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Prevention efforts
Interpol runs four separate "flagship" operations against the production of counterfeit medicine and medical devices, each covering different areas. Operation Storm targets Southeast Asia, Operation Mamba focuses on East Africa, and Operation Cobra aims at West Africa.
The fourth, Operation Pangea, targets online sales in a one-week investigation each year. It has been running since 2008, when there were 10 participants, rising to 100 in 2012. Last year, 3.75 million units of fake medicines, worth $10.5 million, were seized. Over 18,000 websites were shut down and nearly 80 individuals arrested. As a sign of the appreciation of the Internet's contribution to counterfeiting, the Center for Safe Internet Pharmacies, a coalition of 12 major Internet and e-commerce sites, participated in the operation for the first time in 2012.
In Russia, a participant since 2010, Pangea V (2012) proved an exception in "Pharmpiracy's" portrayal of lax pursuit of counterfeiters. During the operation, authorities inspected 134 wholesale warehouses and 900 pharmacies, seizing 800,000 rubles ($26,600) worth of suspect products in one week. The report indicates that Internet users contributed information on some of these locations.
In 2006, the Interior Ministry conducted Operation Farmakolog, which - according to a report by Boris Govorun, then head of the fifth operative investigative bureau - uncovered 3,690 violations, and led to more than 3 million rubles in fines, the suspension of 37 licenses, the initiation of 88 criminal cases, and the seizure of 128,000 packages of falsified medicines, worth more than 5 million rubles. Over one-fifth of the haul was destroyed.
Other international campaigns include the Zanzibar Declaration of 2010, with participants in that year's Operation Mamba agreeing to harmonize operations against counterfeiting in East Africa.
The Council of Europe's Medicrime, the first international treaty to target risks to public health posed by counterfeit devices and medicines, was produced for signatures in Moscow on Oct. 28, 2011, and has been opened for participation to non-member states due to the problem's international nature.
The treaty does not target legal generic drugs, or violations of intellectual property rights, only the production of counterfeit drugs with criminal intent. It also establishes a single contact point within each signatory country to coordinate that country's response.
So far, only Ukraine has ratified the agreement, despite 21 other states - including Russia - having signed it.
Oleg Astafurov, executive director, Union of Professional Pharmaceutical Organizations
Oleg Astafurov
The turnover of counterfeit, falsified and poor-quality medicines is a significantly more serious threat to society than even terrorism. In the past 40 years, international terror has killed 65,000 people, but counterfeit medicine has killed 200,000 people, according to figures from Abercade Consulting.
The turnover of counterfeit medicines carries a direct threat to the health of people and encroaches on their main right - the right to life. It also disrupts the system of state management, engendering corruption and the degradation of the authorities. We juxtapose the scale of negative repercussions for the life of society with the repercussions from the turnover of narcotics, but unlike narcotics, the influence of the turnover of counterfeit medicines is harder to define meaningfully.
Russia is extremely vulnerable in comparison with the countries of the European Union and other countries with a developed system of state regulation of the pharmaceuticals market (in accordance with materials from the World Health Organization). Russia's problems are: the absence of a unified regulatory body; a delay in federal and regional legislation; and a different normative-legal basis, in the regulation of launches of medications on the market and their circulation, from the best international practices, such as good manufacturing practice (GMP) and good clinical practice (GCP).
We should recognize that the actions of the authorities in the suppression of the turnover of counterfeit medicine are absolutely ineffective. The latest notorious event supports this - the purchases by the Health Ministry in August-September 2012 of a counterfeiting party's generic version of the original Novartis medication Glivec, to the sum of more than $200 million.
Aslanbek Aslakhanov, president, the Association of Employees of Law Enforcement Agencies and Special Services (ARPO)
© RIA Novosti. / Alexander Natruskin
Aslanbek Aslakhanov
We have prepared proposals for the corresponding law enforcement agencies, but I don't know how they looked them over, saying they were simply our accusatory biases, requiring the initiation of a criminal case, carrying out an investigation, etc. That we did not have the right to do it.
Our law enforcement, our prosecutors, our internal affairs bodies, they should study the material and adopt laws and measures. And I suspect that those who approach us are not absolutely right, because they don't understand. We say that a huge amount is brought into our country especially from India, from China, from other states, from generic producers who, for the most part, are not checked and do not adhere to the necessary standards.
When there is an incomprehensible pricing policy, it is completely understandable that this surprises and shocks people, and their requirement that we thoroughly grasp and take measures... to create this mechanism, which has become impossible. And, speaking honestly, I consider that that is an assessment of the work of our council, if [people] turn to us because sharp and professional questions are standing, such as what shortcomings [there are]... I will say to representatives [of pharmacy groups], let us work according to the law. Give us the chance to work according to the law in realizing pharmaceutical production.
Sergei Kolesnikov, Russian Academy of Sciences
© RIA Novosti. / Alexander Natruskin
Sergei Kolesnikov
Over many years, we have successfully passed an article on the theft of intellectual property. Intellectual property theft with financial [repercussions] is a crime that may be punished with six years in prison, but there are lesser [penalties], fines or large administrative punishments. Besides that, unfortunately, no legislation has succeeded. We have nothing in legislation or in law about the circulation of medicines, no references to it, and practically nothing about it in the Criminal Code or the Administrative Code, except for a reference to an article on fraud, let's say. This despite the fact that by several articles... there is the possibility to bring [someone to justice] for causing death, because this is often not an effective medication, and a falsified medication kills a patient. This is already a threat to human life or an attempt on a human life.
Unfortunately, these have for the most part not been brought into circulation. In our country, the opposition is quite serious. This is the story with medicinal products, and we even have no law about them... Law 94 is corrupt, on purchases for government and municipal needs, services and goods, because recently, they have even taken out references to putting forward possible preliminary conditions to the conduct of tenders and purchases. It is not allowed to demand a credit agreement, a credit history, an agreement with the producer, etc....
This naturally leads to a very serious violation in purchases. And therefore, of course, why I'm drawing the public's attention today, I wanted the public to acknowledge and understand this, that this strikes at the health and the pocket of each of our citizens. And on the other hand, our lawmakers and executive authorities - those who make the decisions - they should finally understand that if we do not make steps forward, then we will not be able to fulfill that program of development of the medical and pharmaceutical industry, which we have noted for 2020.
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