Worldwide ongoing National and Regional legislative processes in fighting falsified medicines January to March 2019

Falsified medicine, one of the largest health threats to populations around the world, has become a central focus of governments, regional organizations, agencies and pharmaceutical companies over recent years.
A major step forward was taken this year when the EU’s Falsified Medicines Directive (FMD) came into full force on 9 February, 2019.

Overview of Significant events and ongoing legislative processes.

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January 2019 – Benin: Coraq-lab project launch
The Ministry of Health has launched the “Cooperation in strengthening laboratory quality insurance” project in order to enforce the fight against fake medicines. The project was initiated by the Humanitarian Centre for Pharmaceutical Professions and financed by the Global Fund. The project should enable the implementation of a quality control tool for medicines available for consumption and thus guarantee good quality medicines for everybody.
Source: www.lespharaons.com

January 2019 – Guinea: special anti-fake medicines brigade created
The establishment of BRI-Medicrime – the Special anti-fake medicine Brigade – is the government’s first concrete initiative following the ratification of the Medicrime Convention. The Brigade was created by the High Command of the National Gendarmerie, the Ministry of Health and the French Embassy in Guinea. The Brigade’s tasks will be to:
• combat crime related to counterfeiting of medical products and attacks on public health;
• ensure compliance with, and effective implementation of, the provisions of the Medicrime Convention in the Republic of Guinea;
• protect the rights of victims of offences established in accordance with the Convention;
• protect public health by promoting national and international cooperation.
Source: www.ledjely.com

February 2019- Benin: Support to the African Medicines Agency created to tackle fake medicines
The African Union decided to create an African Medicines Agency during its 32nd summit which was held in Addis-Abeba, Ethiopia. The approach is in line with the African Union Health Ministers’ adoption of a resolution in 2018 to implement the African Medicines Agency Treaty. Beninese President, Patrice Talon, has backed the Agency’ upcoming launch.
Source : www.banouto.info

March 2019 – Harmonized Common Technical Document on quality medicines adopted in West Africa
In a bid to ensure that people living in West Africa have access to safe, quality and affordable medicines, the West Africa Health Organization (WAHO) says the implementation of the ECOWAS harmonized Common Technical Document (CTD) will help local medicine manufacturers to meet the standards expected of them by the international community. The CTD aims to harmonize the requirements for registration of medicines in West Africa. “A common technical document has been developed and we want to ensure that every member state uses the same document across the region. The issue is not just about counterfeit medicines, the issue is about quality, safe and accessible medicines. The CTD is a document that was harmonized by the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use; the same CTD that is applicable in Nigeria is applicable all over the world”, said a WAHO spokesperson.
Source : www.punchng.com

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January 2019 – India: Madras and Delhi judges temporarily suspend the sale of online medicines
The High Court of Madras has asked the central government to notify the statutory rules on the online sale of medicines before 31 January 2019 and to ban their online sales until then. This action came just a few days after the Delhi High Court made the same request. The judge said that pharmacies across the country would be allowed to sell medicines online only after obtaining licenses in accordance with the rules which are currently being drafted and not yet finalized. The law on medicines and cosmetics was enacted in India during colonial times, long before the advent of online commerce: according to the 1945 rules on medicines and cosmetics, it is prohibited to ship, mail or deliver prescribed medicines to private residences. However, medicines are available online on different websites and distributed across the country. To date, there are more than 3,500 such websites.
Source: www.indiatoday.in I www.bloombergquint.com

March 2019 – UAE: Government set to pass new measures to enforce fight against fake medicines
The legislation, currently under review, will charge anyone caught selling counterfeit medicine with up to five years in prison and a Dh1 million fine. The laws also stipulate up to a year in jail and a
Dh 500,000 penalty to those found guilty of peddling poisonous substances. Existing UAE legislation for the pharma industry dates back more than 30 years to 1983.
The Chief Executive and co-founder of PRA Health Sciences Inc. – Health Regulatory Consultancy – stated that: “New laws have to be introduced because Dubai has become a hub for pharmaceutical companies and this increases the chances of counterfeiting”.
Source : www.thenational.ae

Europ

January 2019 – Portugal ratifies the medicrime convention
The Medicrime Convention will enter into force in Portugal on April 1, 2019, making it the 12th Council of Europe Member State to have ratified the Convention.
Source: www.coe.int

February 2019 – UK: Less than half of UK pharmacies will be ready to implement the Falsified Medicines Directive on 9 February 2019
Jerome Bertin, General Manager of SecurMed, told The Pharmaceutical Journal that “less than half” of UK pharmacies have registered with the UK Medicines Verification System. However, under the European directive, UK pharmacies are required to register with SecurMed and have the hardware in place to scan the 2D barcode that must feature on all new packs of prescription medicine sold in Europe. The delay is thought to be due to uncertainties surrounding Brexit.
Source : www.pharmaceutical-journal.com

February 2019 – France is still preparing for the Falsified Medicines Directive
As of 9 February, medicines sold in Europe must be automatically scanned to ensure their authenticity. In France, however, pharmacies are not ready for the new legislation. Besides unwillingness on the part of some, pharmacists have flagged up other very real problems: how should out-of-stock medicines be billed? Or, how should medicines for patients who are unable to get to pharmacies, for example, those in retirement homes, be handled? The lack of response from the Department of Public Health, which is also awaiting answers from the European Commission, means that most software in pharmacies has not yet been updated to serialization. Both industrialists and wholesaler-distributors, on the other hand, are ready.
Source : www.nordlittoral.fr

February 2019 – Spain and Russia sign agreement on cooperation to improve fight against fake medicines
Spain and Russia are planning to develop their pharmaceutical cooperation by signing an agreement between the Spanish Agency of Medicines and Medical Devices (AEMPS) and the Russian State Institute of Drugs and Good Practices (SID & GP). The agreement on cooperation will focus on monitoring medicine manufacturing rules and sharing strategies to combat fake medicines.
Source : www.aemps.gob.es

March 2019 – Spain: Legislation review requested to improve “miracle product” sales monitoring
With the rise in allegedly miraculous health product offers, many people are urging that the regulatory framework for medical devices is adjusted and aligned with the framework applied to medicines. “For us, the priority is to update the legal framework, starting with the Royal Decree 1907/1996 on so-called health products approved at a time when the internet was virtually non-existent and monitoring was much easier to implement. Furthermore, for health products or nutritional supplements of questionable efficacy, but legally authorized in EU Member States, (and which can therefore be marketed in Spain), a change in regulation at European level would be necessary for national authorities. They could avoid marketing them”, said the OCU consumer association.
Source : www.65ymas.com

March 2019 –Slovenia signed the MEDICRIME Convention
Slovenia signed the MEDICRIME Convention. In total, there are 15 Parties to the Convention.
Another 15 are signatories or have been invited to accede.
Source : www.coe.int
latin-america

February 2019 – Dominican Republic: New law adopted against illicit trade, contraband and counterfeiting
The law 17-19 on illegal trade was enacted by President Danilo Medina. From now on, illegal trade will be punished by the confiscation of goods, proceeds, vehicles and other effects, and by the closure of premises used to commit the crime. The penalties provided for illicit medicine trading are a maximum of ten years’ imprisonment under the provisions of the General Health Act and its amendments.
Source : www.listindiario.com

March 2019 – Mexico – Senator Monreal introduces bill to improve the fight against fake medicines trafficking
On 29 March, Ricardo Monreal Ávila, Senate Movimiento Regeneración Nacional coordinator, presented his proposed bill to improve the fight against smuggling and fake medicines trafficking. The senator aims to amend the general health law so that any person who falsifies, contaminates, changes or allows medicines or pharmaceuticals to be altered, falsified, contaminated or modified, to be sentenced to 30 years and fined up to almost 11 million pesos.
Source : www.lanetanoticias.com

Capture d’écran 2019-06-03 à 15.50.21

March 2019 – WHO to develop guidance to help member states implement traceability systems for medicinal products
The WHO’s goal is to develop systems that can improve the functioning of healthcare supply chains, strengthen efforts to prevent patients from exposure to fake medicines, and improve the affordability of pharmaceuticals. The first task for the WHO will be to convene an expert group that will be able to assist the agency in issuing “a normative guidance on the establishment of traceability systems and on the policies needed at national and regional level.”
Source : www.securingindustry.com

Serialization I European Union Falsified Medicines Directive

Capture d’écran 2019-05-07 à 12.19.02On February 9 2019, the 2011/62/EU Falsified Medicines Directive introduced the obligation to attach safety devices on medicines to prove their integrity and authenticity. The Directive proposes measures to make the European Union (EU) medicine supply chain safer. For its part, the Delegated Regulation (EU) 2016/161 outlines the provisions within the Directive.

The new rules are mainly based on affixing an anti-tampering and authentication device on prescription medicine packaging. Until now, health product traceability was applied at batch level. From now on, each packaging line generates, prints and checks a unique data matrix code for each box, and uploads the code in a data base. The data matrix code contains several types of information: batch number, expiry date, and presentation identification code (known as the CIP code) which provide information about the medicine type.

In order to monitor and coordinate how the law is set up, the Delegated Regulation provides for the implementation of a European governing body, EMVO (European Medicine Verification Organisation), and national representative bodies, NMVOs (National Medicine Verification Organisation). These bodies are in charge of, respectively, the European-level data management system, known as EMVS (European Medicine Verification System), and that of each Member State, NMVS (National Medicine Verification System).

Source: https://emvo-medicines.eu/mission/emvs/

Source: https://emvo-medicines.eu/mission/emvs/

More than 400,000 European pharmacies affected by the Directive

In practice, security device verification means that pharmacies and health centers must be equipped with a system which checks the unique ID code on each medicine box by carrying out the following actions:
• “Data matrix” code reader affixed to the box by the manufacturer;
• Connection to a national database which checks the authenticity of the unique identifier code; this database also receives data from the EU database in which pharmaceutical manufacturers record the data of the specialties submitted for serialization;
• Serial number deactivation after national database information is received which attests the authenticity of the unique identifier.

Several setting-up issues and delays

  • In France:
    The scope of application for the unique identifier applies to all prescription medicines, except those listed in Annex 1 of the Delegated Regulation for implementing the Directive. However, whilst pharmaceutical companies are able to affix the unique codes on the packaging of their products, pharmacies are currently unable to deactivate the very same codes due to inadequate software.
  • In United Kingdom:
    To date, as no decision has been taken regarding the UK’s exit from the EU, it is hard to determine to what extent pharmaceutical regulations will be affected. If the UK leaves the EU with a deal, there will be little impact as British firms are meant to facilitate the new legislation in the same manner as Member States. If there is no deal, the British supply chain will not be obliged to apply the terms of the Falsified Medicines Directive and UK organizations will not have access to the EU central database.
  • In Belgium:
    The new system for labeling prescription medicines appears to be problematic for pharmacists and patients. Some medicine packaging and doses are said to be currently unavailable, often for several months at a time. The new labeling legislation, as provided for in the EU Fake Medicines Directive, is the reason behind the issue.
  • The Netherlands:
    The Falsified Medicines Directive could wipe some medicines off the market.
    The new EU directive requirements come with a significant price tag, but the EU has not made extra money available. As well as fronting the money to develop EU and national databases, companies have to redesign packaging and buy new hardware and software that can add expenses of around €500,000 per packaging line, according to Medicines for Europe. In the Netherlands, where prices are low in part because health insurers are allowed to pick the cheapest version of a medicine, these additional costs are affecting business decisions. “There’s not enough margin in our prices to overcome these costs,” said a spokesperson from the Dutch association for generic medicine manufacturers. “If there is no solution for these extra costs, there will be the risk that the companies will withdraw their products.” Older generics, that have been on the market for decades and are sold for pennies, such as many antibiotics, could be hit particularly hard – as could medicines made by smaller companies producing less than 100,000 units.

Serialization: global overview

Adents-serialization-mapSerialization is already mandatory in many countries such as Argentina, Saudi Arabia, Iran, South Korea and China. Turkey was one of the first countries to adopt serialization and numerous others have based their laws on Turkey’s experience.

• Belgium, Greece and Italy have already set up coding systems and have until 02/2025 to harmonize their systems with the Falsified Medicines Directive requirements. Some non-Member States like Switzerland, Norway and Iceland have decided to apply the Falsified Medicines Directive.
• Serialization has been mandatory in the US since November 2017, however, the Food Drug Administration (FDA) has stated that it “will not take actions against manufacturers who have not affixed or printed a unique ID code on each medicine packaging before November 27, 2018”.
• Pakistan will implement pharmaceutical serialization in December 2019, followed by Jordan (01/2020). Russia is still changing deadline information. At the time of printing, the official deadline was January 2020.
• In Brazil, serialization and aggregation will be mandatory as of 12/2021.
• On the basis of Saudi Arabia’s initial experiences with serialization, other members of the Cooperation Council for the Arab States of the Gulf are likely to do the same, and will adapt needs if necessary.
• Ukraine will probably implement supply chain safety measures given that its neighboring countries, Europe and Russia, have implemented serialization.
• India is currently demanding serialization and aggregation for exports only and will most likely extend current legislation to pharmaceuticals intended for the domestic market.

WHO has announced that it will develop guidance to help Member States implement medicinal product traceability systems. Its priority task will be to summon a group of experts to assist with publishing “a normative guidance on the establishment of traceability systems and on the policies needed at national and regional level.”

The IRACM is celebrating its 8th anniversary! Awareness-raising actions review.

The IRACM was created in November 2010 and is celebrating its 8th anniversary: a prime opportunity to review one of its vital objectives, which is to make as many people as possible aware of the dangers of fake medicines. A recent survey conducted by French pharmaceutical wholesalers revealed that 64% of French people were “very worried” about the sale of fake medicines on the internet. Has the general public become more aware of the dangers? This is the IRACM’s greatest hope, as one of the main reasons behind increasing fake medicines is the lack of patient awareness and a general lack of information about the associated risks.

The IRACM, an information-sharing pioneer

In developed countries, and most especially in France, healthcare systems are widely trusted. However, certain factors are generating risk behaviors, such as: the desire to bypass regulations for some medicines (psychotropic substances or erectile dysfunction treatments, for example); the rise in self-medication; and the advent of the internet. Over the past eight years, the IRACM has focused on getting to the root of the problem and raising public awareness about the nature, level of danger and extent of the threat.

Illustration-5“Le Faux médicament KESAKO ?” awareness campaign.
A fun website and advice leaflet for patients in doctors’ and hospital waiting rooms.
“Le Faux médicament KESAKO ?” (What in the world is a fake medicine?) is the first ever patient information leaflet which explains the dangers of medicine falsification. A total of 180,000 copies of a 16-page brochure were distributed in doctors’ and hospital waiting rooms.
http://www.le-faux-medicament-kesako.com

“Fake vaccines”, “Fake veterinary products”.
Two information posters illustrate the extent of the trafficking.
In addition to the Kesako awareness campaign, these information brochures deal with two pharmaceutical product categories which are also affected by falsification: vaccines and veterinary products.
http://www.iracm.com/vaccin/mobile/#p=1
http://www.iracm.com/veterinaires/mobile/

“The 12 golden rules to safely purchasing medicines online” awareness campaign.
Useful advice for purchasing safe online medicines.
livret-internet-IRACMThe IRACM’s 12 golden rules aim to equip consumers and internet users against the dangers of buying medicines online and ensure they choose safe e-pharmacies. The campaign was rolled out as a brochure, computer graphics and three educational videos.
• The hidden side of illegal online wesbites
• Max and Tony: The risks of purchasing online medicines
• Max and Tony: 12 golden rules for safe online purchases
http://www.le-faux-medicament-kesako.com/2016/11/16/12-regles-dor-ne-risquer-sante-vie-achetant-medicament-internet/

“Traveling with medicines” 
An educational booklet distributed in French pharmacies.
The IRACM created the booklet in partnership with the National Association of French Pharmacy Students (ANEPF), the National Institute of Industrial Property (INPI), the National Order of Pharmacists (ONP) and the French anti-falsification committee (CNAC). Almost one million copies of the booklet were printed and distributed in almost all French pharmacies.
http://www.le-faux-medicament-kesako.com/les-medicaments-en-voyage-2/

“La famille Toutfaux” (The Allfakes) video. A catchy and viral short film for the whole family.
Illustration-6This sitcom-style humorous film features a French family, three of whom have tried to buy so-called “comfort” products online. The video was viewed by over three million people on social media in several weeks.
https://www.youtube.com/watch?v=JwplAEjzUjI

The IRACM took up the challenge and raised awareness amongst young people

“E-pharmacies” are rife and email and social media spams have become the primary vector for fake medicine trafficking. The concern is that future generations will be increasingly targeted by adverts which spout the virtues of various products. In response to this new concern, the IRACM created information tools to remind users of the basic digital rules. 

Illustration-7“Le choix d’Hugo” (Hugo’s choice) is the first interactive fake medicines video.
This video is the first of its kind and was screened on World Anti-Counterfeiting Day 2016. “Le choix d’Hugo” aims to raise awareness of the dangers of purchasing online medicines amongst younger populations: school children and students. The video features a highly realistic, multiple-choice scenario in which viewers become heroes themselves: Hugo is a young undergraduate who tries to improve his grades with medicines. It’s over to the players to make the right choices!
http://www.iracm.com/hugo/

“Blake Cartel 2.0”, the first fake medicines video game to win the 2017 Trophées de la Communication award.
In “Blake Cartel 2.0” the IRACM makes players take on hero Blake’s persona. Blake is an undercover cop in a south-American drug trafficking cartel. Players are fully immersed in the game and gradually discover the hidden side of organized crime as well as the dangers of medicine falsification. The free game was downloaded almost 1000 times within the space of a month on  Apple Store and Google Play, It also won the 2017 Trophées de la Communication award for the Best Category of independently-organized communications actions.

“Bad pills”, a second video game for mobile phone.
Capture d’écran 2019-05-24 à 15.10.10The player must be able to distinguish the fake drug(s) on drug platelets; as the game progresses, he will discover prevention tips and recommendations for good practice.

http://www.iracm.com/bas-pills

“Faux médicaments, attention danger !” (Fake medicines = danger!), is a cartoon for young African schoolchildren, created in collaboration with the Chirac Foundation.
Capture d’écran 2019-05-24 à 15.06.43The aim is to raise children’s awareness of the danger of buying medicines on the street. It also teaches them how complex and difficult it is to trace criminal networks.
https://youtu.be/QkdO607K9RY

The IRACM, a training program leader

Correctly-trained teams who understand the dangers of, and can identify, fake medicines are indispensable in the fight against new strains of fake medicine traffickers. It is for this reason that eight years ago, the IRACM developed international, high-level, specialized training programs. The Institute also took part in creating diploma-level e-learning modules.

elearning-iracm2A Pharmaceutical Cybercrime Investigation e-learning module with the University of Technology of Troyes.

The UTT (University of Technology of Troyes) has been running cybersecurity training programs for police officers and students for more than 10 years. Through the IRACM’s expertise and support, the UTT was able to develop its offer by adding a pharmaceutical cybercrime training program.

A comprehensive, free, e-learning program to learn everything there is to know about medicine falsification.

The IRACM’s online training program is educational and fun. The program’s seven modules inform viewers how medicines are manufactured and marketed, how medicine falsification is organized, legislation applied and also provide more practical information about how to detect an illegal e-pharmacy or how to authenticate a packet of medicines. The free e-learning program is available in French, English and Spanish and is intended for all ages. http://www.iracm.com/elearning/IRACM_en.html

Research: the IRACM’s priority task

Illustration-8Fake medicine traffickers are still riding on the back of a widespread lack of knowledge of the extent and nature of the problem. This lack of knowledge generates a level of neglect not only from consumers, who are potential victims, but also from national and international law enforcement authorities who could actually effectively fight this trafficking. This is why research is the IRACM’s priority task.

“Medicine counterfeiting and criminal organizations” study report. A pioneering report analyses new criminal strategies related to fake medicine trafficking.
This first-ever international study is based on an analysis of concrete cases and interviews with world-renowned experts and provides a detailed typology of criminal activities revealed in recent years. The report also provides an overview of new health and geopolitical issues which are inherent in the development of such trafficking, and avenues for more effective prevention and repression.

Worldwide ongoing legislative processes in fighting falsified medicines July to December 2018

Through its legislative, judicial and executive authorities, each State try to develop strategies and measures adapted to its particular situation to secure Health of its citizens against falsified medicines.
The initiatives of some states can serve as enlightening models for others. Around the world, Governments, Health agencies, associations and pharmaceutical laboratories are multiplying individual or concerted actions and are effectively stemming the scourge.

Overview of Significant events and ongoing legislative processes

africa-2
July 2018 – Nigeria: mobile medicine authentication system enforced

In response to the House of Representatives’ call to enforce the fight against fake medicines, the National Agency for Food and Drug Administration and Control (NAFDAC) has enforced its Mobile Authentication Scheme (MAS) to curb the menace. MAS was deployed in 2010 as an anti-counterfeiting tool to curb substandard and falsified medical products, primarily antimalarials and antibacterials. NAFDAC is collaborating with Clinton Health Access Initiative (CHAI). Considering that NAFDAC has over 11,000 registered pharmaceuticals, the manpower that will be needed to authenticate all products will be enormous.
Source : www.vanguardngr.com

July 2018 – Uganda: government to centralize importation of veterinary medicines and vaccines to improve fake medication influx monitoring
Many wholesalers import products into Uganda that do not meet standards. Therefore, the government wants to introduce a new veterinary medicine importation policy. “With the new policy, the animal health commissioner will screen all veterinary drug and vaccine dealers before being licensed to distribute veterinary drugs in the country”, said the Minister.
Source : www.busiweek.com

July 2018 – Cameroon: Technical workshop to validate the adoption of a preliminary draft sub-regional reference framework for the harmonization of offences and sanctions related to the practice of pharmacy in the CEMAC zone organized by OCEAC in Douala

December 2018 – Benin: Coraq-lab project launch
The Ministry of Health has launched the “Cooperation in strengthening laboratory quality assurance” project in order to enforce the fight against fake medicines. The project was initiated by the Humanitarian Centre for Pharmaceutical Professions and financed by the Global Fund. The project should enable the implementation of a quality control tool for medicines available for consumption and thus guarantee good quality medicines for all.
Source : www.lespharaons.com

December 2018 – Guinea: Special anti-fake medicines brigade created
The establishment of BRI-Medicrime – the Brigade for the repression of illicit products likely to affect public health – is the government’s first concrete initiative following the ratification of the Medicrime Convention. The Brigade was created by the High Command of the National Gendarmerie, the Ministry of Health and the French Embassy in Guinea. The Brigade’s tasks will be to:
• combat crime related to counterfeiting of medical products and attacks on public health;
• ensure compliance with, and effective implementation of, the provisions of the Medicrime Convention in the Republic of Guinea;
• protect the rights of victims of offences established in accordance with the Convention;
•protect public health by promoting national and international cooperation.
Source : www.ledjely.com

December 2018 – Rwanda Bans Fake Drugs from India And China
Rwanda Food and Drugs Authority (FDA) has banned both Misoprostol and Oxytocin, two types of drugs used to prevent postpartum haemorrhage after finding out that they were substandard. The drugs entered the country between 2017 and June 2018 from India and China.According to FDA’s statement, the decision was taken after a joint investigation by FDA, University of Rwanda (UR) and Tübingen University from Germany indicated that the drugs did not meet the minimum substandard.
Source : www.taarifa.rw

asia-2September 2018 – India: Government presents bill to regulate online medicine sales
The Health Minister has published “draft rules for the sale of medicines by online pharmacies nationwide.” The draft regulations state that no person or entity will distribute or sell, stock, exhibit or offer the sale of drugs until registered with the Central Drugs Standard Control Organisation (CDSCO). The registration is a 3-year license to operate an e-pharmacy, after that period the companies will have to apply for a renewal. The sale of tranquilizers, psychotropics, narcotics and habit-forming medication is prohibited with no exceptions. In addition, online pharmacies are required to set up 24/7 call centers as a customer helpline to address grievances and doubts.
If any e-pharmacy violates these regulations and requirements, their license will be suspended and possibly cancelled.
Source : www.businessinsider.in

September 2018- Pakistan: Enforced medical store inspections
The Balochistan Health Department has introduced new rules under Section 44 of the 1976 Act in a bid to launch a crackdown against fake medicines sales.Using the new rights, the authorities would be responsible for monitoring and launching inspections at nationwide medical stores to ensure that quality medicines are being sold to the people of Balochistan. The inspectors would have full power to launch strict action against, and seal, any medical store found selling fake and counterfeit medicines.
Source : www.tribune.com

October 2018 – China: New draft law to enforce the fight against fake medicines
Companies that produce or sell pharmaceuticals without a permit, or that produce or sell fake medicines, will face fines up to 30 times the value of the products involved, according to the draft amendment to the Drug Management Law. Existing legislation provides for fines of up to five times the value of the product. Producing or selling fake medicines will result in the suspension of business and revoked certificates, while the production or sale of substandard medicines will result in fines of up to 15 times the value of the products produced or sold, and may result in other penalties such as business suspension or revoked permits. In addition to fines, perpetrators may also face criminal sentences. Production or sale of some special types of medicines – such as vaccines and medicines meant for children and pregnant women – will be subject to tougher penalties.
Source : www.china.org

December 2018 – Madras and Delhi judges temporarily suspend the sale of online medicines
The High Court of Madras has asked the central government to notify the statutory rules on the online sale of medicines before 31 January 2019 and to ban their online sales until then. This action came just a few days after the Delhi High Court made the same request. The judge said that pharmacies across the country would be allowed to sell medicines online only after obtaining licenses in accordance with the rules which are currently being drafted and not yet finalized. The law on medicines and cosmetics was enacted in India during colonial times, long before the advent of online commerce: according to the 1945 rules on medicines and cosmetics, it is prohibited to ship, mail or deliver prescribed medicines to private residences. However, medicines are available online on different websites and distributed across the country. To date, there are more than 3,500 such websites.
Source : www.bloombergquint.com

Europ

October 2018 – The Czech Chamber of Deputies is proceeding to the first reading of an amendment to the law on medicines, a change that aims to adapt to European directives against counterfeit medicines.

If it is finally approved, citizens who wish to receive a vaccine that is not compulsory will have to go to the pharmacy with a prescription from the doctor, and then return to the doctor after purchasing the vaccine. This law, which would come into force in February, would affect some of the most typical vaccines in the Czech Republic, such as the flu vaccine or the vaccine used against tick meningoencephalitis. Faced with this perspective, there are doctors and pharmacists who are dissatisfied because they think that this can reduce the percentage of vaccinations. For the Minister of Health, Adam Vojtěch, the Government is in a difficult situation, because it is necessary to comply with the European guidelines.
Source : www.radio.cz

November 2018 – Switzerland: Medicrime Convention to enter into force on January 1
Switzerland ratified the Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health
The Medicrime Convention will enable internationally coordinated action to be taken against fake medicine trade. Switzerland signed the Convention in 2011 which entered into force in 2016. The Convention provides for measures to prevent and protect victims and regulates cooperation between competent authorities at national and international levels. Patent protection and intellectual property law are expressly excluded from the scope of the Convention.

December 2018 – Portugal ratified the Medicrime Convention
Portugal has deposited the instrument of ratification of the MEDICRIME Convention.
The Convention will enter into force concerning Portugal on 1st April 2019. Portugal is the 12th Member State of the Council of Europe to have ratified the MEDICRIME Convention.

etats-unis

September 2018 – New bill to address opioid crisis
The bipartisan bill, H.R. 6 (115), attempts to address nearly every aspect of the public health epidemic from expanding addiction treatment and prevention program access to beefing up law enforcement efforts to curtail the trafficking of illegal drugs. “In H.R. 6, we take important steps to combat illicit and synthetic drugs coming across our borders, encourage the development of new non-addictive painkillers, improve prescription drug monitoring programs, remove outdated barriers that hamper access to care (…). While there is more work to be done, this bipartisan legislation takes an important step forward and will save lives.”
Source : www.docs.house.gov

October 2018 – Adoption of new law to combat national opioid crisis
The new SUPPORT for Patients and Communities Act was introduced to help the FDA intercept illegal medicines arriving in the US. The Act provides for measures such as a higher level of collaboration between the FDA’s Criminal Investigation Department (CID) and the United States Department of Customs and Border Protection (CBP). From now on, it will be easier for the FDA to detain, refuse and destroy imported products without labels and products which are undeclared or contain active ingredients. The Act also includes a mandatory decree by which the American postal service must screen all parcels arriving from overseas for illicit opioids and provide “detailed information about the parcel”. In concrete terms, the law requires data transmission for at least 70% of international parcels by December 31, 2018 and for 100% of all parcels from China and parcels departing from overseas territories by December 31, 2020.
Source : www.libertepolitique.com

October 2018 – US may stop subsidizing certain postal services in order to combat the import of illegal medicines
Donald Trump has announced that the US is withdrawing from the Universal Postal Union (UPU). This UN body works to harmonize national postal services to enable the delivery of mail worldwide, but it also acts by ranking countries according to their economic development, “in order to subsidize trade from less developed countries”. India and China are amongst the countries that receive the largest subsidies but illicit opiate drugs trading in the United States is partly supplied in China and abortion drugs are sent from India to American women who request them on a website called Aid Access. In response to this “cheap import of misoprostol and mifepristone” for abortions, the FDA announced its intention to investigate Aid Access and issued a warning “urging women not to endanger their health by buying these products online”.
Source : www.genethique.org

Medicrime Convention: Signatures and ratifications as of 18thDecember 2018
medicrime-eng copie

REGIONAL CONFERENCE ON FALSIFIED AND SUBSTANDARD MEDICINES I Phnom Penh I 5-6 November 2018

The 5th and 6th November 2018 the “Regional Conference on Combating Falsified Photo-1and Substandard Medicines” has been held in Phnom Penh at the instigation of the Government of Cambodia and the International Institute for Research Against Counterfeit Medicines (IRACM).

For the first time Ministerial representatives of the 5 Mekong countries Photo-2(Myanmar, Thailand, Laos, Cambodia and Vietnam)  met together in order to achieve the common aim of tackling and fighting falsified and substandard medicines. 

 It has been attended by more than 450 participants from various government institutions and the private sector. The final Declaration includes a plan of action for tougher legislation in the Mekong countries and regional cooperation including China. Photo-3It focuses on: «strengthening national legislation; implementing rapid alert and recall system; developing international cooperation in fighting cross border illegal traffic».

In the coming months, three seminars will take place to prepare laws criminalizing these traffics and organizing the regional cooperation. In its conclusion, the Declaration states that in one year, a second regional ministerial conference will be held in the Asian region and will assess the progress achieved. Besides, the five other ASEAN countries (Brunei Darussalam, Indonesia, Malaysia, Philippines and Singapore) will be invited to join the founding members.