Vous êtes sur la page 1sur 13

SPECIAL COMMUNICATION PATENTS AND ACCESS TO AIDS TREATMENT IN AFRICA

Do Patents for Antiretroviral Drugs


Constrain Access to AIDS Treatment in
Africa?
Amir Attaran, DPhil, In this article, we examine the cur- rent relationship
LLB Lee Gillespie- between patents and
White, LLB

I
N RECENT MONTHS, THERE HAS BEEN
a great deal of
controversy about ac-
cess to antiretroviral
medicines to treat human
immunodeficiency vi-
rus (HIV)/acquired
immunodeficiency syndrome
(AIDS) in poor countries,
where tens of millions have
HIV infec- tion and face
certain death without an-
tiretroviral treatment. A
dramatic, of- ten heated
element of this debate has
focused on the role of
intellectual prop- erty law
specifically, patentswhich
activists blame for creating
monopo- lies that keep drugs
inaccessible or un-
affordable, and which
pharmaceutical companies
extol as necessary incentive
for expensive research and
develop- ment. This has led
to highly organized
campaigns, critiques of the
interna- tional patent law
system, White House
executive orders, and calls
to limit the scope of
pharmaceutical patents in
poor countries.1-3

2001 American Medical Association. All rights reserved. (Reprinted) JAMA, October 17, 2001Vol 286, No. 15
1
Public attention and debate (median, 3; mode, 0) and that in countries where antiret- roviral drug
recently have focused on access patents exist, generally only a small subset of antiretroviral drugs are
to treatment of acquired patented (median and mode, 4). The observed scarcity of patents
immunodeficiency syndrome cannot be simply explained by a lack of patent laws because most
(AIDS) in poor, severely affected African countries have offered patent protection for pharmaceuticals for
coun- tries, such as those in many years. Further- more, in this particular case, geographic patent
Africa. Whether patents on coverage does not appear to correlate with antiretroviral treatment
antiretroviral drugs in Af- rica access in Africa, suggesting that patents and patent law are not a
are impeding access to lifesaving major barrier to treatment access in and of themselves. We conclude
treatment for the 25 million that a variety of de facto barriers are more re- sponsible for impeding
Africans with human access to antiretroviral treatment, including but not limited to the
immunodeficiency virus infection poverty of African countries, the high cost of antiretroviral treat- ment,
is unknown. We studied the national regulatory requirements for medicines, tariffs and sales taxes,
patent statuses of 15 and, above all, a lack of sufficient international financial aid to fund
antiretroviral drugs in 53 anti- retroviral treatment. We consider these findings in light of
African countries. Using a policies for enhancing antiretroviral treatment access in poor
survey method, we found that countries.
these antiretroviral drugs are JAMA. 2001;286:1886-1892
patented in few African countries
www.jama.com
antiretroviral drug access. intellectual property the data in tabular form and
We test the hypothesis that divisions of ma- jor then re- turned the data to
pharmaceutical companies that each of the respon- dent
patents are a leading barrier pro- duce or market companies for 1 or more
to widespread AIDS treatment antiretroviral drugs, rounds of clarification,
seeking disclosure and verification, or correc-
in Africa by presenting for affirmation of each patent tion as needed.
the first time, to our or similar legal right in Our inquiries captured
Af- rica of which those
knowledge, comprehensive data companies had knowledge. several dif- ferent types of
on whether patents for Our inquiries captured the legal rights: product pat-
antiretroviral drugs exist on patent status of the ents (covering the
antiretroviral drugs
that continent. We dis- cuss invented or marketed by the pharmacologically
the findings of our case compa- nies in question,
unless a single active
study in light of the current ingredient is marketed in Author Affiliations: Center for International
controversy regard- ing AIDS multiple for- mulations, in Devel- opment and Kennedy School of
which case we sought data for Government, Har- vard University,
medicines and the legal op- the first marketed (primary) Cambridge, Mass (Dr Attaran); In-
tions for enhancing access to for- mulation. All ternational Intellectual Property Institute,
companies we con- tacted Washington, DC (Ms Gillespie-White).
antiret- roviral treatment agreed to furnish data in Corresponding Author and Reprints: Amir
for the worlds poor. re- sponse to our inquiry. Attaran, DPhil, LLB, Center for International
We summarized Development, Har- vard University, 79 JFK
St, Cambridge, MA 02138 (e-mail:
METHODS amir_attaran@harvard.edu).
Between October 2000 and
March 2001, we issued
written inquiries to the

2 JAMA, October 17, 2001Vol 286, No. 15 2001 American Medical Association. All rights reserved.
(Reprinted)
active chemical or status in 53 African among antiretroviral drugs,
formulation), pro- cess countries. TABLE 1 and the most are pat- ented in few
patents (covering a FIGURE summarize the data African countries (me- dian,
manufactur- ing process for and re- cord every patent in 3; mode, 0 countries) and
the same), use patents force at the time we were that among the subset of
(covering the use of a drug notified. We do not present countries where 1 or more
for a medi- cal indication), data on expired or withdrawn patents exist, the number of
and exclusive market- ing patents, which are of no pat- ented antiretroviral
rights (an interim legal legal force, or pending drugs is typically few (median
status in international patent applications, since and mode, 4 drugs). The ex-
patent law that pertains it cannot be presumed that ceptions are South Africa,
only to the least-developed these will be granted or where a com- paratively large
countries under the World rejected. Where a patent is number of antiretrovi- ral
Trade Organization Agreement shown, some form of market drugs are patented (13/15),
on Trade-Related Aspects of exclusivity exists, al- and Agouron, Boehringer
Intellectual Property Rights though this exclusivity may Ingelheim, and GlaxoWellcome
[TRIPS]4). For the purposes not pre- clude all uses of (now GlaxoSmith- Kline)
of this study, it is gen- the pharmacologi- cally products, which are patented
erally unnecessary to active ingredient (eg, in in a large number of
distinguish among these the case of a formulation countries (up to 37 of 53
because they all confer a patent). countries). Overall, of a
degree of market exclusivity The data in the Table and theoreti- cally possible 795
(ie, an exclusive right to Figure can be interpreted as instances of patent- ing that
manufacture, import, or disclosing 1 general rule and we might have identified (as-
sell) in similar ways. 2 specific exceptions. The suming generously that all
Because our method is rule is that countries offer pharmaceutical
survey based, we cannot patents, which is not true),
exclude the possibility that only 172 (21.6%) actually
even after verification some exist.
inaccura- cies exist because While patents do limit the
of human error in re- use of some highly active
porting data to us. However, antiretroviral therapy
in this large crosswise regimens on a no patent ba-
scrutiny of 15 antiret- sis (especially those using
roviral drugs and 53 zidovu- dine, lamivudine, or
countries (com- prising 795 both), the US De- partment of
data points), a small num- Health and Human Services
ber of such inaccuracies (DHHS) clinical guidelines
would not materially affect list several strongly
our broad conclu- sions. recommended regimens for
Although this is which there are encouraging
satisfactory for an academic clinical tri- als and which are
study, given the serious le- unpatented in up to 52 of 53
gal consequences of patent African countries. In addi-
infringe- ment, we strongly tion, other regimens are
recommend that any- one available on a 1 patent
placing reliance on these basis, where that patented
findings seek independent drug may be available at
legal advice. discounted prices. Examples of
RESULTS regimens recom- mended by the
DHHS and their patent statuses
A total of 15 antiretroviral are provided in TABLE 2.
drugs pat- ented by 8
pharmaceutical companies COMMENT
were screened for patent
This study demonstrates that These results rely on Second, companies that
patent pro- tection for patent self- reporting and self-report the lack of a
antiretroviral drugs in may contradict isolated patent probably would do so
Africa is not extensive. press reports.15 However, we truthfully because there is
This is surprising since believe there are 2 no incen- tive to conceal
earlier studies have shown independent reasons that the existence of a patent.
that patent ap- plications patent holders and Concealment would invite
were filed in many African licensees are the most unwanted competition from
countries.13 We now infer that reliable source for these generic drug suppli- ers.
most of these applications data when queried While theoretically companies
were probably aban- doned systematically. may benefit from
because it is common First, the relationship exaggerating the extent of
practice to name a large between a patent and a their patent protection,
number countries on an in- product is not always self- there is no plau- sible
ternational patent evident to anyone other commercial benefit in
application, given the option than the patent holder or a denying the existence of
of establishing a patent licensee. A patent may not valid patents they own.
later on, and later abandon refer explicitly to the As most of the
many or most of them when name of a prod- uct or the antiretroviral drugs we
the patent fees are due.14 formula of the pharmaco- studied are infrequently
There- fore, it is not logically active chemical patented in Af- rica, is
surprising that the num- ber (eg, a process patent for a this situation likely to
of applications is large synthetic intermediate). As persist in coming years?
while the number of patents such, even a highly skilled Most national patent sys-
in force is few. observer searching the tems follow the Paris
records of a national Convention, which stipulates a
patent office (an extremely 1-year grace period during
difficult or impossible which all patent
undertaking in much of applications ordi- narily
Africa) could easily are filed.17 This period
overlook patents pertaining elapsed long ago for the
to a product of interest. antiretroviral drugs we
This problem is avoided studied, meaning that the
when the patent holder or opportunity to file further
licensee self-reports the patent applications and ob-
data, and to the limited tain future patents
extent that our data were generally has ex- pired. It
verifiable against those is conceivable that after-
obtained directly from 1 thought applications could
national patent office be still filed to patent
(Kenya), the results match incidental features of these
per- fectly.16 drugs (eg, a drugs
crystalline form or its
PATENTS AND ACCESS TO AIDS TREATMENT IN AFRICA

(Agenerase)
Lamivudine-zidovudine
Table 1. Patent Coverage in Africa for Antiretroviral Drugs, by Country *

[Pharmacia]
(Combivir) [GSK]
(Epivir) [GSK]
NRTIs NNRTIs Protease Inhibitors

Delavirdine
[Merck]

[Merck][GSK]
(Crixivan)
[Roche]

Amprenavir
(Fortovase)
[BI]
(Rescriptor)
(Stocrin)
(Viramune)

[Abbott]
Indinavir
Lamivudine
(Hivid)
(Retrovir)

[Roche]
Efavirenz

Saquinavir
Zalcitabine

(Norvir)
[GSK]

Nevirapine
Zidovudine

Total

Ritonavir
Algeria 0
Angola 0
Benin X X X X 4
Botswana X X X X X X 6
Burkina Faso X X X X 4
Burundi X X 2
Cameroon X X X X 4
Cape Verde 0
Central African Republic X X X X 4
Chad X X X X 4
Comoros X X X 3
Congo (Republic) X X X X X 5
Congo (Democratic Republic) X X 2
Co te dIvoire X X X 3
Djibouti 0
Egypt X X 2
Equatorial Guinea 0
Eritrea 0
Ethiopia 0
Gabon X X X X 4
Gambia X X X X X X X 7
Ghana X X X X X X 6
Guinea X X 2
Guinea Bissau X 1
Kenya X X X X X X X 7
Lesotho X X X X X X 6
Liberia 0
Libya 0
Madagascar X X 2
Malawi X X X X X X 6
Mali X X X X 4
Mauritania X X X X 4
Mauritius 0
Morocco X X 2
Mozambique 0
Namibia 0
Niger X X X 3
Nigeria X X X X 4
Rwanda X X 2
Sao Tome and Principe 0
Senegal X X X X 4
Seychelles X X X X 4
Sierra Leone X X X 3
Somalia X 1
South Africa X X X X X X X X X X X X X 13
Sudan X X X X X X X 7
Swaziland X X X X X X 6
Tanzania X X X X X 5
Togo X X X 3
Tunisia X X 2
Uganda X X X X X X X 7
Zambia X X X X X X 6
Zimbabwe X X X X X X X X 8
Total 37 33 0 17 1 1 15 1 1 25 12 2 3 0 24 172
*NRTI indicates nucleoside reverse transcriptase inhibitor; NNRTI, non-NRTI; GSK, Glaxo SmithKline; BMS, Bristol-Myers Squibb; and BI, Boehringer Ingelheim.
metabolite), but such claims ents in Africa. Certainly, Intellectuelle) have offered
may be re- garded it is not sim- ply because a system of pharmaceutical
skeptically by courts the option to patent has product and process patents
outside the United States.18- been lacking. Although the since the Bangui Agreement of
20
We think it is un- likely laws of some African 1977. 22 Similarly,
that the observed omissions countries do not permit pharmaceutical patent
to patent in Africa could phar- maceutical patents, or protection has been available
now be reversed, meaning did not when ap- plications in most of the 15 Anglophone
that current antiretroviral to patent these antiretrovi- countries of ARIPO (the
drugs will remain largely ral drugs were filed, most African Regional Indus-
unpatented in Af- rica have allowed pharmaceutical trial Property Organization)
(future antiretroviral patents for years. 21 The 15 since at least 1984.16
drugs, of course, may be member countries of Franco- Despite these and other
another matter). phone West Africa in OAPI opportuni- ties to patent
It is an interesting (the Organisation Africaine antiretroviral drugs in Af-
question why there are not de la Propriete
more antiretroviral drug
pat-

Figure. Patent Coverage by Country

All Antiretroviral Drugs (n = 15) Nucleoside Reverse Transcriptase Inhibitors


(n=7)
TUNISIA

MOROCCO

ALGERIA LIBYA
Western EGYPT
Sahara
CAPE VERDE
MAURITANIA
SENEGAL MALI NIGER SUDAN
CHAD ERITREA
BURKINA
THE GAMBIA CENTRAL DJIBOUTI
FASO BENIN
GUINEA-BISSAUGUINEA AFRICAN REPUBLIC
ETHIOPIA
NIGERIA
SIERRA LEONE CAMEROON UGANDA
LIBERIA GHANA TOGO SOMALIA
CTE D'IVOIRE RWANDA
KENYA SEYCHELLES
EQUATORIAL GUINEA GABON
DEM. REP. OF
SAO TOME & PRINCIPE THE CONGO
REP. OF THE CONGO TANZANIA
BURUNDI
COMOROS
MALAWI
ANGOLA
ZAMBIA MOZAMBIQUE
MAURITIUS
ZIMBABWE MADAGASCAR
NAMIBIA
BOTSWANA

SOUTH SWAZILAND
Protease Inhibitors (n = 5) Nonnucleoside Reverse Transcriptase Inhibitors
AFRICA
(n = 3)
LESOTHO

No. of Patents
13
8
7
6
5
4
3
2
1
0
No Data
Table 2. Patent Status of Antiretroviral Drugs Used in Selected Highly Active Antiretroviral Therapy Regimens (N =
53)*
No. (%) of Countries With
Multiarm
5
Regimen DHHS Assessment 0 Patents 0 or 1 Patents Clinical Trial?
Stavudine-didanosine-indinavir Strongly recommended 51 (96.2) 52 (98.1) Yes6
Stavudine-didanosine-ritonavir-indinavir Strongly recommended 51 (96.2) 52 (98.1) Yes7
Stavudine-lamivudine-indinavir Strongly recommended 19 (35.8) 52 (98.1) Yes8
Zidovudine-lamivudine-nelfinavir Strongly recommended 15 (28.3) 25 (47.2) Yes9
Stavudine-didanosine-efavirenz Strongly recommended 52 (98.1) 52 (98.1) No10
Lamivudine-stavudine-nevirapine Recommended as alternative 18 (34.0) 30 (56.6) No11
Didanosine-stavudine-nevirapine Recommended as alternative 28 (52.8) 52 (98.1) Yes12
*DHHS indicates US Department of Health and Human Services.

rica, patents were not often identify any evidence that nonexistentin most African
sought, sug- gesting 2 the antiretroviral drugs of, coun- tries. Other factors,
important conclusions. for example, Abbott, patented and especially the ubiquitous
First, and perhaps in 0 coun- tries, are poverty of African coun-
surprisingly, it is doubtful consumed in any greater num- tries, must be more to blame.
that patents are to blame for bers than those of Second, also perhaps
the lack of access to GlaxoSmithKline, pat- ented surprisingly, it is doubtful
antiretroviral drug treat- in up to 37 countries. that pharmaceutical re-
ment in most African These observations are search and development will
countries. Con- ventional necessarily qualitative given always re- quire the
wisdom has spuriously as- that accurate data on incentive of patentability in
sumed that drugs patented in African an- tiretroviral drug poor countries, since the
Europe or North America must consumption do not ex- ist, option to patent
also be patented in Africa, but are based on the antiretroviral drugs in
or that a lack of generic consensus that very few of Africa has fre- quently gone
compe- tition and high the 25 million HIV-positive unexercised. The econom- ics
retail prices (sometimes in Africans now receive and profitability of
excess of those charged in treatment (per- haps 25000, antiretroviral drug research
developed countries) are or just 1 in 1000, receive 1 (unlike that of, say, malaria)
prima facie evidence of antiretroviral drug).25 This are driven by consumption of
patents, which they are scarcity of treatment cannot drugs by AIDS patients in the
not.23,24 Deter- mining actual rationally be ascribed to lucrative North Ameri- can and
patent coverage is there- antiretroviral patents that European markets. In compari-
fore instructive, and in are fewor son, the entire African
doing so, we ob- serve that pharmaceutical market, at 1.1%
that there is no apparent of the global whole, is
correlation between access commercially negligible, as is
to antiretro- viral the mar- ket share of
treatment, which is uniformly antiretroviral drugs sold to
poor across Africa, and the poorest third of the
patent status, which varies world (0.5%) (Jean O.
extensively by country and Lanjouw, PhD, written com-
drug. We were unable to munication, August 7, 2001).26
identify any evi- dence, Patent- ing in poor countries
systematic or anecdotal, therefore yields very small
that an- tiretroviral financial returns, and, given
treatment is more accessible the cost of patenting and the
in countries with few or no difficulty of en- forcing ones
antiretrovi- ral patents (eg, patents before sometimes weak
Mozambique, Namibia). judicial systems, most
Similarly, we were unable to companies appear to have
decided that extensive it is to claim that ongoing valid, as is the rule until
patenting in Africa is not pharmaceu- tical research being judicially
worthwhile. and development finds it invalidated. What are the
Thus, the data suggest necessary to protect nonpatent barriers im-
that patents in Africa have intellectual prop- erty peding antiretroviral
generally not been a factor rights on a global treatment in Af- rica?
in either pharmaceutical scale.27,28 Al- though we Certainly, access to
economics and antiretroviral agree that either or both treatment can be impeded
drug treatment access (South of these statements may be many ways: by insuffi-
Africa, with its larger correct in other contexts, cient finances to purchase
affluent mar- ket, is an neither is borne out as relatively costly
exception). This counters true in this case study. antiretroviral drugs; by a
some of the sweeping policy Our data or conclusions lack of political will among
arguments made for or should not be countries; by poor medical
against patents, and, within misinterpreted. It would be care and infrastructure; by
the limited scope of this wrong to cite this study as in- efficient drug
study, it is no more correct proof that patents never regulatory procedures that
to allege that intellectual affect access to medicines exclude competing products
prop- erty protection [has] that conclusion would from the marketplace; by
huge [adverse] in- fluences require research well high tariffs and sales
on . . . access to medicines beyond antiretrovirals in taxes; and so on. Such
than Africa in 2001. Also, in barriers have been
reporting data on identified by others.29-31 A
antiretrovi- ral patent comprehensive treatment
status, it must be remem- access plan for Africa must
bered our data reflect only overcome these non- patent
the exist- ence of patents, barriers and make use of
and never their validity, expe- ditious strategies
which is testable only that combine afford-
through a legal challenge. ability, compliance with
We presume that all pat- patent laws, and sufficient
ents reported to us are finance. We consider
these in turn.
At this writing, both brand 97% below prices in United drugs. An equitable balance is
name and generic sources of States or Japan.33,34 How- that coun- tries ought to
antiretroviral drugs are ever, the risk of driving respect patent laws, but that
available at reduced price, prices down while patent holders reciprocally
typi- cally about 90% less simultaneously increasing supply medi- cines to the
than in the United States. the funds available to global poor without profit,
Prices range from $350 a purchase antiretrovi- ral but also without loss.
year for the cheapest drugs for Africa (as the Various solutions to achieve
possible 3-drug com- much- anticipated this exist. Merck, Bristol-
bination of stavudine, international trust fund for Myers Squibb, and Abbott
lamivudine, and nevirapine infectious disease might soon have dis- counted
(Cipla) to perhaps $1000 for do35) is that it creates antiretroviral drugs to prices
a regimen containing a more market conditions in which not above their stated costs
expen- sive protease it could become lucrative to of production and
inhibitor, which might cost patent anti- retroviral drugs distribution, and
$600 itself (eg, more widely in the fu- ture. GlaxoSmithKline has taken
indinavir).32 The TRIPS agreement will make similar steps for malaria
Patent status is a central this possible in all medi- cines as well. These
consider- ation when sourcing developing countries be- examples should be followed by
drugs. Where a drug is not longing to the World Trade other pharmaceutical com-
patented in a given country, Organiza- tion by no later panies. Alternatively, various
one may freely manufacture, than 2006. legal pro- posals have been
import, and buy the brand- On the other hand, in made to limit the pat-
name drug or its generic African coun- tries where entability of certain
equivalent (provided that antiretroviral drug patents medicines in poor countries
both are reg- istered for do exist, the international without markedly affecting
use by the local drug community should ensure a rev- enues.36,37 Brand-name
regula- tory authorities, supply of affordable pharmaceutical companies might
which is not always the case also consider adher- ing to a
since some authorities code of practice, in which
decline toreg- ister generic they agree to voluntarily
products [Richard O. La- ing, license patents for important
MD, written communication, medicines (antiretroviral drugs
Au- gust 7, 2001]). and others) to high-quality
Therefore, competition can generic manufacturers willing
lead to a concurrent market to supply at low prices (the
for brand-name and generic licenses would be geographi-
antiretroviral drugs, such cally restricted to poor
as exists for other medi- countries, and ge- neric firms
cines. Purchasing for the would pay a modest royalty
public or chari- table sector for the privilege38).
in poor countries could be Arrangements like these would
assisted by a single global signify ethical business lead-
brokering fa- cility that ership and would affect
would receive orders and put revenues negli- gibly, given
them to a competitive tender the diminutive pharmaceu-
among a number of high- tical market in poor
quality suppliers. A cen- countries. Without them, poor
tral, tender-based system countries have only the last
like this has been very resort of compulsory licensing
successful in increasing ac- (a gov- ernmental
cess to tuberculosis drugs authorization that allows com-
for poor coun- tries at petitors to use apatent
prices near the marginal cost without the patent holders
of production, or as much as consent), which both TRIPS and
the Paris Convention nance gap means that even if lamen- table result that even
legitimately allow them to health bud- gets were in cases in which
do.39,40 radically expanded and all pharmaceutical companies
Given these options to waste or corruption discount or freely donate
procure medi- cines at banished, Africas antiretroviral drugs, poor
reduced prices, finance and impoverished economies could African countries still
dis- tribution remain as never af- ford more than a cannot afford to use them.
impediments to treat- ment few percent of the cost of Lack of finance thwarts not
access. The impossibility of treatmentand this is true only expensive AIDS
poor countries paying for even if an- tiretroviral treatment but even the highly
antiretroviral treat- ment drug prices continued to cost-effective use of
themselves cannot be de- cline significantly, antiretrovi- ral drugs in
overempha- sized; countries which is unlikely. preventing pediatric HIV in-
such as Ghana, Nige- ria, Therefore, for fection at birth (1 such
and Tanzania have annual antiretroviral treatment to drug, nevira- pine, is
national health budgets of take place, which it must, donated by Boehringer
$8 or less per capita.41 In international aid finance Ingelheim but is rarely used
contrast, estimates endorsed is essential. in Africa).44 The fail- ure
by 140 faculty members of Based on these data, the of wealthy governments to
Harvard University for a extreme dearth of provide sufficient aid to
treatment plan of diagnosis, international aid finance, fund these highly nec- essary
care, and antiretroviral rather than patents, is most interventions violates not
drugs are about $1200 per to blame for the lack of only ba- sic medical ethics
patient-year (including antiretroviral treatment in but possibly interna- tional
infrastruc- ture development Africa. It is remarkable human rights laws as well.45
and training would cost that the worlds richest na- In summary, patents
somewhat more).42 This vast tions of North America, generally do not appear to
fi- Western Eu- rope, and Asia- be a substantial barrier to
Pacific together set aside an- tiretroviral treatment
only $74 million access in Africa to- day.
specifically for African Activists, industry,
AIDS in 1998about $3 per physicians, and media who
HIV- infected African, or have so successfully raised
what it costs to build 3 public awareness of AIDS
miles (5 km) of rural treatment is- sues are in a
freeway.43 Such sums do not position to challenge the
come close to financing the more important barriers. We
physicians, clinics, and agree that there are other
infrastructure needed to patent issues of public
administer antiretroviral health importance beyond the
therapy, much less to scope of this study (eg,
screen patients for HIV access to new medicines
infection, and this has the after 2005, when TRIPS comes
into force
for all World Trade agoa pandemic so rare that Drafting of the manuscript: Attaran,
Organization mem- bers), but it pre- sents a literally
Gillespie-White.
Statistical expertise: Attaran.
concern for the lives of unprecedented test to Funding/Support: This research was
those now dying of AIDS in Western democracy, which is supported by core funding from the
Center for International Development
Africa makes it necessary to not 650 years old. History at Harvard University (Dr Attaran) and a
unbundle those issues and will not judge kindly an grant from the World Intellectual
Property Organization, a United Nations
proceed toward furnishing avoidable delay. specialist agency (Ms Gillespie-White).
antiretrovi- ral treatment After the study was com- pleted and the
Author Contributions: Study concept and manuscript submitted, the Interna- tional
concertedly and with speed. design: Intellectual Property Institute received a
Acquired immunodeficiency Attaran, Gillespie-White. grant from Merck for $25 000.
Acquisition of data: Attaran, Gillespie- Acknowledgment: We thank Andrew
syndrome is now the most White. Analysis and interpretation of Mellinger for assistance in map
numerically lethal pan- data: Attaran, Gillespie- White. production.
demic since the Black Death
650 years

REFERENCES Viral resistance re- sults from the 14. Regulations under the Patent
1. Pecoul B, Chirac P, Trouiller P, Pinel J. international, multicenter, random- ized, Cooperation Treaty. Rule 90bis.1. Available
Access to essential drugs in poor placebo-controlled, 48-week study of at: http://www.wipo.org/pct
countries: a lost battle? JAMA. hydroxy- urea or placebo combined with /en/texts/pdf/pct_regs.pdf. Accessed August
1999;281:361-367. efavirenz, didanosine and stavudine in 1, 2001.
2. Oxfam. Patent injustice: how world trade treatment-naive and -experienced 15. Harris G. Adverse reaction: AIDS
rules threaten the health of poor people. patients. Paper presented at: 8th gaffes in Africa come back to haunt drug
2001. Available at: Conference on Ret- roviruses and industry at home. Wall Street Journal.
http://www.oxfam.org.uk/cutthecost/pat Opportunistic Infections; February 4-8, April 4, 2001:A1.
ent 2001; Chicago, Ill. 16. Boulet P. Patent protection of medicines
.pdf. Accessed August 1, 2001. 11. Shalit P, Farrell P, Lindgren P. Long- in Kenya and Uganda. Paper presented at:
3. Access to HIV/AIDS pharmaceuticals and term safety and efficacy of nevirapine, Me decins Sans Fron- tie` res Conference
medical technologies. 65 Federal Register stavudine and lamivudine in a real-world on Improving Access to Essential Medicines
30521 (2000). Ex- ecutive order 13155. setting. AIDS. 2001;15:804-805. in East Africa; June 15-16, 2000; Nairobi,
4. Article 70, Agreement on Trade-Related 12. Raffi F, Reliquet V, Ferre V, et al. The Kenya. Available at: http://www.accessmed-
Aspects of Intellectual Property Rights. VIRGO study: nevirapine, didanosine and msf.org
Available at: http:// stavudine combination therapy in /msf/accessmed/accessmed2.nsf/iwpList10
www.wto.org/english/docs_e/legal_e/27- antiretroviral-naive HIV-1-infected adults. /
trips.pdf. Accessed August 1, 2001. Antivir Ther. 2000;5:267-272. BC26F310AE6A0060C125690000347CBE
5. Department of Health and Human 13. Joint United Nations Programme on ?
Services. Guide- lines for the use of HIV/AIDS. Patent Situation of HIV/AIDS- OpenDocument&style= Content_level_2.
antiretroviral agents in HIV- infected Related Drugs in 80 Countries. 2000. Accessed August 1, 2001.
adults and adolescents. August 13, 2001. Available at: http://www.unaids.org 17. Paris Convention for the Protection of
Available at: / Industrial Property. March 20, 1883 (as
http://www.hivatis.org/trtgdlns publications/documents/health/access/patsit amended). Article 4c.
.html#Adult. Accessed September 25, .doc. Ac- cessed August 1, 2001. 18. Smith Kline & French Laboratories
2001. Ltd v Evans Medical Ltd, 1 FSR 561
6. Eron JJ Jr, Murphy RL, Peterson D, et al. (1989).
A com- parison of stavudine, didanosine 19. Availability to the public, EPOR
and indinavir with zi- dovudine, 241 (1993).
lamivudine and indinavir for the initial 20. Merrell Dow v Norton, RPC 76 (HL)
treat- ment of HIV-1 infected (1996).
individuals: selection of thymidine 21. Manual for the Handling of
Applications for Pat- ents, Designs and
analog regimen therapy (START II). Trademarks Throughout the World.
AIDS. 2000;14:1601-1610. Utrecht, the Netherlands: Manual Industrial
7. Rockstroh JK, Bergmann F, Wiesel W, et Property BV; 2000.
al. Effi- cacy and safety of twice daily 22. Boulet P, Forte G-B. Drug patents in
first-line ritonavir/ indinavir plus double French- speaking Africa. Report of an MSF-
nucleoside combination therapy in HIV- UNAIDS-WHO joint mission; Feb 6-10, 2000;
infected individuals. AIDS. Cameroon.
2000;14:1181- 1185. 23. Bala K, Sagoo K. Patents & prices.
Health Action International News.
8. Squires KE, Gulick R, Tebas P, et al. A April/May 2000. Available at: http:
comparison of stavudine plus //www.haiweb.org/pubs/hainews/Patents
lamivudine versus zidovudine plus %20and
lamivudine in combination with %20Prices.html. Accessed August 1,
indinavir in antiret- roviral naive 2001.
individuals with HIV infection: selection of 24. Beyond Our Means? The Cost of
thymidine analog regimen therapy (START Treating HIV/ AIDS in the Developing
I). AIDS. 2000;14:1591-1600. World. London, England: Pa- nos
9. Gartland M. AVANTI 3: a randomized, Institute; 2000. Available at:
double- blind trial to compare the efficacy http://www.oneworld
and safety of lam- ivudine plus .org/panos/aids/BeyondOurMeans.pdf.
zidovudine versus lamivudine plus zido- Accessed August 1, 2001.
vudine plus nelfinavir in HIV-1-infected 25. Report of the WHO International
Consultative Meeting on HIV/AIDS
antiretroviral- naive patients. Antivir Antiretroviral Therapy; May 22- 23, 2001;
Ther. 2001;6:127-134. Geneva, Switzerland.
10. Johnson V, Delaugerre C, Hazelwood J, 26. IMS Health releases five year forecast
et al, for the International 3D Study Team. of global pharmaceutical growth [press
release]. 1999. Avail- able at: ternational Intellectual Property for drug access in the developing world.
http://www.imshealth.com/public/structur Institute. February 5, 2001. Available at: Paper presented at: Me decins Sans
e http://www.tac.org.za/ns010206 Frontie` res/World Health Organization
/dispcontent/1,2779,1010-1010- .txt. Accessed August 1, 2001. Workshop on Drugs for Com- municable
6701,00.html. Ac- cessed August 1,
2001. 31. Bale HE. Consumption and trade in Diseases: Stimulating Development and
27. Letter from European Public Health off-patented medicines. WHO Se- curing Availability; October 14-15,
Alliance, Health Action International, Commission on Macroeconomics and 1999; Paris, France.
Consumer Project on Technol- ogy, Oxfam Health working paper series; 2001. 39. Correa C. Intellectual property rights
UK, Wemos Foundation, and Act-Up Paris to Available at: http:// and the use of compulsory licenses:
the European Commission. September www.cmhealth.org/docs/wg4_paper3.p options for the developing countries.
27, 2000. Available at: df. Ac- cessed August 1, 2001. South Centre Trade-Related Agenda, De-
http://www.cptech.org/ip/health/eu
/lamynielson27092000.html. Accessed 32. Swarns RL. AIDS drug battle deepens velopment and Equity working paper 5;
August 1, 2001. in Africa. 1999. Avail- able at:
28. Bale HE. The conflicts between New York Times. March 8, 2001:A1. http://www.southcentre.org/publications
parallel trade and product access and 33. Laing RO, McGoldrick KM. /complicence/wto5.pdf. Accessed August 7,
innovation: the case of pharma- Tuberculosis drug is- sues: prices, fixed 2001.
ceuticals. J Int Econ Law. 1998;1:637- dose combination products and sec- ond 40. Ford SM. Compulsory licensing
653. line drugs. Int J Tuberc Lung Dis. provisions under the TRIPS agreement:
29. Pe rez-Casas C, for Me decins Sans 2000;4(suppl): S194-S207. balancing pills and patents. Am Univ Int
Frontie` res. HIV/ AIDS Medicines Pricing 34. Gupta R, Kim JY, Espinal MA, et al. Law Rev. 2000;15:941-974.
Report. Setting objectives: is Responding to market failures in 41. Attaran A, Sachs J. Defining and
thereapoliticalwill? tuberculosis control. Science. 2001; refining inter- national donor support for
December2000.Availableat:http:// 293:1049-1051. combating the AIDS pan- demic. Lancet.
www.accessmed- 35. Stephenson J. UN conference 2001;357:57-61.
msf.org/msf/accessmed/accessmed2 endorses battle plan for HIV/AIDS. 42. Consensus statement on
. JAMA. 2001;286:405. antiretroviral treat- ment for AIDS in
nsf/5f67f1de88df2cb9c1256873005c87 36. Lanjouw JO. A patent policy proposal poor countries by individual mem- bers
71 for global diseases. 2001. Available at: of the faculty of Harvard University. Top
/ http://www.brookings HIV Med. 2001;9:14-26.
21b68eca86cdd243c12569a60056c0a1/$ . 43. California Department of
FILE org/views/papers/lanjouw/20010611.p Transportation. Esti- mated costs for
/Update.doc. Accessed August 1, 2001. df. Ac- cessed August 7, 2001. various freeway construction projects.
30. Letter from Treatment Action 37. Correa C. Integrating Public Health July 6, 1999.
Campaign to In- Concerns into Patent Legislation in 44. Marseille E, Kahn JG, Mmiro F, et al.
Developing Countries. Geneva, Cost effec- tiveness of single-dose
Switzerland: South Centre; 2000. nevirapine regimen for mothers and
Available at: http:// babies to decrease vertical HIV-1
www.southcentre.org/publications/publi transmission in sub-Saharan Africa.
chealth Lancet. 1999;354:803-809.
/publichealth.pdf. Accessed August 7, 45. Attaran A. Human rights and
2001. biomedical re- search funding for the
38. Attaran A. Respective contributions developing world: discovering state
of the pub- lic and private sector in the obligations under the right to health.
development of new drugs: implications Health Hum Rights. 1999;4:28-58.

Vous aimerez peut-être aussi