Caution: The Rising Price of Fake Drugs

By: Alan Clock, Senior Vice President, XStream Systems, Inc.

The following is a re-post of a Secure Pharma Chain opinion blog from 2010:

Industry security experts are noticing a significant trend in the illegal counterfeit medication trade and unfortunately it does not bode well for the unsuspecting consumer.

Apparently the sophisticated drug counterfeiter is realizing that as the consumer and supply chain becomes more aware of this deadly crime, they must be more clever in marketing their wares publicly.

With the Internet and its anonymity the counterfeiter has been able to market directly to the supply chain and consumer. In the past all they had to do was to offer their bogus goods online at a dramatically lower price than the genuine product and they would automatically have a ready supply of buyers.

Today as the consumer becomes more aware of the exploding issue of fake medications they are heeding the buyer beware mantra of "if a deal is too good to be true, it probably is" and avoiding nefarious deals.

Naturally the smart counterfeiter is now raising his price, just enough to appear as if it is a dramatically discounted, genuine product but not too good to appear to be "too good to be true" to the end user.

The perfect, high margin crime of pharmaceutical counterfeiting is becoming even more lucrative.

Now more than ever, the pharmaceutical supply chain needs to protect itself by deploying a variety of safeguards and technologies to make certain that products that flow through their inventories are authentic and safe. Consumers need to be very diligent and cautious to make certain that they are buying their medications from a reliable and trusted pharmacy and not from sources that do not require prescriptions from your personal physician.

As it relates to your medications, "buyer beware" not only means protecting your pocketbook but protecting your health and well being as well.


To learn more about pharmaceutical anti-counterfeiting technologies, visit: http://www.xstreamsystems.net/.

Court Told of Multi-Million Pound Medicines Scam

“This is considered the most serious breach of medicine control, the importation of counterfeit medicines into the system,”

The Tuesday, December 7th edition of the Bath Chronicle reports on the court case of five accused of a multi-million pound pharmaceutical plot involving bogus Chinese-manufactured life-saving drugs.

According to the Bath Chronicle story:

• A jury was told the people behind Europe’s biggest ever scam of its kind were motivated by “pure greed.”

• The court was told that as a result of the scam, medicine watchdogs ordered a recall of all suspected drugs – taken by heart and cancer patients and people with mental health problems – resulting in shelves being cleared in pharmacies all over the country.

• “They were prepared to make profits by feeding duff drugs to people with serious illnesses, prostrate cancer, heart disease and psychiatric issues,” prosecutor Andrew Marshall told Croydon Crown Court.

• All five have pleaded not guilty to conspiring between January 1, 2006 and June 30, 2007 together and with others to defraud pharmaceutical wholesalers, pharmacists, the public and holders of intellectual property rights in pharmaceuticals by dishonestly distributing for gain counterfeit medicines.

• Charges were brought following a two-year investigation by the Medicines and Health Care Products Regulatory Agency, part of the Department of Health, into Consolidated Medical Supplies Ltd.

• The company, of Unit 14, Sherrington Way, Lister Road, Industrial Estate, Basingstoke, had its wholesale dealer’s licence revoked by the agency on January 8, 2008.

• “This is considered the most serious breach of medicine control, the importation of counterfeit medicines into the system,” Mr Marshall told the jury.

• “The most serious in the European Union, with far-reaching effects for pharmaceutical companies, patients and the confidence of the general public.

• “The purpose is just greed. To obtain the profits of buying illegal goods cheaply.”

• The charges relate to ‘Casodex‘, used to treat advanced prostate cancer, ‘Plavix‘, a drug prescribed to prevent blood clots and prevent heart attacks for angina patients and ‘Zyprexa’ a anti-psychotic drug prescribed to schizophrenic and bipolar patients.

• “They are just importing danger,” Mr Marshall told the jury. “The drugs imported are not extensively and expensively tested, but instead have been smuggled into the EU and distributed regardless of their chemical qualities.”

• The drugs were said to be manufactured by a notorious Chinese pharmaceutical counterfeiter currently serving a prison sentence for a similar scam in the United States.

• “No one pretended these were cheap counterfeits, they were pretended to be real. These men are not a charity importing cheaper drugs, it is I am afraid, pure greed in order to make money, working totally outside the system.

Hopefully the pharmaceutical supply chain and consumers will use this story to educate themselves about the danger that counterfeit drugs pose, even in sophisticated health care delivery systems within developed nations.

There are bad guys everywhere that realize that huge profits with little risk are involved in the sale of bogus medications.

Secure Pharma Chain encourages all within the regulatory and supply chain to take measures to protect their constituents from fraudulent, adulterated, sub-standard and counterfeit medications.

To read the Bath Chronicle article, visit: http://www.thisisbath.co.uk/health/Court-told-multi-million-pound-medicines-scam/article-2976972-detail/article.html

To learn more about anti-counterfeiting technologies, visit: http://www.xstreamsystems.net/

11% of Ghana's Children Under 5 Die - More Can Live if Counterfeit Drugs are Reduced

Ghanaian religious leaders committed to decreasing child mortality rates decried counterfeit drug purveyors at the 8th Annual National Catholic Health Services Conference.

In a post that appeared on-line at SafeMedicines, the 8th National Catholic Health Services Conference (NCHS) Annual Conference met in October to discuss “Monitoring for Continuous Improvement: Using Whole System Measures”.

The NCHS annual conference was instituted to create a forum for Catholic Church health institutions to share common and peculiar concerns and experiences.

According to the SafeMedicines' post:

• Ghana’s children suffer 110 deaths for each 1000 children under five years of age, or 11%. One of the most common sources of mortality is malaria. Anti-malarial drugs are among the most common counterfeited in Africa and Southeast Asia where malaria is pervasive.

• The Most Reverend Joseph Afrifa-Agyekum Chairman for Catholic Health Services argued that purveyors of dangerous counterfeit drugs take advantage of unsuspecting people who buy their fake medicines. He said drug counterfeiters take advantage of countries where regulations and law enforcement on drug safety are limited to exploit them and indicated that developing countries where regulatory and enforcement agencies are poorly underfunded and understaffed are a haven for the distribution of fake drugs.

• He (Afrifa-Agyekum) then went on to ask the government of Ghana to take action through the Food and Drugs Board, the Ministry of Health, regulatory bodies and security agencies against the threat of counterfeit medications, stressing that the Catholic Church was committed to working alongside the government.

• According to the source, Upper East Regional Minister Mark Woyongo praised Afrifa-Agyekum and the Catholic Church for their involvement in and aid for the fight against counterfeit drugs.

This story is a cautionary tale and a wake up to those within developed countries. Counterfeit products, specifically medications are not a victimless crime. Fraudulent, adulterated, sub-standard and counterfeit drugs have far reaching implications to entire populations. Drug resistant strains of diseases know no borders nor do they differentiate between the rich and poor.

This crime of counterfeit drugs has the potential to create heath care epidemics and deadly disasters and is one of the largest criminal and health issues of the 21st century.

To read the entire SafeMedicines post, visit: http://www.safemedicines.org/

To learn more about anti-counterfeiting technologies, visit: http://www.xstreamsystems.net/.

Officials Investigating Fake Avastin Production

Chinese health officials and police are investigating a pharmaceutical plant, Cancer Center, hospital employees and pharmaceutical dealers for the use and production of fake Avastin that harmed 61 patients last month.

Caj Wenjun in the October 23rd edition of the Shanghai Daily reports on the Chinese State Food and Drug Administration (SDFA) and the Shanghai Public Security Bureau investigating a Beijing pharmaceutical plant for allegedly producing a counterfeit version of the drug Avastin.

The fake Avastin caused eye infections in 61 patients at the Shanghai No. 1 People's Hospital last month according to officials from the Shanghai Health Bureau.

Shanghai No. 1 People’s Hospital illegally treated patients with Avastin on people with eye complaints, though its key component is believed to have a positive effect on some eye conditions, it is only officially approved for treatment of certain cancer conditions.

Roche, Avastin's producer, said the drug is only approved for colorectal cancer treatment in China. It is used in the treatment of five types of cancer in the United States, but is not permitted for use on eyes.

Avastin was not officially approved for use for colorectal cancer until October 22nd nearly a month after the incident at the hospital.

According to the Shanghai Daily story:

• Local police will also investigate the Avastin case.

• The Shanghai Ruijin-AmMed Cancer Center is under suspicion as it allegedly purchased the bogus Avastin and sold it on to hospitals.

• Several employees at the cancer center, along with some pharmaceutical dealers, have been detained. The relevant head of Shanghai No.1 People's Hospital will be charged with poor management and negligence, said health bureau officials.

• Only three patients from the case remain in the hospital. Many of those discharged have received compensation.

This incident features many culprits and plenty of criminal activity. The production of dangerous fake medications, dealing in counterfeit drugs and unofficial medical treatment to name just a few.

In this incident, each member of the supply chain perpetrated some level of criminal, fraudulent and unethical behavior with the consumers suffering serious injury.

It is critical for all members of the global pharmaceutical supply chain to protect their inventories by deploying best practices, solutions and technologies to authenticate and verify the efficacy of the products that flow through their operations.

To read the entire Shanghai Daily article, visit: http://www.shanghaidaily.com/article/?id=452464&type=Metro#ixzz13SEBnJZr

To learn more about pharmaceutical anti-counterfeiting technologies, visit: http://www.xstreamsystems.net/.

Havocscope: Counterfeit Pharmaceutical Drugs Is The Top Black Market Activity Eclipsing Prostitution

Counterfeit Pharmaceutical Drugs are estimated to be valued at $200B per year, significantly eclipsing previous estimates and valued at over $12B more than the second most prevelant black market activity, prostitution.

Havocscope is an independent data and information provider of black market activities around the world.

The rankings by Havocscope are based on monitoring information from public sources including newspaper articles, academic journals, governmental data, non-governmental reports and press releases from relevant institutions.

Havocscope is the global leader in providing information on illicit activities worldwide and has been published and cited in a variety of well known mainstream publications globally.

The $200B annual black market value notably outpaces the previously accepted World Health Organizations 2010 estimate value of counterfeit drugs at $75B and easily outpaces by any single illicit drug black market activity like marijuana, cocaine or heroin.

Hopefully government officials, law enforcement, industry experts, health care professionals and most importantly consumers take note of this suprising statistic and activity.

The deadly crime of pharmaceutical fraud, adulteration and counterfeiting should be taken seriously by populations everywhere because the victims of this black market activity are unaware of the criminal act.

Certainly this data reflects a radical difference in public perceptions regarding counterfeiting and black market activity in general.

Havoscope ranks the United States as the number one market in the world for counterfeit good sales, followed by China, Spain, Mexico, Italy, Japan, Canada, United Kingdom, Russia and Germany.

The following is Havocscope’s Top 54 Black Market Activities and their annual value:

1. Counterfeit Pharmaceutical Drugs $200 Billion
2. Prostitution $187.67 Billion
3. Marijuana $141.80 Billion
4. Counterfeit Electronics $100 Billion
5. Cocaine $88 Billion
6. Opium and Heroin $65 Billion
7. Prescription Drugs $64.82 Billion
8. Web Video Piracy $60 Billion
9. Software Piracy $51.4 Billion
10. Cigarette Smuggling $50 Billion
11. Human Trafficking $32 Billion
12. Amphetamines $28.25 Billion
13. Illegal Fishing $23 Billion
14. Human Smuggling $20 Billion
15. Wildlife and Animal Smuggling $20 Billion
16. Movie Piracy $20 Billion
17. Ecstasy $16.07 Billion
18. Counterfeit Auto Parts $16 Billion
19. Illegal Logging $15 Billion
20. Gas and Oil Smuggling $12.75 Billion
21. Music Piracy $12.5 Billion
22. Counterfeit Clothing $12 Billion
23. Counterfeit Shoes $12 Billion
24. Trash Smuggling $11 Billion
25. Art and Antique Smuggling $10 Billion
26. Cable Piracy $8.5 Billion
27. Counterfeit Medical Devices $7 Billion
28. Counterfeit Sports Goods and Memorabilia $6.5 Billion
29. Counterfeit Cigarettes $4 Billion
30. Video Game Piracy $3.5 Billion
31. Mobile Entertainment Piracy $3.4 Billion
32. Alcohol Smuggling $3.2 Billion
33. Counterfeit Cosmetics 3.0 Billion
34. Counterfeit Money Orders and Checks $2.5 Billion
35. Counterfeit Toys $2.23 Billion
36. Counterfeit Airline Parts $2 Billion
37. Counterfeit Small Arms $1.8 Billion
38. International Adoptions $1.3 Billion
39. Counterfeit Alcohol $1 Billion
40. Counterfeit Watches $1 Billion
41. Counterfeit Credit and Debit Cards $0.82 Billion ($825.05 Million)
42. Counterfeit Pesticides $0.735 Billion ($735 Million)
43. Book Piracy $0.6 Billion ($600 Million)
44. Kidnap and Ransom $0.5 Billion ($500 Million)
45. Diamond Smuggling $0.28 Billion ($280 Million)
46. Arms Trafficking $0.245 Billion ($245 Million)
47. Counterfeit Currency $0.182 Billion ($182 Million)
48. Nuclear Smuggling $0.1 Billion ($100 Million)
49. Counterfeit Cuban Cigars $0.1 Billion ($100 Million)
50. Organ Trafficking $0.075 Billion ($75 Million)
51. Counterfeit Purses $0.07 Billion ($70 Million)
52. Counterfeit Lighters $0.042 Billion ($42 Million)
53. Counterfeit Batteries$ 0.023 Billion ($23 Million)
54. Body Parts and Human Tissue $0.006 Billion ($6 Million)

To read the Havocscope online post, visit: http://www.havocscope.com/ranking/products.

To learn more about pharmaceutical anti-counterfeiting technologies: www.xstreamsystems.net.

Chinese Hospital Pays Patients Hurt By Fake Eye Drug

The Shanghai No. 1 People's Hospital, where a fake drug caused eye infections in 61 out of 116 patients, has paid compensation to recently discharged patients.

As reported in the September 15th issue of the Shanghai Daily, a payout was made by the hospital to patients that were treated with a counterfeit of Roche's drug Avastin that developed complications due to the medication.

Tests by Shanghai officials and Roche confirmed the drug was fake.

According to the Shanghai Daily:

• The minimum paid was 2,000 yuan (US$299), although some patients discharged early this month were not compensated.

• The 61 patients were among 116 people who received the medicine at Shanghai No. 1 People's Hospital on September 6 and 8.

• After the injections, the patients reported eye inflammations and poor vision and were quickly hospitalized. Seventeen patients with severe reactions underwent surgery. The rest received injections to treat the infections.

The issue of fraudulent, adulterated, substandard and counterfeit medications continues to grow and impact the legitimate supply chains and professionally provided health care.

When health care consumers cannot reliably depend upon medication treatment made by health care professionals to be safe and efficacious the entire population suffers.

All members of the global pharmaceutical supply chain need to deploy solutions and technologies to protect their inventories and health care consumers.

To read the article, visit: http://www.shanghaidaily.com/article/?id=450218&type=Metro#ixzz10vZKjmk1.

To learn more about pharmaceutical anti-counterfeiting technologies, visit: http://www.xstreamsystems.net/.

Chinese Counterfeit Cancer Drugs Impact Consumers and Pharmaceutical Firms

While counterfeit pharmaceuticals have been prevalent in China for many years, China’s food and drug regulatory system has once again drawn attention to itself with the recent discovery that large amounts of fake anti-cancer drugs are flooding the market.

In an article written by Michelle Yu of the Epoch Times from June 22nd, Ms. Yu outlines yet another counterfeit drug scandal involving bogus cancer drugs that seem to permeate within China.

According to Ms. Yu’s Epoch Times article:

· Chinese authorities announced on June 12 that a Chinese-American person with a surname of Ding, along with three accomplices, had been arrested for manufacturing and selling fake anti-cancer drugs valued at US$4.4 million.

· Ding, 47, became an American citizen in 2003 after completing his postdoctoral studies abroad. He started selling counterfeit drugs in 2008, while serving as a general manager of a Hangzhou-based biopharmaceutical company.

· The counterfeits were sold through the Internet at one-tenth the price of the genuine products, which average around US$3,000 per bottle. The bogus anti-cancer drugs had been sold throughout at least eight provinces.

· The major counterfeited brands included Norvatis' leukemia drug Gleevec, Bayer's kidney cancer drug Nexavar, Astrazeneca's lung cancer drug Iressa, and Genentech's lung cancer drug Tarceva.

· There is speculation that Ding’s counterfeits account for only a small portion of the fake cancer drugs manufactured and sold in China and abroad.

· A spokeswoman for the Shanghai branch of the U.S.-based SciClone Pharmaceutical International drug company said that more than 20 percent of the company’s anti-cancer drug Thymosin Alpha-1 is counterfeit in the Chinese market, according to a May 26 report by China’s Southern Weekly. She added that counterfeits were found in government-owned drug stores.

Ms. Yu humanizes the scandal by telling the story of some of the victims of this counterfeit drug scandal:

· Among those that have been victimized by the counterfeits is Nanjing resident Geng, who spent thousands of dollars on Thymosin before realizing that the medication was having no effect. Geng purchased his medication from a state-certified drug store, Xinte.

· Tests conducted on the medication concluded the lot was counterfeit. Two members of Geng’s family who also took the counterfeit drug have since passed away.

· The same store’s stock supply of Alimta was also proven to be counterfeit by tests conducted by the brand’s manufacturer, Lilly LLC.

· Although pharmaceutical companies have reported these issues to China’s State Food and Drug Administration (SFDA), the agency has a history of being lenient on distributors of the fake drug products.

The Epoch Times story includes the deep seeded issue of official corruption that continues to feed these deadly criminal acts:

· The SciClone Pharmaceutical spokeswoman said she traveled to Nanjing for the Xinte drugstore case. The company issued a written testimony against the distributor of the bogus medication, but the local SFDA witnesses claimed that the samples collected from the drugstore were, in fact, authentic.

· Shortly afterward, the drugstore’s license—which had been revoked—was reinstated, after the wife of the former store owner registered for a new license and subsequently reopened the store. Her husband has not been indicted or punished.

· Eight different pharmaceutical companies, including SciClone Pharmaceutical and Lilly, have consulted with Nanjing SFDA officials and also reported the case to higher authorities.

· Former head of the SFDA Zheng Xiaoyu was executed in 2007 after being accused by the state of taking bribes to license bogus drugs.

· Chinese citizens have been quick to point the finger at the corruption and inertia of the drug regulatory authorities.

With a country’s regulatory agency either unable or unwilling to combat the deadly crime of counterfeiting drugs it is incumbent upon the industry’s supply chain to protect their individual brands, the supply chain as a whole and their consumer from nefarious entities bent on destroying lives and businesses for profit alone.

Secure Pharma Chain Blog endorses that individual members of the supply chain utilize technology to combat the criminal act of fraudulent, adulterated and counterfeit drugs, specifically solutions that allow the user to authenticate that the material that they have within their inventories is safe and efficacious for the consumer.

To read the entire Epoch Times article, visit:

http://www.theepochtimes.com/n2/content/view/37824/

To learn more about anti-counterfeit authentication technologies, visit: http://www.xstreamsystems.net/.

AP: Chinese Drug Regulator Fired For Suspected Violations

The Associated Press is reporting that Zhang Jingli, the "deputy head of China's food and drug regulator, is being investigated and has been dismissed from his post, a state news agency said Sunday, citing an anti-corruption agency."

Xinhua, a state news agency, "cited the Communist Party of China Central Commission for Discipline Inspection, an anti-corruption body, in a brief report that offered no details on what the suspected violations were."

Highlights of the Associated Press story include:

· The move comes three years after the former chief of the drug agency was executed after a bribe-taking scandal in which several deaths were blamed on medicines the agency approved.

· Zhang Jingli, deputy director of the State Food and Drug Administration is under investigation for suspected "serious disciplinary violations," the official Xinhua News Agency said. The term is a standard party reference for graft and abuse of power.

· In 2007, Zheng Xiaoyu, the former head of the drug and food watchdog was executed after he was convicted of taking bribes to approve flawed medicine blamed for several deaths.

· Zheng was sentenced to death for taking bribes to approve an antibiotic blamed for at least 10 deaths and other substandard medicines.

· China said in April it would step up monitoring of a faulty rabies vaccine that was recalled last year but could have still been on the market. It was the latest in a series of quality problems in China in recent years, including tainted infant formula and other milk products that sickened children.

· China's pharmaceutical industry is lucrative but often poorly regulated. Local manufacturers and other players along the drug supply chain have been blamed in recent years for deaths linked to counterfeit or shoddy medications at home and abroad.

To read the entire Associated Press story: http://www.google.com/hostednews/ap/article/ALeqM5gHqNTMIPOepIIcWUsEuBqru23vrAD9GA86VG0

Given all of the issues with fraudulent, adulterated and counterfeit medications that have emanated from China internal regulatory scrutiny seems a very wise course of action.

Secure Pharma Chain Blog endorses all within the pharmaceutical supply chain to protect their receivables and inventories by deploying authentication technologies which allow for their validation within their unit-of-sale container.

To learn more about pharmaceutical authentication technologies, visit: http://www.xstreamsystems.net/.

Smithsonian.com: The Fatal Consequences of Counterfeit Drugs

In an excellent article written by Andrew Marshall, which appeared in the October 2009 issue of Smithsonian magazine, he discusses the very real and deadly impact that counterfeit drugs are making on the underdeveloped countries of Asia.

In his article, Marshall chronicles the issue, its causes and ways that officials are working to identify the perpetrators of this crime that is killing hundreds of thousands each year.

Various forensic technologies are currently being used in these areas but there are seemingly few interdiction solutions available to those in underdeveloped countries to catch these scurrilous fakes.

Currently there are various authentication technologies available which allow regulatory agencies, government officials and private industry to effectively identify and interdict fraudulent, adulterated, sub potent and counterfeit medications including EDXRD which allows the testing inside a products unit-of-sale container.

To view Andrew Marshall’s article, visit: www.smithsonianmag.com.

To learn more about EDXRD as a solution to counterfeit medications, visit: www.xstreamsystems.net.

Daily Times: Government to Investigate Reports of Counterfeit Drugs Supplied to Hospitals

Pakistan’s Daily Times reported on September 12th about the Senate Standing Committee on Health’s concern over reports of counterfeit medications being supplied to Pakistan’s government hospitals. The Committee has called for a full report from Director General Rasheed Jumma on this issue.

Also mentioned by the Senate Committee was their concern over the importation of over 1,000 Chinese medicines, including critical lifesaving medications and their direction to the Health Ministry for a complete review of their imported medicines’ registration.

To view the entire Daily Times story, link to: http://www.dailytimes.com.pk/default.asp?page=2009\09\12\story_12-9-2009_pg11_6

Drug Counterfeiting Burden Remains a Guess, Experts Say

In the July 15 edition of AJHP News, Kate Traynor writes an excellent article regarding the proliferation of counterfeit medications and experts opinions on the solid data as to the scope of the problem.

This article highlights the difficulties in sizing and dealing with this ever growing healthcare issue. XStream Systems believes that its XT250 Materials Identification technology, which allows the user to screen and verify the contents of a medication inside its unit of sale container, will be a significant contributor to both understanding the scope and defeating counterfeit medications within the supply chain.

In this article Traynor includes quotes and statistics from government and industry experts including Ilsa Bernstein from the FDA, World Health Organization, IMPACT, Patrick Ford from Pfizer and Jeffery Gren from the Office of Health and Consumer Goods at the U.S. Department of Commerce.

Several of the quotes from the article include:

• FDA’s Ilsa Bernstein from a June 10th seminar on fake medicines, "People are always asking us for numbers of how many counterfeits are in the Unites States," said Ilisa Bernstein, director of pharmacy affairs in FDA's Office of the Commissioner. "We have no idea what the prevalence of counterfeiting is in the United States."


• Patrick Ford, Senior Director of Global Security at Pfizer, Ford said Pfizer last year seized more than 11 million counterfeit tablets, capsules, and vials masquerading as trademarked Pfizer products, including more than 2 million units seized in the Americas. Despite the company's actions, Ford said, there likely remain "a lot of patients that took these products and didn't even know that they were counterfeit."


• Jeffrey Gren, Director of the Office of Health and Consumer Goods at the U.S. Department of Commerce, said “The profit levels in counterfeiting are enormous and much greater than narcotics, and...The penalties are significantly less," Gren said. In addition, he said, the Internet has provided "an easy and lucrative way" for counterfeiters to distribute their products. Gren said that although some counterfeiters run fly-by-night operations, others have sophisticated factories capable of making medications that are difficult to visually distinguish from legitimate products.
  

To read the article in its entirety connect to the link below:
http://www.ashp.org/import/news/HealthSystemPharmacyNews/newsarticle.aspx?id=3115

Counterfeit Drug Definition Absent from Agenda of WHO Executive Board Meeting

Currently the World Health Organization definition of a counterfeit medication definition reads as:

"A counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient (inadequate quantities of) active ingredient(s) or with fake packaging."

Once again, bowing to pressure from some member countries, the WHO's Executive Board has left the important issue of counterfeit medication definition off the agenda for its meeting in January 2010 because of controversy surrounding the definition of counterfeit medication.
The WHO contends that a strong, consistent definition of counterfeit is necessary in order to develop global strategies to combat the problem and has been engaged for some time in developing a standard definition that all member countries can agree on.

At the heart of the definition’s continued delay is the objection from countries like India and Brazil over the use of the term "counterfeit" and the contention that it will cause some legitimate generics manufactured in these countries to come under the WHO definition. Essentially these countries believe that drug manufacturers that own international intellectual property rights for medications will use the WHO definition as a legal tool against drug manufacturers in their countries which produce generic medications that may infringe on the intellectual property of companies globally.

These countries are delaying the issue within the Executive Board and continue to ask for a revised definition which would be more specific to falsified or substandard medicines.

The WHO is now hoping that this issue will be discussed at the 2010 World Health Assembly in May.

Although a definition seems trivial and simple to some, this is an important step forward in combating an important healthcare issue that impacts everyone globally. Without this definition, it is difficult for regulatory and law enforcement agencies to collaboratively and comprehensively work together on attacking counterfeit medications at their source. Basic agreement on what is or is not a counterfeit allows unscrupulous organizations and individuals the ability to usurp legal loopholes and to operate, hide and spread their dangerous wares throughout the globe.