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.