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Pharmaceuticals

Life-threatening plagiarism

by Christian Splett
Counterfeit medication is not only a problem of developing countries. Thanks to globalisation and e-commerce this profitable business is spreading in Europe too. Governments, industry and consumers must cooperate to fight such practices. [ By Christian Splett ]

A German customs office recently succeeded in tracing a drugs scam worth some million Euros. An online company had been using the internet to sell drugs for treating erectile dysfunction. During the raid, seven suspects were arrested and some 50,000 pills confiscated. Pharmaceuticals that may only be sold on prescription and that are not licensed in Germany had been smuggled from India and other Asian countries with the goal of selling them throughout Europe.

Besides fake erectile-dysfunction pills, hair-restoring drugs and substances which enhance athletic performance, more and more forged medication for hypertension, cholesterol and osteoporosis is found in Europe. According to the World Health Organisation (WHO), 28 % of worldwide counterfeits are antibiotics, 18 % are hormones, eight per cent are antiallergenics and seven per cent are malaria drugs.

Fake drugs endanger lives, as incidents have shown all over the world. In 1995, some 2,500 died of Meningitis in Niger, after 50,000 people had been vaccinated only with water instead of the appropriate serum. In 2006, dozens lost their lives in Panama because certain pills were contaminated with a poisonous chemical. There is a long list of such examples.

The WHO classifies drugs as counterfeits if fallacious labels concerning origin and identity are deliberately or fraudulently applied. This definition includes counterfeit packaging or fake instruction leaflets, but also medications with insufficient, excessive or even the wrong active ingredients.

The WHO claims that up to 10 % of medications currently available on the market are counterfeits. However, there are substantial regional differences. Plagiarisms in Europe, North America or Japan are estimated to account for less than one per cent of the market volume, but in Africa as well as in parts of Asia and Latin America, their share may well exceed 30 %.

Nigeria was long regarded the front-runner in terms of fake pharma. More than half of the drugs sold in the country were probably counterfeits. Thanks to Dora Akunyili, that share has declined considerably. The long-time director-general of NAFDAC, the National Agency for Food and Drug Administration and Control, has intensified airport and seaport controls, conducted raids and fought corruption in her own agency.

Most legal pharmaceutical substances are produced in India and China, and so are plagiarisms. The latter are often shipped through free-trade areas or seemingly reliable countries. For 2008, the European Commission has confirmed that India was the main source of counterfeit medication – followed by Syria and the United Arab Emirates.
It is estimated that the global volume of the fake drug trade adds up to billions of dollars each year. This business is lucrative, as became evident in an evaluation by ABDA, the Federal Union of German Associations of Pharmacists. One kilogramme of counterfeit of Viagra, the protected erectile-dysfunction drug, for instance, was found to be worth up to € 90,000 on the black market, whereas the same amount of cocaine yields only € 65,000. The BKA, Germany’s Federal Criminal Police Office, expects a further increase in this type of fraud business. Moreover the risk of being discovered and punished is comparatively low.

Profits are not the only thing boosting the plagiarism industry. Another aspect is that many people are too embarrassed to be seen buying medication such as erectile-dysfunction or hair-restoring drugs in public. Some countries are contributing to the fraudulence too, by not passing effective laws. Too often, moreover, authorities are not cooperating well.

So how are counterfeit drugs distributed? Theoretically, they can be smuggled into the supply chain at any stage – from the pharmaceutical manufacturer to the final sales point. However, BKA statistics confirm excellent drug safety in Germany. According to this federal agency, there have been only 35 cases of counterfeit medication in the normal distribution system in the past ten years. In Europe, fake drugs predominantly are a black-market phenomenon.

Riskier, not cheaper

The internet is the major marketing device for fake pharma in Europe. According to the WHO, more than half of the drugs sold worldwide via the web by companies that do not reveal their address are counterfeits.

Test purchases have confirmed this estimate. For instance, the Central Laboratory (ZL) of German Pharmacists ordered the copyrighted hair-restoring medication “Propecia” from dubious online retailers. Six of the twelve products turned out to be counterfeits, four did not contain any active ingredient and two products only contained a significantly smaller amount of the active substance than indicated. The purchased products were not cheaper than in German pharmacies; but they were being made available without prescription. In other words: drugs that are ordered online are not necessarily cheaper, but they may present serious health hazards.

Whoever buys drugs online should therefore thoroughly check retailers’ addresses and registrations. Particular attention is warranted when “special bargains” are on offer or when medication, which normally is available only on prescription, is offered otherwise. Fundamentally, it is safer to purchase drugs from a professional, long established local pharmacy.

Pharmaceutical counterfeits put patients at risk; but they also damage the original producer. If counterfeits shake the confidence in the drug and its brand, they can cause extensive damage to the producer. The public suffers too: controls and prosecution of criminals are expensive, and so is treatment of patients who took fake pharmaceuticals.

Basically, to counterfeit drugs amounts to product and brand piracy. This practice violates intellectual-property rules. In many countries, therefore, ministries of finance or economics are in charge of the matter, rather than those of health or consumer protection. According to the Organisation for Economic Cooperation and ­Development (OECD), trademark rights are easier to check for the customs offices than infringements of patent laws. A copied logo is rather easily recognised; it is much more demanding to examine patented ingredients of any medication.

Recently, several German relief organisations complained about the increasingly rigorous enforcement of patent laws as well as trademark rules. They demanded the free transfer of their drugs after customs officers at Frankfurt Airport had confiscated more than three million antibiotics pills. They kept the pills for examination for several weeks. The suspicion of infringement of trademark rights was not confirmed.

Meanwhile, there is legal action against drug plagiarism at the international level. In 2006, the WHO established a special task force – IMPACT. It is supposed to explicitly combat counterfeit medication. In late 2008, moreover, the European Commission presented its “Pharma Package” with the aim of putting production and distribution of drugs under closer supervision.

Safety through regulations

In countries like Germany, however, drug safety is primarily based on prevention. Raids and confiscations matter much less. The idea is to have a market economy with strict rules. Only registered pharmacies are allowed to sell prescription as well as ­non-prescription drugs, and every German pharmacy has to be equipped with a laboratory to facilitate the testing of substances.

The enforcement of consumer protection, the strong regulation of mail-order as well as online retailers and the international harmonisation of patent and trademark laws – all of this is useful protection against fake pharmaceuticals. However, the main focus is on packaging technology, as simple holograms can be faked in no time. Crime can only be traced comprehensively if all parties involved invest in respective systems. So far, however, even rich nations can hardly afford such tough safety standards.

Stemming the spread of HIV/AIDS, Malaria and Tuberculosis is one of the UN’s Millennium Development Goals (MDGs). Accordingly, the availability of top-quality medication should be guaranteed. But apart from counterfeits, other things matter too – such as medical infrastructure, which is miserable in many developing nations. Another important issue is unfavourable international patent regulation.

By the year 2015, the special WHO task force IMPACT is planning to eradicate all counterfeits from the logistics supply chain. If that is achieved, millions of people from both industrial and developing nations will be protected against a very perfidious hazard to their health and lives.