Julien Delaye: Strengthening conflict of interest management in European Health Technology Assessments
Oktober 2024At EURORDIS, we’re committed to making sure that the patient voice in the European healthcare system is heard and valued, especially when it comes to the assessment of new health technologies. Recently, we contributed our insights to the consultation on the draft Implementing Act on conflict of interest (COI) management within the framework of European Health Technology Assessments (HTAs).
While we support the overall aim of the Act, our response highlights several areas where improvements could enhance the efficiency and clarity of the process.
The importance of robust Conflict of Interest policies
Effective COI management is crucial for maintaining the integrity of HTA processes and the independence of involved stakeholders. In HTAs, where assessments inform decisions that can significantly impact patient care and access to new technologies, even the perception of bias can undermine trust in participating experts and the outcomes of joint work.
The draft Implementing Act aims to establish clear rules to prevent COIs from affecting these assessments. While we support this goal, we also believe that the process could be streamlined and clarified to make it more effective and less burdensome, especially for patient representatives.
Streamlining timelines to avoid delays
One of the key points we raised in our response is the need to shorten the timelines for managing COI. Currently, the process for assessing and resolving COI issues allows for a potential delay of up to 39 days, particularly if the European Commission requires further information from the expert prior to their involvement. In scenarios where an expert’s participation is critical to ongoing work, such delays could disrupt the HTA process, leading to significant setbacks in joint clinical assessments or consultations.
We have recommended that these timelines be shortened to prevent unnecessary delays, particularly when alternative experts must be identified at short notice.
Differentiating COI management by HTA activity
Not everyone involved in an HTA is affected by COIs in the same way. For example, the risks might differ between those involved in Joint Clinical Assessments (which evaluate the effectiveness of a treatment) and those in Joint Scientific Consultations (which focus on how studies should be conducted).
We propose that the Implementing Act adopt a more nuanced approach, with COI management strategies tailored to the specific HTA activity in question.
Making patient contributions visible
Patients and their representatives play a crucial role in HTAs, offering insights that only those with lived experience can provide. We believe that their contributions should be as visible as those of other experts. This means ensuring that any input from patients or their advocates is recognised, prominent and documented, just like the contributions from medical professionals or scientists.
Clarifying the definition of COIs
The draft Act could benefit from clearer definitions and examples of what constitutes a COI. This would help everyone involved understand when a situation might be problematic and ensure consistent application of the rules. For instance, it’s important to specify what types and amount of financial support could potentially influence a patient organisation’s independence.
Flexibility for the future
Given the evolving nature of healthcare and the complexity of HTA processes, it is important that the COI management framework remains adaptable. While the draft Implementing Act aims to establish a robust structure, we believe that certain elements, such as the Declaration of Interest (DoI) forms, should be kept flexible and separate from the main legislative text. This would allow for easier updates and adjustments based on real-world experience without the need to revise the entire legislation.
Moving forward, we will continue to advocate for these improvements, ensuring that the management of COIs in HTAs supports the fair and balanced evaluation of health technologies, ultimately benefiting patients across Europe.
By Julien Delaye, Patient Engagement Manager – HTA
Disclaimer: As a Staff Blog, the opinions – including possible policy recommendations – expressed in this article are those of the author and do not necessarily represent the views or opinions of EURORDIS. The publication of this article on the EURORDIS website does not equate to endorsement.