What Has Been Learned

First, there is no doubt that the major incentive that governments can provide is a period of exclusivity for marketing. Other incentives are secondary and not really necessary for legislation to be successful.

Second, abuses of the law by the pharmaceutical industry must be prevented if orphan drug privileges are to survive. Politicians may well wish to establish sales caps in the future, and legislate that market exclusivity must disappear when the cumulative sales of a drug reach a predetermined level. The sales cap should represent a fair incentive to the companies, yet protect the government or other groups from excessive payments.

There are now several millions of American patients who have benefited from the Orphan Drug Act (Haffner 2002). There is every indication that the same will shortly be true in Europe and the rest of the world.

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