Meddelelse fra Kommisjonen til Europaparlamentet, Rådet, Det europeiske økonomiske og sosiale utvalg og Regionskomiteen: Sikre, innovative og tilgjengelige medisiner: en fornyet visjon for den farmasøytiske sektor
Meddelelse lagt fram av Kommisjonen 10.12.2008
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BAKGRUNN (fra kommisjonsmeddelelsen, engelsk utgave)
The pharmaceutical sector makes an important contribution to European and global wellbeing through the availability of medicines, economic growth and sustainable employment. It has been and remains a strategic sector for Europe. It employs more than 634,000 people and accounts for more than 17% of the EU Research and Development (R&D) expenditure. Most importantly, innovation in human medicines has enabled patients to benefit from treatments considered unimaginable a few decades ago. Demographic change, i.e. ageing, is a global phenomenon which will affect western societies as well as major emerging economies like China and Russia. Hence health-related services and products are growth markets worldwide and offer a potential for Europe's well- established pharmaceutical industry.
Since 1965, Community action in the field has always had the dual objective of safeguarding public health by providing Europe with safe and effective medicines, while at the same time creating a business environment that stimulates research, boosts valuable innovation and supports the competitiveness of the industry. Much has been achieved in forty years. However, at the beginning of the 21st century Europe faces major health, economic and scientific challenges:
– Europe has been losing ground in pharmaceutical innovation. The centre of gravity for research has moved to the US and Asia. New international competitors emerge. In the 1990s pharmaceutical research and development expenditures in Europe were higher than in the U.S. (EUR 7.766 billion compared with EUR 5.342 billion). However, the picture had changed by 2006 (EUR 22.500 billion in the EU while EUR 27.053 billion in the U.S).
With regard to research sites a similar trend can be identified. Between 2001 and 2006 18 research sites of 22 global pharmaceutical companies were closed in Europe (only 2 were opened) while in the same period these companies opened 14 research sites in Asia (one was closed) and six in the U.S. (five were shut down). While in general the number of new pharmaceutical substances has decreased worldwide, the decrease has been significantly sharper in the EU than in the U.S. and other parts of the world.
– Shortcomings in the availability of medicines have been identified. In 2008, European patients still suffer from inequalities in availability and affordability of medicines. The last legislative review and the creation of the High Level Pharmaceutical Forum are major steps forward, but some key issues remain open. Future proposals of the Commission will also have to take into account the findings of the ongoing pharmaceutical sector inquiry.
– The sector is more and more globalised. Globalisation brings new opportunities with the opening of new markets. Industry sales outside the traditional markets, i.e. industrialised regions like the U.S., Europe and Japan, are increasing significantly. At the same time, worldwide cooperation and trade lead to a global division of labour. Hence a new medicine is often the result of research and development in Europe, clinical trials in India, and active ingredients produced in China before finally produced, packaged and sold in the EU. This "global" reorganisation creates new opportunities but also new challenges, in particular counterfeit medicines are on the rise.
– Scientific breakthroughs revolutionize the way medicines are developed and prescribed. Treatments become more personalised. Linked to the ageing of the population and to a proactive involvement of patients, the demand of society is also evolving. At the same time unmet medical needs are to be met, e.g. infectious diseases (like tuberculosis and HIV/AIDS) and rare diseases whose ramifications are not limited to the EU but pose global public health challenges.
To address these challenges, this Communication outlines the Commission's vision of the future of the sector and intends to trigger a process which leads to a way forward. Based on three pillars, concrete objectives are proposed:
(1) To make further progress towards a single and sustainable market in pharmaceuticals and;
(2) To take on the opportunities and challenges of globalisation;
(3) To make science deliver for European patients and restore the EU's role as the natural home for pharmaceutical innovation.
The Commission's vision is to ensure that European citizens can increasingly benefit from a competitive industry that generates safe, innovative and accessible medicines. Many initiatives have been taken in this direction, most recently with the inclusion of eHealth in the Commission's lead market initiative that aims to remove barriers to the acceleration of market development. The five accompanying legislative proposals (on counterfeiting, information to patients and safety monitoring) are further important steps towards this vision, while other concrete objectives are listed in the Annex.