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Mary Kugler, MSN, RN,BC
Guide to Rare/Orphan Diseases
July 21, 2002
The basics: drug patents, generics, and competition
In 1984 Congress passed the Drug Price Competition and Patent Term Restoration Act (called the "Hatch-Waxman Act"). This law sets forth the terms of drug patents. Once a drug's patent expires, if it is not renewed under the specific terms of the Act other companies can develop and market the generic form of the drug.
The reality: private deals, tremendous profits
Some of the ways drug companies work around the Hatch-Waxman Act:
enter into private financial deals with companies wanting to market generic versions of drugs
have the brand-name drug patent extended by attaching a rider onto an unrelated piece of legislation in Congress
change the formulation of a drug slightly so that consumers want the "new and improved" version; then when the patent expires on the original version few consumers want its generic.
Orphan drugs and patents
Developing a drug is expensive. Developing a drug you can only sell to, say, 5,000 people in the world (an "orphan" drug) doesn't make business sense. The Orphan Drug Act of 1983 was passed to encourage companies to develop drugs for rare diseases, by giving them seven years of exclusive marketing rights plus tax credits for research expenses. This Act--and not the traditional patent process--has been the driving force behind orphan drug development for treatment of rare diseases.
"Edwards/Kennedy legislation harms patients"
The Greater Access to Affordable Pharmaceuticals Act of 2001 (S. 812 and H.R. 1862) seeks to speed up the generic drug approval process to increase competition among drug manufacturers and make generic drugs more widely available. It also wants to hold manufacturers to the terms of the Hatch-Waxman Act to ensure fair marketplace practices. Senators Edward Kennedy (D-MA) and John Edwards (D-NC) have been the bill's chief architects.
The response from the Pharmaceutical Research and Manufacturers of America PhRMA) to the proposed legislation has been strong. PhRMA stated, "By weakening patent protection, the Edwards/Kennedy legislation harms patients and weakens the incentive to develop new medicine." PhRMA ran a series of "Just Ask Your Doctor" ads which stated, "weaker patent laws will reduce drug research for rare diseases."
NORD responds
The National Organization for Rare Disorders (NORD) took issue with the PhRMA ads. NORD published ads in two Capitol Hill publications giving the following facts:
the Orphan Drug Act, not patents, has paved the way for the development of orphan products
Biotechnology firms account for 65% of orphan drug research. Pharmaceutical companies account for only 28%.
NORD stated it 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." NORD urges people concerned about research for rare diseases to support the Rare Diseases Acts currently in Congress.
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