"The promotion and development of medicinal products for the
treatment of rare diseases require our particular attention, as
health is our most valuable possession," said Ursula Schleicher,
former Vice-President of the European Parliament. According to
estimates, around 25 million people in Europe are suffering from
5,000 to 8,000 orphan diseases. Many of them are still waiting for
medicines that will allow them to at least be able to lead a
pain-free life, if not always a normal life. From a purely
business-management viewpoint, the development of drugs for rare
diseases is not always economical for the pharmaceutical industry.
Nor can sufferers raise the funds themselves for research into the
drugs that for them are vitally necessary. It is, therefore, a
question of moral values and national priorities as to what extent
society is prepared to help those affected. In 1999 the European
Union adopted the Orphan Medicinal Products Regulation. This offers
the biopharmaceutical and pharmaceutical industry incentives to
develop orphan drugs. This book presents the European Orphan
Medicinal Products Regulation and compares it with the rules of
other countries. It also discusses the possibilities of creating
further incentives.
General
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