Do Patents for Antiretroviral Drugs Constrain Access to AIDS Treatment
in Africa?
Amir Attaran, DPhil, LLB; Lee Gillespie-White, LLB
Public attention and debate recently have focused on access to treatment
of acquired immunodeficiency syndrome (AIDS) in poor, severely affected countries,
such as those in Africa. Whether patents on antiretroviral drugs in Africa
are impeding access to lifesaving treatment for the 25 million Africans with
human immunodeficiency virus infection is unknown. We studied the patent statuses
of 15 antiretroviral drugs in 53 African countries. Using a survey method,
we found that these antiretroviral drugs are patented in few African countries
(median, 3; mode, 0) and that in countries where antiretroviral drug patents
exist, generally only a small subset of antiretroviral drugs are patented
(median and mode, 4). The observed scarcity of patents cannot be simply explained
by a lack of patent laws because most African countries have offered patent
protection for pharmaceuticals for many years. Furthermore, in this particular
case, geographic patent coverage does not appear to correlate with antiretroviral
treatment access in Africa, suggesting that patents and patent law are not
a major barrier to treatment access in and of themselves. We conclude that
a variety of de facto barriers are more responsible for impeding access to
antiretroviral treatment, including but not limited to the poverty of African
countries, the high cost of antiretroviral treatment, national regulatory
requirements for medicines, tariffs and sales taxes, and, above all, a lack
of sufficient international financial aid to fund antiretroviral treatment.
We consider these findings in light of policies for enhancing antiretroviral
treatment access in poor countries.
JAMA. 2001;286:1886-1892
In recent months, there has been a great deal of controversy about access
to antiretroviral medicines to treat human immunodeficiency virus (HIV)/acquired
immunodeficiency syndrome (AIDS) in poor countries, where tens of millions
have HIV infection and face certain death without antiretroviral treatment.
A dramatic, often heated element of this debate has focused on the role of
intellectual property law
specifically, patentswhich activists
blame for creating monopolies that keep drugs inaccessible or unaffordable,
and which pharmaceutical companies extol as necessary incentive for expensive
research and development. This has led to highly organized campaigns, critiques
of the international patent law system, White House executive orders, and
calls to limit the scope of pharmaceutical patents in poor countries.1-3
In this article, we examine the current relationship between patents
and antiretroviral drug access. We test the hypothesis that patents are a
leading barrier to widespread AIDS treatment in Africa by presenting for the
first time, to our knowledge, comprehensive data on whether patents for antiretroviral
drugs exist on that continent. We discuss the findings of our case study in
light of the current controversy regarding AIDS medicines and the legal options
for enhancing access to antiretroviral treatment for the world's poor.
METHODS
Between October 2000 and March 2001, we issued written inquiries to
the intellectual property divisions of major pharmaceutical companies that
produce or market antiretroviral drugs, seeking disclosure and affirmation
of each patent or similar legal right in Africa of which those companies had
knowledge. Our inquiries captured the patent status of the antiretroviral
drugs invented or marketed by the companies in question, unless a single active
ingredient is marketed in multiple formulations, in which case we sought data
for the first marketed (primary) formulation. All companies we contacted agreed
to furnish data in response to our inquiry. We summarized the data in tabular
form and then returned the data to each of the respondent companies for 1
or more rounds of clarification, verification, or correction as needed.
Our inquiries captured several different types of legal rights: product
patents (covering the pharmacologically active chemical or formulation), process
patents (covering a manufacturing process for the same), use patents (covering
the use of a drug for a medical indication), and "exclusive marketing rights"
(an interim legal status in international patent law that pertains only to
the least-developed countries under the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights
[TRIPS]4). For the purposes of this study,
it is generally unnecessary to distinguish among these because they all confer
a degree of market exclusivity (ie, an exclusive right to manufacture, import,
or sell) in similar ways.
Because our method is survey based, we cannot exclude the possibility
that even after verification some inaccuracies exist because of human error
in reporting data to us. However, in this large crosswise scrutiny of 15 antiretroviral
drugs and 53 countries (comprising 795 data points), a small number of such
inaccuracies would not materially affect our broad conclusions. Although this
is satisfactory for an academic study, given the serious legal consequences
of patent infringement, we strongly recommend that anyone placing reliance
on these findings seek independent legal advice.
RESULTS
A total of 15 antiretroviral drugs patented by 8 pharmaceutical companies
were screened for patent status in 53 African countries. Table 1 and Figure 1 summarize
the data and record every patent in force at the time we were notified. We
do not present data on expired or withdrawn patents, which are of no legal
force, or pending patent applications, since it cannot be presumed that these
will be granted or rejected. Where a patent is shown, some form of market
exclusivity exists, although this exclusivity may not preclude all uses of
the pharmacologically active ingredient (eg, in the case of a formulation
patent).
The data in Table 1 and Figure 1 can be interpreted as disclosing
1 general rule and 2 specific exceptions. The rule is that among antiretroviral
drugs, most are patented in few African countries (median, 3; mode, 0 countries)
and that among the subset of countries where 1 or more patents exist, the
number of patented antiretroviral drugs is typically few (median and mode,
4 drugs). The exceptions are South Africa, where a comparatively large number
of antiretroviral drugs are patented (13/15), and Agouron, Boehringer Ingelheim,
and GlaxoWellcome (now GlaxoSmithKline) products, which are patented in a
large number of countries (up to 37 of 53 countries). Overall, of a theoretically
possible 795 instances of patenting that we might have identified (assuming
generously that all countries offer pharmaceutical patents, which is not true),
only 172 (21.6%) actually exist.
While patents do limit the use of some highly active antiretroviral
therapy regimens on a "no patent" basis (especially those using zidovudine,
lamivudine, or both), the US Department of Health and Human Services (DHHS)
clinical guidelines list several "strongly recommended" regimens for which
there are encouraging clinical trials and which are unpatented in up to 52
of 53 African countries. In addition, other regimens are available on a "1
patent" basis, where that patented drug may be available at discounted prices.
Examples of regimens recommended by the DHHS and their patent statuses are
provided in Table 2.
COMMENT
This study demonstrates that patent protection for antiretroviral drugs
in Africa is not extensive. This is surprising since earlier studies have
shown that patent applications were filed in many African countries.13 We now infer that most of these applications were
probably abandoned because it is common practice to name a large number countries
on an international patent application, given the option of establishing a
patent later on, and later abandon many or most of them when the patent fees
are due.14 Therefore, it is not surprising
that the number of applications is large while the number of patents in force
is few.
These results rely on patent self-reporting and may contradict isolated
press reports.15 However, we believe there
are 2 independent reasons that patent holders and licensees are the most reliable
source for these data when queried systematically.
First, the relationship between a patent and a product is not always
self-evident to anyone other than the patent holder or a licensee. A patent
may not refer explicitly to the name of a product or the formula of the pharmacologically
active chemical (eg, a process patent for a synthetic intermediate). As such,
even a highly skilled observer searching the records of a national patent
office (an extremely difficult or impossible undertaking in much of Africa)
could easily overlook patents pertaining to a product of interest. This problem
is avoided when the patent holder or licensee self-reports the data, and to
the limited extent that our data were verifiable against those obtained directly
from 1 national patent office (Kenya), the results match perfectly.16
Second, companies that self-report the lack of a patent probably would
do so truthfully because there is no incentive to conceal the existence of
a patent. Concealment would invite unwanted competition from generic drug
suppliers. While theoretically companies may benefit from exaggerating the
extent of their patent protection, there is no plausible commercial benefit
in denying the existence of valid patents they own.
As most of the antiretroviral drugs we studied are infrequently patented
in Africa, is this situation likely to persist in coming years? Most national
patent systems follow the Paris Convention, which
stipulates a 1-year grace period during which all patent applications ordinarily
are filed.17 This period elapsed long ago for
the antiretroviral drugs we studied, meaning that the opportunity to file
further patent applications and obtain future patents generally has expired.
It is conceivable that "afterthought" applications could be still filed to
patent incidental features of these drugs (eg, a drug's crystalline form or
its metabolite), but such claims may be regarded skeptically by courts outside
the United States.18-20
We think it is unlikely that the observed omissions to patent in Africa could
now be reversed, meaning that current antiretroviral drugs will remain largely
unpatented in Africa (future antiretroviral drugs, of course, may be another
matter).
It is an interesting question why there are not more antiretroviral
drug patents in Africa. Certainly, it is not simply because the option to
patent has been lacking. Although the laws of some African countries do not
permit pharmaceutical patents, or did not when applications to patent these
antiretroviral drugs were filed, most have allowed pharmaceutical patents
for years.21 The 15 member countries of Francophone
West Africa in OAPI (the Organisation Africaine de la Propriété
Intellectuelle) have offered a system of pharmaceutical product and process
patents since the Bangui Agreement of 1977.22 Similarly, pharmaceutical patent protection has been
available in most of the 15 Anglophone countries of ARIPO (the African Regional
Industrial Property Organization) since at least 1984.16
Despite these and other opportunities to patent antiretroviral drugs
in Africa, patents were not often sought, suggesting 2 important conclusions.
First, and perhaps surprisingly, it is doubtful that patents are to
blame for the lack of access to antiretroviral drug treatment in most African
countries. Conventional wisdom has spuriously assumed that drugs patented
in Europe or North America must also be patented in Africa, or that a lack
of generic competition and high retail prices (sometimes in excess of those
charged in developed countries) are prima facie evidence of patents, which
they are not.23, 24 Determining
actual patent coverage is therefore instructive, and in doing so, we observe
that that there is no apparent correlation between access to antiretroviral
treatment, which is uniformly poor across Africa, and patent status, which
varies extensively by country and drug. We were unable to identify any evidence,
systematic or anecdotal, that antiretroviral treatment is more accessible
in countries with few or no antiretroviral patents (eg, Mozambique, Namibia).
Similarly, we were unable to identify any evidence that the antiretroviral
drugs of, for example, Abbott, patented in 0 countries, are consumed in any
greater numbers than those of GlaxoSmithKline, patented in up to 37 countries.
These observations are necessarily qualitative given that accurate data on
African antiretroviral drug consumption do not exist, but are based on the
consensus that very few of the 25 million HIV-positive Africans now receive
treatment (perhaps 25 000, or just 1 in 1000, receive 1 antiretroviral
drug).25 This scarcity of treatment cannot
rationally be ascribed to antiretroviral patents that are fewor nonexistentin
most African countries. Other factors, and especially the ubiquitous poverty
of African countries, must be more to blame.
Second, also perhaps surprisingly, it is doubtful that pharmaceutical
research and development will always require the incentive of patentability
in poor countries, since the option to patent antiretroviral drugs in Africa
has frequently gone unexercised. The economics and profitability of antiretroviral
drug research (unlike that of, say, malaria) are driven by consumption of
drugs by AIDS patients in the lucrative North American and European markets.
In comparison, the entire African pharmaceutical market, at 1.1% of the global
whole, is commercially negligible, as is the market share of antiretroviral
drugs sold to the poorest third of the world (0.5%) (Jean O. Lanjouw, PhD,
written communication, August 7, 2001).26 Patenting
in poor countries therefore yields very small financial returns, and, given
the cost of patenting and the difficulty of enforcing one's patents before
sometimes weak judicial systems, most companies appear to have decided that
extensive patenting in Africa is not worthwhile.
Thus, the data suggest that patents in Africa have generally not been
a factor in either pharmaceutical economics and antiretroviral drug treatment
access (South Africa, with its larger affluent market, is an exception). This
counters some of the sweeping policy arguments made for or against patents,
and, within the limited scope of this study, it is no more correct to allege
that "intellectual property protection [has] huge [adverse] influences on
. . . access to medicines" than it is to claim that ongoing pharmaceutical
research and development finds it "necessary to protect intellectual property
rights on a global scale."27, 28
Although we agree that either or both of these statements may be correct in
other contexts, neither is borne out as true in this case study.
Our data or conclusions should not be misinterpreted. It would be wrong
to cite this study as proof that patents never affect access to medicinesthat
conclusion would require research well beyond antiretrovirals in Africa in
2001. Also, in reporting data on antiretroviral patent status, it must be
remembered our data reflect only the existence of patents, and never their
validity, which is testable only through a legal challenge. We presume that
all patents reported to us are valid, as is the rule until being judicially
invalidated.
What are the nonpatent barriers impeding antiretroviral treatment in
Africa? Certainly, access to treatment can be impeded many ways: by insufficient
finances to purchase relatively costly antiretroviral drugs; by a lack of
political will among countries; by poor medical care and infrastructure; by
inefficient drug regulatory procedures that exclude competing products from
the marketplace; by high tariffs and sales taxes; and so on. Such barriers
have been identified by others.29-31
A comprehensive treatment access plan for Africa must overcome these nonpatent
barriers and make use of expeditious strategies that combine affordability,
compliance with patent laws, and sufficient finance. We consider these in
turn.
At this writing, both brand name and generic sources of antiretroviral
drugs are available at reduced price, typically about 90% less than in the
United States. Prices range from $350 a year for the cheapest possible 3-drug
combination of stavudine, lamivudine, and nevirapine (Cipla) to perhaps $1000
for a regimen containing a more expensive protease inhibitor, which might
cost $600 itself (eg, indinavir).32
Patent status is a central consideration when sourcing drugs. Where
a drug is not patented in a given country, one may freely manufacture, import,
and buy the brand-name drug or its generic equivalent (provided that both
are registered for use by the local drug regulatory authorities, which is
not always the case since some authorities decline to register generic products
[Richard O. Laing, MD, written communication, August 7, 2001]). Therefore,
competition can lead to a concurrent market for brand-name and generic antiretroviral
drugs, such as exists for other medicines. Purchasing for the public or charitable
sector in poor countries could be assisted by a single global brokering facility
that would receive orders and put them to a competitive tender among a number
of high-quality suppliers. A central, tender-based system like this has been
very successful in increasing access to tuberculosis drugs for poor countries
at prices near the marginal cost of production, or as much as 97% below prices
in United States or Japan.33, 34
However, the risk of driving prices down while simultaneously increasing the
funds available to purchase antiretroviral drugs for Africa (as the much-anticipated
international trust fund for infectious disease might soon do35)
is that it creates market conditions in which it could become lucrative to
patent antiretroviral drugs more widely in the future. The TRIPS agreement
will make this possible in all developing countries belonging to the World
Trade Organization by no later than 2006.
On the other hand, in African countries where antiretroviral drug patents
do exist, the international community should ensure a supply of affordable
drugs. An equitable balance is that countries ought to respect patent laws,
but that patent holders reciprocally supply medicines to the global poor without
profit, but also without loss. Various solutions to achieve this exist. Merck,
Bristol-Myers Squibb, and Abbott have discounted antiretroviral drugs to prices
not above their stated costs of production and distribution, and GlaxoSmithKline
has taken similar steps for malaria medicines as well. These examples should
be followed by other pharmaceutical companies. Alternatively, various legal
proposals have been made to limit the patentability of certain medicines in
poor countries without markedly affecting revenues.36, 37
Brand-name pharmaceutical companies might also consider adhering to a code
of practice, in which they agree to voluntarily license patents for important
medicines (antiretroviral drugs and others) to high-quality generic manufacturers
willing to supply at low prices (the licenses would be geographically restricted
to poor countries, and generic firms would pay a modest royalty for the privilege38). Arrangements like these would signify ethical business
leadership and would affect revenues negligibly, given the diminutive pharmaceutical
market in poor countries. Without them, poor countries have only the last
resort of compulsory licensing (a governmental authorization that allows competitors
to use a patent without the patent holder's consent), which both TRIPS and
the Paris Convention legitimately allow them to do.39, 40
Given these options to procure medicines at reduced prices, finance
and distribution remain as impediments to treatment access. The impossibility
of poor countries paying for antiretroviral treatment themselves cannot be
overemphasized; countries such as Ghana, Nigeria, and Tanzania have annual
national health budgets of $8 or less per capita.41
In contrast, estimates endorsed by 140 faculty members of Harvard University
for a treatment plan of diagnosis, care, and antiretroviral drugs are about
$1200 per patient-year (including infrastructure development and training
would cost somewhat more).42 This vast finance
gap means that even if health budgets were radically expanded and all waste
or corruption banished, Africa's impoverished economies could never afford
more than a few percent of the cost of treatmentand this is true even
if antiretroviral drug prices continued to decline significantly, which is
unlikely. Therefore, for antiretroviral treatment to take place, which it
must, international aid finance is essential.
Based on these data, the extreme dearth of international aid finance,
rather than patents, is most to blame for the lack of antiretroviral treatment
in Africa. It is remarkable that the world's richest nations of North America,
Western Europe, and Asia-Pacific together set aside only $74 million specifically
for African AIDS in 1998about $3 per HIV-infected African, or what
it costs to build 3 miles (5 km) of rural freeway.43
Such sums do not come close to financing the physicians, clinics, and infrastructure
needed to administer antiretroviral therapy, much less to screen patients
for HIV infection, and this has the lamentable result that even in cases in
which pharmaceutical companies discount or freely donate antiretroviral drugs,
poor African countries still cannot afford to use them. Lack of finance thwarts
not only "expensive" AIDS treatment but even the highly cost-effective use
of antiretroviral drugs in preventing pediatric HIV infection at birth (1
such drug, nevirapine, is donated by Boehringer Ingelheim but is rarely used
in Africa).44 The failure of wealthy governments
to provide sufficient aid to fund these highly necessary interventions violates
not only basic medical ethics but possibly international human rights laws
as well.45
In summary, patents generally do not appear to be a substantial barrier
to antiretroviral treatment access in Africa today. Activists, industry, physicians,
and media who have so successfully raised public awareness of AIDS treatment
issues are in a position to challenge the more important barriers. We agree
that there are other patent issues of public health importance beyond the
scope of this study (eg, access to new medicines after 2005, when TRIPS comes
into force for all World Trade Organization members), but concern for the
lives of those now dying of AIDS in Africa makes it necessary to unbundle
those issues and proceed toward furnishing antiretroviral treatment concertedly
and with speed. Acquired immunodeficiency syndrome is now the most numerically
lethal pandemic since the Black Death 650 years agoa pandemic so rare
that it presents a literally unprecedented test to Western democracy, which
is not 650 years old. History will not judge kindly an avoidable delay.
Author/Article Information
Author Affiliations: Center for International
Development and Kennedy School of Government, Harvard University, Cambridge,
Mass (Dr Attaran); International Intellectual Property Institute, Washington,
DC (Ms Gillespie-White).
Corresponding Author and Reprints: Amir
Attaran, DPhil, LLB, Center for International Development, Harvard University,
79 JFK St, Cambridge, MA 02138 (e-mail: amir_attaran@harvard.edu).
Author Contributions: Study
concept and design: Attaran, Gillespie-White.
Acquisition of data: Attaran, Gillespie-White.
Analysis and interpretation of data: Attaran,
Gillespie-White.
Drafting of the manuscript: Attaran, Gillespie-White.
Statistical expertise: Attaran.
Funding/Support: This research was supported
by core funding from the Center for International Development at Harvard University
(Dr Attaran) and a grant from the World Intellectual Property Organization,
a United Nations specialist agency (Ms Gillespie-White). After the study was
completed and the manuscript submitted, the International Intellectual Property
Institute received a grant from Merck for $25 000.
Acknowledgment: We thank Andrew Mellinger for
assistance in map production.
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