Benefit – Risk Balance
Benefit – Risk Balance, A shared Responsibility
In recent years, the development of new biotechnology medicines has made tremendous progress and contributed to reducing the burden of diseases in Europe. As with any novel therapy, benefits and risks of such innovative medical treatments are the subject of societal debate. Usually the debate would focus on the inherent risks of such products. However, what is often not fully reflected is the responsibility of each concerned stakeholder group, such as researchers, industries, healthcare professionals, ethics committees, regulators and patients.
EBE calls for a greater understanding of the roles played by the different stakeholders involved in the management of diseases and the introduction as well as use of new medicines. Sharing responsibility among all parties engaged will help ensure a balanced approach that reflects the interests of all, while benefiting patients and society as a whole.
EBE initiated in 2008 discussions on benefit-risk balance around the "shared responsibility" concept, engaging with the different stakeholders involved. EBE hosted a first panel discussion on the subject at its General Assembly in May 2008, followed by a workshop at the European Health Forum Gastein in October 2009 on “Balancing Benefits and Risks - Sharing Responsibility”. The workshop contributed to establish a new multi-stakeholder platform on benefit-risk balance. Such a forum helped foster better understanding of the roles and responsibilities of each stakeholder in the identification, assessment and management of risks during the development process of a medicinal product.
- How much risk for how much benefit? The patient's perspective, European Multiple Sclerosis Platform presentation– Gastein October 2009.pdf
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- Shared responsibility for optimal patient outcomes, Novartis presentation - Gastein October 2009.pdf
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- Balancing Benefits and Risks -Sharing Responsibility – EBE press release - Gastein October 2009.pdf
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- EBE Brochure on "Balancing Benefits & Risks: Sharing Responsibility" - November 2008.pdf
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