Commission Implementing Regulation (EU) 2024/3169 of 18 December 2024 laying down rules for the application of Regulation (EU) 2021/2282 of the European Parliament and of the Council with regard to the procedures for joint scientific consultations on medicinal products for human use at Union level

• CELEX: Implementing Regulation (EU) 2024/3169
• Articles: 16

Article 1 Subject matter

This Regulation lays down detailed procedural rules for joint scientific consultations carried out pursuant to Articles 16 to 21 of Regulation (EU) 2021/2282, as regards:

(a)

submission of requests from health technology developers for joint scientific consultation on medicinal products for human use (‘medicinal products’);

(b)

the selection and consultation of stakeholder organisations and patients, clinical experts and other relevant experts (‘individual experts’) in joint scientific consultation on medicinal products;

(c)

cooperation, in particular by exchange of information, 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 the scientific advice on medicinal products by the European Medicines Agency pursuant to Article 57(1), point (n), of Regulation (EC) No 726/2004 (‘scientific advice’).

Article 2 Setting of request periods for joint scientific consultation

1.   By 30 November each year, the Coordination Group shall set the dates of request periods for joint scientific consultation on medicinal products for the subsequent year and the planned numbers of joint scientific consultations for each of those request periods.

2.   The Coordination Group shall set at least three request periods for joint scientific consultation on medicinal products per year.

3.   By way of derogation from paragraphs 1 and 2, by 31 March 2025, the Coordination Group shall set at least two request periods for joint scientific consultation on medicinal products for 2025.

Article 3 Submission of requests for joint scientific consultations

1.   Any time during the request period published pursuant to Article 17(3) of Regulation (EU) 2021/2282, the health technology developer may submit a request for a joint scientific consultation on the medicinal product through the IT platform referred to in Article 30 of that Regulation (‘the HTA IT platform’).

The request shall follow the template established by the Coordination Group pursuant to Article 21, point (a), of Regulation (EU) 2021/2282.

2.   When submitting the request referred to in paragraph 1, the health technology developer shall indicate whether, in parallel, it is requesting scientific advice from the European Medicines Agency.

3.   By the end of a request period, the Commission acting as secretariat of the Coordination Group (‘HTA secretariat’) shall make available through the HTA IT platform the requests for joint scientific consultation on medicinal products complying with the requirements in paragraph 1, second subparagraph, to the subgroup on joint scientific consultations of the Coordination Group (‘JSC Subgroup’) and indicate for which of those requests scientific advice will be sought in parallel.

Article 4 Provision of information to the health technology developer on engagement in joint scientific consultations

1.   With regard to joint scientific consultations on medicinal products, the information referred to in Article 17(4) of Regulation (EU) 2021/2282 shall be provided by the JSC Subgroup via the HTA secretariat and shall, where applicable, include a timetable for the joint scientific consultation.

2.   Within 15 working days after the end of each request period, the HTA secretariat shall notify the European Medicines Agency of the list of the granted requests for joint scientific consultation on medicinal products to be carried out in parallel with the scientific advice.

3.   Where the health technology developer requests the joint scientific consultation to be carried out in parallel with the scientific advice, the timetable referred to in paragraph 1 shall be agreed between the HTA secretariat, in consultation with the JSC Subgroup, and the European Medicines Agency and shall be synchronised with the timing of the process for scientific advice as specified in Article 7(5), points (a) and (c), Article 9(2), point (a), Article 12(2) and Article 13(2), point (b).

Article 5 Selection of individual experts for joint scientific consultations

1.   When selecting the medicinal products that are to be subject to joint scientific consultations, the JSC Subgroup shall specify, for each medicinal product, the following:

(a)

the disease;

(b)

the therapeutic area;

(c)

other specific expertise if needed for the joint scientific consultation.

2.   On the basis of the information listed in paragraph 1, the HTA secretariat shall identify individual experts to be consulted during the joint scientific consultation and shall compile a list of relevant individual experts, in consultation with the JSC Subgroup and the assessor and co-assessor for joint scientific consultation appointed pursuant to Article 18(3) of Regulation (EU) 2021/2282 (‘the assessor and co-assessor’). When compiling the list, the HTA secretariat may consult one or more of the following:

(a)

the members of the stakeholder network established pursuant to Article 29 of Regulation (EU) 2021/2282;

(b)

the European reference networks for rare and complex diseases and their respective European patient advocacy groups;

(c)

the portal for rare diseases and orphan drugs;

(d)

the national contact points designated in accordance with Article 83(1) of Regulation (EU) No 536/2014 of the European Parliament and of the Council  ( 6 ) ;

(e)

the European Medicines Agency.

3.   Where the consultation of the sources referred to in paragraph 2 has not yielded a sufficient number of relevant individual experts, the HTA secretariat may consult the following for compiling a list of individual experts:

(a)

other databases or directories than the ones listed in paragraph 2;

(b)

members of the Coordination Group and its subgroups;

(c)

relevant Union and international agencies and organisations.

4.   After the Commission, in accordance with the rules set out in Article 5 of Regulation (EU) 2021/2282 and Article 4 of Implementing Regulation (EU) 2024/2745, has assessed the declared interests of individual experts in the list compiled by the HTA secretariat in accordance with paragraphs 1 to 3 of this Article, the HTA secretariat shall provide the JSC Subgroup with a list of available individual experts.

5.   The JSC Subgroup shall make the final selection of individual experts to be consulted during the joint scientific consultation from the list of individual experts provided by the HTA Secretariat in accordance with paragraph 4. In making the final selection, the JSC Subgroup shall give priority to individual experts who have expertise across a number of Member States in the disease or the therapeutic area of the joint scientific consultation.

Article 6 Professional secrecy obligations of individual experts

The HTA secretariat shall ensure that only individual experts who have signed a confidentiality agreement are involved in joint scientific consultations on medicinal products.

Article 7 Briefing package and further data for joint scientific consultations

1.   The health technology developer shall submit the dossier of information, data, analyses and other evidence for joint scientific consultation on medicinal products pursuant to Article 21, point (b), of Regulation (EU) 2021/2282 including the list of questions (‘the briefing package’) by means of the template established by the Coordination Group pursuant to Article 21, point (b), of Regulation (EU) 2021/2282 or pursuant to Article 8 of this Regulation through the HTA IT platform.

2.   The deadline to submit the briefing package shall be set in the timetable referred to in Article 4(1). The HTA secretariat shall make available through the HTA IT platform the briefing package complying with the requirements in paragraph 1 to the assessor and co-assessor and the JSC Subgroup.

3.   Where the assessor or the co-assessor considers that further specifications or clarifications or additional information, data, analyses or other evidence are necessary in the briefing package, or that one or several questions submitted by the health technology developer are out of scope of joint scientific consultation, the HTA secretariat shall request the health technology developer to submit an amended briefing package within the deadline set in the timetable referred to in Article 4(1).

4.   Where the assessor or the co-assessor, at any time during the preparation of the draft joint scientific consultation outcome document considers that further specifications or clarifications or additional information, data, analyses or other evidence are necessary, the HTA secretariat shall request the health technology developer to provide such information, data, analyses or evidence within the deadline set by the assessor and co-assessor.

5.   In addition to the rules set out in paragraphs 1 to 4, where the joint scientific consultation on medicinal products is carried out in parallel with the scientific advice, the following shall apply:

(a)

the health technology developer shall submit the briefing package containing the information necessary for the joint scientific consultation on medicinal products and for scientific advice at the same time to the HTA secretariat and the European Medicines Agency, by the deadline set in the timetable referred to in Article 4(1);

(b)

the HTA secretariat and the European Medicines Agency shall exchange their respective requests to submit an amended briefing package, if any, at the same time as they send these requests to the health technology developer;

(c)

the health technology developer shall submit the amended briefing package at the same time to the HTA secretariat and the European Medicines Agency, by the deadline set in the timetable referred to in Article 4(1);

(d)

the HTA secretariat and the European Medicines Agency shall exchange with each other confirmation of receipt of the briefing package referred to in points (a) and (c) at the same time as they send confirmation of receipt to the health technology developer;

(e)

the European Medicines Agency shall notify the HTA secretariat of the validation of the application for scientific advice;

(f)

the HTA secretariat shall notify the European Medicines Agency of the acceptance of the briefing package for joint scientific consultation by the JSC Subgroup;

(g)

the health technology developer shall submit the information, data, analyses or other evidence referred to in paragraph 4 at the same time to the HTA secretariat and the European Medicines Agency.

Article 8 Establishment of the template of the briefing package where the joint scientific consultation is carried out in parallel with the scientific advice

The Coordination Group shall, after consulting and reaching agreement with the European Medicines Agency, establish a specific template of the briefing package to be used where the joint scientific consultation on medicinal products is carried out in parallel with the scientific advice.

Article 9 List of issues to be discussed in the meeting for an exchange of views

1.   After having assessed the briefing package and where applicable the documentation referred to in Article 7(4), the JSC Subgroup, via the HTA secretariat, shall share with the health technology developer the list of issues indicating the topics to be addressed at the meeting referred to in Article 18(7) of Regulation (EU) 2021/2282 and where relevant the specific questions to be addressed only in writing before that meeting (‘the list of issues’). The health technology developer shall provide the JSC Subgroup, via the HTA secretariat, with written responses, if any, to the list of issues as well as any necessary materials or presentations for the meeting at the latest 10 days before that meeting.

2.   In addition to the rules set out in paragraph 1, where the joint scientific consultation on medicinal products is carried out in parallel with the scientific advice, the following shall apply:

(a)

the JSC Subgroup, via the HTA secretariat, and the European Medicines Agency shall send their respective lists of issues to the health technology developer within the deadline set in the timetable referred to in Article 4(1);

(b)

the HTA secretariat and the European Medicines Agency shall exchange with each other the lists of issues on the same day as sending them to the health technology developer;

(c)

the health technology developer shall send to the JSC Subgroup, via the HTA secretariat, a copy of their written responses, if any, to the list of issues provided by the European Medicines Agency at the same time as it sends those responses to the European Medicines Agency;

(d)

the health technology developer shall send to the European Medicines Agency a copy of their written responses, if any, to the list of issues provided by the JSC Subgroup at the same time as it sends those responses to the JSC Subgroup, via the HTA secretariat.

Article 10 Input of individual experts on joint scientific consultation

No later than 30 days after the submission of the amended briefing package referred to in Article 7(3) or, where the joint scientific consultation on medicinal products is carried out in parallel with the scientific advice, no later than 30 days after the validation of the application referred to in Article 7(5), point (e), the JSC Subgroup, via the HTA secretariat, shall share the briefing package with the individual experts selected in accordance with Article 5 and give them the opportunity to provide input on the joint scientific consultation.

Article 11 Consultation of stakeholder organisations during joint scientific consultation

1.   At any time during the joint scientific consultation on medicinal products, the JSC Subgroup, via the HTA secretariat, may seek input on the disease and therapeutic area relevant for the medicinal product from patient organisations, healthcare professional organisations or clinical and learned societies via the members of the stakeholder network established pursuant to Article 29 of Regulation (EU) 2021/2282, whilst respecting the confidential nature of the request for joint scientific consultation.

2.   Where the joint scientific consultation on medicinal products is carried out in parallel with the scientific advice, the HTA secretariat shall share the input referred to in paragraph 1 with the European Medicines Agency at the same time as sharing it with the JSC Subgroup.

Article 12 Meeting with the health technology developer

1.   The following participants shall be invited to the meeting referred to in Article 18(7) of Regulation (EU) 2021/2282:

(a)

the representatives of the health technology developer;

(b)

the assessor and co-assessor;

(c)

individual experts selected in accordance with Article 5;

(d)

other representatives of the JSC Subgroup than the ones listed in point (b);

(e)

the staff members of the HTA secretariat responsible for providing secretariat support to the JSC Subgroup.

2.   In addition to the participants listed in paragraph 1, where the joint scientific consultation on medicinal products is carried out in parallel with the scientific advice, the following participants shall be invited to the meeting referred to in Article 18(8) of Regulation (EU) 2021/2282:

(a)

the coordinators for scientific advice;

(b)

other members of the scientific advice working party of the Committee for Medicinal Products for Human Use than the ones listed in point (a);

(c)

the staff members of the European Medicines Agency responsible for providing secretariat support to the scientific advice working party.

On request from the European Medicines Agency, other experts selected in accordance with the relevant rules of the European Medicines Agency to participate during the scientific advice may be invited to the meeting for an exchange of views.

3.   The meeting referred to in paragraph 2 shall be held virtually. It shall be co-chaired by the assessor or co-assessor for the joint scientific consultation and one of the coordinators for scientific advice.

4.   Before the meeting referred to in paragraph 2, the European Medicines Agency shall send to the HTA secretariat the list of meeting participants who are to be invited to the meeting in accordance with paragraph 2.

Article 13 Joint scientific consultation outcome document

1.   Where, after the submission of the amended briefing package, the health technology developer submits updates related to the amended development plan for the relevant medicinal product, the JSC Subgroup shall ensure that those updates are considered in the outcome document, provided that it receives them no later than 10 days before the meeting referred to in Article 18(7) of Regulation (EU) 2021/2282.

2.   In addition to the rules set out in paragraph 1, where the joint scientific consultation on medicinal products is carried out in parallel with the scientific advice, the following shall apply:

(a)

the health technology developer shall submit the amended development plan referred to in paragraph 1 at the same time to the HTA secretariat and the European Medicines Agency;

(b)

the Coordination Group shall approve the joint scientific consultation outcome document and the Committee for Medicinal Products for Human Use of the European Medicines Agency shall adopt the advice letter to the health technology developer within the deadline set in the timetable referred to in Article 4(1);

(c)

the HTA secretariat and the European Medicines Agency shall exchange with each other the outcome document approved by the Coordination Group and the advice letter adopted by the Committee for Medicinal Products for Human Use on the same day as sending them to the health technology developer.

Article 14 Correspondence during joint scientific consultations

Any documentation referred to in Regulation (EU) 2021/2282 and in this Regulation shall be sent in a digital format and shall be exchanged with and between the Coordination Group, the JSC Subgroup, the HTA Secretariat, the health technology developer and individual experts during joint scientific consultations on medicinal products through the HTA IT platform.

Article 15 Personal data processing

1.   The Commission shall be the controller of the processing of personal data collected for the purpose of conducting joint scientific consultations on medicinal products under this Regulation.

2.   The categories of personal data necessary for the purpose referred to in paragraph 1 are:

(a)

the identity, email address and affiliation of the representatives appointed to the Coordination Group and the JSC Subgroup;

(b)

the identity and email address of individual experts in any of the following cases:

(i)

they are identified as relevant for joint scientific consultation;

(ii)

they are selected to be consulted in a joint scientific consultation;

(iii)

they are consulted in a joint scientific consultation;

(c)

the identity, email address and affiliation of the representatives of health technology developers;

(d)

the identity, email address and affiliation of the representatives of the members of the stakeholder network established pursuant to Article 29 of Regulation (EU) 2021/2282;

(e)

the identity, email address and affiliation of participants involved in the scientific advice referred to in Article 12(2) that are to be invited to the meeting with the health technology developer.

3.   The representatives appointed to the Coordination Group and the JSC Subgroup shall have access only to the parts of the secure system of the HTA IT platform that are relevant for the performance of their tasks. Representatives may collaborate, through the HTA IT platform, with other representatives appointed to the Coordination Group, or the JSC Subgroup to which they belong, for the purposes of conducting joint scientific consultations on medicinal products.

4.   During the meeting referred to in Article 12, patients shall not be obliged to disclose their identity to the health technology developer.

5.   The Commission shall keep the personal data referred to in paragraph 2 only for as long as necessary for the purpose referred to in paragraph 1 and no longer than 15 years after the date on which the data subject no longer participates in joint scientific consultation. The Commission shall review the necessity of storing the personal data every 2 years.

The Commission shall keep the personal data of individual experts not selected to be consulted in a joint scientific consultation only for as long as necessary in order to ensure the relevant in-depth specialised expertise in joint scientific consultation and no longer than 3 years after the date on which the Commission received this data.

Article 16 Entry into force and date of 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.