E-DRUG: Counterfeit medicines, fake medicines and the illicit market
--------------------------------------------------------------
[Long posting from Pharmaciens sans frontieres. Moderator]
The French drug industry agrees that:
'The injustice is blatant: 90% of the demand for health care and medicines
comes from developing countries, and WHO estimates that only 10% of these
needs are met
the 10% of the worlds population living in the richest
countries receive 90% of the total supply of medicines' - From 'Le
Médicament, parlons-en' - LEEM, page III-34 October 2006.
In that context, where 80% of the worlds demand is ignored, a parallel
market has developed.
During its 22 years of daily struggle to help developing countries to
develop supply and distribution channels for essential drugs of assured
quality, Pharmaciens Sans Frontières has seen this illicit and extremely
dangerous market expand very rapidly. At first, it was just a diversion of
those unused medicines that passed through thousands of relief organisations
not much concerned with existing international legal provisions on the
export of dangerous waste and even less with the pharmaceutical legislation
in developing countries. Under the guise of humanitarian aid, the export of
unused medicines became common currency with the blessing of developed
country governments.
This benefited the many street vendors who had finally found a high paying
'job' to support their family: drug vendor, part prescribing doctor and part
pharmacist, while 80% of them could not read and were totally unaware of the
dangers of these medicines. Since the people in poor countries had no
alternative, the market was still in its infancy.
It was a market where demand continued to exceed supply and which soon
attracted the attention of bigger sharks. Illegal laboratories producing
fake or counterfeit medicines [1], and organised networks, often protected by influential individuals, developed around the world. In the 1990s, with the rich countries passively looking on, medicine trafficking increased
dramatically in the poorer countries where it has more than 25% market
share, with peaks of up to 80% in some countries. The medicines which are
most often counterfeited in developing countries are those that are most
essential in these countries (anti-malaria drugs, anti-parasitic drugs and
anti-infective drugs), but nearly all medicinal products can be found on the
markets and on the streets.
For many years, industrialised countries with strict pharmaceutical
regulations, vigilant public health care systems and efficient customs
services, thought that they were relatively immune to counterfeiting and
smuggling of medicines. The few reports of counterfeiting of medicines in
those countries were regularly met with silence from the pharmaceutical
industry that was concerned that the general public would be suspicious of
these products and that sales would drop significantly.
But a World Health Organization (WHO) survey of counterfeit medicine reports
from 20 countries between January 1999 and October 2000 found that 60% of
counterfeit medicine cases occurred in poor countries and 40% in
industrialised countries. This places the annual earnings from the sales of
counterfeit medicines at over US$32 billion [2]. The dimensions of the
problem are not well known. The only proven and alarming fact is that it is
growing very quickly.
The advent of online selling had a multiplier effect on this already
flourishing market. Counterfeiters, realising the potential of e-commerce to
reach rich markets more easily, got into this new form of commerce. As
medicines are considered by global economic policies to be like other
consumer goods, this trade can only grow in the coming years and create well
organised parallel networks that are increasingly difficult to dismantle.
In developing countries, public awareness campaigns on the dangers of drugs
that are sold on the street take place every year for a week in May. But the
continuing campaigns do not achieve the intended results. If success is not
achieved, it is because today the network is very extensive and very solid.
The reason: according to the International Federation of Pharmaceutical
Manufacturers and Associations, medicine trafficking is 25 times more
profitable than heroin smuggling and 5 times more profitable than cigarette
smuggling. A couple of destroyed containers and some posters cannot do
permanent damage to it.
Although aware of the dangers, the populations continue to buy medicines
from street vendors. At best, the use of these drugs leads to therapeutic
failure or drug resistance. At worst, it can lead to death. During the
meningitis epidemic in Niger in 1995, over 50,000 people were inoculated
with fake vaccines. This resulted in 2,500 deaths. The consumption of cough
syrup led to 89 deaths in Haiti in 1995 and 30 infant deaths in India in
1998. Since 2001, an estimated 400,000 people have died from fake drugs in
China. Today, however, it is difficult to quantify the health problems and
deaths caused by this criminal trade. The reported scandals are likely to be
the tip of the iceberg.
'It is a fatal scourge' according to Dorothy Akunyili, head of Nigerias
National Agency for Food and Drug Administration and Control (NAFDAC), whose
21-year-old diabetic sister died because of a counterfeit insulin injection.
Before she took office, the level of fake drugs was 70% in Nigeria. Three
years later, this percentage had fallen to 35%. The counterfeiters have
responded with unprecedented force: in 2002, a gang destroyed a laboratory
at NAFDAC, in 2004, fire struck the agencys administrative building,
destroying computers, vital records and another laboratory, and there were
several assassination attempts on Ms Akunyili [3]. Thats enough to cause the most determined governments to not to want to fight against this illicit
trade, despite the obvious public health risk!
In order to protect public health, consideration should to be given to
reinforcing international and national laws on medicines as particularly
sensitive products, criminalising the illicit trade of medicines and
applying sanctions, assuming that these actions are implemented and yield
the desired impact. There is, however, substantial doubt about this.
Romain Castelbous PhD thesis (January 2005) on fake medicines in
emerging-market countries reported that 'To address the growing problem [of
counterfeiting in China], the Chinese government developed and promulgated
new pharmaceutical regulations in December 2001. The agency responsible for
enforcing these regulations is the State Drug Administration (SDA). It
issued guidelines for Good Manufacturing Practice, Good Quality Control
Laboratory Practice, and Good Clinical Practice in Clinical Trials. New laws
to protect intellectual property on new drugs and to regulate the import and
export of drugs have been passed. Pharmacy and provincial hospital budgets
were cut and the SDA prompted hospitals to purchase drugs locally rather
than expensive foreign proprietary drugs. This, coupled with the
strengthening of the legislation, had the unfortunate effect of increasing
demand for counterfeit drugs.' [4]
While recognising that medicines should not be considered like other
consumer goods and that strict national and international laws should
monitor sales of pharmaceuticals, especially in the context of globalisation
and market openness, PSFCI has no illusions about their effectiveness in
fighting counterfeiting and illicit trade.
Up to now, studies, reports, legal documents and legislations on drug
trafficking have not curbed this traffic. Why would they curb the
counterfeiting and smuggling of medicines?
The only actions that could really affect counterfeiting in poor countries
are those that would aim to meet demand; those that would increase
geographical and financial access to essential drugs of assured quality for
the population; those that would set up reliable supply and distribution
systems; those that would ensure that health centres are financially viable
and those that would ensure training and motivation of staff. Then, and only
then, the population can be made aware of the dangers of street medicines;
because a reliable alternative is available.
Article 50 of the debate in the standing committee of the Council of Europe
on counterfeiting held in February 2004 recognises that 'the quickest way to
halt any market is to curb the demand that created that market.' and that
'developed countries in which are the most eager defenders of intellectual
property rights, should be ready to show the necessary flexibility when
negotiating within the WTO framework with developing countries regarding the
latters access to essential medicines on affordable terms.'[5].
Unfortunately, today there are attempts to negotiate bilateral agreements
containing STRIPS-plus standards rather than a flexibility that allows
southern countries to have access to essential medicines.
Article 25 paragraph 1 of the Universal Declaration of Human Rights (1948)
states that 'Everyone has the right to a standard of living adequate for the
health and well-being of himself and of his family, including food,
clothing, housing and medical care and necessary social services.' This
right is also recognised in other international and regional instruments[6].
The supply, as well as the availability, acceptability and quality of
essential medicines are mentioned in those documents. All countries that are
signatories to the Universal Declaration of Human Rights and the various
international and regional instruments must share responsibility to ensure
that this right is guaranteed for all. But all these are useless as long as
the bulk of the GNP of poor countries goes to pay the debt imposed by
structural adjustments that only serve the interests of the rich countries,
rather than finance their own development, particularly essential public
services such as education and health.
The people in Africa, Latin America or South-East Asia are not suicidal. Why
would they run the risk of putting their lives and that of their children in
danger if protected health care systems offered them treatments and
medicines at an affordable price?
The European Parliament fully understands that access is one of the
essential elements of the fight against counterfeiting, because its joint
motion for a resolution, dated 6 September 2006, on counterfeiting of
medicinal products 'calls on the EU to take steps to strengthen the
regulatory and quality-control capacity for medicinal products and medical
equipment put on the market in countries with inadequate resources and to
improve access to affordable medicines'.
Private businesses, especially pharmaceutical companies, have another direct
interest in helping to develop secured channels and build a healthier
pharmaceutical market in poor countries: their own future development.
Todaywith the exception of a few promising examples they have little
interests in poor countries and their problems of access to essential
medicines because 95% of them are generics. Still these countries represent
86% of the worlds population. An important potential market for the future,
but only if these countries are given the opportunity to become solvent.
The problem of counterfeiting of medicines should be addressed within the
overall context of the accelerated pauperisation of a large part of the
worlds population who has no choice but to go to the parallel market in
order to survive! Poverty is increasing even in developed countries as the
report on the first five years of implementation of the Millennium
Development Goals states. The example of the United States, where the number
of people living below the official poverty line increased from 31.5 million
in 2000 to 37 million in 2004 indicates that the economic system currently
operating in developed countries is not sustainable.
Poverty increases every day and it is not in the interest of companies that
need healthy, strong and solvent markets to survive and grow.
Planning a long-term trade strategy requires to prepare future markets. For
pharmaceutical companies, helping the 86% of potential customers to become
solvent would be an investment for their own future.
Contrary to a widespread misconception about their utopian vision,
humanitarian aid organisations recommend solutions that are much more
pragmatic than the limited and often aggressive solutions of the business
world [7] which, today, more than ever before, leads the world into a vicious circle, which leads to the expansion of poverty.
These solutions are pragmatic and objective because they are based on
concrete experiences and reality.
Indeed, measures must be taken rapidly to strengthen national and
international laws on pharmaceuticals, but where are the financial and human
resources for their implementation in poor countries?
Awareness raising activities for the population must be intensified, but
what do we offer them as an alternative?
When are we going to stop ignoring the real origins of the problem of the
growth of the counterfeit market of medicines?
When are we going to stop confusing cause with effect? It is not the
development of counterfeiting that created the market, but unmet demand that
led to an increase in counterfeiting.
When are we going to tackle the problem at the roots and deploy the
necessary resources to eliminate the root cause of the problem: unmet
demand?
It would be the most efficient and the cheapest solution. It would help to
create a healthy market for pharmaceuticals in poor countries, and to
accelerate their development to enable them, over time, to become solvent
economic partners. What primarily causes societies to turn to the
underground economy is poverty.
How much would it cost?
Certainly less than fighting a market unsuccessfully for years, with none of
the stakeholders from counterfeit manufacturers to consumers- willing to
give up this market.
Certainly less than the substantial amounts that are going to be spent in
research and development of optical and electronic security devices, micro
printing, holograms and intelligent packaging which will become obsolete a
few months after being installed.
Certainly less than increasing Customs staff who are able to physically
examine only 3 to 5% of all goods crossing borders, and who have limited
ability to inspect the millions of postal packages containing medicines
bought via the internet, of which more than 50% are counterfeit products.
Certainly less than strengthening policing and law enforcement at the
international and national levels, with a number of countries not being able
to afford it.
Certainly less than the health problems caused by these medicines (liver
problems, kidney problems, disabilities, resistance and, too often, death).
As with other problems, an ounce of prevention would have been worth a pound
of cure, but nothing is lost yet
if we quickly prescribe a suitable cure,
and work to ensure that people have access to essential medicines.
When people will have access to quality health care, they will not go to the
illicit market to buy less expensive treatments. Without demand, supply will
dry up. It is not realistic to try to fight the supply side before meeting
the demand side.
Pharmaciens Sans Frontières Comité International
e-mail : g.soulier@psf-ci.org
Site Web : www.psfci.org