[Ip-health] Congress should reject the 12-14.5 year monopoly for biologic products provided for in HR 1548

[James Love]

http://www.keionline.org/blogs/2009/07/16/reject-hr1548/

16 July 2009

Congress should reject the 12-14.5 year monopoly for biologic products
provided for in HR 1548.

Knowledge Ecology International (KEI) is a non-profit organization that
focuses on issues about innovation and access to knowledge goods,
including new medical inventions.

KEI opposes H.R.1548, the bill to =E2=80=9Cestablish a pathway for the lice=
nsure
of biosimilar biological products,=E2=80=9D on the grounds that the period =
of
the monopoly is excessive, and not subject to safeguards that would
protect consumers.

HR 1548 conditions market entry for biosimilar products on a 12 to 14.5
year period of legal monopoly for products that is independent of the
patent status of products.  The putative rationale is to reward
investments in new products.  However, there is no requirement that the
monopoly bear any relationship to the investments in particular
products, pricing, or the cumulative revenues generated by the product.
The period of exclusivity can extend 9 years beyond that currently
exists for pharmaceutical drugs, and presents considerable risks to the
public as consumers, taxpayers, employers and subjects of medical
experimentation.

The alternative approach supported by Representative Waxman and the
White House of providing a 5 to 7 year monopoly is also excessive, but
certainly preferred to an approach that provides a 14.5 year monopoly.

KEI agrees with Essential Action and others that believe a bill based
upon exclusive rights to rely upon safety and efficacy of products is
itself fundamentally flawed, for several reasons, including the fact
that it provides economic incentives for unnecessary and unethical
clinical testing of products on human subjects.  KEI encourages members
of Congress to reflect on the provisions of the Declaration of Helsinki
on the ethical principles for medical research involving human subjects,
including but not limited to Articles 20 and 21, and to consider if
other approaches are more appropriate, including those that allow
biosimiliars to enter into agreements to share the risk adjusted costs
of clinical trials./1/

Congress should reject the 12-14.5 year approach provided for in HR
1548.
In any case, the grant of a monopoly should not be without limits or
safeguards to protect consumers and taxpayers.  Any bill that grants a
legal monopoly from competition should also include provisions that
allow the monopoly to be eliminated if products are priced excessively,
or if other factors merit a review of the monopoly status.  The bill
should also require that companies disclose actual R&D costs, prices and
revenues for products, and that that the federal government should have
the opportunity to review the provision periodically to determine if the
term of the monopoly is excessive, or if there is a need for additional
safeguards to protect the public, or if new approaches, such as cost
sharing, are more appropriate in the context of a policy to advance
health interests.

Knowledge Ecology International
FMI:  =09Judit Rius judit.rius@keionline.org (1.202.332.2670)
=09James Love james.love@keionline.org (1.202.361.3040)


/1/.  See: Judit Rius Sanjuan- James Love =E2=80=93 Robert Weissman, PROTEC=
TION
OF PHARMACEUTICAL TEST DATA: A POLICY PROPOSAL, 21 November 2006


--
James Love, Director, Knowledge Ecology International
http://www.keionline.org | mailto:james.love at keionline.org
Wk: +1.202.332.2671 | US Mobile +1.202.361.3040 | Geneva Mobile +41.76.413.=
6584