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15 May 2014

Personalised Medicine 2010 - Establishing an EU dialogue platform on Personalised Medicine

http://www.ehfg.org

22 May 2014

CSA PerMed Kick-Off end of March 2014 in Berlin

http://www.permed2020.eu/1408.php

13 June 2014

Public Health Genomics Joins Forces with the Genomic Medicine Alliance

Public Health Genomics 2014;17:125-126 (DOI:10.1159/000363559)  http://www.permed2020.eu/1408.php

14 June 2014

Launch of the Swiss SAMW report on Personalized Health on 11th of June 2014

http://samw.ch/en/pershealth

14 June 2014

IGEN-HUNGARIAN Meeting 17th of June 2014 in Debrecen, Hungary

http://igen.tamop422.unideb.hu

Selected publications:

1. Horgan D, Byrne D, Brand A. EU directive on patients’ rights to cross border healthcare. BMJ 2013; 347.

2. Hafen E, Kossmann D, Brand A. Health Data Cooperatives - Citizen Empowerment. Methods of Information in Medicine 2014 (in print)

3. Brand A. Public Health Genomics and Personalized Healthcare: a pipeline from cell to society. Drug Metab Drug Interact 2012; 27(3): 121–123

4. Brand A, Lal JA for the Public Health Genomics European Network (PHGEN II). European Best Practice Guidelines for Quality Assurance, Provision and Use of Genome based Information and Technologies: the 2012 Declaration of Rome. Drug Metab Drug Interact 2012; 27(3): 177–182

5. Cesuroglu T, van Ommen B, Malats N., Sudbrak R, Lehrach H, Brand A. Public health perspective: from personalized medicine to personal health. Personalized Medicine 2012; 9(2): 115-119.

6. Harvey A, Brand A, Holgate ST, Kristiansen LV, Lehrach H, Palotie A, Prainsack B. The future of technologies for personalised medicine. New Biotechnology  http://dx.doi.org/10.1016/j.nbt.2012.03.009.

7. Lal JA, Schulte in den Bäumen T, Morre SA, Brand A. Public health and valorization of genome-based technologies: a new model. Journal of Translational Medicine 2011; 9(207).

8. Becla L, Lunshof JE, Gurwitz D, Schulte in den Bäumen T, Westerhoff HV, Lange BM, Brand A: Health technology assessment in the era of personalized health care. International Journal of Technology Assessment in Health Care 2011; 27:118-126.

9. Brand A. Public health genomics – public health goes personalized? Eur J Public Health 2011; 21(1): 2–3.

10. Rosenkötter N, Vondeling H, Blancquaert I, Mekel OC, Kristensen FB, Brand A. The contribution of health technology assessment, health needs assessment, and health impact assessment to the assessment and translation of technologies in the field of public health genomics. Public Health Genomics 2011; 14(1): 43-52.

EJPH 1/2011 - Viewpoint

Paola Testori Coggi, Directorate-General for Health and Consumers, European Commission, Brussels

A European view on the future of personalised medicine in the EU

"At the European Health Forum Gastein in October 2010, personalized medicine was presented as a new paradigm for health care in Europe. I had the opportunity to participate in this session and to listen to the views of my esteemed co-participants on what can be done at the European level to achieve implementation of personalized medicine approaches and other emerging technologies.

Personalized medicine is becoming an ever more important area for the application of genome-based information and technologies identified under public health genomics. The scope and vision of public health genomics, according to the 2005 Bellagio Conference is ‘the responsible and effective translation of genome-based knowledge and technologies for the benefit of population health’. This concept encompasses both population and individual health. It covers prevention, treatment and care. Genomics is clearly an area of innovative research that seeks to close the evidence gap of today’s biomedical and health research. This is an important area of potential innovation in Europe.

As the Commission has set out in the Europe 2020 strategy and its related initiatives, it is essential for Europe to build on our strengths to develop innovations to promote growth and benefit European citizens. Genomics has the potential to be a key sector contributing to this in the future.

Future epidemiological studies may begin by grouping participants according to their genomic patterns, then according to environmental factors like exposure levels e.g. by life styles. The relationship between environmental factors and genetics is an area that needs more exploration. This will enable us to pin down and predict disease patterns and susceptibility in individuals. Genomics not only has potential for epidemiological research but also for individual prediction and prevention of health risks as well as for personalized treatment and care. This involves developing tailor-made treatments.

In the treatment of cancer, for example, the concept of pharmocogenomics is gaining ground due to the fact that there are so many different types of cancers. This kind of medicine is already making its mark. It is taken into account in pharmaceutical companies’ business strategies, the design of clinical trials and the way medicines are prescribed. Although personalized medicinal products are expensive, their efficacy and safety could actually make them more cost effective in the long run than traditional medicines. Their potential is therefore huge. If the specific quality, safety and efficacy of individual personalized medicines can be assured, they will respond to patient needs in a much more targeted manner.

There is currently an assumption that personalized treatment options would put a strain on public healthcare budgets.

An alternative viewpoint is that they would in fact reduce health spending in the long run, through greater effectiveness and the avoidance of unwanted side-effects. Indeed, being able to immediately select and offer patients the medicine that is effective for them will be a bonus, as trial and error can be avoided. However, we need to ensure that equity and access are also taken into account. The progress offered by emerging technologies and therapies needs to be analysed by the Commission over the coming years in order to keep the EU regulatory framework up to date. We need to constantly look at better ways to address medical needs and one way to do this is by encouraging the development of innovative technologies.

The concept of personalized medicine is an important driver for innovation. It is clear to all that ‘pharmaceutical innovation’ is a crucial component of this concept. It is of key importance in addressing unmet medical needs within society. The lack of adequate treatment for many diseases requires continuous innovative efforts to find new medicines. This equally entails the engineering of innovative in vitro diagnostic medical devices. But we need collaboration and co-operation. The Innovative Medicines Initiative (IMI) is an excellent example of how collaboration between industry and the Commission can deliver concrete results. We are determined to take this agenda forward. Our ambition must be to continue our strong support for fundamental pharmaceutical research in Europe to improve chances of translating researchresults into successful products on the market. With regard to the regulatory framework for pharmaceuticals, we have a comprehensive EU legal framework coupled with detailed scientific guidance documents, enabling economic operators to foster public health by bringing safe, efficacious and quality medicines to the market.

The Commission has in place several mechanisms to support innovation. The Internal Market framework provides various incentives for innovation. In addition to the Community Code relating to medicinal products, there is the Regulation on orphan medicinal products. This seeks to encourage research and development of medicines for patients suffering from rare diseases. This has proved to be a great success over the past 10 years. Another example is the Regulation on Advanced Therapy Medicinal Products, adopted in 2007. This legislation aims to speed up the development of regenerative medicine products and promote industry’s competitiveness, while respecting national prerogatives on ethics. This initiative is also starting to yield results.

The Commission funded Public Health Genomics European Network (PHGEN) has mapped the foreseeable impacts of the evolving genome-based information and technologies in all areas of public health, health care and health systems and is developing the 1st edition of European guidelines for quality assurance, provision and use of genome-based information and technologies due in 2012. Furthermore, we continue with interest to follow developments in science, product development and public discussions on this subject.

In this context, I should also mention that the European Medicines Agency (EMA), together with its network of expertise in the Member States, is an excellent pool of knowledge. At the Commission, we are working across different departments, from Research to Public Health, to share information.

I am convinced that the area of personalized medicine, and its fascinating emerging technologies such as pharmacogenomics, patient-specific modelling and disease simulators, has enormous potential for our citizens. It will lead to Europeans ageing in better health and receiving better health care when necessary."

 

 

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