To take part in joint clinical assessments or joint scientific consultations at EU level as a clinician, patient or carer, you must complete a declaration of interest (DOI) and state any relevant links or interests in that you might have with the health-technology-development sector.
This page seeks to explain the issue of potential conflicts of interests regarding clinicians, patients and carers vis-à-vis health technology developers.
It is for information purposes only. The only authentic and legally binding text is Implementing Regulation 2024/2745 – application of Regulation 2021/2282 to conflicts of interest in joint work of the Member State Coordination Group on HTA and its subgroups, particularly Annexes I and II.
What is a health technology developer?
- A health technology developer (referred to in the legislation as an ‘entity’) is an organisation or company involved in the development or manufacturing of health technologies such as medicinal products and medical devices.
- Examples of entities include pharmaceutical and medical device companies, and any unit within a research organisation (universities and hospitals) that:
- develops or manufactures these products
- has been authorised to sell these products in the EU or has requested such authorisation.
Regarding units within organisations, it is important to note that only the specific unit involved is considered as the health technology developer.
What can constitute a potential conflict of interest?
1. You cannot participate in the joint work on clinical assessments and scientific consultations if you have any current interests with any health technology developers, including:
- holding an executive position
- serving in a non-executive role with broad responsibilities across multiple health technologies or therapeutic areas (pharmacovigilance, regulatory affairs and statistical methodology…).
- serving in a role involving individual product responsibility
- being employed by a consulting or contract research organisation that has contractual arrangements with a health technology developer to outsource its activities.
| Example: if you are currently working for a research organisation providing services to health technology developers on a contractual basis, you cannot participate in any joint work. It is irrelevant whether you are involved specifically with the health technology developer whose health technology is currently undergoing a joint clinical assessment or joint scientific consultation. |
- advising or conducting research for a health technology developer on a specific product or horizontal issues.
- holding a strategic advisory role, such as participating in an advisory board or steering committee, whether related to a single product or multiple products.
holding shares, equity or intellectual property rights in a health technology developer.
2. You cannot participate in the joint work if that work relates to a specific health technology developer and you are or have been involved with that developer as follows:
- executive role in the past 5 years and were responsible for horizontal matters (for example, not for a specific therapeutic area).
| Example: if you worked as director for regulatory affairs and therefore held responsibilities across several therapeutic areas for health technology developer “XY” until 2021, you cannot participate in the joint work with regard to health technology developer “XY” until 2026. |
- non-executive role with horizontal responsibilities in the past 3 years and were responsible for horizontal matters (meaning, not for a specific therapeutic area).
- horizontal consulting or research services in the past 3 years.
- strategic advisory role in the past 3 years with horizontal responsibilities.
- currently (co-)chair, president, director, treasurer or similar in an organisation receiving funding from the health technology developer in the current or last financial year.
- received in the past 3 years, payments or reimbursements exceeding EUR 1,000 for professional engagements or events where the therapeutic area cannot be identified.
- currently a principal investigator or an investigator in a clinical study sponsored by the health technology developer
immediate family member(s) (spouse, children or parents) currently employed by or holding ownership or shares of the health technology developer.
3. You cannot participate in the joint work if that work relates to a specific health technology and you are or have been involved with the health technology developer within the specific therapeutic area of that technology, including:
- held an executive position in the past 5 years pertinent to that therapeutic area.
| Example: if you worked as executive director for health technology developer “XY” and were responsible for the therapeutic area of antineoplastic agents until 2023, you cannot participate in joint work about any antineoplastic agents from “XY” until 2028. |
- worked in a non-executive role with cross-cutting responsibilities related to that therapeutic area in the past 3 years.
- consulting or research services related to that therapeutic area in the past 3 years.
| Example: if you wrote a research article related to breast cancer for health technology developer “XY” in 2024, you cannot participate in the joint work with regard to any antineoplastic agents from “XY” until 2027. |
- strategic advisory position related to that therapeutic area in the past 3 years.
currently receive, or have received in the past 3 years, payments or reimbursements exceeding a total of EUR 1,000 for professional engagements or events related to that specific therapeutic area.
4. You cannot participate in the joint work if that work relates to a specific health technology and you are or have been involved with that health technology, as follows:
- role with responsibility about that specific health technology in the past 3 years.
- employed by a consultancy or contract research organisation about that specific health technology in the past 3 years.
- consulted or conducted research for a health technology developer on that specific health technology in the past 3 years.
- held a strategic advisory role on that health technology within the last 3 years.
| Example: if you participated in the advisory board of a health technology developer by providing advice on a specific health technology in 2024, you cannot participate in the joint work with that health technology until 2027. |
- principal investigator or investigator* on that health technology in non-industry-sponsored clinical study.
- principal investigator or investigator on that health technology in the past 3 years.
Example: You are eligible to participate in the joint work related to a specific health technology if you served as a sub-investigator in a clinical trial for that technology. According to the ICH 6 guidelines, a sub-investigator is any clinical trial team member designated by and working under the oversight of the investigator to perform significant trial-related procedures and/or make important trial-related decisions. |
immediate family member(s) with intellectual property rights in that health technology.
In certain exceptional cases, such as with rare diseases, there might not be any individual experts available who do not have conflicts of interest. In these situations, the Commission may propose to the relevant Subgroup experts who have conflicts of interests. It is up to the Subgroup to decide whether to select the experts identified by the Commission.
Further examples:
Marie is the treasurer of an organisation that received funding from health technology developer XY in the most recently closed financial year. From 2020 to 2023, she was also part of a paid advisory board for a health technology developer, AB, providing advice on their breast cancer development activities. She cannot be involved in any joint work with XY. Similarly, she cannot participate in any joint work involving antineoplastic agents from AB until 2026. However, she has been selected to participate in a joint clinical assessment of a medicinal product from the health technology developer QV, which does not include comparator health technologies from XY or AB. |
Pablo is currently working as a doctor in dermatology at Hospital QY. He is also providing remunerated consultancy services on a specific medicinal product JK for the treatment of acne for the health technology developer YZ. Although the medicinal product subject to the joint work is for the treatment of skin melanoma and is from the health technology developer ABC, Pablo has not been proposed by the HTA Secretariat to the relevant Subgroup, given that he is currently providing individual product-related consultancy services to a health technology developer and other experts with no conflicts of interest are available. However, his data will remain on file for up to 3 years and he may be contacted again by the HTA Secretariat for future joint work. In that case, if he is interested, he will be asked to submit an updated declaration of interest form and CV. |
* According to the ICH E6 guidelines, an investigator is responsible for conducting a trial and overseeing its participants. If the trial is team-based, this person is known as the principal investigator.
