Work programme CD-P-PH/CMED
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.
Risk Communication Model
Expert support for the organisation of international events
Projects of interest
Resolution or recommendation on theft of medicines
The CMED committee is working on a new project that will cover issues related to the theft, loss and diversion of medicines from the legal supply chain from a public health angle; the criminal law aspects will be outside its scope. The goal of this project is to draft a Committee of Ministers recommendation to member states in order to involve health authorities at an early stage by obliging stakeholders to report thefts, losses or diversions of medicines to them; to provide guidance on how authorities should deal with the information they receive and the follow-up action to be taken; and to promote international co-operation.
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.
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.
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)
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
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.
The term "counterfeiting" as used in the Medicrime Convention is meant in its broadest sense of "falsification".
- A webinar on the use of the KnowX database is in preparation for Q2 2021
- 5th MEDICRIME Workshop for GMDP and Pharmacy Inspectors 23-24 June 2020, Bern, Switzerland (cancelled due to the COVID-19 pandemic)
- 4th MEDICRIME Workshop for GMDP and Pharmacy Inspectors 3-4 December 2019, Malta
- 3rd MEDICRIME Workshop for GMDP and Pharmacy Inspectors 22-23 March 2018, London, UK
- 2nd MEDICRIME Workshop for GMDP and Pharmacy Inspectors 4-5 Oct 2017, Warsaw, Poland
- 1st MEDICRIME Workshop for GMDP and Pharmacy Inspectors 8-9 November 2016, Oslo, Norway
- National Cooperation Programme Against Counterfeiting (Falsification) of Medical Products: Single Point of Contact (SPOC) Networks 28-29 April 2016, Dakar, Senegal
- National Training: Cooperation & Networking among SPOCs to Effectively Fight Counterfeiting (Falsification) of Medical Products and Similar Crimes & to Protect Public Health 18-19 November 2015, Amman, Jordan; 28-29 October 2015, Yaounde, Cameroun; 7-8 October 2015, Accra, Ghana
- APEC Life Science Innovation Forum (LSIF) Regulatory Harmonization Steering Committee (RHSC) Training Program on Establishing of a ‘Single Point of Contact System (SPOCs) Building International Cooperation to Protect Patients 26-29 January 2015, Clark, Philippines
- National Training: Cooperation & Networking among SPOCs to Effectively Fight Counterfeiting (Falsification) of Medical Products and Similar Crimes & to Protect Public Health
- 25-26 November 2014, Rabat, Morocco
- Regional Training: Angola, Burundi, The Central African Republic, The Republic of the Congo, The Democratic Republic of the Congo, Rwanda, Sudan, Uganda, Tanzania, Zambia 3-7 November 2013, Kinshasa, D. R. Congo
- Regional Training: Estonia, Finland, Latvia, Lithuania, Poland, Russian Federation (St Petersburg & Kaliningrad Region) 28-29 May 2013, Riga, Latvia
- Regional Training: Albania, Bosnia & Herzegovina, Croatia, Greece, Montenegro, Serbia, Slovenia, ‘The Former Yugoslav Republic of Macedonia’ 4-5 December 2012, Zagreb, Croatia
- Regional Training: Armenia, Belarus, Georgia, Kazakhstan, Moldova, Russian Federation, Ukraine 8-9 November 2012, Yerevan, Armenia
- Regional Training: Bulgaria, Hungary, Poland, Romania, Slovak Republic, Republic of Türkiye, Ukraine
- 27-29 March 2012, London, UK
- Expert Workshop: Communication about the Risks Posed by Counterfeit Medical Product and Similar Crimes
- 29 November 2011, Rome, Italy
- Regional Training: Estonia, Finland, Latvia, Lithuania, Norway
- 19-20 May 2011, Oslo, Norway
- Working Across Disciplines and Borders – Best Practices to Combat Counterfeiting of Medicines and to Protect Public Health: 19-20 January 2010, Lisbon, Portugal; 16-17 June 2009, Rome, Italy; 18-19 November 2008, Larnaca, Cyprus; 27-28 June 2008, Strasbourg, France; 6-7 December 2007, Strasbourg, France.
The EDQM Know-X database collates reports on falsified medical products in the Council of Europe member states and allows its users to send out Rapid Alerts to their authorised network. It also provides a tool for information exchange between experts from different countries and authorities.
CD-P-PH/CMED Committee meetings take place twice a year, during spring and autumn, usually in Strasbourg.
Meetings have continued during the COVID-19 pandemic, but in a virtual format.