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Orphan Drugs In Mexico

January 30, 2013

The Orphan Druganaut Blog is continuing its series on international rare disease and orphan drug regulations.  This is a previous Blog Post (published in September 2012) that has been updated with additional references and information.

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 2003, legislation in Mexico set up a national health insurance program called Seguro Popular, with the purpose of providing coverage to everyone who is not already covered by another program. It covers basic medical needs but also has programs for catastrophic diseases, which has resulted in a number of medical conditions treated under Mexican public health insurance to nearly quintuple.

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”. This important legislation recognizes that there are orphan diseases and orphan drugs to treat them. 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”.


Nature August 2012 article titled, “Mexico chalks up success in health-care reforms” August 1, 2012 article titled,”Country Report: Mexico” March 14, 2012 article titled,”Mexico defines orphan drugs, but questions remain; US patent deal”.

Copyright © 2012-2013, Orphan Druganaut Blog. All rights reserved.

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