Information to Patients

The package of legislative proposals on pharmaceutical issues consisting of pharmacovigilence, counterfeit medicines and the proposals on Information to patients was prepared by The Directorate General on Enterprise and Industry of the European Commission. Please read about the progress of the package here

Background

The provision of information to patients has been under discussion at European level for a number of years. The report on current practices with regard to the provision of information to patients on medicinal products was released in December 2007 as a communication to the European Parliament and Council from the Commission. This report recommends that information on medicinal products is harmonised within the European Union (EU) in order to ensure that all patients have equal access to information on medicinal products. DG Enterprise and Industry states the purpose of this proposal is to ensure that all EU citizens have access to good-quality, objective, reliable and non promotional information on prescription-only medicinal products.

The production of the package was decided on during a working group in the Pharmaceutical Forum. On 5 February 2008, the Commission launched the latest in a series of public consultations on ’Information to Patients’. The public consultation focused on Information to Patients and the consultation ran until 7 April 2008.

EPHA Comments on the Consultation

The EPHA Consultation response was based on a a questionnaire circulated to members:

 The current EU legislation regarding the prohibition of advertising on prescription-only medicines should not be relaxed in any way.
 A clear distinction must be made between 3 types of information, namely: Information to Patients, Information on Medicines and Health Information areas.
 Healthcare professionals should remain the primary source of health information.
 The skills of patients need to be built up to evaluate the information about available medicines.
 The right to access objective information about health, medical conditions and best available treatments should be a fundamental principle of medicinal information.
 Any EU action on provision of medicinal information should not contribute to an increase in the existing health inequalities.
 The subject and its discussion should be ’owned and led’ by DG SANCO, as it has the responsibility for health protection and promotion.

EPHA strongly believes that this proposal would undermine the spirit of the existing article 88a of Directive 2001/83/EC which bans advertising of prescription only medicines directly to the patient/consumer. We urge the Commission to reconsider its approach and the implications that any liberalisation of existing rules will have on demand, supply and sustainability and patient safety within healthcare systems.

EPHA calls on the European Commission, the Member States and the European Parliament to put health first in its proposals on health information.

Please find the EPHA position paper from the consultation process on ’Information to Patients’ available here.

EPHA Members Consultation Responses on ’Information to Patients’

 Royal College of Nursing UK (RCN)
 Health Action International (HAI) Europe
 European Heart Network

Main Actors

The following is a brief overview of specific existing stakeholder views:

 Some Patient Groups express concerns about the lack of consistent and high-quality information provided by credible sources available in the public domain. They welcome attempts to address this by the Commission.

 Some Professional Groups want to ensure clear and scientifcally-based evidence in information provision to patients. This informations should be easy to understand and that the primary responsibility for dispensing this information should remain within their roles as health experts.

 Industry believe that their inability to communicate directly to target patient groups under current legislation is detrimental to health of patients and wish to see a relaxation of current rules.

EPHA Members’ Consultation Responses on ’Information to Patients’

 Royal College of Nursing UK (RCN)
 Health Action International (HAI) Europe
 European Heart Network