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Counterfeiting imperils Millennium Development
Goals
By Thompson Ayodele
Thursday, 24 Feb 2011
The World Health Organissation working group on
counterfeit and
substandard medical products will be meeting in Geneva
at the end of this month. The key issue on the agenda is how to ensure the
availability of good-quality, safe, efficacious and affordable
medicines.
The meeting is coming amid a new report by an
international aid agency, which indicates that rich countries use the
proliferation of poor quality and substandard medicines in poor countries as an excuse
to tighten intellectual property rules, drive up the profits of big
pharmaceuticals,while making it difficult for the poor
to get access to essential medicines.
Counterfeit and substandard medicines remain a public
health threat in developing countries where regulatory oversight and
enforcement are either weak or can be easily compromised. It is misleading to
portray anti-counterfeiting measures as ploys by makers of
branded medicines to undercut the sale of generic medicines. The reality is
counterfeiters do not differentiate between R & D-based pharmaceuticals
and generic medicines.
The World Health Organisation has estimated that between
eight per cent and 10 per cent of the world pharmaceutical market is
made up of counterfeit drugs. It is also estimated that there is a
13 per cent annual growth rate in fake drugs, outpacing the annual growth
rate for legitimate pharmaceuticals by almost twofold.
Over the years, healthcare delivery in Africa has been
undermined by counterfeit and substandard medicines. Throughout the
late 1990s and early 2000s, many peer-reviewed studies estimated the spread
rate to between 36 per cent and 48 per cent. Recent data from the National
Agency for Food and Drug Administration and Control in Nigeria put
counterfeit rate at 16 per cent. Since regulatory and enforcement agencies
usually base their reports on raids and seizure, which represent only a
small percentage of
the problem, there is a possibility of underestimation.
However, figures from Pharmaceutical Security Institute,
which bases its method on number of reported incident shows that the
scope of the problem and the number of incidents are on the increase by
almost 50 per cent in 2009. Generic manufacturers should be concerned as well
as producers of branded medicines. The primary consideration for
counterfeiters is to make profit by flooding the market with low-cost drugs, which
patients in poor countries will buy. This consideration does not exclude
generic medicines.
Many countries have not benefitted from the full
potential of new
medicines because of self-generated policy failures that
really impede access to medicines. What prevents access to essential
medicines in Africa is not intellectual property rights enforcement but
excessive bureaucracy, poverty and poor health infrastructure, which actually
hinder delivering those medicines. Weak healthcare system does not only
result in a failure to distribute existing treatments, they also have a
knock-on effect for the demand of new medicines. In many countries, annual
spending on health
per person is less than $2.
Poverty level further compounds the challenge of getting
quality health services and quality medicines. A study by Dr. Amir
Attaran, fellow at the Royal Institute of International Affairs in London,
evaluates the relationship between patents and access to essential
medicines in 65 countries, covering a total population of four billion
people.
Of the 319 drugs on the World Health Organisation’s
Essential Medicines List, only 19 are on patents. One of those 19 drugs,
eflornithine, has been donated by its inventor; another, tamoxifen, is
off-patent in most countries. In reality, only 17 essential medicines are
on patents. This means in the world’s poorest countries, less than two
per cent of drugs are on patents. For instance, most of the anti-malaria
drugs are not covered by patents. Delivering those medicines to
patients who actually
need them remains a challenge.
The real cost of counterfeit medicines on legitimate
businesses is the infringement on their trademarks. Difficulties in
enforcing trademarks mean that a company that attempts to market its products
may find that it faces competition from counterfeit and substandard
products.
Counterfeiters do not differentiate between trademarks.
They therefore damage the name and reputation of legal companies
through counterfeiting of their products.
There is, however, a general consensus that
counterfeiting of medical products puts people’s health and lives at risk. They
subsequently constitute a barrier to improving global health. Since
the medical product supply chain is global, counterfeiting threatens
everyone. It is misleading for anyone to portray the campaign against
counterfeit as the fight against generic drugs. Obviously, there ought not
to be confusion between generic drugs and counterfeited drugs. While
generic producers are involved in legitimate business, counterfeiting is
purely a criminal
activity.
Concerted efforts to undermine and thwart the activities
of counterfeiters are urgently required. Each country in the past had
attempted to fight the menace alone. It is now recognised on the need for
collaboration among countries, particularly in the area of information to
track suspected shipment and arrest offenders. This has led to the
establishment of International Medical Products Anti-Counterfeit
Taskforce spearheaded by WHO. This provides an avenue for stakeholders to share
experience and put global pressure on counterfeiters.
The multi-sectoral approach adopted by IMPACT ensures
productive
collaboration with other critical sectors. Its advisory
and capacity-building mechanisms have been a boost to
regulatory and
enforcement capacity in Africa. There is a need to have
a unified voiceagainst counterfeit medicines across the continent.
That is why other African countries must support the
Nigeria’s bid for a resolution for establishing a coalition against the
menace of drug counterfeiting on the African continent. According to
the director-general of Nigerian drug regulatory agency, Paul Orhii, it is
better for African countries to have a strong coalition against
counterfeiting and it is in Africa best interest to come together under the WHO to
fight the menace.
That means combating the counterfeiting of medical
products cannot be successfully achieved by the health sector alone.
Coordination of efforts and effective collaboration through building of
partnership among pharmaceutical companies, law enforcement, customs
officials and the media are imperative.
To single out strong intellectual property rules and the
desire of
pharmaceutical companies to make profits for blocking
access to medicines are off target. The priority should be on increasing the
economic well-being of the people on the continent through
increases in trade and economic freedom. Only then can they upgrade their
infrastructure and invest in health care and prevention, and people will be
able to pay for their health costs.
* Ayodele is the director of the Initiative for Public
Policy Analysis, a
public policy think-tank based in Lagos.
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