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.

 

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.

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.

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.

63rd World Health Assembly – outcomes and resolutions

The 63rd World Health Assembly concluded at the end of last week, with delegates adopting proposed resolutions on a number of global health issues, including:

Counterfeit medical products
The World Health Assembly resolved that the WHO should convene an intergovernmental working group on counterfeit medical products, participation in which is to be open to all Member States.

This group will examine WHO’s:

• role in ensuring availability of good-quality, safe, efficacious and affordable medicines
• relationship with the International Medical Products Anti-Counterfeiting Taskforce (IMPACT)
• role in prevention and control of substandard/spurious/falsely-labelled/falsified/counterfeit medical products.

The group’s mandate is to focus on public health issues only – IP and trade issues will not be considered. Recommendations will be presented at the 64th World Health Assembly, in 2011.

Treatment and prevention of pneumonia
WHO Member States adopted a resolution on the treatment and prevention of pneumonia — the number one killer of children under five years globally. The resolution makes it clear that intensified efforts to address pneumonia are imperative if the achievement of Millennium Development Goal 4 is to be achieved.

Polio
On the topic of polio eradication, Member States welcomed the new Global Polio Eradication Initiative (GPEI) Strategic Plan 2010-2012, developed over the past 24 months at the request of the Assembly.  The delegates expressed serious concern that insufficient financing for the new Plan is compromising its full implementation, as US$1.3 billion is still needed for the period 2010-2012.

Global eradication of measles
Member States endorsed a series of interim targets set for 2015 as milestones towards the eventual global eradication of measles.  Success in achieving the measles 2015 targets is a key issue if the Millennium Development Goal 4 to reduce child mortality is to be reached.

Public health, innovation and intellectual property: global strategy and plan for action
A new consultative working group will examine the way to take this work forward and is expected to report back to the 65th Health Assembly in 2012.

Discussions on other global health issues at the 63rd WHA were summarized in a previous Patients and Patents posting.

Additional information on the resolutions is available at the World Health Organization site.

WHO – Counterfeit drugs on the rise, pose global threat

As reported yesterday by Reuters (Counterfeit drugs on rise, pose global threat: WHO), World Health Officials warned that the production and sale of counterfeit drugs is on the rise in rich and poor countries, with more unwary consumers buying them over the Internet.

The WHO experts added that fake or substandard versions of medicines are often hidden in cargos taking circuitous routes to mask their country of origin as part of criminal activity worth billions.

India’s Fake Drugs – commentary from the WSJ

The following is an interesting commentary published in yesterday’s Wall Street Journal on the threat to global health posed by counterfeit medicines.  Counterfeit medicines are a global problem, but this article focuses on India.

India’s Fake Drugs Are a Real Problem
Bad drugs don’t just threaten lives, they undermine the entire medical system

Opinion by Roger Bate

The Food and Drug Administration of the Indian State of Uttar Pradesh recently conducted a series of raids throughout its region to uncover counterfeit drugs. The raids yielded large quantities of substandard medicines and resulted in several arrests.

Patient safety and counterfeit medicines

Discussions around counterfeit medicines – and the definition thereof — are heating up again prior to the start of the World Health Assembly.  While this has become a contentious issue, all sides can agree that counterfeit medicines pose a global public health risk, leading to resistance to treatment, illness, disability and even death.

A series of principles on counterfeit medicines were recently released by IFPMA to refocus attention on this important public health issue.  Key points included:

• Medicine counterfeiting is first and foremost a crime against patients.
• Counterfeit medicines threaten the full spectrum of legitimate medicines.
• Government regulatory and enforcement authorities must be fully vested with the proper power and adequately resourced to fight counterfeits.
• Global cooperation is needed.
• The leadership of the World Health Organization is crucial.

Stopping the international trade in counterfeit medicines is vital.   As the leader on global health matters, and particularly with respect to threats to public health in developing countries, the World Health Organization has a key role to play.

The bottom line is that patients – in developed and developing countries – need to be protected.