Brussels, 16/10/2008 (Agence Europe) - After a discussion among EU commissioners in Strasbourg on Tuesday 21 October 2008, the European Commission will adopt a new pharma package comprising an umbrella communication and four items of legislation - a directive on preventing counterfeiting, a directive on providing information to patients, a directive on pharmaceutical surveillance and a regulation on pharmaceutical surveillance. Several sections of these items of legislation, drawn up by Commission Vice-President Günter Verheugen's services, are subject to disagreement among the commissioners. On Tuesday, the Commission will demonstrate whether it is able to protect European patients and promote therapy innovations. The situation thus far:
The communication is aimed at promoting a pharmaceutical industry centred around safe, innovative and accessible medicine. It stresses the need to reduce the time between medicines being authorised and actually appearing on the market, by improving application of the transparency directive and exchange of information among the member states about prices, refunds and the relative effectiveness of a medicine (compared with other treatments). Based on analysis of an industry investigation carried out by the services of EU Competition Commissioner Nellie Kroes and an in-depth analysis of how the markets operate, the Commission is considering extending competition in the pharmaceutical industry. Alongside this, it is expected to try to cut red tape on companies. The Commission will announce that it will present a draft modification to the directive on clinical trials in 2010.
The first directive will try to prevent counterfeit medicines entering the marketing chain, making use to this end of the main recommendations made by a series of experts: - extending the pharma legislation's scope so that it covers all actors in the distribution chain; - introducing security measures to authenticate and trace products; - banning substantial changes to packaging; - giving the member states the option of opting out of the banning of “re-packaging” in certain circumstances (especially the adaptation of a product to the local market of a small member state) and in certain limits. The draft directive will aim to prevent the “re-packaging” of medicines - changing the packaging and sometimes the expiry date. Such changes are banned for any perishable products sold in a supermarket but are common practice for medication where companies operating in a “parallel universe” buy products in lower-cost countries and sell them on in northern European countries for a higher price. Labels are removed from boxes of medicines and a new label stuck on with sticking tape. In extreme cases, the contents are altered and blister packs unevenly cut into sections with scissors. This makes it easy to introduce counterfeit medicines. The draft directive is being opposed by Competition Commissioner Nellie Kroes and Internal Market Commissioner Charlie McCreevy, who are defending a trade worth €4 billion a year.
The draft directive on providing information to the public about prescription medicines includes most of the recommendations made by the Pharmaceutical Forum. The Commission is suggesting paving the way for the publication of non-promotional information by the pharma industry but only in written format or on the web. The draft directive introduces quality standards and controls by the member states and the London-based European Medicines Agency (EMEA). Health Commissioner Androulla Vassiliou has expressed reservations about several aspects of the directive.
The draft directive on pharmaceutical surveillance will strengthen and rationalise the existing system. It is being published with a regulation establishing a pharmaceutical surveillance committee at the EMEA. (O.J./transl.fl)