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Decision No. 2014.0250/dc/sj Of December 10, 2014, Adopting The Rules Of Procedure Of The College

Original Language Title: Décision n° 2014.0250/DC/SJ du 10 décembre 2014 adoptant le règlement intérieur du collège

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JORF n ° 0300 of December 28, 2014
text no 94




Decision No. 2014.0250/DC/SJ of 10 December 2014 adopting the rules of procedure of the college

NOR: HASX1430642S ELI: Not available


The College of the High Health Authority, having deliberated at its meeting on December 10, 2014,
Seen Articles L R. 161-76 and R. 161-77 of the Safety Code Social,
Decides:

Article 1


The enclosed College Rules of Procedure are adopted.

Article 2


The Director of the High Health Authority is responsible for the execution of this Decision, which will be published in the Official Journal of the French Republic.

  • Annex


    APPENDIX
    INTERNAL COLLEGE OF THE HAUTE HEALTH AUTHORITY REGULATIONS ADOPTED BY DECISION NO 2014.0250/DC/SJ OF DECEMBER 10, 2014 TO THE COLLEGE

    • Chapter I: Rules for the College of the High Health Authority (HAS)


      Article I-1
      College Composition


      In accordance with the article L. 161-42 of the Code of Social Security, the College is composed of eight members, including its President, appointed by decree of the President of the Republic. The term of office is six years, renewable once. The college is renewed every three years.


      Article I-2
      Terms of Reference


      I-2.1. The College carries out the tasks defined in Articles L. 161-37 to L. 161-42, L. 162-1-7, L. 162-16-5-2, L. 162-17-2-1, L. 162-17-4, L. 322-3 [3 °], L. 165-1-1 of the Code de la sécurité sociale (CSS) and L. 1151-1, L. 1151-3, L. 1161-2, L. 4011-2 of the code of the Public health (CSP), with the exception of those specific to the committees referred to in Articles L. 5123-3 of the CPMP and L. 161-37 and L. 165-1 of the SSC, in particular:


      -the development of guides for the use of care and Recommendations of good practice (L. 161-3 [2 °] of the CSS);
      -the development of recommendations on the merits and conditions for repayment of a care package or classes of products or benefits (R. 161-71 [3 °] of the CSS);
      -certification of health care facilities (L. 161-37 [4 °] of the CSS);
      -the evaluation of the service expected from the acts with a view to their assumption of responsibility for health insurance (L. 161-37 [1 °] of the CSS);
      -accreditation of the quality of professional practices of physicians and medical teams (L. 161-37 [3 °] of the CSS);
      -the definition of long-term conditions (ALD) and the acts and benefits necessary for their treatment (L. 322-3 [3 °] of the CSS);
      -the analysis, for opinion, of the protocols for cooperation between health professionals (L. 4011-2 of the CSP);
      -the contribution to the quality of actions contributing to continuing professional development (art. L. 161-40 of the CSS);
      -partial or full and derogatory support and for a limited period of products, benefits or innovative acts covered by the expenditure objective referred to in Article L. 162-22-9 (art. L. 165-1-1).


      I-2.2. The College shall adopt its multiannual work programme, in the context of an annual review, pursuant to Articles L. 161-39, R. 161-71 and R. 162-52 of the SSC, as well as its procedures for
      . UNCAM general may refer to the HAS for work in areas other than health product and technology assessment activities, and activities related to the certification of health care facilities or the accreditation of health care providers. Physicians.
      At the sole request of the Ministry of Health, references may Be integrated outside the annual revision of the work programme, their integration which may lead the College to modify its original schedule of work.
      Approved associations of patients and national colleges May suggest work topics to the HAS.
      When the College refuses to include work in its work program, it informs the applicant of the reasons for this refusal.
      I-2.3. The College may delegate some of its powers to the specialised committees which it creates for that purpose and which are chaired by one of its members
      At the President's decision, and pursuant to Article L. 161-41 of the Social Security Code, the College may exercise the powers of the CT, the CNEDIMTS or the EPSO.
      The President shall seek the opinion of the President of the The
      shall be kept informed by the chairmen of the committees, at least once a month, of their programme of work.
      When the College is entrusted with a request for an opinion which normally falls within the scope of the CT, CNEDIMTS or the PSARC, the applicant shall be informed without delay.
      The committee initially concerned shall proceed to the investigation of the case in accordance with the procedure laid down in its rules of procedure and shall adopt a report to the College.
      The report shall be presented to the College by the President of that Committee or, in the event of its inability to act, by one of its Vice-Presidents.
      The College may hear any qualified person or expert whose hearing he considers appropriate.
      After the presentation of the report, possible hearings Experts and debates, the College Deliberates.
      If the file submitted to the College Vote on the reimbursement of a health product, the President shall put to the vote a draft opinion proposing the various motions resulting from the discussions and, where appropriate, the claims of the industrial.
      The draft opinion is sent To the industrial concerned which has a period of eight calendar days at the time of receipt of the said project to make written observations or to request to be heard by the college. At the end of this period, in the absence of written submissions or an application for an industrial hearing, the notice becomes final.
      In the case of written submissions, they give rise to discussion in college
      By the College in accordance with the rules laid down in the rules of procedure of the committee concerned. The hearings give rise to discussion in college.
      After deliberation and vote, the opinion, possibly modified, becomes final.
      I-2.5. The College shall deliberate on the budget, financial management and accounts (Art. R. 161-78 of the CSS).


      Article I-3
      Publication of decisions and opinions


      The decisions and opinions of the College are published on the website of the HAS.
      The decisions referred to in Articles R. 161-76 and R. 161-81 of the SSC are the subject of A publication in the Official Journal of the French Republic.


      Article I-4
      College Meetings


      The College holds:


      -meetings whose number cannot be less than 10 per year, during which decisions and opinions are taken corresponding to the tasks assigned by the law to the HAS;
      -hearing and reflection meetings, which may be Public at the college initiative;
      -exchange meetings with the representatives of ministers and key institutional partners.


      The college meets on convocation, by electronic means, by its president or by Request of half of its members, or at the request of the member of the oldest college Where the Chair is absent or unable to act.
      In the event of the Chair's absence or incapacity, the meeting shall be held under the chairmanship of the oldest member.
      The Director, as well as the staff appointed by him, shall attend meetings College.


      Article I-5
      Agenda


      The agenda for meetings shall be drawn up by the President, on his initiative and on the proposal of the members of the College and the Director.
      In the event of absence or incapacity of the President, The meeting agenda shall be decided by the member of the oldest college.
      Except as a matter of urgency, the agenda of the meetings and the corresponding files shall be sent to the participants by electronic means no later than five days before the meeting.
      Any member may ask the President to include a Or several questions, no later than ten days before the session.


      Article I-6
      Session Organization


      The College can validly deliberate only if at least five members are present.
      However, if a Member on grounds of conflict of interest, this member shall not be taken into account For the determination of the applicable quorum rules.
      However, during the period of renewal of the College provided for in Article L. 161-42 of the SSC, as long as all the members have not been appointed, the College shall deliberate in the presence of the Less than three members.
      If the quorum is not reached, the college is reconvened with the same agenda within a maximum of eight days. It then validates in the presence of at least three members.
      The college can, exceptionally, meet by videoconference. In this case, the college uses a validation of the decision by e-mail.
      Always in an exceptional manner, the college can release by e-mail after sending the working papers and the draft decision or opinion by way of Electronic. The decision or opinion can only be adopted unanimously.
      A member of the college who is unable to attend a session may give another member of the college authority for the subjects on the agenda for that session.
      Each
      The College shall deliberate by a majority of the members present.
      Voting shall take place by show of hands.
      In the event of an equal sharing of votes, the voice of the President shall be paramount.


      Article I-7
      Minutes


      At the end of each deliberative meeting, a Minutes containing:


      -the agenda;
      -account of the debates;
      -details and explanations of vote, including minority opinions.


      Minutes are approved by the College at the sitting
      It is signed by the President of the College and published on the HAS website

    • Chapter II: Rules for the operation of the specialised committees of the High Health Authority


      The High Authority comprises the committees mentioned in the Articles L. 5123-3 of the CPMP (Commission de la transparency), L. 165-1 of the SSC (National Commission for the Evaluation of Medical Devices and Health Technologies) and L. 161-37 of the SSC (Committee on Economic and Public Health Assessment) and Any commission whose college decides the creation (art. R. 161-77 of the CSS).
      The College appoints the Chair, Vice-Presidents and members of the Commission de la Transparency (CT) and the National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDIMTS) in compliance Articles R. 163-15 and R. 165-18 of the CSS.
      It shall adopt the composition, appoint the President, and, where appropriate, the Vice-Presidents, and shall determine the general rules of operation of the Economic and Public Health Evaluation Commission (CEESP) and the specialized commissions it creates.


      Article II-1
      Specialized commission list and missions


      II-1.1. In addition to the three committees mentioned in Articles L. 5123-3 of the SSC, L. 161-37 and L. 165-1 of the SSC, the HAS consists of the following committees:


      -the Health Facilities Certification Commission;
      -the Committee on Support policies;
      -the Professional Care Paths and Practices Commission.


      II-1.2. Specialized commission missions.
      1. The Transparency Commission (TB) shall carry out the tasks defined in Articles R. 163-18 et seq. Of the CSS, in particular:


      -give an opinion on the appropriateness of the registration and renewal of drug registration, as well as the modification of the conditions of entry on the list referred to in Article L. 162-17 of the CSS;
      -propose The listing of drugs on the list referred to in Article L. 5123-2 of the CPMP; and
      -provide advice on the maintenance of the listing of all drugs of the same pharmaco-therapeutic or therapeutic class on the lists Referred to in Articles L. 162-17 of the SSC and L. 5123-2 of the CPMP;
      - Recommendations to prescribers on the proper use of drugs.


      It is also the mission's mission to prepare the advice of the HAS referred to in articles L. 161-39, L. 162-1-7, L. 162-16-5-2, L. 162-17-2-1, and L. 165-1-1 of the CSS and L. 1151-1 of the CSP, including:


      -on any repository project submitted by the UNCAM (art. L. 161-39 of the CSS);
      -on the existence of therapeutic alternatives to certain medicinal products benefiting from temporary authorisation of use (art. L. 162-16-5-2 of the CSS);
      -on the waiver of medicinal products subject to a temporary recommendation for use (art. L. 162-17-2-1 of the CSS);
      -on the conditions for the recording of an act of biology or imaging provided for in the marketing authorisation of a medicinal product on the list referred to in Article L. 162-1-7 of the SSC and on their deletion from that list List (section R. 161-71 [1 °, a] and R. 162-52-1 of the CSS).


      2. The National Commission for the Evaluation of Medical Devices and Health Technologies (CNEDIMTS) exercises the tasks defined in Articles L. 165-1, L. 165-11, R. 165-11, R. 165-11-1, R. 165-13, R. 165-21, R. 165-22, R. 165-25 of the SSC, in particular:


      -give an opinion on the merits of registration, renewal and modification of the conditions of registration, on the list referred to in Article L. 165-1 of the CSS, individual medical devices, fabrics and Cells derived from the human body, and health products other than drugs;
      -provide advice on any matter affecting the care, conditions of prescription and use, and technical specifications for Products or services provided for in Article L. 165-1 of the CSS (Article R. 165-21 of the CSS), The re-evaluation, with a view to their renewal, of all the generic descriptions (Articles R. 165-3, R. 165-10-1 of the CSS);
      -give an opinion on medical devices belonging to a homogeneous category of products for That this assessment is required with a view to their inclusion on the list referred to in Article L. 165-11 of the SSC enabling them to be used by health care institutions and their assumption of sickness insurance in benefits Hospitalization;
      -establish and disseminate the information documents referred to in Article R. 165-22 of the CSS.


      It also has the task of preparing the opinions of the High Authority referred to in Articles L. 161-37, L. 161-39, L. 162-1-7, L. 162-17-2-1, L. 165-1-1 of the SSC and Article L. 1151-1 of the CSP, in particular:


      -health technology assessment studies (CSS Article L. 161-37);
      -the conditions for the registration of an act or benefit and their inclusion on the list referred to in Article L. 162-1-7 of the SSC, as well as their Delisting (article R. 161-71 [1 °, a] and article R. 162-52-1 of the CSS), with the exception of the acts of biology or imaging provided for in the marketing authorisation of a medicinal product;
      -the framework for the practice of acts, Diagnostic or therapeutic methods, techniques and methods, as well as Prescription of certain medical devices requiring specific supervision for reasons of public health or which may result in unjustified expenditure (Article L. 1151-1 of the CSP).


      3. The Committee on Economic Evaluation and Public Health (CEESP) carries out the tasks defined in the fourteenth paragraph of Article L. 161-37 of the CSS:


      -establishing and disseminating medico-economic recommendations and opinions on the strategies of The most efficient care, prescribing or management referred to in Article L. 161-37 of the CSS, and in particular to issue an opinion on the efficiency of health products.


      It also has the task of preparing the deliberations Of the College concerning:


      -the opinions referred to in Article L. 161-40 of the SSC on the list of regular preventive medical consultations and screening examinations implemented in the framework of the health programmes referred to in Article L. 1411-6 of the CSP;
      - The evaluation of the quality of public health care, referred to in Article L. 161-40 of the SSC, concerning the quality and effectiveness of prevention activities or programmes, in particular health education, of Diagnosis or care;
      -notices of cosmetic acts, including implementation Presents a serious danger or a suspicion of serious danger to human health (Article L. 1151-3 of the CSP).


      It carries out the methodological work that is useful in carrying out the HAS missions in its field of competence.
      4. The Committee on Management Strategies, in coordination with the three regulatory committees involved in the evaluation of health products, has the task of preparing the deliberations of the College on the strategies of Support, including recommendations:


      -proposed to health professionals or public authorities in terms of good practice or organization of care;
      -on the proper use of health products and their efficiency.


      On the basis of the work of the Services, hearings of experts or stakeholders, and, where appropriate, its own contribution, it shall give an opinion on:


      -the method of development and content of the recommendations;
      -actions by promoting impact;
      -the complementary perspectives that can be proposed to the college of HAS.


      5. The Committee on Practices and Routes is responsible for preparing the deliberations and opinions of the College concerning:


      -guides, tools and methods for improving the quality of care and patient safety, including in the care pathways of people with chronic diseases and new technologies ;
      -strategies for disseminating and integrating this work into professional practice;
      -physician accreditation;
      -validation of continuing professional development methods;
      -cooperation protocols between Health care professionals;
      -guides, methods, and tools Therapeutic education of the patient, including the evaluation of therapeutic education programs for patients authorized by the regional health agencies.


      6. The Committee on the Certification of Health Care Facilities is responsible for preparing the deliberations of the College concerning:


      -the procedure for certifying health care facilities;
      -the guidelines, tools, procedures, and monitoring of the certification procedure for health care institutions, both public and private;
      -the decisions of Certification of health care facilities;
      -definition of hospital quality and health care indicators.


      In addition to the missions defined above, each of the specialized committees may be assigned by the College Any work, study or consultation that it considers relevant to the preparation of its
      The CT, the CNEDIMTS and the PSARC report to the College, at least once a quarter, of their activity.


      Item II-2
      Composition of Commissions


      II-2-1. Composition of the CT and the CNEDIMTS
      The composition of the TC and the NEDIMTS is set out in sections R. 163-15 and R. 165-18 of the CSS.
      II-2-2. Composition of the ECESP and the committees established by the College
      The PSARC, the Committee on the Certification of Health Care Institutions, the Committee on Management Strategies and the Committee on Practices and Paths include a President who is a member of the College, one or two Vice-Presidents and at least five permanent members and, where appropriate, alternates, all appointed by the College.
      The President of the Treasury Board shall be Vice-President, Law of the Committee on Support policies.
      Members are appointed for a term of three years Renewable twice. On an exceptional basis, members may be extended for a period of up to six months.
      In the event of a vacancy in the seat of a member of a committee, for any reason, or for repeated absence, A new appointment, under the same terms and conditions, for the remainder of the term of office.
      The President may appeal to any competent person whose contribution is deemed to be useful, in particular to collaborators external to the HAS, for Ad hoc missions.
      Representatives of ministers responsible for health and health Social security may attend meetings of specialised committees (art. R. 161-77 [2 °] of the CSS).
      Any member of the college can attend the meetings of the various commissions.


      Article II-3
      How Commissions


      II-3-1. How the TB and the CNEDIMTS work.
      The rules for the operation of the TC and the CADTH are set out in sections R. 163-16, R. 163-17, R. 165-19 and R. 165-20 of the CSS.
      II-3-2. Functioning of the ECESP and the committees established by the College.
      The College shall define the rules of procedure of the PSARC and each of the specialised committees it creates.
      The rules of procedure shall specify in particular:


      -the rules for the agenda and the convening of the committee;
      -the rules for the organization of meetings;
      -the quorum and majority rules for the adoption of opinions, proposals or recommendations ;
      -the procedures for reporting the work.


      Each chair determines the order of the committee's work and sets the schedule for meetings.
      In the event that the chair is absent or unable to act, the committee entrusting the committee Care to preside over the session to a Vice-Chair, if there is one named, or another Member of the Commission.
      It is established, after each meeting, a statement of the decisions or orientations taken by the committee. This statement is signed by the chairman of the committee and published on the HAS website

    • Chapter III: Deontology


      Members of the College comply with the provisions set out in the Guide to Declarations of Interest and Management Conflicts of interest as well as in the charter of ethics
      In accordance with Chapter 1 of Decree No. 2014-90 of 31 January 2014, any member of the college who considers himself in a conflict of interest shall inform the President in writing as soon as he has Knowledge of this situation or, at the latest, at the beginning of the session The
      shall inform the other members of the College without delay of any conflicts of interest he or she is aware of, or of any conflict of interest.
      The member of the College who decides to abstain shall not No meetings or opinions in relation to the deliberation at issue.
      When a member fails to sit on the basis of a conflict of interest, the minutes of the meeting are referred to in the minutes of the meeting

    • Chapter IV: Miscellaneous provisions


      Article IV-1
      Publication and dissemination of the rules of procedure of the College


      The rules of procedure will be published in the Official Journal of the French Republic.
      It is available on the website of the High Health Authority.


      Article IV-2
      Amendment of the Rules of Procedure


      The rules of procedure may be amended by the College, By a decision adopted by at least five of its members.


      Article IV-3
      Entry into force of the rules of procedure


      The rules of procedure shall enter into force the day following the decision of the College


    December 10, 2014.


    For College:

    The President,

    J.-L.
    network


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