Brussels, 01/06/2007 (Agence Europe) - From 30 May-1 June, the European Federation of Pharmaceutical Industries and Associations (EFPIA) held its annual General Assembly in Brussels. Concerns raised include the safety of medicines and the fight against counterfeiting (this was also the theme of a recent European Parliament colloquy, see EUROPE 9427). The new EFPIA president seized the opportunity provided by the occasion to lay into parallel imports presented as a failing that allows counterfeiting.
As Jean-Marc Bobée, chairman of Sanofi-Aventis SA, explains, the EFPIA has begun work on an initiative aimed to generalise the use of a new system of medical coding in the European Union. Given the risk of counterfeits and the ensuing potential health risks for patients, some member states have already set precautionary measures in place. Italy, for example, uses the “bolino”, a small label that gives the batch and serial number, bought from the public authorities and placed on every packet of medicine sold in the Italian peninsula. The system provides protection from counterfeiting but also from reimbursement fraud. The industry wishes to avoid having 27 different systems while strengthening product safety. To achieve this, it hopes to introduce the secure two-dimensional matrix barcode, known as the Matrix Data code. Placed on every packaging, the code would contain a product identification code, its use-by date, a batch number and serial number. A networking system (of the bank card kind) for pharmacies, hospitals, distributors and manufacturers would ensure the distribution chain is completely secure. France has already planned to establish such a system by 2011, but without including the product serial number. Jean-Marc Bobée takes the view that we are currently witnessing a “traceability revolution” which should be used to combat counterfeiting. He nonetheless acknowledges that the system cannot be applied to the less developed countries that are the most severely hit by this scourge, and that it is inoperative when it comes to the development of electronic trade. “The only solution would be to step up the campaigns explaining to people that they should not buy on the internet”, he said.
A workshop organised in Brussels on Wednesday confirmed the industry's commitment to promoting this system despite the doubts expressed by dispensary pharmacists who fear its complexity, and express concern about the impact that it could have on their independence if the scheme were to be financed according to data collected on sales made in each pharmacy. Generic medicine manufacturers are, on the other hand, totally opposed to a system they consider too costly.
Although some representatives of the pharmaceuticals industry admit that the parallel trade in medicinal products has become a legal reality of the internal market and consider that a solution must be found to prevent this new system from making the parallel trade almost impossible, some questions are still unanswered. The only non-discriminatory solution would in fact be to associate parallel importers with the system by granting them a new code after the products are reprocessed. Parallel importers are still in the line of fire of the new EFPIA president. “The pharmaceutical parallel trade has no economic benefits for member states or for patients”, Arthur J. Higgins told the press on Thursday 31 May, before going on to say that “parallel importers only bring risks (…) and threats for the safety of medicines”. Furthermore, the president of Bayer HealthCare AG set out the objectives of the EFPIA grouped under the logo, AIMS (Access, Innovation, Mobilisation, Security). He explained that work must continue to gather pace on the authorisation and the processes for fixing prices and reimbursement for new medicines, to make governmental controls on non-reimbursed medicines disappear. Arthur J. Higgins gave his support to the development of traceability and to the fight against counterfeit products. He promised a code of conduct on relations between the industry and patients' associations would be adopted in 2008, and also called for the liberalisation of patient information. The new EFPIA president finally insisted on the two-fold need for “a brain gain” to resolve the “brain drain” and to support innovation so that Europe becomes the pharmacy of the world once more. (oj)