EGA Press Release
Wednesday, 10 December 2008
EGA WELCOMES EUROPEAN COMMISSION’S PHARMACEUTICAL PACKAGE,
BUT MAINTAINS CERTAIN RESERVATIONS
The EGA welcomes the European Commission’s “pharmaceutical package” of legislation presented today to the Council of Ministers and to European Parliament. The set of proposals on the future of the European single market in pharmaceuticals appears to be well-balanced following the intense discussions conducted during its elaboration. But the association, which represents companies that produce nearly 50% of all medicines used in Europe, still maintains major concerns about certain public health issues.
- The EGA supports the Commission’s proposals on pharmacovigilance in that it increases public health protection by removing national disparities and by improving the overall operation of the Community pharmacovigilance rules. The EGA also welcomes the proposed harmonised and risk-based approach to pharmacovigilance. The association notes, however, that some fine-tuning will be necessary, particularly with regard to the new “summary of essential information” which must be inserted into the product leaflet. This summary could be counterproductive for patient compliance.
- The EGA also welcomes the proposal’s attempt to harmonise the current framework of industry information to patients throughout member states. The EGA sees this as a constructive step forward, but reasserts its concern over the possible misuse of information as a marketing tool. It is crucial to the EGA that the proposal ensures better — rather than simply more — information to patients in order to avoid any form of direct marketing and exerting undue commercial influence over consumers.
- As regards the anti-counterfeiting proposal, the EGA supports the Commission proposal for tighter control of the supply of active pharmaceutical ingredients (API) based on newly introduced import notification and on the inclusion of a risk-based assessment with regard to the safety features for medicinal products. The EGA believes that unified standards for controls on APIs will render the medicines distribution network even safer. However, caution should be taken not to exert a negative impact on supply from outside the EU. The EGA also stresses that counterfeiting of medicinal products involves almost exclusively popular, expensive originator products and on sales through the internet. “Solutions should focus on where the problems are. The EGA therefore is concerned that the main source of counterfeiting — ie, the internet — is not addressed and that the European Commission may be promoting an overreliance on technical features rather than an improvement of the behavioural activity of the supply chain actors”, says Greg Perry, Director General, EGA.
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