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2016

Communication / Conference: Enhancing traceability to combat counterfeiting and illicit trade

International - 07 December 2016

December 7th, 2016 - Euractiv et CAIT


On December 6, 2016, the seminar “Enhancing traceability to combat counterfeiting and illicit trade” organized at the EurActiv panel discussion event took place on Brussels, Belgium. It was an opportunity for industries across different sectors and policy makers to exchange their views on best practices in tracking, tracing and authenticating traded goods. Geoffroy Bessaud, responsible for anti-counterfeiting coordination at Sanofi, was speaker at this event and provided information about the issue of medicines counterfeiting, in particular the public health impact and Sanofi's initiatives in the fight against fake drugs. The Coalition Against Illicit Trade (CAIT) launched its new white paper and recommendations for action at the national, European and international levels.


Enhancing traceability to combat counterfeiting and illicit trade

Photo credit : Euractiv

Communication / Conference: First Medicrime workshop for GMDP and Pharmacy Inspectors

International - 28 November 2016

November 28th, 2016 - Edqm.eu


On November 8-9, 2016, the first Medicrime workshop for GMDP (GMP - Good Manufacturing Practice and GDP - Good Distribution Practice) and pharmacy inspectors took place in Oslo, Norway. It was organised in collaboration between the Norwegian Medical Agency and the EDQM (European Directorate for the Quality of Medicines), and is part of the training strategy of the Committee of Experts to organise more technical workshops focusing on inspectors potentially coming across falsified medical products.

Communication / Conference: Fake medicines won't be called “counterfeit”, WHO says

International - 26 November 2016

November 26th, 2016 - Securing Industry


End of 2015, a working group of the WHO (World Health Organisation) had been set up to refine the working definitions of "substandard/spurious/falsely-labelled/falsified/counterfeit" (SSFFC) medical products. On November 23, 2016, the definition adopted dropped the word “counterfeit” and uses the term “falsified”. The proposed definitions are as follows: “Substandard medical products - Also called 'out of specification', these are authorized medical products that fail to meet either their quality standards or their specifications, or both; Falsified medical products - Medical products that deliberately/fraudulently misrepresent their identity, composition or source.”

Communication / Conference: ASOP Global successfully convenes International Symposium on Drug Chain Security and Combating Counterfeit Drugs

International - 19 November 2016

November 19th, 2016 - SafeOnlineRx.com


Alongside local China partners, Alliance for Safe Online Pharmacies (ASOP Global), an international non-profit organization that works to protect patient safety online and ensure patient access to safe medications, brought together key international stakeholders of private and public sectors during an October 28 symposium titled “International Symposium on Drug Chain Security and Combating Counterfeit Drugs” in Beijing. The symposium had two sub-forums, one combating illegal Internet drug sales and the other on track-and-trace systems.

Communication / Conference: WHO issues draft guidance to test suspected spurious, falsely-labelled, falsified and counterfeit medicines

International - 01 November 2016

November 1st, 2016 - OMS


The World Health Organisation (WHO) issued in October 2016 a draft guidance to test suspected spurious/falsely-labelled/falsified/counterfeit (SFFC) medicines. It expects the industry to comment before January 10, 2017. This document provides technical guidance on laboratory testing of samples of suspected SFFC products detected on the market of WHO Member States and related aspects of sampling and reporting.

Communication/Conference: 10.2 billion euros each year is the economic cost of IPR infringement in the pharmaceutical sector

Europe - 29 September 2016

September 29th, 2016 - EUIPO - Report “The economic cost of IPR infringement in the pharmaceutical sector”

A study of the EUIPO (European Union Intellectual Property Office), published in September 2016, focuses on the economic impact of counterfeit medicines in the European Union marketplace and its wider costs to industry, government and society as a whole. Fake medicines cost the EU pharmaceutical sector 10.2 billion euros each year and the loss of 37,700 jobs. The study refers only to manufacturing and wholesale and does not include retailers such as pharmacies.

Communication/Conference: Almost 900,000 medicines and other products were led by EU Customs in 2015

Europe - 23 September 2016

September 23th, 2016 - Report on “EU customs enforcement of intellectual property rights - Results at the EU border 2015” European Commission

The report on the EU customs detentions of articles suspected of infringing intellectual property rights (IPR) in 2015 was published on 22 September 2016 by the European Commission. Last year, up to 80,000 detention cases were registered by Customs and over 40 million detained articles are concerned, the value of the equivalent genuine products is estimated to be just over 642 million euros. Regarding medicines and other products (condoms), 1,554 procedures were led for a total of 895,324 articles and a retail value of original goods of 12,392,626 euros.


The first countries of provenance are India (56.80%), China (18.06%) and Hong Kong (16.11%).

Internet: Not drugs, but poison: rumors on mass deaths of children from counterfeit medicines are spreading on social networks in Russia

Russia - 22 September 2016

September 22th, 2016 - Vesti.ru

News about mass deaths of children due to counterfeit drugs spread at an incredible rate on social networks. Only in Moscow, twelve alleged cases would have occurred. A lot of people would have shared a post on social networks, urging parents to be vigilant and not to buy some drugs listed in the post (antibiotics, painkillers and homeopathics). From Moscow, those rumors have spread throughout Russia, and even to Kazakhstan and Azerbaijan. The Kazakh Ministry of Health had to make a formal denial. Such a situation would already have happened last year – also in the fall, and the text published in the online post would be identical.

Internet: NABP issued its report on rogue internet drug outlets and illegal purchase of medication online

United States - 03 August 2016

August 3rd, 2016 - NABP

The National Association of Boards of Pharmacy (NABP) released its Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators in July 2016. NABP reviewed 11,299 online drug outlets selling prescription drugs and revealed that almost 96% have been classified as “not recommended” websites. The classification relates to websites out of compliance with State and Federal laws. They recommend to check the list of approved websites with .pharmacy domain name. See “Buying Safely” section at www.safe.pharmacy.

Enforcement: A network of trafficking on fake and counterfeit drugs dismantled in Colombia

Colombia - 27 July 2016

July 27th, 2016 - El Colombiano

On 27 July 2016, Colombian police arrested 10 people suspected of being part of a gang smuggling and counterfeiting medicines. Among the fake drugs, the authorities reported having seized treatments against cancer, HIV-AIDS, contracptifs, almost 18 000 units worth 800 million pesos, or about UD$260.000. This network would be located in Bogota, Cucuta and Medellin. The counterfeits were produced in underground factories equipped with machines to copy and reproduce real packaging drugs, and machines to falsify expiry dates to remarket expired drugs.

Communication/Conference: Counterfeit prescription pills containing fentanyls: a global threat

United States - 22 July 2016

July 22nd, 2016 - www.dea.gov

The DEA (Drug Enforcement Administration) published in July a report regarding the issue of counterfeit prescription pills introduced into the United States markets the last months, exacerbating the fentanyl and opioid crisis. Some of the pills contained deadly amounts of fentanyl, resulting in an increase in overdoses, deaths and opiate-dependent individuals.

Enforcement: Black market mixing real, fake and expired drugs

China - 16 July 2016

July - August, 2016 - http://www.quda100.com
http://www.booyuan.com

A CCTV program reports the case of Mr. Li (李师长), from Shiyan City, Hubei Province. As he wanted to buy Plavix for his father, he discovered a pharmacy selling the drug for 20 yuans. He bought several boxes, but saw that the pills were rapidly deteriorating. He alerted Shiyan city FDA, who identified them as counterfeits. Investigations revealed that the fake Plavix were probably sold by a certain Mr. Feng (冯), a 30-year-old Chinese citizen from Guizhou. The latter however claims that he ignored that the pills were fake, and the identity of the counterfeited drugs manufacturers remains unknown.

Communication/Conference: Conference on anti-counterfeiting and brand protection – Pharmasafe India 2016

India - 14 July 2016

July 14th, 2016 - www.pharmasafeindia.com

The conference PharmaSafe India 2016 on anti-counterfeiting and brand protection will be held on September 22-23 (Holiday Inn, Mumbai). It will bring together over 180 delegates and speakers (business leaders from top pharmaceutical companies, experts in anti-counterfeiting technology, government and regulatory authorities, customs, investigators, legal experts…) at a common platform to enable discussions, sharing of valuable insights, best practices, domestic and global trends and challenges as well as strategies to tackle the counterfeiting challenge. Pramod Bhatt, Shailesh Ayyangar and Edmond d’Arvieu from Sanofi are speakers at this event.

Enforcement: 39 fake vaccines found in almost 40 Indonesian medical facilities

Indonesia - 12 July 2016

July 12th, 2016 - SecuringIndustry.com

According to two articles issued by Securing Industry in June and July 2016, a massive fake vaccines racket has been dismantled in Indonesia late in June. After a three-month investigation, seventeen people have been arrested for their alleged involvement in this trafficking that lasted 10 years. At least 12 vaccines brands have been found as counterfeits, seized in 37 health facilities accross 9 provinces: South Sumatra, Lampung, Banten, Jakarta, West Java, East Java, Bangka Belitung, Riau and Riau Islands.


“Meanwhile, the country’s Health Ministry believes at least 197 children had been given fake vaccines and will now roll out a revaccination programme”, said SecuringIndustry.

Communication/Conference: IRACM and CNAC mobilize for the battle against the worldwide blight of counterfeit medicines

France - 20 June 2016

June 20th, 2016 - www.lequotidiendumedecin.fr
www.contrefacon-riposte.info

The international Institute of Research Against Counterfeit Medicine (IRACM) and the National Anti-Counterfeiting Committee (CNAC) presented a conference - debate on 20 June 2016 in Paris entitled "The Counterfeiting of Medicines in France: Myth or Reality". Numerous international experts participated in the event, held in the presence of Senator Richard Yung and French Ambassador Jean-David Levitte, also President of the Board of Directors of IRACM.

Three round tables were held to examine drug counterfeiting in France, in Europe and in the world. They shed light on obstacles and bottlenecks that have hampered the battle against medical counterfeiting over the past ten years. A significant advancement toward resolving these issues is the Medicrime Convention, but this latter is still awaiting implementation.

Internet: Pangea IX targets the sale of fake medicines on the internet and takes down 4,932 illicit pharmaceutical websites

France - 09 June 2016

June 9th, 2016 - www.interpol.int
www.ansm.sante.fr

The international operation Pangea IX was held 30 May through 7 June 2016 with the mission of fighting the illegal sale of medicines on the internet. This Interpol-coordinated event, the largest of its kind, has been deployed yearly across numerous countries since 2008. It draws the participation of close to 200 police, customs and health regulations agencies as well as private businesses such as Sanofi.

The 2016 Operation Pangea IX involved 103 countries and resulted in 393 arrests worldwide and the seizure of US$53 million worth of potentially dangerous medications, among which were fake cancer medications, non-conform HIV/AIDS screening tests and diabetes tests, counterfeited dental materials and illicit surgical equipment.

In France, 961,192 illicit health products and 1,422 kilograms of bulk health products were seized by customs during the operation. Comprised therein were mainly medications without French marketing authorization (580,000) counterfeited health products (close to 190,000 tablets), and medicines used outside of their medical indications as narcotics (more than 30,000 doses).

More than 77% of the seized products came from Asia (primarily India, 64.22%).

Photo credit: Interpol

Communication/Conference: Sanofi's major international initiatives in the fight against counterfeit medicines

France - 08 June 2016

June 8th, 2016 - www.lehub.sanofi.com

Medical counterfeiting lurks in many corners: the internet, in African markets, even in the jackleg pharmacies of some developing countries. Counterfeiting is a worldwide problem affecting public health everywhere and causing hundreds of thousands of deaths every year.

It is for these reasons that major healthcare entities such as Sanofi join their forces with those of nations to find solutions to counterfeiting and ensure the shared goal of protecting the health of patients. Sanofi thus contributes to the yearly Operation Pangea coordinated by Interpol, by bringing its support to legislations deployed locally and internationally, such as the Medicrime Convention, implementing simple and effective means to strengthen the protection of its products, and, since 2008, analyzing suspicious products collected from numerous countries in its Central Anti-Counterfeiting Laboratory in Tours. The Sanofi Group also participates in numerous events and conferences across the globe to raise public awareness and knowledge on this growing bane.

Communication/Conference: Sanofi Anti-Counterfeiting Day mobilizes Group affiliates for the fight

France - 06 June 2016

June 6th, 2016 - www.en.sanofi.com

Again this year, Sanofi held its international Anti-Counterfeiting Day in most of its affiliates to continue a mission of informing its employees of the dangers of faked medicines and their trafficking across the globe.

This day designed to increase awareness and knowledge was held on 6 June 2016 at the Sanofi headquarters in Paris and thereafter repeated throughout the Group’s affiliates. Anti-Counterfeiting Day is an opportunity to review the major initiatives deployed to rein in the threat of fake drugs, for both the group and the world. The event provides employees with the knowledge they need to understand this scourge and increase the awareness of their friends and families as to the progression of counterfeiting in the market and on the web and its significant impact on public health, including its role in the deaths of hundreds of thousands of people each year.

To fight this battle, the main stakeholders in healthcare are committing and organizing. Over the past decade, the international community has worked to identify distribution networks, seize faked products, increase public awareness and diffuse facts, and it will continue to do so for as long as it takes.

Legislation: The Medicrime Convention will be ratified by France and Belgium soon

France - 19 May 2016

May 19th, 2016 - www.coe.int

Belgium adopted the law ratifying the Medicrime Convention on 12 May 2016, just before France who did it on May 19. Before the end of 2016, these two countries should ratify the first international instrument in the criminal law field on counterfeiting of medical products and similar crimes involving threats to public health.

The Medicrime Convention is a Council of Europe international criminal law treaty. The 47 states in Europe that are members of the Council of Europe, as well as states in other regions of the world, can sign and ratify the Convention and thus join the international co-operation under the Convention.

Enforcement: Seizure of 67 website domain names involved in selling misbranded and counterfeit prescription drugs in the US

United States - 26 April 2016

April 26th, 2016 - www.justice.gov

On April 26, seizure orders against 67 domain names of commercial websites engaged in the illegal sale and distribution of counterfeit and prescription drugs were executed late in April 2016. The seized domains are in the custody of the federal government.

The US Attorney Bill Nettles said “to be safe and effective, prescription drugs must be taken under the care and supervision of appropriate health care professionals; not purchased off the internet from unknown and unregulated foreign sources.”

Legislation: The Turkish Parliament has drafted a law to toughen sanctions against counterfeit criminals

Turkey - 21 April 2016

April 21st, 2016 - www.tbmm.gov.tr
www.disab.saglik.gov.tr

Thanks to a Turkish Penal Code dated 2004, the counterfeiting is already being penalized in Turkey with an emprisonment of 5 years maximum under articles 186 & 187. In addition to this, the Turkish Republic had signed the Convention Medicrime of the Council of Europe regarding the counterfeit of medicinal products on 29 June 2012. The Council is encouraging and obliging the countries to execute serious precautions and legal/criminal sanctions against the counterfeit criminals.

The Turkish Parliament had already drafted a legislation to put in force but the law had not been approved yet, thus the law is not yet effective. To date, a draft law process seems under evaluation.

Communication/Conference: Counterfeit and pirated trade weigh heavily on the European economy

Europe - 18 April 2016

April 18th, 2016 - www.oecd.org “Trade in Counterfeit and Pirated Goods: Mapping the Economic Impact”

According to the OECD and EUIPO study published on April 18, 2016, the counterfeit and pirated products accounts for USD 461 billion in world trade in 2013 - about 2.5% of total world trade - the equivalent of the GDP of Austria. We can discover the American, Italian and French brands are the most affected by counterfeiting and part of the proceeds fuels organized crime. Up to 5% of goods imported into the European Union are counterfeit, which mostly originate in "middle-income or emerging countries, China being the largest producer." Apparently, still according to the report, the phenomenon has evolved over the last decade.

In the 2011-13 seizures, the United States were the most affected by intellectual property rights infringement with a rate of 20%, followed by Italy (14.6%), France (12.1%) and Switzerland (11.7%).

The counterfeiting of medicines is also singled out in the report for threatening the lives of the consumers-patients. It is also reported that a large volume of counterfeit goods is shipped by mail or express related to purchases made on the internet, and particularly via e-commerce solutions.

Communication/Conference: In Russia, 2.2 million packages of substandard and counterfeit drugs withdrawn from circulation in 2015

Russia - 18 April 2016

April 18th, 2016 - www.mskagency.ru

Employees of the Federal Service for Supervision in the health sector (Roszdravnadzor) withdrew nearly 2.2 million packages of substandard and counterfeit medicines from circulation in 2015. This figure was announced at the final meeting of the board of Roszdravnadzor by the head of the agency, Mikhail Murashko. He noted that 62.9% substandard medicines identified were manufactured in Russia.

Communication/Conference: In Russia, 2.2 million packages of substandard and counterfeit drugs withdrawn from circulation in 2015

Russia - 18 April 2016

April 18th, 2016 - www.mskagency.ru

Employees of the Federal Service for Supervision in the health sector (Roszdravnadzor) withdrew nearly 2.2 million packages of substandard and counterfeit medicines from circulation in 2015. This figure was announced at the final meeting of the board of Roszdravnadzor by the head of the agency, Mikhail Murashko. He noted that 62.9% substandard medicines identified were manufactured in Russia.

Communication/Conference: Preventing the illegal sale of “Ticafrani” in Ivory Coast

Ivory Coast - 18 April 2016

April 18th, 2016 - www.theglobalfund.org
www.ispeakoutnow.org

The Office of the Inspector General of the Global Fund, in partnership with the Ministry of Health and Public Hygiene of Côte d'Ivoire, announced the launch of an anti-corruption campaign called “J'en parle maintenant !” (“I Speak Out Now!”). One of the campaign’s targets is linked to the “Products issues”: it aims at raising awareness of the dangers of taking medicines purchased in the markets without proper medical prescription. Through public service announcements on national radio and in the media, the campaign is based on the work of the foundation Chirac by using its slogan “Le médicament de la rue tue !” (“Street medicine kills!”).

Enforcement: 76,000 counterfeit tablets of an opioid analgesic seized in Quebec

Quebec - 18 April 2016

April 18th, 2016 - www.lapresse.ca

After twelve investigations conducted in Quebec between March 1 and April 8, 2016, the police seized 76,000 counterfeit tablets of Fentanyl1 worth $ 1.5 million. Five suspects were arrested in Quebec City.

1 Fentanyl is an opioid analgesic.

Communication/Conference: Sanofi contributed to the 4th OECD Task Force meeting on Countering Illicit Trade

France - 18 April 2016

April 18th, 2016 - www.oecd.org

On 18 Avril 2016, Sanofi was invited to speak during the “4th OECD Task Force meeting on Countering Illicit Trade” about the impact of fake medicines on public health and the key activities conducted by Sanofi concerning the fight against drug counterfeiting on the Internet.

Technology: ProCheck debuts text message verification of drugs in Pakistan

Pakistan - 13 April 2016

April 13th, 2016 - www.securingindustry.com

Start-up company ProCheck has started protecting medicinal products in Pakistan from counterfeiting using SMS verification technology. The company has deployed serialized codes on packs of medicines sold in Pakistan by local drugmaker Ferozsons Laboratories, focusing initially on several products for high blood pressure and diabetes. Each of the packs bears a unique code that can be texted to a number (9900) in order to get confirmation within a few seconds of whether the medicine pack is authentic or fake.

Communication/Conference: German fake drug seizures quadrupled in 2015

Germany - 12 April 2016

April 12th, 2016 - www.zoll.de

The German Customs published their performance results in 2015. The number of illegal or fake pills confiscated at the German border increased fourfold to 3.9 million in 2015. In the past year, the focus has been on medicines sold online. The products seized are not only steroids, erectile dysfunction, slimness and hair growth products, but also sedatives and sleeping pills. Confiscated pharmaceutical substances came predominantly from China, while finished products were often from India, China, Thailand and eastern EU member states.

Communication/Conference: New strategy to fight falsified medicines in Spain in 2016-2019

Spain - 11 April 2016

April 11th, 2016 - www.aemps.gob.es

The Spanish Agency for Medicines and Medical Devices (AEMPS) published its new strategy for 2016-2019 to fight falsified medicines, promote the development of actions by all stakeholders and better protect patients against the risks linked to this phenomenon.

Communication/Conference: The Medicrime Convention soon ratified in France

France - 06 April 2016

April 6th, 2016 - www.leem.org

In France, the bill authorizing the ratification of the Medicrime Convention of the Council of Europe on the counterfeiting of medical products and similar crimes involving threats to public health will be discussed in second reading in the National Assembly on 12 May 2016.

As a reminder, this bill was adopted in first reading in the Senate on December 17, 2015.

Communication/Conference: Great mobilization of the Academies and Orders of medicine, pharmacy and veterinary against the scourge of counterfeit medicines

France - 05 April 2016

April 5th, 2016 - AFP
www.pourquoidocteur.fr

On April 5, 2016, in Paris, the three French scientific Academies were mobilized against the scourge of counterfeit medicines. The Academy of Medicine, the Academy of Pharmacy and the Veterinary Academy and the three Orders organized a conference to alert the public about the seriousness of the risks of falsified medicines, booming in France and worldwide.

The announcement of this conference came as France and other European countries are planning to ratify the Medicrime Convention of the Council of Europe on the counterfeiting of medical products and similar crimes involving threats to public health. Today, only six countries have ratified the Convention: Armenia, Hungary, Moldova, Spain, Ukraine and Guinea1.

After the conference, a common manifesto which calls for international prevention and enforcement measures - considered too low today - was signed and will be presented to the French Health Minister, Marisol Touraine. The six French organizations define the pharmaceutical crime as terrorism and call for the same sanctions to be applied.

According to the three Academies, the population is not well informed on the matter and would benefit of a larger communication. Sanofi supports this initiative which is part of the implementation of concrete actions against the criminals who manufacture and sell fake medicines, and threaten global public health.

1Chart of signatures and ratifications.

Communication/Conference: According to a report, 58% of counterfeiting cases involve pharmaceutical establishments

Peru - 04 April 2016

April 4th, 2016 - www.bmjopen.bmj.com

A new retrospective review on counterfeit medicines in Peru (1997–2014) aims at consolidating and assessing information on counterfeit medicines subject to pharmaceutical alerts issued by the Peruvian Medicines Regulatory Authority over 18 years (1997–2014) of health monitoring and enforcement.

A total of 669 DIGEMID alerts were issued during the study period, 354 (52.91%) of which cover 1,738 cases of counterfeit:

  • 1,010 cases (58.11%) involved pharmaceutical establishments;
  • and 349 (20.08%) involved non-pharmaceutical commercial outlets.
  • In 126 cases (7.25%), counterfeit medicines were seized in an unauthorized trade (without any marketing authorization).
  • In 253 cases (14.56%) the type of establishment or business associated with the seized product was not identified.

Enforcement: Dismantling of two clandestine laboratories in Honduras

Honduras - 02 April 2016

April 2nd, 2016 - www.elheraldo.hn

Two clandestine laboratories dedicated to medicines manufacturing were raided on April 1st, 2016 by the Honduran authorities in Colonia Cantarero López, Tegucigalpa. The owner, Melvin Rolando Garcia Betanco, was arrested and numerous products were seized including medicines without labels, plastic bottles, raw material and boxes.

Enforcement: Counterfeit tablets of an opioid analgesic seized in Sacramento that caused the death of 9 people

United States - 01 April 2016

April 1st, 2016 - www.dea.gov

Federal authorities in San Francisco issued a public safety alert that several individuals in the Sacramento area have died from a counterfeit drug bought in the street. Fentanyl is a 80 times more potent painkiller than morphine. The Drug Enforcement Administration is trying to track down the source.

Communication/Conference: Zentiva in Nigeria to provide population with access to affordable and quality drugs

Nigeria - 01 April 2016

April 1st, 2016 - www.thisdaylive.com

The ThisDayLive.com website announces the launch of Zentiva in Nigeria and highlights the counterfeiting issue in connection with the access to medicines in this country. Africa is the region the most affected by fake medicines, and specifically sub-Saharan Africa where 30% of medicines are counterfeit, adulterated, substandard, illegally imported or mislabeled.

Nigeria is therefore facing a high level of trafficking in counterfeit drugs probably rated between 30 to 60%. However, the health authority in the country, NAFDAC, is proactive and regularly seizes and arrests counterfeiters or resellers. People have very limited or no access to essential and good quality care, and are usually victims of serious infectious diseases such as malaria, tuberculosis and HIV-AIDS. In this context, it was urgent for Sanofi to help this country particularly affected by this scourge by implementing a production site with safer generic drugs for Nigerian and regional patients. The generic medicines are legal copies of “princeps” drugs with lower cost. They remain high quality medicines.

The Director of Sanofi Nigeria-Ghana, Abderrahmane Chikabi, said "Zentiva is a Sanofi company and is the third leader in the field of generics. Zentiva produces and distributes cost-effective generic medicines approved by NAFDAC, and thus provides quality care to patients in the whole region. Zentiva offers a broad portfolio of generic drugs covering all major therapeutic areas: cardiovascular, female health, respiratory, anti-infectives and anti-fungals, urology, central nervous system, pain and gastrointestinal."

Communication/Conference: Clinigen joins both ASOP EU and EAASM to protect patients from the threat of counterfeit drugs

United States - 29 March 2016

March 29th, 2016 - www.eaasm.eu
asop.eu

Clinigen Group plc becomes a full member of the European Alliance for Access to Safe Medicines (EAASM) and Alliance for Safe Online Pharmacy in the EU (ASOP EU), both aiming to protect patients from the dangers of falsified or counterfeit drugs.

Enforcement: Seizure of 3 tons of illicit medicines in Cameroon

Cameroon - 23 March 2016

March 23rd, 2016 - www.cameroononline.org

More than three tons of smuggled drugs from neighboring Nigeria were destroyed in Bamenda in March 2016. The products, worth 500 million CFA francs, are the result of the intensification of border controls. They were manufactured in South Africa, Brazil, India and Nigeria.

Enforcement: Istanbul police seized half a ton of counterfeit drugs

Turkey - 23 March 2016

March 23rd, 2016 - www.aa.com.tr

The anti-smuggling and organized crime branch of the Istanbul police arrested a 37-year-old woman and seized over 1,500 boxes of counterfeit drugs which supposedly helped weight loss. The suspect, found in the district of Basaksehir, reported having imported herbal powders from Iran and Romania. She is suspected of selling them illegally on the Internet using fake labels.

Communication/Conference: French customs issued a significant decrease of counterfeit medicines seized in France in 2015

France - 17 March 2016

March 17th, 2016 - www.douane.gouv.fr

Among 7.7 million counterfeit items seized by French Customs in 2015, "only" 173,385 counterfeit medicines were seized. The clothes are the main counterfeit seizures (761,542), followed by shoes (595,160), mobile phones (528,925) and games, toys and sporting items (460,796).

2014 was a record year with 2,580,793 counterfeit drugs impacted by the interception of 2.4 million counterfeit drugs in Le Havre in February 2014. The year of 2013 has also allowed the interception of 1,354,705 counterfeit medicines and over 1.2 million in Le Havre in May. Those two years had scored two exceptional successive seizures on the French territory.

Enforcement: 19 pharmacies closed for counterfeiting in Dominican Republic

Dominican Republic - 17 March 2016

March 17th, 2016 - www.noticiassin.com

The Directorate General of Drugs, Food and Medical Devices (DIGEMAPS) definitively closed 19 pharmacies and drug distributors for the crime of smuggling, counterfeiting and adulteration of medicines. Four establishments were operating illegally and the others did not respect good manufacturing practices.

Legislation: A European regulation adopted on the packaging of medicinal products for human use will apply from 2019

Europe - 16 March 2016

March 16th, 2016 - www.eur-lex.europa.eu

The regulation governing the identification of medicine packaging lays down the characteristics and technical specifications of the unique identifier to verify the authenticity of medicines and identify the individual packs. The unique identifier consists of a product code and a serial number. This unique identifier is part of a two-dimensional barcode (Data Matrix) also containing a batch number and expiry date of the medicine, and if necessary a national reimbursement number. The EU directive requires the integrity of the secondary packaging which must be fitted with an anti-tampering device.

The manufacturers will evaluate the Data Matrix quality of printing and print on the packaging (in a human-readable format) the product code, serial number, batch number, expiry date and national reimbursement number when necessary.

In case of suspected falsification, the pharmacist or persons authorized or entitled to supply medicinal products to the public will verify the safety features and will inform the relevant competent authorities.

The regulation will entry into force on February 9, 2019.

Read the Official Journal of the European Union L32 of Feb. 9, 2016: “Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European Parliament and of the Council by laying down detailed rules for the safety features appearing on the packaging of medicinal products for human use.”

Legislation: China Supreme Court supervised 81 cases involving counterfeit drugs or food

China - 15 March 2016

March 15th, 2016 - www.legal.china.com.cn
www.xinhuanet.com

According to the specialized information platform Legal China, the Chinese Supreme Court handled 81cases in relation with counterfeit drugs and/or food, while 1,646 cases were handled countrywide, leading to the prosecution of 13,240 persons. The report also states that in 2015, the Supreme People's Procuratorate deployed a two-year special oversight activity, focused on unsafe and fake drugs and foods, which is supposed to play a deterrent role.

This report was also discussed in early March during the “Two Assemblies” or “lianghui”, the annual meeting that conveys the National People's Congress, China’s legislative body and the Chinese People's Political Consultative Conference, a consultative body that gathers representatives from the different provinces, and economic sectors, to discuss China’s main concerns and offer policy suggestions.

Enforcement: Counterfeit botulinum toxin imported from Hong Kong

Taiwan - 13 March 2016

March 13th, 2016 - www.taipeitimes.com

A package labelled as containing 11 boxes of botulinum toxin type A product sent from Hong Kong was intercepted by the Customs Administration in Taiwan. The packaging of the counterfeit goods looked very similar to the genuine goods but the components did not contain botulinum toxin type A, and the brand name on the box was “Allercan”.

Enforcement: Several tons of fake medicines incinerated in Guinea

Guinea - 12 March 2016

March 12th, 2016 - www.french.cri.cn

Hundred tons of illicit and counterfeit medicines like antimalarial syrup and pills to treat parasites with no ingredient were incinerated on March 11, 2016 in Guinea. Fifty four tons were seized in the port of Conakry alone, and the other part was taken in the streets of Conakry.

Internet: Efforts are made in China to tackle the counterfeit drugs sold via an online platform

China - 10 March 2016

March 10th, 2016 - www.sda.gov.cn

According to the Chinese Health authority, Yunnan province has started making a special effort on tackling the counterfeit drug selling problems via the internet. The provincial authorities are implementing four policies including the strengthening of the leadership on dealing with the investigation, strengthen the daily supervision on monitoring the internet illegal drugs publication, focus on the information provided by the internet complaints and start promotion, guidance and warning activities on the counterfeit and illegal drugs issues for Chinese citizens.

Legislation: How to protect yourself from counterfeit medicines in Ukraine?

Ukraine - 07 March 2016

March 7th, 2016 - www.rian.com.ua

The new bill of the Ministry of Economic Development (toughening responsibility for the violation of intellectual property rights) will have a negative impact on the pricing policy on the pharmaceutical market in Ukraine, in which about 30% of medications are fake.

According to Ruslan Svitlyn, director of a pharmacy network, this bill could lead to higher prices on the black market and will affect primarily the pharmaceutical market. These counterfeit products are mainly imported from Russia, Bulgaria, Romania and Turkey. Because of a memorandum, control on medication has not been applied for 2 or 3 years, at the same time there has been a constant increase of the prices of medicines. According to Ruslan Svitlyn, the most counterfeit drugs in Ukraine are the most popular drugs in the retail network: medication for hypertension, for cardiovascular system problems, for children.

According to Evgeniy Loktionovoy, Director of the Company Ukrainian Trade Guild, the adoption of the bill will not destroy the market of illegal products. This bill will only increase the price of bribes, and increase the price of counterfeit goods on average (20% to a maximum of 25%). He stated that the illegal market will continue to exist due to the fact that, today, there is a huge difference between the prices of genuine and counterfeit goods. The difference can be up to 70-80% and even more.

Legislation: How to protect yourself from counterfeit medicines in Ukraine?

Ukraine - 07 March 2016

March 7th, 2016 - www.rian.com.ua

The new bill of the Ministry of Economic Development (toughening responsibility for the violation of intellectual property rights) will have a negative impact on the pricing policy on the pharmaceutical market in Ukraine, in which about 30% of medications are fake.

According to Ruslan Svitlyn, director of a pharmacy network, this bill could lead to higher prices on the black market and will affect primarily the pharmaceutical market. These counterfeit products are mainly imported from Russia, Bulgaria, Romania and Turkey. Because of a memorandum, control on medication has not been applied for 2 or 3 years, at the same time there has been a constant increase of the prices of medicines. According to Ruslan Svitlyn, the most counterfeit drugs in Ukraine are the most popular drugs in the retail network: medication for hypertension, for cardiovascular system problems, for children.

According to Evgeniy Loktionovoy, Director of the Company Ukrainian Trade Guild, the adoption of the bill will not destroy the market of illegal products. This bill will only increase the price of bribes, and increase the price of counterfeit goods on average (20% to a maximum of 25%). He stated that the illegal market will continue to exist due to the fact that, today, there is a huge difference between the prices of genuine and counterfeit goods. The difference can be up to 70-80% and even more.

Communication/Conference: The CIOPF offers an e-learning to know more about falsified medicines

France - 04 March 2016

March 4th, 2016 - www.ciopf.org
www.globe-network.org

The International Conference of Francophone Pharmacists Associations (CIOPF) provides an e-learning on falsified medicines launched in 2015, whose publishers are TRACMED and the Merieux Foundation. Two modules are proposed in open access in English and French: the first module is an introduction to the problem of falsified medicinal products; and the second is on prevention, detection and reporting.

Through the GLOBE (Global Link for Online Biomedical Expertise) portal, the two interactive modules offer healthcare professionals and scientists with information to fight against falsified medicines, especially in Africa.


Communication/Conference: Warning in Switzerland on counterfeit hepatitis C medicines discovered in Israel

Switzerland - 03 March 2016

March 3rd, 2016 - www.swissmedic.ch

On March 3rd, 2016, Swissmedic, the Swiss Health agency, has issued a warning on counterfeit packs of the preparation Harvoni® discovered in Israel. This drug is dedicated to treat chronic hepatitis C in adults. The seized plastic bottles contain white film-coated tablets instead of yellow (genuine). These counterfeit drugs are originate in India and imported via a Swiss trading company.

This treatment is expensive in Switzerland and patients prefer to buy it on line. Swissmedic recalls to not purchase medicines from unknown sources and especially to be careful on the internet.

Legislation: Seven years imprisonment for manufacture, distribution and sale of fake drugs in Nigeria

Nigeria - 03 March 2016

March 3rd, 2016 - www.mynewswatchtimesng.com

On 2 March 2016, the Federal High Court in Lagos has sentenced a woman, 35, to seven years in prison and NGN 50,000 fine (or $252) for manufacture, distribution and sale of fake drugs. She was selling, among others, an antibacterial antibiotic anti-parasite of the nitro-5-imidazole family. A laboratory analysis demonstrated this was a counterfeit drug.

The accused pleaded for mercy and said she was not informed of the non-compliance of the drugs. The investigators have yet discovered she was a graduate of microbiology and manufactured them herself.

Communication/Conference: Fake drugs for animals in Brazil reach 15% of the market

Brazil - 01 March 2016

March 1st, 2016 - www.brasileiros.com.br

According to the Association of National Pharmaceutical Laboratories (Alanac), counterfeiting has reached 15% of the market of veterinary products. The products are not only for pets but also for cattle, pigs, horses and poultry. Some of these drugs are manufactured in the country while another part is smuggled.

Legislation: The CFDA suppresses the state-owned drug electronic supervision system in China

China - 21 February 2016

February 21st, 2016 - www.zqb.cyol.com

On February 20, 2016, the China Food and Drug Administration (CFDA) announced that it will gave up the “drug electronic supervision number” (药品电子监管码) system. This 20-digit number was delivered by the CFDA and acted like an ID enabling the CFDA to retrieve all product information (regulatory, manufacturing, composition and expiration data). Some people thought that the drug electronic supervision number was useless since it overlapped with other numbers, such as the bar code, serial number and registered number of approval. Chinese drug manufacturers also complained it created additional printing costs and forced them to purchase a new equipment to do so. Nevertheless, many people were surprised since this number system was useful for the government to check products in case of problem or crisis, and conduct anti-counterfeiting actions. It seems that the main reason that drove the Chinese State decision was to increase the drug manufacturer’s responsibility and encourage them to improve their traceability practices, so that the whole system will rely less on Chinese administrations.

This announcement significantly affects Alibaba’s future plans for selling drugs online. The database was created and operated by Citic 21CN, a pharmaceutical data firm in which Alibaba took a controlling stake in 2014, and renamed Alibaba Health Information Technology Ltd. As the company played a key role in monitoring pharmaceuticals in China, it was an important argument for Alibaba to ensure the safety of drugs sold on Alibaba website (maybe prescription drugs in the future).

Legislation: A new law soon to be enacted in Algeria to eradicate counterfeiting

Algeria - 20 February 2016

February 20th, 2016 - www.leconews.com

To clean up the market from counterfeit medicines and other types of fraud, a new law will be enacted in the coming months in Algeria. It aims at tightening controls on importers and local manufacturers involved in the national medicines market.

Enforcement: A group of fake drugs sellers exposed in Chelyabinsk

Russia - 17 February 2016

February 17th, 2016 - www.chel.mk.ru

32 members of a criminal group who extorted money to elderly and disabled people by selling expensive medications had to be judged soon. It would have been founded in 2007 by 2 men from Chelyabinsk and 2 men from Moscow who established a firm in Chelyabinsk specialized in the sale of expensive medicines. Their company, which in fact sold dietary supplements and non-certified products, was only looking for lonely elderly and disabled people in a difficult situation.

Between 2007 and 2010, the group would have managed to extort a total of 13.8 million rubles from 217 residents of Chelyabinsk, Sverdlovsk and Kirov regions.

Enforcement: Market flooded with spurious and fake medicines in Bangladesh

Bangladesh - 06 February 2016

February 6th, 2016 - www.amarhealth.com

The markets in Bangladesh are flooded with fake and spurious medicines but there is no arrangement for protecting the affected patients. According to the Drug Administration Department sources, 1,189 cases were filed on the charges of importing, hoarding and selling illegal, spurious or smuggled medicines from January to 13th December 2015. During this period, 31 people were sentenced. The problems will be solved, at least partially, if the “National Drug Policy”, currently on-going, is approved and implemented by the government.

Enforcement: Huge anti-counterfeiting operation in Guangdong province

China - 05 February 2016

February 5th, 2016 - www.sda.gov.cn

In February 2016, Guangdong and Shenzhen Food & Drug Departments launched an operation against online sale of counterfeit medicines. It led to the identification of 14 cases. Overall, the authorities found 15 manufacturing workshops, arrested 17 suspects, and seized 40 sorts of drugs for a total value of 30 million yuans (or almost USD4,630,000).

The China Food and Drug Administration (CFDA) released the name of 12 companies that were used to sell the fake medicines: Tibet Tanggula Julong Biotech Co., Ltd; Hong Kong Julong Biotech Co., Ltd; American High-tech Biotech Institute; Hong Kong Sanniu Biopharma (International) Group Ltd; Guizhou Lipanshui City Xingda Drug & Health Products Co., Ltd; American California Ouhua Pharmacy; Hong Kong Longwei Biotech Co., Ltd; Hong Kong Jiulong Herbal Medicine Group Co., Ltd; Hong Kong Weixin Biotech Co., Ltd; Guangdong Shenzhen Yisheng Biotech Co., Ltd; Hong Kong Tianlong Biotech (International) Group Limited and Tibet Nima Biotech Co., Ltd.

Enforcement: 5 clandestine laboratories dismantled and 750,000 tablets seized in Portugal

Portugal - 03 February 2016

February 3rd, 2016 - www.policiajudiciaria.pt
www.portugalresident.com

The Operation Underground Pharma led by the Judicial Police achieved to dismantle 5 clandestine laboratories manufacturing anabolic products. They have seized 750,000 tablets and 50,000 injectable forms as well as falsified medicines bought on the black market and raw materials for the production of medicines.

Communication/Conference: 90% of internet pharmacies identified by the NABP classified as "Not recommended site"

United States - 01 February 2016

February 1st 2016 - www.contrefacon-riposte.info

The National Association of Boards of Pharmacy (NABP) issued January 29, 2016 a report entitled "Internet Drug Outlet Identification Program - Progress Report for State and Federal Regulators: January 2016". This one focuses on the fight against illegal drug sales sites accessible in the US and provides recent figures of this phenomenon. Of the 10,668 sites identified by the NABP, 90% do not comply and are classified as "not recommended" by NABP. 60% of these stores online "not recommended" hide their address on the website. In addition, over 50% of malicious web sites provide drugs that are foreign or not approved by the Food and Drug Administration (FDA) of the United States and 90% of them seem to have affiliations with mafia networks selling drugs on the internet.

Enforcement: Illegal pharmaceutical products seized in Spanish police raids

Spain - 29 January 2016

January 29th, 2016 - www.guardiacivil.es

During the joint Operation Mazinger, the Guardia Civil dismantled a criminal international network dedicated to manufacturing, counterfeiting and distribution of forbidden products in the sport market. Investigations started in 2015 had revealed a network linked to a Spanish criminal gang. Since the operation began, police have searched 28 homes and other premises in Malaga, Alicante and Murcia, arresting 37 people and seizing 70,000 doses of illegal medicines in addition to 120 kilos of products, including steroids, hormones and sexual enhancers.

Communication/Conference: Unifab issues a report on the link between counterfeiting and terrorism

France - 29 January 2016

January 29th, 2016 - www.unifab.com

The Union des Fabricants (UNIFAB) published an interesting report in January which aims to provide an insight on the link between terrorism and counterfeiting, as well as demonstrating this illegal activity is one of the favorite activities for financing terrorist actions. For example, the counterfeiting of medicines is quoted in link with the IRA (Irish Republican Army) and with the Hezbollah.

Legislation: In Russia, the Governor of Tomsk proposed to judge the counterfeit of medicines as a murder

Russia - 25 January 2016

January 25th, 2016 - www.news.vtomske.ru

Sergey Zhvachkin, Governor of Tomsk, proposed to consider manufacturers of counterfeit medicines as murderers during trials, and to judge them accordingly. He expressed this view during the first session of the regional commission on counteraction against illegal circulation of industrial products: “We have cases of alcohol poisoning, and, very often, counterfeit medicines. Thus, I propose to consider toughening liabilities for the production of counterfeit related to the life of people (medicines, food). I would like that those who are engaged in the falsification and production of counterfeit medicine would be included in the group of articles of the Criminal Code pertaining to the judgment of a murder. There are cases where such people are fined and keep on doing their activities. I propose to consider such a possibility in terms of law and to submit to the government and to the parliament a proposal to toughen the punishment for the counterfeit of goods of food and pharmaceutical industries”. According to the same article, the Deputy Governor in charge of the industrial policy, Nikolay Glebovich, stated that in 2014 more than two million packages of substandard and counterfeit medicines had been withdrawn from circulation.

Legislation: Spain and Latin America united against the sale of fake drugs on the internet

Spain - 22 January 2016

January 22th 2016 - www.infosalus.com

The Spanish Agency of Medicines and Health products (AEMPS) has signed an agreement with health authorities in Mexico, Paraguay, Colombia and El Salvador to fight together against illegal sale of medicines on the internet. The MoU foresees the establishment of an Observatory which aims to monitor the commercialization, promotion and advertising of medicines on the internet. This international cooperation should develop legal mechanisms deployed against this scourge. The issue is, as illustrated by international organization data’s (WHO, the United Nations, INTERPOL), more and more alarming. Indeed, the sale of counterfeit products constitute the third most lucrative business in the world while it directly affects public health and is very complex to combat.

Internet: CSIP published a report on the Internet pharmacy market in 2016

United States - 15 January 2016

January 15th, 2016 - www.safemedsonline.org

The report “The Internet Pharmacy Market in 2016: Trends, Challenges and Opportunities” was commissioned by the Center for Safe Internet Pharmacies (CSIP) and prepared by Legitscript in order to give CSIP members and other stakeholders an understanding of the current trends and challenges in the Internet pharmacy market.

This report also illustrates the impact of zero-tolerance policies on illegal activity and how companies are protecting consumer health and safety through their work to block unsafe sites, collaborate with law enforcement, and educate consumers.

Communication/Conference: The EU supports the Senegal in the fight against trafficking of fake drugs

Senegal - 12 January 2016

January 12th, 2016 - www.rept-falsifiedmedicines.eu

The European Union (EU) and the Government of Senegal launched the REPT-Falsified Medicines project (or Responding Effectively to the Production of and Trafficking in falsified medicines) on January 12 in Dakar, Senegal. The activity of this project will focus on cooperation in the fight against trafficking in fake drugs (2014-2017). Besides Senegal, the project covers Cameroon, Ghana, Jordan and Morocco. The project aims at supporting the judicial authorities, police and other regulatory entities. One of the first actions in Senegal is to train 33 pharmacists inspectors.

Communication/Conference: The deployment of the project REPT (Respond effectively to the production and trafficking of falsified medicines) by training Senegalese pharmacists

Africa - 12 January 2016

January 12th 2016 - www.aps.sn

To effectively fight against illicit trafficking of drugs in Senegal, thirty pharmacists will be trained during the month of January 2016. This initiative follows the launch of the European project "Responding effectively to the production and trafficking of falsified medicines" (REPT) funded by the European Union and operating in five countries (Jordan, Morocco, Ghana, Cameroon and Senegal). This project aims to help organizations such as the Ministries of Health and Social Action, Justice, the Interior, the Armed Forces and of Economy and Finance to fight against falsified medicines. Professor Amadou Moctar Dièye, pharmacist and director of pharmacy and medicine, highlights the fact that in case of taking fake drugs, the disease may get worse as well as the risk of death.

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Fight the fakes

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