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
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
September 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
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.
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