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Sustainability through personalised medicine: Opportunities and challenges

Presented by: Healthcare Interest Group

Workshop #8



 Thursday, 5 September

 14:00 – 16:00

 Sforza D+E room; Level B-C (-2 floor)


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 companies in relation to market authorisations, advertising, clinical studies, reimbursement and – last but not least – named patient use and other forms of not (yet) approved usage, with an overall view on how healthcare companies may contribute to a more sustainable world.

Detailed schedule:


Speaker: 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.

Speaker: Elena Cappellaro, AstraZeneca (Italy)

The presentation will address that cost-containment is more and more the driving factor for the national healthcare system, but at what costs? Elena will discuss the challenges for innovative and highly costs medicines in accessing the market.

Speaker: 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.

Speaker: 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.

Speaker: 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.

Speaker: Deirdre Ní Annracháin, NKF (Switzerland)

The presentation will address the ways the medical device industry is addressing sustainability concerns, taking a Swiss manufacturer of orthopaedic implants that carried out an IPO in Switzerland in 2019 as a case study.


Elena Cappellaro

AstraZeneca, Italy


Stepan Holub

Holubová, Czech Republic


Tomás García Navarro

Estudio Garcia Navarro, Basail & Asociados, Argentina


Daniel Avila Failla

Dannemann Siemsen, Brazil


Deirdre Ní Annracháin

NKF, Switzerland


Koen T’Syen

Van Bael & Bellis, Belgium


Jan Henning Martens

FGvW, Germany



Jan Henning Martens

FGvW, Germany

Tomás García Navarro

Basail & Asociados, Argentina