ANNEX IISupplementary provisions
ANNEX II Exclusions from and limitations of the participation in the joint work based on the declared interests Declared interest Time frame (Co)Chair Representative, including (co)assessor Individual expert (patient, clinical expert, other relevant expert) 1. EMPLOYMENT 1.1a. Executive role Current X X X Within the past 5 years XC X T /X HTD * X T /X HTD * 1.1b. Horizontal responsibility other than executive role Current X X X Within the past 3 years XC X T /X HTD * X T /X HTD * 1.1c. Individual product responsibility Current X X X Within the past 3 years XC X HT X HT 1.2. Employment in consultancy company or contract research organisation Current X X X Within the past 3 years XC X HT X HT 2. CONSULTANCY 2a. Individual product related Current X X X Within the past 3 years XC X HT X HT 2b. Horizontal Current X X X Within the past 3 years XC X T /X HTD * X T /X HTD * 3. STRATEGIC ADVISORY ROLE 3a. Individual product related Current X X X Within the past 3 years XC X HT X HT 3b. Horizontal Current X X X Within the past 3 years XC X T /X HTD * X T /X HTD * 4. FINANCIAL INTERESTS 4.1. (Co)ownership, shares etc., intellectual property rights Current X X X 4.2. Payment/ reimbursement of expenses Current X X T /X HTD * X T /X HTD * Within the past 3 years RC HTD X T /X HTD * X T /X HTD * 5. PRINCIPAL INVESTIGATOR AND INVESTIGATOR Current XC X HTD /X HT ** X HTD /X HT ** Within the past 3 years RC HTD /RC HT ** X HT X HT 6. LEAD MEMBER IN AN ORGANISATION/INSTITUTION RECEIVING FUNDING FROM HEALTH TECHNOLOGY DEVELOPERS Current financial year X X HTD X HTD Most recent financial year closed RC HTD X HTD X HTD 7. INTERESTS OF IMMEDIATE FAMILY MEMBERS Current RC HTD /RC HT *** X HTD /X HT *** X HTD /X HT *** Explanations Interests constituting a conflict of interest deemed incompatible with the participation in the joint work X No participation in joint work Interests constituting a conflict of interest deemed incompatible with taking up certain roles and responsibilities in the joint work XC Cannot be elected as chair/co-chair Interests constituting a conflict or potential conflict of interest in relation to the health technology developer or to the specific health technologies RC HTD To be replaced as chair/co-chair with regard to any health technologies under assessment or comparator health technologies from the health technology developer RC HT To be replaced as chair/co-chair with regard to specific health technologies under assessment or comparator health technologies X HTD No involvement of the representative as (co)assessor nor in any discussions or decision making in relation to any health technologies under assessment or comparator health technologies from the health technology developer No involvement of the individual expert in joint work in relation to any health technologies under assessment or comparator health technologies from the health technology developer X HT No involvement of the representative as (co)assessor nor in any discussions or decision making in relation to specific health technologies under assessment or comparator health technologies No involvement of the individual expert in joint work in relation to specific health technologies under assessment or comparator health technologies X T No involvement of the representative as (co)assessor nor in any discussions or decision making in relation to health technologies under assessment or comparator health technologies from the health technology developer within the therapeutic area No involvement of the individual expert in joint work in relation to health technologies under assessment or comparator health technologies from the health technology developer within the therapeutic area X T /X HTD * X T where the role, horizontal responsibility, presentation, training course, participation in a conference/seminar/event is/was related to a therapeutic area or several therapeutic areas X HTD where the therapeutic area cannot be identified RC HTD /RC HT ** RC HTD if clinical trial, observation study, clinical investigation or performance study was sponsored by a health technology developer RC HT if clinical trial, observation study, clinical investigation or performance study was sponsored by other means except by health technology developers X HTD /X HT ** X HTD if clinical trial, observation study, clinical investigation or performance study is/was sponsored by a health technology developer X HT if clinical trial, observation study, clinical investigation or performance study is/was sponsored by other means except by health technology developers RC HTD /RC HT *** RC HTD in case of financial interests listed in Question 4.1, except the intellectual property rights in a health technology RC HT in case of intellectual property rights in a health technology X HTD /X HT *** X HTD in case of financial interests listed in Question 4.1, except the intellectual property rights in a health technology X HT in case of intellectual property rights in a health technology ‘ Comparator health technology ’ means a health technology identified in the assessment scope for the joint clinical assessment finalised by the subgroup on joint clinical assessments. Comparator health technology that is no longer covered by a patent or supplementary protection is not taken into consideration for the conflict of interest management.