Guidance for national early dialogues on medicinal products

In accordance with article L. 161-37 of the French Social Security Code (CSS), one of HAS mission is to organise early dialogues with companies developing innovative medicinal products or other technologies that have a new mechanism of action, are targeting an insufficiently covered medical need and if the request is submitted before the start of pivotal clinical trials.

The objective of these early dialogues (ED) is to provide companies with recommendations on the last development phase (pivotal study/studies) and support generation of good quality evidence for proper Health Technology Assessment (HTA). 

This guidance highlights ideal timelines and actions for each party undertaking a national early dialogues (i.e., consultations with HAS departments only) for a medicinal product before the start of the pivotal trial(s). Please contact the dedicated secretariat (contact.rp@has-sante.fr) should you have any question related to this procedure. 

For an early dialogue with the EUnetHTA network, in collaboration with other European HTA agencies and/or in parallel with the European Medicines Agency (EMA), please refer to the EUnetHTA guidance or contact the ED secretariat (eunethta-has@has-sante.fr). If HAS participates in an early dialogue in collaboration with other European HTA agencies and/or in parallel with the EMA, the procedure will not be duplicated on a national level. 

General principles

Early dialogues are optional, confidential and not binding for either HAS or the pharmaceutical companies. The recommendations provided by HAS departments reflect the state-of-the-art of medical knowledge and national requirements at the time of the early dialogue. Therefore, they do not constitute an appraisal and are not an indicator of the final appraisals reached by the Transparency Committee (CT) and/or the Commission for Economic and Public Health Evaluation (CEESP) based on future submission dossier.

During these early dialogues, HAS answers medical and medico-economic questions raised by pharmaceutical companies regarding draft protocols for pivotal studies (generally phase III trials) in accordance with HTA methods and current clinical guidelines. 

Discussions and documents submitted during these national early dialogues can be in English, at the request of the pharmaceutical company seeking the early dialogue. 

Confidentiality and conflict of interest management

In accordance with article R.161-84 of the CSS and HAS code of ethics, HAS staff are obliged to maintain professional secrecy. This obligation guarantees confidentiality of all the information submitted by the Applicant. No additional confidentially agreement will be signed by HAS. HAS staff participating in these early dialogues have no conflicts of interest in relation to the technology assessed.

Experts and patients who may be involved in this early dialogue at the request of HAS, are also obliged to maintain professional secrecy in accordance with article L. 1451-1 of the French public health code and HAS code of ethics. They are selected after an internal evaluation of their declaration of interest and if no conflict of interest in relation with the technology assessed is observed.

Experts participating in these early dialogues will not be able to participate in the future assessment and appraisal process. Moreover, members of appraisals committees (CT and CEESP) can not participate in these early dialogues.
When submitting an early dialogue request, the Applicant agrees to share HAS final written recommendations with an external medical editor subject to the same confidentially rules.

Procedures

Early dialogues can be organised following a standard procedure (with a face-to-face meeting) or an accelerated procedure (without a face-to-face meeting), as defined hereafter. The timelines including the date of the face-to-face meeting, depends on the submission date, in accordance with the early dialogues calendar published on HAS website. The early dialogue’s step and calendar are detailed below, depending on the procedure defined by HAS.