Ethical Issues Regarding Emerging Technologies 465 PHARMAC.docx

Ethical Issues Regarding Emerging Technologies 465
PHARMACEUTICAL PATENTS
Intellectual P r o p e r t y a n d Pharmaceutical Drugs:
An Ethical Analysis
Richard T. De George
r e c o m p e n s e if t h e result they achieve is useful
a n d beneficial to others w h o are willing to pay
for it. It w o u l d b e unfair o r unjust for o t h e r s t o
take that result, market it as their own, a n d profit
from it w i t h o u t having e x p e n d e d c o m p a r a b l e
time or m o n e y in development, before t h e orig-
inal d e v e l o p e r has a c h a n c e to r e c o u p his in-
vestment a n d possibly make a profit. Intellectual
property protection gives innovators this chance.
T h e second p a r t of the a r g u m e n t is based o n
c o n s e q u e n c e s . It states t h a t unless developers
a r e allowed a p e r i o d d u r i n g which to r e c o u p
their investment a n d m a k e a profit, t h e incen-
tive to p r o d u c e new p r o d u c t s beneficial to so-
ciety will b e greatly r e d u c e d . Society benefits
from new p r o d u c t s , b o t h initially a n d after they
are n o l o n g e r p r o t e c t e d a n d fall into t h e public
d o m a i n . H e n c e , t h e greatest benefit to t h e com-
m o n g o o d or to society is achieved by offering
inventors a n d developers of n e w p r o d u c t s a pe-
riod d u r i n g which they can m a k e their profits
without t h e c o m p e t i t i o n of free riders. B o t h ar-

g u m e n t s t o g e t h e r lead to t h e conclusion t h a t
p r o t e c t i o n of intellectual p r o p e r t y for a limited
p e r i o d of time is j u s t a n d p r o d u c e s m o r e g o o d
for society t h a n a n absence of such p r o t e c t i o n .
I shall call t h e two a r g u m e n t s t o g e t h e r t h e
S t a n d a r d A r g u m e n t (SA). F o r t h e sake of ar-
g u m e n t , let us accept SA as a valid m o r a l justi-
fication for intellectual property. It is general in
form, a n d applies to pharmaceutical products as
well as to inventions, m a c h i n e s , a n d o t h e r types
of intellectual property. T h e r e have b e e n m a n y
studies by economists to support the second part
of t h e Standard A r g u m e n t . T h e pharmaceutical
T h e n o t i o n of intellectual p r o p e r t y (IP) is con-
tentious. N o n e t h e l e s s t h e r e is justification for
g r a n t i n g exclusive rights t o s o m e original use-
ful p r o d u c t s or processes if t h e result benefits
t h e c o m m o n g o o d . T h i s is r e c o g n i z e d in Arti-
cle 1, Section 8 of t h e U.S. Constitution, which
establishes t h e p o w e r of Congress "to p r o m o t e
t h e progress of science a n d useful arts, by se-
c u r i n g for limited times to a u t h o r s a n d inven-
tors t h e exclusive r i g h t t o t h e i r r e s p e c t i v e
writings a n d discoveries." T h e l e n g t h of time is
s o m e w h a t arbitrary, has v a r i e d over t h e p a s t
c e n t u r y , a n d is vastly d i f f e r e n t for c o p y r i g h t
t h a n for p a t e n t s , t h e l a t t e r offering m u c h
stronger protection for a shorter period of time.
THE MORAL JUSTIFICATION
OF INTELLECTUAL PROPERTY
Because intellectual p r o p e r t y is significandy dif-
ferent from o t h e r kinds of property,1 t h e ethical

defenses of intellectual p r o p e r t y differ from the
defenses—such as the Lockean—of o t h e r kinds
of property, a n d traditions in different parts of
t h e world treat intellectual p r o p e r t y differently.
Nonetheless, t h e r e is a two-part a r g u m e n t in de-
fense of the ethical legitimacy of limited intel-
lectual property rights that is intuitively attractive,
widely held, a n d , I believe, s o u n d .
T h e first p a r t is a fairness, o r j u s t i c e , argu-
m e n t t h a t says that, within the e c o n o m i c system
of free e n t e r p r i s e , t h o s e w h o s p e n d t i m e a n d /
o r m o n e y in d e v e l o p i n g a p r o d u c t or t h e ex-
pression of a n i d e a deserve a c h a n c e t o receive
© 2 0 0 5 . Business Ethics Quarterly 15, n o . 4.
466 Ethical Issues Regarding Emerging Technologies
industry a n d s o m e economist have persuasively
a r g u e d t h a t m o r e n e w d r u g s a r e d e v e l o p e d
w h e n p h a r m a c e u t i c a l c o m p a n i e s m a k e suffi-
cient profits to invest in research a n d develop-
m e n t , a n d the p h a r m a c e u t i c a l industry argues
t h a t t h e large profits for which t h e industry is
k n o w n a r e n e c e s s a r y to u n d e r w r i t e b o t h t h e
high cost of developing a new d r u g a n d the large
n u m b e r of initial attempts t h a t never t u r n into
successful, m a r k e t a b l e drugs.
T h e i n d u s t r y t h e n builds o n t h e S t a n d a r d
A r g u m e n t t o d e v e l o p w h a t I shall call t h e
Status Q u o A p p r o a c h (SQA), w h i c h is a legal-
e c o n o m i c a p p r o a c h , to reply to critics of t h e i r

p o l i c i e s w h o a d o p t n o t a n e c o n o m i c b u t a
m o r a l a p p r o a c h to p h a r m a c e u t i c a l s . T h e Sta-
tus Q u o A p p r o a c h takes existing i n t e l l e c t u a l
p r o p e r t y law, especially p a t e n t law, as settin g
t h e a p p r o p r i a t e p a r a m e t e r s w i t h i n w h i c h t o
view a n d answer all challenges to t h e practices
of p h a r m a c e u t i c a l c o m p a n i e s . Taking this ap-
p r o a c h leads to c o n c e n t r a t i o n o n using t h e law
t o h e l p t h e s e c o m p a n i e s p r o t e c t a n d i n c r e a s
e
their profits so that they can develop new drugs.
T h u s they d e f e n d t h e i r t e c h n i q u e s t o e x t e n d
t h e time before which g e n e r i c drugs can b e in-
t r o d u c e d , to e x t e n d p a t e n t p r o t e c t i o n o n a n
i n t e r n a t i o n a l level t h r o u g h t h e W o r l d T r a d e
Organization ( W T O ) , to p r o d u c e me-too drugs
or drugs that are only marginally different from
e x i s t i n g d r u g s r a t h e r t h a n c o n c e n t r a t i n g o
n
b r e a k t h r o u g h drugs, a n d so o n . Morally b a s e d
attacks t h a t m a k e a link b e t w e e n p a t e n t s a n d
t h e availability of d r u g s for t h e p o o r a r e r e -
j e c t e d as misconceived. Nonetheless, t h e r e is a n
a t t e m p t to diffuse t h e latter attacks by giving
away some drugs in some circumstances. T h e s e
giveaway p r o g r a m s a r e p r e s e n t e d as t h e in-
dustry's o r a p a r t i c u l a r c o m p a n y ' s living u p to
its social responsibility. Social responsibility is
t h e s u r r o g a t e for m o r a l responsibility, is p a r t
of t h e Status Q u o A p p r o a c h , a n d is seen by t h e
i n d u s t r y as answering morally b a s e d criticism.
T h e SQA is a n a p p r o a c h t h a t p h a r m a c e u t i -
cal c o m p a n i e s are comfortable with, as well as
o n e t h a t is widely a c c e p t e d . It has t h e benefits

of tradition, of r e q u i r i n g n o c h a n g e in c u r r e n t
practices or law, a n d of having p r o d u c e d b e n -
eficial results in the past. H e n c e , o n e can argue,
it is m o r e likely t h a n u n t r i e d alternative schemes
of intellectual p r o p e r t y p r o t e c t i o n to p r o d u c e
beneficial results in t h e future. T h e a p p r o a c h
thus e n t r e n c h e s a n d sanctifies t h e status q u o .
B o t h t h e S t a n d a r d A r g u m e n t a n d t h e Sta-
tus Q u o A p p r o a c h , however, are c o m i n g u n d e r
i n c r e a s e d strain a n d attack, a n d i n this p a p e r
I shall a t t e m p t t o e x a m i n e t h e d i r e c t i o n of
t h o s e strains a n d t h e validity of t h e s e attacks.
O n l y if we fully a p p r e c i a t e t h e S t a n d a r d Ar-
g u m e n t a n d t h e Status Q u o A p p r o a c h , a n d
t h e i r s h o r t c o m i n g s , c a n we m a k e sense of t h e
c o n t i n u i n g c h a r g e s m a d e by critics a n d t h e re-
sponses m a d e by t h e p h a r m a c e u t i c a l industry.
My a i m is to b r i n g s o m e o r d e r t o a very c o n -
fused a n d confusing p u b l i c discussion o n t h e
a c t i o n s of p h a r m a c e u t i c a l c o m p a n i e s , t h e
o b l i g a t i o n s a t t r i b u t e d t o t h e m , a n d t h e
c l a i m e d r i g h t of t h e p u b l i c w i t h r e s p e c t t o
n e e d e d d r u g s . A l t h o u g h clarifying t h e discus-
s i o n is m y m a i n p u r p o s e , I s h a l l also m a k e
s o m e suggestions for i m p r o v i n g t h e situation.
THE LIMITS OF THE
STANDARD ARGUMENT
Patents, I have a r g u e d , can b e justified from a n
e t h i c a l p o i n t of view. B u t t h a t justification is
l i m i t e d . D e s p i t e t h e c o n s t i t u t i o n a l l y s t a t e
d
basis for p a t e n t s , n e i t h e r c o m m o n g o o d ( n o r
utilitarian) c o n s i d e r a t i o n s form p a r t of w h a t is

r e q u i r e d for a p a t e n t . N o r h a v e e t h i c a l c o n -
s i d e r a t i o n s b e e n a d o m i n a n t c o n s i d e r a t i o n
in
c h a n g e s t h a t h a v e b e e n m a d e i n p a t e n t law.
H e n c e t h e d e t a i l s of h o w p a t e n t p r o t e c t i o n
has d e v e l o p e d d o n o t follow f r o m t h e ethical
j u s t i f i c a t i o n . I t is n o t t h a t t h e way i n w h i c h
p a t e n t law has d e v e l o p e d is u n e t h i c a l , b u t t h a
t
it is only o n e of m a n y sets of ethicallyjustifiable
ways of p r o t e c t i n g p h a r m a c e u t i c a l s .
Discussions of intellectual property are very
complex and involve knowledge of convoluted
laws, legal decisions, and economic and busi-
ness analyses. Typically, at any negotiation in-
volving intellectual property prior to the
drafting of legislation, the parties are govern-
ment officials, lawyers, and corporate repre-
sentatives. Thus the best defense of those
policies is given not in ethical but in legal and
economic terms. This is why the SQA uses
these. Critics, however, fail to be convinced by
such considerations. It is not clear to them
who, if anyone, represents the general public
in the general process. It is difficult for any
government to represent both the consumer
and the industry, and the public's trust in gov-
ernment as representing the public's interest
is lessened when the industry present in the
negotiations is the pharmaceutical industry,
which is known for being one of the most suc-

cessful lobbying groups and for being among
the top spenders of lobbying money.
The complaint about the Standard Argu-
ment is not that it is wrong, but that it is taken
to prove too much and to respond to all ob-
jections. The mantra that is repeated by in-
dustry representatives in every context and in
reply to every criticism with respect to intel-
lectual property protection, pricing, and access
is that unless the pharmaceutical companies
are profitable enough to have the funds to do
so and can expect future profits from their
products, they will not engage in R&D and will
not develop new drugs, which, of course, ben-
efit society as a whole. When critics point to
the fact that the industry has the highest rate
of profit of any industry year after year, this is
the primary answer. When critics complain
about the high cost of drugs and the fact that
the price of drugs increases much faster than
the inflation rate, this is their answer. When
the critics claim that the developed nations are
forcing the less-developed ones to adopt stan-
dards of intellectual protection that go against
their traditions and may not be in their best
interests, this is their answer. When critics say
that the reason for intellectual property pro-
tection is not private profit but the common
good, this is the answer. And all this makes
some sense because there is ample evidence
that, without profits, there are few new drugs
developed. Yet the answer covers over a good
deal, as I shall try to show. . . .

THE RIGHT-TO-HEALTH-CARE
ARGUMENT
Just as the Standard Argument is often as-
sumed by the pharmaceutical industry, the de-
fense of the right to health care is often
assumed by its critics. The critics do not deny
the overall validity of the SA and the SQA, but
at its limits the critics challenge the applica-
tion of the argument and the defenses of their
practices given by representatives of the phar-
maceutical industry. The central claim is that
although the Standard Argument justifies the
right to intellectual property, the right is only
a prima facie and n o t an absolute right. In
many cases the right holds sway and trumps
other considerations. But in the case of phar-
maceuticals it comes up against other prima
facie rights, namely the right to life, the right
to adequate health care, and the right to access
essential lifesaving drugs; it comes up against
the obligation to aid those in need; and it
comes up against competing claims made in
the name of the common good. The right to
life, the right to adequate health care, the right
to access to essential lifesaving drugs, and the
obligation to aid those in need, critics note,
must be given at least as much consideration
as intellectual property rights. Not only do IP
rights not necessarily trump those other rights,
but they are in fact often trumped by them.
The pharma industry tends to argue that in-
tellectual property rights are always sacrosanct,
when they are not. Although critics sometimes
give too little weight to the actual strength of

IP rights, t h e rights to health a n d to h e a l t h care
raise s e r i o u s issues in c e r t a i n c i r c u m s t a n c e s
a b o u t t h e p h a r m a industry's claims. H e n c e t h e
discussion d o e s n o t e n d with simply asserting
t h e S t a n d a r d A r g u m e n t a n d t h e SQA.
W h a t t h e n a r e t h e a r g u m e n t s in s u p p o r t of
t h e r i g h t t o h e a l t h a n d h e a l t h c a r e a n d t h e
r i g h t to access, a n d h o w c a n they b e w e i g h e d
against t h e r i g h t to i n t e l l e c t u a l p r o p e r t y ?
T h e r e is considerable confusion in t h e liter-
a t u r e , a n d a l t h o u g h the basic ethical claims are
usually fairly clear, how they are justified is n o t .
We c a n start by distinguishing two different
rights t h a t are often confused. T h e y are related
b u t are n o t identical. O n e is t h e r i g h t to health;
t h e o t h e r is t h e r i g h t to h e a l t h care. T h e U N
Declaration of H u m a n Rights, Article 2 5 , states
(1) Everyone has the right to a standard of liv-
ing adequate for the health and well-being of
himself and of his family, including food, cloth-
ing, housing, and medical care and necessary
social services, and the right to security in the
event of unemployment, sickness, disability, wid-
owhood, old age, or other lack of livelihood in
circumstances beyond his control.
A l t h o u g h t h e r e a r e a n u m b e r of different
rights i n c l u d e d in this s e n t e n c e , for o u r p u r -

p o s e s two a r e c e n t r a l . O n e is t h e r i g h t t o
h e a l t h ; t h e o t h e r is t h e r i g h t to m e d i c a l o r
h e a l t h c a r e . I t is g e n e r a l l y a g r e e d t h a t t h e
rights stated in t h e D e c l a r a t i o n a r e p r i m a r i l y
r i g h t s t h a t m e m b e r s of a state enjoy vis-a-vis
t h e i r g o v e r n m e n t s . T h u s , t h e p r i m a r y obliga-
t i o n t h a t is correlative to t h e r i g h t to h e a l t h
falls o n t h e s t a t e . T h e r i g h t t o h e a l t h h a s
p e r h a p s r e c e i v e d so little a t t e n t i o n i n devel-
o p e d n a t i o n s b e c a u s e i n its m o s t p l a u s i b l e
sense t h e s e n a t i o n s face n o p r o b l e m with re-
spect to it. Most plausibly t h e r i g h t to h e a l t h is
a n a l o g o u s to t h e r i g h t t o life. T h e state c a n -
n o t give a n y o n e h e a l t h . Its o b l i g a t i o n , r a t h e r
,
is to e n s u r e t h a t t h e c o n d i t i o n s necessary for
m a i n t a i n i n g g o o d h e a l t h a r e p r o v i d e d a n d t o
p r e v e n t any party from d a m a g i n g t h e h e a l t h of
a n o t h e r . U n d e r s t o o d in this way, t h e state h a s
t h e obligation to provide those c o n d i t i o n s t h a t
p r o m o t e t h e h e a l t h of its citizens, s u c h as e n -
s u r i n g c l e a n w a t e r a n d air, p r o v i d i n g sewers
a n d s a n i t a t i o n , a n d t a k i n g o t h e r basic m e a -
s u r e s n e c e s s a r y to p r o m o t e a n d p r o t e c t t h e
h e a l t h of its m e m b e r s . But a l t h o u g h states may
have t h a t g e n e r a l o b l i g a t i o n , t h e i r o b l i g a t i
o n
does n o t e x h a u s t t h e obligation of o t h e r s . T h e
r i g h t s i m p o s e o b l i g a t i o n s o n b u s i n e s s , i n d i
-
viduals, a n d o t h e r s as well. It is a violation of
t h e h u m a n r i g h t to h e a l t h , for i n s t a n c e , for
m a n u f a c t u r e r s to d u m p toxic waste t h a t will
infiltrate a community's water supply a n d cause
p e o p l e to fall ill. T h e o b l i g a t i o n n o t to cause

h a r m to p e o p l e ' s h e a l t h a n d t h u s n o t to act in
this way is a negative obligation. Positively, com-
p a n i e s a r e b o u n d to p r o v i d e safe a n d h e a l t h y
w o r k i n g c o n d i t i o n s for t h e i r e m p l o y e e s . P r o
-
v i d i n g t h e s e c o n d i t i o n s is a n o b l i g a t i o n im-
p o s e d o n t h e m by t h e i r e m p l o y e e s ' r i g h t to
h e a l t h , w h e t h e r o r n o t it is also r e q u i r e d by
law. A n d positively, t h e g o v e r n m e n t h a s t h e
o b l i g a t i o n to pass a n d e n f o r c e s u c h laws.
If o n e r e a d s t h e r i g h t to h e a l t h c a r e in t h e
s a m e way, t h e n it is a n o b l i g a t i o n of states o r
g o v e r n m e n t s to see t h a t m e d i c a l c a r e is avail-
able to t h e i r p e o p l e , w h e t h e r o r n o t t h e gov-
e r n m e n t s actually p r o v i d e it. A l t h o u g h states
a r e generally h e l d r e s p o n s i b l e for p r o t e c t i n g
t h e h e a l t h of t h e i r citizens by p r o v i d i n g t h e
c o m m o n g o o d s of c l e a n d r i n k i n g w a t e r a n d
sewers a n d o t h e r g e n e r a l s a n i t a t i o n facilities,
they a r e n o t usually h e l d r e s p o n s i b l e for p r o -
viding h e a l t h care in t h e same way. T h e r e a s o n
is t h a t t h e p r i n c i p l e of subsidiarity c o m e s i n t o
play. T h e p r i n c i p l e of subsidiarity states t h a t
o n e d o e s n o t call o n a h i g h e r level to d o a j o b
t h a t c a n b e d o n e at a lower level. With r e s p e c t
to h e a l t h c a r e , it is usually a p p l i e d intuitively,
even by t h o s e w h o d o n o t use t h a t t e r m . T h u s ,
w h e n c h i l d r e n g e t sick, for i n s t a n c e , it is typi-
cal for their p a r e n t s to care for t h e m , a n d fam-
ily m e m b e r s usually are t h e p r i m a r y caregivers,
r a t h e r t h a n t h e state. W h e n a family is u n a b l e

to adequately care for someone who needs
medical care, they might first go to the circle
of friends, or to the larger community. When
the community cannot handle the need, they
go to the city or the state or federal level. Al-
though in a developed society the structures
are in place to handle the needs of people at
the appropriate level, they are considerably
different in a country that has a socialized med-
icine program than in a country that does not.
If a government is unable to handle the need
or needs it faces, it might appeal to the inter-
national community. Also assumed by this
process is that individuals have not only the
right to health and health care, but they also
have the obligation to do what they can to pre-
serve their health and to care for themselves
to the extent they are able to do so. Thus the
rights to health and to health care impose cor-
relative obligations on many parties. So far the
obligations of pharmaceutical companies are
no different from the obligations of other com-
panies. But this is only part of the story.
Another a r g u m e n t comes into play her e
that develops the obligation to help others in
serious need to the extent that one can do so.
There are two versions of this. One is a weak
version which says that one has the obligation
to help others in serious need to the extent
that one can do so with little or moderate cost
to oneself. A stronger version says that one
must do so even at great expense to oneself,
although one does not have to make oneself
worse off than the person or persons one is

helping. The obligation to aid others in serious
need can be justified by either a rule-utilitarian
approach, which argues that more good is
achieved overall if this rule is followed than if
it is not; or by a deontological approach, which
bases it on the respect due others as persons
and beings worthy of respect. The obligation
is one that is widely acknowledged. Intuitively,
if one sees a child drowning and one can save
the child's life by extending a hand, one has
the obligation to do so. Not to do so would be
characterized by most people as inhuman or
barbaric. The obligation holds even if one will
be late to an appointment, or if one will get
one's shoes wet in the process of saving the
child. The obligation becomes less clear as the
cost to oneself increases, and most would agree
that one is not obliged to save the child at the
risk of one's drowning oneself.
The application of this principle with re-
spect to an individual vis-a-vis a drowning child
is straightforward. It becomes more and more
problematic as the case becomes more com-
plex. What if the child is drowning in the water
of a crowded beach, with a thousand people
on it? Is it the obligation of each of the thou-
sand to save the child? Is the obligation greater
for those closer? Is it exculpatory for someone
who is dressed to say that the obligation falls
on those in bathing suits? Would all be equally
blameworthy if no one did anything and the
child drowned? Now increase the number of
children drowning, say from an overturned
boat, to twenty. Each person on the beach can

save at most one of the children. Is it the oblig-
ation of every person on the beach to save all
the children, or to save only one, and, if the lat-
ter, which one? When we then move to mil-
lions of people in danger of death from the
lack of medical care in the world and ask what
is the obligation of developed countries, of
those living in developed countries, of NGOs,
and of pharmaceutical companies with respect
to the needy, the arguments tend to get more
and more tenuous. This is not to say that there
is no obligation to help based on the right of
the people to health or medical care. But the
complexity of the situation suggests the need
for action by many parties on many levels.
If one accepts the obligation of aid, then it is
not difficult to argue that those in the best po-
sition to help have the greatest obligation to do
so. Nowjoin that with the fact that those in the
health professions have special obligations with
respect to health and health care. They have
these special obligations because of the field
they have freely chosen, because they are related
to h e a l t h care in a way o t h e r s are n o t , because
they have the expertise t h a t others lack, a n d be-
cause t h e y m a k e t h e i r living o r p r o f i t f r o m
health-related activities. A doctor, for instance,
has a gr eat er obligation to h e l p an accident vic-
tim if o t h e r aid is n o t available, t h a n does some-
o n e w i t h o u t medical training. A hospital has a

g r e a t e r obligation to h e l p a n a c c i d e n t victim
b r o u g h t t h r o u g h its doors t h a n does a b a n k or
a d e p a r t m e n t store, a n d p e o p l e naturally would
b r i n g such victims to a hospital r a t h e r t h a n to
some o t h e r kind of enterprise. . . .
With this b a c k g r o u n d we c a n d e v e l o p t h e
r i g h t to access t o n e e d e d medicines. B u t t h e ar-
g u m e n t works differently with r e s p e c t to life-
saving m e d i c i n e s , to those which are necessary
for h e a l t h b u t w h i c h t r e a t n o n - l i f e - t h r e a t e n
-
i n g illnesses, a n d t o those t h a t a r e n e i t h e r a n d
a r e simply l i f e- enhanci ng.
T h e s t r o n g e s t case c a n b e m a d e f o r t h e
r i g h t to access to those d r u g s t h a t are essential
for t h e preservation of life. If o n e has t h e r i g h t
to life, t h e n o n e has t h e r i g h t to t h a t w h i c h is
necessary to sustain o n e ' s life—be it food a n d
shelter, o r m e d i c i n e s a n d m e d i c a l c a r e . Med-
icines, obviously, a r e i n c l u d e d in m e d i c a l care.
T h e r i g h t of access to available lifesaving m e d -
icine has b o t h a negative a n d a positive aspect.
Negatively, all h a v e t h e o b l i g a t i o n n o t t o p r e -
v e n t a n y o n e from h a v i n g access to w h a t they
n e e d to sustain t h e i r lives. T h e positive oblig-
a t i o n to e n s u r e t h a t access is available, as in
t h e e a r l i e r case, falls o n a variety of p a r t i e s
(applying t h e p r i n c i p l e of subsidiarity) a n d is
practically limited by t h e g o o d s a n d r e s o u r c e s
available in a given situation. . . .
I shall call t h e s e t of a r g u m e n t s I h a v e
s k e t c h e d o u t above t h e M o r a l A r g u m e n t .

P e o p l e typically invoke s o m e t h i n g like t h e
above g e n e r a l a r g u m e n t s with r e s p e c t t o t h e
d r u g i n d u s t r y a n d d r u g c o m p a n i e s . T h e vari-
ous claims are t h a t t h e industry as a whole a n d
t h e individual c o m p a n i e s t h a t m a k e it u p have
special o b l i g a t i o n s ; t h a t t h e s e a r e r e l a t e d to
w h a t t h e y p r o d u c e , n a m e l y p h a r m a c e u t i c a l
d r u g s ; t h a t t h e y a r e in a s p e c i a l p o s i t i o n t o
h e l p a n d t h a t t h e r e f o r e they have t h e special
o b l i g a t i o n t o d o s o ; a n d t h a t t h o s e i n d i r e
n e e d , b e c a u s e of their r i g h t to h e a l t h care, im-
p o s e o b l i g a t i o n s o n t h o s e a b l e t o h e l p , in-
c l u d i n g t h e p h a r m a c e u t i c a l industry.
We can apply this claimed right to access b o t h
o n the international a n d o n the national level in
t h e U n i t e d States a n d see h o w we can weigh it
against t h e right to intellectual property.
We s h o u l d n o t e t h a t a p p r o a c h i n g e t h i c a l
issues r e l a t i n g to t h e p h a r m a c e u t i c a l i n d u s t r
y
from t h e perspective of t h e M o r a l Right to Ac-
cess dramatically c h a n g e s t h e issues t h a t rise to
t h e surface as o p p o s e d to those that arise w h e n
t a k i n g t h e S t a n d a r d A r g u m e n t a n d t h e Status
Q u o A p p r o a c h . To see how, we c a n start with
t h e p h a r m a c e u t i c a l c o m p a n i e s ' u s e of t h e
t e r m "social responsibility."
THE MORAL RESPONSIBILITY
OF PHARMACEUTICAL COMPANIES
With this b a c k g r o u n d , we c a n n o w ask: W h a t
a r e t h e obligations, from a n ethical p o i n t of

view, of t h e p h a r m a c e u t i c a l industry as a whole
a n d of individual p h a r m a c e u t i c a l c o m p a n i e s ?
T h e above discussion f o r m s t h e b a c k g r o u n d
t h a t is g e n e r a l l y u n d e r s t o o d by critics, e v e n
t h o u g h they d o n o t often a r t i c u l a t e t h e i r ar-
g u m e n t s very clearly. C a n we c o m e u p with
g e n e r a l obligations t h a t s t e m from t h e rights
of those in n e e d of medical care? Clearly, phar-
maceutical c o m p a n i e s are n o t t h e only health-
care providers a n d t h e entire obligation to fulfill
t h e r i g h t s in q u e s t i o n d o e s n o t fall o n t h e m .
A n d clearly if t h e y h a v e special o b l i g a t i o n s ,
t h a t does n o t m e a n that g o v e r n m e n t s , individ-
uals, families, NGOs, a n d so o n d o n o t also have
obligations. Since g o v e r n m e n t s have t h e pri-
m a r y responsibility to p r o v i d e for t h e h e a l t h
care of their citizens, they bear the primary oblig-
a t i o n . T h e y m a y e i t h e r m e e t this o b l i g a t i o n
directly or indirectly by ensuring the needs of
the public are met in some other way.
Given present structures, the pharmaceuti-
cal industry, as part of the health-care system, ar-
guably has two basic ethical obligations. I shall
call the first the Production Obligation and the
second the Access Obligation. The obligations
of the industry with respect to health care are
broader and more general than the obligations
of any particular pharmaceutical company. The
industry's obligations can only be met to the
extent that individual companies take the ap-

propriate action. Yet the two levels—industry
and company—should be kept distinct, even
though many critics conflate the two.
The Production Obligation
T h e Production Obligation consists in the
obligation to develop and produce beneficial
drugs. This is the area of the industry's ex-
pertise and it is that which the companies in
the industry can do that others cannot. More-
over, in this regard one can argue that the
pharmaceutical industry as well as individual
companies have the obligation to pursue
needed new lifesaving drugs more than to pur-
sue alternatives to drugs that already exist and
are effective, namely, so-called me-too drugs.
Benefit to the patient, and hence to the pub-
lic and the common good, should play a
greater role in the case of health care than in
other industries, just as safety is paramount in
the engineering industries, whether it be in
airplane or building and bridge safety. This
first obligation is not an unjust imposition by
society, but simply reflects part of the role of
pharmaceutical companies in society. The
obligation is one that is arguably shared by
governments also. The United States Govern-
ment funds billions of dollars worth of medical
research, and it is appropriate that it does so
because of its obligation to fulfill the rights of
its citizens to health and to health care. In a
free enterprise system governments do not
engage directly in production, although they
can encourage and promote production

through their system of intellectual property
protection and their tax system, among oth-
ers. To the extent that the pharmaceutical in-
dustry fails to produce needed drugs, it is up to
governments to ensure that they are produced.
Many pharma companies and the industry
in general, as well as government-sponsored pro-
grams, are engaged in the search for cures or
remedies for cancer, various kinds of heart dis-
ease, new and improved antibiotics to fight in-
fections, and so on. The industry as a whole,
therefore, not only is actively engaged in fulfill-
ing this obligation, but individual pharmaceu-
tical companies have an economic interest in
pursuing breakthrough and essential new drugs.
The market for such drugs, if they treat diseases
suffered by large numbers of people in the de-
veloped countries, is potentially lucrative.
Nonetheless the market incentive fails with
respect to orphan drugs. Diseases which are
lifethreatening but in which the market is ei-
ther small or the potential recipients poor, re-
quire a different approach.
In the United States the Orphan Drug Act
has proven to be a successful marriage of
government and pharmaceutical companies.
The government provides tax incentives and
guarantees 7 years of exclusivity (after FDA ap-
proval) to encourage drug makers to develop
drugs that affect fewer than 200,000 people and
are generally unprofitable. The result has been,
on the whole, positive, despite abuses. . . .

The market similarly fails with respect to the
development of drugs for diseases restricted
to those living in tropical countries. Although
the governments in such countries have the re-
sponsibility for providing for the health of their
people, they have insufficient funds to promote
research and in addition they lack the facili-
ties and the expertise needed. With minimal
budgets for health care, they have difficulty pro-
viding the bare essentials of clean water and
sanitation and developing an adequate delivery
system for h e a l t h care, regardless of t h e cost of
drugs. U n d e r these c o n d i t i o n s t h e obligation
of aid c o m e s to t h e surface. I n this case t h e ap-
p r o p r i a t e aid is t h e d e v e l o p m e n t of d r u g s for
t h e diseases i n q u e s t i o n . T h e obligation d o e s
n o t clearly fall o n any particular p h a r m a c e u t i -
cal company, a n d h o w it is to b e a p p o r t i o n e d
a m o n g c o u n t r i e s a n d t h e p h a r m a c e u t i c a l in-
dustry worldwide is a t o p i c t h a t u r g e n t l y n e e d s
addressing. T h e first step in any solution, how-
ever, is to r e c o g n i z e t h e o b l i g a t i o n . P e r h a p s
s o m e t h i n g c o m p a r a b l e to a n i n t e r n a t i o n a l
or-
p h a n d r u g a c t c a n b e a g r e e d u p o n ; p e r h a p s
g o v e r n m e n t s can subsidize special r e s e a r c h in
t h e s e areas; p e r h a p s c o m p a n i e s c a n a g r e e to
fund j o i n t research for drugs that w o u l d n o t b e
covered by patents a n d w o u l d b e p r o d u c e d a n d
d i s t r i b u t e d a t cost. T h e a c t u a l a c t i o n t a k e n
s h o u l d b e t h e result of n e g o t i a t i o n s a m o n g all

t h e i n t e r e s t e d a n d affected parties. T h e p h a r -
m a c e u t i c a l i n d u s t r y clearly h a s a n i m p o r t a n t
r o l e to play in any s u c h n e g o t i a t i o n s . B u t ap-
p r o a c h i n g t h e p r o b l e m from t h e p o i n t of view
of t h e Moral A r g u m e n t brings to the fore oblig-
a t i o n s i n this r e g a r d t h a t t h e S t a n d a r d Argu-
m e n t a n d t h e Status Q u o A p p r o a c h d o n o t .
A l t h o u g h I have i n d i c a t e d t h e financial in-
centive t h a t d r u g c o m p a n i e s have t o p u r s u e
i m p o r t a n t n e w d r u g s , critics of t h e p h a r m a -
c e u t i c a l i n d u s t r y h a v e c o n c e n t r a t e d o n
w h e t h e r t h e d r u g i n d u s t r y is actually d o i n g ei-
t h e r all it can a n d s h o u l d d o , o r all it claims to
b e d o i n g with r e s p e c t t o t h e d e v e l o p m e n t of
n e w d r u g s . T h e issue arises in p a r t b e c a u s e of
t h e i n d u s t r y ' s use of t h e S t a n d a r d A r g u m e n t
a n d t h e Status Q u o A p p r o a c h . T h e m a n y tac-
tics u s e d by p h a r m a c e u t i c a l c o m p a n i e s t o p r o
-
d u c e p r o f i t s a r e j u s t i f i e d , t h e SA a n d S Q A
claim, b e c a u s e t h e s e profits a r e necessary t o
f u n d t h e r e s e a r c h t h a t has l e d to a n d will l e a d
t o t h e d e v e l o p m e n t of n e w e s s e n t i a l d r u g s .
T h e industry thus implicitly acknowledges t h a t
t h e p r o d u c t i o n of s u c h d r u g s is its goal, even
if it d o e s n o t a c k n o w l e d g e t h a t it is also its
o b l i g a t i o n .
I t is in this c o n t e x t t h a t s o m e critics claim
t h a t t h e a m o u n t t h a t t h e i n d u s t r y s p e n d s o n
R&D is less t h a n t h e a m o u n t t h a t it s p e n d s o n
m a r k e t i n g (including advertising, free samples
to d o c t o r s , e t c . ) , t h a t t h e a m o u n t may even b e
less t h a n the a m o u n t it s p e n d s o n lobbying gov-
e r n m e n t officials; t h a t m o s t of t h e profits it

makes are n o t in fact plowed back into research
b u t d i s t r i b u t e d as d i v i d e n d s to s h a r e h o l d e r
s ;
a n d t h a t m o s t of t h e r e s e a r c h t h a t leads to n e w
d r u g s c o m e s f r o m g o v e r n m e n t - f u n d e d r e -
search, t h e results of w h i c h a r e a p p r o p r i a t e d
for private gain. All of this m a y b e a p p r o p r i -
a t e . B u t it is n o t self-evidently so, a n d this is
w h a t m o s t c o n c e r n s t h e critics. T h e i n d u s t r y
in its b l a n k e t claims fails to b e convincing.
A c c o r d i n g t o a 2002 study of t h e N a t i o n a l
I n s t i t u t e for H e a l t h C a r e M a n a g e m e n t Re-
search a n d Educational F o u n d a t i o n for t h e pe-
r i o d 1989-2000, only 35 p e r c e n t of n e w d r u g
applications c o n t a i n e d n e w active i n g r e d i e n t s
(of which only 15 p e r c e n t were c o n s i d e r e d to
provide "significant i m p r o v e m e n t over existing
d r u g s " ) , while 5 4 p e r c e n t w e r e i n c r e m e n t a l
m o d i f i c a t i o n s of e x i s t i n g d r u g s ( a n d u n d e r
H a t c h - W a x m a n get u p to 3 years of m a r k e t ex-
clusivity) a n d 11 p e r c e n t were identical to ex-
isting drugs.2 Although these facts by themselves
prove n o t h i n g with r e s p e c t to t h e obligation to
provide new drugs, they are used by critics to off-
set t h e i m a g e t h a t t h e p h a r m a c e u t i c a l industry
suggests by its u s e of t h e SA t o justify its a p -
p r o a c h t o t h e d e v e l o p m e n t of n e w d r u g s .
To b e convincing t h e industry m u s t first ac-
k n o w l e d g e its obligations; b u t even m o r e im-
p o r t a n t it must b e willing to show why the above
activities a r e necessary to p r o d u c e n e w drugs.
Simply p o i n t i n g to n e w d r u g s as p r o o f is a n in-
stance of a logical fallacy. Simply b e c a u s e new
drugs have b e e n p r o d u c e d a n d t h e industry has

b e e n profitable u s i n g its advertising, lobbying,
a n d o t h e r techniques, does n o t show t h a t these
techniques are necessary to p r o d u c e new drugs.
If o n e takes t h e o b l i g a t i o n to p r o d u c e n e w
lifesaving d r u g s seriously, t h e n o n e m i g h t
c o n s i d e r c h a n g e s i n t h e s t a t u s q u o w i t h r e -
spect to IP. Essential, lifesaving d r u g s c a n a n d
a r g u a b l y s h o u l d b e d i s t i n g u i s h e d from o t h e r
d r u g s for a variety of p u r p o s e s . Me-too d r u g s
a n d i n c r e m e n t a l c h a n g e s , as well as c o s m e t i c
c h a n g e s , d o n o t clearly deserve t h e s a m e p r o -
t e c t i o n o r t h e s a m e e n c o u r a g e m e n t a n d in-
d u c e m e n t o n t h e p a r t of g o v e r n m e n t . . . .
T h e A c c e s s O b l i g a t i o n
T h e s e c o n d obligation, t h e Access O b l i g a t i o n ,
is t h e o b l i g a t i o n t o m a k e t h e d r u g s t h e i n d u s -
try o r a c o m p a n y develops available to t h o s e
w h o n e e d t h e m . S i m p l y d e v e l o p i n g t h e m
w o u l d n o t serve any p u r p o s e o t h e r w i s e . Ful-
filling this o b l i g a t i o n m a y b e c o m p a t i b l e with
t h e existing structures relating to existing prac-
tices c o n c e r n i n g intellectual property, pricing,
g o v e r n m e n t r e g u l a t i o n , charity, a n d so o n . Yet
critics c l a i m t h a t b o t h t h e i n d u s t r y a n d t h e
m a r k e t fail to s o m e e x t e n t with r e g a r d to this
o b l i g a t i o n , a n d t h e y claim t h a t if a n d w h e n
c u r r e n t p r a c t i c e s i m p e d e t h e f u l f i l l m e n t of
this o b l i g a t i o n , t h e n t h e r i g h t to access a n d

t h e c o n c o m i t a n t o b l i g a t i o n to p r o v i d e access
take p r e c e d e n c e over IP a n d o t h e r rights.
T h e a r g u m e n t as we have d e v e l o p e d it so far
imposes a s t r o n g e r obligation o n g o v e r n m e n t s
to e n s u r e access t h a n it d o e s o n t h e p h a r m a -
ceutical industry. As we have d e v e l o p e d t h e ar-
g u m e n t t o aid, it c o m e s i n t o play m o s t clearly
in times of d i r e n e e d . This w o u l d apply m o s t
clearly with respect to essential lifesaving drugs.
T h e obligation to h e l p those in n e e d in less dire
c i r c u m s t a n c e s is p r o p o r t i o n a t e l y weaker. B u t
t h e obligation of g o v e r n m e n t s is n o t to e n s u r e
access only for lifesaving drugs, b u t for all drugs
n e e d e d for h e a l t h . G o v e r n m e n t s a r e o b l i g e d
to e n s u r e t h e i r p e o p l e have access, w h e t h e r by
actually buying a n d supplying t h e d r u g s or by
o t h e r m e a n s — s u c h as m a k i n g s u r e t h e p r i c e
of d r u g s m a k e s t h e m accessible. T h e r i g h t to
access p u t s a strain o n any s t r o n g claim to in-
tellectual property rights in drugs, if what stands
in t h e way of p e o p l e receiving lifesaving drugs
is maximizing c o r p o r a t e profit.
(a) Let us look at the poor countries first. The
question of access to many medicines is a press-
ing need. Although governments have the re-
sponsibility to enable or provide access, it is
beyond the ability of many of them to do so.
Hence the obligation falls on others able to do
so. Included in that number are pharmaceu-
tical companies, especially those that manu-
facture the n e e d e d drugs. The issue was
brought to global attention by the AIDS epi-
demic. The drugs in question are very expen-

sive and only a few are on the current WHO list
of essential drugs because of that. The most
widely used such drug in poor countries is a
combination of three generic drugs produced
by the Indian pharmaceutical company Cipla.
Nonetheless, it is clear from the Moral Argu-
ment that when millions of people are dying
and can benefit substantially from available
medicines, they have a right to access with re-
spect to them. A consensus is emerging that
many parties are ethically responsible for ac-
cess—the patient, the local government, other
governments that can help, NGOs, interna-
tional organizations, and the drug companies.
The problem is clearly not only the result of
practices of pharmaceutical companies. Even
if the drugs were given away free, access by
many of the needy would still be a problem.
And a number of pharmaceutical companies
have instituted plans to give away antiretroviral
drugs, to sell them at cost, or to license them
for production by generic manufacturers in
less developed countries under certain condi-
tions. Arguably they are at least to some extent
meeting their obligation to be part of the so-
lution. (We have already seen the arguments of
critics to the industry's approach that it is being
socially responsible by its programs.)
Both nations and companies seem to ac-
knowledge in principle the obligation to re-
spond in case of dire need. Thus, for instance,
a provision of the TRIPS agreement states that
mandatory licensing of necessary medicines is
justifiable in times of extreme national emer-
gencies (such as epidemics) as decided by the

country in question. Yet despite the Agreement
the right to access is not being met and the phar-
maceutical industry bears part of the blame.
The TRIPS Agreement, despite its recognition
of the obligation to aid, has in practice had little
effect and has been faulted for a number of rea-
sons. In 2001 PhRMA and a group of pharma-
ceutical companies charged South Africa with
violating the WTO's rules on patents by pro-
ducing the drugs needed by their people and 40
companies filed suit. After much adverse pub-
licity, the charges and the suit were withdrawn.
But neither the industry nor the companies in-
volved ever acknowledged the right of the South
African government to provide access to the
needed life saving drugs in accord with the
spirit of TRIPS, if not with its letter.
The TRIPS Agreement requires that poor
countries adopt the type of IP protection found
in the developed countries. They must do so
whether or not it impedes the government of
the country in question from meeting its oblig-
ation to provide access to needed drugs for its
people. In this way it fails to consider the com-
mon good of the people of the country in ques-
tion. For instance, while strong defenses of
intellectual property with respect to pharma-
ceuticals may produce the best results overall
for developed countries, they do not seem to do
so for poor and developing countries, such as

India. If, as drug companies claim, new drugs
cost $800,000,000 to develop, then developing
countries are probably not able to develop any.
They are better served by developing generic
drugs or by requiring compulsory licensing of
drugs or by some other strategy. Compulsory
licensing and parallel importing policies—with
measures adopted to prevent the development
of a gray market—would arguably benefit poor
countries more than present arrangements.
The Moral Argument puts these as well as other
suggestions on the table for consideration,
while the Standard Argument and the Status
Quo Approach—used in negotiating TRIPS—
in effect prevent their being r a i s e d . . . .
(b) As opposed to poor countries that cannot af-
ford drugs, the United States can afford to pay
for drugs. In fact the United Stated both pays
more for drugs and contributes more to the
profit of the pharmaceutical companies than
any other nation. So the aspect of the right to
access that has received the greatest attention
is the barrier of high prices to access, even
though access and price are not the same
thing. Even if drugs were free, access requires
that the drugs be transported, distributed, and
administered to patients. At issue is accessibil-
ity, especially of the newer drugs for which no
competitive generic drug is available. Although
the lack of accessibility for the poor and el-
derly on restricted incomes gets most publicity,
more and more people are complaining that
the high cost of drugs is limiting accessibility by
putting the cost of insurance out of their reach.

As insurance prices rise, employers are less and
less willing to pay the escalating costs and are
forcing employees to bear a larger and larger
portion of the cost. The complaints against the
pharmaceutical industry focus especially on
two issues that are seen as limiting access. One
is the high and ever increasing price of new
drugs covered by patents. Not only the poor
and elderly, but even middle-class families find
that the "co-pay" portion of medicines is in-
creasing at a rate so much faster than inflation
that they are having a harder time keeping up.
The second is what is seen as illegitimate at-
tempts by drug companies to "extend" their
patents and to prevent generic drugs from en-
tering the market, thereby keeping prices high
and restricting access for those who can afford
only the lower cost of the generics.
The Status Quo Approach simply applies
market economics, assuming the force of law
in protecting intellectual property rights with
respect to patents, and adding that the over-
all result is not only fair but produces the most
good for society. A rights approach to health
care yields a different focus. If the right to
access to needed drugs is more important than
the right to property, then the status quo is up
for evaluation and becomes a candidate for
change, rather than for passive acceptance.
The issue then is not what does market eco-
nomics prescribe, but how should the status
quo be changed to do justice to the right to
access to needed drugs. This means once again
that intellectual property rights with respect
to pharmaceutical drugs should be carefully

scrutinized and perhaps changed. . . .
i. Access and the Cost of Drugs. My earlier ar-
g u m e n t d i s t i n g u i s h e d b e t w e e n t h o s e d r u g s
t h a t a r e necessary for life a n d t h o s e t h a t a r e
i m p o r t a n t for illnesses t h a t a r e n o t life-threat-
e n i n g . I n the U n i t e d States critics of p h a r m a -
ceutical industry pricing are critical of b o t h , a n d
for t h e most p a r t i n s u r a n c e plans d o n o t distin-
guish clearly b e t w e e n t h e two kinds of d r u g s .
T h e assumption—and as we have seen a dubious
assumption—of most Americans is that they are
entitled or have a right to the best drugs available
for their c o n d i t i o n . T h e r e l a t i o n b e t w e e n t h e
cost of h e a l t h i n s u r a n c e a n d t h e p r i c e of medi-
cines a n d between t h e cost of h e a l t h care a n d
t h e price of medicines is complicated. B u t t h e
cost of medicines has increased m u c h faster t h a n
t h e cost of h e a l t h care generally, a n d t h e justi-
fication for the increase in n o t obvious, e x c e p t
if o n e invokes m a r k e t e c o n o m i c s a n d p r o d u c e s
t h e n o t - s u r p r i s i n g result t h a t t h e m a r k e t has
b e e n willing to pay t h e h i g h e r prices.
T h e r i g h t t o access a r g u m e n t in t h e U.S. is
j o i n e d to a fairness a r g u m e n t . T h a t a r g u m e n t
says that fairness involves all parties paying their
fair share for medicines, including paying suffi-
cient a m o u n t s so t h a t d r u g c o m p a n i e s have a
c o n t i n u i n g incentive to p r o d u c e m o r e benefi-
cial drugs. T h e c o m p l a i n t is n o t that American

c o n s u m e r s are subsidizing drugs for t h e p o o r
countries, o r even t h a t they are subsidizing t h e
pharmaceutical companies' compassionate pro-
grams. T h a t would b e acceptable, a n d the better
off—such as A m e r i c a n s i n g e n e r a l — m a y well
have t h e obligation to b e a r this cost. But u n d e r
t h e Status Q u o A p p r o a c h , in effect, Americans
are subsidizing n o t only p o o r countries b u t also
s e e m to b e a r a d i s p r o p o r t i o n a t e l o a d . J a p a n ,
Canada, a n d the countries of E u r o p e all nego-
tiate m u c h lower prices t h a n are available in the
U n i t e d States. Americans are increasingly find-
i n g it n o t only ironic b u t unfair t h a t U.S. drugs
cost m o r e in the U n i t e d States t h a n in o t h e r de-
veloped countries. This leads to such anomalies
as t h e U.S. g o v e r n m e n t presently p r o h i b i t i n g
the importation of U.S.-made drugs from Canada
for personal use. while various state governments
a t t e m p t to find ways of m a k i n g it legal for senior
U.S. citizens to b u y U.S.-made d r u g s from
Canada, where t h e g o v e r n m e n t helps k e e p t h e
price lower t h a n it is in t h e U n i t e d States. . . .
T h e standard reply to all questions a b o u t the
h i g h cost of drugs is to a p p e a l to the SA a n d the
SQA a n d claim t h a t unless t h e r e are t h e profits
b r o u g h t a b o u t by high prices, there will b e many
fewer future drugs. T h e Status Q u o A p p r o a c h
t e n d s to p r e s e n t a q u e s t i o n a b l e d i c h o t o m y :
e i t h e r p r o t e c t d r u g s a n d d r u g p r i c i n g to t h e
m a x i m u m o r face a future with fewer n e w in-
novative d r u g s . T h e claim is m a d e n o m a t t e r
w h a t t h e p e r c e n t of profit, n o m a t t e r what t h e
prices, n o m a t t e r h o w m u c h t h e industry spends
o n lobbying a n d advertising to c o n s u m e r s . T h e

claims are blanket, t h e justification is blanket,
a n d t h e p u b l i c is asked t o take t h e claims o n
faith. T h e c o n s u m i n g p u b l i c m u s t take it o n
faith t h a t m o n e y s p e n t o n t h e recently devel-
o p e d technique of advertising prescription drugs
to t h e general public, for instance, is necessary
to p r o d u c e the profits that will lead to new drugs.
T h e y m u s t take it o n faith t h a t m o n e y s p e n t o n
r e s e a r c h i n g m i n o r changes in existing drugs is
necessary to p r o d u c e t h e profits t h a t will l e a d
to new drugs. They must take it o n faith that the
v a r i o u s tactics t h a t seek l o o p h o l e s i n legisla-
tion—whether with respect to the O r p h a n D r u g
Act to g a r n e r windfall profits o r Hatch-Waxrnan
o r o t h e r legislation to k e e p c o m p e t i t i o n at bay
as l o n g as possible—are necessary to p r o d u c e
t h e profits that will lead to new drugs.
T h a t faith has b e e n s h a k e n . Because t h e r e
is very little t r a n s p a r e n c y i n d r u g p r i c i n g e c o -
nomics, t h e claims have worn thin. T h a t t h e in-
dustry n e e d s t h e h i g h e s t r a t e of profit of any
i n d u s t r y is n o t obvious, even for t h e p r o d u c -
t i o n of n e w p r o d u c t s / T h e lack of a d e q u a t e
t r a n s p a r e n c y e x a c e r b a t e s t h e c o m m u n i c a t i
o n
g a p a n d h i n d e r s fruitful d i a l o g u e . Abuses a n d
a t t e m p t s at g a m i n g t h e system f u r t h e r e r o d e
trust. . . .
ii. Access and Patents. If t h e r e is a difference
b e t w e e n different kinds of drugs, a n d if p e o p l e
have a g r e a t e r r i g h t to access to t h e m o r e es-
s e n t i a l d r u g s t h a n to t h e less essential o n e s ,
t h e n at least it b e c o m e s a n o p e n q u e s t i o n w h a t
the best m e a n s of protecting the different kinds

is. If o n e takes seriously t h e M o r a l A r g u m e n t ,
t h e n t h e a s s u m p t i o n of t h e SQA t h a t all d r u g s
d e s e r v e t h e s a m e l e n g t h o r s t r e n g t h of p r o -
t e c t i o n a n d t h a t t h e y s h o u l d b e t r e a t e d t h e
same as all o t h e r patents in all o t h e r areas, is o n
t h e t a b l e for d i s c u s s i o n . A l t h o u g h t h e laws
g o v e r n i n g p a t e n t s are u n i f o r m for all p r o d u c t s
a n d processes, t h e range of processes a n d prod-
ucts is extensive, t h e differences a m o n g t h e m
c o n s i d e r a b l e , a n d so t h e a r g u m e n t for a o n e -
size-fits-all a p p r o a c h is questionable. Moreover,
t h e p r e s s u r e o n p h a r m a c e u t i c a l p a t e n t s is
dif-
ferent from t h e pressure o n p a t e n t s in general.
N o o n e has a r i g h t to a b e t t e r m o u s e t r a p , a n d
t h e m a r k e t m a y l e g i t i m a t e l y d e t e r m i n e w h o
gets o n e ; b u t t h e r i g h t t o access to essential
m e d i c i n e s p l a c e s a n o b l i g a t i o n o n all t h o s e
w h o can satisfy t h a t r i g h t t o c o m e u p with a n
e q u i t a b l e m e a n s of d o i n g so. . . .
Since access a n d p r i c e a r e related, a t t e m p t s
to e x t e n d t h e p r o t e c t e d life of a d r u g by intro-
d u c i n g slight modifications to get n e w p a t e n t s
o r to delay t h e e n t r y of g e n e r i c c o m p e t i t o r s —
which w o u l d lower t h e p r i c e a n d increase ac-
cessibility—are n o t j u s t i f i e d by t h e S t a n d a r d
A r g u m e n t a n d a r e m o r e a p p r o p r i a t e l y seen as
taking advantage of t h e system.. . .
T h e task with r e s p e c t t o p h a r m a c e u t i c a l

p r o d u c t s is to b a l a n c e claims t o i n t e l l e c t u a l
p r o p e r t y rights against t h e rights to access t o
n e e d e d medicines, t h e c o m m o n good, a n d the
obligation to aid. T h e e c o n o m i c a r g u m e n t t h a t
unless c o m p a n i e s can m a k e a profit from their
r e s e a r c h in discovering, d e v e l o p i n g , a n d p r o -
d u c i n g d r u g s , they will n o t p r o d u c e t h e m , is
only a partial defense of t h e existing p a t e n t sys-
t e m a n d o n e t h a t focuses o n l y o n p r o p e r t y
rights. It is only a partial defense because p a t e n t
p r o t e c t i o n is n o t t h e only conceivable way of ei-
t h e r p r o t e c t i n g intellectual p r o p e r t y o r of guar-
a n t e e i n g profits. It d o e s n o t show t h a t o t h e r
alternatives—public financing of r e s e a r c h a n d
d e v e l o p m e n t , c o o p e r a t i o n instead of c o m p e -
tition o n some d r u g d e v e l o p m e n t , g o v e r n m e n t
r e g u l a t i o n of prices o r g u a r a n t e e s of profits at
a certain level for certain d r u g s , a n d so o n , a r e
n o t viable a l t e r n a t i v e s . I n p a r t i c u l a r , t h e SA
a n d SQA d o n o t show t h a t intellectual p r o p -
erty rights, n o m a t t e r h o w s t r o n g a n d justifi-
able, t r u m p t h e r i g h t to basic h e a l t h c a r e a n d
t h e r i g h t of access to n e e d e d m e d i c i n e s or t h a t
t h e r i g h t to profits t r u m p s th ese, t h e c o m m o n
g o o d , o r t h e obligation t o aid. . . .
NOTES
1. Unlike other property, intellectual property is
infinitely shareable. It can be stolen, borrowed,
copied, and one still has it. Intellectual property
refers to some products of the mind. But ar-
guably the most important products—ideas—
cannot be claimed as one's property. Only the
expressions of ideas or their embodiment in

some product or process can with any plausi-
bility be said to constitute property in any sense.
Even in these cases, no expression or invention
is developed completely independendy. In the
realm of knowledge one always builds on what
has gone and has been developed before and
is part of the public domain.
2. NIHCM, "Changing Patterns of Pharmaceuti-
cal Innovation," p. 3 at http://www.nihem.org/
innovations.pdf.
3. According to the Fortune 500 Report, in 2001,
the pharmaceutical industry was the most prof-
itable industry again for several years running.
In 2001 the profit of the top 10 drug makers
increased 33 percent, a n d drug prices in-
creased 10 percent, even though the rate of
inflation was only 1.6 percent. The Public Citizen
(April 18, 2002, "Pharmaceutical Industry
Ranks as Most Profitable Industry—Again" at
http://www.citizen.org/congress/refoirn/drug_
industry/profits) notes that "The drug industry
maintains that it needs extraordinary profits to
fuel risky R&D into new medicines. But com-
panies plow far more into profits than into R&D.
Fortune 500 drug companies channeled 18.5
percent of revenue into profits last year. Yet they
spentjust 12.5 percent of revenue on R&D." It
also reports that for 2002 the industry had re-
turn on assets of 14.1 percent (compared with
a median of 2.3 percent for Fortune 500 com-
panies) ; that it spent 30.8 percent of its revenue
on marketing and administration, but only 14.1
percent on R&D; and that its direct-to-consumer
advertising increased from $800 million in 1996

to $2.7 billion in 2001. (Public Citizen, Congress
Watch, J u n e 2003, "2002 Drug Industry Profits:
Hefty Pharmaceutical Company Margins Dwarf
Other Industries," at http://www.citizen.org/
congress/reform/drug_industry/r_d/articles.
cfm?ID=9923).
http://www.nihem.org/
http://www.citizen.org/congress/refoirn/drug_
http://www.citizen.org/

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