hiv/aids: a case study of patient rights over patent rights

7/21/2019 HIV/AIDS: A Case Study of Patient Rights over Patent Rights

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HIV/AIDS: A Case Study of Patient Rights over Patent Rights

Zhihong XuENAS 335: Professional EthicsDate Due: December 4th, 2!4

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Zhihong Xu"#$%A#DS: A &ase Stu'( of Patient )ights o*er Patent )ightsENAS 335: Professional EthicsDate Due: December 4th, 2!4

Abstract

Human immunodefciency virus (HIV) and acquired immune defciency

syndrome (AIDS) are diseases o inequality. Specifcally, those livin in

developed o areas o the !orld are a"le to receive the adequate treatment

o anti#retroviral drus (A$Vs) !hile those in developin areas are una"le to

a%ord the costly reimen o drus that prevent death. &he hih costs o the

dru are directly associated !ith the patent rihts that lare pharmaceutical

companies o"tain, allo!in them to enerate proft ater years o costly

research and development and clinical trials. 'nderstandin that there is a

"alance "et!een savin the lives o those !ho cannot a%ord HIVAIDS

treatment and protectin the interests o pharmaceutical companies as !ell

as the interity o the patent system, this paper !ill present evidence rom a

utilitarian and corporate social responsi"ility perspective, demonstratin that

there are instances !here patients rihts supersede patent rihts.

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"#$+count hels sto the .ea0ening of the immune s(stem an' gi*es the

immune s(stem a chance to reco*er an( e;isting 'amage cause' b(

"#$%A#DS1 ften, a mi;ture of A)$s is ta0en in a treatment 0no.n as

combination thera( that re*ents "#$ from ac9uiring resistance to the

'rugs1 hese 'rugs ha*e gi*en millions of those aecte' b( "#$%A#DS both

the abilit( to li*e a higher 9ualit( of life as .ell as the abilit( to li*e longer1

"o.e*er, the regimen of 'rugs is e;tremel( e;ensi*e an' must be ta0en for

the rest of a atient-s life1


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must e;cee' the total costs associate' .ith bringing the 'rug to mar0et1 n

the cost si'e of the e9uation, harmaceutical comanies sen' on a*erage 6

to ! (ears an' 5 million in research an' 'e*eloment before a 'rug is

e*en submitte' for clinical trials14)unning clinical trials to obtain aro*al

for sale of the 'rug through organiGations such as the oo' an' Drug

A'ministration is once again, a costl( an' length( en'ea*or1 inall(, gi*en

the laborious rocess it has alrea'( ta0en to obtain aro*al, harmaceutical

comanies 'esire to ma;imiGe the mar0et share of their 'rugs an'

conse9uentl( our millions into mar0eting an' e'ucating 'octors about the

ne. 'rugs1 ith four out of /*e 'rugs failing at the clinical trial stage,

harmaceutical comanies must le*erage the fe. 'rugs that 'o ass the

clinical trials to co*er the losses from their unsuccessful alications1

Accounting for the research an' 'e*eloment costs of both 'rugs that are

successful an' ones that fail, the cost to bring one successful 'rug to mar0et

is estimate' to be 5 billion15 ith such high costs associate' .ith the

'e*eloment of the 'rug, not onl( 'o harmaceutical comanies /le for

atent to rotect their in*estments an' maintain the e;clusi*e right to

ro'uce the 'rug for 2 (ears, but the( also charge high rices un'er

monoolistic mar0et con'itions to reco*er their costs1

hile rotection un'er atent la. to a certain 'egree gi*es large

harmaceutical comanies the incenti*e to 'e*elo otentiall( successful

'rugs, the( re*ent generic, lo. cost harmaceutical comanies from

4?Drugs: h( Drugs &ost So Huch1? edicine*et1 eb1 ! Dec1 2!415"erer, Hatthe.1 ?he &ost f &reating A Ne. Drug No. 5 Iillion, Pushing Iig Pharma o &hange1? -or"es1orbes HagaGine, !! Aug1 2!31 eb1 3 No*1 2!41

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relicating the 'rugs that are currentl( out of the rice range of the roughl(

26 million eole li*ing .ith "#$%A#DS in sub+Saharan African an' South East

Asia1 that has create'

a uniform, global gui'eline for intellectual roert( stan'ar's1 &ountries that

.ish to recei*e referential treatment for international tra'e that the

oers to its member nations must a'here strictl( to the ro*isions of )#PS1

urthermore, recent 'e*eloments in the


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restriction of comulsor( licenses an' arallel imorting for generic

manufacturers1J

he 'ata e;clusi*it( clause in the )#PS+Plus agreement ser*es to

ime'e the Ko. of 'rugs into "#$+bur'ene' areas1 hen a large

harmaceutical coman( in the : E3F5+3FJ1 eb1 ! Dec1 2!41

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comanies together, the millions rel(ing 'eseratel( nee'ing A)$s are

unable to obtain access to these 'rugs urel( 'ue to cost .hile large

harmaceutical comanies in the to 'emonstrate that

it is in the harmaceutical in'ustr(-s best interest to allo. atient rights to

suerse'e atent rights in certain instances such as the "#$%A#DS ei'emic1

Section $ conclu'es1 Note: his aer uses "#$%A#DS as a latform for

anal(sis but the atient rights *s1 atent rights 'ebate can be e;ten'e' an'

e;traolate' to other areas of ublic health1

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II. Interests of the Relevant Staeholders: Patients! "ig Phar#a! andthe Patent Syste#

#n the 'iscussion of .hether atient rights or atent rights comman'

more .eight, it is imortant to establish the moti*ations an' interests of the

arties in*ol*e'1 he t.o ob*ious organiGations in this case stu'( are

atients li*ing .ith "#$%A#DS an' harmaceutical comanies that o.n the

rorietar( 0no.le'ge regar'ing the comosition of the A)$s1 "o.e*er, one

must not forget the interme'iar( bet.een the atient an' the

harmaceutical coman(1 he interme'iar( resonsible for creating high

rices an' restricting access to A)$s in 'e*eloing areas of the .orl' is the

global atent s(stem1

he in'i*i'uals li*ing .ith "#$%A#DS ha*e simle an' linear interests1

hese in'i*i'uals siml( .ish to obtain access to aor'able A)$s that .ill

sa*e their li*es1 hese atients onl( .ish to be able to enBo( the health( an'

ro'ucti*e li*es of those .ho ha*e "#$%A#DS but are able to aor' the A)$s1

Accor'ing to the #nternational Declaration of "uman )ights, all humans ha*e

the basic an' intrinsic right to life an' health1 i*en this right, atients .ith

"#$%A#DS focus on .hether uni*ersal access to treatment is a moral

imerati*e rather than .hether uni*ersal access is economicall( feasible1

he interests of Obig harma are slightl( more nuance'1 ne can

argue that these comanies ha*e a *ariet( of consi'erations, as the( are in

the business of ro*i'ing healthcare solutions, but also oerate as regular

cororations1


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through the creation of no*el 'rugs1 "o.e*er, healthcare aroach can be

easil( rule' out b( e;traolating the scenario to the en'C it is har' to imagine

that harmaceutical comanies 'e/ne success b( see0ing to cure e*er(

ossible 'isease, as 'oing so .oul' eecti*el( ruin their o.n mar0et1 hese

comanies cannot ma0e mone( if e*er(one is health(1 he more comelling

stor( falls bac0 to economics1 At the en' of the 'a(, harmaceutical

comanies function Bust li0e an( other /rm in an( other in'ustr(1 he focus

lies in generating ro/ts for the coman( an' its sharehol'ers1 #n the conte;t

of the "#$%A#DS case stu'(, harmaceutical comanies are able to maintain

high rices for the A)$s as long as the( ha*e the intellectual roert(

rotection necessar( to re*ent mar0et entr( from cometitors1

hile not necessaril( a Osta0ehol'er, the atent s(stem la(s an

imortant role in shaing the 'ebate bet.een atients an' harmaceutical

comanies1 here are man( cases to be ma'e to suort the rotection of

intellectual roert( rights1 he sole urose of the atent s(stem is to

re.ar' an' rotect an in'i*i'ual-s or /rm-s har' .or0 of 'e*eloing a ne.

creation1 his argument states that gi*en the high costs of research an'

'e*eloment, comanies ought to ha*e the right to ro/t an' recuerate the

research an' 'e*eloment costs b( rotecting the creation from the han's of

cometitors1 Another strong argument is that .ithout the rotection of

intellectual roert( rights, social .elfare as a .hole .oul' 'ecrease as

comanies an' in'i*i'uals .oul' be less moti*ate' to sin0 time an' mone(

into 'e*eloing ne. technologies an' reme'ies1 hus, in the case of

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harmaceutical comanies, fe.er life+sa*ing 'rugs .oul' be 'e*eloe'

because these comanies coul' not guarantee that the( .oul' reco*er the

costs of bringing a 'rug to mar0et1 #n the 'ebate of atients *s1 atents, it is

of the utmost imortance to .al0 the /ne line bet.een allo.ing in'i*i'uals

to retain their intrinsic an' uni*ersal rights to life an' health .hile not

un'ermining the integrit( of the atent s(stem1

III. $ives %orth &ore 'han Pro(t via )tilitarianis#

he aer .ill no. consi'er .hether a atient-s utilit( gaine' from

access to A)$s out.eighs the ro/t an' the bene/ts that are generate' .ith

the rotection of the harmaceutical in'ustr(-s atents1 i*en that the

'iscussion of utilit( ultimatel( boils 'o.n to hainess, one must /rst agree

uon the 'e/nition of .hat hainess is1 or the uroses of this case,

hainess is 'e/ne' as leasure an' the absence of ain1

here are t.o schools of utilitarian thought: erem( Ientham-s act+

utilitarianism an' ohn Hill-s rule+utilitarianism1 Act+utilitarianism a'*ocates

for 'oing .hate*er ma;imiGes utilit( at the en' of the 'a(1 "o.e*er,

Ientham-s act+utilitarianism runs into trouble as it 'oes not resect

in'i*i'ual rights, it is unable to ma0e interersonal comarisons of utilit(,

an' it cannot account for the or'inal nature of utilit( an' hainess1 Hill-s

rule+utilitarianism reconciles some of the obBections that eole ha*e to

Ientham-s rincilesC he still a'*ocates for ma;imiGing utilit(, but focuses on

rules of con'uct that if follo.e' uni*ersall(, .oul' ro'uce the greatest long+

term utilit(, rather than re'ucing the 'ecision tree to one singular e*ent as

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Ientham 'oes1 urthermore, Hill-s rule+utilitarianism states that the actions

of ma;imiGing utilit( must be groun'e' in the rincile of 'oing no harm an'

resecting human libert(1 #t aears that using Hill-s rule+utilitarianism is the

most aroriate frame.or0 for e*aluating utilit( in the case of "#$%A#DS as

it ac0no.le'ges the imortance of long+term utilit( an' catures the

fun'amental, moral imerati*e of 'oing no harm an' resecting human

libert(1

o anal(Ge the utilit( gaine' from the rotection of atents b( large

harmaceutical comanies, a roer anal(sis from the Hill ersecti*e must

searate the asects of the harmaceutical in'ustr( that generate either

ositi*e or negati*e utilit( into the comonent ieces1 he harmaceutical

in'ustr( gains utilit( or Ohainess b( generating ro/t an' in 2!2, the !!

largest harmaceutical comanies in the


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ith harmaceutical comanies ha*ing little to gain in "#$+re*alent

areas of the .orl', the focus no. shifts to .hat the harmaceutical

comanies ha*e to lose if the( .ere to lo.er rices an' e;an' access to

A)$s1 he genericall( ro'uce' A)$s, often costing Bust 2 er (ear

comare' to 2 to 5 a month for atent rotecte' A)$s, reresents

the cost of inuts an' materials necessar( to create the A)$s1 hese lo.

cost formulations 'o not charge a remium to reco*er losses in the research

an' 'e*eloment stages1


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human life1 he


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atent rights b( large harmaceutical comanies e;cee' the otential gains

of atients .ho .oul' obtain access to the life+sa*ing A)$s1

he abo*e calculations are a rough attemt to estimate the total loss

of letting atent rights o*errule atient rights1 "o.e*er, it seems rather

cru'e to attach numbers to .hat a human life is .orth1 )eferring bac0 to the

#nternational Declaration of "uman )ights, all humans ha*e the basic an'

intrinsic right to life an' health, regar'less of income an' abilit( to a( for

treatment an' this right to life an' health is an absolute that cannot be

circum*ente' or 'iminishe'1 ith these rights as absolutes, it then becomes

a uni*ersal, moral 'ut( for an(one an' e*er(one to ensure that each human

being 'oes not ha*e his or her fun'amental rights infringe' uon1 rom this,

one can conclu'e that it is imossible assign *alues to .hat a human life is

.orth, as the *alue of a human life is riceless an' is greater than an(

ossible utilit( that a harmaceutical coman( recei*es1 Iringing the focus

bac0 to Hill-s rule+utilitarianism of a'*ocating for actions that (iel' the

highest long+term utilit( as long as the( 'o no harm, it is ob*ious that

harmaceutical comanies raising the rices of A)$s un'er the rotection of

the atent s(stem *iolate the 'o no harm rincile an' ha*e 'isregar'e'

long term utilit(C these comanies ha*e ta0en a.a( the uni*ersal right to life

an' health through the le*eraging of atent olicies1 he utilitarian anal(sis

ro*i'es conclusi*e e*i'ence that atient rights are far more imortant that

atent rights in the case of "#$%A#DS1

IV. Cor*orate Social Res*onsibility

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his aer .ill no. transition to anal(Ging atent rights *s1 atient

rights in the case of "#$%A#Ds from a &S) ersecti*e1 Hore seci/call(, the

aer .ill sho. that it is actuall( in the harmaceutical comanies- best

interest to gi*e u the atent rotection an' the otential ro/ts an'

instea', lo.er the rices of A)$s1 irst, it is imortant to un'erstan' .hat

&S) is an' ho. comanies can engage in &S)1 &S) is the cororate initiati*e

to assess an' ta0e resonsibilit( for a coman(-s eect on the en*ironment

an' imact on social .elfare1 &S) is also 0no.n as cororate citiGenshi an'

often means that a coman( bears short+term costs that 'o not ro*i'e

imme'iate, /nancial gains to the coman(, but rather in*ests in a long+term

social or en*ironmental strateg(1 Accor'ing to Hichael Porter an' Har0

ramer in Stratey and Society, le*eraging &S) roerl( can be a source of

oortunit(, inno*ation, an' cometiti*e rather than cost1

.o Busti/cations of moral obligation an' reutation for &S) resonate in

the conte;t of the "#$%A#DS case stu'(1 he moral obligation argues that

comanies ha*e an intrinsic 'ut( to be goo' citiGens an' to O'o the right

thing1 &omanies shoul' achie*e commercial success in .a(s that honor

ethical *alues an' resect eole, communities, an' the en*ironment1

orbes HagaGine in*estigates the bene/ts of &S) in 3hy 0S$4 &he 5enefts

o 0orporate Social $esponsi"ility 3ill ove 6ou to Act1 #n an inter*ie. .ith

orbes,arratt "asenstab, Director of Sustainabilit( at the $er'igris rou, a

real estate 'e*eloment an' consulting /rm, oints to the *alue a''e'

'imensions of &S) from the moral ersecti*e:

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Our &S) olic( is at the core of our 'ail( oerations an' gui'es our

future rogress1 e bene/t from these eorts in a number of .a(s1

ur clients .ant to .or0 .ith us because .e are focuse' on a healthier

an' more ro'ucti*e .orl'1 he true *alue .e recei*e from our

ongoing initiati*es is that of social goo' .ill Q .e belie*e that setting a

goo' e;amle is the greatest bene/t in that .e insire other

organiGations, comanies an' in'i*i'uals to Ru their game- .hen it

comes to social an' en*ironmental resonsibilit(, .hich in turn

encourages further insiration in the communit( lea'ing to a more

enlightene' ersecti*e on ho. to run ones business or lea' one-s

life1!3

ohn 1 aft, &E of )I& ealth Hanagement+


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re*enue from ro'ucts that are re' colore', .ith re' being the color

associate' .ith "#$%A#DS, are 'onate' to.ar's the lobal un' that ro*i'es

humanitarian assistance for those li*ing .ith "#$%A#DS1!4 o 'ate, this

camaign has alrea'( contribute' 265 million to the lobal un'1 his

highl( *isible camaign not onl( ro*i'es a re*enue boost to the comanies

b( encouraging consumers to hel a .orth( cause, but also allo.s the

coman( to remain on high groun' in the e(es of the ublic as lea'ers in the

crusa'e to eliminate "#$%A#DS1 urthermore, this high ro/le nature of the

)ED camaign acts as a free mar0eting oortunit( for comanies such

&oca+&ola1 i*en the bene/ts to these comanies- reutation b( engaging in

&S), harmaceutical comanies shoul' seiGe the oortunit( to also arta0e

in this ractice1 #nstea' of being *ie.e' b( the ublic as giants that

maniulate rices through atent rotection an' monoolistic ractices,

harmaceutical comanies can ositi*el( transform their image into one of

being o.erful lea'ers searhea'ing the /ght against "#$%A#DS b( allo.ing

for atient rights to come before atent rights1

V. Conclusion

his aer has use' "#$%A#Ds as a latform to e*aluate .hether atent

rights or atient rights carr( more .eight1 his aer has establishe' the

scale of the "#$%A#DS ei'emic, the treatment necessar( to combat the

'isease, an' the mechanisms such as atent rotection that re*ent millions

in the 'e*eloing .orl' from obtaining access to A)$s at aor'able rices1

!4?"A #MM # AE? =)ED>1 N11, n1'1 eb1 ! Dec1 2!41

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he aer also constructe' the moti*ations of the rele*ant arties in the

'ebate1 Iase' on Hill-s utilitarian aroach, the aer has sho.n that the

otential utilit( gains from granting access to A)$s far out.eigh the

otential loss in ro/ts for the harmaceutical comanies1 urthermore, this

aer has reinforce' its stance that atient rights e;cee' atent rights in

instances of humanitarian crises b( resenting e*i'ence that engaging in

cororate social resonsibilit( is in the best interest of the large

harmaceutical /rms1 "o.e*er, the aer .oul' not be comlete .ithout

oering a solution to ro*i'e the fun'amental rights of life an' health to

those .ho cannot aor' A)$s .ithout un'ermining the integrit( of the

atent s(stem1

he best metho' of chamioning atient rights o*er atent rights is to

create e;emtion clauses that .oul' re*ent 'ata e;clusi*it( an' allo. for

ease in issuing comulsor( licenses for life+sa*ing 'rugs such as A)$s1 Such

e;emtions for comulsor( licensing ha*e been create' in the 2! Doha

Declaration, but more nee's to be 'oneC )#PS+Plus has increase'

intellectual roert( rights restrictions an' has re*ente' countries from

e;orting the genericall( ro'uce' A)$s1!5 ranting e;emtions .oul'

re*ent the information from clinical trials of re*olutionar( me'icines from

being loc0e' a.a( for ten (ears an' .oul' allo. the generic harmaceutical

in'ustr( to create an' 'istribute aor'able A)$s to the millions of "#$%A#Ds

atients that currentl( 'o not ha*e access1 he


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largest e;orter of intellectual roert(, .oul' remain on /rm groun' in

rotecting the status of atents .hile ser*ing the interests of eole aroun'

the .orl' b( allo.ing e;emtions to )#PS+PM


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?Iig Pharma1? anuacturers Dru / Device 0ompanies1 2a!suits / -acts1

N11, n1'1 eb1 2F No*1 2!41

&ollier, )1 ?Drug Patents: he E*ergreening Problem1? 0anadian edical

Association 8ournal!F517 =2!3>: E3F5+3FJ1 eb1 ! Dec1 2!41

?&omulsor( Micensing of Pharmaceuticals an' )#PS1? 3&71 orl' ra'e

rganiGation, n1'1 eb1 3 No*1 2!41

?Declaration on the )#PS Agreement an' Public "ealth1? 3&71 orl' ra'e

rganiGation, 2 No*1 2!1 eb1 ! Dec1 2!41

?Drugs: h( Drugs &ost So Huch1? edicine*et1 N11, n1'1 eb1 ! Dec1

2!41

"erer, Hatthe.1 ?he &ost f &reating A Ne. Drug No. 5 Iillion, Pushing

Iig Pharma o &hange1? -or"es1 orbes HagaGine, !! Aug1 2!31

eb1 3 No*1 2!41

ingsbur(, athleen1 ?he $alue of a "uman Mife: !27,1? &ime1 ime #nc1,

2 Ha( 2F1 eb1 2F No*1 2!41

Partno(, ran01 ?he &ost of a "uman Mife, Statisticall( Sea0ing + he

lobalist1? &he 9lo"alist1 N11, 2! ul( 2!21 eb1 2F No*1 2!41

hore, De*in1 ?h( &S) he Iene/ts f &ororate Social )esonsibilit(

ill Ho*e Tou o Act1? -or"es1 orbes HagaGine, F Ha( 2!31 eb1

! Dec1 2!41

?)#PS, )#PS Plus an' Doha1? S- Access 0ampain1 N11, n1'1 eb1 3 No*1

2!41

?"A #MM # AE? ($:D)1 N11, n1'1 eb1 ! Dec1 2!41

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?orl'.i'e "#$ @ A#DS Statistics1? HIV and AIDS Inormation and $esources1

N11, n1'1 eb1 26 No*1 2!41

hiv/aids: a case study of patient rights over patent rights

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