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 Biosimilar Medicinal Products: raising the bar of quality and safety - a public health perspective
EuropaBio believes that the European Commission and EU Council of Ministers should adopt measures to improve patient access to beneficial innovative therapies. These innovative therapies provide an improved quality of life for many patients with life-threatening, serious, chronic and debilitating diseases. Policies and legislation that limit access to innovative medical technology lead to delays in access to medical care, also resulting in higher healthcare costs. All patients deserve access to these therapies regardless of their income level or the rarity of their disease.
The final beneficiary, namely the patient, is the ultimate arbiter of how innovative a new product is. The views, experiences and expertise of patients must be integrated into the evaluation process to allow for a better balance between benefits, costs and risk. Physicians and other clinical experts must also be involved in the assessment and decision-making. Decisions should not be made without input from clinical experts on the full range of benefits delivered.
EuropaBio Actions
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Delivery of biotech industry input into the 2007 review of the European Commission’s Life Sciences and Biotechnology – A Strategy for Europe (2002 Communication to the European Parliament, the Council, the Economic and Social Committee and the Committee of the Regions).
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Direct participation in the Pricing and Reimbursement Working Group of the Pharmaceutical Forum to ensure innovation is rewarded by appropriate levels of pricing and reimbursement, in a timely fashion.
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Direct advocacy for the Relative Effectiveness Working Group of the Pharmaceutical Forum to ensure that health technology assessments are carried out by agencies that are independent from involved parties, and are at a national level, to ensure best outcomes, transparency and accountability.
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To develop a series of shared European Standards for Health Technology Assessment, including social values (stakeholder in EU netHTA).
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Participate as stakeholder in the EU Commission JRC’s "Biotech for Europe" synthesis report.
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