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.


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.

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.

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.
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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.
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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.
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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”.
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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.

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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.”
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