The assessment all information accompanying medicines for human use published at the end of March by the Commission is unsatisfactory in the view of Peter Liese (EPP, Germany). In a press release published on 22 March, the MEP in charge of health questions at the EPP group said that this report came too late and lacked concrete proposals, particularly with regard to key information.
The directive 2001/83/EC directive establishes a Community code for medicines for human use. It brings together all the current provisions in force on the sale, production, labelling, classification, distribution and advertising of medicines for human use in the EU. It has been in application for the past 15 years and made it incumbent on the European Commission to publish a report before 1 January 2013 on the possible shortcomings in the package leaflets on the characteristics and information accompanying medicine for human use.
The Commission points out that this report was only published on 22 March 2017 because of the, “need to obtain additional proof from an external experts’ study and to consult the member states about the results of this study and analyse the responses received”. It provides a whole range of recommendations, such as, improving the readability and understanding of information for all patient groups, including the elderly or those with problems reading, as well as the need to pursue exploratory work on the question of including key information in the summary of characteristics or in package leaflets, so that patients and healthcare professionals can swiftly identify safety messages and the benefits from medicines or the possibility of using rapid response barcodes.
Peter Liese the MEP from Germany, however, was not satisfied with the recommendations and although he also believes that package leaflets should be more understandable, he criticised the European Commission’s delay and the lack of concrete proposals. He concluded that, “The proposal by the European Parliament to introduce a key information section was not included… After six years, I cannot understand why the Commission only summarises that this issue needs to be further examined”. The Commission report is available at:
https://ec.europa.eu/health/sites/health/files/files/documents/2017_03_report_smpc-pl_en.pdf (Original version in French by Sophie Petitjean)