How can the Data Governance Act and Data Altruism Organizations facilitate innovation in the rare diseases sector?

Details

Supervisors

Belleflamme, Paul

Faculty

Louvain School of Management

Degree label

Master [120] : ingénieur de gestion, à finalité spécialisée

Abstract

In Europe, a rare disease is defined as one that affects less than one person in 2,000. People affected suffer severe handicaps and their prognosis is very often life-threatening. However, to date, none of these diseases can be cured. Pharmaceutical companies and research institutes justify this lack of curative treatments by the rarity of rare diseases and the consequent lack of scientific knowledge. Innovation in rare diseases is therefore essential but remains complicated. One way of stimulating innovation in this sector would be to exploit the potential of health data, which can have enormous benefits for advancing scientific research. In 2023, a new legislative instrument from the European Commission came into force – the Data Governance Act – by putting in place a legal framework that aims to enable and facilitate the sharing of data, particularly health data. The aim of this master's thesis is to understand how the implementation of the Data Governance Act could facilitate innovation for rare diseases, by providing a preliminary theoretical analysis of the benefits and challenges of implementing this law in this sector. Our analysis will allow us to conclude that the Data Governance Act can offer significant opportunities for innovation in the field of rare diseases, thanks to the benefits of health data sharing that it regulates, including the facilitation of clinical trials, collaboration, reduction of redundancies and costs. However, certain challenges and risks of the law could hinder and complicate the health data sharing process, such as the lack of clarity regarding the notion of consent, the lack of confidence in data sharing and the risk of fragmentation.