Commission Implementing Regulation (EU) 2024/2745 of 25 October 2024 laying down rules for the application of Regulation (EU) 2021/2282 of the European Parliament and of the Council as regards the management of conflicts of interest in the joint work of the Member State Coordination Group on Health Technology Assessment and its subgroups

• CELEX: Implementing Regulation (EU) 2024/2745
• Articles: 14

Article 1 Submission of the DOI

1.   Before submitting a signed declaration of interests (‘DOI’) to the Commission and until the Commission has assessed the declared interests in accordance with Article 4, the representatives appointed to the Coordination Group and its subgroups referred to in Article 5(3) of Regulation (EU) 2021/2282 (‘representatives’) may not do any of the following:

(a)

access the parts of the secure system of the IT platform, as defined in Article 30 of Regulation (EU) 2021/2282 (‘the HTA IT platform’) relevant for the performance of their tasks;

(b)

take up the roles and responsibilities of a chair or a co-chair in the Coordination Group or its subgroups;

(c)

take up the roles and responsibilities of an assessor or a co-assessor for a joint clinical assessment or a joint scientific consultation;

(d)

attend meetings of the Coordination Group or its subgroups for conducting joint clinical assessments, joint scientific consultations, developing methodological guidance for joint work or for preparing reports on emerging health technologies.

2.   Before submitting a signed declaration of interests (‘DOI’) to the Commission and until the Commission has assessed the declared interest in accordance with Article 4, patients, clinical experts and other relevant experts referred to in Article 5(5) of Regulation (EU) 2021/2282 (‘individual experts’) may not be selected and take part in a joint clinical assessment or a joint scientific consultation and may not access the parts of the secure system of the HTA IT platform relevant for the performance of their tasks.

Article 2 Content of the DOI

1.   Representatives and individual experts shall declare in the DOI all financial or other interests, whether of direct or indirect nature, in the health technology developers’ industrial sector, by answering the standard questions listed in the DOI form set out in Annex I to this Regulation. Representatives or individual experts who answer to the questions in the affirmative shall provide further details in the respective sections of the DOI form.

2.   Representatives and individual experts shall assume full responsibility in relation to the content of the DOI submitted.

Article 3 Format of the DOI

1.   The DOI of a representative or individual expert shall be submitted digitally through the HTA IT platform in the form set out in Annex I and shall be accompanied by a comprehensive curriculum vitae (‘CV’) of the representative or of the individual expert based on the Europass CV template. The DOI shall be deemed submitted only if it is duly completed, signed, and accompanied by such CV.

2.   When an interest declared in the DOI referred to in paragraph 1 has changed, an updated DOI shall be submitted without undue delay in accordance with the procedure set out in paragraph 1.

Article 4 Assessment of information submitted in the DOI

1.   The Commission shall assess the interests declared in the DOI, as well as the information in the CV of the representative or the individual expert, submitted in accordance with Article 3.

2.   If necessary, the Commission may request that the representative or the individual expert submit any additional information needed for the assessment of the declared interests. The representative or the individual expert shall provide that information within 10 days from the day of the notification of the request.

3.   Where no further information is needed for the assessment of the declared interests, the Commission shall complete the assessment within 15 working days from the submission of the DOI in accordance with Article 3.

4.   If the Commission decides that the declared interest does not constitute a conflict or potential conflict of interest within the meaning of Annex II, the representative or the individual expert may participate in the joint work.

5.   If the Commission decides that the declared interest constitutes a conflict or potential conflict of interest within the meaning of Annex II, Articles 6, 7 and 8 shall apply.

Article 5 Validity and publication of DOI

1.   The DOI shall be valid as long as the representative or the individual expert is involved in the joint work if:

(a)

no change in the declared interest has occurred;

(b)

information referred to in point (a) has been confirmed by the representative or the individual expert by the end of each year starting on the day on which the DOI was submitted in accordance with Article 3(1) or (2). Where such confirmation is not provided, the HTA secretariat shall ensure that the representative or the individual expert is no longer involved in the joint work.

2.   The DOI and the information on the qualifications and areas of relevant expertise from the accompanying CVs of the representatives shall be made available on the publicly accessible webpage of the HTA IT platform for the period of their involvement in the joint work.

3.   The DOI and the information on the qualifications and areas of relevant expertise from the accompanying CVs of clinical experts and other relevant experts shall be made available on the publicly accessible webpage of the HTA IT platform for one year after the finalisation of the joint work in which they participated.

Article 6 Action with regard to conflicts or potential conflicts of interest of the representatives

1.   If the Commission decides, in accordance with Article 28, point (b), of Regulation (EU) 2021/2282, that an interest declared in a DOI submitted by a representative in accordance with Article 3(1) of this Regulation constitutes a conflict of interest within the meaning of Annex II thereto that is deemed incompatible with the participation in the joint work, the HTA secretariat shall invite the member of the Coordination Group or its subgroup to appoint another representative. The member may re-appoint the same representative once the conflict of interest no longer exists.

2.   If the Commission decides, in accordance with Article 28, point (b), of Regulation (EU) 2021/2282, that an interest declared in a DOI submitted by a representative in accordance with Article 3(2) of this Regulation constitutes a conflict of interest within the meaning of Annex II thereto that is deemed incompatible with the participation in the joint work, the HTA secretariat shall ensure that the representative is no longer involved in the joint work and shall inform the representative thereof. The HTA secretariat shall invite the member of the Coordination Group or its subgroup to appoint another representative. The member may re-appoint the same representative once the conflict of interest no longer exists.

3.   If the Commission decides, in accordance with Article 28, point (b), of Regulation (EU) 2021/2282, that an interest declared in a DOI submitted by a representative in accordance with Article 3(1) or (2) of this Regulation constitutes a conflict of interest within the meaning of Annex II thereto that is deemed incompatible with taking up certain roles and responsibilities in the joint work, or a conflict or potential conflict of interest in relation to the health technology developer or to the specific health technologies, the HTA secretariat shall inform the representative, the member of the Coordination Group or its subgroup and, as appropriate, the Coordination Group or its subgroups of the conflict or the potential conflict of interest of the representative and shall ensure the enforcement of the measures set out in Annex II to this Regulation.

Article 7 Action with regard to conflicts or potential conflicts of interest of individual experts

1.   If the Commission decides, in accordance with Article 28, point (b), of Regulation (EU) 2021/2282, that an interest declared in a DOI submitted by an individual expert in accordance with Article 3(1) of this Regulation constitutes a conflict of interest within the meaning of Annex II thereto that is deemed incompatible with the participation in the joint work or a conflict of interest in relation to the health technology developer or to the specific health technologies, the HTA secretariat shall ensure that that individual expert is not selected to be involved in the joint clinical assessment or joint scientific consultation and shall inform the individual expert thereof.

2.   If the Commission decides, in accordance with Article 28, point (b), of Regulation (EU) 2021/2282, that an interest declared in a DOI submitted by an individual expert in accordance with Article 3(2) of this Regulation constitutes a conflict of interest within the meaning of Annex II thereto that is deemed incompatible with the participation in the joint work or a conflict of interest in relation to the health technology developer or to the specific health technologies, the HTA secretariat shall ensure that the individual expert is no longer involved in the joint clinical assessment or joint scientific consultation and shall inform the individual expert thereof. The HTA secretariat shall inform, as appropriate, the relevant subgroup, assessor and co-assessor for the joint clinical assessment or joint scientific consultation of the exclusion of the individual expert from the relevant assessment or consultation.

3.   By way of derogation from paragraph 1, where in exceptional cases, for example, for rare diseases, no individual experts free from conflicts of interests within the meaning of Annex II that have the relevant in-depth specialised expertise are available, the Commission may propose to the relevant subgroup the appropriate involvement of such individual experts in the joint work considering their conflicts of interest.

The same applies where the exclusion of an individual expert in accordance with paragraph 2, would result in no involvement of a patient or a clinical expert in a joint clinical assessment or a joint scientific consultation.

Article 8 Obligations of the representatives and individual experts in case of a new conflict of interest

1.   If a representative or an individual expert involved in the joint work has a new interest listed in Annex II as constituting a conflict of interest that is deemed incompatible with the participation in the joint work, they shall immediately step down from their roles and responsibilities. The representative or the individual expert shall declare that interest in a DOI submitted in accordance with Article 3(2) of this Regulation. Alternatively, they may declare the interest in writing to the HTA secretariat.

2.   If during a meeting of the Coordination Group or its subgroups a representative or an individual expert becomes aware of a new interest listed in Annex II as constituting a conflict of interest in relation to the items on the agenda, they shall immediately declare that interest to the chair or the co-chair of the Coordination Group or its subgroup and to the HTA secretariat and withdraw from the relevant part of the meeting. The representative or the individual expert shall update their DOI without undue delay.

3.   If during a joint clinical assessment or joint scientific consultation or a meeting of the Coordination Group or its subgroups a representative or an individual expert becomes aware of new circumstances in which the limitations listed in Annex II apply to them, they shall immediately inform the HTA secretariat and, as appropriate, the assessor, co-assessor, chair or the co-chair of the Coordination Group or its subgroup and withdraw from the relevant assessment, consultation or part of the meeting.

4.   If a representative or an individual expert involved in the joint work intends to be engaged in activities with a health technology developer and will therefore acquire an interest listed in Annex II as constituting a conflict of interest that is deemed incompatible with the participation in the joint work, they shall immediately declare that interest in a DOI submitted in accordance with Article 3(2) of this Regulation or in writing to the HTA secretariat irrespective of whether a contract with the health technology developer has been signed or not. Articles 6(2) and 7(2) shall apply with regard to the action to be taken.

5.   By way of derogation from paragraphs 1 to 4, where the exclusion or the withdrawal of an individual expert would result in no involvement of a patient or a clinical expert having relevant in-depth specialised expertise in a joint clinical assessment or a joint scientific consultation, the Commission may propose to the relevant subgroup the appropriate involvement of such individual experts in the joint work considering their conflicts of interest.

Article 9 Obligations of the members of the Coordination Group and its subgroups

Members of the Coordination Group and its subgroups shall notify the HTA secretariat in writing, if a representative has resigned or has been removed from their duties, at the latest by the day of their actual resignation or removal.

Article 10 Failure to declare an interest

1.   If the Commission becomes aware of information that is not consistent with the information included in the DOI of a representative or an individual expert, it shall inform the representative or individual expert in writing and request a clarification of the situation. The representative or the individual expert shall provide the requested clarification within 14 days from the day of the notification of the request.

2.   If the representative or the individual expert does not provide the requested clarification within the period referred to in paragraph 1, the Commission may decide to exclude the representative or the individual expert from participation in the joint work until the clarification is provided and assessed by the Commission.

3.   If the requested clarification is provided, and irrespective of the assessment of the interests at issue, the Commission may exclude the representative or the individual expert from the joint work for a period up to 2 years, if the representative or the individual expert failed to declare the interest intentionally or by gross negligence.

4.   The HTA secretariat shall inform the representative, the individual expert and, as appropriate, the member of the Coordination Group or its subgroup, the Coordination Group or its subgroups of the decisions of the Commission referred to in paragraph 3 and shall ensure the enforcement of the measures imposed in those decisions.

Article 11 Personal data processing

1.   The Commission shall be controller of the processing, through the HTA IT Platform, of personal data of representatives and individual experts collected under this Regulation.

2.   The categories of personal data referred to in paragraph 1 of this Article shall be the DOI and CV listed in Article 3 and Annex I, information confirmed in accordance with Article 5(1), point (b), as well as other related personal data.

3.   The DOI and CV of patients involved in joint clinical assessments and joint scientific consultations, as well as the information submitted by them in accordance with Article 4(2), shall not be made publicly available. Such documents and information shall be only made available to the Commission when performing its tasks under this Regulation with restricted access on a need-to-know basis and subject to safeguards as required by Article 10(2), point (i), of Regulation (EU) 2018/1725. Such safeguards may include in particular pseudonymisation, prevention of unauthorised access, prevention of unauthorised reading, copying, modification or deletion of personal data, as well as organisational measures ensuring that personnel authorised to process data have access only to data covered by their access authorisation, and that it is possible to verify and establish what data have been accessed, by which member of the personnel and at what time.

4.   The Commission shall keep the personal data included in DOI and CV submitted in accordance with Article 3, and information confirmed in accordance with Article 5(1), point (b), as well as other related personal data, of the representatives and individual experts only for as long as necessary for the purpose referred to in paragraph 1 of this Article and no longer than 15 years after the date on which the representatives or individual experts no longer participate in the joint work. The Commission shall review the necessity of storing the personal data every 2 years.

Article 12 Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

It shall apply from 12 January 2025.

Schedules & Appendices

ANNEX I

ANNEX I

Declaration of interests form for the participation in the joint work carried out under Regulation (EU) 2021/2282

Please answer each of the questions below. If the answer to any of the questions is ‘yes’, please provide further requested details on relevant interests, as appropriate.

If you do not do so, your declaration of interests form will be considered incomplete and, therefore, you will be excluded from joint work carried out in line with Regulation (EU) 2021/2282.

First name:

Family name:

Organisation/company ( where applicable ):

Country:

Job title in the organisation/company (where applicable) :

Type of activity ( choose one or several, as appropriate ):

Representative in the Coordination Group

Representative in the subgroup on joint clinical assessments

Representative in the subgroup on joint scientific consultations

Representative in the subgroup on the identification of emerging health technologies

Representative in the subgroup on development of methodological and procedural guidance

Patient

Clinical expert

Other relevant expert

1.   EMPLOYMENT

Q1.1.

Are you or were you employed by a health technology developer:

—

within the past 5 years in an executive role, such as president/vice president, chief executive officer, chief scientific officer, executive director/director/associate director (Question 1.1a);

—

within the past 3 years in a role involving horizontal responsibility other than executive role (Question 1.1b);

—

within the past 3 years in a role involving individual product responsibility (Question 1.1c)?

‘

employed by a health technology developer

’ means any form of occupation, part-time or full-time, paid or unpaid, in a health technology developer.

‘

horizontal responsibility

’ means support activities for multiple health technologies across one or several therapeutic areas/full product range, such as pharmacovigillance, regulatory affairs, statistical methodology.

yes

no

□

□

Function

Time period (from… until month/year)

Name of the health technology developer

Role/area of activity

Therapeutic area(s) (where relevant)

Q1.1a.

Executive role ( within the past 5 years )

Q1.1b.

Horizontal responsibility other than executive role ( within the past 3 years )

Function

Time period (from… until month/year)

Name of the health technology developer

Name of the health technology(ies) and the respective therapeutic indication(s)

Q1.1c.

Individual product responsibility ( within the past 3 years )

Q1.2.

Are you or were you within the past 3 years employed in a role involving individual product responsibility by a company or organisation, to which a health technology developer has outsourced its activities on a contractual basis, such as clinical research, regulatory affairs, health technology assessment, marketing or sales?

‘

employed by a company or organisation

’ means any form of occupation, part-time or full-time, paid or unpaid, in a company or organisation.

yes

no

□

□

Name of the company /organisation of employment

Time period (from … until month/year)

Name of the health technology developer

Name of the health technology(ies) and the respective therapeutic indication(s)

2.   CONSULTANCY

Q2.

Do you currently, or did you within the past 3 years, provide advice to or conduct research including writing articles for a health technology developer regardless of contractual arrangements or any form of remuneration?

This question does

not

cover:

—

advice provided to a health technology developer on behalf of a national or regional authority or body. Such activity is

not

to be declared;

—

employment in consultancy companies or contract research organisations providing advice to health technology developers. Such activity is to be declared under

Question 1.2

(‘Employment’);

—

participation in an advisory board, steering committee, executive committee in the role of providing advice/expressing opinions on the (future) strategy, direction or development activities of a health technology developer. Such activity is to be declared under

Question 3

(‘Strategic advisory role’);

—

providing presentations or training courses. Such activity is to be declared under

Question 4.2

(‘Financial interests’) under the conditions specified therein;

—

conducting clinical trials, clinical investigations or performance studies where you acted as a principal investigator or investigator. Such activity is to be declared under

Question 5

(‘Principal investigator and investigator’).

yes

no

□

□

Type of consultancy

Time period (from… until month/year)

Name of the health technology developer

Name of the health technology(ies) and the respective therapeutic indication(s)

Q2a.

Individual product related

Type of consultancy

Time period (from… until month/year)

Name of the health technology developer

General role/area of activity

Therapeutic area(s) (where relevant)

Q2b.

Horizontal

3.   STRATEGIC ADVISORY ROLE

Q3.

Do you currently, or did you within the past 3 years, participate in a(n) (scientific) advisory board/steering committee/executive committee in the role of providing advice/expressing opinions on the (future) strategy, direction or development activities of a health technology developer, regardless of contractual arrangements or any form of remuneration?

This question does

not

cover:

—

involvement in data monitoring committees. Such activity is to be declared under

Question 5

(‘Principal investigator and investigator’);

—

non-remunerated participation in community advisory boards or other similar entities that aim at patients being able to provide their objective input to research and development of health technologies. Such activity is

not

to be declared.

yes

no

□

□

Type of role

Time period (from… until month/year)

Name of the health technology developer

Name of the health technology(ies) and the respective therapeutic indication(s)

Q3a.

Individual product related

Type of role

Time period (from… until month/year)

Name of the health technology developer

General role/area of activity

Therapeutic area(s) (where relevant)

Q3b.

Horizontal

4.   FINANCIAL INTERESTS

Q4.1.

Do you currently have any of the following financial interests with a health technology developer:

—

(co)ownership, shares and other stocks, stock options, stock warrants, equities, bonds. This does not cover the holding of financial interests through an investment fund, pension fund or similar arrangements provided that they are diversified and independently managed;

—

intellectual property rights owned by you or of which you are directly a beneficiary?

yes

no

□

□

Financial interest

Name of the health technology developer and/or the health technology

Q4.2.

Do you currently, or did you within the past 3 years, benefit from:

—

payment by a health technology developer to provide a presentation or training course, attend a conference/seminar/event;

—

reimbursement by a health technology developer of expenses incurred in relation to providing a presentation or training course, attending a conference/seminar/event?

This question does

not

cover:

—

payment(s)/reimbursement(s) of expenses of a cumulative total value below EUR 1 000 from one health technology developer over the past 3 years. Such interests are

not

to be declared.

yes

no

□

□

Financial interest

Payment/ reimbursement directly to you

Date of payment/ reimbursement

Name of the health technology developer

Therapeutic area(s) (where relevant)

Yes

No

□

□

5.   PRINCIPAL INVESTIGATOR AND INVESTIGATOR

Q5.

Do you currently, or did you within the past 3 years, act as a principal investigator or an investigator in a clinical trial, observation study, clinical investigation or performace study?

yes

no

□

□

Time period (from… until month/year)

Name of the sponsor health technology developer (where relevant)

Name of the health technology(ies) and the respective therapeutic indication(s)

6.   LEAD MEMBER IN AN ORGANISATION/INSTITUTION RECEIVING FUNDING FROM HEALTH TECHNOLOGY DEVELOPERS

Q6.

Are you currently (co)chair, president, director, treasurer of an organisation/institution that during the current financial year or during the most recent financial year closed received direct funding from a health technology developer or several health technology developers?

This question does

not

cover:

—

funding of national or regional authorities or bodies by fees from health technology developer. Such interests are

not

to be declared;

—

funding for the organisation of non-remunerated community advisory boards or other similar entities that aim at patients being able to provide their objective input to research and development of health technologies. Such interests are

not

to be declared.

yes

no

□

□

Organisation/ institution

Registration number in the Transparency Register (where applicable)

Name of the health technology developer(s)

Current financial year

Most recent financial year closed

Yes

No

Yes

No

□

□

□

□

7.   INTERESTS OF IMMEDIATE FAMILY MEMBERS

Q7.

Do your immediate family members have interests referred to in Questions 1.1a, 1.1b, 1.1c, 1.2 (‘Employment’) and 4.1 (‘Financial interests’)?

‘

immediate family member

’ means the individual’s spouse, children and parents. ‘Spouse’ includes a partner with whom the individual has a registered non marital regime.

‘

children

’ means the children that the individual and the spouse have in common, the individual’s own children and the spouse’s own children.

yes

no

□

□

Type of interest declared

Name of the health technology developer and/or the health technology

8.   OTHER RELEVANT INFORMATION

Do you have any additional information relevant to the joint work that you would like to disclose?

yes

no

□

□

Please provide the description here (please do

not

provide any personal data of other individuals) :

ANNEX II

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.