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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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