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Towards Patient-Centred Healthcare Systems
The EU Commission President, José Manuel Barroso, recently launched a series of ambitious reforms at national and European level aimed to make the European Union “the most dynamic and competitive knowledge-based economy in the world” by 2010.
As such, biotechnology and healthcare are a high priority on the political agenda of the Member States and of the European Union. Innovation in these two areas has contributed to, and will continue to be, a key element in achieving the ambitious goal set by the European Commission and EU governments. However, policies in these two areas must become more and more interlinked, as practically all future medicines and therapies will use healthcare biotechnology in the R&D process and/or in manufacturing.
Yet designing policy to foster innovation in biotechnology is not an easy task, because biotechnology is a complex field with complex potential outcomes and impacts. And this policy-making process faces a number of further challenges when transferred to the healthcare sector including a small knowledge base mostly found within the companies themselves, complex ideas to pass on to patients, new approaches to treating diseases that introduce new paradigms into patient/physician relationships (eg: monoclonal antibodies and personalised medicines), a significant SME base, and potentially polarising issues (such as gene therapy).
The EU is attempting to address this issue through initiatives such as the introduction of orphan drug legislation to foster research into rare diseases, opening an SME office at the EMEA, attempting to harmonise the assessment of advanced therapies (cell, gene and tissue therapies), and inviting EuropaBio to be a stakeholder in the High Level Pharmaceutical Forum.
2007 will see a continuation of these initiatives. However, as the European Council itself noted in 2005: “Given the challenges to be met, there is a high price to pay for delayed or incomplete reforms, as is borne out by the gulf between Europe’s growth potential and that of its economic partners. Urgent action is therefore called for”. The Commission must be encouraged to use the opportunity of this year’s mid-term review of the Life Science and Biotechnology Strategy for Europe to add further impetus to this area of policy development.
This Manifesto sets out how EuropaBio will contribute to this process of policy development, as well as regulatory implementation, in 2007. These actions are laid out under seven key Policy Principles, areas that will need to be addressed in order to handle the healthcare innovations expected over the next few years that will provide the answers to unmet medical needs. EuropaBio also calls for healthcare systems to put the patient at the centre of any medical, social, economical and ethical consideration, rather than budgetary issues.
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