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International Psychiatry Volume 5 Number 3 July 2008 International Psychiatry Volume 5 Number 3 July 2008
53
Editorial
Counterfeit medicines and the unregulated
market for drugs
Hamid Ghodse
Editor, International Psychiatry
The unregulated market for medicines has evolved in
different ways and exists in different forms in different
parts of the world. Given this wide variation, the phrase
‘unregulated market for drugs’ is commonly used in a
generic sense and encompasses the sale of medicines that
have been licitly manufactured but diverted from legiti-
mate sales routes as well as the illicit manufacture and
sale of (counterfeit) pharmaceuticals. Also within this un-
regulated environment, prescription-only drugs are sold
(illegally) without prescription.
In countries that can offer only limited access to healthcare
professionals, hospitals, clinics or pharmacies, unauthorised
or unregulated outlets are more likely to exist, because con-
sumers may be forced to buy drugs of whatever sort, from
wherever they can. In low- and middle-income countries, the
unregulated market may include makeshift outlets at village
fairs or on street markets, where medicines are sold along
with commodities such as balms, tonics and creams. There
are also more organised systems, operated by unscrupulous
manufacturers, importers, retailers, wholesalers and healthcare
professionals, driven by the possibility of substantial profits.
Medicines are likely to be cheaper on the unregulated market.
In higher-income countries, the internet plays a significant
role in the unregulated market. It facilitates contact between
suppliers and consumers, and offers almost limitless opportun-
ities to sell drugs; delivery to the buyer is often via postal or
courier services. The level of privacy offered by internet phar-
macies, combined with the weakness of drug regulatory and
enforcement mechanisms, contribute to a thriving unregulated
market and it is not surprising that the number of illegally
operating internet pharmacies continues to rise and has long
surpassed the number of licensed and accredited internet
pharmacies. They are major suppliers of counterfeit medicines.
Although selling drugs out of a suitcase in a village market
may seem very different to selling drugs over the internet, the
consequences and the associated problems are similar. Specific-
ally, they offer opportunities for prescription-only medicines
to be bought without a prescription, so that powerful drugs
become available and may be used in wholly inappropriate
ways. In addition, any type of unregulated market represents
a useful sales outlet for counterfeit medicines.
The nature of the problem
Although the existence of counterfeit medicines is not
new, their availability was first formally acknowledged as a
problem only in the mid-1980s. It has been identified as a
growing problem since then, constituting a serious health
risk to users. Indeed, the situation has been dramatically
worsened by the rapid expansion of unregulated markets,
and the World Health Organization (2006) estimates that
counterfeits could account for more than 10% of the global
medicines market. The expansion is undoubtedly due to
the fact that counterfeiting medicines is a lucrative criminal
activity. According to the US Center for Medicines in the
Public Interest, counterfeit drug sales will reach US$75 billion
globally in 2010, an increase of more than 90% from 2005
(see World Health Organization, 2006).
While counterfeits can be found in all regions of the
world, low- and middle-income countries are dispropor-
tionately affected. Indeed, according to the World Health
Organization (2006), an estimated 25–50% of the medicines
consumed in those countries are counterfeit.
It requires little imagination to appreciate the nature
and magnitude of the problem represented by counterfeit
medicines, which are specifically manufactured to maximise
profits. The products are of doubtful quality, safety and
efficacy, and their sources are not guaranteed. In addition
to violating intellectual property rights, they undermine
healthcare systems through their frequent lack of therapeutic
efficacy and safety. Above all, they pose serious health risks
to their users because their constituents may be at best in-
effective and, at worst, positively harmful (even resulting in
death). The problem is compounded by the fact that counter-
feit drugs often closely resemble the genuine products in
their appearance and packaging. This lulls consumers into
believing that they are buying the ‘real’ drug.
The true criminality of counterfeit medicines is illustrated
by the use in Africa of counterfeit vaccines, which, in 1995,
resulted in some 2500 deaths (World Health Organization,
2006). It is therefore not an exaggeration to consider traffick-
ing in counterfeit drugs as a potentially life-threatening crime.
Psychotropic medicines
A wide range of psychotropic medicines, including anti-
depressants, anxiolytics, stimulants and even narcotic
analgesics, are available from unregulated markets in both
high-income and low- and middle-income countries. The
manufacture and trade of these drugs, which are frequently
subject to misuse, are strictly controlled under international
conventions and they should be dispensed only on pre-
scription. Their wide availability without prescription via the
unregulated market is dangerous for those who may consume
them inappropriately and also has public health implications
because of the increased risk of misuse and dependence.
Internet pharmacies appear to play a particularly impor-
tant role in the unregulated market for psychotropic drugs.
For example, a recent US survey of 185 internet pharmacies
found that 85% of them sold benzodiazepines, 68% sold
International Psychiatry Volume 5 Number 3 July 2008
54
International Psychiatry Volume 5 Number 3 July 2008
tHEMatiC PaPErS – iNtrodUCtioN
Migration and psychiatric adjustment
David Skuse
Behavioural and Brain Sciences Unit, Institute of Child Health, London WC1 1EH, UK, email d.skuse@ich.ucl.ac.uk
opioid analgesics, 8% sold stimulants and 1% sold barbitur-
ates; 89% of them did not require a prescription and only
3% indicated that, before they dispensed a medicine, a
prescription would be required (National Center on Addic-
tion and Substance Abuse, 2006). In 2006, 34 illegal internet
pharmacies dispensed more than 98 million dosage units of
hydrocodone products (International Narcotics Control Board,
2008). In the USA, the law enforcement authorities examined
1153 imported parcels containing medicinal products during
a 3-day operation in 2003. The overwhelming majority of the
products (88%) were illegally imported drugs, including more
than 25 different controlled psychotropic medicines, such
as diazepam and codeine (Food and Drug Administration,
2003).
Law enforcement and
cooperation
According to a study conducted by the World Health Organi-
zation (2003), in 30% of countries drug regulation is either
non-existent or very limited. Clandestine manufacture and
trafficking are facilitated by weak drug regulations, weak en-
forcement of existing regulations and lenient penal sanctions
for counterfeiters. If sanctions are not commensurate with
the enormous profits that are made, they do not serve as a
sufficient deterrent.
Effective action requires the existence of competent national
drug regulatory authorities, with a sustained resource base, to
ensure control and regular inspection of those involved in the
manufacture, trade and distribution of pharmaceuticals.
To regulate the medicines market effectively, national drug
regulatory authorities require political will, relevant legislation,
appropriate organisational capacity and skilled profession-
als. The training of healthcare professionals should include
guidance on how to promote the rational use of medi-
cines in general and psychotropic medications in particular.
Codes of conduct for associations of healthcare profession-
als, industry and chambers of commerce should address the
issue of incorrect or improper handling of drugs. Drug regu-
latory authorities, law enforcement agencies, manu facturers
of pharmaceuticals, professional associations of medical
practitioners and pharmacists, as well as consumer protec-
tion groups, need to work in concert to identify counter feit
medicines that are in national distribution channels and their
sources, so that adequate preventive measures can be under-
taken. Without the cooperation of all concerned, there will
be little chance to overcome this problem.
These actions at national level need to be complemented
by strengthened, concerted international preventive and
investigative efforts. National drug regulatory authori-
ties should cooperate effectively in eliminating counterfeit
medicines from international commerce. Cooperation and
intelligence sharing among national drug regulatory and
law enforcement authorities would help to stop shipments
of counterfeit medicines and would facilitate the arrest of
persons engaged in counterfeiting. Furthermore, national
drug regulatory authorities should cooperate with the Inter-
national Medical Products Anti-Counterfeiting Taskforce, set
up with the Declaration of Rome of 18 February 2006.
Govern ments need to be appropriately sensitised to the
health and economic risks associated with the counterfeiting
of medicines, so that appropriate laws against counterfeiting
are enacted, and resources and infrastructure are provided
for effective law enforcement at national level.
Apart from governments, the pharmaceutical industry, pro-
fessional organisations, consumer associations and health care
professionals, mass media and particularly the health and
medical journals all have an important role to play in public
education. Psychiatrists, particularly through psychiatric and
mental health societies and associations, have a pivotal role to
play in relation to the appropriate use of psycho tropic medi-
cines, which should include education of both patients and
their carers in the risks associated with the use and misuse of
medicines, especially those from unregulated sources.
References
Food and Drug Administration (2003) Customs import blitz exams reveal
potentially dangerous import drug shipments. FDA News, 29 September.
International Narcotics Control Board (2008) Report of the International
Narcotics Control Board for 2007. United Nations. Available at http://
www.incb.org/incb/en/annual-report-2007.html
National Center on Addiction and Substance Abuse at Columbia Uni-
versity (2006) ‘You’ve Got Drugs!’ Prescription Drug Pushers on the
Internet: 2006 Update. CASA White Paper.
World Health Organization (2003) Effective Medicines Regulation:
Ensuring Safety, Efficacy and Quality. WHO Policy Perspectives on
Medicines No. 7. WHO.
World Health Organization (2006) Counterfeit Medicines. Fact Sheet No.
275. WHO. Available at http://www.who.int/mediacentre/factsheets/
fs275/en/
With the extraordinarily large movements of popula-
tions from some of the former Soviet Union states
into Western Europe, since their recent membership of the
European Union, attention has been focused in recent years
on how easy or otherwise it has been for these people to
adjust to life in very different economic and social circum-
stances. It has been estimated that the UK has absorbed
up to a million immigrants from Eastern European states
