PhRMA disputes Indian claims relating to cancer drug shortages

In a recent interview with Times of India, a trade association that represents several major generic drug manufacturers in India has attempted to justify the issuance of compulsory licenses by alleging that the USA has done the same by allowing temporary importation of certain drugs.

“This assertion is wrong for several reasons,” argues Pharmaceutical Research and Manufacturers of America (PhRMA) vice president of International Jay Taylor in a statement issued yesterday, pointing out that the US Food and Drug Administration’s decision to allow temporary importation to address critical cancer drug shortages is not a compulsory license – no patents were revoked, waived or violated.

Mr Taylor said: “The US government only resorts to temporary importation of foreign drugs when a shortage is critical to patient health and cannot be resolved by manufacturers of the approved US drug. Importantly, this is done with the consent and cooperation of the manufacturer. Temporary importation is not used to resolve intellectual property disputes nor does it address pricing issues. The drugs prescribed in crisis are not necessarily patented and the importation of a substitute product may not be covered by the patent or have any intellectual property implications. The drugs prescribed were not under patent, nor were prices of imported drugs manipulated or altered by the process.”