Marie Gårdmark: Big data evidence generation drives change in the EU regulatory system

Rapid developments in technology have led to the possibility for the generation and analysis of vast volumes of data. Will the availability of big data lead to fundamental changes to the regulatory system? In a column Marie Gårdmark, CEO and Senior Consultant at RegSmart Life Science, develops her views on this subject.

The HMA/EMA task force addressed the question on Big Data with the aim to “inform strategic decision-making and planning and for input to the EU regulatory Network Strategy to 2025. The report will support regulators and stakeholders seizing the opportunity for data-driven, evidence-based, robust decision-making”.

The work has focused on how Big Data, described in the report as generally large data sets, accumulating rapidly, incorporating multiple data types and forms, and being of varying quality, can be used in a structured way for regulatory decision making. The task force has taken on a broad scope, and one must welcome the highly set ambition. It is chaired by the Danish agency and collaborates with the EMA and other national agencies under the HMA (Heads of Medicine Agencies) umbrella.

The output from the task force includes actions that propose fundamental changes to the current EU regulatory system. For example, one of the ten prioritised actions is the “Delivery of a sustainable platform to access and analyse healthcare data from across the EU”.

The technical platform would represent a network of databases of agreed quality and content. It would be used to inform regulatory decision-making with robust evidence from healthcare practice, which is an admirable initiative but is likely to meet challenges in terms of national legislation and costs.

There are already several pan-EU databases under development with challenges to meet timelines and budget. The task force acknowledges the funding issue, and increased application fees have been suggested as one solution. However, it should be noted that the EU-commission is already working on an update of the current fee regulation with the distribution of resources from the EMA to the national agencies as one discussion item. However important it may be, one could wonder whether adding costs for another database would be acceptable to the member states.

Furthermore, the task force proposes to “Build EU network capability to analyse Big Data. Build computing capacity to receive, store and analyse large data sets including patient-level data (PLD), establish a network of analytics centres linked to regulatory agencies, and strengthen the network’s ability to validate AI algorithms.”

I believe that this will lead to a deviation from the current system with industry conducting the research and data analysis to support product approval. EU regulators generally do not conduct their own data analyses. Hence this proposal would lead to a fundamental change in the regulatory evaluation process.

Whether the proposal would require legislative adjustments, changes to the procedural timeline and alternative funding remains to be seen. There is no controversy in data emerging from “alternative” data sources should be used to complement data from randomised clinical trials to optimise regulatory decisions.

The task force rightly concludes that the regulatory system needs to evolve and presents ambitious proposals for next steps. It has been suggested that several new working groups and committees are to be formed to govern the proposed framework.

However, to be successful, I believe that the proposed development agenda must be balanced against the increased governance and bureaucracy in an already crowded system. Instead of creating a new framework, existing infrastructure could be used to encourage pilot projects to lead the development and drive change. 

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