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Russia cracks down on counterfeit drugs


Counterfeit medicines top the agenda at a Council of Europe conference in Moscow this week. The Russian government says it is stepping up its own battle to sweep fake drugs off the market, but critics in the drugs industry complain that some new efforts are misguided. Tom Parfitt reports.

At first glance, it looked like a normal abandoned warehouse on the edge of Moscow: crumbling walls, dripping pipes and the odd rat scuttling across the floor. In fact, the run-down building was still in useas an illegal distribution centre for fake medicines being sent to pharmacies and hospitals all over Russia.

The operationbusted earlier this year by police and inspectors from the Russian Federal Agency for Monitoring Health and Social Development, or Roszdravnadzorwas a sharp reminder of the scale of drug counterfeiting in Russia.

Stored at the warehouse were an estimated US$2 million worth of copies of popular, mostly foreign drugs such as vinpocetine (Cavinton), a drug used for the treatment of various cerebral insufficiency conditions, the cold remedy TeraFlu and the antibacterial drug cotrimoxazole (Biseptol).

Inspectors discovered about 600 boxes of the fake Cavintonmade in its genuine form by the Hungarian company Gedeon Richterhad been delivered from the warehouse to the main hospital of Khabarovsk in the Russian Far East. Thank God, the medicine was replaced with a neutral substance that had no effect on vital functions, Boris Merkeshkin, the hospital's chief doctor told reporters from state television after the fraud was exposed. If not, it would have been a tragedy.

Worldwide, copycat medicines are on the increase. The Centre for Medicines in the Public Interest in the USA predicts that counterfeit drug sales will reach $75 billion globally in 2010, an increase of more than 90% from 2005.

Counterfeit drug production is worth an estimated $300 million per year in Russia and although the government claims counterfeiting is on the decrease, it admits that up to 10% of medicines are still faked.

Industry groups have praised recent steps by Roszdravnadzor to tackle the problem but claim new initiatives to control the trade could be ineffective.

One major concern is the extent to which production of fake medicines is so closely meshed with legitimate production. Corruption is huge and many pharmaceutical companies have powerful stooges within Russia's all powerful bureaucracy.

The medicines found at the abandoned Moscow warehouse turned out to be owned by a company whose founder was Vladimir Bryntsalov, a member of parliament and billionaire pharmaceuticals magnate who once ran for president. A police investigation started in April is ongoing.

About 70% of fake drugs in circulation in Russia are produced inside the country, and an estimated 70% of them are copies of foreign medications.

Whereas a decade ago many fakes were made in basements and small backroom enterprises, most are now coming from legitimate factories that make copies on the side. A night shift is run to produce extra quantities of a certified drug that does not pass through quality control, or sophisticated copies of well-known drugs are produced, often with reduced levels of expensive active ingredients. These fakes can be exact copies or put in packaging where only a letter or two is altered on the name.

I wouldn't call them high-quality but the trend is certainly toward high craftsmanship in counterfeits, says Gennady Shirshov, executive director of the Union of Professional Pharmaceutical Organisations (SPFO), an industry body representing major wholesalers, pharmacy chains, and foreign and local manufacturers.

Shirshov praises the government for several high-profile raids this year saying the biggest manufacturers of fakes have been forced to stop. But he fears that smaller producers making lower-quality counterfeits may yet move in to fill the void. Law enforcement bodies are under-resourced and there is little deterrent. The legislation is inadequate. It's a civil liability, not a criminal one [for producing counterfeits] and the fines are negligible, he says.

While there are no statistics on the harm caused to patients by fake drugs, it is generally thought that the good quality of most of them has prevented deaths. However, that has led to complacency on the part of some officials. We have had people in the regional governments even saying about improper medicines, what's wrong with that, the quality is super and we're going to buy it, says Shirshov. And that's just awful.

The fear is that while accurate fakes are rarely harmful, those that are simply placebos made from chalk and water could present a danger if they prevent a patient receiving a vital course of drugs. About 45% of counterfeits in Russia are thought to be medicines for serious cardiovascular or gastrointestinal illnesses.

What concerns the pharmaceuticals industry, police, and regulatory bodies now is how to bring the illegal trade to its knees. Ramil Khabriev, head of Roszdravnadzor, says rapid progress is being made and denies a recent report in The New York Times which suggested that counterfeit production in Russia was on the rise. I can say for certain that is not true, he told The Lancet in an interview at his office in Moscow. The number of inspections has increased while at the same time the quantity of counterfeits being found has decreased.

All drugs entering the country are certified and a new law introduced in June made it possible to take distributors and pharmacieswhich are often in on the sale of counterfeitsto arbitration court and annul their licences, he says.

This year, Khabriev clashed with foreign pharmaceuticals manufacturers over plans for a new law that would oblige them to register a partner company in Russia.

His agency wanted to make the supply chain more transparent by obliging international companies to verify their imports inside Russia, he says. At present distributors often cannot confirm the exact origin of their products. We do not have limitations on import of any medicine if it has the licence of a distributoreven from offshore zones, he says. If there was a licence for production on the territory of the Russian Federation, we would be able to ask [the companies] to confirm if it is their medicine being imported at this point in time or not.

But the Moscow-based industry group, the Association of International Pharmaceutical Manufacturers (AIPM), fought hard against the proposal. The problem was that they wanted to insist at the same time that the Russian legal entity would also be the owner of the intellectual property being registered, which means that our companies would have to transfer ownership of their blockbuster medicines to a Russian legal entity, explains executive director, Sergei Boboshko. The fact that it's Russian is not the point. What happens if tomorrow Korea says we want to do the same thingwho's going to own that intellectual property?

Boboshko, whose organisation speaks for some 45 foreign companies including giants like Pfizer, GlaxoSmithKline, and AstraZeneca, stresses that Roszdravnadzor backed down from the demand to transfer intellectual rights after pressure from officials at the ministry of economic development and trade who recognised it was wrongheaded. We are very grateful to the authorities for recognising our concerns and deciding this requirement is no longer necessary, he says.

Khabriev is not so content. He believes foreign companies are lobbying against the law because they simply wanted to avoid extra work and expense.

Foreign manufacturers bridle at the suggestion that they would hinder the exposure of counterfeit drugs. Why would we do that? says one industry source. Besides patients, we're the first people to suffer. Individual companies are often reluctant to discuss the topic of fakes for fear of creating adverse publicity that would put shoppers off their products. But there is genuine concernboth for hoodwinked patients and lost profits.

At the premises of Intertech Corporation in Moscow, Shurshov's union is piloting an analyser using near infrared technologycommon elsewhere in Europethat can be used to identify counterfeit drugs and packaging within minutes.

The suitcase-sized analyser, which is linked to a desktop computer, has a pistol-shaped probe to test liquids, powders, and receptacles for scanning ampoules and pills. Look at these clusters, says Georgy, the spectograph operator, pointing to two groups of red dots as he tests a Biseptol tablet. We can see right away that its fake.

SPFO wants to set up a database of profiles of legitimate medicines to compare with suspected copycats. Roszdravnadzor, meanwhile, is considering introducing a system of coded labels to identify legitimate drugs. Boboshko of AIPM is convinced that will not help. There are no stamps, no holograms, no secret passwords, or anything that's going to eradicate this problem, he says. What you should put your money on is political will, enforcement and legislation.

The Lancet 2006; 368:1481-1482 DOI:10.1016/S0140-6736(06)69619-0