Abstract

The pharmaceutical industry, like any other in a free-market society, exists by producing profits and thus dividends for its investors. The latest estimate of the average research and development cost for creating a new drug for human use in the U.S. is about $55 million. Moreover, it typically takes about 10 years to bring such a drug to market. It is no wonder, then, that the drug industry, despite its awareness of its unique role in health care, is hesitant to invest in the development of drugs that may have little commercial potential. This presents the pharmaceutical industry with a serious dilemma—how to continue the development of products to treat rare diseases or conditions (the so-called orphan drugs) despite high R&D costs, small markets, inadequate patent protection, potentially high liability risks, and the inability of most patients in developing countries to pay for the drugs. Although this problem has long been recognized by many academic ...

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