Pharmaceutical industry: products single market

Without debate, the European Parliament adopted the resolution by Imelda Read (PSE,UK) on the communication from the Commission on the single market in pharmaceuticals. The report warmly welcomes the Commission communication and calls on the Commission to bring forward a proposal to complete the internal market in pharmaceuticals, based on the following principles: - encouraging innovation through a competitive market and an appropriate regulatory framework; - protecting new medicinal products by intellectual property rights both in the EU and in third countries; - guaranteeing the availability of medicinal products providing optimum health protection for European citizens; - guaranteeing the availability of medicinal products providing optimum health protection for European citizens; - creating the right economic conditions so that important medicinal products are actually available throughout the Union; - developing EU-wide measures to promote research on innovative therapies which are particularly important from the point of view of public health and encouraging research into diseases which cannot yet be treated satisfactorily and into rare diseases. The Commission is called upon to establish a framework for a dialogue between all stakeholders (governments, patients' organisations, the pharmaceutical industry, trade unions etc.) on how to manage jointly the fast pace of change in the health area. The Parliament notes, once again, that the pharmaceutical industry has a different economic structure in comparison to other industries. It urges the Commission to remember that the further development of a European-based pharmaceutical industry forms a positive contribution to pharmaceutical competition, including both SMEs and research-based firms. It demands that the Commission continue to monitor closely mergers and competitive structures in the pharmaceutical sector in compliance with Community competition policy, especially given the ability of SMEs in the sector to innovate in direct competition with larger enterprises. The Parliament believes that it is essential to complete the internal market in pharmaceuticals, but stresses that this market must first and foremost consider the needs of the public for safe, effective and high quality pharmaceutical products, while ensuring that European citizens have timely access to innovatove and affordable medicines. It strongly urges the Commission, when formulating its proposal to complete the single market in pharmaceuticals, to distinguish between the three sub-sectors of the industry: medicines that are available for sale directly to patients without prior medical endorsement ("over-the-counter" medicines), medicines which are patent-expired ("generic" medicines) and medicines which are still in-patent. Any legislation needs to provide for there to be appropriately trained staff available to advise customers who are purchasing over-the-counter products. The Parliament would welcome a proposal for a comprehensive evaluation of the pharmocovigilance system, including the European Medicines Evaluation Agency (EMEA). It recalls its belief in the importance of transparent procedures which define the method by which prescription medicines can be transferred to non-prescription status. Finally, the report calls for a review of the directive on the transparency of measures regulating the prices for medicinal products for human use and their inclusion in the scope of national health insurance systems (89/105/EEC) to ensure that the delays observed by the Commission for pharmaceutical products to reach the market are minimised.�