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ACADEMIC PROGRAMME

Sustainability through personalised medicine: Opportunities and challenges

Presented by: Healthcare Interest Group

Workshop #8

DATE & TIME

LOCATION

 Thursday, 5 September

 14:00 – 16:00

 Hotel Parco dei Principi (Meeting room to be communicated in the event mobile app)

DESCRIPTION

The rise of rare diseases and personalised medicine is revolutionising healthcare worldwide. In the last years, tremendous progress has been made in developing new forms of tailored treatments which allow to treat diseases previously considered incurable. 

Better results, but at what costs? 

The session of the recently established AIJA Healthcare Interest Group will address the sustainability of such companies due to the impact of these treatments on healthcare, human health and well-being. Particularly, speakers will discuss the difficulties for the Companies on market authorisations, advertising, clinical studies, reimbursement and last but not least named patient use and other forms of not (yet) approved usage.

Detailed schedule:

 

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.

SPEAKERS & MODERATORS

Stepan Holub

Stepan Holub

Holubová, Czech Republic

Speaker

Daniel Avila Failla

Daniel Avila Failla

Dannemann Siemsen, Brazil

Speaker

Tomás García Navarro

Tomás García Navarro

Estudio Garcia Navarro, Basail & Asociados, Argentina

Speaker

Daria Wierzbińska

Daria Wierzbińska

KRK, Poland

Speaker

Koen T’Syen

Koen T’Syen

Van Bael & Bellis, Belgium

Speaker

Elena Cappellaro

Elena Cappellaro

AstraZeneca, Italy

Speaker

Jan Henning Martens

Jan Henning Martens

FGvW, Germany

Moderator

GENERAL REPORTERS

Jan Henning Martens

Jan Henning Martens

FGvW, Germany

Tomás García Navarro

Tomás García Navarro

Basail & Asociados, Argentina