Here's some info on European consideration of their own orphan drug legislation:
EU Devising Regulations For Orphan Drugs
BRUSSELS, Sep 24 (Reuters) - The European Commission expects to issue, in
November, long-awaited legislation aimed at promoting the development of drugs to
treat rare diseases, a Commission official said Tuesday.
The plan, which mimics the system used in the United States and Japan, would give
incentives to pharmaceutical companies to produce "orphan drugs." The Commission,
the executive body for the 15-member European Union, is drawing up proposals to
give producers the exclusive right to market an orphan drug for 10 years, said Patrick
Deboyser, head of the pharmaceuticals unit.
The company would also be automatically entitled to use the EU's streamlined
procedure for getting drugs approved across the bloc, a system operated by the
European Agency for the Evaluation of Medicinal Products (EMEA) in London. The
EMEA's "centralized" approval system is normally limited to biotechnology or other
"innovative" medicines. The usual 200,000 Ecu ($218,000) registration fee would be
waived, Deboyser told a conference on orphan drugs.
One of the key questions facing the EU is how to determine when a disease is so rare
that it deserves "orphan" status. The United States has decided that an orphan disease
affects less than 200,000 people--1 per 1,300 Americans. The Commission's draft
text sets the prevalence at 1 patient per 1,200 people, Deboyser said.
After the legislation is finalized, it must be approved by the European Parliament and
EU national ministers. Deboyser said that it could be law by December 1998.
Abby S. Meyers, president of the US National Organization for Rare Disorders, told
the conference that the 1983 Orphan Drug Act had "...been one of the most successful
pieces of health-related legislation ever enacted" in the United States, adding that over
800 products had been designated by the government as orphan drugs.
However, she complained that some companies had turned some orphan drugs--for
example, human growth hormone and the AIDS treatment drug AZT--into big
money-makers. "So the question is, can Europe assure...that companies are allowed to
earn reasonable profits from orphan drugs, yet prevent companies from abusing the
intent of the law by earning extraordinary profits?"
However, Erik Tambuyzer, a board member of the industry group EuropaBio, said
only 2% of the US-designated orphan drugs were highly profitable. Deboyser said that
the Commission was debating whether a company could continue to enjoy market
exclusivity in cases where a price became excessive. |
