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Patient Safety and biological medicines: what matters?

9 November 2011

On 8 November, Health First Europe attended the lunch debate in the European Parliament entitled "Patient Safety and biological medicines: what matters?" The event was organised by the Parliament Magazine and Novo Nordisk, in association with EuropaBio, and discussed the role of the bio-pharmaceutical industry in the patient safety debate.  Hosted by MEP Marisa Matias (EFA/Greens, Portugal), the event brought together the European Commission, the European Parliament, patients and industry to facilitate a dialogue alongside legislative dossiers such as the pharmacovigilance package, falsified medicines and information to patients.

MEP Matias opened the lunch debate by outlining some of her priorities with regards to patient safety in terms of medicines.  Having been extensively involved in Parliamentary discussions of pharmaceuticals in the EU, Ms. Matias highlighted the need for a direct dialogue with patients and healthcare professionals in order to develop legislation which is holistic in nature and can protect patients.

Mr. Stéphan Hogan, Head of Unit for Horizontal Issues at the European Commission's Directorate General Research, discussed some of the ongoing projects the European Commission has been involved with to develop a knowledge base on patient and drug safety.  He asserted that the European Commission has supported extensive research in the areas of efficacy and safety of medicines for patients in addition to the education and training of professionals and patients through the Innovative Medicines Initiative (IMI).  He also asserted that for 2012, the European Commission is looking to support research on new methodologies for health technology assessment (HTA) under the Framework 7 Programme.

Additionally, Anne-Marie Felton of the Federation of European Nurses for Diabetes (FEND), spoke to the patient experience with regards to medicines highlighting particular areas for which the EU can do more to assist and protect the safety of patients.  In particular, she expressed that the reliability of treatments is critical stating that policymakers "Need to ensure commonality across the whole of the EU in terms of the accuracy and readability of information to patients."  She further declared that information to patients should never be "a marketing tool."

The event also saw a presentation by Inger Mollerup, Vice-President of Novo Nordisk, regarding the development of bio-pharmaceuticals and the complicated process through which medicines are created.  Ms. Mollerup drew attention to the fact that bio-medicines involve living organisms and that no batch of bio-medicines is identical – even though the process for generation may be the similar.  This means that patient safety must be protected through reliable systems of traceability and through clearly identified products.

Overall, the event highlighted the importance of patient safety in the ongoing debates around pharmaceuticals and the need for cooperation between stakeholders to find legislative solutions where the priority is protecting the patient.

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