EU Pharmaceuticals Review

This article is an update regarding the renewal of patents of pharmaceuticals companies in the infectious disease market. The two biggest sectors for drugs targeting infectious disease, antibiotics and antifungals, have seen major decline over 2005-2006. Imminent patent expiries of major products urge pharmaceutical companies to decide what sort of presence they should maintain in the market. Some experts claim that this would have a positive effect on the market since certain (...)

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 (...)

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 (...)

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 (...)

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 (...)