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Patients need quality medicines
Tuesday, 22 March 2011 00:00
By Thompson Ayodele Opinion - Columnists
EARLY this month, the World Health Organization (WHO)
working group on substandard
and counterfeit medical products concluded its meeting
in Geneva. The deliberations
which would form core of discussion during the
64th World Health Assembly next May centered on
WHO’s role in the prevention
and control of medical products of compromised quality
and measures to ensure the
availability of good-quality, safe and affordable
medical products. The relationship between the
WHO and the International
Medical Products Anti-Counterfeiting Taskforce (IMPACT)
also featured during
discussion.
It is generally recognized that counterfeit and
substandard medicine
undermines effective healthcare delivery in Africa. It
aggravates the
health conditions of patients and threatens the survival
of manufacturers of lawful
drugs, both patented and generics. Above all it has led
to untimely death of many,
with an estimated 700,000 killed a year.
In the face of this challenge, the concern is ensuring
genuine drugs are available to
patients, orientate them on the harm posed by
counterfeit medication and
consequently encourage them to desist from patronizing
outlets known for peddling counterfeit medicines.
Of late, there has been a call on the WHO to review its
relationship with
International Medical Products Anti-Counterfeiting
Taskforce (IMPACT). One
international aid agency has called on the WHO to
disband the organization. This
is borne out of believe that the task-force activities’
hinder the supply of generic medicines while
promoting a strong
intellectual property rights protection at the detriment
of generic manufacturers. This
is misleading. The distribution of counterfeit and
substandard medicines undercut the market share
of both branded and generic
medicines as counterfeiters often sneak in their
products into the legitimate
supply chain for maximum profits.
Despite the recent aver sion
towards activities of the organization and thesupportive
roles played by the WHO, the taskforce was set up in
response to the global
recognition of the need to tackle the menace through
inter-sectoral and cross-border enforcement. This
follows the realization that
fake drug peddling is often a cross-border crime. Normal
regulatory and enforcement
effort is not seen appropriate tool to stamp out the
trade completely.
The birth of IMPACT spearheaded by WHO in 2006 is to
give a strong fillip to
information sharing regarding counterfeit and
sub-standard medicines among
the regulators and enforcement agencies, pharmacists,
distributors, the public and
hospital staff regarding the authenticity or otherwise
of a medicine or vaccine. It
further aims to inject the needed steam through
which governments can crack down on corruption
which has become the hallmark
of police and customs with respect to enforcing laws
against drug counterfeiting.
In addition, drug manufacturers are goaled to make their
products more difficult to fake.
There are hordes of problems plaguing the fight against
counterfeiting.
Firstly, the penal system in many African countries is
weak. Secondly, there is
insufficient regulation of drug manufacturing. Thirdly,
there is poor enforcement of
existing legislation, and lastly lack of co-operation
between countries with respect to information
sharing to track shipment ofcoun
terfeit and substandard medicines pose a
significant challenge.
Without this framework, patients in Africans will remain
more vulnerable to counterfeit
and substandard medicines. Ultimately, the impact on the
healthcare system will be very devastating. With
the increased sophistication
employed by counterfeiters coupled with their ability to
maneuver, phasing out the task force could
trigger the rate of counterfeit
drugs in circulation.
The taskforce fills this vacuum by coordinating and
ensuring that custom services,
law enforcement and drug regulatory agencies cooperate
to thwart and frustrate
counterfeiters’ activities before getting their
medicines to patients.
According to the WHO, many African countries do not have
functioning drug regulatory authorities and
technical competence also
differs across countries. Its abolition will make the
fight to stamp out counterfeit
haphazard.
The fears that this framework could hamper the sale of
generic medicines is
precipitated by misrepresentation of the role played by
task force in strengthening
healthcare industry and ensuring patients’ safety. More
so that counterfeit
medicine affect both generic and branded. It is in the
best interest of drug manufacturers to allow the
taskforce play its roles under
the auspices of the WHO.
Medicine quality is an issue that requires a broad
effort cutting across a range
of stakeholders. That means stakeholders in the health
sector should be genuinely
concerned about quality of medicines that patients take.
In this regard, whatever
strategies put in place to address the scourge
should be consistent without letting up. Should
it wane, it has the potential
of reversing previous gains and consequently emboldens
counterfeiters.
The calls that the WHO should disengage from
coordinating anti-counterfeit
efforts are largely misplaced. Combating counterfeiting
requires building consensus
around priorities and key stakeholders should be more
flexible.
The WHO should be allowed to continue to spearhead
global leadership in
addressing a broad range of medicine quality issues.
The implications of WHO disengagement will be a setback
for the fight against
poor-quality medicines globally. Firstly, it will
further
incentivise counterfeiters. Secondly, in view of poor
countries’
shoe-string budgets arising from aftermath of global
financial crisis,
there might be reduced activities on the part of
regulatory and
enforcement agencies which will be explored by
counterfeiters. And
thirdly, the global effort at stopping the trade won’t
be properly
coordinated. That means the present framework that
addresses the
international dimension of the trade should be allowed
to sail along.
It is very important that the WHO should continue to
play leadership role in order
to build a long-term strategies to fight the menace. The
involvement of WHO provides institutional support to
fight counterfeit and
sub-standard medicines. This is because the WHO has a
broad mandate which is
recognized globally. The quality of medicine is a
critical part of this mandate
and it has been fighting drug counterfeiting since it
became a major global threat
in the 1980s. The WHO through the task force stands in
a better position to coordinate and provide the
needed leadership towards
providing access to essential and quality medicines.
• Ayodele is the Director of Initiative for Public
Policy Analysis, a
public policy think-tank in Lagos.
Thompson Ayodele
Director
Initiative for Public Policy Analysis
P.O.Box 6434
Shomolu,Lagos
Nigeria
Email:thompson@ippanigeria.org
Backup: thompson.ayodele@gmail.com
Website: www.ippanigeria.org
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