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Medicines in Europe - managing risks
A closer look at the legislative proposals on pharmacovigilance

Hosted by the European Parliament rapporteurs Linda Mc Avan (S&D) and Michèle Rivasi (Greens)

Press release

On Wednesday, January 27, Michèle Rivasi MEP (France, Greens) and Linda McAvan MEP (United Kingdom, S&D) chaired an expert meeting on the European Commission’s legislative proposals on pharmacovigilance, at the European Parliament in Brussels.

The experts highlighted the need to improve patients’ safety in Europe by genuinely strengthening pharmacovigilance, which is the process of evaluating and improving the safety of medicines. The experts questioned a number of the Commission’s proposals that could weaken the current pharmacovigilance system, such as the possibility that premature marketing authorisations become the rule rather than an exception justified on public health grounds or the risk that Member States’ pharmacovigilance authorities could be increasingly bypassed in favour of pharmaceutical companies.

The legal provisions to allow direct reporting of adverse drug reactions by patients to health authorities were strongly welcomed and experts shared recent evidence on the added value of spontaneous patient reports that provided crucial complementary information to health professional reports.

Following presentations were made:

Medicines’ Adverse Reactions are a public health issue: a proactive approach is needed, Prof. Joan-Ramon Laporte, Catalan Institute of Pharmacology (ICF), Spain
How to deal with adverse drug reactions reports? The role of National and regional pharmacovigilance centres, Dr. Thomas Stammschulte, German Medical Association (Arzneimittelkommission der deutschen Ärzteschaft, akdä), Germany
The European Commission’s Pharmacovigilance proposals: more than a technical Issue, Florence Vandevelde, Medicines in Europe Forum
Direct patient reporting: what works and why it matters. Findings of an international survey, Dr. Andrew Herxheimer, UK Cochrane Collaboration, United-Kingdom
Access to pharmacovigilance information – Patients and consumers’ demands
Interventions from:

Martine Van Hecke, Belgian Consumers’ Organisation Test-Achats
Ilaria Passarani, European Consumers’ Organisation BEUC

Medicines’ Adverse Reactions are a public health issue: a proactive approach is needed, Prof. Joan-Ramon Laporte, Catalan Institute of Pharmacology (ICF), Spain
How to deal with adverse drug reactions reports? The role of National and regional pharmacovigilance centres, Dr. Thomas Stammschulte, German Medical Association (Arzneimittelkommission der deutschen Ärzteschaft, akdä), Germany
The European Commission’s Pharmacovigilance proposals: more than a technical Issue, Florence Vandevelde, Medicines in Europe Forum
Direct patient reporting: what works and why it matters. Findings of an international survey, Dr. Andrew Herxheimer, UK Cochrane Collaboration, United-Kingdom
Access to pharmacovigilance information – Patients and consumers’ demands
Interventions from:

Martine Van Hecke, Belgian Consumers’ Organisation Test-Achats
Ilaria Passarani, European Consumers’ Organisation BEUC

Following presentations were made:

Medicines’ Adverse Reactions are a public health issue: a proactive approach is needed, Prof. Joan-Ramon Laporte, Catalan Institute of Pharmacology (ICF), Spain
How to deal with adverse drug reactions reports? The role of National and regional pharmacovigilance centres, Dr. Thomas Stammschulte, German Medical Association (Arzneimittelkommission der deutschen Ärzteschaft, akdä), Germany
The European Commission’s Pharmacovigilance proposals: more than a technical Issue, Florence Vandevelde, Medicines in Europe Forum
Direct patient reporting: what works and why it matters. Findings of an international survey, Dr. Andrew Herxheimer, UK Cochrane Collaboration, United-Kingdom
Access to pharmacovigilance information – Patients and consumers’ demands
Interventions from:

Martine Van Hecke, Belgian Consumers’ Organisation Test-Achats
Ilaria Passarani, European Consumers’ Organisation BEUC

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News Press Releases Position Papers AIM Flash AIM Briefing		Media 27-01-2010 » EP expert meeting on pharmacovigilance - Brussels, 27 January 2010 Expert meeting in the European Parliament, Brussels, Wednesday 27 January 2010 Medicines in Europe - managing risks A closer look at the legislative proposals on pharmacovigilance Hosted by the European Parliament rapporteurs Linda Mc Avan (S&D) and Michèle Rivasi (Greens) Press release On Wednesday, January 27, Michèle Rivasi MEP (France, Greens) and Linda McAvan MEP (United Kingdom, S&D) chaired an expert meeting on the European Commission’s legislative proposals on pharmacovigilance, at the European Parliament in Brussels. The experts highlighted the need to improve patients’ safety in Europe by genuinely strengthening pharmacovigilance, which is the process of evaluating and improving the safety of medicines. The experts questioned a number of the Commission’s proposals that could weaken the current pharmacovigilance system, such as the possibility that premature marketing authorisations become the rule rather than an exception justified on public health grounds or the risk that Member States’ pharmacovigilance authorities could be increasingly bypassed in favour of pharmaceutical companies. The legal provisions to allow direct reporting of adverse drug reactions by patients to health authorities were strongly welcomed and experts shared recent evidence on the added value of spontaneous patient reports that provided crucial complementary information to health professional reports. Following presentations were made: Medicines’ Adverse Reactions are a public health issue: a proactive approach is needed, Prof. Joan-Ramon Laporte, Catalan Institute of Pharmacology (ICF), Spain How to deal with adverse drug reactions reports? The role of National and regional pharmacovigilance centres, Dr. Thomas Stammschulte, German Medical Association (Arzneimittelkommission der deutschen Ärzteschaft, akdä), Germany The European Commission’s Pharmacovigilance proposals: more than a technical Issue, Florence Vandevelde, Medicines in Europe Forum Direct patient reporting: what works and why it matters. Findings of an international survey, Dr. Andrew Herxheimer, UK Cochrane Collaboration, United-Kingdom Access to pharmacovigilance information – Patients and consumers’ demands Interventions from: Martine Van Hecke, Belgian Consumers’ Organisation Test-Achats Ilaria Passarani, European Consumers’ Organisation BEUC Medicines’ Adverse Reactions are a public health issue: a proactive approach is needed, Prof. Joan-Ramon Laporte, Catalan Institute of Pharmacology (ICF), Spain How to deal with adverse drug reactions reports? The role of National and regional pharmacovigilance centres, Dr. Thomas Stammschulte, German Medical Association (Arzneimittelkommission der deutschen Ärzteschaft, akdä), Germany The European Commission’s Pharmacovigilance proposals: more than a technical Issue, Florence Vandevelde, Medicines in Europe Forum Direct patient reporting: what works and why it matters. Findings of an international survey, Dr. Andrew Herxheimer, UK Cochrane Collaboration, United-Kingdom Access to pharmacovigilance information – Patients and consumers’ demands Interventions from: Martine Van Hecke, Belgian Consumers’ Organisation Test-Achats Ilaria Passarani, European Consumers’ Organisation BEUC Following presentations were made: Medicines’ Adverse Reactions are a public health issue: a proactive approach is needed, Prof. Joan-Ramon Laporte, Catalan Institute of Pharmacology (ICF), Spain How to deal with adverse drug reactions reports? The role of National and regional pharmacovigilance centres, Dr. Thomas Stammschulte, German Medical Association (Arzneimittelkommission der deutschen Ärzteschaft, akdä), Germany The European Commission’s Pharmacovigilance proposals: more than a technical Issue, Florence Vandevelde, Medicines in Europe Forum Direct patient reporting: what works and why it matters. Findings of an international survey, Dr. Andrew Herxheimer, UK Cochrane Collaboration, United-Kingdom Access to pharmacovigilance information – Patients and consumers’ demands Interventions from: Martine Van Hecke, Belgian Consumers’ Organisation Test-Achats Ilaria Passarani, European Consumers’ Organisation BEUC

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