International treaty signed to combat growing counterfeit drug industry

According to a report by The Moscow Times, many European leaders have recently agreed to cooperate in the fight against counterfeit medicines:

Convention to Combat Fake Medicine Signed

(Moscow Times)  Russia, France, Germany and several other mostly European countries on Friday signed the first-ever international treaty to combat the growing multibillion-dollar counterfeit drugs industry.

The Council of Europe-sponsored Medicrime Convention, signed in Moscow, obliges signatory states to criminalize a broad range of activities that make possible the sale of fake medicines that harm patients and deprive legal producers of revenues.  The convention introduces minimum standards for the criminal law of the signatory countries, said Council of Europe media officer Estelle Steiner.

Ambassadors and diplomats of Austria, Finland, Italy, Israel, Iceland, Portugal, Switzerland and Ukraine have signed the treaty. It establishes as criminal offenses such activities as the manufacturing of counterfeit medical products (including equipment), their supply and offers to supply, trafficking and the falsification of related documents.

Many fake drugs contain an insufficient amount of active ingredients, which could cause fatal consequences for the patient.

According to the World Health Organization, counterfeit medical products represent between 6 percent and 20 percent of the market in some parts of Europe.

 

UN working group on counterfeit medicines – preliminary report

“The first priority for public health, and this is the priority for WHO, is to protect populations from the harm caused by poor-quality, unsafe medicines,” stated Dr. Chan, WHO’s Director General in a recent release.  ”The objective is to keep these harmful products off the market everywhere, but especially in the developing world.”

An intergovernmental working group focused on this issue has delivered its preliminary report on the World Health Organization’s future role in the fight against substandard and counterfeit medicines.

According to the initial report, the working group recommended that the WHO concentrate its efforts on substandard and SSFFC medical products in three areas: information and awareness creation; norms and standards; and providing technical support to countries.

mPedigree awarded $200,000 in Global Security Challenge

mPedigree was recently announced as the Best Security Start-up in 2010 by the Global Security Challenge.  mPedigree from Ghana is the first system in the world which enables consumers and patients to verify the authenticity of their medicines by sending a free text message of the unique, product-embossed codes.

Across the developing world, especially in West Africa, the issue of fake and counterfeit medication has become a huge problem – the WHO estimates that in many emerging markets, up to 30% of drugs are compromised. The growing sophistication of cheap graphic software and hardware kit means that packaging, including traditional security features such as holograms, can be perfectly replicated by even smalltime counterfeit operators making the need for a highly robust but economically feasible system urgent.

While being just as robust as emerging methods such as EMID and RFID, and far more secure than holograms, the mPedigree approach is widely accessible through basic text messaging, requires no specialist equipment or training, is free to access for consumers, and a fraction of the price of holograms, and RFID and EMID techniques.

mPedigree has been awarded $200,000 sponsored by the Technical Support Working Group of the US Department of Defense and mentorship from Advent Venture Partners.

Google and Microsoft help fight illegal internet pharmacies

Bloomberg reports that Google Inc. and Microsoft Corp. are helping to establish a nonprofit organization targeting illegal Internet pharmacies in support of Obama administration efforts.  The group is comprised of companies that serve as Internet choke points and was in response to a call from the administration for private efforts to police illegal pharmacies, said Victoria Espinel, the White House intellectual property enforcement coordinator.

Counterfeit drug sales account for about $75 billion in global sales, according to the National Association of Boards of Pharmacy. An estimated 1 percent to 2 percent of drugs in North America are counterfeit, according to the group’s website.

Companies participating in the effort include Yahoo! Inc., MasterCard Inc., Visa Inc., American Express Co., GoDaddy.com Inc., Neustar Inc., eNom Inc. and EBay Inc.’s Paypal Inc.

Booming trade in counterfeit medicines

An article in the November 2010 issue of The Lancet

According to Paul Newton, who is part of the Wellcome Trust-Mahost Hospital-Oxford Tropical Medicine Research Collaboration, “The main consequences (of counterfeit medicines)…are increased mortality and morbidity, endangering drug resistance and loss of medicine efficacy, loss of confidence in health systems and health workers, economic loss for patients, their families, health systems, and the producers and traders in good-quality medicines, adverse effects from incorrect active ingredients, a waste of enormous human efforts and financial outlay in the development and manufacture of medicines…”

Steve Allen, Senior Director of Pfizer Global Security, emphasised the importance of international collaboration among regulators, the pharmaceutical industry and political representatives, and thinks this strategy will have the best chances of tackling counterfeiting. “This is not just an issue for one company, it is not an issue for one country, it is an issue for all of us.”

Google vs. illegal online pharmacies

On its official blog, Google says that it has filed a civil lawsuit against advertisers it believes has deliberately broken its rules in regards to obtaining prescription medication.  Scores of online pharmacies have set up shop and offer to illegally sell prescription medication over the Internet.

In recent years, we have noticed a marked increase in the number of rogue pharmacies, as well an increasing sophistication in their methods. This has meant that despite our best efforts, a small percentage of pharma ads from these rogue companies is still appearing on Google.

Rogue pharmacies are bad for our users, for legitimate online pharmacies and for the entire e-commerce industry—so we are going to keep investing time and money to stop these kinds of harmful practices.

– Google blog posting

Last year, Google filed a similar lawsuit against “Google Money” scammers (source: Mashable.com). As Google continues to rise in importance to brands and companies, keeping its search results and advertisement sanitized remains crucial for maintaining Google’s reputation.

9 tons of counterfeit medicines seized: East Africa

Authorities have seized 9,072 kilograms (20,000 pounds) of counterfeit medicine and arrested 80 people suspected of illegal trafficking in six East African nations, Interpol said Thursday.  (source: CNN)

More than 300 premises were checked or raided in the two-month operation across Uganda, Burundi, Kenya, Rwanda, Tanzania and Zanzibar, according to a news release from the international police agency.

The confiscated loot included anti-malaria drugs, vaccines and antibiotics. There was also a significant quantity of government medicines diverted to illegal resale markets.

It was the third such seizure operation in as many years in East Africa, intended to curb the manufacture and distribution of counterfeit medical products.

The World Health Organization defines counterfeit drugs as “medicine, which is deliberately and fraudulently mislabelled with respect to identity and/or source.”  Counterfeiting can apply to both brand-name and generic products, and forged products may include those with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients, or with fake packaging, WHO says.

The United Nations agency created a global task force in 2006 to deal with the problem, which has been growing as international markets expand and become globalized and internet commerce has taken off.

The fake products can prove detrimental to public health efforts in disease-ridden countries and in worst-case scenarios can cause death, according to the WHO task force.

WHO reports progress in fight against drug-resistant malaria

Efforts to eliminate a drug-resistant strain of malaria near the Cambodian-Thai border have shown signs of success, according to the World Health Organization and local health officials. (reported by AFP)

The WHO warned early last year that the emergence of parasites resistant to artemisinin along the Cambodia-Thai border could “seriously undermine” efforts to bring the disease under control.

But initial results from the screening of 2,782 villagers in Cambodia’s Pailin province found only two cases of falciparum malaria, the deadliest type of the disease and the one in which resistance to artemisinin has emerged.

A malaria control project launched last year, has distributed more than half a million mosquito nets and trained and equipped more than 3,000 village malaria workers in diagnosis and treatment on both sides of the border.

The director of Cambodia’s National Centre for Malaria Control, said the results suggested the efforts are “significantly reducing the cases of malaria and could ultimately eliminate the resistant parasites from the area.”

New artemisinin-based medication has been largely credited in recent years for increasing recovery rates from the mosquito-transmitted disease that kills one million people a year, mostly in Africa.

Why innovation is sometimes just as important as invention for pharmaceutical patents

An interesting article on incremental innovation, invention, access to medicines and IP — from Global Health Progress.

The Asian Age recently discussed the dilemma around the language of the Indian Patents Act, which requires “significant” improvements or efficacy in existing medicines for them to become eligible for pharmaceutical patents.  Reporter Deepak Joshi discusses the role of “incremental innovation” in many breakthrough inventions, including medical improvements like the new generation of HIV/AIDS treatments.  Joshi adds that these improvements, while not groundbreaking, nevertheless play an important role in medical progress.  Below is an excerpt from this article.

“In India, however, the debate about incremental innovations has become an unsettling one, particularly in the pharmaceutical sector. Section 3(d) of the Indian Patents Act has a controversial clause calling for “significant” improvement or efficacy in an existing compound to become eligible for a patent. Who defines “significant” and how? The issue is left delightfully vague.

Why does India more or less bar incremental innovations? There is a popular misperception that incremental innovations are unnecessary and will only result in more expensive medicines. The first point is plain wrong and the second one only half true. Of the 325 drugs on the World Health Organisation’s essential medicines list, 95 per cent are off-patent. This means they will be freely available to any drug manufacturer even if incremental innovation results in a better version also being in the market.

It is another matter that some two billion people worldwide don’t have access to these 325 drugs. That is an issue of access and health infrastructure. Patents and the presence or absence of incremental innovations have nothing to do with it. Look at it another way, if a large number of people across the planet don’t have black and white televisions, should the government stop attempts to develop and produce high-end plasma televisions? It may sound ridiculous, but that analogy holds true for the pharmaceutical industry.”

Read the full The Asian Age article here.

Customs groups commit to fight counterfeit drug industry

Counterfeit drugs have become a $200-billion-a-year industry and the 176-nation World Customs Organisation (WCO) will sign a declaration later this month to fight the scourge, an official said on Thursday (Source:  Reuters).

Fake or substandard versions of medicines are often hidden in cargoes sent on circuitous routes to mask their country of origin. “We have more fakes than real drugs in the market,” said Christophe Zimmermann, the WCO’s anti-counterfeiting and piracy coordinator. “In 2007-2008 alone, it rose 596 percent.”

The World Trade Organisation says fake anti-malaria drugs kill 100,000 Africans a year and the black market deprives governments of 2.5-5 percent of their revenue.

The Brussels-based WCO represents customs operations globally and has joined with former French president’s Jacques Chirac’s foundation to raise awareness at upper echelons to curtail the illicit industry.

Fake medicines often contain the wrong or toxic ingredients and pose a growing health threat worldwide, especially in poor countries where drugs are sold to treat conditions such as malaria, tuberculosis and HIV.

“If these subjects are not dealt with and strong action not taken, they will be a source of conflict,” said Catherine Joubert, director general of the Fondation Chirac, adding that so far 30 groups had signed the declaration.

In a sign Europe is taking the issue seriously too, justice ministers on the Council of Europe are set to ratify a convention on counterfeit medicines in Istanbul this November.