What is a generic drug? According to the World Health Organization (WHO), a generic drug is a pharmaceutical product intended to be interchangeable with the originator product, and which is generally manufactured without a license from the originator company. Generic products may be marketed either under a non-proprietary or approved name rather than a proprietary name. Generic does not mean counterfeit, fake, or substandard.
Recently, WHO, in collaboration with other United Nations agencies, launched a project to "pre-qualify" producers of ARVs and other AIDS drugs, including generic manufacturers. Many generic ARV producers have been "pre-qualified" by the WHO as meeting international standards for quality, and the list is updated regularly.
What is the TRIPS Agreement? The World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which came into being in 1995, is an international agreement on the protection of various intellectual property rights, including patents, copyrights and trademarks. It sets out guidelines for minimum standards for intellectual property protection that must be met by all WTO Members within specific timeframes. The deadline has been extended to 2016 for least developed countries, as per paragraph 7 of the WTO Ministerial Declaration on the TRIPS Agreement and Public Health ("Doha Declaration").
What is compulsory licensing? Compulsory licensing allows the production or importation of a generic medicine without the consent of the patent holder (though they receive adequate compensation). Compulsory licenses may be issued by public authorities for various reasons, including, but not limited to, addressing public health or emergencies. They are permitted under the TRIPS Agreement, and are considered a regular feature of any good intellectual property legislation. They are commonly used by industrialized countries such as the US. Compulsory licensing of pharmaceuticals is one of the most important policy tools for ensuring generic competition.
What is parallel importation? Parallel importation allows a country to "shop around" for the best price of a branded drug on the global market, without the permission of the patent holder. It is an attractive option for developing countries when the same branded medicine is being sold for different prices in different markets. Many European countries, such as the UK, benefit from significant parallel trade to reduce the overall cost of medicines.
Parallel importing does not involve the purchase of generics.What are "strategies to accelerate the introduction of generics"? To sell a generic version of a drug, a manufacturer has to put its product through various tests to obtain regulatory approval. A "Bolar provision" is a strategy to accelerate the introduction of generics by allowing the manufacturer to conduct these tests while the product is still under patent. The producer can then put the generic product onto the market as soon as the patent expires. Without this provision, the introduction of a generic could be delayed by two to four years after the patent expires.