Beware of Counterfeits

Topical News, Information and Details about Counterfeit Drugs

Medicine crime: Inconsistent European legislations

Every country has different laws pertaining medicine crimes. However, the differences can vary so vastly that prosecuting drug counterfeiters across borders can become a very challenging task. This is one of the results of ALPhA, a project funded by the German government (we reported previously on this). The final results were presented in Osnabrück, Germany, at a closing press conference.

“We are in desperate need for a harmonization of medicine laws”, legal scholar Arndt Sinn, from the University of Osnabrück, said to the press. He also criticized authorities for not cooperating closely enough. Former director of Europol, Jürgen Storbeck, urged the German government and authorities to develop a European strategy that takes product piracy and medicine crime more into account.

Furthermore, consumers should be made more aware of counterfeit drugs, experts said. Illegal online pharmacies increasingly are forged to take on the appearance of a legitimate store explained Marina Bloch, in-house counsel at Bayer AG. And counterfeit medicines available at these illegal pharmacies resemble their original counterparts so much that even experts have a hard time distinguishing them from real medication.

August 5, 2016
Sources: University of Osnabrück, DAZ

#CrossfingerChallenge: Social media campaign raises awareness on counterfeit drugs

Pharmaceutical students have created a social media campaign warning of the dangers of fake medicines worldwide. A big problem is the rising number of illegal online stores selling counterfeits to unsuspecting consumers. Even medicines – especially drugs with a shame-factor such as weight loss pills or those against erectile dysfunction – are being forged.

For the campaign, users simply take pictures of themselves crossing their fingers, thereby representing the chemical hazard symbol for irritant and harmful substances. These photos can then be posted on Facebook using the hashtag #CrossfingerChallenge.

The campaign was brought to life by the International Pharmaceutical Students’ Federation (IPSF). However, it is not restricted to pharmaceutical students alone – anybody can participate, says Sebastian Lehmann, German spokesperson of IPSF, in apotheke adhoc. Their goal is to reach as many people as possible.

March 21, 2016
Quellen: apotheke adhoc, IPSF

News-Archive 2015

New survey reveals: Germans trust their local pharmacies to protect them from counterfeit drugs

Counterfeit drugs do not seem to be an issue for most Germans. Eight of ten people consider their local pharmacy to be safe, according to a current survey performed by the consumer magazine “Apotheken Umschau”. Nearly 90 percent of the interviewees regard purchasing medicines at the pharmacy store as the safest way to protect themselves from fake drugs.

Furthermore, over half of the Germans polled trust in the efficiency of authorities and are convinced that most counterfeits are found through controls, making illegal trade with counterfeit drugs unattractive for criminals.

The survey was performed by GfK Marktforschung Nürnberg. A total of 2,077 women and men aged 14 and above participated.

November 16, 2015
Source: Apotheken Umschau


EU Falsified Medicines Directive: Draft of Delegated Acts on safety features published

The European Commission has now published its draft of Delegated Acts on safety features for medicinal packages. It is a key part of the Falsified Medicines Directive to protect consumers within the European Union (EU) from counterfeit drugs.

The document covers the technological and organizational requirements that medicinal packages will have to fulfill if they are to be marketed within the EU. One of these important features is going to be a unique identifier. The draft proposes the usage of a 2D bar code carrying a serial number, product code, batch number and expiry date.

Annexed to the draft are also two lists providing information on which medicines must bear all security measures, regardless of whether they are prescription or non-prescription drugs. A “white list” will include all medicines and medicine categories that will be exempted from requiring these safety features. Countries and organizations are able to submit medicines which they deem suitable for either the white or black list.

The text will be reviewed by the European Parliament and Council before it will be finalized and published in the Official Journal of the EU, which is expected to take place in the first quarter of 2016.

September 4, 2015
Sources: SecuringPharma, European Commission


Research project “ALPhA” to develop road map for legislation in the fight against counterfeit drugs

The internet provides a lucrative platform for the illegal trade with fake medicines. In many cases, the culprits cannot be apprehended because they live overseas. German law experts at the University of Osnabruck are seeking a solution to take down online trading with counterfeit drugs. Together with the help of national pharmacy associations and pharmaceutical companies such as Bayer, the ALPhA project seeks to study the effects caused by the liberalization of the internet trade in Europe, particularly in association with pharmaceutical crime.

Marina Bloch, lawyer and head of Bayer HealthCare’s Global Anti-Counterfeiting Management, says: “Our goal is to develop concrete recommendations for action by June 2016 to improve prosecution of internet-based pharmaceutical crime, and also create a broad data base to help legislators establish more effective standards.”

The research project, which is funded by the German Federal Ministry of Education and Research, was initiated by Professor Arndt Sinn, expert on European and International criminal law. “The legal space is completely in disarray, making prosecution virtually impossible”, he says regarding the current situation between the European countries. In a first step, he has collected all relevant passages in the criminal law of the respective countries. At the same time, criminologists have been establishing perpetrator profiles based on known cases and interviews with pharmacists, doctors, and consumers. Currently, the results are being analyzed.

In addition to developing a road map, the Fraunhofer Institute for Secure Information Technology is currently developing a technical solution, which will be also presented in June 2016.

August 19, 2015
Sources: Apotheke adhoc, Bayer


Bayer successful in legal action against international crime ring

The Regional Court in Potsdam, Germany, has convicted members of an international crime ring that was accused of counterfeiting medicines, in what is to be considered a landmark decision. The defendants were sentenced to up to more than six years of imprisonment. Altogether, more than 20 people were indicted. The crime ring was held responsible for counterfeiting medicines in different countries as well as re-packaging and selling them in Germany. This way, the ring generated revenue of 21 to 30 million Euros between the years 2008 and 2011. Among the drugs falsified by the counterfeiters was Bayer’s Levitra®.

Bayer was involved in the case as a joint plaintiff and has also claimed damages according to civil law. “We hope the victory before Potsdam Regional Court will serve as a deterrent in future cases. As an injured party, Bayer spares no effort in combating the illegal activities of criminal counterfeiters”, says Marina Bloch, lawyer and head of Bayer HealthCare’s Global Anti-Counterfeiting Management.

For many years, Bayer is committed to fighting counterfeit medicines. The new video “Counterfeits: How to protect yourself” found in the right column illustrates Bayer’s commitment.

June 24, 2015


Vienna: Crime ring indicted for counterfeiting drugs

Using the names and addresses of existing pharmacies, an international crime ring sent out fake medicines to unsuspecting consumers. They mainly sold prescription drugs against obesity and erectile dysfunction, such as Levitra. Currently, six members face trial at the regional court in Vienna, Austria. One of the defendants is a 37-year-old Israeli who was recruited by instigators in his home country and persuaded to move to Austria. Together with his older brother, his sister and her partner, as well as two friends, the group managed different bank accounts used for the illegal online pharmacies, and sent out the counterfeits by mail to consumers all over Europe.

Bayer HealthCare, too, is involved with this indictment, and has taken all possible legal measures to prosecute this case. Marina Bloch, lawyer and head of Bayer HealthCare’s Global Anti-Counterfeiting Management, says: “We want to protect patients from counterfeit drugs in the future, while punishing criminals accordingly.”

The fraud came to light when some of the parcels returned to the senders, due to insufficient stamps. One affected pharmacy in Vienna recognized the returned shipment to be a fake and contacted the authorities.

According to the indictment, more than 120,000 people were fooled into purchasing counterfeits tablets. The prosecution estimates a total damage of several million Euros.

March 11, 2015
Source: ORF


Counterfeit drugs: Organized crime groups are increasingly jumping on the bandwagon

Counterfeit drug trafficking is becoming more and more professionalized, with organized crime rings pulling the strings from the sidelines. This is the conclusion of a conference organized by Interpol in Dublin, Ireland. It provided the international community an ideal opportunity to set a roadmap for combating pharmaceutical crime.

In 2014, different medicines were stolen from Italian hospitals and delivery trucks (see article from May 13,2014). Investigations later revealed that the perpetrators possessed links to the Camorra organization. Aline Plançon, head of Interpol’s pharmaceutical crime unit, told Agence France-Presse (AFP): “You can see the Mafia people saw the opportunity to make money and they know that pharmaceutical crime is one of the good havens for them right now because of lack of legislation and the complexities of co-ordination in countries.” She therefore stressed the significance of the cooperation between law enforcement, health agencies, customs and the private sector, on a national, regional and global scale.

One such successful cooperation is Interpol’s operation “Pangea” which is executed globally every year. At this year’s operation, Pangea VII, a total of 113 countries and 300 agencies worked together, seizing more than 9.6 million illicit tablets and closing down nearly 12,000 websites selling counterfeit drugs. Another campaign targeted at consumers is #TurnBackCrime. Its website www.turnbackcrime.com provides detailed information on how to prevent purchasing counterfeit goods.

February 20, 2015
Sources: Interpol, Securing Pharma

News-Archive 2014

Anti-counterfeit campaign: FDA wants health care providers to “know their source”

The Food and Drug Administration (FDA) has launched its new educational program known as “Know Your Source” in the fight against counterfeit and unapproved drugs in the USA. The campaign is aimed at raising awareness among health care providers to keep a close eye on where and what they purchase from wholesale distributors.

By using e.g. flyers, the campaign urges those in charge of purchasing to check the labeling of the drugs, as well as be wary of price discounts that seem too good to be true. Also, doctors and nurses should take patient claims such as a sudden lack of therapeutic efficacy or newly experienced side-effects seriously and report them to the FDA.

The National Association of Boards of Pharmacy (NABP) has also referred to its own accreditation program, the VAWD® seal (verified-accredited wholesale distributors), which ensures the integrity of a distributor. The VAWD® seal exists since 2004 and is reviewed annually. It enables purchasers to immediately distinguish trustworthy wholesale distributors from dubious sellers.

November 17, 2014
Sources: Pharmacy Times, NABP


US courier service faces charges of supporting illegal online pharmacies

The Californian Department of Justice has indicted a big global courier service company for delivering controlled substances and prescription drugs to consumers who had purchased them through illegal online pharmacies. The prosecutors accuse the company of knowing the perpetrators as early as 2004, yet it never undertook any actions to prevent illegally purchased prescription drugs from being delivered. If convicted, the courier company faces a potential maximum fine of 1.6 billion US dollars.

“Illegal Internet pharmacies rely on illicit Internet shipping and distribution practices. Without intermediaries, the online pharmacies that sell counterfeit and other illegal drugs are limited in the harm they can do to consumers”, said Philip J. Walsky, Acting Director at the FDA’s Office of Criminal Investigations.

The courier service company denies the charges made by Drug Enforcement Administration (DEA), and Food and Drug Administration (FDA), claiming that it had regularly requested to receive a list of illegal online pharmacies, but had never received one. The DEA argues, however, that the company was informed of illegal activities right from the start. Instead of stopping business relations, the company even released a Sales policy to secure the privacy of their customers, which illegal pharmacies took advantage of, according to the prosecutors.

This indictment is the second that seeks to define how much responsibility courier services bear for the contents of the packages they deliver. Already in 2013, another US courier service was charged for a similar offense. The company had signed a nonprosecution agreement and was fined 40 million US dollars.

August 15, 2014
Sources: US Department of Justice, Wall Street Journal online


EU Customs report: Amount of counterfeit drugs takes a giant leap

The number of confiscated fake medicines at European customs has skyrocketed, according to the current customs report of the European Commission. In 2013, authorities have seized about 3.7 million counterfeit drugs, five times as much as the year before. Currently, counterfeit drugs make up about one tenth of all confiscated fake products.

The total number of counterfeits has, however, decreased. In 2012, custom officers had immobilized more than 40 million fake wares, in 2013 it was only 36 million. Most counterfeits were found in postal and courier packages. About one fifth of these goods were fake drugs.

Algirdas Šemeta, Commissioner for Taxation, Customs, Anti-fraud and Audit said: “Innovation and creativity is where Europe creates value. Protecting Intellectual Property Rights is not only important for health and safety of European consumers but also supports growth and job creation in the EU."

August 6, 2014
Source: European Commission


European logo certifies trustworthy online pharmacies

To protect European consumers from illegal websites, the European Commission has released a special logo that certifies trustworthy online pharmacies.

Tonio Borg, European Commissioner for Health, explains: “When buying medicines online, consumers must be aware that unless they buy from legally-operating online medicine suppliers, they run the risk of buying medicines that are falsified. Falsified medicines can be ineffective, harmful or even deadly.”

The logo depicts a white cross on four green and gray stripes. It will link to a list containing all certified online pharmacies that are managed by the respective national regulatory authority. All member states must therefore implement the new logo within one year. The regulation is expected to be in force within the next six weeks.

The European Commission provides images of the new logo on its website.

July 8, 2014
Source: European Commission


International “Pangea” operation strikes a blow against counterfeit drug smuggling

Once again, prosecuting authorities from all around the world have successfully taken action against drug counterfeiters. The “Pangea VII” operation, an international week of action from May 13 to 20, led to a total of 237 arrests and the seizure of 9.4 million counterfeit medicines worth 36 million US Dollars. Authorities confiscated about 20,000 postal packages. Additionally, they shut down more than 19,000 illegal medicine advertisements in social networks and more than 10,000 websites.

In the USA, the Food and Drug Administration (FDA) had seized 583 postal packages with suspected drug counterfeits. Among them were not only lifestyle medications such as diet pills or drugs against erectile dysfunction, but also medicines against diabetes and other diseases. “Consumers have little or no legal recourse if they experience a reaction to the unregulated medication or if they receive no therapeutic benefit at all”, said Douglas Steam, director of the FDA’s Office of Enforcement and Import Operations.

“Pangea” is an operation initiated by Interpol and is performed annually. During one week of action, prosecuting authorities all over the world specifically target illegal trading with counterfeit drugs. This year the operation took place for the seventh time, with a total of 111 countries participating.

June 5, 2014
Sources: US FDA, Interpol


Counterfeited drugs confiscated in EU

The European Medicines Agency (EMA) has reported that fake drugs from Italy have been discovered in countries of the European Union (EU). The counterfeits are expensive drugs used for cancer therapy and against rheumatism. Drugs produced by Bayer currently are not affected.

The counterfeiters had stolen vials with medication from different sources in Italy, including from distribution trucks and hospitals. They were then manipulated and re-labeled, before the highly organized crime ring tried to smuggle the medicines back into the legal chain of distribution. The manufacturers have recalled the affected batches to ensure patients’ safety. Currently, Italian authorities are investigating this matter.

According to EMA, only a small number of vials are affected and have not been delivered to pharmacies or hospitals. The Agency, however, has alerted healthcare practitioners to be wary of falsified medicines. In this case, for example, the batch number and expiry dates do not match the specifications on the outer package.

May 13, 2014
Sources: European Medicines Agency, Wall Street Journal


French customs seize containers full of counterfeit drugs

The French Customs have confiscated several million of fake drugs against headache and erectile dysfunction. A total of 2.4 million medicines were seized, however, no Bayer product is affected.

This haul is the largest in the European Union, according to the authorities. The counterfeits were stored in two containers which were labeled as “Tea from China”, but actually they carried 601 cartons full of fake drugs.

Already in 2013, French Customs at Le Havre had discovered a total of 1.2 million counterfeit drugs that were hidden in a shipment from China.

In France, fake medicines stand at the top of the list of confiscated goods. In 2013, French customs found a total of 7.6 million falsified goods, of which about 1.4 million (18 percent) were counterfeit drugs.

May 13, 2014
Sources: French Customs, SecuringPharma


EU experts develop guideline to secure drug supply chain in Europe

The European collaboration project “Pharmacrime” has introduced its third guideline to fight counterfeit drugs in the European Union (EU). During its Pharmacrime conference in March at the Interpol headquarters in Lyon, France, European experts finalized the Investigation Guide. This document has been specially developed for police and customs authorities and is aimed at preventing counterfeit medications from entering the legal drug supply chain in the EU. It will provide new tools for investigative officers, including a check list for customs, which encompasses all offenses listed in the Medicrime Convention database.

The Investigation Guide had been drafted over the course of 2013 and is the third guideline published by Pharmacrime. The first guideline focused on identifying counterfeit drugs on the market, whereas the second one particularly scrutinized illegal online vendors. In 2015, the network plans to establish a fourth guideline to raise awareness for counterfeit drugs among judiciary authorities such as judges and lawyers.

Pharmacrime is an informal collaboration between different European organizations such as Interpol, the French Institute of Research Against Counterfeit Medicines (IRACM), as well as national customs authorities and medicine agencies. It is coordinated by the Belgian International Association for European Cooperation on Justice and Home Affairs. The network focuses on investigating pharmaceutical crimes such as counterfeit medicines. One of their goals is to increase awareness of stakeholders within the EU, and to train enforcement and judicial authorities.

April 22, 2014
Sources: IRACM, Pharmacrime


FDA implements ten-year plan to make prescription drugs safer in the USA

The Food and Drug Administration (FDA) has introduced a measure plan to enhance the security of prescription drugs in the United States of America (USA) under the Drug Supply Chain Security Act. It is part of the Drug Quality and Security Act that was signed into law in November 2013. The plan mentions several key measures which will be implemented over the next ten years and which are similar to the established regulations of the European Falsified Medicine Directive.

One major improvement will be that manufacturers and repackagers will have to develop a unique identification system such as a bar code that will be placed on prescription drug packages. This should ease both identifying and tracing the product. If any member of the supply chain, i.e. manufacturer, wholesaler or dispenser, should find a suspect medicine, the FDA calls for an immediate immobilization and investigation to exclude the possibility of it being a counterfeit. If, however, the drug is verified to be a fake, the FDA has to be notified immediately so that further steps can be taken.

Another important step will be that contact information of licensed wholesale distributers for drugs will be entered into a public database. Transport or warehouse companies which are involved with medicines are also required to acquire a state or federal license to continue their businesses. A detailed description of their planned actions can be seen on their website (www.fda.gov)

April 01, 2014
Source: FDA


Europe agrees on new rules to bolster scope of action to tackle in-transit counterfeits

On February 25, 2014, the European Parliament (EP) has voted in favor of new rules which give European countries more power to fight in-transit counterfeits. Should this directive be implemented, member states of the European Union (EU) will have an easier hand at freezing and confiscating criminal assets.

Currently, national authorities in Europe are not allowed to confiscate counterfeits such as fake medicines if its destination is not within the EU. This was the result of a series of court cases in 2011, where it had been established that imitations of goods protected in the EU by intellectual property rights cannot be considered counterfeit or pirated simply because they are in-transit. The new rules now enable countries to pass laws that ease freezing and confiscating counterfeited products.

Businesses across Europe embraced the decision by the EP. “The new provisions will allow customs to stop trademark counterfeit goods even if destined to a country outside the EU,” a joint statement by several organizations such as the European Federation of Pharmaceutical Industries & Associations (EFPIA) says. “Likewise, these provisions ensure that genuine generic medicines will reach their final destination.”

The EP expects that the agreement will be formally approved by the Council in the coming weeks. EU member states will then be able to transpose the directive into new laws within 30 months.

March 06, 2014
Source: European Parliament, European Federation of Pharmaceutical Industries & Associations


Successful crackdown against drug counterfeiters in China

After a six-month nationwide crackdown on the sale of illegal medicine, Chinese authorities have arrested more than 1,300 suspects and closed down about 140 unlicensed websites and online drug stores, the Chinese Ministry of Public Security reports. The police has seized more than 300 million fake medicines and nine tons of raw materials, with a total value of 2.2 billion yuan (270 million Euro).

The ministry also reports that illegal online sellers often used deceptive advertisements to lure buyers into purchasing fake drugs by pretending to be a regular pharmacy or an official “factory outlet”. The counterfeits seized were mostly made of starch, spoiled raw material, as well as different kinds of psychedelic or poisonous substances.

The issue of counterfeit drugs has been a known problem to Chinese regulators for years. In the past, there had been several campaigns conducted to stop illegal activities. Even though the campaign was successful, the ministry warns consumers to purchase their medications only at trustworthy online pharmacies and to not be deceived by slogans such as “very effective” or “one-time solution”.

February 21, 2014
Source: Chinese Ministry of Public Security, Xinhuanet


Turkey busts counterfeit drug crime ring

In a special operation carried out by Istanbul police, Turkish authorities have raided an organized crime gang that had been selling counterfeit drugs in Turkey and abroad, according to the Turkish newspaper Hürriyet Daily News. A total of 56 suspects were arrested after the police took down 130 places in nine cities throughout the country.

The crime ring had been manufacturing around 30 different counterfeited versions of drugs, among them also medication used to treat cancer. The gang was mainly focusing on producing medication that is scarce in pharmacies. Also, five hospital workers who were allegedly acting as suppliers of the counterfeit drugs were taken into custody. The police suspect a further two doctors to be involved as well and are currently searching for them.

The counterfeit drugs were first detected by a nurse at the state-run Şişli Etfal Education and Research Hospital in Istanbul. She had noticed that the expiration date of the drug was listed as 2013 in the medicine database, however, the package had the year 2014 printed on it. She then sent the drug to the original manufacturer where it was identified to be counterfeit, containing poisonous chemicals. About 95 cancer patients had taken this counterfeit version of their cancer medication and experienced a worsening of their condition. The victims have now filed a formal complaint against the counterfeiters.

February 21, 2014
Source: Hürriyet Daily News

News-Archive 2013

“Fight the Fakes” – A global campaign raises awareness about dangers of fake medicines

Fake medicines increasingly put patients and the general public at risk across the world. In order to raise awareness about the dangers of fake medicines, ten international health organizations have joined forces and established the global campaign „Fight the Fakes“. Amongst them are the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), which is also supported by Bayer, healthcare professionals, foundations and disease-specific organizations. On their website www.fightthefakes.org they inform about the negative impact that fake medicines have on people around the globe and give a voice to those who have been personally affected. Furthermore the website serves as a resource for organizations and individuals who want to support the campaign.

“Fake medicines are one of the biggest threats to global public health”, says Dr. Stephen Opuni, Chief Executive of the Ghana Food and Drugs Authority. “It’s a global problem and we all need to come on board in fighting together, and once we’re able to do that we are going to make some real strides globally in fighting counterfeit medicines.” It is reported that figures about sales of fake medicines rise to ten percent globally. In some areas of Asia, Africa and Latin America the number may increase up to 30 percent. On illegal Internet sites it is estimated that even one medicine in two purchased is fake. The partners believe that coordination among people involved in the manufacturing and distributing of medicines helps to tackle the threat. Organizations as well as private persons can join the campaign in order to ensure a broader education on the topic.

December 04, 2013
Source: Fight the Fakes www.fightthefakes.org


Interpol: 30 percent of drugs sold worldwide are counterfeit

According to the International Criminal Police Organization (Interpol), as much as 30 percent of the drugs sold worldwide are counterfeit, causing health problems and even death for millions of people. The most common drugs that are counterfeited are antibiotics, medication against HIV/AIDS and cancer, as well as lifestyle drugs such as weight-loss pills or treatments against erectile dysfunction. Interpol reports that more than 200,000 people die each year from counterfeited antiallergic drugs alone.

The World Health Organization estimates that about 50 percent of the fake drugs are sold online. Interpol’s coordinator of the Medical Products Counterfeiting and Pharmaceutical Crime (MPCPC) unit, Aline Plançon, said at an Interpol press conference in Cartagena, Colombia, that the internet provides an ideal platform for criminal organizations. “We are talking about powerful mafia structures that are earning billions of dollars with this crime”, she explained. Plançon presented at Interpol’s 82nd General Assembly current information on Interpol’s activities in the fight against counterfeit drugs, such as the recent worldwide operation Pandora VI.

November 19, 2013
Sources: InSightCrime.org Counterfeit Drugs Kill 1 Mn People Annually: Interpol, El Tiempo Un millón de personas mueren al año por medicamentos falsos: Interpol


European Commission: Fakes are “too good to be true”

The European Commission (EC) has introduced its “EU Stop Fakes” campaign to German media on October 15 at the headquarters of the German Federal Customs Investigation Office (Zollkriminalamt) in Cologne, Germany. The “EU Stop Fakes” campaign aims to promote awareness among consumers and support close cooperation between the EC and national authorities. For consumers, the EC has published the brochure “Too Good To Be True” which provides information about the risks and dangers of purchasing counterfeit products such as fake drugs.

At the press conference, EC Vice President Antonio Tajani called for more cooperation in the fight against counterfeits: “Counterfeiting is a serious threat to our economies. In a context of economic crisis, we must defend our business and firmly fight against counterfeiting for a decent, moral and fair society. When European and national authorities work together, we become stronger.”

The information brochure can be downloaded from the EC website at http://ec.europa.eu/commission_2010-2014/tajani/stop-fakes/index_en.htm

October 24, 2013
Source: European Commission www.ec.europa.eu


US Senate Committee passes bill to increase drug safety

The US Senate Committee on Health, Education, Labor, & Pensions has agreed on the “Drug Quality and Security Act”. The bill consists of two major changes in order to improve drug safety and reduce the risk of counterfeit drugs in the USA.

The legislation calls for a track-and-tracing system to prevent counterfeits from entering the supply chain. This system is to be implemented on a national scale and resolve the patchwork of current federal regulations. Currently, the USA has no tracking system for drugs, making it easy to introduce stolen or counterfeit drugs.

Furthermore, the Senate has agreed to tighten regulations for compounding pharmacies in an effort to prevent another public health crisis such as the 2012 meningitis outbreak due to tainted steroid injections. Originally, the “outsourcing facilities” were under surveillance of the FDA but were exempt from the full spectrum of regulations that apply to traditional pharmaceutical companies. The new bill removes this exemption. In future, the FDA will not only know which compounding pharmacies exist, but also which products they are making and receive adverse event reports on compounded drugs.

It is expected that this legislation will quickly pass through the full House and Senate.

October 10, 2013
Source: US Senate Committee on Health, Education, Labor, & Pensions


Current EU Customs report: Counterfeited drugs arrive mostly by mail

European customs have seized a total of 40 million counterfeited products worth nearly one billion Euros, according to a current report by the European Commission. Most of the illegal products were found in postal controls. About one fourth of the seized products were counterfeit drugs. The EU Commission believes that this is due to the rising number of orders made online. Not only lifestyle medications such as weight-loss pills or drugs against erectile dysfunction are counterfeited, but also pain killers, antidepressants and cancer drugs.

Most of the counterfeits originated from China (64 percent). For medications, China is the leading country from which counterfeited drugs come from, followed by India and Hong Kong. Algirdas Šemeta, Commissioner for Taxation, Customs, Anti-fraud and Audit said: “[The] report shows the intensity and importance of the work being done by Customs in this field. I will continue to push for even greater protection of intellectual property rights in Europe, through our work with international partners, the industry and Member States."

The EU commission reports that customs have seized about 75 million articles less than last year. However, with almost 90,000 reports recorded, the number of cases remained nearly the same.

September 27, 2013
Source: European Commission, www.europa.eu


Information Forum: Bayer HealthCare is engaged in the fight against counterfeit drugs

Consumers should be alert when buying medicines on the internet. According to the World Health Organization, one out of two medicines bought online is counterfeited. On September 11, Bayer HealthCare has hosted together with the Federal Union of German Associations of Pharmacists (ABDA) and Pfizer the 2nd Counterfeit Medicine Information Forum in Berlin. On this occasion, the company has introduced a short film regarding the Interpol operation “Pangea”.

“Pangea” is an initiative designed to combat illegal online pharmacies. The video shows “Pangea’s” success story, from its beginnings in 2008 with just ten participating countries to this year’s “PangeaVI” with over 100 countries taking part. During the recent “PangeaVI” operation, more than 9,000 illegal websites selling fake drugs were found and taken offline.

At the Information Forum, Richard Bergström, General Director of the European Federation of Pharmaceutical Industries and Assocaiations (EFPIA) underlined the necessity of cross-border collaboration. “We must ensure that patients in Europe receive their medicines from safe sources on a sustained basis”, he explained. “To do that, we need cross-border systems and processes that effectively eliminate forgeries from the pharmaceutical supply chain and track down criminal forgers.” The video can be viewed and downloaded at http://vimeo.com/73928473.

September 11, 2013
Source: Bayer


Strike against illegal online pharmacies – more than 9,000 websites shut down

International prosecuting authorities from all over the world have united to fight against online trading with counterfeit drugs. Under the name “Pangea”, authorities cooperated for one week (18 to 25 June) to take a closer look at websites and postal packages. Interpol reports that there have been 58 arrests worldwide and that about 9.8 million potentially dangerous medications worth about 41 million US dollars have been seized. More than 9,000 websites linked to illicit online pharmacies were taken offline. The authorities also suspended payment facilities to illegal websites and disrupted a substantial number of spam messages.

“I am pleased that police, customs and national regulatory authorities continue to work closely together at both the international and national levels to combat this dangerous form of illicit trade, with the full support of our public and private sector partners across the globe,” says World Customs Organization (WCO) general secretary Kunio Mikuriya.

The US FDA reports that it has shut down some 1.677 illegal pharmacy websites. These websites were offering “Levitra Super Force”, amongst other things. This drug is a fake form of Levitra®, containing dapoxetine instead of vardenafil. The FDA recommends that users should verify their online pharmacy of choice by visiting the FDA’s BeSafeRx website.

“Pangea” is an operation initiated by Interpol and is performed annually. During one week, prosecuting authorities all over the world specifically target illegal trading with counterfeit drugs. This year, “Pangea” took place for the sixth time, with about 100 countries participating.

July 24, 2013
Sources: US FDA, Interpol


Google continues to permit ads for illegal online pharmacies

Google features an increasing amount of advertisements for illegal online pharmacies. The National Association of Attorneys General (NAAG) has therefore criticized the popular search engine. Users need to pay extra attention when clicking on Google Ads or search engine results, especially if a pharmacy is offering drugs without prescription.

In 2011, the internet giant had to pay a fine of 500 million US dollars for placing ads for online pharmacies selling counterfeit drugs. Jim Wood, speaker of NAAG, now states towards the newspaper USA Today that after testing Google with typical queries, many websites known to sell counterfeit goods continue to appear in the top results of the search engine. The amount of suspicious-looking videos dealing with counterfeits has also increased on Google’s YouTube service.

Google has denied the accusations, claiming in a statement that “we take the safety of our users very seriously and we've explained to Attorney General Hood how we enforce policies to combat rogue online pharmacies and counterfeit drugs. In the last two years, we've removed more than 3 million ads for illegal pharmacies, and we routinely remove videos that are flagged for violating YouTube's Guidelines regarding dangerous or illegal content."

According to the NAAG, these measures do not go far enough. They warn users to be wary of Google search engine results and suspicious videos on YouTube.

June 30, 2013
Source: USAToday Direct Link: Google allows ads for illegal drugs, state AG says


Norway: “Fake Pharmacy” warns consumers of counterfeits

With the fake online pharmacy www.pharmacyforyou.no, Norwegian authorities have taken an unusual path to raise awareness on counterfeit drugs. The project is a cooperation between the Norwegian Medicines Agency LMV, the Norwegian pharmaceutical industry union LMI, and the Norwegian customs.

Pharmacyforyou is intended to imitate a typical online pharmacy and therefore aims at potential customers who obtain their medication online without prescription. However, instead of being able to purchase medication, each link on the website leads to a page with a warning note, explaining the dangers of counterfeited drugs. Furthermore, the page warns readers of purchasing drugs online, claiming “most internet pharmacies are illegal. How do you know your source can be trusted?”

May 08, 2013
Source: DAZ online


Looking out for counterfeit drug manufacturers – risk management is becoming increasingly important to pharmaceutical companies

The number of counterfeit drugs remains at an alarmingly high rate. According to the Pharmaceutical Security Institute , there is a constant rise in illegal reimports, theft and product piracy. It is thus of utmost importance for pharmaceutical companies to fight back by implementing effective risk management measures. For this reason, Bayer has established “Bayer HealthCare Global Anti-Counterfeiting Management”. Under the guidance of Marina Bloch, different departments such as analytics, legal affairs, and packaging technology collaborate to counter product counterfeiting. To support their investigative work, the Anti-Counterfeiting Management collaborates with Bayer’s Corporate Security. Michael Sorge, Head of Corporate Security, and his team are currently working on 20 cases. The company has a “zero tolerance” mentality, which is incorporated in internal guidelines. “Every perpetrator we find can expect a charge and damage suit,” Sorge points out.

Additionally, the company fosters close collaborations with national authorities. Beside a well-working network in the EU, Corporate Security has established a new partnership with Columbian investigators and a cooperation with US-American authorities is as good as certain. In a next step, Bayer strives to create collaborations both with Brazil and China.

Though Corporate Security works together with the police or state prosecutors, it remains a private organization and thus is restricted by law. “Otherwise, we would be jeopardizing our investigational success. And that is what matters – we must protect ourselves from financial damage, protect our intellectual property, and most importantly, protect our consumers’ health,” Sorge explains.

April 23, 2013
Source: bayer direkt 6/2012 www.psi-inc.org


Bayer cooperates with Interpol in the international war against counterfeit drugs

Together with Interpol, Bayer has started an initiative to protect patients even better against counterfeited medicines. The “Pharmaceutical Industry Initiative to Combat Crime” (PIICC), which also includes other pharmaceutical companies, will specifically target forgery rings.

The internationally active task force will thus track down and crush criminal organizations. To achieve this, specially trained Interpol teams will support manufacturers and local authorities with their investigations across borders. This includes establishing a large information database and performing joint operations. Additionally, Interpol seeks to raise awareness among the public regarding the dangers of counterfeited medicines with this initiative.

PIICC is currently supported by 28 pharmaceutical companies and will run for the next three years.

March 12, 2013
Sources: Bayer, Interpol Direct Link: INTERPOL and pharmaceutical industry launch global initiative to combat fake medicines


Report calls for global strategies to fight growing problem of counterfeit drugs

The Institute of Medicine demands developing global strategies to counter the problem of counterfeit drugs. In a recently published report, the Institute concludes that the problem of fake and substandard drugs is still rising on a global scale. Therefore, both national and international organizations need to improve standards and work transnationally to fight back.

According to the report, in 2011, counterfeited drugs were sold in at least 124 countries. The highest burden is seen in developing countries. However, the Institute heavily criticizes the lack of information, pointing out that the true magnitude of counterfeit drugs remains unknown.

Therefore, the Institute of Medicine recommends that governments should improve systems that focus on detecting substandard, falsified, and unregistered medicines, for example, by implementing a track-and-trace system that can keep tabs on the origin of drugs. The Institute also claims establishing international networks among investigators and the support of smaller pharmaceutical companies intending to upgrade to international standards.

The full report can be read online or purchased as a hard copy from the Institute of Medicine. February 15th, 2013 Source: Institute of Medicine