- All > Medicine Information and Evidence for Policy > Medicines Policy
- All > Medicine Access and Rational Use > Pricing
- All > Quality and Safety: Medicines > Regulatory Support
- Keywords > access to new and existing pharmaceutical products
- Keywords > competition - pharmaceutical sector
- Keywords > drug pricing policy
- Keywords > European medicines policy
- Keywords > innovation and access
- Keywords > medicines policy development
- Keywords > pharmaceutical legislation
- Keywords > pharmaceutical market
- Keywords > pharmaceutical policies
- Keywords > regulation - pharmaceutical markets
(2010; 48 pages)
The European Union pursues two major objectives in its policy on pharmaceutical products: its policies strive to secure a high level of public health and innovation and, at the same time, provide support for a competitive industry that ensures that Europe continues to benefit from new medicines.
The first objective requires that access to medicines and treatments is affordable and that medicines are safe and effective, but also, increasingly, that patients should receive the information necessary to make informed choices about their own treatment. The second objective requires enhancing the competitiveness of Europe’s pharmaceutical sector. The competence to intervene in the market, and the related tools with which the EU institutions pursue – or, rather, attempt to reconcile – these two objectives are by no means similar in legal scope or nature. Although the European Union has now created a centralized licensing agency, the European Medicines Agency (EMEA), and also enjoys extensive legislative powers to determine what might be termed the ‘regulatory pathway’ for authorizing the marketing of new products in accordance with strict criteria on safety, quality and efficacy, it has less direct influence on what can be termed the commercial or ‘market pathway’ – the prices and conditions under which products are purchased by national heath care providers and insurance companies, and, indeed, patients. The role of the Member States in defining the ways they provide access to medicines, the price of those medicines and how patients and consumers gain access to information on pharmaceutical products is still crucial in determining overall policy, even though a certain amount of secondary legislation adopted at the European level is of increasing importance in shaping the market pathway...