Strasbourg, 22/10/2008 (Agence Europe) - In Strasbourg on Wednesday 22 October, the European Parliament held a debate with Vice-President Günter Verheugen on the proposed directive on variations and the Medicines package, the latter of which the Commission failed to adopt on Tuesday (EUROPE 9763).
In its adoption, by 675 votes in favour, 21 against and 8 abstentions, of the report by French UMP member Françoise Grossetête (EPP-ED), the European Parliament has approved, with a few amendments, the proposed directive which aims to simplify the authorisation procedures for the "variations" on drugs which have already obtained a marketing authorisation (MA). As Ms Grossetête reminded the plenary, these "variations" usually relate to minor modifications to a product which is already available: changing the production method, updating the package leaflet and, in certain cases, adding a new indication. For a medium-sized company which produces generic drugs with 400 brands, the number of annual variations is in the region of 4000, rising to 19,000 a year for the large laboratories. However, current rules which impose burdensome procedures are "increasingly ineffectual", states the rapporteur, pleading in favour of harmonisation of the procedures in order to move away from an overly bureaucratic system, which leads through multiple national authorisations to almost the same number of different treatments. Like the rapporteur, many of those who took the floor supported this text, not withstanding a few technical modifications.
In a declaration on the fight against counterfeiting, Günter Verheugen said that he understood Ms Grossetête's impatience, MEP having recently called on the Commission to present its new Medicines package as quickly as possible. "I am impatient too", he added, going on to stress that the pressure brought to bear by the Parliament supports him in his position aiming to set in place instruments to fight to prevent counterfeit drugs from entering the distribution chain. "This has become a European problem (...), a serious threat to public health (...) and the Commission has pledged to take action", he said, going on to acknowledge that the proposal had not yet been dealt with by the College and that there remained "a whole range of difficult questions to clarify". In his view, however, there is no doubt that this will be done "in a few weeks' time". He went on to explain that the distribution circuits must be tightened up and original packaging kept in place, traceability ensured and permanent authenticity controls carried out. These are highly ambitious requirements, he said, but "all of the stakeholders have recognised that it is a good solution". In parallel, "imported products must be subject to particular controls", he advised, pointing out that it is very often the case that the main active ingredient comes from third countries and "should be produced to our standards". He went on to promise that the proposal would be "reasonable and balanced", but strict.
Almost all of those who took the floor agreed with the Vice-President of the Commission, pleading, as Spanish MEP Cristina Guttierez-Cortines (EPP) did, in favour of strict legislation to protect society. In the view of German Social-Democrat Dagmar Roth-Behrendt, it is vital to guarantee the integrity of packaging and a system of traceability. Pilot projects in Belgium and Switzerland have shown that this can work, she said, before referring to the recent heparin scandal, which proves that it is also vital to carry out controls on the quality of substances going into the ingredients of a medicine.
Answering questions from the MEPs, Günter Verheugen said that "in our societies, there is a conflict between the health bureaucracies and the needs of the patients". This is one of the things flagged up by the Medicines package currently being prepared: "the bureaucracies of the Member States do not want patients to have more information", because "well-informed patients ask questions, make demands...". In Günter Verheugen's opinion, "people have the right to know (...). One might even say this is a fundamental right of a democratic society". "I hope that the Parliament will support me in guaranteeing the freedom of the citizens in the field of health also", he added, going on to reaffirm the need to fight against counterfeiting, which is a criminal activity. "Parallel trade is a legal activity", Mr Verheugen, albeit wondering how it could be justified that it is not permitted to open "a packet of noodles", yet anything can be done to a box of medication.
"We cannot wait for it to be a criminal activity", concluded Françoise Grossetête, pleading for better control of active ingredients, rules on traceability, sanctions for infringements and extra security for the distribution chain by banning repackaging practices.
The Commission was set in theory to approve the Medicines package (three directives and a regulation on patient information, the fight against counterfeiting and pharmacovigilance) at its meeting on Tuesday 21 October in Strasbourg, but in the face of the opposition of Commissioners Charlie McCreevy (Internal Market) and Neelie Kroes (Competition), who give priority to competition and the free movement of goods over the protection of health, President Barroso has postponed discussions on this package. Two further members have reservations: Margot Wallstrom (Communication) and Androulla Vassiliou (Health), opposing a number of elements of the proposal on patients' access to information on drugs. (O.J./trans.fl)