discussing drug patents

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.

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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 .

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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

468 Ethical Issues Regarding Emerging Technologies

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

Ethical Issues Regarding Emerging Technologies 469

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

470 Ethical Issues Regarding Emerging Technologies

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

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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

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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

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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

474 Ethical Issues Regarding Emerging Technologies

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

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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

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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).