[Ip-health] Congress Should Not Adopt “No Generics” Proposals for Biologics: Evergreening and t he Creation of Perpetual Marketing Monopolies

[Sarah Rimmington]

New Fact Sheet by Essential Action:

Congress Should Not Adopt “No Generics” Proposals for Biologics
The Eshoo-Barton-Inslee and Hatch-Enzi-Hagan Approach to Biogenerics:
Evergreening and the Creation of Perpetual Marketing Monopolies


Congress is now considering proposals to establish a process for
regulatory approval of generic versions of biotech medicines
("biologics"). Proposals passed by the Senate health committee and
sponsored by Representatives Eshoo, Barton and Inslee, however, would
establish prolonged delays before permitting price-lowering generic
competition.

The HELP (Senate Health, Education, Labor and Pensions Committee) and
Eshoo-Barton proposals would establish a 12-year marketing monopoly
(known as “data exclusivity”) for brand-name biologics, a monopoly that
is separate and distinct from the patent monopoly. During this period,
generic competitors would be prohibited from relying on the safety and
efficacy tests conducted by brand-name companies, effectively preventing
them from coming to market. This excessively long period of monopoly
protection (conventional drug makers get only five years) has no
correlation with biologics' manufacturing or research and development
(R&D) costs.

Even more worrisome, the HELP and Eshoo-Barton proposals would permit
brand-name companies to pursue "evergreening" strategies that would
enable them to obtain sequential 12-year marketing monopolies on
biologics. The effect would be to prevent price-lowering generic
competition for decades and to torpedo the objective of cost
containment, which is central to current health care reform efforts.


***You can access text of downloadable versions of the complete fact
sheet at:
http://www.essentialaction.org/access/index.php?/archives/202-Congress-Shou=
ld-Not-Adopt-No-Generics-Proposals-for-Biologics-Evergreening-and-the-Creation-of-Perpetual-Monopolies.html

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Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: +1 (202) 387-8030
Cell: +1 (202) 422-2687
www.essentialaction.org/access/