Brussels, 25/11/2008 (Agence Europe) - Although interest groups stepped up the pressure last week to assert their views on information for patients and/or the business in medicines, the European Commission again postponed examination of the legislative package on medicine. The latter contains a communication and three directives on 1) information for patients, 2) the fight against counterfeiting and 3) pharmacovigilance (EUROPE 9767 and 9763).
If Günter Vergeheugen's (European commissioner responsible for this dossier) spokesperson is to be believed, this postponement is only linked to an upset in the Commission's agenda. On Wednesday 27 November it is due to adopt a raft of economic measures to respond to the crisis. The College is therefore expected to examine the medicines package on 3 December and it will not, according to the same spokesperson, have undergone any major alteration. An additional delay, however, has been mentioned until 10 December. These consecutive delays mean that the first reading being completed by the end of the current legislative really is in danger. A brief insight into the dossier and the pressure being exerted, which has prompted these three proposals, now follows.
An initial conflict of interest appears to have been solved, given that on Thursday 20 November, the parallel trade interests welcomed the new casting of the draft directive on fighting counterfeiting. Despite energetically decrying the opening up of packaging and recomposing the contents of medicine boxes, Vice-President Verheugen had to give in to the joint pressure from a business that is worth €4bn and from Commissioners Charlie McCreevy (internal market and services) and Neelie Kroes (competition), who at the Commission, defended this practice. The article in the initial proposal banning these practices has disappeared from the new version where there is no longer a ban on opening up the medicine's protective package (blister or tube). If, however, the parallel trader is still able to open up the original package and modify the contents, without directly affecting the product, he must also: 1) verify the authenticity of the medicine and 2) affix a safety and traceability mark on the new package that is the equivalent of that on the original packaging. The proposal effectively means that the party that possesses market authorisation now has to add a safety bar code. In brief, the new version of the proposal helps to enhance traceability and safety of the product and contains a cost to parallel traders, even if they have successfully kept most of the profits generated by the re-composition of the boxes' contents (including that for opening up the packaging) in batches corresponding to the requirements of the different markets they supply. The directive also introduces a mechanism imposing more quality controls on active substances imported from third countries.
Although the proposal on pharmacovigilance appears to have won general acceptance, the item on information for patients provoked real resistance. Mr Verheugen is proposing to authorise laboratories to supply non-commercial information on the internet and in the printed media (indications for use, dosage, side-effects, contra-indications etc.) Commissioner Androulla Vassiliou, in charge of health and consumer protection, opposes this, particularly the part on publication of information in the written press. She is backed by the European Social Insurance Platform (ESIP) which pointed out, in an open letter dated 19 November to all Commission members, that it is opposed to any watering down of the ban on communicating information to patients. On the same day, twenty organisations including ESIP, AIM (grouping of autonomous health insurance and social protection bodies), BEUC (consumers), EAHP (hospital pharmacists), ECCH (homoeopathists), EFN (nursing personnel), EPHA (patients), PGEU (community pharmacists), UEMS (medical specialists) wrote to the president of the Commission, José Manuel Barroso, to request the separation of the package into three separate dossiers and the transfer of medicine from DG Enterprise to DG Health and Consumer Protection. (O.J./transl.rh)