Pharmaceuticals and Medical Devices

In July 2007, the Commission launched a public consultation on the future of pharmaceuticals for human use in Europe. EPHA contributed to it.
The consultation ended in October. Here is a summary of the outcome.
DG Enterprise and Industry conducted a public consultation on the future of pharmaceuticals between 19 July and 12 October 2007.
Stakeholders were invited to express their position on the basis of six general questions:
Do you agree with the analysis of the main challenges outlined (...)

John Bowis, MEP, hosted a lunch debate on 16 October 2007 in the European Parliament on combating increases in antibiotic resistance. Along with parliamentarians, the event bought together experts from Member States, the European Commission and the European Centre for Disease Prevention and Control. They discussed the large discrepancies between antibiotic resistance prevalence across the EU and what could be done to reduce it.
The prevalence of antibiotic resistance varies widely across (...)

This article has been updated with a recent press release signed by Health Action International (HAI), the International Society of Drug Bulletins (ISDB), and the Medicines in Europe Forum (MiEF) (attached).
In order to re-launch the debate on Pharmaceutical issues and on information to patients, the European Commission has set up the Pharmaceutical Forum, which proves to be very unbalanced and non-transparent.
The Pharmaceutical Forum was jointly established by Vice President Verheugen (...)

EudraPharm is the name of the public database launched by the European Medicines Agency (EMEA) to facilitate access to information about medicines available in the European Union. This article was updated to include information about new languages.
The EudraPharm database is designed to give on-line access to information about all medicinal products for human or veterinary use that have been authorised in the European Union (EU).
It includes the summary of product characteristics, package (...)

This article includes EPHA response and also some of the responses of our members.
The Pharmaceutical Forum working group on Information to Patients has launched a consultation on a case study on diabetes information package and guiding principles.
EPHA main messages
Drawing upon the expertise of EPHA members and further to EPHA’s responses to the European Transparency Initiative and the Green Paper on the role of Civil Society in drug policy in the European Union, the European Public (...)

The Health On the Net code has been created for evaluating medical websites. It sets up eight ethical standards in the presentation of health information on internet and aims to make sure readers know the source and purpose of the information they read.
Created by the Health On the Net Foundation, the code has been adopted by the French National Authority for Health as an accreditation system for website giving medical information.
What is the HON Code?
The HON code defines a set of rules (...)

Against the background of the consultation on Pharmacovigilance launched last year, DG Entreprise has presented the results of the consultation The main message is that EU rules regarding pharmacovigilance need to be reviewed.
DG Entreprise therefore proposes two main actions:
better implementation of the current system or
changing the legal framework for pharmacovigilance in the EU.
Better implementing the current system
According to DG Enterprise improving the implementation of the (...)

The European Union institutions and Japan have recently signed an agreement to exchange confidential information about the authorisation and safety of medicines.
The confidentiality arrangements cover human medicines subject to evaluation, or authorised under the centralised authorisation procedure. Medicinal products authorised at national level by the EU Member States, that are subject to official EU arbitration and referrals will also be covered by the agreement. The confidentiality (...)

In 2006, Complementary and Alternative medicines (CAM) have stepped up recognition at European level in the 7th Research Framework Programme and in the European Medicines Evaluation Agency. However the legal framework still needs improvement.
With regard to research, the CAM advocates have been successful in ensuring that EU funding for research, including homeopathy, is allocated in the 7th Research Framework Programme.
Within the European Medicines Agency, things have also moved ahead: (...)

EMEA Budget News for 2007
The European Community contribution to the European Medicines Agency (EMEA) budget has been cut in 2007 EU budget discussions but not to the degree first feared.
Although the Agency had originally requested 46.32 million EUR, initial indications suggested that the Agency would receive only a small increase over the 2006 level of 34 million EUR.
However, the EMEA management board petitioned the European Parliament, expressing the concerns expressed by a great (...)