Content uploaded by Philippe J Guerin
Author content
All content in this area was uploaded by Philippe J Guerin
Content may be subject to copyright.
Available via license: CC BY 4.0
Content may be subject to copyright.
Essay
The Primacy of Public Health Considerations in Defining
Poor Quality Medicines
Paul N. Newton
1,2,3
*, Abdinasir A. Amin
4
, Chris Bird
5
, Phillip Passmore
6
, Graham Dukes
7
,Go
¨ran
Tomson
8
, Bright Simons
9
, Roger Bate
10
, Philippe J. Guerin
2,3
, Nicholas J. White
2,11
1Wellcome Trust-Mahosot Hospital-Oxford Tropical Medicine Research Collaboration, Microbiology Laboratory, Mahosot Hospital, Vientiane, Lao PDR, 2Centre for
Tropical Medicine, Nuffield Department of Medicine, University of Oxford, Churchill Hospital, Oxford, United Kingdom, 3WorldWide Antimalarial Resistance Network
(WWARN), University of Oxford, Oxford, United Kingdom, 4Malaria & Child Survival Department, Population Services International, Nairobi, Kenya, 5Wellcome Trust,
London, United Kingdom, 6School of Pharmacy, Curtin University of Technology, Bentley, Western Australia, Australia, 7University of Oslo, Oslo, Norway, 8IHCAR Div
Global Health, Karolinska Institute, Stockholm, Sweden, 9IMANI Center for Policy & Education, Accra, Ghana, 10 American Enterprise Institute, Washington, D.C., United
States of America, 11 Mahidol Oxford Research Unit, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
Poor Quality Medicines—A
Major Public Health Problem
There is growing, but belated, concern
that much of the developing world’s supply
of medicines—in particular, its supply of
anti-infective drugs—is of poor quality.
This constitutes a major public health pro-
blem because the high prevalence of poor
quality drugs in developing countries results
in avoidable morbidity, mortality, and drug
resistance [1–7]. Moreover, any efforts to
improve public health by developing new
medicines or by changing treatment poli-
cies will ultimately be pointless if the drugs
patients actually take contain insufficient or
incorrect ingredients.
Unfortunately, efforts to improve the
quality of medicines in developing coun-
tries are being hampered by confusion over
the terms used to describe different types of
poor quality medicines. This confusion has
arisen because of poor science and because
of tension between the defence of commer-
cial interests and the public health impor-
tance of enhanced access to good quality
medicines in developing countries. Specif-
ically, some commentators have argued
that counterfeit medicines are being viewed
primarily as intellectual property (IP) rather
than public health concerns and that the
innovative pharmaceutical industry is using
action against counterfeit medicines to im-
pede the trade in competing generics [8–
20]. In this essay, we call for public health
concerns to be made the prime consider-
ation in defining and combating counterfeit
medicines and argue that recent World
Health Organization (WHO) initiatives
eschew IP concerns. We also discuss some
related but neglected interventions that
might help to improve drug quality in
developing countries.
Current Definitions of Poor
Quality Medicines
Since 1992, the WHO has used a
definition of counterfeit medicines that
regards them as products produced fraud-
ulently without any regard to regulatory
and public health concerns (Box 1) and
usually, but not always, lacking in any
active pharmaceutical ingredients (API)
[3–5,9]. By contrast, the definition used
by WHO for ‘‘substandard’’ medicines de-
scribes them as medicines produced by
legitimate manufacturers that do not meet
pharmacopoeial standards because of errors
in the quality or quantity of raw materials or
in manufacturing (see Box 1; [7]).
Surprisingly, some commentators argue
that it is ‘‘not immediately obvious that a
specific definition of ‘counterfeit medicine’
is a necessary tool to effectively combat the
public health problem of unsafe medicines’’
[8]. We strongly disagree with this view-
point. It is clearly crucial to distinguish
counterfeits from othertypes of poor quality
medicines, in particular, substandard med-
icines. Counterfeit and substandard medi-
cines are fundamentally different problems
and without common understanding, through
consensus definitions, the public health pro-
blems associated with poor quality medi-
cines cannot be measured and interventions
planned and evaluated (see Text S1).
Unfortunately, although it is essential to
distinguish substandard from counterfeit
medicines because their origins and solu-
tions differ, these terms are often used
interchangeably, which is both confusing
and incorrect [3,5,8] (Box 1 and Text S1).
For example, ‘‘poor quality medicines’’—
drugs that have failed physical/chemical
tests—are often classified as ‘‘counterfeit’’
even when it is unclear whether they have
been produced fraudulently (i.e., they are
counterfeit) or whether they are the re-
The Essay section contains opinion pieces on topics
of broad interest to a general medical audience.
Citation: Newton PN, Amin AA, Bird C, Passmore P, Dukes G, et al. (2011) The Primacy of Public Health
Considerations in Defining Poor Quality Medicines. PLoS Med 8(12): e1001139. doi:10.1371/journal.pmed.
1001139
Published December 6, 2011
Copyright: ß2011 Newton et al. This is an open-access article distributed under the terms of the Creative
Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium,
provided the original author and source are credited.
Funding: Wellcome Trust (UK) for PNN & NJW. The funders had no role in study design, data collection and
analysis, decision to publish, or preparation of the manuscript, except for the involvement of Chris Bird as an
author.
Competing Interests: PN and NJW have scientific collaborations with the Enforcement Working Group of
IMPACT, and NJW is co-chair of the WHO malaria treatment guidelines committee but none of the authors have
shares in pharmaceutical companies or works as a part of IMPACT. NJW is a member of the PLoS Medicine
Editorial Board. The Wellcome Trust had no role in the writing or decision to submit this viewpoint for
publication, except for the involvement of CB as an author. BS is co-founder of MPedigree, which is a non-profit
based in Ghana that advocates for the development of strategies to fight counterfeiting. All other authors have
declared that no competing interests exist.
Abbreviations: IP, intellectual property; MRA, medicine regulatory authority; WHO, World Health
Organization
* E-mail: paul@tropmedres.ac
Provenance: Not commissioned; externally peer reviewed.
PLoS Medicine | www.plosmedicine.org 1 December 2011 | Volume 8 | Issue 12 | e1001139
sult of poor quality control (i.e., they are
substandard) (Figure 1). The problem of
substandard medicines can potentially
be remedied through action by medicine
regulatory authorities (MRAs), through
initiatives such as WHO prequalification,
and through support for improvement of
factory processes. By contrast, the remedies
for counterfeits include covert MRA, police,
and customs investigations, ‘‘factory’’ clo-
sures, prosecutions, and the reduction of
the profit incentive of counterfeiting by
ensuring that genuine medicines are af-
fordable and accessible [21].
A New Definition for
Counterfeit Medicines
An important unresolved issue with
existing definitions of counterfeit medicines
is the tension between the implicit or
explicit understanding that counterfeit,
unlike substandard, medicines are pro-
duced intentionally and the difficulty, in
law, of proving that a counterfeit medicine
has been manufactured ‘‘deliberately’’ with
an intention to mislead. With the current
definition, prosecutors have to show both
that the manufacture of a ‘‘counterfeit’’
medicine actually took place and that the
manufacturer had the intention to mislead.
To help MRAs combat the problem of
counterfeit drugs, WHO [9] and its part-
ners in the International Medicinal Prod-
ucts Anti-Counterfeiting Taskforce (IM-
PACT) recently proposed a refinement to
the 1992 definition of counterfeit medicines
to provide a model text for national legis-
lation (Box 2; [8,9]). Some agree with this
refinement, but others have argued that it
defines counterfeit medicine from an IP
perspective and could therefore damage
access to generic medicines. While we agree
that any public health–oriented definition of
counterfeit medicines should not invoke IP
issues, we argue that the proposed WHO
definition does not invoke such issues [10–
20]. Importantly, there has been little
discussion of alternative non-IP legislation
that could be used to prevent the circula-
tion of counterfeit medicines [1–6,10,20].
A Public Health Perspective
Definition of Counterfeit
Medicines
Although some commentators have
expressed the view that counterfeit medi-
cines are not a public health issue, despite
the evidence to the contrary [1–7,22], we
believe that a logical response to the above
concerns about definitions would be a
robust public health–oriented definition of
counterfeit medicines designed to protect
access to good quality medicines.
Importantly, it is not only innovator
medicines that are counterfeited (we prefer
the term ‘‘innovator medicines’’ to ‘‘brand-
ed medicines’’ in this context because
generic medicines can also be branded).
Generic medicines, which are of enormous
benefit to global public health because they
make essential medicines less expensive and
more accessible, are also counterfeited; and
so any definition of counterfeited medicines
must be appropriate for both innovative
and generic drugs. In fact, contrary to the
opinion of some [6,10,12–20], the new
WHO definition of counterfeit medicines
(Box 2) is less likely to damage access to
generic drugs than the 1992 version (see
Text S1), and it distances itself from patent
issues, as WHO states explicitly (Box 3; [9]).
However, in addition to the potential
that IP-based definitions of counterfeit
medicines have for hampering the trade
in generics, such a perspective is inappro-
priate for a public health problem for three
more reasons. First, in stark contrast to the
counterfeiting of consumer goods, such as
DVDs, the primary victims of medical
counterfeiting are not the legitimate man-
ufacturers but patients, and often the
poorest and most vulnerable of patients.
We believe that patients deserve to be pro-
tected under unequivocal public health–
oriented law rather than being subject to
the uncertainties of contentious IP law.
Second, crucially, allegations of trademark
or patent violations will not protect the
public adequately against counterfeit med-
icines that are labeled as manufactured by
non-existent companies because a non-
entity cannot be sued. For example, coun-
terfeit tetracycline tablets that contained no
API were recently found in Cambodia.
These tablets were labeled as made by a
non-existent company with no patents or
trademark rights and therefore no viable
claims under IP law could be made against
this medication [22]. Third, IP law cannot
necessarily be used to protect unbranded
generic medicines against the production of
counterfeit medicines.
A further controversial problem is the
issue of whether ‘‘counterfeit’’ is the best
term for this particular class of poor
quality medicines. There has been much
discussion as to whether the correct term
for counterfeit medicine should be ‘‘coun-
terfeit’’, ‘‘fake’’, ‘‘falsified’’, or ‘‘spurious’’
medicine, as it is claimed that using
Summary Points
NPoor quality essential medicines, both substandard and counterfeit, are serious
but neglected public health problems. Anti-infective medicines are particularly
afflicted.
NUnfortunately, attempts to improve medicine quality have been hampered by
confusion and controversy over definitions. For counterfeit (or falsified)
medicines, this has arisen from perceived differences between public health
and intellectual property approaches to the problem.
NWe argue that public health, and not intellectual property or trade issues,
should be the prime consideration in defining and combating counterfeit
medicines, and that the World Health Organization (WHO) should be
encouraged and supported to take a more prominent role in improving the
world’s medicine quality and supply.
NAn international treaty on medicine quality, under WHO auspices, could be an
important step forward in the struggle against both substandard and
counterfeit (or falsified) medicines.
Box 1. Current Definitions as used by WHO
Substandard medicines ‘‘Substandard medicines (also called out of specification
(OOS) products) are genuine medicines produced by manufacturers authorized by
the NMRA which do not meet quality specifications set for them by national
standards.
‘‘Normally, each medicine that a manufacturer produces has to comply with quality
standards and specifications. These are reviewed and assessed by the national
medicines regulatory authority before the product is authorized for marketing.’’ [34]
Counterfeit medicines ‘‘A counterfeit medicine is one which is deliberately and
fraudulently mislabelled with respect to identity and/or source. Counterfeiting can
apply to both branded and generic products and counterfeit products may include
products with the correct ingredients, wrong ingredients, without active ingredients,
with insufficient quantity of active ingredient or with fake packaging.’’ [9]
PLoS Medicine | www.plosmedicine.org 2 December 2011 | Volume 8 | Issue 12 | e1001139
‘‘‘counterfeit’ (a term defined in the TRIPS
Agreement as trademark violation) to also
refer to spurious pharmaceuticals is a dis-
service to public health as it conflates issues
of health and IPRs’’ [20,23,24]. Which of
the above terms is used for what we refer to
as ‘‘counterfeit medicine’’ throughout this
essay is of relatively little importance in
comparison to consensus on the accompa-
nying definition, which is vital. If the use of
an alternative term, such as ‘‘falsified’’ or
‘‘spurious’’, creates the conditions for con-
structive vital dialogue, such a change in
terminology should be enthusiastically em-
braced. Further neglected issues con-
cerning the definitions of different types of
poor quality medicines are discussed in
Text S1.
The World Health Assembly’s
Failure to Deal with Counterfeit
Medicines
The World Health Assembly (WHA)
should be an ideal setting in which to
thrash out solutions to the problem of poor
quality medicines in the developing world.
However, two days of debate on counter-
feit medicines at the 63rd WHA (May
2010) failed to reach any agreement about
the way forward apart from establishment
of a working group to ‘‘examine, from a
public health perspective, excluding trade
and intellectual property considerations…
WHO’s role in measures to ensure avail-
ability of quality, safe, efficacious and
affordable medical products…WHO’s re-
lationship with the International Medici-
nal Products Anti-Counterfeiting Taskfor-
ce…WHO’s role in the prevention and
control of medical products of compro-
mised quality, safety and efficacy such as
substandard/spurious/falsely-labelled/fal-
sified/counterfeit medical products from a
public health perspective….’’ [23–28].
The Working Group met at the 64th
WHA in May 2011 and requested more
time for its deliberations [29]. This delay
is not in the interest of global public
health, and we hope that a consensus on
counterfeit medicine definitions, terminol-
ogy, and interventions will soon be ex-
pedited by MRAs and public health officials
working together, as urged by 40 African
countries [26] whose voices reflect public
health concerns and whose people are most
likely to suffer from this stagnation. The
Working Group met, for the second time, on
October 25–28, 2011. The report is avail-
able at http://www.ip-watch.org/weblog/
wp-content/uploads/2011/11/SSFFCRe
port_28OCT.pdf.
The Way Forward
The problems of poor quality medicines
cannot be viewed in isolation, as they are
enmeshed with many other complex
health system problems, especially the
affordability and accessibility of medicines
and the (often limited) capacity of MRAs.
Here, we highlight three potential inter-
Figure 1. A Venn diagram illustrating
public health–oriented definitions of
poor quality medicines. ‘‘Poor quality
medicines’’ is a term inclusive of counterfeit,
substandard, and degraded medicines and also
for medicines that fail chemistry analysis but
with insufficient information to determine
whether they are counterfeit, substandard, or
degraded. The available data do not allow
relative sizing of the area of each circle in
proportion to the frequency of type of poor
quality medicine. There could be grey areas
between all three main types (see Text S1). For
example, both substandard medicines and
counterfeits could become degraded after
manufacture.
doi:10.1371/journal.pmed.1001139.g001
Box 2. Proposed New Definitions
Substandard medicines ‘‘Each pharmaceutical product that a manufacturer
produces has to comply with quality standards and specifications at release and
throughout the product shelf-life required by the territory of use. Normally, these
standards and specifications are reviewed, assessed and approved by the applicable
National Medicines Regulatory Authority before the product is authorized for
marketing.
‘‘Substandard medicines are pharmaceutical products that do not meet their quality
standards and specifications.’’ [35]
Counterfeit medical products ‘‘A medical product is counterfeit when there is a
false representation in relation to its identity and/or source. This applies to the
product, its container or other packaging or labeling information. Counterfeiting can
apply to both branded and generic products. Counterfeits may include products with
correct ingredients/components, with wrong ingredients/components, without active
ingredients, with incorrect amounts of active ingredients, or with fake packaging.
‘‘Violations or disputes concerning patents must not be confused with counterfeiting
of medical products. Medical products (whether generic or branded) that are not
authorized for marketing in a given country but authorized elsewhere are not
considered counterfeit. Substandard batches or quality defects or non-compliance
with Good Manufacturing Practices/Good Distribution Practices in legitimate and
medical products should not be confused with counterfeiting.’’ [9] (Footnotes
omitted.)
And gave the following explanation:
‘‘Many Member States do not have specific or effective legal instruments for
combating counterfeit medical products, and may for that reason resort to non-
specific legislation related to trademark protection. However, for several reasons
such an approach is not satisfactory, as follows. Legal instruments related to
intellectual property rights have a broad scope and are not focused on the protection
of public health. Counterfeiting of medical products does not always entail the
violation of intellectual property rights. The intellectual property rights approach
identifies the rights holder as the main victim of counterfeiters and as the main
trigger of enforcement and prosecution while, in the case of medical products, the
real victim of counterfeiting is the patient; legislation should therefore enable
patients and health authorities to undertake appropriate procedures regardless of
the action of the holders of intellectual property rights. The technical complexity of
the regulation of manufacture, trade, distribution and dispensing of medical
products warrants an approach much wider than one based on intellectual property
rights. The new text therefore states clearly that the violations or disputes about
patents must not be confused with counterfeiting of medical products.’’ [9]
PLoS Medicine | www.plosmedicine.org 3 December 2011 | Volume 8 | Issue 12 | e1001139
ventions that might help to deal with poor
quality medicines; many other parallel
interventions will be needed to solve this
problem, few of which have been, as yet,
planned or enacted [1–5,7].
First, it is very important for public
health that the generics industry is pro-
tected from the inappropriate use of IP law
to stifle competition, but at the same time
it is vital that more is done to combat the
disastrous public health consequences of
poor quality medicines. Access to medi-
cines and medicine quality are two sides of
the same coin. Importantly, both innova-
tive and generic drug industries can
experience conflicts of interest in relation
to public health, as they are both for-profit
enterprises [30]. We believe, therefore,
that public health–oriented definitions
should help improve the overall quality
of the world’s medicine supply by both
creating common understanding on poor
quality medicines and facilitating the
protection of trade in generics.
Second, we suggest that the current
situation could potentially be helped and
trust increased if organizations with po-
tential conflicts of interests and IP per-
spectives issued unambiguous statements
eschewing the use of IP law to counter
generic medicines. For example, the
director general of the International Fed-
eration of Pharmaceutical Manufacturers
& Associations (IFPMA) has done this by
recently stating that: ‘‘We have no agenda
to interfere with the legitimate trade in
generics. Heightened efforts by high in-
come country governments to fight fake
products of all kinds are not a pretext for
imposing high IP standards on others that
may not be ready for them’’ [31] and ‘‘A
medicine that is authorized for marketing
by one regulatory authority but not by
another should not be regarded as coun-
terfeit on these grounds alone in the
latter’s territory’’ [32] and called for
WHO leadership in this matter [31,32].
Third, a treaty on medicine quality,
drafted under the auspices of the WHO,
has recently been suggested as a way forward
[33]. This could be negotiated incrementally,
starting from the agreement by all parties
that poor quality medicines are unaccept-
able,withemphasisonreachingaconsensus
on the contentious points, such as definitions
and terms. Such a treaty could facilitate
transnational jurisdiction over widespread,
systematic counterfeiting as a crime against
humanity. It could also include positive legal
powers and a financial mechanism to
facilitate good quality manufacturing and
access to affordable high quality medicines to
reduce the frequency of substandard medi-
cines (A. Attaran, personal communication).
Conclusions
Counterfeit medicines should be defined
in terms of harm to health, with punishments
appropriate for the injury or killing of
patients. Moreover, it is imperative that
public health institutions, ministries, and
lawyers, and not primarily IP specialists or
industrial and trade bodies, take the strategic
lead in countering poor quality medicines.
We strongly suggest that those concerned
with medicine quality and access put the
recent controversies behind them and work
positively towards agreement on definitions
and a treaty to facilitate access to good quality
essential medicines and medical products.
Supporting Information
Text S1 Some further problematic
issues relating to medicine quality.
(DOC)
Acknowledgments
We thank Michael D. Green, Facundo Ferna´n-
dez, Ans Timmermans, and Julian Harris for
useful comments on the paper.
Author Contributions
Wrote the first draft: PN. Contributed to the
writing of the manuscript: PN AAA CB PP GD
GT BS RB PJG NJW. ICMJE criteria for
authorship read and met: PN AAA CB
PP GD GT BS RB PJG NJW. Agree with the
manuscript results and conclusions: PN AAA
CB PP GD GT BS RB PJG NJW.
References
1. Wellcome Trust (2009) Opinion formers’ confer-
ence on counterfeit medicines: perspectives and
action. Available: http://www.wellcome.ac.u k/
stellent/groups/corporatesite/@policy_communi
cations/documents/web_document/WTX057518.
pdf. Accessed 10 October 2011.
2. Fondation Chirac (2009) The Cotonou Declara-
tion. Available: http://www.fondationchirac.eu/
en/the-cotonou-declaration-october-12-2009-benin/.
Accessed 10 October 2010.
3. Newton PN, Green MD, Ferna´ndez FM,
Day NJP, White NJ (2006) Counterfeit anti-
infective medicines. Lancet Infect Dis 6: 602–613.
4. Newton PN, McGready R, Fernandez F,
Green MD, Sunjio M, et al. (2006) Manslaughter
by fake artesunate in Asia–will Africa be next?
PLoS Med 3: e197. doi:10.1371/journal.pmed.
0030197.
5. Newton PN, Green MD, Ferna´ndez FM (2010)
Impact of poor-quality medicines in the ‘devel-
oping’ world. Trends Pharmacol Sci 31: 99–
101.
6. Shepherd M (2010) Beef up international coop-
eration on counterfeits. Nat Med 16: 366.
Box 3. Separating the Issue of Counterfeit Medicines from
Patent Issues
A report by the WHO Secretariat on counterfeit medical products includes the
following draft resolution:
‘‘
14.
The Executive Board is invited to consider the following draft resolution:
The Executive Board,
Having considered the report on counterfeit medical products,
RECOMMENDS to the Sixty-second World Health Assembly the adoption of the
following resolution:…….
Recognizing that the primary focus of combating counterfeit medical products is the
protection of public health and that the main victims of counterfeiters are patients;
Recognizing the importance of ensuring that combating counterfeit medical
products does not result in hindering the availability of legitimate generic medicines;
Recognizing that disputes about, or violations of, patents are not to be confused with
counterfeiting;
Recognizing that medical products (whether generic or branded) that are not
authorized for marketing in a given country but authorized elsewhere are not
considered counterfeit;
Recognizing that quality defects or non-compliance with Good Manufacturing
Practices/Good Distribution Practices in legitimate medical products must not be
confused with counterfeiting;’’
([9], with corrigendum.)
PLoS Medicine | www.plosmedicine.org 4 December 2011 | Volume 8 | Issue 12 | e1001139
7. Caudron JM, Ford N, Henkens M, Mace´C,
Kiddle-Monroe R, et al. (2008) Substandard
medicines in resource-poor settings: a problem
that can no longer be ignored. Trop Med Int Hlth
13: 1062–1072.
8. Park CS (2009) Legal aspects of defining ‘‘coun-
terfeit medicines’’: a discussion paper. WHO-
SEARO.
9. World Health Org anization (2008) Executive
Board 124th session provisional agenda item
4.11. Counterfeit medical products. EB124/14.
Available: http://www.who.int/gb/ebwha/pdf_
files/EB124/B124_14-en.pdf. With corrigendum:
http://apps.who.int/gb/ebwha/pdf_files/EB124/
B124_14Corr1-en.pdf. Accessed 10 October 2011.
10. Simons B (24 February 2009) Vested interests in
fake drugs. AfricanLiberty.org. Available: http://
www.africanliberty.org/node/640. Acces sed 27
October 2011.
11. Liang BA (2008) Counterfeit drugs–defining the
problem. Vienna (Virginia): Partnership for Safe
Medicines, Available: http://www.safemedicines.
org/2008/07/defining-the-problem.html. Ac-
cessed 10 October 2011.
12. [No authors listed] (14 January 2009) OPPI,
IDMA come out with contrasting views on defini-
tion of counterfeit drugs. Pharmaquest. Available:
http://www.pharmaquest.biz/Policy-and- Regula
tions/Important-Report/OPPI-IDMA-come-out-
with-contrasting-views-on-definition-of-counterfeit-
drugs.html. Accessed 3 November 2011.
13. Harris J (5 December 2008) New definition of
fake drugs envisages better health. The Pioneer.
Available: http://www.policynetwork.net/health/
media/new-definition-fake-drugs Accessed 3 Novem-
ber 2011.
14. Shukla N, Sangal T (2009) Generic drug industry
in India: the counterfeit spin. J Intell Prop Rights
14: 236–240. Available: http://nopr.niscair.res.in/
bitstream/123456789/4192/1/JIPR%2014(3)%20
236-240.pdf. Accessed 10 October 2011.
15. Clift C (2010) Combating counterfeit, falsified
and substandard medicines: defining the way
forward? Chatham House Briefing Paper. Avail-
able : http://www.chathamhouse.org/publications/
papers/view/109517. Accessed 27 October 2011.
16. Shrivastava B (23 May 2008) India fears generic
drugs may be hit by fake medicine definition.
Livemint.com. Available: http://www.livemint.
com/2008/05/23004023/India-fears-generic-
drugs-may.html?d=1. Accessed 10 October 2011.
17. Taylor L (31 March 2010) India chides WHO
over ‘counterfeit’ drugs. PharmaTimes. Available:
http://www.pharmatimes.com/WorldNews/article.
aspx?id=17638. Accessed 10 October 2011.
18. Dey S, Singh K (27 January 2009) WHO won’t
redefine fake drugs. Economic Times. Available:
http://articles.economictimes.indiatimes.com/
2009-01-27/news/27645724_1_counterfeit-drugs-
generic-drug-legitimate-generic-medicines. Ac-
cessed 27 October 2011.
19. Shashikant S (16 January 2009) WHO: approach
to ‘‘counterfeit’’ drugs may affect access to
medicines. TWN Info Service on Intellectual
Property Issues (Jan09/01). Published in SUNS
#6618 dated 15 January 2009. Third World
Network. Available: http://www.twnside.org.sg/
title2/intellectual_property/info.service/2009/
twn.ipr.info.090101.htm. Accessed 27 October
2011.
20. Third World Network (2010) Briefing paper 2.
WHOs ‘‘counterfeit’’ programme: legitimises IP
enforcement agenda, undermines public health.
Available: http://www.twnside.org.sg/title2/briefing
_papers/nontwn/Briefing.paper.on.WHO.Counter
feits.pdf. Accessed 10 October 2011.
21. Arrow KJ, Panosian CB, Gelband H (2004)
Saving lives, buying time: economics of malaria
drugs in an age of resistance. Washington (D.C.):
Institute of Medicine of the National Academies,
Available: http://www.nap.edu/books/030909
2183/html/. Accessed 10 October 2011.
22. Lon CT, Tsuyuoka R, Phanouvong S, Nivanna N,
Socheat D, et al. (2006) Counterfeit and substan-
dard antimalarial drugs in Cambodia. Trans R Soc
Trop Med Hyg 100: 1019–1024.
23. Oxfam (2011) Eye on the ball. Medicine regulation
– not IP enforcement – can best deliver quality
medicines. Available: http://www.oxfam.org.nz/
resources/onlinereports/BP14 3-Eye-on-the-Ball-
Medicine-Regulati on-020211-summ-en. pdf. Ac-
cessed 10 October 2011.
24. Me´decins sans Frontie`res (2010) Patients first:
access to safe, quality and effective drugs. Avail-
able: http://www.msfaccess.org/sites/default/
files/MSF_assets/Access/Docs/ACCESS_briefing
_PatientsFirst_CounterfeitWHA_ENG_2010.pdf.
Accessed 10 October 2011.
25. Third World Network (11 May 2010) NGO open
letter over WHO’s involvement in ‘‘counterfeit
medical products’’ & in the IMPACT. Available:
http://www.twnside.org.sg/announcement/Open.
Letter.to.WHO.DG.final.PDF. Accessed 10 Octo-
ber 2011.
26. World Health Organization (2010) Draft resolu-
tion proposed by the delegation of Algeria,Angola,
Benin, Botswana, Burkina Faso, Burundi, Camer-
oon, Cape Verde, Central African Republic,
Chad, Comoros, Congo, Cote d’Ivoire, Equatorial
Guinea, Ethiopia, Gabon, Gambia, Ghana, Gui-
neea, Guinea-Bissau, Kenya, Lesotho, Liberia,
Madagascar, Malawi, mali, Mauritius, Namibia,
Niger, Nigeria, Rwanda, Senegal, Sierra Leone,
South Africa, Swaziland, Togo, Uganda, United
Republic of Tanzania, Zambia and Zimbabwe.
Agenda item 11.20. Sixty-third World Health
Assembly A63/A/Conf.Paper No. 5. 19 May
2010.
27. World Health Organization (2010) Draft resolu-
tion proposed by the delegation of India and
Thailand. Sixty-third World Health Assembly
A63/A/Conf.Paper No. 7 18 May 2010.
28. World Health Organization (2010) Substandard/
spurious/falsely labelled/falsified/counterfeit
medical products. Draft decision of the Working
Group. Sixty-third World Health Assembly
Agenda Item 11.20. 21 May 2010.
29. World Health Organization (2011) Substandard/
spurious/falsely-labelled/falsified/counterfeit
medical products. Report by the Director Gen-
eral. 24th March 2011. Available: http://apps.
who.int/gb/ebwha/pdf_files/WHA64/A64_16-en.
pdf. Accessed 10 October 2011.
30. Currais L, Rivera B, Rungo P (2008) Potential
conflicts in the fight against counterfeit drugs.
Economics Bulletin 9: 1–7. Available: http://
www.accessecon.com/pubs/EB/2008/Volume9/
EB-08I10002A.pdf. Accessed 10 October 2011.
31. Pisani E (2011) IFPMA: building a consensus to
address the health threat posed by fake medicines.
Available: http://www.essentialdrugs.org/edrug/
archive/201103/msg00001.php. Accessed 10
October 2011.
32. The International Federation of Pharmaceutical
Manufacturers & Associations (2010) The IFPMA
ten principles on counterfeit medicines. Available:
http://www.ifpma.org/fileadmin/content/Global
%20Health/Counterfeits/IFPMA_Ten_Principles
_Counterfeit_Medicines_12_May_2010.pdf. Ac-
cessed 10 October 2011.
33. Attaran A, Bate R, Kendall M (2011) Why and
how to make an international crime of medicine
counterfeiting. J Int Criminal Justice 9: 325–354.
doi:10.1093/jicj/mqr005.
34. World Health Organization (2009) What are
substandard medicines? Available: http://www.
who.int/medicines/services/counterfeit/faqs/06/
en/index.html. Accessed 10 October 2011.
35. World Health Organization (2010) New definition
for ‘‘substandard medicines’’. Working document
QAS/10.344/Rev.1. Available: http://www.who.
int/medicines/services/expertcommittees/pharm
prep/14052010NewDefinitionSubstandardMeds-Q
AS10-344Rev1.pdf. Accessed 10 October 2011.
PLoS Medicine | www.plosmedicine.org 5 December 2011 | Volume 8 | Issue 12 | e1001139
