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.”

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.

Access to new test for drug-resistant TB must be improved: WHO expert

A World Health Organization expert called for greater access to a new diagnostic tool for multidrug-resistant tuberculosis (MDR-TB) in the Western Pacific and southeast Asia.  The new diagnostic tool reduces the time needed to detect MDR-TB from eight weeks to two hours.

Drug-resistant TB emerges when patients fail to follow treatment regimens, take substandard drugs or stop treatment too early.  Patients with MDR-TB can then transmit the disease to others.

According to the WHO, there are 120,000 new cases of MDR-TB in the Western Pacific each year, which makes up 28 percent of the global caseload.  Combined with cases in southeast Asia, all MDR-TB cases in Asia make up 58 percent of the global caseload.

Number of drug-resistant TB cases, 2007

• India – 131,000
• China – 112,000
• Russia – 43,000
• Bangladesh – 15,000
• South Africa – 16,000

TB killed 1.8 million people across the world in 2008, or a person every 20 seconds. It is not only a scourge in poor countries but also in the West, where it has flared anew in the last 20 years because of AIDS, which weakens the immune system.

US releases IP enforcement strategy

Today, Vice President Joe Biden and Victoria Espinel, Intellectual Property Enforcement Coordinator, released the U.S. government’s official IP enforcement strategy.  The plan — developed following extensive public consultation — identifies 33 key action items to combat intellectual property infringement, both domestically and internationally.

Download the PDF to read the complete 2010 Joint Strategic Plan on Intellectual Property Enforcement.

The following are highlights from Vice President Joe Biden’s remarks, delivered today at the Eisenhower Executive Office Building:

Whether we’re talking about fake drugs that hurt instead of help the patient or knockoff car tires that fall apart at 65 miles an hour causing injury and death, counterfeits kill — counterfeits kill.  There’s a reason why they counterfeit, they don’t know how to do it in the first place.

But to state it very bluntly and obviously, piracy hurts.  It hurts our economy to the tune of billions — some argue tens of billions of dollars — in lost private sector profit and government revenue.  It hurts our health and safety, the health and safety — that’s why the FDA commissioner is here, in part.

Piracy is theft, clean and simple.  It’s nothing but theft.

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.