Sustainability of healthcare system vs Rare diseases company – Tomás García Navarro, Estudio Garcia Navarro, Basail & Asociados (Argentina)

The presentation will address rare diseases in Argentina, specifically the impact on the healthcare system – name patient – regulatory process – advertising.

Off-label use – a way to sustainable healthcare system – Daria Wierzbińska, KRK (Poland)

The presentation will address off-label use of medicinal products – regulatory and healthcare system level, professional and patient level, policy options, pros & cons of off-label use (economic advantages vs. patients’ interests).

Management of public healthcare companies – Stepan Holub, Holubová (Czech Republic)

The presentation will focus on a groundbreaking decision of the Czech Constitutional Court from just last year, on the composition of healthcare insurance company’s management. This very much relates to the necessity of transparency in the way decisions within the context of medical care provision are made and to the need for a long-term sustainability of medical care financing.

The challenges of new therapies – Daniel Avila Failla, Dannemann Siemsen (Brazil)

Brazil adopts a universal health system (the so called SUS) and, in this context, new therapies, including those related to rare diseases, can be a challenge. The presentation will draw an overview of the Brazilian scenario given the option for universal access to health, walking through aspects that affect the sustainability of the system such as the free provision of these therapies by the Government and the regulatory initiatives aiming aimed at reducing bureaucracy and accelerating clinical trials and marketing approval.

Is the EU regulatory framework on off-label use sustainable? – Koen T’Syen , Van Bael & Bellis (Belgium)

The presentation will address the state of the EU regulatory framework on off-label use in the light of the latest case law of the Court of Justice of the European Union in the field (including, in particular, its judgment of 21 November 2018 in Case C-29/17, Novartis Farma v. AIFA, Roche Italia and others). It will also examine whether the current system is sustainable for (i) national legislators/regulators; (ii) hospitals and physicians; and (iii) pharmaceutical companies.