EU Pharmaceuticals Review

MEPS vote against advertising but ask for clarity on the provision of information
In early November 2003 the Parliament’s Environment Committee began to discuss its response to the review of the Pharmaceutical’s legislation.
There are three proposals under consideration:
Regulation 2309/3 concerns the provision of a legislative framework for medicinal products.
2 Directives: 2001/83 on human medicine, and 2001/82 concerning vetinary medicines
The Committee retabled amendments rejected (...)

Medicines In Europe Forum publish a paper on international nonproprietary names (INNs)
The Medicines in Europe Forum have a published paper in English and French calling for Members of the European Parliament to vote for the international nonproprietary names of all substances to be clearly written on packaging items and information leaflets.
According to the current EU draft legislation this will not be the case with all substances.
To read the paper please click on the attached (...)

Pharmaceutical brand name corporations are pushing hard so that the revised EU legislation provides for prolongation of "data protection" and "commercial exclusivity" for their products.
You’ll find Medicines in Europe Forum position on this issue in the attached PDF.
For more information click here.
Related EPHA articles
Accession Countries issue declaration on EU pharma review
European pharmaceutical association makes its case to EPHA

Health ministers of the 10 new Member States decided to issue a declaration on 5 September, on the margins of the informal meeting of EU health ministers in Milan, Italy, to draw attention to their fears over the new medicines legislation’s provisions on data exclusivity.
The Italian Presidency has stated that they want to make as much progress as possible on the pharma review package with a view to its final adoption before the impending EU enlargement in May 2004.
In the Declaration, (...)

Pharmaceutical companies in the European Union are currently prohibited from advertising prescription drugs directly to the public, however Article 88 of DG Enterprise’s proposed draft of the EU Pharmaceuticals relaxes the ban for three diseases: diabetes, asthma and respiratory diseases, HIV/AIDS.
Opponents of the proposal argue that direct-to-consumer advertising (DTCA) leads to unsustainable health care spending and may have other negative effects for patients.
In contrast, its (...)