

–          Hunter’s Disease

–          Fabry Disease

–          Gaucher’s Disease. 

       In the “IP tango Blog” , which is a “weblog for intellectual property law and practice for Latin America Hola”,  the March 11, 2012 Blog Post, briefly discusses the January 31, 2012 new provision to Mexico’s General Health Law (GHL).  Under Article 224 bis of the GHL, an orphan drug is defined as a “drug to diagnose, treat, or prevent a rare disease, affecting no more than 5 in 10,000 individuals”. Per this Blog Post, an orphan drug definition was previously in the Mexican Pharmacopeia, but is now officially a Federal Law.

       Under Article 224 Bis 1, Mexico’s Health Ministry now has the power to implement measures that are necessary to “encourage and promote access to orphan drugs”. The Health Ministry can issue marketing authorizations for orphan drugs.

         However the new regulations don’t provide an “exhaustive body of law” for orphan drugs, nor is there any regulations for “exclusivity”.

Copyright © 2012-2013, Ann-Teresa Cusenza and Orphan Druganaut Blog.  All rights reserved.

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