Pharmaceuticals & Health Technology Assessment
Regulators and EU agencies and institution often require expertise in specific areas, and healthcare professionals play an important role in the approval and assessment of medicines and health technologies. BioMed Alliance is active in the fields of pharmaceutical legislation and Health Technology Assessment (HTA) in those areas that where the input of healthcare professionals and researchers can be of added value. We have shared recommendations on the proposals for the Revision of the EU Pharmaceutical Legislation and the implementation of the Regulation on Health Technology Assessment.
Highlights
Consultation response
BioMed Alliance Calls for Expert Involvement in EMA COI Policy
The BioMed Alliance recently responded to a public consultation regarding conflict of interest within the European Medicines Agency (EMA). The consultation published by the EMA follows a recent court of justice ruling due to which EMA along with other EU institutions are now revising their conflict of interest policy. The members of BioMed Alliance recognize the importance of well established rules for managing conflict of interest, but have concerns regarding the revised guidance particularly in the involvement of experts in regulatory processes.
Our specific concerns for the revised draft conflict of interest policy:
- Proportionality: While clear conflicts of interest must be avoided, it’s essential to prioritize involving top scientific experts.
- Managing conflict on interest in research organisations: the definition of research organisation remains board in the revised guidance and needs further clarifying. Additionally, the revised guidance suggests that certain research organization units involved in developing or manufacturing medicinal products or medical devices could be treated like pharmaceutical or medical device companies. Given the essential role of in-house devices, especially in rare diseases where experts often develop ATMPs or devices due to limited alternatives, a flexible approach with clear guidelines is needed. While managing conflicts of interest, these special circumstances should be considered to avoid excluding key expertise.
- Role of learned societies: learned societies can be valuable partners in identifying experts with specific knowledge. These societies generally have well-established conflict of interest policies, allowing them to account for potential conflicts when recommending experts.
News
BioMed Alliance Responds to new HTA Consultation
Following the Public Consultation on the draft implementing act on the joint scientific consultations on medicinal products for human use under the Health Technology Assessment (HTA) Regulation, the BioMed Alliance has shared a response on the proposal. The aim of the initiative was to establish clear procedural rules for health technology developers when it comes to receiving early guidance that is required for conducting a joint clinical assessment of products.
The BioMed Alliance welcomes the proposed implementing regulation for joint scientific consultations on medicinal products under Regulation (EU) 2021/2282. Healthcare professionals and researchers agree that HTA should have a strong scientific basis, and the Alliance would therefore like to offer the following remarks and suggestions for consideration:
- Expert Selection: High-quality HTA requires the participation of top experts from diverse fields. European medical societies can help identify these experts, ensuring that only those with the most relevant, specialized knowledge are included.
- Timely Information Sharing: Medical societies require clear timelines and prompt information sharing to accommodate experts’ busy schedules.
- Conflict of Interest Management: A balanced approach to managing Conflict of interest, acknowledging that experts may be involved in various initiatives with different stakeholders, including industry and institutions.
Consultation response
BioMed Alliance replies to new consultation on HTA & cooperation with the EMA
In a new public consultation response, BioMed Alliance shares its views on the proposed implementing regulation detailing procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment (HTA) and the Commission with the European Medicines Agency. While welcoming the draft regulation, the Alliance also shares key recommendations on the timely and efficient exchange of information, creating synergies, involving experts, and balanced conflict of interest policies. The feedback is published on the EU Have Your Say Portal here, and replies to the consultation will be considered before the final regulation is adopted.
News
Enhancing BioMed Alliance Activities with the EXHALE operating grant
The BioMed Alliance has been awarded the EXHALE operating grant (BioMed Alliance EXpertise in Health Across Legislation at EU level) for 2024 under the EU4Health programme (grant agreement no 101176496). This grant aims to further strengthen the representation of medical societies, healthcare professionals, and researchers in the EU health field.
The EXHALE grant will enable the Alliance to enhance the expertise and knowledge of the medical and research communities on the regulatory system and policy developments in the health field, and how these impact their work. The focus will be on EU4Health priorities including the Medical Devices Regulation, In Vitro Diagnostics Regulation, the European Health Data Space, Health Technology Files, and the Health Emergency Preparedness and Response authority.
Over the coming months the BioMed Alliance will work with its Committees and Task Forces to build on the proposed activities, strengthen its representation at EU level and build skills in the regulatory field. We will organise a series of workshops and share materials, and more information will follow soon.
News
Medical societies share their views on managing competing interests in HTA
The BioMed Alliance has replied to a public consultation on HTA on procedural rules for assessing and managing conflicts of interest. In the reply prepared by the HTA Working Group, the Alliance welcomed increased cooperation on joint Health Technology Assessment (HTA) as we believe this can enhance the affordable and equitable access to innovative new health technologies for European patients. Such assessments must be evidence-based, and depend on the feedback of patients, clinicians and other experts in the health field.
Transparency throughout this process is key. Declarations of interest must be shared, and risks of potential competing interests managed to reduce the risk of bias. However, conflict of interest policies must also be proportionate and take into account that many (leading) scientists and clinicians with the necessary expertise to provide an authoritative review of a new medicine or medical device, are likely to be involved in a variety of research, academic and regulatory roles. Too restrictive approaches may therefore prevent the inclusion of the necessary expertise, particularly in niche fields like rare diseases.
Consultation response
BioMed Alliance replies to consultation on HTA Implementing Regulation
BioMed Alliance replied to the public consultation on the HTA Implementing Regulation on joint clinical assessments of medicinal products. In the reply, BioMed Alliance argues that the involvement of stakeholders including clinicians is key to achieve a high scientific quality of joint clinical assessment reports. In order to facilitate the process and ensure the right experts are able to provide a meaningful contribution, it is necessary to ensure a systematic and consistent involvement of stakeholders, facilitate cooperation with medical societies as key partners, give sufficient time for stakeholders to provide their input, and set up appropriate conflict of interest policies. The reply is available here and on the ‘have your say’ website.