Medical organizations disagree about product exclusivity bill

Biosimilars bill would give companies 12 years of data exclusivity.

The Pathway for Biosimilars Act , a bill that has been added to the U.S. SenateâÄôs health care reform proposal, has sparked controversy among University of Minnesota associated groups. The bill, which was brought to committee in 2008, but did not pass Congress , would have companies making biological medical products make their research data available to other companies after a 12 to 14 year exclusivity period. Backers of the bill say the release of data will increase competition, and the exclusivity period would encourage innovation. Biosimilars are generic versions of medical products, including vaccines and gene therapy, made through biological processes. Biosimilars (also called follow-on biologics) are less expensive than biologic products like AVONEX , a therapy used to treat relapsing Multiple Sclerosis, which costs about $30,000 annually. Biologics are expensive because of their complexity. They are difficult to copy exactly, and lack of competition has kept prices high. James Greenwood, President and CEO of the Biotechnology Industry Organization said competition is healthy and has worked in the pharmaceutical world for 25 years. The Association of American Universities (AAU) , of which the University of Minnesota is a member, has written a letter of support to the three representatives sponsoring the bill, including author of the bill Sen. Anna Eshoo, D-Calif., Jay Inslee, D-Wash. and Joe Barton, R-Tex . The letter, written by the president of the Association of American Universities, Robert Berdahl , said the 12 year exclusivity will be important, âÄúbecause universities hold many of the patents on fundamental biotechnology inventions.âÄù He said exclusivity ensures âÄúsufficient economic incentives to commit the substantial investments necessary to develop such discoveries.âÄù The AAUâÄôs support drew criticism from the American Medical Student Association (AMSA ), who said the bill would limit access of economical, potentially life-saving products. âÄúPart of health care for all is not only funding health care reform, but is also access to medications, which drug exclusivity, being unreasonably long, really restricts,âÄù AMSAâÄôs Jack Rutledge Legislative Director Farheen Qurashi said. Greenwood said people who want cheaper drugs faster are being âÄúvery short-sightedâÄù and without an incentive for the people making âÄúhuge investments in what are often risky efforts,âÄù there would not be any new investments or products. Qurashi said AMSA has been doing grassroots advocacy to petition against the bill. AMSA students have been contacting legislators to urge them to work for more affordable medications. The group also wrote a letter to the AAU, critiquing its support of the bill. Berdahl responded saying, âÄúI believe we share the common goal of creating a process to promote the development of promising new biologics and provide affordable access to them âĦ We disagree on the specific properties of that process.âÄù