Counterfeit medicines are medical products, whose identity, nature and/or source are fraudulently misrepresented and labelled.
Even though these products are a serious threat to public health, the trade in counterfeit and illegal medical products is increasing worldwide: Today, it is a multi-billion Euro industry, often linked to organised crime.
The reasons for this trend are the high profits, the relative anonymity on the internet, the low risk of prosecution for the traders and the comparatively mild penalties.
Medicrime Convention
In order to put a stop to this dangerous development, the Council of Europe has set up its Convention on the counterfeiting of medical products and similar crimes involving threats to public health (CETS No. 211).
The Medicrime Convention, as it is called for short, is the first international treaty of its kind. It entered into force in 2016 and is open to member states and non-member states of the Council of Europe.
The Convention provides a framework for national and international co-operation as well as for coordination at national level.
Its scope covers all medical products; all accessories designated to be used together with medical devices and all substances and materials designated to be used in the production of medical products.
Parties to the convention are obliged to criminalise certain acts, such as:
- the manufacturing of counterfeit medical products
- the supplying, offering to supply and trafficking in counterfeit medical products
- the falsification of documents
- the unauthorised manufacturing or supplying of medicinal products
- the placing on the market of medical devices which do not comply with conformity requirements
Furthermore, members of the Convention are asked to take the necessary measures to establish the quality and safety requirements of medical products and ensure the safe distribution of medical products. They are required to provide for:
- the training of healthcare professionals, providers, police and customs authorities, as well as relevant regulatory authorities
- the promotion of awareness-raising campaigns addressed to the general public
- the prevention of the illegal supplying of counterfeit medical products
In addition, each Party has to take the necessary legislative and other measures to protect the rights and interests of victims of counterfeit medical products, in particular by:
- ensuring that victims have access to information relevant to their case
- assisting victims in their physical, psychological and social recovery
- providing for the right of victims to compensation from the perpetrators
Monitoring – Medicrime Committee
Responsible for the monitoring of the implementation of the Medicrime Convention by the member States is the Medicrime Committee.
Composition
Each member State nominates an expert to the Medicrime Committee, who has the right to vote and can be accompanied by other national representatives without voting rights. The Parliamentary Assembly of the Council of Europe, the European Committee on Crime Problems (CDPC), and other relevant Council of Europe intergovernmental or scientific committees nominate participants without voting rights. Other Council of Europe bodies such as the the Congress of Local and Regional Authorities, or the Conference of International Non-Governmental Organisations (INGOs) may appoint representatives without the right to vote as well.
Observers
Representatives of relevant international bodies such as the United Nations, the European Union, or Interpol, as well as those of non-governmental organisations (NGOs) can be admitted as observers.
Country profiles
Based on a questionnaire addressed to each member State – which provides the Medicrime Committee with a general overview of the legislative practice, institutional framework and policies for the implementation of the Convention at national level – the Committee publishes country profiles which are regularly updated.
Thematic monitoring
Thematic monitoring is carried out in rounds. Each round is dealing with a theme chosen by the Medicrime Committee and addresses a questionnaire to the member States. Based on this information as well as information gained through non‐governmental organisations (NGOs), the Committee publishes implementation reports.
European Pharmacopoeia and EDQM
All legally manufactured and sold medicines in Europe are subject to strict standards concerning composition, production and quality.
The Council of Europe’s European Pharmacopoeia includes more than 2’500 quality standards and guidelines and is the most comprehensive set of regulations of its kind in Europe.
It is elaborated and supervised by the European Directorate for the Quality of Medicines & HealthCare (EDQM).
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Photos: Medicrime Convention © Europarat; Medicines © Sir Robin Photography
