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URPP ITINERARE

Legal and policy aspects

Equality before the law is a central concept in democratic governance. It has great implications on the question of egalitarian treatment access for rare disease patients. With ITINERARE, we will investigate the associated challenges and implications from the perspective of constitutional law, with a focus on human rights, diversity, and disability, and in the light of recent federal tribunal decisions on the issue. In addition, we will address legal questions concerning human research, data access, and privacy protection. At the legal-economic spectrum, we will explore issues surrounding market authorization, access (WZW criteria and off-label use), and reimbursements. Drug pricing and price negotiations are of major importance in the field of rare diseases. New pricing models are currently under discussion, which are associated with legal and ethical uncertainties. Which drugs are reimbursed and which price is determined, as well as the structure of the confirmation of coverage (Kostengutsprache) procedure in the context of Art. 71b KVV, significantly affect the treatment of patients in the in-patient as well as the outpatient sector. In addition to the healthcare economics, we will investigate the policy issues surrounding invalidity insurance (IV) reimbursements and the transition to health insurance.

Approach: An actor analysis provides a structured inventory of the healthcare system as faced by rare disease patients. It addresses the (mandated) roles, interests, goals, and strategies of all actors involved in the management of two relevant diseases (Ataxia telangiectasia from WP1 and Methylmalonic aciduria from WP2). Participants will be recruited through the Swiss Rare Disease Registry (SRDR). Analysis of the Swiss healthcare system will be conducted, as it pertains to rare disease patients with a focus on governance, identifying system gaps, overreach of actors, and lack of role fulfillment. The study will include a  multidisciplinary analysis of legal and policy implications. Subsequently, we will analyze the roles of flagged actors (e.g. the ‘medical officer’, who lacks rare disease-specific knowledge). The actor analysis will also provide novel perspectives to follow up on market authorization, pricing, and reimbursement. Based on the outcomes, the diverse everyday-life challenges of patients with a rare disease can be identified. This allows to develop new legal solutions and to integrate them into the system.

Weiterführende Informationen

MEHR

Kompetenzzentrum Medizin - Ethik - Recht Helvetiae

More about Kompetenzzentrum Medizin - Ethik - Recht Helvetiae

Lead

Prof. Brigitte Tag
Faculty of Law, University of Zurich

Prof. Nikola Biller-Andorno
Institute of Biomedical Ethics and History of Medicine (IBME), University of Zurich