Counterfeit pharmaceuticals flood Russian market

James Schofield Moscow
International pharmaceutical manufacturers and Russian federal authorities
say that an explosion of counterfeit drugs is seriously endangering the
public health.
As much as 3.6% of all drugs in Russia are fake, the deputy minister of
health, Anton Katlinsky, said at a recent press conference in Moscow. The
health ministry reported 56 separate drugs and medicines counterfeited in
2000.
The Russian health ministry’s announcement comes only a month after the US
Food and Drug Administration launched an investigation into fake drugs on
the US market (16 June, p 1443).
Most of the fake drugs in Russia are high volume, low cost antibiotics,
which turn an enormous profit when copied in bulk. They are also far easier
to introduce to the market than rare treatments used in only a handful of
institutions.
Concerned by the phenomenal growth of the trade, Robert Rozen, executive
director of the Association of International Pharmaceutical Manufacturers,
has urged the government to form a special commission for combating the
lethal trade. "This is a question of life or death," he argued.
In a recent example, Aventis Pharma was forced to recall the antibiotic
cefotaxime (Claforan) after fakes were discovered containing dangerous
levels of methanol. The drug is commonly used to treat postoperative
infections such as pneumonia and septicaemia, and Dr Kirill Litovchenko of
Aventis warned: "If it doesn’t work, the patient can simply die."
As many as 80% of the copies are thought to be made domestically, some by
fully licensed "legitimate" producers, which are themselves making an extra
profit on the side using low quality chemical components.
Part of the problem is that the fakes have become so good. Well financed
counterfeiters, equipped with the latest technology, can even buy their
packaging from the same companies as the legitimate manufacturers, making it
impossible for authorities to identify the fakes without expensive chemical
analysis.
Manufacturers claim that the government has failed to respond to the
problem. Weaknesses in the legal system and corruption by law enforcement
agencies are a major obstacle to justice.
The Russian judicial system is stretched to the limit, underpaid, and
understaffed. Applications for search warrants and the revocation of
production licences all too often get bogged down. Eugene Arievich of Baker
and McKenzie, an international law firm with an office in Moscow, describes
the way cases are dealt with as "a conveyor belt at an assembly plant."
Frustrated by delays, many manufacturers take their cases to the civil
courts. However, without the right to conduct warehouse raids, as soon as a
suit is filed the defendant is alerted and can move the counterfeits into
hiding.
Even when a conviction is secured, meagre fines of $5000 (£3570) are little
deterrent to organised gangs. With no legal provision permitting destruction
of seized fakes, state officials are easily bribed, and many drugs find
their way back on to the open market.
Without a firm lead from the federal government, cash strapped and
overworked enforcement agencies are also slow to get involved. "They don’t
even see it as a second priority to address this issue," claimed Mr
Katlinsky at the press conference.
The call by the Association of International Pharmaceutical Manufacturers
for a coordinating anti-counterfeiting committee, supported by the ministry
of health, is a first step towards solving the problem.
Robert Rozen warns that the dangers will spiral out of control if nothing is
done and that the relative safety of the fakes currently on the market could
plummet as the growing trade becomes increasingly lucrative and organised
gangs become ever more ruthless.




Edward E. Rylander, M.D.
Diplomat American Board of Family Practice.
Diplomat American Board of Palliative Medicine.