- Joint Working Group with the Committee of Experts 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 the Committees of Experts CD-P-PH/PC and CD-P-PH/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 "MEDICRIME vs Volcano" looked at violations noted during the Volcano case and compared the applied sanctions with those available in other European countries. These sanctions were then compared to possible sanctions under the Medicrime Convention. The idea behind the study was 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 was carried out in cooperation between CMED delegates and prosecutors of participating countries. It has been published and can be downloaded on the EDQM website.
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.
- 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
- Joint initiative to develop best practices for traceability of medicines in hospital setting to minimise the occurrence of medication administration errors and ensure patient safety.
- Guideline “Falsified medicines – what does it mean?” - the main objective is to provide guidance to regulatory authorities on which specific falsification practices should be considered as falling under the broad legal definition of ‘falsification’ as put in e.g. the MEDICRIME convention. Further insight will be given to the differences in national legislation, interpretation or cultural aspects, which may influence practical considerations of defining falsified medicines between countries, and provide a first step to a harmonised understanding of falsification.
Survey: Falsification of medical devices