Brussels, 15/05/2007 (Agence Europe) - The huge rise in the counterfeiting of medicines is worrying. It has already led to countless victims in developing countries. False medicines are beginning to reach Europe. In the long term, the credibility of medicines is under threat. The pharmaceutical industry cannot afford to lose the trust of its patients.
The first meetings of MEPs on medicines, entitled “Putting a Stop to the Counterfeiting of Medicines”, and chaired by Françoise Grossetête (EPP-ED, France) and John Bowis (EPP-ED, United Kingdom) took place on Monday 14 May at the European Parliament. During this event, participants from the pharmaceutical industry expressed their opinions on measures to take for fighting this ever increasing phenomenon. Miroslaw Zielinski, director of customs policy at the European Commission, affirmed that the data was “not just alarming but terrifying” and pointed the finger at countries like India and the United Arab Emirates. Almost 7% of medicines on the market are counterfeit. Africa and Asia are the most affected zones. Although Europe still appears to have been spared, the development of e-commerce has given rise to the fear of a rapid development in years to come. According to Bowis, 50% of medicines sold on the internet are counterfeit. Ms Grossetête warned against “a scourge that threatens patient safety” and called on medicine producers to adopt a “tough line” in order to, “guarantee the origin and quality of available medicines”.
Jean-François Dehecq is both the president of Sanofi-Aventis and vice president of the European Federation of Pharmaceuticals Industries and Associations (EFPIA). Mr Dehecq was pleased to see that the European institutions had finally shown an interest in what he describes as a “real public health problem, which is no longer a marginal business but a real industry” that could in some cases even be described as “a crime”. He also identified a number of shortcomings in European Union policies: Europe is not organised enough to carry out international police enquiries; the arsenal of penal sanctions is particularly unsuitable: the profits reaped by this trade are colossal but the punishments are minimal; control throughout the distribution chain is increasingly difficult and this phenomenon has intensified with the single market. He encouraged the European Commission to: 1) impose stricter rules to prevent counterfeit products entering the distribution circuit; 2) impose standards on product reconditioning; 3) implement a genuine penal sanctions arsenal that is adapted to what is happening in the industry. By taking action in this way, the EU would assume “leadership” and find “an echo at an international level”. In this perspective, Dehecq said that he wanted minsters from the EU27 to reach an agreement on a common declaration. He was also keen to point out that developing countries should not be ignored and explained that he was in favour of aid, by way of an intermediary “price differentiation” on medicines.
Heinz Zourek, the director general at the European Commission Industry directorate, acknowledged that the principles framing pharmaceutical activities in the Union dated back several decades. Moreover, counterfeiting was generally dealt within the remit of intellectual property and not public health. A significant number of false medicines did not constitute a violation of property rights. Zourek announced that the European Commission wanted to implement a “battle plan”, which, following an analysis and assessment phase, could lead to concrete legislative proposals. Nonetheless, he did illustrate the difficulty of the exercise in the field of subsidiarity. In some countries, weaknesses in legislation in force harmed the work of the national inspection authorities. At an international level, participants underlined the important role now played by the World Health Organisation's (WHO) IMPACT task force in the definition of a global framework for fighting counterfeit medicines and in working on the harmonisation of definitions and the improvement of international cooperation.
Certain solutions are technological. In terms of traceability and authentification the distribution sector is increasingly using RFID technology. Zourek declared, however, that this technology was still not advanced enough and that planning on other technology was necessary. RFID is still proving to be expensive. Other solutions could be envisaged, such as chemical codes, DNA labels and watermarks. (gc/oj)