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Work programme CD-P-PH/CMED

Work Programme

Falsification of medical products and similar crimes in healthcare poses a risk to public health.

The CD-P-PH/CMED has given priority to the following projects:

  • transferring "know-how" and proven practices to member states' officials and concerned professionals through the delivery and management of multisectorial training and education and through publications;

  • providing public health authorities with model approaches and strategies on risk communication;

  • promoting a network of (Single) Points of Contact (SPOCs);

  • building and maintaining specific knowledge and intelligence;

  • support the implementation and monitoring of the Council of Europe Convention on counterfeit medical products and similar crimes involving threats to public health (MEDICRIME);

  • sharing model approaches with other international institutions and organisations.

 

Working methods

  • Trainings

  • Risk Communication Model

  • Publications

  • Expert support for the organisation of international events

Overview of Activities Related to MEDICRIME

 

Projects of interest

  • Joint working group with CD-P-PH/PC on borderline products. Products that have no clear-cut status and do not fall into specific regulatory categories are called borderline products. The decision as to whether these can be considered as medicinal products is usually taken on a case-by-case basis by national competent authorities. When a product is established as an unauthorised medicinal product, procedures for removing it from the market are not always clear and can vary across countries. This Working Group is tasked with assessing the extent of the issue and how countries deal with these problematic products, sharing experiences and devising potential ways forward to address the matter.

  • Joint working group with CD-P-PH/PC and PHO on the revision of Resolution ResAP(2007)2 on good practices for distributing medicines via mail order. This Working Group is tasked with revising and updating the resolution where needed and on the basis of recent developments. The resolution focuses mostly on the distribution of medicines and does not take into account the new EU regulation concerning online pharmacies. The Working Group will also take into consideration digitalisation of healthcare and remote prescriptions; the latter in particular has become a problem in some EU countries.

  • Volcano case – Follow up study
    The study aims at looking at violations noted during the Volcano case and to compare the applied sanctions with those available in other European countries. These sanctions will then be compared to possible sanctions when a country ratifies the Medicrime Convention. The idea behind the study is to analyse a large range of laws relating to pharmaceutical crime in full. The participants include Belgium, Bosnia and Herzegovina, Switzerland, and Germany. The study is carried out in cooperation between CMED delegates and prosecutors of participating countries.

  • Signals of Harm
    Project addressing a topic of importance for public health and researching into a practical tool (“decision aid”) for physicians to identify, during consultations, on whether it was probable or unlikely that a patient’s health damage was caused by falsified, falsely-labelled (counterfeit) medicines (misrepresented also as health care products or supplements). The article has been published on 21 June 2017 in BMC Health Services Research and can be downloaded here.

  • Medical Devices

    In an effort to support activities related medical devices, various activities are being considered to cover this field which also falls under the MEDICRIME convention and hence should not be neglected. One proposal of a member country currently being discussed is the setup of a web application to help medical device inspectors evaluating the risk of dealing with counterfeits. Furthermore, the current update of the Know-X database has taken into account specific aspects for better reporting of cases involving medical devices.

  • Study on "Identification of health damage caused by counterfeit/falsified medical ("Medicrime") products in Europe", 2011-2012, by the National Institute for Public Health and the Environment (RIVM)

  • UN Internet Governance Forum (IGF) Workshop Report "Medicines on the web - risks and benefits", 15-18 November 2009

  • Counterfeit medicines - Survey report (2006) by Dr Jonathan Harper and Mr Bertrand Gellie. For more information or to order this publication, please go to Council of Europe's Online Bookstore

  • Model Approach "Counterfeit Medicines in Europe: Risk Communication Strategies for Drug Regulatory Authorities", 25 November 2008

The term "counterfeiting" as used in the Medicrime Convention is meant in its broadest sense of "falsification".

 

More information on Falsified Medical Products activities

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