Legal provisions of COM(2018)51 - Health technology assessment

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dossier COM(2018)51 - Health technology assessment.
document COM(2018)51 EN
date December 15, 2021


Chapter I

General Provisions

Contents

Article 1 - Subject Matter

1. This Regulation establishes:

(a)a support framework and procedures for cooperation on health technology assessment at Union level;

(b)common rules for the clinical assessment of health technologies.

2. This Regulation shall not affect the rights and obligations of Member States with regard to the organisation and delivery of health services and medical care and the allocation of resources assigned to them.

Article 2 - Definitions

For the purposes of this Regulation, the following definitions shall apply:

(a)'medicinal product' means a medicinal product for human use as defined in Directive 2001/83/EC 16 ;

(b)'medical device' means a medical device as defined in Regulation (EU) 2017/745;

(c)'health technology' means a health technology as defined in Directive 2011/24/EU;

(d)'health technology assessment' means a multidisciplinary comparative assessment process, based on clinical and non-clinical assessment domains, which compiles and evaluates the available evidence about the clinical and non-clinical issues related to the use of a health technology;

(e)'clinical assessment' means a compilation and evaluation of the available scientific evidence on a health technology in comparison with one or more other health technologies based on the following clinical domains of health technology assessment: the description of the health problem addressed by the health technology and the current use of other health technologies addressing that health problem, the description and technical characterisation of the health technology, the relative clinical effectiveness, and the relative safety of the health technology;

(f)'non-clinical assessment' means the part of a health technology assessment based on the following non-clinical domains of health technology assessment: the cost and economic evaluation of a health technology, and ethical, organisational, social, and legal aspects related to its use;

(g)'collaborative assessment' means a clinical assessment of a medical device carried out at Union level by a number of interested health technology assessment authorities and bodies participating on a voluntary basis.

Article 3 - The Member State Coordination Group on Health Technology Assessment

1. The Member State Coordination Group on Health Technology Assessment (the Coordination Group) is hereby established.

2. Member States shall designate their national authorities and bodies responsible for health technology assessment as members of the Coordination Group and its sub-groups and inform the Commission thereof and of any subsequent changes. Member States may designate more than one authority or body responsible for health technology assessment as members of the Coordination Group and one or more of its sub-groups.

3. The Coordination Group shall act by consensus, or, where necessary, vote by simple majority. There shall be one vote per Member State.

4. Meetings of the Coordination Group shall be co-chaired by the Commission and a co-chair elected from the members of the group for a set term to be determined in its rules of procedure.

5. Members of the Coordination Group shall appoint their representatives in the Coordination Group and the sub-groups in which they are members, on an ad-hoc or permanent basis, and inform the Commission of their appointment and any subsequent changes.

6. Members of the Coordination Group, and their appointed representatives shall respect the principles of independence, impartiality, and confidentiality.

7. The Commission shall publish a list of the designated members of the Coordination Group and its sub-groups on the IT platform referred to in Article 27.

8. The Coordination Group shall:

(a)adopt rules of procedure for the conduct of its meetings and update them where necessary;

(b)coordinate and approve the work of its sub-groups;

(c)ensure cooperation with relevant Union level bodies to facilitate additional evidence generation necessary for its work;

(d)ensure appropriate involvement of stakeholders in its work;

(e)establish sub-groups for the following:

(i)joint clinical assessments;

(ii)joint scientific consultations;

(iii)identification of emerging health technologies;

(iv)voluntary cooperation;

(v)preparation of the annual work programmes and annual reports, and updates of the common rules and working documents.

9. The Coordination Group may meet in different configurations for the following categories of health technology: medicinal products, medical devices, and other health technologies.

10. The Coordination Group may establish separate sub-groups for the following categories of health technology: medicinal products, medical devices, and other health technologies.

Article 4 - Annual Work Programme and Annual Report

1. The sub-group designated in accordance with Article 3(8)(e) shall prepare an annual work programme for approval by the Coordination Group by December 31st of each year.

2. The annual work programme shall set out the joint work to be carried out in the calendar year following its approval, covering:

(a)the planned number of joint clinical assessments and the types of health technologies to be assessed;

(b)the planned number of joint scientific consultations;

(c)voluntary cooperation.

3. In the preparation of the annual work programme, the designated sub-group shall:

(a)have regard to the annual study on emerging health technologies referred to in Article 18;

(b)take into account the resources available to the Coordination Group for the joint work;

(c)consult the Commission on the draft annual work programme and take into account its opinion.

4. The designated sub-group shall prepare an annual report for approval by the Coordination Group by February 28th of each year.

5. The annual report shall provide information on the joint work carried out in the calendar year preceding its approval.

Chapter II

Joint Work on Health Technology Assessment at Union Level

Section 1

Joint Clinical Assessments

Article 5 - Scope of Joint Clinical Assessments

1. The Coordination Group shall carry out joint clinical assessments on:

(a)medicinal products subject to the authorisation procedure provided for in Regulation (EC) No 726/2004, including where an amendment has been made to the Commission Decision to grant a marketing authorisation based on a change in the therapeutic indication or indications for which the original authorisation was granted, with the exception of medicinal products authorised under Articles 10 and 10a of Directive 2001/83/EC;

(b)medical devices classified as class IIb and III pursuant to Article 51 of Regulation (EU) 2017/745 for which the relevant expert panels have provided a scientific opinion in the framework of the clinical evaluation consultation procedure pursuant to Article 54 of that Regulation;

(c)in vitro diagnostic medical devices classified as class D pursuant to Article 47 of Regulation (EU) 2017/746 17 for which the relevant expert panels have provided their views in the framework of the procedure pursuant to Article 48(6) of that Regulation.

2. The Coordination Group shall select the medical devices referred to in paragraph 1 points (b) and (c) for joint clinical assessment based on the following criteria:

(a)unmet medical needs;

(b)potential impact on patients, public health, or healthcare systems;

(c)significant cross-border dimension;

(d)major Union-wide added value;

(e)the available resources.

Article 6 - Preparation of Joint Clinical Assessment Reports

1. The Coordination Group shall initiate joint clinical assessments of health technologies on the basis of its annual work programme by designating a sub-group to oversee the preparation of the joint clinical assessment report on behalf of the Coordination Group.

The joint clinical assessment report shall be accompanied by a summary report and they shall be prepared in accordance with the requirements in this Article and the requirements established pursuant to Articles 11, 22, and 23.

2. The designated sub-group shall request relevant health technology developers to submit documentation containing the information, data and evidence necessary for the joint clinical assessment.

3. The designated sub-group shall appoint, from among its members, an assessor and a co-assessor to conduct the joint clinical assessment. The appointments shall take into account the scientific expertise necessary for the assessment.

4. The assessor, with the assistance of the co-assessor, shall prepare the draft joint clinical assessment report and the summary report.

5. The conclusions of the joint clinical assessment report shall be limited to the following:

(a)an analysis of the relative effects of the health technology being assessed on the patient-relevant health outcomes chosen for the assessment;

(b)the degree of certainty on the relative effects based on the available evidence.

6. Where, at any stage in the preparation of the draft joint clinical assessment report, the assessor considers that additional evidence from the submitting health technology developer is necessary in order to complete the report, it may request the designated sub-group to suspend the time period set for the preparation of the report and to request additional evidence from the health technology developer. Having consulted the health technology developer on the time needed to prepare the necessary additional evidence, the request from the assessor shall specify the number of working days for which the preparation shall be suspended.

7. The members of the designated sub-group shall provide their comments during the preparation of the draft joint clinical assessment report and the summary report. The Commission may also provide comments.

8. The assessor shall provide the draft joint clinical assessment report and the summary report to the submitting health technology developer and set a time-frame in which the developer may submit comments.

9. The designated sub-group shall ensure that stakeholders, including patients and clinical experts, are given an opportunity to provide comments during the preparation of the draft joint clinical assessment report and the summary report and set a time-frame in which they may submit comments.

10. Following receipt and consideration of any comments provided in accordance with paragraphs 7, 8, and 9, the assessor, with the assistance of the co-assessor, shall finalise the draft joint clinical assessment report and summary report, and submit those reports to the designated sub-group and to the Commission for comments.

11. The assessor, with the assistance of the co-assessor, shall take into account the comments of the designated sub-group and the Commission and submit a final draft joint clinical assessment report and the summary report to the Coordination Group for approval.

12. The Coordination Group shall approve the final joint clinical assessment report and summary report, wherever possible by consensus or, where necessary, by a simple majority of Member States.

13. The assessor shall ensure the removal of any information of a commercially sensitive nature from the approved joint clinical assessment report and the summary report.

14. The Coordination Group shall provide the approved joint clinical assessment report and the summary report to the submitting health technology developer and the Commission.

Article 7 - The List of Assessed Health Technologies

1. Where the Commission considers that the approved joint clinical assessment report and summary report comply with the substantive and procedural requirements laid down in this Regulation, it shall include the name of the health technology which has been the subject of the approved report and summary report, in a list of technologies having undergone joint clinical assessment (the 'List of Assessed Health Technologies' or the 'List') at the latest 30 days after receipt of the approved report and summary report from the Coordination Group.

2. Where, within 30 days of receipt of the approved joint clinical assessment report and the summary report, the Commission concludes that the approved joint clinical assessment report and summary report do not comply with the substantive and procedural requirements laid down in this Regulation, it shall inform the Coordination Group of the reasons for its conclusions and request it to review the report and summary report.

3. The designated sub-group shall consider the conclusions referred to in paragraph 2 and invite the health technology developer to submit comments by a specified deadline. The designated sub-group shall review the joint clinical assessment report and summary report taking into account the comments provided by the health technology developer. The assessor, with the assistance of the co-assessor, shall modify the joint clinical assessment report and summary report accordingly and submit them to the Coordination Group. Article 6, paragraphs 12 to 14 shall apply.

4. Following the submission of the modified approved joint clinical assessment report and summary report, and where the Commission considers that the modified approved joint clinical assessment report and summary report comply with the substantive and procedural requirements laid down in this Regulation, it shall include the name of the health technology which has been the subject of the report and summary report, in the List of Assessed Health Technologies.

5. If the Commission concludes that the modified approved joint clinical assessment report and summary report do not comply with the substantive and procedural requirements laid down in this Regulation, it shall decline to include the name of the health technology in the List. The Commission shall inform the Coordination Group thereof, setting out the reasons for the non-inclusion. The obligations laid down in Article 8 shall not apply with respect to the health technology concerned. The Coordination Group shall inform the submitting health technology developer accordingly and include summary information on those reports in its annual report.

6. For those health technologies included on the List of Assessed Health Technologies, the Commission shall publish the approved joint clinical assessment report and summary report on the IT platform referred to in Article 27 and make them available to the submitting health technology developer at the latest 10 working days following their inclusion in the List.

Article 8 - Use of Joint Clinical Assessment Reports at Member State Level

1. Member States shall:

(a)not carry out a clinical assessment or an equivalent assessment process on a health technology included in the List of Assessed Health Technologies or for which a joint clinical assessment has been initiated;

(b)apply joint clinical assessment reports, in their health technology assessments at Member State level.

2. Member States shall notify the Commission of the outcome of a health technology assessment on a health technology which has been subject to a joint clinical assessment within 30 days from its completion. That notification shall be accompanied by information on how the conclusions of the joint clinical assessment report have been applied in the overall health technology assessment. The Commission shall facilitate the exchange of this information between Member States through the IT platform referred to in Article 27.

Article 9 - Updates of Joint Clinical Assessments

1. The Coordination Group shall carry out updates of joint clinical assessments where:

(a)the Commission Decision to grant the marketing authorisation of a medicinal product referred to in Article 5(1)(a) was conditional on the fulfilment of additional post-authorisation requirements;

(b)the initial joint clinical assessment report specified the need for an update once additional evidence for further assessment is available.

2. The Coordination Group may carry out updates of joint clinical assessments where requested by one or more of its members.

3. Updates shall be carried out in accordance with the procedural rules established pursuant to Article 11(1)(d).

Article 10 - Transitional Arrangements for Joint Clinical Assessments

During the transitional period referred to in Article 33(1):

(a)the Coordination Group shall:

(i)base the annual number of planned joint clinical assessments on the number of Member States participating and the resources available to it;

(ii)select medicinal products referred to in Article 5(1)(a) for joint clinical assessment based on the selection criteria referred to in Article 5(2).

(b)members of the Coordination Group from Member States not participating in joint clinical assessments shall not:

(i)be appointed as assessors or co-assessors;

(ii)comment on the draft joint clinical assessment reports and summary reports;

(iii)take part in the approval process of the final joint clinical assessment reports and summary reports;

(iv)take part in the preparation and approval process on the parts of the annual work programmes on joint clinical assessments;

(v)be subject to the obligations set out in Article 8 as regards the health technologies which have undergone joint clinical assessment.

Article 11 - Adoption of Detailed Procedural Rules for Joint Clinical Assessments

1. The Commission shall develop, by means of implementing acts, procedural rules for:

(a)submissions of information, data and evidence by health technology developers;

(b)the appointment of assessors and co-assessors;

(c)determining the detailed procedural steps and their timing, and the overall duration of joint clinical assessments;

(d)updates of joint clinical assessments;

(e)cooperation with the European Medicines Agency on the preparation and update of joint clinical assessments of medicinal products;

(f)cooperation with the notified bodies and expert panels on the preparation and update of joint clinical assessments of medical devices.

2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 30(2).

Section 2

Joint Scientific Consultations

Article 12 - Requests for Joint Scientific Consultations

1. Health technology developers may request a joint scientific consultation with the Coordination Group for the purposes of obtaining scientific advice concerning data and evidence likely to be required as part of a joint clinical assessment.

Health technology developers of medicinal products may request that the joint scientific consultation takes place in parallel with the process of receiving scientific advice from the European Medicines Agency pursuant to Article 57(1)(n) of Regulation (EC) No 726/2004. In such a case, it shall make that request at the time of submitting an application for scientific advice to the European Medicines Agency.

2. In considering the request for joint scientific consultation, the Coordination Group shall take into account the following criteria:

(a)the likelihood that the health technology under development will be the subject of a joint clinical assessment in accordance with Article 5(1);

(b)unmet medical needs;

(c)potential impact on patients, public health, or healthcare systems;

(d)significant cross-border dimension;

(e)major Union-wide added value;

(f)the available resources.

3. Within 15 working days after receipt of the request, the Coordination Group shall inform the requesting health technology developer whether or not it will engage in the joint scientific consultation. Where the Coordination Group refuses the request, it shall inform the health technology developer thereof and explain the reasons having regard to the criteria laid down in paragraph 2.

Article 13 - Preparation of Joint Scientific Consultation Reports

1. Following the acceptance of a request for a joint scientific consultation in accordance with Article 12 and on the basis of its annual work programme, the Coordination Group shall designate a sub-group to oversee the preparation of the joint scientific consultation report on behalf of the Coordination Group.

The joint scientific consultation report shall be prepared in accordance with the requirements in this Article and in accordance with the procedural rules and documentation established pursuant to Articles 16 and 17.

2. The designated sub-group shall request the health technology developer to submit the documentation containing the information, data and evidence necessary for the joint scientific consultation.

3. The designated sub-group shall appoint from among its members, an assessor and a co-assessor, with responsibility for conducting the joint scientific consultation. The appointments shall take into account the scientific expertise necessary for the assessment.

4. The assessor, with the assistance of the co-assessor, shall prepare the draft joint scientific consultation report.

5. Where, at any stage in the preparation of the draft joint scientific consultation report, the assessor considers that additional evidence from a health technology developer is necessary in order to complete the report, it may request the designated sub-group to suspend the time period set for the preparation of the report and to request the additional evidence from the health technology developer. Having consulted the health technology developer on the time needed to prepare the necessary additional evidence, the request from the assessor shall specify the number of working days for which the preparation shall be suspended.

6. The members of the designated sub-group shall provide their comments during the preparation of the draft joint scientific consultation report.

7. The assessor shall provide the draft joint scientific consultation report to the submitting health technology developer and set a time-frame in which the developer may submit comments.

8. The designated sub-group shall ensure that stakeholders, including patients and clinical experts are given an opportunity to provide comments during the preparation of the draft joint scientific consultation report and set a time-frame in which they may submit comments.

9. Following receipt and consideration of any comments provided in accordance with paragraphs 6, 7 and 8, the assessor, with the assistance of the co-assessor, shall finalise the draft joint scientific consultation report and submit the draft report to the designated sub-group for comments.

10. Where the joint scientific consultation is carried out in parallel with scientific advice given by the European Medicines Agency, the assessor shall seek to coordinate with the Agency as regards the consistency of the conclusions of the joint scientific consultation report with those of the scientific advice.

11. The assessor, with the assistance of the co-assessor, shall take into account the comments of the members of the designated sub-group and submit the final draft joint scientific consultation report to the Coordination Group.

12. The Coordination Group shall approve the final joint scientific consultation report, wherever possible by consensus or, where necessary, by a simple majority of Member States, at the latest 100 days following the start of the preparation of the report referred to in paragraph 4.

Article 14 - Joint Scientific Consultation Reports

1. The Coordination Group shall communicate the approved joint scientific consultation report to the requesting health technology developer at the latest 10 working days following its approval.

2. The Coordination Group shall include anonymised summary information on the joint scientific consultations in its annual reports and the IT platform referred to in Article 27.

3. Member States shall not carry out a scientific consultation or an equivalent consultation on a health technology for which a joint scientific consultation has been initiated and where the contents of the request are the same as those covered by the joint scientific consultation.

Article 15 - Transitional Arrangements for Joint Scientific Consultations

During the transitional period referred to in Article 33(1):

(a)the Coordination Group shall base the annual number of planned joint scientific consultations on the number of Member States participating and the resources available to it;

(b)members of the Coordination Group from Member States not participating in joint scientific consultations shall not:

(i)be appointed as assessors or co-assessors;

(ii)comment on the draft joint scientific consultation reports;

(iii)take part in the approval process of the final joint scientific consultation reports;

(iv)take part in the preparation and approval process on the parts of the annual work programmes on joint scientific consultations.

Article 16 - Adoption of Detailed Procedural Rules for Joint Scientific Consultations

1. The Commission shall develop, by means of implementing acts, procedural rules for:

(a)submissions of requests from health technology developers and their involvement in the preparation of joint scientific consultation reports;

(b)the appointment of assessors and co-assessors;

(c)determining the detailed procedural steps and their timing;

(d)the consultation of patients, clinical experts and other relevant stakeholders;

(e)cooperation with the European Medicines Agency on joint scientific consultations on medicinal products where a health technology developer requests the consultation to be carried out in parallel with a process for scientific advice from the Agency;

(f)cooperation with the expert panels referred to in Article 106(1) of Regulation (EU) 2017/745 on the joint scientific consultations on medical devices.

2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 30(2).

Article 17 - Documentation and Rules for Selecting Stakeholders for Joint Scientific Consultations

The Commission shall be empowered to adopt delegated acts in accordance with Article 31 concerning:

(a)the contents of:

(i)requests from health technology developers for joint scientific consultations;

(ii)dossiers of information, data and evidence to be submitted by health technology developers for joint scientific consultations;

(iii)joint scientific consultation reports.

(b)the rules for determining the stakeholders to be consulted for the purpose of this Section.

Section 3

Emerging Health Technologies

Article 18 - Identification of Emerging Health Technologies

1. The Coordination Group shall annually prepare a study on emerging health technologies expected to have a major impact on patients, public health or healthcare systems.

2. In the preparation of the study, the Coordination Group shall consult:

(a)health technology developers;

(b)patient organisations;

(c)clinical experts;

(d)the European Medicines Agency including on the pre-notification of medicinal products prior to marketing authorisation applications;

(e)the Medical Devices Coordination Group established in Article 103 of Regulation (EU) 2017/745.

3. The conclusions of the study shall be summarised in the Coordination Group's annual report and shall be taken into account in the preparation of its annual work programmes.

Section 4

Voluntary Cooperation on Health Technology Assessment

Article 19 - Voluntary Cooperation

1. The Commission shall support cooperation and the exchange of scientific information among Member States on:

(a)non-clinical assessments on health technologies;

(b)collaborative assessments on medical devices;

(c)health technology assessments on health technologies other than medicinal products or medical devices;

(d)the provision of additional evidence necessary to support health technology assessments.

2. The Coordination Group shall be used to facilitate the cooperation referred to in paragraph 1.

3. The cooperation referred to in paragraph 1 points (b) and (c) may be carried out using the procedural rules established in accordance with Article 11 and the common rules established in accordance with Articles 22 and 23.

4. The cooperation referred to in paragraph 1 shall be included in the annual work programmes of the Coordination Group and the results of the cooperation shall be included in its annual reports and the IT platform referred to in Article 27.

Chapter III

Rules for Clinical Assessments

Article 20 - Harmonised Rules for Clinical Assessments

The common procedural rules and methodology established in accordance with Article 22 and the requirements established in accordance with Article 23 shall apply to:

(a)joint clinical assessments carried out in accordance with Chapter II;

(b)clinical assessments of medicinal products and medical devices carried out by Member States.

Article 21 - Clinical Assessment Reports

1. Where a clinical assessment is carried out by a Member State, that Member State shall provide the Commission with the clinical assessment report and summary report at the latest 30 working days after the completion of the health technology assessment.

2. The Commission shall publish the summary reports referred to in paragraph 1 in the IT platform referred to in Article 27 and make the clinical assessment reports available to other Member States through that IT platform.

Article 22 - Common Procedural Rules and Methodology

1. The Commission shall adopt implementing acts concerning:

(a)procedural rules for:

(i)ensuring that health technology authorities and bodies carry out clinical assessments in an independent and transparent manner, free from conflicts of interest;

(ii)the mechanisms for the interaction between health technology bodies and health technology developers during clinical assessments;

(iii)the consultation of patients, clinical experts, and other stakeholders in clinical assessments.

(b)methodologies used to formulate the contents and design of clinical assessments.

2. Implementing acts referred to in paragraph 1 shall be adopted in accordance with the examination procedure referred to in Article 30(2).

Article 23 - Contents of Submission and Report Documents and Rules for Selecting Stakeholders

The Commission shall be empowered to adopt delegated acts in accordance with Article 31 concerning:

(a)the contents of:

(i)dossiers of information, data and evidence to be provided by health technology developers for clinical assessments;

(ii)clinical assessment reports;

(iii)summary clinical assessment reports.

(b)the rules for determining the stakeholders to be consulted for the purposes of Section 1 of Chapter II and of this Chapter.

Chapter IV

Support Framework

Article 24 - Union Funding

1. The financing of the work of the Coordination Group and its sub-groups and activities in support of that work involving its cooperation with the Commission, with the European Medicines Agency, and with the stakeholder network referred to in Article 26 shall be ensured by the Union. The Union's financial assistance to the activities under this Regulation shall be implemented in accordance with Regulation (EU, Euratom) No 966/2012 of the European Parliament and of the Council. 18

2. The funding referred to in paragraph 1 shall include funding for the participation of Member States' designated health technology authorities and bodies in support of the work on joint clinical assessments and joint scientific consultations. Assessor and co-assessors shall be entitled to a special allowance compensating them for their work on joint clinical assessments and joint scientific consultations in accordance with internal Commission provisions.

Article 25 - Commission Support for the Coordination Group

The Commission shall support the work of the Coordination Group. In particular the Commission shall:

(a)host on its premises and co-chair the meetings of the Coordination Group;

(b)provide the secretariat for the Coordination Group and provide administrative, scientific and IT support;

(c)publish on the IT platform referred to in Article 27 the Coordination Group's annual work programmes, annual reports, summary minutes of its meetings, and reports and summary reports of joint clinical assessments;

(d)verify that the work of the Coordination Group is carried out in an independent and transparent manner;

(e)facilitate cooperation with the European Medicines Agency on the joint work on medicinal products including the sharing of confidential information;

(f)facilitate cooperation with the relevant Union level bodies on the joint work on medical devices including the sharing of confidential information.

Article 26 - Stakeholder Network

1. The Commission shall establish a stakeholder network through an open call for applications and a selection of suitable stakeholder organisations based on selection criteria established in the open call for applications.

2. The Commission shall publish the list of stakeholder organisations included in the stakeholder network.

3. The Commission shall organise ad-hoc meetings between the stakeholder network and the Coordination Group in order to:

(a)update stakeholders on the work of the group;

(b)provide for an exchange of information on the work of the Coordination Group.

4. On the request of the Coordination Group, the Commission shall invite patients and clinical experts nominated by the stakeholder network to attend meetings of the Coordination Group as observers.

5. On the request of the Coordination Group, the stakeholder network shall support the Coordination Group in the identification of patient and clinical expertise for the work of its sub-groups.

Article 27 - IT Platform

1. The Commission shall develop and maintain an IT platform containing information on:

(a)planned, on-going, and completed joint clinical assessments and Member State health technology assessments;

(b)joint scientific consultations;

(c)studies on the identification of emerging health technologies;

(d)results of the voluntary cooperation between Member States.

2. The Commission shall ensure appropriate levels of access to the information contained in the IT platform for Member State bodies, members of the stakeholder network, and the general public.

Article 28 - Implementation Report

No later than two years after the end of the transitional period referred to in Article 33(1), the Commission shall report on the implementation of the provisions on the scope of the joint clinical assessments and on the functioning of the support framework referred to in this Chapter.

Chapter V

Final Provisions

Article 29 - Evaluation and Monitoring

1. No later than five years after the publication of the report referred to in Article 28, the Commission shall carry out an evaluation of this Regulation, and report on its conclusions.

2. By … [insert date one year after the date of application] at the latest, the Commission shall establish a programme for monitoring the implementation of this Regulation. The monitoring programme shall set out the means by which and the intervals at which the data and other necessary evidence will be collected. The monitoring programme shall specify the action to be taken by the Commission and by the Member States in collecting and analysing the data and other evidence.

3. The annual reports of the Coordination Group shall be used as part of the monitoring programme.

Article 30 - Committee Procedure

1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Article 31 - Exercise of the Delegation

1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2. The power to adopt delegated acts referred to in Articles 17 and 23 shall be conferred on the Commission for an indeterminate period of time from … [insert date of entry into force of this Regulation].

3. The delegation of power referred to in Articles 17 and 23 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement on Better Law-Making of 13 April 2016.

5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6. A delegated act adopted pursuant to Articles 17 and 23 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

Article 32 - Preparation of Implementing and Delegated Acts

1. The Commission shall adopt the implementing and delegated acts referred to in Articles 11, 16, 17, 22, and 23, at the latest by the date of application of this Regulation.

2. When preparing those implementing and delegated acts, the Commission shall take into account the distinctive characteristics of the medicinal product and medical device sectors.

Article 33 - Transitional Provisions

1. Member States may delay their participation in the system of joint clinical assessments and joint scientific consultations referred to in sections 1 and 2 of Chapter II until ... [insert date 3 years after the date of application].

2. Member States shall notify the Commission where they intend to make use of the transitional period set out in paragraph 1 at the latest one year before the date of application of this Regulation.

3. Member States which have delayed their participation in accordance with paragraph 1 may begin participating with effect from the next financial year after having notified the Commission at least three months before the beginning of that financial year.

Article 34 - Safeguard Clause

1. Member States may carry out a clinical assessment using means other than the rules provided for in Chapter III of this Regulation, on grounds related to the need to protect public health in the Member State concerned and provided the measure is justified, necessary and proportionate as regards achieving that aim.

2. Member States shall notify the Commission of their intention to carry out a clinical assessment using other means together with the justifications for doing so.

3. The Commission shall, within three months of the date of receiving the notification provided for in paragraph 2, approve or reject the planned assessment after having verified whether or not it complies with the requirements referred to in paragraph 1 and whether or not it is a means of arbitrary discrimination or a disguised restriction on trade between Member States. In the absence of a decision by the Commission by the end of the three month period, the planned clinical assessment shall be deemed to be approved.

Article 35 - Amendment of Directive 2011/24/EU

1. Article 15 of Directive 2011/24/EU is deleted.

2. References to the deleted Article shall be construed as references to this Regulation.

Article 36 - Entry into Force and Date of Application

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

2. It shall apply from [insert date 3 years after date of entry into force].

This Regulation shall be binding in its entirety and directly applicable in all Member States.