Contrefacon des medicaments et strategies technologiques pour securiser la chaine d'approvisionnement pharmaceutique.

摘要

Counterfeit products in general and counterfeit medicines in particular constitute a serious global phenomenon with important social and economic impacts. Counterfeit medicines are indeed a great social concern since they may have adverse effects on patients' health and on the healthcare systems' steadiness. On the economic side, counterfeit medicines represent 10% of the total amount of medicines traded today and will reach 75 billion (USD) in 2010, a 92% increase since 2005. Counterfeit medicines generate substantial lost revenues for pharmaceuticals companies and discourage innovation and research and development activities. They also entail a reduction in tax revenues and require additional costs for anti-counterfeiting measures (increased controls in the drug distribution network, reinforcement of legal systems, etc.);Efficient technological strategies leverage on 1) traceability using a unique numerical identifier at unit level (mass serialization) 2) verification systems allowing to identify medicines by checking unique identifiers at one point of the drug supply like the point of dispense, also called end-to-end verification systems, or all along the supply chain, also known as e-pedigree verification systems) and 3) traceability technologies, namely the two-dimensional matrix barcode called Datamatrix and the radiofrequency identification technologies (RFID). Mass serialization seems to be the key aspect of all effective technological anti-counterfeiting strategies for the pharmaceutical industry. However, verification systems currently raise conflicting views among the pharmaceutical community, with diverging opinions in Europe and in North-America. Similar conflicting views also prevail for traceability technologies at unit level for drugs: some firms favor RFID, others prefer to implement Datamatrix technologies.;In order to analyze the technological strategies pursued by the pharmaceutical industry to prevent counterfeit medicines, we have collected empirical data study from 72 respondents (34 from Europe and 38 from the United States, Canada, and Mexico). We have targeted respondents who are directly involved in the pharmaceutical supply chain, either from upstream side of the supply chain (active ingredients and final products manufacturers) or from the downstream side (wholesalers, distribution centers, pharmacies or hospitals). We have also targeted respondents who are indirectly involved such as governmental institutions, members associations, national or international organizations since they influence the supply chain members' strategies. We have conducted on-site interviews and an on-line survey, collecting both quantitative and qualitative data. It is important to put forward the fact that this study is exploratory and will constitute a starting point for larger research program.;Results indicate that both respondents and the organizations they are working for are indeed aware of the counterfeit medicines phenomenon. The respondents feel that the regulatory framework is ineffective at the state or province level and at the national and international levels. Results also demonstrate that both verification systems, namely the end-to-end and e-pedigree verification systems seem effective to fight counterfeit medicines. However, the end end-to-end verification system seems to be preferred by the European industry, whereas none of the two systems appears to be promoted by North-American respondents. Results confirm that both traceability technologies (RFID and Datamatrix) are relatively efficient in securing the drug supply chain and confirm the existence of an adoption scheme according to respondents' geographical localizations: Datamatrix are most valued by the European industry whereas neither of the two traceability technologies is promoted by the North-American industry which reveals a lack of consensus. RFID technologies appear to be the key enabler of e-pedigree systems while Datamatrix barcodes can be used in both verification systems. Hybrid technological strategies relying on RFID and Datamatrix can be implemented in either verification systems, although these hybrid strategies are positively biased towards the e-pedigree verification system. European respondents value the use of RFID or Datamatrix for the end-to-end verification system whereas North-American respondents seem to promote hybrid solutions for e-pedigree systems. (Abstract shortened by UMI.);There are three key dimensions for anti-counterfeiting strategies. The first focuses on the reinforcement of legal systems and the establishment of more serious penal sanctions for counterfeiters. The second dimension aims at rising awareness among consumers on the disastrous effects of counterfeit medicines consumption. Finally, the third dimension relies on the use of more sophisticated technologies which is the main focus of our research. The overall objective here is to analyze and evaluate the effectiveness of technological strategies in order to secure the pharmaceutical supply chain, by preventing the insertion of fraudulent products in the legal drug supply chain. The main goal is therefore to ensure products integrity and authenticity all along the supply chain, from the active ingredients manufacturers until the dispense to patients.