Health technologies subject to joint clinical assessments
1. The following health technologies shall be subject to joint clinical assessments:
(a)
medicinal products as referred to in Article 3(1) and Article 3(2), point (a), of Regulation (EC) No 726/2004, for which the application for a marketing authorisation is submitted in accordance with that Regulation after the relevant dates set out in paragraph 2 of this Article, and for which that application is in compliance with Article 8(3) of Directive 2001/83/EC;
(b)
medicinal products authorised in the Union for which a joint clinical assessment report has been published, in cases where an authorisation is granted pursuant to the second subparagraph of Article 6(1) of Directive 2001/83/EC for a variation to an existing marketing authorisation which corresponds to a new therapeutic indication;
(c)
medical devices classified as class IIb or 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, and subject to selection pursuant to paragraph 4 of this Article;
(d)
in vitro diagnostic medical devices classified as class D pursuant to Article 47 of Regulation (EU) 2017/746 for which the relevant expert panels have provided their views in the framework of the procedure pursuant to Article 48(6) of that Regulation, and subject to selection pursuant to paragraph 4 of this Article.
2. The dates referred to in paragraph 1, point (a), shall be as follows:
(a)
12 January 2025, for medicinal products with new active substances for which the applicant declares in its application for authorisation submitted to the European Medicines Agency that it contains a new active substance for which the therapeutic indication is the treatment of cancer and medicinal products which are regulated as advanced therapy medicinal products pursuant to Regulation (EC) No 1394/2007 of the European Parliament and of the Council ( 15 ) ;
(b)
13 January 2028, for medicinal products which are designated as orphan medicinal products pursuant to Regulation (EC) No 141/2000 of the European Parliament and of the Council ( 16 ) ;
(c)
13 January 2030, for medicinal products referred to in paragraph 1 other than those referred to in points (a) and (b) of this paragraph.
3. By way of derogation from paragraph 2 of this Article, the Commission, upon a recommendation from the Coordination Group, shall adopt a decision by means of an implementing act establishing that medicinal products referred to in that paragraph shall be subject to joint clinical assessment at a date earlier than the dates set out in that paragraph, provided that the medicinal product, in particular according to Article 22, has the potential to address an unmet medical need or a public health emergency or has a significant impact on healthcare systems.
4. After 12 January 2025, the Commission, after seeking a recommendation from the Coordination Group, shall adopt a decision, by means of an implementing act and at least every two years, selecting the medical devices and in vitro diagnostic medical devices referred to in paragraph 1, points (c) and (d), for joint clinical assessment based on one or more of the following criteria:
(a)
unmet medical needs;
(b)
first in class;
(c)
potential impact on patients, public health or healthcare systems;
(d)
incorporation of software using artificial intelligence, machine learning technologies or algorithms;
(e)
significant cross-border dimension;
(f)
major Union-wide added value.
5. The implementing acts referred to in paragraphs 3 and 4 of this Article shall be adopted in accordance with the examination procedure referred to in Article 33(2).
Initiation of joint clinical assessments
1. The Coordination Group shall carry out joint clinical assessments on health technologies on the basis of its annual work programme.
2. The Coordination Group shall initiate joint clinical assessments of health technologies by designating the subgroup on joint clinical assessments to oversee the conduct of the joint clinical assessment on behalf of the Coordination Group.
3. The joint clinical assessment shall be conducted in accordance with the procedure established by the Coordination Group according to the requirements set out in this Article, in Article 3(7), point (e), and in Articles 4, 9, 10, 11 and 12, as well as the requirements to be established pursuant to Articles 15, 25 and 26.
4. The designated subgroup shall appoint, from among its members, an assessor and a co-assessor from different Member States to conduct the joint clinical assessment. The appointments shall take into account the scientific expertise necessary for the assessment. If the health technology has been the subject of a joint scientific consultation in accordance with Articles 16 to 21, the assessor and the co-assessor shall be different from those appointed pursuant to Article 18(3) for the preparation of the joint scientific consultation outcome document.
5. Notwithstanding paragraph 4, where, in exceptional circumstances, the necessary specific expertise is otherwise not available, the same assessor or co-assessor, or both, involved in the joint scientific consultation may be appointed to conduct the joint clinical assessment. Such an appointment shall be justified and subject to approval by the Coordination Group and shall be documented in the joint clinical assessment report.
6. The designated subgroup shall initiate a scoping process in which it identifies the relevant parameters for the assessment scope. The assessment scope shall be inclusive and reflect Member States’ needs in terms of parameters and of the information, data, analysis and other evidence to be submitted by the health technology developer. The assessment scope shall include in particular all relevant parameters for the assessment in terms of:
(a)
the patient population;
(b)
the intervention or interventions;
(c)
the comparator or comparators;
(d)
the health outcomes.
The scoping process shall also take into account information provided by the health technology developer and input received from patients, clinical experts and other relevant experts.
7. The Coordination Group shall inform the Commission of the assessment scope of the joint clinical assessment.
Joint clinical assessment reports and the dossier of the health technology developer
1. A joint clinical assessment shall result in a joint clinical assessment report that shall be accompanied by a summary report. Those reports shall not contain any value judgement or conclusions on the overall clinical added value of the assessed health technology and shall be limited to a description of the scientific analysis:
(a)
of the relative effects of the health technology as assessed on the health outcomes against the chosen parameters which are based on the assessment scope as set out pursuant to Article 8(6);
(b)
of the degree of certainty of the relative effects, taking into account the strengths and limitations of the available evidence.
2. The reports referred to in paragraph 1 shall be based on a dossier that contains complete and up-to-date information, data, analyses and other evidence submitted by the health technology developer to assess the parameters included in the assessment scope.
3. The dossier shall meet the following requirements:
(a)
the submitted evidence is complete with regard to the available studies and data that could inform the assessment;
(b)
the data has been analysed using appropriate methods to answer all research questions of the assessment;
(c)
the presentation of the data is well structured and transparent, thereby allowing for an appropriate assessment within the limited timeframes available;
(d)
it includes the underlying documentation in respect of the submitted information, thereby allowing the assessor and co-assessor to verify the accuracy of that information.
4. The dossier for medicinal products shall include the information set out in Annex I. The dossier for medical devices and in vitro diagnostic medical devices shall include the information set out in Annex II.
5. The Commission is empowered to adopt delegated acts, in accordance with Article 32, to amend Annex I as regards the information required in the dossier for medicinal products, and to amend Annex II as regards the information required in the dossier for medical devices and in vitro diagnostic medical devices.
Obligations of health technology developers and consequences of non-compliance
1. The Commission shall inform the health technology developer of the assessment scope and request the submission of the dossier (first request). That request shall include the deadline for submission as well as the dossier template pursuant to Article 26(1), point (a), and refer to the requirements for the dossier in accordance with Article 9(2), (3) and (4). For medicinal products, the deadline for submission shall be at the latest 45 days prior to the envisaged date of the opinion of the Committee for Medicinal Products for Human Use referred to in Article 5(2) of Regulation (EC) No 726/2004.
2. The health technology developer shall submit the dossier to the Commission in accordance with the submission request made pursuant to paragraph 1.
3. The health technology developer shall not submit any information, data, analyses or other evidence at the national level that has been already submitted at Union level. That requirement shall not affect requests for additional information on medicinal products that fall within the scope of early access programmes at Member State level that aim to provide patient access to medicinal products in situations of high unmet medical needs before a centralised marketing authorisation has been granted.
4. Where the Commission confirms the timely submission of the dossier pursuant to paragraph 1 of this Article and that the dossier meets the requirements laid down in Article 9(2), (3) and (4), the Commission shall make the dossier available to the members of the Coordination Group in a timely manner via the IT platform referred to in Article 30 and inform the health technology developer thereof.
5. Where the Commission finds that the dossier fails to meet the requirements laid down in Article 9(2), (3) and (4), it shall request the missing information, data, analyses and other evidence from the health technology developer (second request). In such a case, the health technology developer shall submit the requested information, data, analyses and other evidence in accordance with the timeframe established pursuant to Article 15.
6. Where, after the second request referred to in paragraph 5 of this Article, the Commission deems that a dossier was not submitted in a timely manner by the health technology developer, or attests that it fails to meet the requirements laid down in Article 9(2), (3) and (4), the Coordination Group shall discontinue the joint clinical assessment. If the assessment is discontinued, the Commission shall make a statement on the IT platform referred to in Article 30, justifying the reasons for the discontinuation and shall inform the health technology developer accordingly. In the case of discontinuation of the joint clinical assessment, Article 13(1), point (d), shall not apply.
7. Where the joint clinical assessment has been discontinued and the Coordination Group, pursuant to Article 13(1), point (e), subsequently receives information, data, analyses and other evidence that formed part of the submission request referred to in paragraph 1 of this Article, the Coordination Group may re-initiate a joint clinical assessment in accordance with the procedure set out in this Section at the latest six months after the submission deadline referred to in paragraph 1 of this Article, once the Commission has confirmed that requirements laid down in Article 9(2), (3) and (4) have been fulfilled.
8. Without prejudice to paragraph 7, where a joint clinical assessment has been re-initiated, the Commission may request the health technology developer to submit updates of previously provided information, data, analyses and other evidence.
Assessment process for joint clinical assessments
1. On the basis of the dossier submitted by the health technology developer and the assessment scope as set out pursuant to Article 8(6), the assessor, with the assistance of the co-assessor, shall prepare the draft joint clinical assessment and summary reports. The Coordination Group shall endorse the draft reports in accordance with the timeframe set out pursuant to Article 3(7), point (e). Those timeframes shall be:
(a)
for medicinal products, no later than 30 days following the adoption of a Commission decision granting a marketing authorisation;
(b)
for medical devices and in vitro diagnostic medical devices, in accordance with the procedures for joint clinical assessments adopted pursuant to Article 3(7), point (e), and Article 15(1), point (b).
2. Where the assessor, with the assistance of the co-assessor, at any time during the preparation of the draft reports, considers that further specifications or clarifications or additional information, data, analyses or other evidence are necessary in order to carry out the assessment, the Commission shall request the health technology developer to provide such information, data, analyses or other evidence. The assessor and the co-assessor may also have recourse to databases and other sources of clinical information, such as patient registries, where it is deemed necessary. Where new clinical data becomes available during the assessment process, the health technology developer concerned shall proactively inform the Coordination Group.
3. The members of the designated subgroup shall provide their comments on the draft reports.
4. The subgroup shall ensure that patients, clinical experts and other relevant experts are involved in the assessment process by being given the opportunity to provide input on the draft reports. Such input shall be provided within the framework and the timeframe set out pursuant to Article 15(1), point (c), and Article 25(1), point (b), and the procedure adopted by the Coordination Group, and shall be made available in a timely manner to the Coordination Group via the IT platform referred to in Article 30.
5. The draft reports shall be provided to the health technology developer. The health technology developer shall signal any purely technical or factual inaccuracies in accordance with the timeframes established pursuant to Article 15. The health technology developer shall also signal any information it considers to be confidential and justify its commercially sensitive nature. The health technology developer shall not provide any comments on the results of the draft assessment.
6. Following receipt and consideration of comments provided in accordance with this Article, the assessor, with the assistance of the co-assessor, shall prepare revised draft reports, and submit those revised draft reports to the Coordination Group via the IT platform referred to in Article 30.
Finalisation of the joint clinical assessments
1. Upon receipt of the revised draft joint clinical assessment and summary reports, the Coordination Group shall review those reports.
2. The Coordination Group shall, within the timeframe set out pursuant to Article 3(7), point (e), and pursuant to Article 15(1), point (c), endeavour to endorse the revised draft reports by consensus. By way of derogation from Article 3(4), where a consensus cannot be reached, divergent scientific opinions, including the scientific grounds on which those opinions are based, shall be incorporated in the reports and the reports shall be deemed endorsed.
3. The Coordination Group shall submit the endorsed reports to the Commission for procedural review pursuant to Article 28, point (d). Where the Commission, within 10 working days of receipt of the endorsed reports, concludes that those reports do not comply with the procedural rules laid down pursuant to this Regulation or that they depart from the requirements adopted by the Coordination Group pursuant to this Regulation, it shall inform the Coordination Group of the reasons for its conclusion and request a review of the reports. The Coordination Group shall review the reports from a procedural point of view, take any necessary corrective actions, and re-endorse the reports in accordance with the procedure laid down in paragraph 2 of this Article.
4. The Commission shall publish, in a timely manner, the procedurally compliant reports endorsed or re-endorsed by the Coordination Group on the publicly accessible webpage of the IT platform referred to in Article 30(1), point (a), and shall inform the health technology developer of the publication.
5. If the Commission concludes that the re-endorsed reports still do not comply with the procedural rules referred to in paragraph 3 of this Article, it shall, in a timely manner, make available those reports and its procedural review on the secure intranet of the IT platform referred to in Article 30(1), point (b), for the consideration of Member States and inform the health technology developer accordingly. The Coordination Group shall include summary reports of those reports as part of its annual report adopted pursuant to Article 6(4) and published on the IT platform as laid down in Article 30(3), point (g).
Member States’ rights and obligations
1. When carrying out a national HTA on a health technology for which joint clinical assessment reports have been published or in respect of which a joint clinical assessment has been initiated, Member States shall:
(a)
give due consideration to the published joint clinical assessment reports and all other information available on the IT platform referred to in Article 30, including the statement of discontinuation pursuant to Article 10(6), concerning that joint clinical assessment in their HTAs at Member State level; this shall not affect Member States’ competence to draw their conclusions on the overall clinical added value of a health technology in the context of their specific healthcare system and to consider the parts of those reports relevant in that context;
(b)
annex the dossier submitted by the health technology developer in accordance with Article 10(2) to the documentation of the HTA at Member State level;
(c)
annex the published joint clinical assessment report to the HTA report at Member State level;
(d)
not request at the national level information, data, analyses or other evidence that has been submitted by the health technology developer at Union level in accordance with Article 10(1) or (5);
(e)
immediately share through the IT platform referred to in Article 30 any information, data, analyses and other evidence with the Coordination Group that they receive from the health technology developer at Member State level and which form part of the submission request made pursuant to Article 10(1).
2. Member States shall provide the Coordination Group through the IT platform referred to in Article 30 with information on the national HTA in respect of a health technology which has been subject to a joint clinical assessment within 30 days from the date of its completion. In particular, Member States shall provide information on how joint clinical assessment reports have been considered when carrying out a national HTA. The Commission shall, based on information from Member States, summarise the uptake of the joint clinical assessment reports in HTAs at Member State level and publish a report on that overview on the IT platform referred to in Article 30 at the end of each year to facilitate the exchange of information between Member States.
Updates of joint clinical assessments
1. The Coordination Group shall carry out updates of joint clinical assessments where the initial joint clinical assessment report specified the need for an update when additional evidence for further assessment becomes available.
2. The Coordination Group may carry out updates of joint clinical assessments where requested by one or more of its members and new clinical evidence is available. When preparing the annual work programme the Coordination Group may review and decide on the need for updates of joint clinical assessments.
3. Updates shall be carried out in accordance with the same requirements set out pursuant to this Regulation for a joint clinical assessment and the procedural rules established pursuant to Article 15(1).
4. Without prejudice to paragraphs 1 and 2, Member States may carry out national updates of assessments on health technologies that have been subject to a joint clinical assessment. The members of the Coordination Group shall inform the Coordination Group before such updates are initiated. Where the need for the update concerns more than one Member State, the members concerned may request the Coordination Group to conduct a joint update pursuant to paragraph 2.
5. Once concluded, national updates shall be shared with the members of the Coordination Group via the IT platform referred to in Article 30.
Adoption of detailed procedural rules for joint clinical assessments
1. The Commission shall adopt, by means of implementing acts, detailed procedural rules for:
(a)
cooperation, in particular by exchange of information, with the European Medicines Agency on the preparation and update of joint clinical assessments of medicinal products;
(b)
cooperation, in particular by exchange of information, with the notified bodies and expert panels on the preparation and update of joint clinical assessments of medical devices and in vitro diagnostic medical devices;
(c)
interaction, including timing thereof, with and between the Coordination Group, its subgroups and the health technology developers, patients, clinical experts and other relevant experts during joint clinical assessments and updates.
2. Implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 33(2).
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
