Pharmaceutical Executive Europe - January 2008 - (Page 21) Pharmaceutical Executive Europe January 2008 Q&A 21 It should be noted in addition that activities are taking place at various international levels, such as the World Health Organisation, the World Customs Organisation, the Council of Europe and the OECD. This international work is important as the fight against counterfeits needs to take place at a global level to be truly effective. In this spirit, results of the international work are a good reference for DG Enterprise and Industry in bilateral discussions with countries such as India and China. These countries were reported to have been the main sources for the counterfeit medicines seized by European customs offices in 2006 as reported in the statistics of the Directorate General on Taxation and Customs Union. PEE: How are you working with the WHO’s anticounterfeiting task force in this area? TVL: Vice president Günter Verheugen is convinced that WHO’s Anti-Counterfeiting Task Force IMPACT is an important initiative, as it will represent a major step in the global fight against counterfeiting. At the first European Parliament Symposium in May 2007 — “Putting an End to Drug Counterfeiting” — Commissioner Verheugen emphasised his support for this task force. Of the five IMPACT working groups on legislation, enforcement, technologies, communication, and regulatory issues, the EC has decided specifically to support the work on principles on legislation with an ad hoc grant. The project is being funded through the Commission’s Competitive and Innovation Framework Programme 2007–2013 (CIP). It is important that there will be broad support by all IMPACT members for the draft principles and that WHO will monitor its subsequent implementation. PEE: What lessons, if any, have you learned from the US approach to tackling counterfeiting and will you be implementing any US-style measures? TVL: The EU is closely monitoring the developments and discussions in the United States on anti-counterfeiting strategies. We have established mechanisms to co-operate on these topics, for instance the EU-US confidentiality agreement. Discussions are also continuing between the Directorate General on Information Society and the US on radio frequency identification (RFID) technology. One part of the project is, firstly, to identify the objectives for traceability and, secondly, to reflect on various technologies and a possible standardisation. Following the consultation of pharmaceutical stakeholders it has become obvious that there is no “one-size-fits-all solution” in the area of technologies; this has also been confirmed by the WHO IMPACT Working Group on technologies. Therefore, different products and regions may need different technical solutions. During a broad consultation on RFID by the Directorate General Information Society, substantial positive feedback was received on the future of this technology in 2006. In this consultation, the pharmaceutical sector was identified as an area that could benefit from RFID applications. Stakeholders from the industry, however, have expressed concerns that the technology needs further development before it will be affordable for healthcare systems. However, joint activities of various Commission Services on RFID and other track and trace solutions are meant already to prepare today for the options of the future. Similarly, as foreseen in the EU, we are aware that the US has recently been taking a differentiated approach in this field. Pharma … must map any potential gaps in its regulatory and enforcement systems in a similar way to counterfeiters… PEE: What do you see as the future challenges facing regulators and industry with regard to counterfeiting? TVL: Counterfeiters are smart in finding out any potential gaps in any regulatory and enforcement systems. They keep surviving because they constantly change their strategies. This is particularly relevant for illegal sales over the internet. Industrial, legislative, pharmaceutical, customs and police enforcement agencies should map any potential gaps in a similar way to counterfeiters, with a view to developing their own proactive strategies. This is one reason why ‘multidimensional’ co-operation is an important factor in this fight. However, it should not be forgotten that there seems to be a demand for illegal products — be it for lifestyle drugs over the internet or for cheap supplies by criminal actors in the legal supply chain. An understanding of the motivation of those who intentionally buy these products will be an important factor in developing a strategy, both for regulators and for industry. This is why ‘awareness’ raising is another important factor. Profile Ton van Lierop is a spokesperson for the cabinet of Günter Verheugen, the EC vice president responsible for Enterprise and Industry. http://ec.europa.eu/enterprise/newsroom/cf/document.cfm?action=display&doc_id=248 http://www.impactglobalforum.org/ http://ec.europa.eu/cip/docs/eip_wp2007_measures.pdf http://ec.europa.eu/cip/docs/eip_wp2007_measures.pdf http://ec.europa.eu/enterprise/pharmaceuticals/pharmacos/docs/doc2006/02_2006/eu-fda_pr14_14-03-2006.pdf
Table of Contents Feed for the Digital Edition of Pharmaceutical Executive Europe - January 2008 Pharmaceutical Executive Europe - January 2008 Contents From the Editor News and Analysis Calendar Corporate Strategy: Walking the Line Executive Profile: The Pharmacist’s Friend Q&A: An End to Drug Counterfeiting Healthcare Cost Assessment: Ready to Make NICE? Pricing and Reimbursement: Through the Reimbursement Barriers Generics: India Inc. The Mix: New Models of Excellence Last Word: Mid-size Matters Pharmaceutical Executive Europe - January 2008 Pharmaceutical Executive Europe - January 2008 - Pharmaceutical Executive Europe - January 2008 (Page 1) Pharmaceutical Executive Europe - January 2008 - Pharmaceutical Executive Europe - January 2008 (Page 2) Pharmaceutical Executive Europe - January 2008 - Contents (Page 3) Pharmaceutical Executive Europe - January 2008 - From the Editor (Page 4) Pharmaceutical Executive Europe - January 2008 - From the Editor (Page 5) Pharmaceutical Executive Europe - January 2008 - News and Analysis (Page 6) Pharmaceutical Executive Europe - January 2008 - News and Analysis (Page 7) Pharmaceutical Executive Europe - January 2008 - News and Analysis (Page 8) Pharmaceutical Executive Europe - January 2008 - News and Analysis (Page 9) Pharmaceutical Executive Europe - January 2008 - News and Analysis (Page 10) Pharmaceutical Executive Europe - January 2008 - News and Analysis (Page 11) Pharmaceutical Executive Europe - January 2008 - Calendar (Page 12) Pharmaceutical Executive Europe - January 2008 - Calendar (Page 13) Pharmaceutical Executive Europe - January 2008 - Corporate Strategy: Walking the Line (Page 14) Pharmaceutical Executive Europe - January 2008 - Corporate Strategy: Walking the Line (Page 15) Pharmaceutical Executive Europe - January 2008 - Corporate Strategy: Walking the Line (Page 16) Pharmaceutical Executive Europe - January 2008 - Corporate Strategy: Walking the Line (Page 17) Pharmaceutical Executive Europe - January 2008 - Executive Profile: The Pharmacist’s Friend (Page 18) Pharmaceutical Executive Europe - January 2008 - Executive Profile: The Pharmacist’s Friend (Page 19) Pharmaceutical Executive Europe - January 2008 - Q&A: An End to Drug Counterfeiting (Page 20) Pharmaceutical Executive Europe - January 2008 - Q&A: An End to Drug Counterfeiting (Page 21) Pharmaceutical Executive Europe - January 2008 - Healthcare Cost Assessment: Ready to Make NICE? (Page 22) Pharmaceutical Executive Europe - January 2008 - Healthcare Cost Assessment: Ready to Make NICE? (Page 23) Pharmaceutical Executive Europe - January 2008 - Healthcare Cost Assessment: Ready to Make NICE? (Page 24) Pharmaceutical Executive Europe - January 2008 - Pricing and Reimbursement: Through the Reimbursement Barriers (Page 25) Pharmaceutical Executive Europe - January 2008 - Pricing and Reimbursement: Through the Reimbursement Barriers (Page 26) Pharmaceutical Executive Europe - January 2008 - Pricing and Reimbursement: Through the Reimbursement Barriers (Page 27) Pharmaceutical Executive Europe - January 2008 - Generics: India Inc. (Page 28) Pharmaceutical Executive Europe - January 2008 - Generics: India Inc. (Page 29) Pharmaceutical Executive Europe - January 2008 - Generics: India Inc. (Page 30) Pharmaceutical Executive Europe - January 2008 - The Mix: New Models of Excellence (Page 31) Pharmaceutical Executive Europe - January 2008 - The Mix: New Models of Excellence (Page 32) Pharmaceutical Executive Europe - January 2008 - The Mix: New Models of Excellence (Page 33) Pharmaceutical Executive Europe - January 2008 - The Mix: New Models of Excellence (Page 34) Pharmaceutical Executive Europe - January 2008 - Last Word: Mid-size Matters (Page 35)
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