Brussels, 23 Sep 2005
European bioindustry leaders issued a Healthcare Manifesto on 22 September calling for political support to develop innovative medicines.
The Manifesto, published by EUROPABIO, the European Biotechnology Association, sets out seven key policies focused on creating an optimal environment for the discovery and development of such biotech medicines in Europe, allowing bioindustry to meet the healthcare innovations expected over the next few years, including so far unmet medical needs.
Biotechnology is a strategic sector for healthcare - 50 per cent of all new medicines originate from it, notably the most innovative medicines to treat or prevent heart attacks, multiple sclerosis, breast cancer, cystic fibrosis, leukaemia and other diseases including rare disorders. Almost 250 million patients are already benefiting from advances made in biotechnologies, both in terms of diagnostics and treatment. But many patients do not have access to treatments and many diseases are still untreated.
Launching the Manifesto in Brussels, the Chairman of EuropaBio's Healthcare Council, Dr. Andrea Rappagliosi said: 'Our intention is to set out the policy agenda to deliver a more patient-oriented approach to human healthcare by delivering innovative and dynamic growth of products that can substantially improve the quality of life for patients and meet unmet medical needs.'
The Manifesto's sets out seven priorities:
-The role of economic evaluation of biotechnology medicines and emerging technologies;
- Biosimilar Medicinal Products: raising the bar of quality and safety - a public health perspective;
- Orphan Drugs: completing a European dream;
- Reaching for new medical frontiers with emerging cell and tissue engineered products;
- Bioethics as an invaluable component in today's healthcare industry;
- Diagnosis and innovative medicines go hand in hand: towards targeted therapies, the role of genetics and pharmacogenetics;
- Biotech to biotech: where size matters: creating a friendly environment for SME's and the biotech industry. 'Healthcare biotech with its exceptional understanding of the underlying causes of disease is producing solutions to some of the world's most devastating diseases like cancer, infectious diseases and autoimmune disorders,' says Johan Vanhemelrijck, Secretary General of EuropaBio. 'It is a key technology in developing new healthcare therapies and a major contributor to growth as over 50 per cent of future medicines will be derived from it.'
Last February, EuropaBio in association with France Biotech and the French pharmaceutical trade bodies, published the first ever scientific study on the impact of biotechnology derived medicines on the quality of life and life expectancy of patients. BioImpact highlights the major advances made thanks to years of research. Biomedicines and other biotechnologies represent a large and growing segment of innovative medicines (35 to 40 per cent of the authorisations for commercialisation in 2003 were biotech). Many of these molecules were developed in the United States. To guarantee continued access to the most innovative care, it is vital to create an optimal environment for the discovery and development of such biotech medicines in Europe.
The manifesto comes just one day after the publication of a less optimistic scientific report on the near future of pharmacogenetics.
The UK's Royal Society published a paper, drawn up by a working group of experts from healthcare, industry and research, that warns against exaggerated expectations in this field: 'Personalised medicines: hopes and realities'. The report concludes that even though personalised medicines have a promising future, it will be another 15 to 20 years before their use is widespread. According to the authors, the field is still in its infancy, but understanding how genetic factors influence a person's response to a drug could make new and existing treatments safer and more effective. Clinicians and pharmaceutical companies will continue to favour drugs that work well regardless of genetic differences, but where this is not possible, pharmacogenetic medicines, with an associated diagnostic test, will increasingly play an important role.
According to this report, large scale clinical trials are needed to assess the cost-effectiveness of developing and using pharmacogenetic therapies and investment needs to come from both the public and private sectors. For new drugs, these trials will be conducted by the pharmaceutical industry, but for existing medicines, studies should be encouraged by public funding in public-private partnerships between medical research charities, public health departments and the pharmaceutical and diagnostic industries.
For further information on EuropaBio, please visit:
The Healthcare Manifesto can downloaded from the following web address: http:///www.europabio.or g/HC%20Manifesto/ manifesto_final%20050913.pdf
For the 'Personalised medicines: hopes and realities' report, please visit:
http:///www.royalsoc.ac.uk/displaypaged oc .asp?id=15874