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[e-drug] Lomé Initiative is not answer to Africa?s problem of fake medicine

E-DRUG: Lomé Initiative is not answer to Africa’s problem of fake medicine
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February 5, 2020
Written by DENIS KIBIRA
https://observer.ug/viewpoint/63418-lome-initiative-is-not-answer-to-africa-s-problem-of-fake-medicine

On January 18, 2020, Ugandan president Yoweri Museveni was among seven African 
heads of state that signed a political declaration to stem the problem of 
trafficking in substandard and falsified medicines in Africa under an agreement 
that has been called the Lomé Initiative.
The Lomé Initiative is spearheaded by the Brazzaville Foundation, a 
non-government organisation based in the United Kingdom. The initiative was 
born out of a resolution of a conference organised by the Brazzaville 
Foundation in March 2018 in London under the theme ‘’Medicines that lie: a 
deadly public health crisis’’.

The meeting, co-organised by the Harvard Global Health Institute and the London 
School of Hygiene and Tropical Medicine, resolved  “to end the traffic in 
substandard and falsified medicines to ensure universal health care as part of 
the 2030 Agenda for Sustainable Development.’’

The initiative aims at stemming the traffic in counterfeit medicines by 
introducing legislation to criminalize this traffic, impose tougher criminal 
penalties and ensure vigorous enforcement of the legislation.

Substandard and falsified medicines are a major public health threat across the 
world. The World Health Organisation (WHO) estimates the value of this illegal 
medicine market at approximately $200 billion annually comprising 10 to 15 per 
cent of the global pharmaceutical market.
This is big business with dire consequences. WHO estimates that in 2015 alone, 
122,000 children under the age of five died from poor-quality antimalarials in 
sub-Saharan Africa.

There are also concerns that 42 per cent of all falsified medicines discovered 
since 2013 were in Africa and that falsified medicines account for 20 to 30 per 
cent of all medical products on the continent.

Fake medicines thrive because the African continent and healthcare systems 
present perfect conditions for this illegal trade. There is inadequate 
financing of health by African governments, which leads to limited availability 
of medicines in the public sector. Patients are then forced to revert to the 
private sector where sometimes they cannot afford the prices of medicines.

Whereas we have very good and professional national drug regulatory agencies 
such as the National Drug Authority (NDA), these agencies often do not get 
financing from governments and, therefore, do not have the capacity to monitor 
all border entry points for medicines.

The public is also not sensitized to identify and report those that traffic in 
fake medicines and many times there is lack of harmony in policies, enforcement 
and punishment of culprits. The common person is, therefore, left deserted.

The Lomé Initiative proposes to interdict the traffic in substandard and 
falsified medicine by imposing tough penalties such as a minimum 10-year jail 
term for offenders, introduction of mechanisms to ensure strict application of 
the new legislation, strengthening capacities for rigorous enforcement and 
garnering African countries’ support for signing of the Medicrime Convention 
and Palermo Convention against transitional organized crime.

This by all means looks like another anti-counterfeiting campaign, which may 
not solve Africa’s problems. Therefore, our governments should be careful that 
this initiative does not provide a platform for pushing forth stronger 
intellectual property rights (IPR) protection mechanisms that hinder access to 
approved generic medicines using public health as a front.

Articles about the Lomé Initiative use many terms to describe fake medicine; 
illegal, counterfeit, substandard and falsified. These terms are very different 
and often using them interchangeably is aimed to confuse the public to conflate 
intellectual property issues and enforcement with legitimate public health and 
safety issues.

These are the terms the public ought to know and differentiate: illegal 
medicine are unregistered or unlicensed products that have not undergone 
evaluation and approval by the NDA to be marketed, distributed or used in the 
country.

Substandard medicines are authorized medicines that fail to meet their 
specified quality standards due to poor manufacturing, storage and/or 
distribution but there may be no element of “intent.”
Falsified medicines are those that intentionally and fraudulently misrepresent 
their identity, composition or source either through substitution, adulteration 
or reproduction of an authorized medicine.

On the other hand, counterfeit medicine refers to intentional and fraudulent 
misrepresentation of a medicine through commercial-scale willful infringement 
of another trademark or trade name of a medicine. Counterfeiters aim to benefit 
from popular trade names.

In Lomé, President Museveni called for concerted efforts among African 
countries towards elimination of trafficking of substandard, falsified 
medicines and other medical products. He asked his fellow leaders to work 
together to form a system that is managed and regulated by Africans; to invest 
in research and development of health-related technologies, among others.

What is required is high-level political and financial support to strengthen 
existing healthcare systems in Africa. The problem of substandard and falsified 
medicine has been widely talked about but with anecdotal evidence, yet the 
impact fearfully shown requires empirical research on the extent of the 
problem. It is time to invest in research and solutions to the root causes to 
solve the problem.
info@heps.or.ug

Carinne Bruneton E-med
<carinne.bruneton@hotmail.fr>

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