A Practical Guide for EU investigations on Falsified Medicines
This Guide is the main result of the project “Pharmacrime 3“. The intention of the Guide is to provide investigative processes and techniques to countries developing investigative capability to combat pharmaceutical crime. The Guide has been made for the benefit of EU investigators with no or limited experience on falsified medicines investigations. The Guide proposes a step-by-step approach illustrated with practical examples. This step-by-step approach is illustrative only: in most countries these steps will have to be adjusted to national rules and legislation.
The Guide has been drafted in English. It has been translated in 12 European languages (see table below). The English Version of the Guide will be regularly updated. Readers are invited to share their comments or inputs. Relevant inputs will be included in each new version of the Guide and source of the inputs will be acknowledged. Contact info@eucojust.org for more information.
| ENGLISH | click here
(original version of 1rst June 2014) |
| Croatian | click here |
| Dutch | click here |
| German | click here |
| Greek | click here |
| Hungarian | click here |
| Latvian | click here |
| Lithuanian | click here |
| Polish | click here |
| Slovak | click here
(available in October) |
| Slovenian | click here |
| Spanish | click here |
Table of contents of the Guide
Introduction 4
Aide memoire 6
1. Definitions 8
1. What is a Medicine? 8
2. What are falsified medicines? 83. Criminal conducts related to falsified medicines 11
2. Main steps of an investigation on falsified medicines 12
STEP 1: Receiving the signal 12
STEP 2: Establishing basic facts 13
STEP 3: Assessing health risks 14
STEP 4: Laboratory analysis 14
STEP 5: Consider quarantine and alert 16
STEP 6: Identify the offence and the jurisdiction 17
STEP 7: Identify points to prove and ways to obtain admissible evidence 18
STEP 8: Structure your investigation team 21
STEP 9: Identify a spokesperson and a media strategy 21
STEP 10: Establish reporting lines 22
STEP 11: Trace the point of entry into the distribution system 22
STEP 12: Inspection of wholesaler premises and seizures of evidences 23
STEP 13: Identify the type of falsification 24
STEP 14: Assess financial documents 25
STEP 15: Collect statements 26
STEP 16. Map the extent of the distribution of falsified medicines 26
STEP 17. Charge the suspect 27
ANNEX 1 – Definitions 28
1. Medical devices 28
2. Pharmaceutical crime 29
3. Falsified Medicines, Counterfeit, Substandard and Fraudulent 29
4. Substandard medicines 30
5. The Legal Supply Chain 30
6. Risks of entry into the legal distribution chain 31
7. The European Falsified Medicines Directive 32
8. The Medicrime Convention 33
9. Similar crimes involving threats to public health 34
ANNEX 2 – Investigation team 35
ANNEX 3 – International cooperation 37
1. Situation 37
2. Framework for international cooperation 37
ANNEX 4 – Identifying Assets and proceeds of crime for forfeiture applications 39
ANNEX 5 – dentifying Stakeholders in pharmaceutical investigations 40
1. Industry 40
1.1. Manufacturers 40
1.2. Wholesalers & Distributors 41
1.3. Retailers / Pharmacists 41
1.4. The Pharmaceutical Industry 41
1.5. The Chemical Industry 42
2. Enforcement 42
2.1. Police 42
2.2. INTERPOL 43
2.3. Europol and Eurojust 43
2.4. Customs 43
2.5. WCO 44
2.6. RILO 44
2.7. Permanent Forum on International Pharmaceutical Crime (PFIPC) 44
2.8. Heads of Medicines Agencies Working Group of Enforcement Officers (HMA WGEO) 45
2.9. Department of Immigration 45
2.10. Department of Internal Affairs/Passport Office 45
2.11. Scientific or Forensic Laboratories 45
2.12. State Prosecution Services 46
2.13. Tax and Revenue Regulators 46
2.14. Food Safety Regulators 46
2.15. Environmental Protection Agencies 47
3. Health Stakeholders 47
4. Private sector 47
4.1. Telephone Companies and Communication Service Providers (CSPs) 47
4.2. Financial Institutions 47
4.3. Power or Utility provider companies 48
4.4. Courier Companies – Freight Forwarders – Transportation Companies – Mail Service Providers 48
4.5. Internet Service Providers (ISP’s) 49
5. Other stakeholders 49
5.1. Media 49
5.2. Pharmacy and other Schools in Universities/Third level educational institutions49
5.3. Education Providers 49