Details
- Status
- Closed
- Opening date
- Deadline
- Department
- Directorate-General for Health and Food Safety
Target audience
Public health community
Why we are consulting
Period of consultation
From 15 March 2006 to 12 May 2006.
Contributions to and results of the consultation
A summary of the responses is available here.
Based on the results of the public consultation of 2006, on 26 February 2007 Commission Vice-President Günter Verheugen announced a strengthening of the EU pharmacovigilance system. The announcement includes both better implementation of the current system and proposals to change the legal framework for pharmacovigilance in the EU. The change to the legal framework will involve an impact assessment during the course of 2007 with a view to a legal proposal in 2008.
To aid analysis, where joint responses were received from more than one organisation falling within the same stakeholder group these responses were counted only once. In contrast, if joint responses were received from organisations falling within different stakeholder groups these were counted separately.
In the list of individual responses provided below the number corresponds to the numbers listed against specific comments in Annex 1 of the summary of the consultation responses.
Below are the public responses to the above-mentioned public consultation:
Patients, consumers and victims
- Thalidomide UK
- European Patients' Forum
- EATG - European AIDS Treatment Group
- European Cancer Patient Coalition
- EFA / IPCRG - European Federation of Allergy and Airway Diseases Patients Associations joint response with IPCRG
- Danish Consumer Council
- Health Action International (Europe)
Healthcare professionals
- EUGMS - European Union Geriatric Medicine Society
- IPCRG / EFA - International Primary Care Respiratory Group (primary care doctors) joint response with European Federation of Allergy and Airway Diseases Patients' Associations
- CPME - Standing Committee of European Doctors
- ESMO - European Society for Medical Oncology
- PGEU / EuroPharm / FIP - Pharmaceutical Group of the European Union (community Pharmacists) joint response with EuroPharm Forum (pharmacists + WHO European Office) and International Pharmaceutical Federation (pharmacists)
- EFN - European Federation of Nursing Associations
- Professor Pascal Demoly, University Hospital of Montpellier
- Joanne Barnes Associate Professor in Herbal Medicines, School of Pharmacy, University of Auckland
- Prof. Dr. Joerg Hasford, Department of Medical Informatics, Biometry and Epidemiology, University of Munich
- Maria Judith Marquez Pradera, healthcare professional and medical advisor for the pharmaceutical industry
Industry
- AESGP – Association of the European Self-Medication Industry
- EFPIA – European Federation of Pharmaceutical Industries and Associations : [19a] - [19b] - [19c] - [19d]
- EGA – European Generic Medicines Association
- IFAH-Europe – International Federation for Animal Health Europe
- EuropaBio
- GIRP – European Association of Pharmaceutical Full-Line Wholesalers
- PPTA-Europe - Plasma Protein Therapeutics Association
- LIF – The Danish Association of the Pharmaceutical Industry
- BAH - Bundesverband der Arzneimittel-Hersteller e.V. (German proprietary medicines manufacturers association)
- BPI – Bundesverband der Pharmazeutischen Industrie (German Pharmaceutical Industry Association)
- GlaxoSmithkline
- Rottapharm Italy and Delta Laboratories
- Dr Wolfgang Matthies, Ecolab Deutschland
- Dr Brian Edwards, Janssen Cilag Ltd.
- EU PhRMA Pharmacovigilance Working Group
- Voisin Consulting
Regulators
- EMEA - European Medicines Agency
- CHMP / PhVWP - EMEA Committee on Human Medicinal Products and CHMP Pharmacovigilance Working Party
- PhVWP - CHMP Pharmacovigilance Working Party
- EMEA Committee for Herbal Medicinal Products
- EMEA - CHMP Working Group with Patient Organisations (report of March 2005 provided by Dr Priya Bahri of the EMEA)
- The Danish Medicines Agency
- The Dutch Ministry of Health, Welfare and Sport
- Swedish Medical Products Agency
- Abdelkader Helali, Director, Centre National de Pharmacovigilance et de Materiovigilance
- Dr Priya Bahri of the EMEA
Others
- International Society for Pharmacoepidemiology
- An ad-hoc group of ten pharmacoepidemiologists
- Professor Saad Shakir, Director, Drug Safety Research Unit (UK)
- WHO Collaborating Centre for International Drug Monitoring
- La revue Prescrire
Objective of the consultation
The objective of the consultation is to collect the views of stakeholders on the community system, including comments on the current functioning of the system and how it might be further strengthened.
The consultation document
The consultation document can be downloaded here.
Protection of personal data
The policy on "protection of individuals with regard to the processing of personal data by the Community institutions" is based on Regulation (EC) N° 45/2001 of the European Parliament and of the Council of 18 December 2000. More information is available here.