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Counterfeit drugs are flooding poor countries, where up to one in three medicines can be fake, causing widespread suffering and death. The World Health Organization wants an international agreement to tackle the threat but is being thwarted by members such as India and Brazil, more concerned with vested interests than African patients.
In Israel such problems are confined mainly to "lifestyle" pills for impotence and baldness, but in most countries it is a deadly threat.
To fight counterfeits, the WHO's International Medical Products Anti-Counterfeiting Taskforce (IMPACT) first needs to define them - but this new definition is opposed by an unholy coalition ranging from global anticorporate activists to certain Indian and Brazilian pharmaceutical associations and heavily-lobbied governments. They claim the definition would covertly introduce stricter patent protection and prevent generics manufacturers from exporting cheap drugs, mainly to Africa (generics are copies of drugs whose patents have expired, although some are in dispute).
They accuse IMPACT of being a front for Western "Big Pharma." But IMPACT principally consists of and is led by national drug-regulatory authorities. Participation is open to every WHO member, so power lies mainly with developing countries that have negligible pharmaceutical sectors - and where counterfeit drugs are most common. A leading light in IMPACT has been Nigerian cabinet minister Dora Akunyili, the famous fighter against counterfeit drugs.
Moreover, there is no basis in the accusation that the new definition of "counterfeit" would stifle the trade of good quality generic medicines through tougher patent enforcement.
The new definition states "disputes concerning patents must not be confused with counterfeiting." This seems clear enough. If IMPACT threatens the global trade in quality generics, as its opponents claim, why do international generics associations support it? In December the European Generic Medicines Association welcomed the new definition, specifically because it "puts an end to any confusion with alleged patent infringement products which have nothing to do with counterfeiting." The International Generic Pharmaceuticals Alliance was a founder of IMPACT.
Indeed its fundamental principles match those of reputable Indian organizations such as the Confederation of Indian Industry. Fakes and substandards have "tainted the image of many Indian brands," it notes, "...placing patients' health at risk." The Organization for Economic Cooperation and Development estimated last year that up to 75 percent of the world's counterfeit drugs come from India, most of which end up in Africa.
BUT A STRANGE alliance of antibusiness activists and business associations purporting to represent India's best interests has successfully lobbied the government to oppose IMPACT. The Indian Pharmaceutical Association says the counterfeit definition would harm the drug industry. The SME Pharma Industries Confederation called "for safeguarding the export interests of the SME [small- and medium-sized enterprises] sector" by opposing it. Indian delegates subsequently blocked IMPACT's progress at the recent WHO executive board meeting and are threatening to prevent progress at May's World Health Assembly: All the horse-trading will be done in coming months because WHA decisions are based on consensus and can be blocked by a small group of countries.
But India's own world-class and brand-conscious major producers stand to lose from India's opposition to IMPACT. Fake versions of successful Indian generics have begun to flood the market, not least in India itself, losing them money, damaging their image and increasing disease.
Another fake argument is that "counterfeiting is an issue of trademark violation and has no bearing on public health," to quote anti-patent campaigner K.M. Gopakumar of the Indian Center for Trade and Development think-tank. IMPACT's definition makes no specific mention of trademark violation but does of course outlaw "false representation" and "fake packaging": If the packet is fake, do you really expect to find real medicine inside?
Without trademark protection, manufacturers cannot protect against counterfeits and patients cannot be sure where their medicine has come from. It further helps patients by making brands compete on quality and price. Like IMPACT's mission, this has nothing to do with patents - and it does protect health.
Cheap drugs are a boon to health but they must be of a high standard, lest they do more harm than good. IMPACT cannot save poor countries nor does it set out to do so. It merely provides guidance to countries.
IMPACT's definition can, for example, serve as a template for a legislature tightening laws against counterfeiting - or improving trademark law to help genuine brands compete. Another huge blow to counterfeits would be to cut taxes and tariffs, not just cutting prices for the poor but also encouraging competing brands to enter a country's marketplace - reducing prices even further and therefore squeezing the profits of counterfeiters.
This must not prejudice us against Indian drugs, many of which are very good. Yet the Indian government remains influenced by powerful vested interests, while the high-quality producers are not being heard.
Governments must not allow fake accusations to obstruct the campaign against fakes. An advanced country like Israel has little to fear from counterfeits but it can only gain from taking a stand against them. WHO members must stand up between now and the World Health Assembly in May and defend the campaign: High quality drugs would benefit both India's generics industry and poor patients.
The writer is an executive of Ghana's IMANI, judged this year as the sixth most influential think-tank in Africa by Foreign Policy magazine. He is also involved in developing SMS verification for medicines.