PhRMA Disputes Claim that Import Authorization is a Compulsory License

PhRMA Disputes Claim that Response to Cancer Drug Shortage is a Compulsory License In a recent interview with the Times of India the trade association that represents several major generic drug manufacturers in India attempts to justify the issuance of patent waivers by alleging that the US has done the same by allowing temporary importation of certain drugs. This assertion is wrong for several reasons. The US FDA’s decision to allow temporary importation to address critical cancer drug shortages is not a compulsory license – no patents were revoked, waived or violated. 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. As set out under the WTO TRIPS Agreement, compulsory licensing is a valuable tool for addressing true public health emergencies. It is not intended as a mechanism for furthering local industrial policies or achieving commercial advantage. Compulsory licensing will never cure the many issues facing healthcare around the world, many of which are attributable to a lack of core healthcare infrastructure and inadequate financing mechanisms. This is acutely evident in India, where less than one percent of all medicines in the market are patented and none of the medicines on India’s Essential Drug List are patented. Nevertheless, the World Health Organization estimates that a mere 20 percent of the country can afford those off-patent treatments. Jay Taylor Vice President International PhRMA The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the country’s leading pharmaceutical research and biotechnology companies, which are devoted to inventing medicines that allow patients to live longer, healthier, and more productive lives. PhRMA companies are leading the way in the search for new cures. PhRMA members alone invested an estimated $49.5 billion in 2011 in discovering and developing new medicines. Contact: Mark Grayson Deputy Vice President Public Affairs PhRMA 202 835 3465