Brussels, 10/12/2008 (Agence Europe) - After many weeks of uncertainty, the European Commission finally managed, on Wednesday 10 December, to agree on a raft of texts on pharmaceutical legislation: a communication reiterating the importance of scientific innovation and the competitiveness of the pharmaceutical industry and three directives and to regulations (1) the fight against the counterfeiting of the medicines, (2) the access of patients to information on medicines and (3) pharma-covigilance.
As we previously stressed (EUROPE 9790, 9767 and 9763), the texts on information from patients and the fight against counterfeiting were the subject of very tricky negotiations between, on the one hand, the cabinets of Commissioners Kroes (Competition), McCreevy (Internal Market) and Vassiliou (Health) and, on the other, that of vice-president Verheugen (Entreprise), which is competent for European pharmaceutical legislation. For these painstaking negotiations, several important provisions were modified, amongst other things to take account of the interests of parallel trade and refer back the question of distributing information via the printed press to the Member States.
During a press conference, Günter Verheugen welcomed the "unanimous" adoption of this legislative package. While recognizing that these texts had taken much work, he added that he was happy that he had been able to keep a promise made in 2005 to put forward proposals on these subjects before the end of the legislature. Referring to the directive on the fight against counterfeiting, he stated that boxes of medicines must in future include three security elements: a barcode to ensure traceability, an authentication element (hologram or other) allowing the pharmacist to verify the authenticity of the product, and a seal allowing the patient to verify that the box has not been opened. This rule will apply both to the pharmaceutical industry and the parallel trade when handling medicines. Parallel traders will not, however, have the right to open primary packaging (blister or tube). Without infringing the "legal activity" of parallel trade, this system will ensure the integrity of medicine packaging throughout the entire legal distribution chain for medicines in Europe, states Günter Verheugen. He did not dwell on the improvements to pharma-covigilance in Europe. The measures proposed aim to reinforce the surveillance of unwanted side-effects, with the assistance of the laboratories of the European Medicines Agency in London. Günter Verheugen devoted a greater proportion of his speech to the access of patients to information. In this area, the Commission is to authorise laboratories directly to provide information for patients. "The advertising of medicines remains banned", stated the vice-president of the Commission, explaining that laboratories will be able to provide information via three channels: (1) Internet, where citizens already have access to information available in other countries; (2) on request of patients; (3) in the printed press. In this last scenario, the principle of subsidiarity will apply, even though publication may, in principle, be made in the specialist press or in supplements and sections of the general press devoted to health issues. This information will be developed on the basis of a code of conduct and enshrined by a prior or ex-post authorisation system, the choice of which will be left up to the Member States individually. In principle, the distribution of already authorised information (that featuring on the information sheet accompanying the medicine) will not need an additional authorisation.
No fewer than 2,711,410 medical products were seized by Customs at the borders of the European Union in 2006, an increase of 384% compared to 2005, according to a report by the European commission. (O.J./trans.fl)