Brussels, 28/10/2002 (Agence Europe) - The European Parliament's vote on the medicines package has given rise to a rather lukewarm response reflecting the broad balance of the outcome in the favour of patients aiming to give some priority to public health rather than economic interests. As reported on 24 October, p.12, the EP also managed to strike a balance between the divergent interests of innovative laboratories and the manufacturers of generic drugs, giving the former ten year protection of clinical data (eleven years for new therapeutic indications). The EP also introduced compulsory notification of parallel imports to holders of market authorisations, which can be seen as a certain advantage for laboratories, which have always seen parallel imports as a scourge. Generic drug manufacturers have been given the option of taking the necessary measures two years ahead of the expiry of the period of data protection but can only market generic drugs once the ten years is up. , expect for exports to poor countries which have issued the necessary licence. At the same time, the EP introduces a tighter definition of bio-equivalence to prevent generics from benefiting from research carried out into the reference produce if they are not absolutely identical.
Outcome welcomed by BEUC and MEPs
The European Consumers' Organisation (BEUC) issued a press release after the vote welcoming the MEPs' decision to give patients the option of making an informed choice rather than boosting still further the popularity of branded medicines. It is important for patients and health professionals to have access to high quality, impartial and comparable information about medicines, explains BEUC, thanking the European Parliament for putting patients' interests before the interests of the pharmaceutical industry.
The two rapporteurs, Françoise Grossetête (EPP-DE, France) and Rosemarie Müller (SPD, Germany) hailed the EP's vote, particularly its support for all new active substances being subject to a centralised procedure. Grossetête said the European Parliament's vote would help encourage generic medicines and support innovation. Müller hailed the outcome for plant-based medicines, which can be given centralised authorisation and the stepping up of the monitoring of medicines (setting up a database of side effects, introducing a warning on patient information for new drugs) and clinical trials (on children for drugs to be used on children and the involvement of women). On behalf of the French Socialist delegation, Anne Ferreira welcomed the rejection of the Commission's plans to allow laboratory information about three pathologies, but regretted the adoption of an amendment she said could delay by three years the arrival of generics on the market. Belgian Liberal Frédérique Ries welcomed the adoption of a compromise on data protection but regretted the EP had decided to completely reject the Commission's proposal on patient information rather than amending it with a more suitable framework. The Greens/EFA group says it broadly welcomes the vote putting the pharmaceutical legislation back into a context of public health and consumer protection and opposing the market logic of the European Commission whose prime objective is to promote the competitiveness of the pharmaceutical industry, notes a press release by French MEP Didier Rod. He welcomed the rejection of the Commission's information plans, hailing the adoption of his amendment introducing a renewal of authorisations after the first five years. Rod regretted, however, that the EP had not followed his group's views on therapeutic added value, adding that it hadn't gone far enough to promote generics. Peter Liese (CDU) hailed the vote over information, while Horst Schnellhardt (CDU) regretted the EP had not left the choice of centralised or national authorisation to industry. British Liberal Democrat Elspeth Attwood welcomed the derogations for veterinary medicines.
Semi-satisfaction at EFPIA and European Commission
Press releases from the European Federation of Pharmaceuticals Industries and Associations (EFPIA) and the European Commission carry the same headline but for different reasons. The EFPIA hailed the outcome of the vote on information, seeing it as a political message for the Commission to make a greater effort. The EFPIA did not favour the Commission's proposal because it only covered three pathologies. It welcomed the rejection of amendments that would have virtually banned information from industry, but regretted that the EP did not agree to leaving the pharmaceutical industry to choose between centralised authorisation procedures or authorisation by national agencies.
Disgruntled generic medicine manufacturers
Repeating that generic medicines save European health systems over EUR 12 billion a year, the European Generic Medicines Association (EGA) expressed disappointment in a press release criticising European Parliament procedures. It is unhappy about the adoption of several amendments providing tighter legal support for reference products and restrictive definitions of generics. Greg Perry, EGA Director General, said: "These amendments, if they ever become law, would enable brand pharma companies to play around with formulation and minor chemical changes to prevent the marketing of equivalent generic versions of their products", recognising that the compromise over protection of clinical data worked in favour of the generics' sector.
Pharmacists and, to a lesser degree, the self-medication industry express content
The Pharmaceutical Group of the European Union (PGEU) hailed the European Parliament vote recognising the special nature of medicines and highlighting the role of pharmacists. The PGEU is very happy at the rejection of pilot projects on direct patient information from industry. While hailing the outcome of the vote, EUCOMED expressed concern at the vagueness of various measures which do not fully exclude medical equipment from the scope of the pharmaceutical legislation currently being revised. The European association of medical devices points out that some devices have pharmacological side effects and feels it should be made clearer in the definition of medicines whether these are products having a pharmacological reaction as their main effect. The Association of the European Self-Medication Industry (AESGP) welcomed the new measures for herbal medicines but expressed concern at the potential impact of amendments introducing uninterrupted supply obligations.