The Pharmaceutical Research and Manufacturers of America (PhRMA), a trade association representing pharmaceutical manufacturers, has recently run a series of ads claiming that “weaker patent laws will reduce drug research for rare diseases”.

However, NORD says that patents have never provided ample incentive for drug companies to develop treatments for rare diseases. That is why the Orphan Drug Act of 1983 was enacted. This law provides seven guaranteed years of marketing exclusivity without competition, as well as tax credits for research expenses. It is these incentives, not patents, that have spurred development of treatments for rare diseases.

Furthermore, according to a recent Tufts University study, despite these financial incentives, large brand-name pharmaceutical companies have developed only 28 percent of the new “orphan drugs”. Small biotechnology firms have developed 65 percent.

NORD believes that PhRMA's ads are needlessly alarming rare-disease patients by telling them that there is a significant link between patent protection and rare-disease research. Instead, NORD is urging the rare-disease community to recognize the importance of the Orphan Drug Act in encouraging the development of new treatments and to support three bills now being considered by the U.S. Senate and House of Representatives to increase government support of rare-disease research.

Those bills are the Rare Diseases Act of 2001 (S. 1379), the Rare Diseases Act of 2002 (H.R. 4013) and the Rare Diseases Orphan Product Development Act of 2002 (H.R. 4014). Patents are not of major importance to the orphan drug effort, but these three pending bills, which would provide significant new funding to develop treatments for rare diseases, are.

For additional information about patents and patent reform, contact NORD's Vice President for Public Policy, Diane Dorman, at ddorman@rarediseases.org.

Click here to view the ad published by NORD during the week of June 19, 2002, in two widely read Capitol Hill publications, Congress Daily and Roll Call.