[Ip-health] Boston Globe Editorial: Biotech bills give drugmakers too many years of exclusivity

[Sarah Rimmington]

http://www.boston.com/bostonglobe/editorial_opinion/editorials/articles/200=
9/11/24/biotech_bills_give_drugmakers_too_many_years_of_exclusivity/

GLOBE EDITORIAL
Biotech bills give drugmakers too many years of exclusivity
November 24, 2009

THE BIOTECH INDUSTRY is vital to the Massachusetts economy and the
complex drugs made by companies here deserve robust protection as
intellectual property. But giving exclusive markets to those companies
for too long means that the drugs are priced beyond the reach of some
patients for years - and it only adds to the upward pressure on health
care costs.

Expensive biotechnology drugs - typically made from living cells - cost
patients and insurers billions of dollars a year even as they treat
intractable illnesses. Congress has tried admirably, in pending
legislation, to open the door for approval of generic versions of drugs
known as biologics. But, after intensive lobbying by the biotech
industry, the measures that are emerging from Congress grant too many
years of exclusivity to the original makers. Provisions in the House
health care bill and in a bill approved by the Senate Health Committee
would not allow generic imitators of biotech drugs on the market until
after the original drugs have been on sale for 12 years.

That=92s too long, more than double the five years of protection from
competition guaranteed for conventional drugs. It=92s quite likely that
extensive lobbying accounts for some of the disparity; The New York
Times recently reported that lobbyists for the biotech firm Genentech
ghostwrote parts of official statements made by 42 members of Congress
on the parts of the health care reform bill related to generic biotech
drugs.

The 12-year protection is also excessive because competition from
generics is not likely to erode the ability of the original biotech
manufacturers to continue reaping profits. There are onerous technical
barriers to making so-called biogenerics, unlike generic versions of
conventional medications, so companies that invent original drugs are
likely to retain market share despite the new competition. In Europe,
where a path for approving generic versions of biologics already exists,
the original drugs=92 prices have dropped only by about 25 to 30 percent,
according to the New England Journal of Medicine.

The downside of this, of course, is that approving generic versions is
unlikely to eliminate the drugs=92 annual five- and six-figure price tags
anytime soon.Yet even modest savings add up. Medicare spends more than
$2 billion per year on just one biologic drug, Epogen, used to treat
anemia in kidney patients. The Congressional Budget Office estimates
that the government could save more than $9 billion over the next decade
if biogenerics come on the market after seven years. The long-term
savings would be even greater.

In clearing the path for generic alternatives to expensive biologics,
Congress should enact a shorter window of market exclusivity than 12
years, but more than the five years afforded to simpler, conventional
drugs. A protection period that falls directly in between these extremes
would strike a balance between encouraging companies to make biologic
drugs and making them affordable.

In this case, what=92s optimal for Massachusetts drug firms is not good
for the nation or for suffering patients. A compromise is necessary.


--
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/

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