Intellectual Property
One of the objectives of the PAHO Strategic Fund is to promote access to affordable medicines in the region of the Americas. To achieve this the Strategic Fund will, where possible, purchase generic medicines when cost savings are evident. In such circumstances, participating countries are required to ensure that products purchased comply with national patent law and regulations.
It is recognized that generic medicines represent one of the most cost effective interventions in public health. In countries such as the United States and Canada, even though generic medicines share of the total market value in US$ is very low (11% and 15% respectively), almost 50% of all prescriptions in both countries are issued in generic form. Additionally the WHO World Medicines Situation Report provides important data on the increasing market shares for generic medicines in Argentina, Brazil and Mexico.
Generics are pharmaceutical products that contain the same active ingredient in the same amounts as the original products on which they are based. Marketed after the expiry of patent or other exclusivity rights, generics are legally available from multiple sources and are:
- intended to be interchangeable with the original product,
- approved for marketing by national authorities after they are found to have the same quality, safety and efficacy as the original product,
- marketed either under a non-proprietary name (INN or other approved name) or under brand names ("branded generics").
Depending on national legislation, the above elements may be different in some countries. For this reason the term 'multisource' products has been introduced to encompass both branded and unbranded generics. The core of the generic concept is that, regardless of local variations in definition, generics are products containing well-established drugs, i.e. drugs whose safety and efficacy are well established.
http://www.paho.org/spanish/ad/ths/ev/acceso-intelectual.htm
