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QUARTERLY NEWS

INTERNATIONAL

MEDICINESAGAINST COUNTERFEITINSTITUTE OF RESEARCH

SPECIAL EDITION2017

QUARTERLY NEWS - SPECIAL EDITION #2017

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MED

ICINES

M E DICINE

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CONTENTS

3 Editorial

4 Leading news reports

7 Statistics & current trends

11 Public health alerts

14 Legislation & implementation

17 Effective action

This quarterly publication is prepared by IRACM.

Please send any comments, questions, or suggestions about the publication to [email protected]. We look forward to receiving your feedback.

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EDITORIAL

Bernard Leroy, Director of IRACM

Both 2016 and the first three quarters of 2017 were very eventful in terms of falsified medicines, on an international level.

Some of the most remarkable trafficking reports represent a wealth of findings regarding developments in transnationally organized criminal strategies: an American report revealed that terrorists are focusing on supply-chain attacks; Mexican drug cartel involvement in falsified medicine trafficking caused numerous overdose deaths in the United States; a BBC investigation exposed how the dark web is profiting from monitoring gaps in the British postal system, and a study revealed that a growing number of Americans are ready to risk purchasing online medicines.

As regards effective action: the World Health Organization (WHO) managed to simplify its definitions by now only referring to “substandard” or “falsified” products; the Medicrime Convention was ratified by the Swiss Confederation, Burkina Faso and Guinea in Africa; during the France-Africa Summit in Bamako in January 2017, heads of state and governments tackled security and agreed to make combating falsified medicines Africa’s second priority following the fight against terrorism; India improved its distribution-monitoring and medicine quality-control legislation; in 2016, Google

blocked six times more illegal medicine adverts than in 2015; INTERPOL’s PANGEA X operation resulted in record hauls and more than 420 tons of illegal medicines was seized in operations in Western Africa.

In this context, from IRACM’s perspective, it is vital that increasingly consistent, global and coordinated actions are carried out on an international level. Governments must become aware of the severity of the situation and define strategies and develop solid regional cooperation. Customs and law enforcement authorities need to be able to count on improved, deterrent and enforced national legislation.

Prevention programs are, for the moment, only at the development stage and need to be multiplied. Communication should include two distinct pillars: experts and the general public. Research, until now, has been sparse yet its development is indispensable for improved strategies and action.

To conclude, IRACM will be focusing more than ever before over the coming months on uniting all the stakeholders concerned.

Bernard LEROY Director of IRACM


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AFRICA, 06/26/2017

ZIMBABWE: thousands of expired medicines stored in veterinary premisesAuthorities discovered that veterinarians across the country are stocking vast stocks of expired veterinary medicines which pose a potential risk to animal health. A total of 23,400 expired units of 2014 Newcastle disease vaccines (a virus spread by birds) and stocks of hundreds of thousands of expired Tetinil units were uncovered. The Auditor General has ordered the products to be immediately destroyed.

AFRICA, 01/20/2017

DRC: misbranded medicine intoxicates over 1000 people, reports Doctors Without Borders At the end of 2014, patients with meningitis symptoms were admitted to Ituri health centers near the Ituri and Uganda border; 11 patients, five of whom were under the age of five, have died. Thorough patient tests have revealed that the symptoms were

not caused by meningitis but by the intake of a toxic substance. Various tests on medicines prescribed in the area show that the toxin detected in the patients came from pills which had been sold as diazepam. The latter contain haloperidol, an antipsychotic treatment used for schizophrenia. The average dose of haloperidol found in the tablets was 13.1 mg. This is «20 to 25 times higher than the daily maximum recommended dose for a child weighing 5kg». The misbranded medicines were supplied by an Indian laboratory which officially sold haloperidol. The products were deliberately repackaged as diazepam and sold by a distributor in Kampala (Uganda).

ASIA, 01/26/2017

PAKISTAN: Lahore fake stent racket increases patient mistrust of medical servicesAuthorities discovered a major fake stent racket in January during an undercover police investigation in Lahore’s Mayo Hospital. The racket involved hospital doctors and the investigation led to a police search. The surgeons were selling fake stents for cardiac

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LEADING NEWS REPORTS

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patients at prices 30 times higher than the purchasing price: up to Rs 200.000 (€2,814). A stent may become fractured or dislodged if its quality is compromised and this can result in serious health problems. All stents available in Pakistan are imported and there is no «test lab” to check their quality. The stents are legally imported from the US, the European Union and Japan but smuggled, falsified and fake stents also arrive from China and Hong Kong. This type of traffic is the result of regulatory flaws. The authorities have revealed that: “Counterfeit, unregulated and expired stents have affected many heart patients”. Many patients have lost confidence in hospitals and doctors and are now putting off, and even canceling, their heart surgeries.

EUROPE, 05/10/2017

UK: 18-year old woman tells how she almost died after taking online medicines

An 18-year old British woman, Natalie-Jade, tried to lose weight with pills she purchased online. Her experience shows how easily young women may succumb to empty online promises. Natalie-Jade explained how she did not stop to consider whether the products were dangerous as she felt “invincible”. She took the tablets for several days and was close to having a heart attack. The British Medicines and Healthcare products Regulatory Agency (MHRA) shut down 4000 illegal online medicine sites in 2016.

EUROPE, 01/06/2017

UK: BBC dark web investigation on how UK postal workers are unknowingly becoming trafficking accomplices

The BBC spent several months investigating illicit products purchased on the dark web and British Royal Mail’s role in importing dangerous products into the UK. Journalists explain how they used identity-concealing Tor software to freely order ecstasy and steroids on the dark web and receive the products in the post. A postman, who wanted to remain anonymous, said that it is illegal for postal staff to open suspect parcels and that parcels are not checked when there is no on-site customs office. Despite the British authorities’ commitment to improving the system, the British model is still far from being as efficient that of New Zealand where efficient cooperation between the police and postal services mean that three times more suspect packages are checked than in Great Britain.

LATIN AMERICA, 03/21/2017

US/MEXICO: Mexican drug traffickers behind fentanyl trafficking which caused 32 overdose deaths in ArizonaThirty-two overdose deaths were recorded in Arizona between May 2015 and February 2017. The deaths were caused by the consumption of black-market falsified prescription medicines which had been mixed with fentanyl. The American authorities say that the falsified medicines were manufactured and smuggled into the US by Mexican drug cartels.

LATIN AMERICA, 09/19/2017

COLUMBIA: falsified medicine may have caused death of 16 new-borns

An enquiry was launched eight months ago to establish if a falsified medication for premature lung development in infants caused the deaths of 16 new-borns at Valedupar hospital. The medicine was prescribed as Survanta, a well-known product, but showed obvious signs of falsification such as spelling mistakes and blurred barcodes, etc. The enquiry will determine if the babies died because of the product or due to ill health.

NORTH AMERICA, 03/13/2017

CANADA: 14-year-old girl dies after taking falsified Percocet

Investigators confirm that pills found near Chloe Kotval’s body were falsified Percocet and contained a le-thal dose of fentanyl. Chloe, 14, is the second Ottawa teenager to die

from taking the fake pills. Teslin Russell, 18, died in similar circumstances in October 2016.

Packages sent from dark web drug suppliers to BBC reporter.

Photo credit: BBC


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US: teenager sentenced for practicing medicine without a license

A 20-year-old man, accused of illegally practicing medicine in Florida when he was a teenager, has been arrested in Virginia. The man has been charged with a one-year prison sentence and will probably appear before the Florida court for

claiming to be the president, CEO and founder of NBNL Medical Center and for practicing medicine and giving medical advice under the guise of a qualified doctor.


US: report reveals risk of supply-chain terrorist attacks on the rise

A BSI report found that an average of 3.7 terrorist attacks on the global supply chain have occurred each week over the past 10 years. A total of 346 attacks took place last year across 33 countries. Terror attacks on the supply chain include targeting infrastructure, hijacking, cargo theft, contraband smuggling, extortion and kidnapping. The report found that Columbia, India and Turkey are the most affected countries. Islamic State is the leading group for supply-chain terrorism. The report also reveals that terrorists are targeting a wider range of industries and modes of transport.

www.youtube.com/watch?v=RiK5OGWxdC8

LEADING NEWS REPORTS

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S TATISTICS & CURRENT TRENDS

The 2016 EU customs report on the enforcement of intellectual property rights (results at the EU border 2016) reveals that there have been significant decreases (>50% decrease compared to 2015) in the number of detained medicines.

India is the main country of provenance for falsified medicines and medical packaging material. Medicines and labels are in the top 5 detained articles.

Medicines and other products generated 1968 procedures for 392,037 articles with a retail value of €4,498,898. The top 3 countries in terms of the number of medicines and other products not released are: India 62.60%, China 15.70% and Germany 10.43%. 16.98% of detained postal traffic articles were medicines.

INTERPOL’s international PANGEA X operation generates a record-breaking 25 million seized illicit medicines

The international PANGEA X action week (12 to 19 September) targeting the illicit online sale of medicines and medical devices mobilized 123 countries and led to a record seize worth more than $50m. The operation resulted in almost 400 arrests, 1,058 investigations and the suspension of more than 3,500 websites worldwide. Amongst the 25 million illicit medicines seized were dietary supplements, painkillers, epilepsy medication, erectile dysfunction pills, anti-psychotic medication and nutritional products. The operation also focused on illicit medical devices, such as dental devices and implants, syringes and condoms, etc. worth an estimated $500,000.

INTERPOL stated that these results show that there is “an increasing number of unlicensed, unregulated online pharmacies”.

• FRANCE: 433,000 illicit health products and 1.4tons of bulk health products were seized and 185 illegal online falsified medicine sites were identified during the operation.

• UNITED STATES: 500 websites illegally selling potentially dangerous and unapproved medicines were suspended.

• SINGAPORE: 39,000 doses of illegal health products were seized.

• SPAIN: 6 people were arrested and more than 4000 illicit tablets seized.

• IRELAND: 200,000 illicit medicines were seized, 38 illegal websites and 8 social media pages were suspended.


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KENYA

Viagra is the leading seized illicit medicine During an international meeting in Mombasa, Kenyan authorities once again highlighted the fact that the highest level of counterfeit medicines seized in the country are lifestyle medicines, erectile dysfunction treatments in particular, which mainly come from China. The meeting served as reminder that counterfeiting also concerns antimalarial tablets and antibiotics.

JAPAN

More fake hepatitis C medicines discovered Last week, the Japanese health minister announced the discovery of five bottles of fake hepatitis C medicine in Kansai Medico, a legal Nara pharmacy chain. The authorities have issued a second statement which reveals that a further nine bottles of misbranded Harvoni have been found in two Tokyo wholesale companies. The batch numbers on the fake bottles are the same as the manufacturer’s; this would suggest that the Harvoni tablets in the original bottles were replaced by fakes before being distributed. The authorities have confirmed that at least nine businesses are involved in distributing fake medicines. Three of the businesses purchased the medicines from companies who are not licensed to sell pharmaceuticals.

CHINA

Falsified reagent trade on the riseA Nature Journal report has revealed a vast research reagent traffic in China. Many scientists have had suspicions for some time that they were using poor quality research reagents and that the antibodies, serum for cell culture and lab test kits were falsified. The fake reagents are sold online via websites featuring both legal and illegal supplies. Cheap, common antibodies are relabeled and resold as expensive and rare antibodies, while other genuine reagents are diluted. The traffickers take advantage of the complexity of the Chinese supply chain which has led foreign companies to become dependent on local distributors.

New EUROPOL and European Union Intellectual Property Office report on counterfeiting in EuropeIn global terms, the report reveals that in 2015 “86% of the world’s counterfeit goods, that is to say $396.5bn, came from China and Hong Kong”. Two areas of concern were highlighted: an increase in seized labels and packaging and increased use of rail transport connections between China and Europe by traffickers. In terms of counterfeit pharmaceuticals, India is the leading manufacturing country with China following just behind. The products transit via several countries before arriving in sub-Saharan Africa by boat and in the EU and the US by post. As for postal trafficking, medicines are the most frequently intercepted products at 16% and are generally purchased online by the general public.

AFRICA

ASIA

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IRELAND

Increasing online anti-HIV medication purchases

Pre-Exposure Prophylaxis (PrEP) is a medication which reduces the risk of HIV infection. The cost of PrEP is not covered by social security in Ireland. It can be purchased on prescription for a costly €400 a month. The medication’s high price means that an increasing number of Irish people are purchasing it online. Customs officials have recently been instructed to step up surveillance of PrEP imports. Since the beginning of the year, eight shipments totaling 630 tablets have been seized.

SPAIN

Illegal medicine websites increase by 176% in 2016 The Spanish Agency of Medicines and Medical Devices (AEMPS) published its annual 2016 activity report in which it announced that 993 websites were singled out for illegal health product trade. This is a vast increase in comparison to 2015 when “only” 360 websites were caught.

MEXICO

Increasing stolen prescription medicine trade in markets

Stolen medicines from Mexico pharmacies are being sold in the city’s flea markets. A report revealed that prescription-only antibiotics, such as Ciproflox, are freely sold in the street without prescriptions. The health agency has issued a reminder that storage conditions may change the quality of medicines. Prolonged exposure to the sun may, for example, alter the quality of medicines.

Officials concerned over rise in illegal medicine sales on social mediaA Facebook survey has shown that numerous medicines may be purchased without prescrip-tions in Mexico. Consumers can buy Clonaze-pam, for example, a treatment for depression, anxiety and bipolar disorders. It is also very easy to purchase antidepressants, antipsychotics, in-sulin (for diabetes), all types of antibiotics, pain-killers, anti-hyper-tensive medicines and also contra-ceptives. The au-thorities are highly concerned by this increasing illegal trade.

FRANCE

2016 customs report reveals list of top 10 seized fake productsIn 2016, customs seized more than 9 million fake products. Even though fake medicines rank much lower than clothes, toys and even mobile phones, they are still one of the top 10 most counterfeited products; almost 200,000 units were seized in 2016 and this excludes more than 212,000 body-care products. This total was mainly reached due to the dismantling of a laboratory in November 2016 during which 167,000 fake cosmetic, face and body creams were seized. The products were sold in pharmacies.

AUSTRIA

Massive increase in customs-intercepted falsified medicines in 2016The Austrian federal ministry of finance has announced the 2016 customs results which reveal a record year with 1.947 hauls of 67.535 fake goods worth almost €3m. The 900 types of fake medicines amongst the fake goods represent 53.000 articles worth €1m. This is an increase of 17,000 compared to 2015. The top three seized falsified products are: erectile dysfunction pills, slimming pills and hair regrowth treatments.

UNITED KINGDOM

Report reveals social media increasingly influencing falsified productsA British Intellectual Property Office report reveals that 17.5% of online transactions are for falsified products and 17.5% of said transactions are from consumers who wittingly choose to buy counterfeit products. Facebook is the most “risky” social media, as suspicious activities are more widespread in closed groups.

All the news are posted on the IRACM website

EUROPE

LATIN

AMERICA


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CANADA

More falsified Percocet seized in Newfoundland and Labrador Canadian officials have yet again seized falsified Percocet tablets. The fake products, which are said to be very similar to the genuine tablets, contain fentanyl. They are round and are stamped with the letters “TEC”. The police has not disclosed further information about the haul but has issued a warning to remind the public of fentanyl overdose side effects:

• intense drowsiness,

• very slow heart rate,

• breathing complications,

• cold, clammy skin,

• difficulty speaking or walking.

UNITED STATES

Americans ready to take risks for cheaper medicines According to an Alliance for Safe Online Pharmacies (ASOP) survey of 500 people, 55% of Americans have bought, or would consider buying, prescription medicines online. In addition, ASOP also found that 74% of consumers who had purchased prescription medicines from an online pharmacy in the past would do it again. Fifty-three per cent of respondents perceive Canadian online pharmacies as risky but 20% would take the risk if the medicines were sold at a cheaper price. The investigation also revealed that those most likely to purchase online medicines are young people and regular social media users.

Sanofi survey shows fake drugs awareness growingA questionnaire was filled out by over 7,000 people in Latin America, and despite cross-

country differences, 59 per cent of interviewees associate counterfeiting and drugs. Almost a third, 27 per cent, of respondents has already purchased medicines online. In Asia, Thailand and Malaysia had the highest scores for online purchases with over 70 per cent of respondents buying medicines online. In the United States, 40 per cent of interviewees feel that counterfeit medicines are potentially, rather than, completely dangerous. A huge majority (82 per cent) feel they have never been exposed to counterfeit medicines. In Europe, 96 per cent of pollsters feel that falsified medicines are dangerous and only 18 per cent of Europeans have bought online medicines.

Google blocked almost 6 times more illegal health product ads in 2016 than in 2015Google deleted 1.7bn illegal ads (“bad ads”) in 2016. This is double the 2015 figure. The American giant also identified an increase in illicit pharmaceutical product ads in 2015. More than 68m unlicensed pharmaceutical product ads were deleted in 2016. This is an increase in comparison to 12.5m in 2015.


NORTH

AMERICA WORLD

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PUBLIC HEALTH ALERTSWHO and UNAIDS issue alert against Immunorex, a fake HIV treatment Following a Sciences et Avenir magazine investigation which denounced Immunorex’s marketing authorization in Africa (Immunorex is a fake HIV treatment), WHO and UNAIDS have made their position very clear and have issued a warning against using this medicine whose efficiency has not been proven. WHO and UNAIDS published a joint press release: “The joint UN HIV/Aids program strongly objects to the commercialization and sales of products which have not undergone clinical trials and whose efficiency has not been proven by WHO.”

NIGERIA

WHO issues alert following falsified meningitis vaccine discovery The first WHO alert of the year concerns a falsified Meningococcal meningitis vaccine in Nigeria. On 31 May 2017, manufacturer Bio-Manguinhos/Fiocruz informed WHO that a falsified version of Polysaccharide Meningococcal ACWY Vaccine was available in Niger. Despite the packaging claims, the manufacturer has stated that it does not manufacture Polysaccharide Meningococcal ACWY Vaccine. No adverse events following immunization attributed to this falsified vaccine are known to have been reported at this stage. The product is being screened.

UGANDA

WHO alert: two falsified cancer treatments uncoveredIn July 2017, falsified versions of Avastin and Sutent were discovered in Uganda. Both products were being distributed near various cancer treatment centres in Kampala. Avastin is a medicine manufactured by Roche, not by AstraZeneca as stated on the falsified versions. The falsified version of Avastin is being presented in tablet form whereas the genuine version of Avastin is supplied as an injection. Sutent is manufactured by Pfizer, not by AstraZeneca. The falsified version of Sutent is presented in tablet form whereas the genuine version of Sutent is only available as gelatine capsules.

UNITED ARAB EMIRATES

warning issued against 12 unlicensed and potentially dangerous medical products The health minister has issued a warning against 12 falsified medicines which may contain unlicensed and potentially dangerous chemical substances. The 12 medicines contain mainly sildenafil and sibutramine and also other dangerous chemical substances. The products could cause a sharp increase or decrease in blood pressure for cardiovascular patients. Both adults and children are concerned by the warning which also includes homeopathic teething products, “XtraHRD”, “N-desmethyl tadalafil”, “Goldreallas Original”, “Platinum Weight”, “Solution”, “Ginseng for Reinforcing Kidney” and “Fat Loss Metabolizer-Solution.”

AFRICA

Avastin falsifié

Sutent falsifié

Avastin falsifié

Sutent falsifié


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PUBLIC HEALTH ALERTS

TAIWAN

Nationwide Crestor recall after falsified tablets discoveredAs a precautionary measure, the AstraZeneca laboratory has launched a nationwide recall of its cholesterol-lowering medicine, Crestor, in Taiwan after falsified products were found in the supply chain. The Taiwan Health Agency announced several days earlier that Crestor (rosuvastatin) 10mg tablets – bearing the batch numbers MK479 and MV503 – had been discovered in the legal supply chain. Local media has reported that the fake tablets do not contain rosuvastatin but another molecule in the same medicine class. Two suspects have been arrested and face 10 years in prison and a $3m fine.

SINGAPORE

Health Agency warns against dangerous weight loss product Nutriline Bluvelle was marketed as a health supplement for rapid weight loss with claims that it contains natural plant ingredients which are “safe and free of side effects”. However, the Health Sciences Authority (HSA) said that it contains sibutramine, a prescription-only medicine which can cause heart attacks

and strokes. A twenty-year-old woman has experienced negative side effects from the product which she purchased online from a Malaysian website.

IRELAND

Health minister issues warning against buying illicit anti-epileptic medicineThe Irish health minister has warned the general public against buying black market pregabalin. The antiepileptic is only available on prescription and comes in the form of a red and white capsule. It is currently in circulation on the black market in Northern Ireland. According to officials, the medicine has been illegally manufactured and is potentially dangerous.

SPAIN

Health Agency issues alert against fake hyaluronic acid injections The Spanish Agency of Medicines and Medical Devices (AEMPS) published a report warning against Aqua secret HA’s hyaluronic acid gel syringes, follow-ing a warning from German authori-ties. The syringes are manufactured by Jointlaser Tech-nology Ltd, a Chi-nese company. The Health Agen-cy reports that the products have false EC labels and a false Italian health authority number: n° 1282.

EUROPE

ASIA

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EUROPE Mexican Health Agency issues warning after discovering two falsified medicinesThe Mexican Health Agency (COFEPRIS) has issued a health warning against an OCTAGAM an-tibiotic and human immu-noglobulin manufactured by Octopharma laborato-ry. Octopharma discov-ered a falsified batch in a 200ml bottle registered as N° B517A899T1, with an expiry date in October 2017. The falsified treat-ment is sold in different packaging than that of the genuine treatment and in bottles which are not made by Octopharma. COFEPRIS has al-ready identified two people who were dealing the illicit product. The falsified antibiotic is Proflax-F in 500mg tablet form. The medicine is allegedly manufactured in a fictive Mexican factory.

Warning against online slimming pillsSECRETAuthorities have issued a warning against buying online slimming pills via Facebook or Snapchat from a company named Avitia. The pills are called “Cobrax” and have allegedly caused the death of a 24-year-old woman. The Mexican health agency has also discovered other products such as Ares, Zoi, Gluk, forte Cobrax, Rox, Eshu, Fer X and Tralix, etc.

UNITED STATES

American laboratory Gilead warns against buying hepatitis C from online «buyers’ clubs» Gilead laboratory has warned against the use of generic versions of its blockbuster Hepatitis C medicine, Harvoni and Sovaldi. The products are procured by patients directly online through “buyers’ clubs” in which they group together to import medicines at a low-cost rate. Gilead warned that the generic online versions have not been approved for use in the countries into which they are imported, that they may be falsified medicines and are therefore potentially dangerous.

LATIN

AMERICA

SPAIN

Warning against falsified pregnancy and ovulation testsThe Spanish Agency of Medicines and Medical Devices (AEMPS) has issued a warning against online pregnancy and ovulation tests manufactured by Chinese company, SafeCare Biotechles. Both products are marked EC 0197; this number is registered under TÜV Rheinland, a German screening body. However, the latter informed health authorities that the certificate is falsified. The tests do not, therefore, comply with European quality standards. A further case involving an American company’s, Ever Ready First Aid & Medical Supply/Dixie Ems, surgical masks, gowns and caps with falsified EC numbers has also been revealed.

BRAZIL

Two batches of Hormonotrop 12 UI withdrawn from market after falsified products discovered The Brazilian Health Agency (ANVISA) has forbidden the distribution, sale and use of two batches of Hormonotrop 12 UI (a product used for growth failure in children). The medicine manufacturer, Chemical Laboratory Bergamo Ltda., confirmed that batches CC40706 and CC30963 are falsified. The Laboratory said that it noticed differences between the falsified products’ registration numbers and those of the authentic products.

MEXICO

Mexican Health Agency issues warning after discovering batch of falsified antibioticsThe Mexican Health Agency has opened an investigation following the discovery of a batch of falsified Penrexyl in 500mg form. The original product’s batch number is N° 3K02348. The fake product’s batch number is N° 3XO2348. Several differences in the labels are also visible on the falsified boxes. For example, on the fake product’s box, “500mg capsules” is written in red type, whereas on the original box it is in red type and the pharmaceutical laboratory name, which is usually written in upper case, is in lower case on the fake boxes.

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L EGISLATION & IMPLEMENTATION

BENIN

Parliament approves Medicrime Convention ratificationBenin deputies have approved the European Council’s Medicrime Convention signature and ratification. Claudine Afiavi Prudencio, President of the Education, Culture, Employment and Social Affairs Commission, urged deputies to «rapidly implement» the Convention in order to step up the fight against counterfeit medicines in Benin. The President outlined that «99%, if not 100%, of Benin dispensing pharmacies sell medicines of suspect quality».

MOZAMBIQUE

New medical product trading lawThe Mozambique parliament has adopted a new bill to amend the 1998 text on manufacturing and selling medicines and vaccines in

Mozambique. The bill will guarantee access to medicines for all and help the fight against fake medicines. From now on, medicines which are not registered with health authorities will not be permitted for sale or distribution within the country.

RUSSIA

New rules for medicine transportation and storageThe new rules for storage and transportation of medicines, approved by the Russian Ministry of Public Health, took effect on 1 March 2017. The amended Rules aim to preserve the quality of medicines throughout the supply chain. The adoption of the Rules is the next step in the harmonization of Russian and European laws. The Rules include:

• the creation of a separate area for storing falsified, substandard and fake medicines; this is intended to provide additional protection against such medicines being put on sale,

• stricter requirements for staff,

• a more effective quality control system,

• increased warehouse and transport supplier monitoring, and

• fines from €1,655 - €3,310 if the Rules are not respected.

The new storage, quality control and staff training requirements will reduce the number of substandard medicines in the Russian market.

AFRICA

ASIA

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SWITZERLAND

Medicrime convention ratification and tighter medicine packaging legislationOn 22 February 2017, the Federal Council presented parliament with its Medicrime Convention approval and implementation project. Switzerland signed the convention in 2011. The project entails improved information exchange, developed criminal investigation methods and clarified legal status for supplying therapeutic products. In line with the EU “falsified medicines” directive 2011/62/UE, the Federal Council also proposes that placing security devices on medicine packaging is legalized so that product authenticity may be checked and individual boxes identified

Stricter rules to increase medical device traceability receive EU approvalAfter several years of negotiations and the revelation of faulty breast implants and joint replacements, EU deputies have agreed on new medical device security rules. The rules provide for:

• random inspections of producers’ facilities after devices have been placed on the market,

• stricter controls on notified bodies, which will have to employ medically skilled people,

• an additional safety checking procedure for high risk devices, such as implants or HIV tests. Not only a notified body, but also a special committee of experts, will check that all requirements are met,

• an “implant card” for patients, enabling patients and doctors to track which product has been implanted, and

• a unique ID code for all medical devices to increase traceability.

INDIA

Reinforced medicine distribution and quality law The health minister has issued a draft amendment notification to the Indian Drugs and Cosmetics Rules of 1945 to prevent unqualified people from trading and distributing wholesale medicines. Only health authority-registered pharmacists will be authorized to supply and store medicine for distribution to retail pharmacy outlets. This law will also enable illicit and misbranded medicine trading to be more closely monitored throughout the country.

PAKISTAN

Health officials forbid trade in illegal traditional and alternative medicines containing allopathic ingredients

The Peshawar health minister, in north Pakistan, plans to ban the illegal sale of homoeopathic, Ayurvedic, herbal and Chinese medicines and nutritional and food supplements containing allopathic ingredients. This ban will be effective until quality, security, efficiency and price control mechanisms are implemented. The screening of 53,450 alternative medicine products taken from city markets between January and October 2016 has revealed that they contained allopathic ingredients. The fake medicines, which are sold as alternative medicines, are dangerous for patients’ health. The illegal manufacturing, importation, promotion and sale of these products has developed due to a 2012 Pakistan law which made selling non-prescription and alternative medicine sales legal. Action has been taken against the fake medicine manufacturers in Peshawar; not only are the products dangerous, they are also far from being natural, despite their claims

ASIA EUROPE


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CARIBBEAN

New regulation system to strengthen fight against fake medicinesThe CRS - Caribbean Regulatory System - will strengthen the current national regulatory capacity to improve the quality of pharmaceuticals and ensure safe access to medicines. The CRS was set up by the Caribbean Public Health Agency (CARPHA) in collaboration with CARICOM (the Caribbean Community Secretariat of 20 countries) and the World Health Organization/Pan American Health Organization. It is thought that the fake market share in the Caribbean could be as high as 30%. A recent report reveals that Haiti, Trinidad and Jamaica are believed to be the region’s biggest importers of illicit medicines from India. Guyana (often included as part of the Caribbean) was seen as a transshipment point for illicit medicines coming out of Brazil.

UNITED STATES

President signs order to prevent counterfeits from entering the USThe American president’s anti-dumping law is, amongst others, boosting the Customs and Border Protection’s ability to share information with rights holders to seek out intellectual property violations. The US attorney general has also been given new powers to develop prosecution practices and allocate resources to treat significant trade law violations as a high priority. American industry leaders have highly welcomed the decisions.

Florida adopts new fake opioids billFollowing a series of deaths linked to the use of falsified opioids, especially fentanyl, the Florida House of Representatives has unanimously passed a bill to crack down on the dangerous activity of falsifying this type of product. The bill introduces tougher laws, including first-degree murder charges, in the event of overdose deaths. As for heroin, the bill also intends to add fentanyl and other synthetic opioids, such as carfentanil, to the regulated products list.

Traffickers could face as many as 25 years in prison, fines between $50,000 and $500,000 and a first-degree murder charge if a person dies after ingesting the product.

CANADA

Six Canadians await extradition in counterfeit cancer treatment caseKristjan Thorkelson, Thomas Haughton, Ronald Sigurdson, Darren Chalus, Troy Nakamura and James Trueman have been accused by the US Department of Justice of illegally importing and selling $78 million worth of falsified medicines as Altuzan and Avastin brands. It is thought that CanadaDrugs.com, and its subsidiaries in the UK and Barbados, are central to a network which was importing and trading counterfeit cancer medicine to American doctors between 2009 and 2012. The medicines did not contain active ingredients. The six Canadian men were arrested under the Extradition Act then released on bail. They are currently awaiting their extradition hearing dates.

WHO to apply “substandard” and “falsified” as official terms On 25 January, the WHO Executive Board approved a new medicine-term decision. From now on, the SSFFC terms (substandard/spurious/falsely-labeled/falsified/counterfeit) used until recently, will be reduced and replaced by “substandard” and “falsified”. The new terms will respectively describe medicines as being of inferior quality or representing something that they are not. The word “counterfeit” will now be applied to defining a trademark violation. It is now up to The World Health Assembly, the annual gathering of all WHO members, to

a p p r o v e the draft decision.

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AMERICA

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L EGISLATION & IMPLEMENTATION

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legislation against counterfeit medicine. Jackson Ngnie Kamga, Cameroon Bar Association president, says the current penalties are not enough of a deterrent: “It is high time for Cameroon to join African states to start considering the transportation and commercialization of counterfeit medicines as a major crime, not a simple offence punishable by fines.”

IVORY COAST

Plans to destroy Roxy Market The Ivory Coast health minister announced that Roxy Market, widely known as the largest counterfeit medicine black market in Western Africa, will soon be completely destroyed. No date has been set at this stage. This decisive action aims to show the Ivory Coast government’s commitment to combating counterfeit medicines.

More than 400 tons of illicit medicines seized during operation held in seven African countries More than 420 tons of illicit medicines have been seized in an INTERPOL operation in West Africa. Operation Heera (15 May – 17 June) involved some 1,150 police and customs officials from Benin, Burkina Faso, the Ivory Coast, Mali, Niger, Nigeria and Togo. Raids were carried out on illicit factories, markets, shops, pharmacies, warehouses and vehicles. Forty-one million antibiotic pills, painkillers and antimalarial medicine and 13,000 cartons of illicit pharmaceuticals, such as vitamins and food supplements, were seized. One hundred and fifty people were also arrested.

ECOWAS steps up the fight against fake medicinesMembers of the Economic Community of West African States (ECOWAS), the parliament’s Committee on Health and Social Service and the Committee on Trade, Customs and Free Movement met in Morovia, Liberia, from 10-14 March to address fake medicines and how to combat them in the region. The participants adopted a resolution which calls on the State members to launch a large-scale investigation into fake and expired medicine trafficking, sponsor a campaign against this illicit activity, and take all the necessary steps to fight the proliferation of fake medical products. The document also encourages ECOWAS member States to implement “community legislation” in these areas.

BENIN

American agency USAID to provide Benin with new medicine-testing equipment

As part of its action against malaria in Africa, USAID has provided the Benin National Drug Quality Control Laboratory (LNCQ) with new medicine-testing equipment in the form of a high-pressure liquid

chromatography chain (HPLC). A USAID spokesperson said: “Benin is the second largest fake medicine entry point on the continent after Nigeria and represents almost a quarter of total trafficking.” The new device will reveal a medicine’s impurity levels and will strengthen the fight against fake medicines, especially fake malaria treatments.

CAMEROON

African lawyers seek tougher counterfeit medicine lawsLawyers from around Africa gathered in Cameroon this week to call for tougher

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BURMA

Fake-medicine crack downThe Burma Health Agency has announced its plans to step up the fight against falsified medical products by setting up more district branches in the country. The FDA director general said that: “27 new district branches have been set up since January and four more will be opened by the end of March.” Since 2016, 400 new staff have been appointed. The authorities plan to extend their actions to public awareness programs in villages in the near future.

AUSTRALIA

Hospital pharmacists’ key role in protecting patients from Sydney Children’s Hospital 2010 fake Viagra incident A recent ABC television report has shed light on the 2010 case during which thousands of falsified Viagra pills made their way into Australia’s official supply chain. The case highlights the vital role hospital pharmacists play in protecting patients from fake medicines.

A Sydney Children’s Hospital staff member raised the alarm when he noticed that the Viagra tablets, used to treat children with pulmonary hypertension, were grittier than normal and harder to crush. The tablets were supplied by one of Australia’s biggest medical distributors. The latter purchased the tablets from a Sydney pharmacist who, in turn, purchased the fake tablets from an unauthorized supplier. The pharmacist is currently appealing the court’s decision to cancel his pharmacist registration.

FRANCE

French National Academy of Medicine warns against falsified medicines and announces creation of inter-academic and inter-regional surveillance and monitoring committee The inter-academic and inter-regional surveillance and monitoring committee will carry out the following missions in conjunction with field operators (police, customs, justice and public health):

• ensure adherence to, and application of, academic and regional recommendations,

• alert decision makers,

• assist in implementing a strict legal framework,

• raise public awareness,

• support the implementation of traceability devices in poorer countries.

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UNITED STATES

New Mexico launches awareness campaign about the dangers of purchasing medicines elsewhere than in pharmaciesThe Order of Pharmacists, the local govern-ment and Santa Fe County have launched a campaign to raise consumer awareness about the risk of purchasing medicines elsewhere than in pharmacies. The campaign’s slogan is: “They are not sweets”. Consumers are en-couraged to denounce any shop which illegally sells medicines by calling this hotline number: 0800 999 7661. The campaign is a repeat 2013 initiative and was activated following a health ministry alert concerning an increase in unau-thorized medicine sales points.

FDA launches supply chain security toolkit for medical productsThe FDA has joined an international partner-ship to create and launch a new initiative to fight against illicit prescription medicines. The aim is to offer a supply chain security toolkit and to incite international industry players and regulators to adopt best practices whilst enforcing laws and regulations to protect con-sumers. The toolkit contains training materials intended to educate regulators, industry, health care professionals, and others, on supply chain fundamentals:

• good manufacturing practices;

• good distribution practices;

• good import/export practices;

• clinical/retail pharmacy practices;

• product security;

• detection technology;

• internet sales;

• track and trace systems;

• surveillance and monitoring;

• and single points of contact.

www.nifds.go.kr/apec/SupplyChain/APEC_SupplyChainToolkit_170317.pdf

European Economic and Social Committee (EESC) urges EU and Member States to step up the fight against falsificationThe latest EESC report reveals that the 5% of falsified products imported to Europe are worth €85m and generate the loss of roughly 800,000 jobs. The Committee reports that differences in EU legislation means that the problem is ongoing. The EESC has drawn up an action plan to:

• promote innovative tracking and monitoring applications;

• strengthen intelligence procedures and bilateral crackdown agreements;

• include anti-counterfeiting clauses in new FTAs;

• adopt specific joint rules to monitor online medicine and other sensitive product sales;

• draw up specific regulations together with the EMA (European Medicines Agency), Europol, the EFSA (European Food Safety Authority) and the ENISA (European Union Agency for Network and Information Security) to monitor sales of medicines, foodstuffs and other sensitive products on the internet, etc., and

• raise consumer awareness.

THE NETHERLANDS

Dutch police arrests 60 in national action against roaming criminal gangsThe police, the tax authorities, the local police branches and the immigration and naturalization service have collaborated in a wide-scale national crack-down. The search was for roaming criminals involved in numerous scams, including illicit medicine trafficking. As the criminals are mobile, the police also cooperated closely with the authorities in Germany, Belgium and Romania. Sixty people have been arrested.

DOMINICAN REPUBLIC

Suspicious medicine app launchThe health minister has developed an application for the general public to report suspicious medicines, food and other products. Consumers will be able to use the DigemApps application, available soon on the Google Play Store, to anonymously report products which they think are falsified, fraudulent or which do not meet health and quality standards. Consumers will also be able to upload a photograph of the incriminated product.

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