At the meeting, organised jointly by the Pharmaceutical Group of the EU (PGEU) and the European Patients' Forum (EPF) and sponsored by the Pharmacovigilance Rapporteur, Mrs Linda McAvan MEP, an audience of interested stakeholders heard the views of pharmacists' and patients' representatives, regulators (including the European Medicines Agency and the MHRA), academics (the Netherlands Pharmacovigilance Centre Lareb), the European Commission and the pharmaceutical industry.
All speakers welcomed the new directive as a major step forward towards achieving a better balance between benefits and risks of medicines. In particular, speakers stressed the importance of effective reporting of adverse drug reactions. The new directive proposes a stronger reporting framework for pharmacists and health professionals, and introduces direct reporting by patients. The data gathered from such reports will be used to monitor risks posed by medicines once they have been approved and become available to patients.
PGEU President Mr Filip Babylon said "75% of medicines are prescribed and dispensed in primary care settings. Pharmacists often come into contact with many groups - such as children and the elderly, and those taking a number of medicines simultaneously, - who do not take part in clinical trials. Pharmacists have a key role in reporting adverse drug reaction, and helping patients to understand their importance. I believe the new Directive is a significant step in creating a basis for effective collaboration between pharmacists and patients in the area of medication safety."
EPF President Mr Anders Olauson said "We welcome the proposals regarding direct patient reporting and giving patients wider access to safety data, as this contributes to patients' empowerment and greater patient safety. These efforts should be seen as integral to the wider EU debate on patient empowerment and health literacy, with the aim of enhancing the safety and quality of care for all patients across the European Union."
About The Pharmaceutical Group of the European Union (PGEU)
The Pharmaceutical Group of the European Union (PGEU) is the European association representing community pharmacists. PGEU's members are the national associations and professional bodies of pharmacists in 30 European countries, including EU Member States, EEA members and EU applicant countries.
For more information, please visit the PGEU website www.pgeu.eu.
About The European Patients' Forum (EPF)
The European Patients' Forum (EPF) is the umbrella organisation of European patient organisations active in the field of European public health and health advocacy. EPF currently represents 44 patient organisations, which are national coalitions of patient organisations and chronic disease-specific patient organisations operating at European level. EPF’s vision is high-quality, patient-centred, equitable healthcare for all patients throughout the European Union.
For more information, please visit the EPF website, www.eu-patient.eu.