Information to Patients - Responses to the Public consultation

Responses to the Public consultation on the key ideas of a legal proposal on information to patients - See note (*).

Below are the public responses to the above-mentioned public consultation.

Healthcare professionals and organisations

Patient organisations

Regulators

Pharmaceutical industry organisations and companies

Research and others

Consumer organisations

ECCG - The European Consumer Consultative Group - Opinion on information to patients (20 February 2008) - See note (**)

Media and patient information organisations

Social insurance organisations

* Only those responses are published here, where no confidentiality was specifically requested.
** The reply has been provided in accordance with the Code of Good Administrative Behaviour.

Additional information:

Information to patients

European citizens are increasingly attentive towards new developments in public health which can positively affect their well-being. What is more, information can be easily collected by people, through different channels, such as newspapers, the mass media and the internet. As people play a leading role in the decisions about their own treatment, the dissemination of appropriate high-quality information has became of primary importance.

To ensure adequate information to patients on diseases and treatment options, the European Commission has been looking at different ways of improving the quality and accessibility of information within the High Level Pharmaceutical Forum and with the adoption of legal proposals on information to patients.

A non-legislative approach
A legislative approach
Further information on EU activities in this area in the Health EU Portal

The EU legal framework for medicinal products guarantees high standards of quality and safety. It also promotes the functioning of the internal market, with measures that encourage innovation and competiveness in Europe. It is based on the principle that medicinal products may be placed on the market only following a marketing authorisation granted by the competent authorities. A large body of legislation has developed around this principle with the progressive harmonisation of requirements implemented across the whole European Economic Area.

Today, medicinal products are authorised at EU level by the European Commission or at national level by the competent authorities of EU countries. Special rules exist for the authorisation of medicinal products for paediatric use, orphan medicines, traditional herbal medicines, vaccines and clinical trials. Once placed on the market, the safety of a medicinal product continues to be monitored throughout its entire lifespan through the EU system of pharmacovigilance.

The European Medicines Agency, established in 1995, underpins the centralised authorisation procedure and supports coordination between national competent authorities. The Agency is the hub of a European medicines network comprising over 40 national regulatory authorities guaranteeing a constant exchange and flow of information regarding the scientific assessment of medicinal products in the EU.

Legal framework	Medicines for children	Orphan medicines	Advanced therapies	Pharmaceutical committeeand expert groups
Clinical trials	Falsified medicines	EU Logo foronline sale of medicines	Good Manufacturing and Distribution Practices	Pharmacovigilance
Traditional herbalmedicines	Personalised medicine	Medicines andthe environment	Call for EMA committeesand board members	Veterinary medicinal products
International cooperation on pharmaceuticals	Pharmaceutical strategy for Europe