The Politics of Biotechnology - Indiana University

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5 Δεκ 2012 (πριν από 4 χρόνια και 8 μήνες)

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The Politics of
Biotechnology

Jeffrey Hart

Mini University at Indiana University

June 23, 2005

What is Biotechnology?


“the use of cellular and bio
-
molecular processes
to solve problems or make products” [the BIO
definition]


“the application of scientific and engineering
principles to the processing of materials by
biological agents” [the OECD definition]

What is the Biotechnology Industry?


Traditional industries that use biotechnology,
e.g.:


Pharmaceuticals


Agriculture (GM crops)


Chemicals


Beverages and other food processing


New industries, e.g.:


Bioinformatics


Genome science
-
based



How Big is the Industry?

U.S. Biotech Industry Statistics:
1994

2003
*


Year

2003

2002

2001

2000

1999

1998

1997

1996

1995

1994

Sales*

28.4

24.3

21.4

19.3

16.1

14.5

13

10.8

9.3

7.7

Revenues

39.2

29.6

29.6

26.7

22.3

20.2

17.4

14.6

12.7

11.2

R&D Ex
-
penses

17.9

20.5

15.7

14.2

10.7

10.6

9.0

7.9

7.7

7.0

Net Losses

5.4

9.4

4.6

5.6

4.4

4.1

4.5

4.6

4.1

3.6

No. of
Public
Companies

314

318

342

339

300

316

317

294

260

265

No. of
Companies

1,473

1,466

1,457

1,379

1,273

1,311

1,274

1,287

1,308

1,311

1000s

Employed

198

194

191

174

162

155

141

118

108

103

*Amounts are U.S. dollars in billions.


Sources
: Ernst & Young LLP, annual biotechnology industry reports,
1993

2004
.


Financial data based primarily on fiscal
-
year financial statements of publicly traded companies.

Source:
http://www.bio.org
.


Some Notable Facts


The industry is growing rapidly in both revenues
and employees but not in profits because of
high research expenditures required


Most of the money so far is in pharmaceuticals
and other biomedical applications


Market capitalization is over $
300
billion


Consumers are becoming more and more
dependent on bioengineered crops (e.g. soy,
corn, papaya)


What is Political about
Biotechnology?


All industries are regulated in some form by
governments


New industries are frequently promoted by
governments to generate wealth and employment


Biotechnology itself is politically controversial,
e.g.


Cloning of humans


Stem cell research


GM foods

What Does the Industry Want?


Two most influential industry groups:


Biotechnology Industry Organization (BIO)


Pharmaceutical Research and Manufacturers
Association (PhRMA)




Some Policy Changes the Industry
Wants


Less restrictive regulatory environment,
especially for drug discovery and approval


Stronger intellectual property protection


Permanent R&D tax credits


Improved grants to small businesses through
the SBIR program


Passage of the Stem Cell Therapeutic and
Research Act (HR
2520
)


Help in combating European restrictions on
GM foods

Biotech Drug Discovery Process

Importance of Intellectual
Property Protection

Importance of the SBIR Program


The Small Business Innovation Research (SBIR)
program is administered by the Small Business
Administration (SBA)


Many other US agencies have SBIR programs:
e.g. Defense, NASA, and EPA


Awards only go to firms with less than
500
employees

HR 2520


Requires the Secretary of Health and Human Services
to contract with qualified cord blood stem cell banks to
assist in the collection and maintenance of human cord
blood to be made available for transplantation through
the C.W. Bill Young Cell Transplantation Program.


Requires the Secretary to require that recipients of such
contracts: (
1
) acquire and store donated units of human
cord blood acquired with the informed consent of the
donor in a manner that complies with applicable
Federal and State regulations; and (
2
) make collected
cord blood units available for stem cell transplantation
or, if not appropriate for clinical use, available for peer
-
reviewed research.

President Bush’s Council on
Bioethics


Led by Leon R. Kass, conservative bioethicist


Reports took strong stand against human
cloning and stem cell research


Basis for opposition to stem cell research is that
creating new “stem cell lines” would result in the
“destruction of human embryos”


The President opposes destruction of human
embryos because of the need to promote a
“culture of life.”

US
-
EU Dispute over GM Foods


EU opposed GM foods because of over potential
negative effects of the cultivation of GM species


EU invokes the “precautionary principle”


US claims that the EU has not proven scientifically
that GM foods are dangerous in any way in cases
presented to the World Trade Organization (US
won its case against EU beef restrictions)


EU beef producers pay a fine of $
100
billion
annually to maintain these restrictions

The Precautionary Principle


“When there are threats of serious or irreversible
damage, lack of full scientific certainty shall not
be used as a reason for postponing cost
-
effective
measures to prevent environmental damage.” (p
101
)

The original source is the Declaration of Rio signed at the Rio
Earth Summit in 1992.

Ruth Ozeki,
All Over Creation


Web site:
http://ruthozeki.com


Basic premise: struggle over factory potato
farms in Idaho


Intro of genetically modified potatoes


Purpose to reduce overuse of fertilizers and
pesticides


“The terminator”


genetic modification to prevent
farmer sales of seeds of new organisms


How Should Policy Be Made?


Public interest criteria


Promotion of economic development


Science
-
based research on environmental
impacts


Addressing the concerns of major electoral
groups (democratic responsiveness)