Guatemala - The international medical humanitarian organization Médecins Sans Frontières (MSF) warns that a ruling by the Guatemalan government in April seriously jeopardizes access to life-saving medicines for the most vulnerable people in Guatemala.
There are 67,000 Guatemalans living with HIV/AIDS, and 4,800 of them children. Since antiretrovirals (ARVs) are not protected by patents in Guatemala, MSF has been able to use generic ARVs in its programs in the country. Thus MSF has been able to buy ARVs 75-99% cheaper than the government. On April 15, 2003, the Guatemalan Industrial Property (IP) Law was modified by the Guatemalan Congress to give originator pharmaceutical companies five years of market exclusivity starting from when the originator drug is registered in Guatemala.
The decree bans the drug regulatory agency from using an originators’ product data - which is necessary when giving the equivalent generic version approval. This drastic change in Guatemalan law will prevent generic drugs from being registered even when there are no patents on those drugs. Such a five-year exclusivity does not exist in any IPR legislation in Latin America. "The decree is bad news for poor people living with HIV/AIDS in Guatemala," says Luis Villa, Head of the MSF mission in Guatemala.
"Because of this decree, registration of generics like the ones we use will be delayed and patients outside the MSF project will not be able to benefit from these cheaper alternatives. Five years can be a question of life and death for people living with HIV/AIDS." The new decree creates an unnecessary barrier to accessing cheaper medicines. "This is particularly alarming since ARVs are not under patent in Guatemala and importing and using generic drugs has therefore been unlimited," says Cailin Morrison, legal expert for the MSF Campaign for Access to Essential Medicines.
"The WTO TRIPS Agreement does not require countries to provide such market exclusivity to originator companies, and there is no reason for countries to be doing this." MSF urges the Guatemalan Congress to repeal Decree 9-2003, which would abolish data exclusivity, thus promoting generic competition and improving access to assured quality medicines. For too many people living with HIV/AIDS and other diseases in Guatemala, medicines have been a luxury.
There is only one thing that has brought down the prices of ARVs in Central America, and that is the introduction of generic competition. The Guatemalan government must uphold its commitment made in Doha to protect public health over commercial interest. In Guatemala, MSF teams provide medical care for people with HIV/AIDS and Chagas disease, as well as primary health care and other services for vulnerable populations. MSF has been present in Guatemala since 1988.