Counterfeit drugs raise Africa`s temperature
By: Jocelyne Sambira
Africa Renewal Magazine
June 27, 2013
Drugs on sale at a market in Mali. Photo: Bert Spiertz/Hollandse Hoogte/Redux
Profits too high, penalties too low to stop crime
For someone with advanced technical know-how and a devious mind, a piece of chalk or some flour or starch can be shaped into a tablet or pill. With the naked eye, it`s almost impossible to tell it`s a copycat. The global counterfeit drug trade, a billion-dollar industry, is thriving in Africa. The markets are flooded with fake and poor-quality drugs, making a trip to the pharmacy seem like a game of Russian roulette. If you pick the wrong box, it could literally mean your death.
About 100,000 deaths a year in Africa are linked to the counterfeit drug trade, according to the World Health Organization (WHO). The agency defines counterfeit medicine as “one which is deliberately and fraudulently mislabelled with respect to identity and/or source.” Both branded and generic products are faked. In some parts of Africa, Asia and Latin America, more than 30% of the medicines on sale can be fake, notes the organization.
The detection of fakes has become more difficult over the years, notes a 2012 study published by the Lancet, because of “counterfeiters` increased ability to reproduce holograms and other sophisticated printing techniques.” Some even add active ingredients that pass quality test controls but don`t provide any benefit to the user.
Roger Bate, an economist specialising in international health policies, believes that substandard drugs—the result of poor manufacturing or “deliberate corner-cutting”—are a much bigger health problem than fake medicines. “Off-the-shelf drugs made by Chinese and to a lesser extent, Indian manufacturers tend to perform inconsistently on quality tests,” he claims in an article for the US-based think tank American Enterprise Institute (AEI).
Crime against humanity
The proliferation of fake, falsified and substandard drugs has had tragic consequences. “Counterfeiting is more than a criminal act,” writes Professor Pierre Ambroise-Thomas, the WHO expert on malaria and tropical parasitic diseases, in the Mediterranean Journal of Haematology and Infectious Diseases. “Manslaughter is perfectly justified to describe such an act although some prefer calling it simply murder.”
Unfortunately, the penalties for the crime are not strong enough to deter criminals, lead researchers Gaurvika Nayyar and Joel Breman emphasize in a June 2012 report on poor-quality drugs published in the Lancet Infectious Diseases. They strongly advocate that the “production and distribution of counterfeit anti-malarial drugs should be prosecuted as crimes against humanity.”
Weak regulations and drug licensing
A major sweep across 16 seaports on the east and west coasts of Africa last July allowed the World Customs Organization, an intergovernmental organization that advises customs administrations worldwide, to seize more than 82 million doses of illicit medicines estimated to be worth over $40 million. The fake drugs found during the raid included cough syrup, anti-parasitic and anti-malarial drugs, antibiotics and even contraceptives.
However, the raid also exposed the Achilles` heel of African government agencies in charge of licensing and regulating drugs. Lack of training, insufficient manpower and corruption often plague national regulatory agencies. Furthermore, government inspectors frequently accept bribes and kick-backs to allow the fake drugs to pass borders.
To fast-track registration, the WHO encourages national regulatory authorities to choose medicines from its list of pre-qualified products. But it`s up to the individual countries to decide to register a product or not.
Seloi Mogatle, Botswana`s principal pharmacist in drugs registration told the WHO she appreciates “the opportunity to use the agency`s work without losing national autonomy.”
High drug prices
Another major weakness of the regulatory agencies is their inability to close what Olike Chinwendu, in her thesis, “The Fight Against Fake Drugs by NAFDAC in Nigeria,” calls the “chaotic drug market.” This includes unlicensed drug vendors—most of them street, kiosk or open-market vendors.
Instead of “seizing, destroying and penalizing violators,” Chinwendu suggests strategies used by Tanzania and Ghana to train, license and regulate illegal drug vendors.
A joint study by the WHO and Health Action International found that “duties, taxes, mark-ups, distribution costs and dispensing fees regularly constitute between 30% to 40% of retail prices, but occasionally up to 80% or more of the total.”
People will continue to patronize drug outlets like open drug markets for first-line treatments, observes Chinwendu, because they`re cheaper.
While educating consumers has been crucial in fighting counterfeit medicines, regional coordination has also been effective. In West Africa, health and law enforcement officials, together with the WHO and Interpol, have been running multi-country operations aimed at disrupting transnational fake drugs criminal networks. Their latest operation in 2011, called Cobra, resulted in the seizure of 170 tonnes of counterfeit and illicit medical products.
China, a global manufacturer of generic drugs and the maker of the award-winning anti-malarial drug, artemisinin, has also joined the fight. According to the Xinhua News Agency, China is installing “recognition and tracing technology on its drugs,” and anti-counterfeit labels are sealed on each drug package. Chinese pharmaceutical companies are also strengthening cooperation with African governments and drug distributors to trace imported drugs.
New technology is also revolutionizing the fight against counterfeits in Africa. TruScan is a handheld spectrometer being used at airports and border posts to analyze the chemical composition of drugs, helping to spot “bad drugs” in seconds.
In addition, simple and free text messages are being used to check the authenticity of drugs. Start-ups like mPedigree Network and Sproxil have designed systems that allow legitimate drug manufacturers to label their packages with an encrypted code. Consumers simply scratch off the label on the package and text the code for free to the company that maintains the system. The response, sent by text, is instant, informing the consumer whether the drug is real.
Countries like Ghana, Nigeria and Kenya have integrated mobile telephony–based consumer verification into their safety regulations. The system is also being replicated in Asia. The brilliance of the service is that it allows consumers to protect themselves, giving them the power. But more importantly, the low-tech innovation is helping restore the public`s trust in the health sector.
Source: Africa Renewal www.un.org/africarenewal
Note: Africa Renewal promotes (social, economic political, human rights, communication technology, trade...) issues of interest to Africa. Africa Renewal contributed this article, free-of-charge, to Biyokulule Online.
RSA Writer Urges States To Enforce Law Against Trade in Counterfeit Drugs
Institute for Security Studies
Wednesday, June 9, 2010
Commentary by Annette Hubschle: "Treatment Perils: the Proliferation of Fake Medicines"
Counterfeit pharmaceuticals are flooding regional markets. This not only provides a `hard pill to swallow` to health and pharmaceutical boards but also to law enforcement authorities. An ISS research study on organised crime in southern Africa has identified the trafficking and trade of fake medicines as an emerging concern. The Southern African Regional Police Chiefs Cooperating Organisation (SARPCCO) and INTERPOL recognises it as a priority crime, which has led to a number of regional initiatives to stamp out the trade.
A 2006 report by the World Health Organisation (WHO) estimated that in developing countries in Africa, parts of Asia and Latin America, up to 30 percent of pharmaceutical drugs are counterfeit. Sub-Saharan Africa is particularly affected as weaknesses of health-care systems in many countries have created the vacuum into which merchants of counterfeit pharmaceuticals have been slipping in. The United Nations Office on Drugs and Crime (UNODC) estimates that 50 to 60 percent of all medications used in West Africa may be substandard or counterfeit. This increases health risks in a region with a high demand for anti-infection and anti-malarial drugs, apart from promoting the development of drug-resistant strains, which are a hazard to the entire world. The true extent of the problem is unknown since no global or regional study exists.
According to the WHO, counterfeit medicine is `one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, with insufficient active ingredients or with fake packaging.` In the past, bogus pills used to be blank replicas of the originals. But counterfeiters nowadays often add other active ingredients, such as mild pain relievers such as acetaminophen into pills that might make patients temporarily feel better. This was the case with fake Tamiflu seized from UK pharmacies in 2007. In 2004, Medecins Sans Frontieres (MSF) discovered counterfeits ARVs on markets in the Democratic Republic of Congo (DRC) containing anti-depressants and muscle relaxants.
The addition of false active ingredients to counterfeit pharmaceuticals alarms health professionals. More worrisome is the substitution of real active ingredients with potentially life-threatening chemicals. The antifreeze component diethylene glycol has been used in place of glycerine in cough medicines, killing hundreds of people in Nigeria, Panama and Bangladesh in recent years.
Any pharmaceutical product can be counterfeited: expensive lifestyle and anticancer medicines, antibiotics, medicines for hyper-tension and cholesterol-lowering medicines, hormones, steroids and generic versions of simple pain killers and antihistamines, vitamins and nutritional supplements and pills in treatment of erectile dysfunction or sex-enhancing drugs. The proliferation of fake anti-malarial and anti retroviral drugs (ARVs) for people living with HIV/Aids is of particular concern in sub-Saharan Africa. The consequences are dire since a person may die if they do not access the genuine drug. Inefficacy of counterfeit drugs also makes people loose confidence in such drugs.
The trade in fake drugs is extremely lucrative and with the escalating cost of medicines, the trade in counterfeits is likely to grow. For example, the profit margin from counterfeit Viagra is 10 times higher than for the narcotic drug heroin. Pharmaceuticals are high value items in relation to their size and the demand for them is indefinite. For the counterfeiter, ingredient costs can be low if cheap substitutes are used or vital ingredients may be omitted altogether. Little infrastructure is required as the counterfeiter can produce the fake medicines in a backyard. Overhead costs due to quality assurance or meeting Good Manufacturing Practices (GMP) standards are not applicable. Global counterfeit syndicates use evolving consumer technologies that make it easier to imitate legitimate drugs. The law in quite a few countries has not yet caught up with the seriousness of counterfeiting of medical drugs. While traffickers in `hard` drugs face severe penalties of imprisonment, counterfeiters face trademark and fraud charges, for which the penalties are usually financial.
Developing countries are particularly vulnerable to the proliferation of fake dugs because of inadequate regulatory capacity or political will to curb distribution. And while legitimate drugs can be expensive, poor consumers fuel the demand by knowingly or unwittingly purchasing cheaper fake variations. Price controls also cause shortages in medicines, creating a gap that counterfeiters then fill. Price caps in South Africa resulted in the closure of more than 100 small rural pharmacies because they had to charge more than large urban shops. In the past, the rural poor could choose whether to pay more locally or travel into the cities for cheaper drugs. Now they have to travel or buy them cheaply from peddlers that often sell fakes.
In 2008 and 2009, INTERPOL conducted raids on the pharmaceutical and cosmetics sector in east Africa. During Operation Mamba I, 100 varieties of illegal products were found in 191 facilities searched in Tanzania. 44 police cases were opened, 4 pharmacies and 18 drug shops were closed during the raid. Operation Mamba II, which took place throughout August 2009, involved raids across Uganda, Tanzania and Kenya. The operation resulted in 83 police cases and a few convictions. Of the Tanzanian traders, 9% were found to be selling expired medicines, 18% sold medicines which are restricted to government handling, 28% had in their possession medicines strictly for prescription only, but found in undesignated shops, while 46% stocked unregistered medicines.
Beyond the INTERPOL initiatives, what is to be done to deal with the proliferation of fake drugs? Countries may choose to enact special national legislation. Kenya, Tanzania and Uganda are at various stages of implementing laws against counterfeit medicines. They realise that enacting laws will not solve the problem, as the laws need to be enforced. More resources should also be dedicated to drug regulation. At the same time, a comprehensive study that looks at the supply chains and assesses the size of the industry should be undertaken.
(Description of Source: Pretoria-based Institute for Security Studies in English -- Independent policy research institute providing research and analysis of human security issues in Africa to policy makers, area specialists, and advocacy groups. The think tank is headquartered in Pretoria, South Africa with offices in Kenya and Ethiopia; URL: http://www.iss.co.za)
© Compiled and distributed by NTIS, US Dept. of Commerce. All rights reserved.
Nigeria: World Bank Report Says 50% of Drugs Sold in 1990s `Counterfeit`
Daily Trust Online
Monday, March 15, 2010
Report by Idris Ahmed: “W/Bank: Over 50% Drugs Sold in 1990s Were Fake”
More than 50 percent of drugs sold in drugstores in Nigeria in the 1990s were counterfeit, the World Bank said in a report.
In its Africa Development Indicators 2010 report, released at the weekend, the bank said “Quite corruption” is undermining development in Africa, including Nigeria.
Quiet corruption, according to the bank, is the failure of public servants to deliver goods or services paid for by governments.
This is pervasive and widespread across Africa and is having a disproportionate effect on the poor, with long-term consequences for development, according to the report.
The report said that the number of people living with less than $2 a day in Sub-Saharan Africa (SSA) has nearly doubled since 1981 from 292 million to about 555 million in 2005.
“Every day thousands of people, many of them children, still die from preventable diseases. Aids and malaria are still ravaging the Africa continent, especially SSA,” the report added.
The new study shifted from the usual focus on an exchange of money - bribes to powerful political designees or kickbacks to public officials but focused on how “quiet corruption” leads to an increasingly negative expectation of service delivery systems, causing families to ignore the system.
According to the Chief Economist for the World Bank, Africa Region, Shanta Devarajan, tackling quiet corruption will require a combination of strong and committed leadership, policies and institutions at the sectoral level, and increased accountability and participation by citizens.
(Description of Source: Abuja Daily Trust Online in English -- Website of the independent pro-North daily; URL: http://www.news.dailytrust.com/)
© Compiled and distributed by NTIS, US Dept. of Commerce. All rights reserved.