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Brand-name biotech drugs should only have seven years` protection from generic competition, say US authorities.
The often much higher prices of branded “biologics” compared with generic alternatives reflect the research and development costs borne by the big pharmaceutical companies.
But the US is seeking more ways to ensure that the benefits of particular medicines are more affordable, usually through the production of generic alternatives.
According to the White House, seven years is an “appropriate time period” to protect brand-name drugs from cheaper generic rivals.
This is despite attempts by industry lobby groups to extend protection to 12 to 14 years on the grounds that companies must be encouraged to invest in the development of new medicines.
In a letter to Congress, budget director Peter Orszag and health reform colleague Nancy-Ann DeParle write: “Seven years strikes the appropriate balance between innovation and competition by providing for seven years of exclusivity. Innovation is driven by appropriate competition, and the administration’s policy will spur that competition.”
But says Jim Greenwood, president of the Biotechnology Industry Organisation: “We believe this abbreviated period will undermine the incentives necessary for continued biotech research into breakthrough medicines.”
Copyright Press Association 2009