CAFTA, Data Protection and Generic Drugs
Fact Sheet Generics
FACT SHEET 01/10/2005
What is Data Protection?
The "data" in question refers to the results of clinical research and testing a company must present to health authorities before marketing a new drug.
The data must prove the effectiveness and safety of the new product.
This research typically takes eight to ten years and costs an average of $800 million to $1,000 million per product.
"Data Protection" under U.S. law and the CAFTA means competitors have to wait five years before registering their copy, IF they are using the inventor's test data, as if it were their own, to demonstrate the effectiveness and safety of a generic drug.
The Data Protection required by CAFTA, five years, is less than what is required in the European Union, where protection of six to eight years is typical.
Why is Data Protection important?
Without protection, innovative companies would not invest the hundreds of millions of dollars needed to generate the drug or the clinical test data. There would be no new drugs, and certainly no generic copies of them.
What Data Protection is NOT
Data Protection has no relationship to standard patent protection.
It applies from the moment a drug is approved for sale in the market, whether or not a patent covers the drug’s active ingredient or manufacturing process.
In the U.S., Data Protection typically expires before patent protection, if a drug is also covered by a patent. It does not extend a patent's life.
Why does Law 34-2004 fail to comply with CAFTA?
Law 34-2004 says it offers data protection, using WTO language.
However, it limits this protection to “new” products, defined as products never before registered in Guatemala or anywhere else in the world.
As a practical matter, new drugs are not registered in Guatemala before they are registered in the countries where they are invented.
This definition eliminates any chance that data protection can be obtained in Guatemala.
Why Can't This Wait Until CAFTA is Ratified?
This law gives the U.S. Congress the impression that Guatemala is not serious about complying with commitments it made in the CAFTA.
This could result in CAFTA not being ratified by the U.S. Congress, where a close vote is expected.
Must Guatemala choose between CAFTA and access to generic drugs?
No. Guatemala had access to generic drugs under 9-2003 and will continue to have access to generic drugs if CAFTA is approved.
Over 50% of medications consumed in the U.S. are generic.
The United States consumes more generic drugs than any other country.
9-2003 was in compliance with CAFTA and international obligations.
There are 13,000 drugs approved for use in Guatemala. Only 25 new drugs were granted data protection in the almost two years that 9-2003 was in force.
Under CAFTA, Guatemala maintains all of its WTO rights through compulsory licensing of patents to address epidemics, such as HIV/AIDS, tuberculosis and malaria, and national health emergencies. A CAFTA side letter ensures that data protection will not prevent a government from responding to such an emergency.