Guatemala: New Congressional Decree Hinders Access to Medicines
67.000 Guatemalan people, 4.800 of them children, are living with HIV/AIDS. Since antiretrovirals (ARVs) are not protected by patents in the country, MSF has been able to use generic ARVs in its programs in Guatemala and subsequently has been able to buy drugs more than 75-99% cheaper than the government.
On April 15th 2003, the Guatemalan Industrial Property (IP) Law was modified: the Congress passed Decree 9-2003, which gives originator pharmaceutical companies five years of market exclusivity in the country starting from the registration of the originator drug in Guatemala. The decree bans the drug regulatory agency use of originators’ product data, which is necessary to give the equivalent generic version marketing approval. This drastic change in Guatemalan law will prevent generic drugs from being registered even when there are no patents on those drugs. This 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 the new 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,” Villa says.
Decree 9-2003 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 of the MSF Campaign for 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, as well as primary health care and other services for vulnerable populations. MSF is present in Guatemala since 1988.