In view of the Social Security Code and particularly articles L. 172-17-3, L.162-16-1, L. 162-17-4 and L. 138-10, R. 162-20 to R. 162-20-3 and R. 163-6 to R. 163-10, D. 162-2-3 to D. 162-2-7.
Whereas the present interior regulation exclusively concerns the activities of CEPS in relation to drugs and that it will therefore be revised to take into account the new missions conferred by law on the Committee in the field of medical devices…
a) Secretary General and Committee services
The Secretary General is responsible for the satisfactory functioning of the services of the Committee. He is particularly vigilant regarding the legal standing of the acts of the Committee, in the conduct of procedures and in adhering to deadlines. He negotiates with companies on these issues. He prepares the decisions of the President relative to the naming of rapporteurs and the compilation of the session agenda. He organises the work of the services of the Committee, with the exception of that of the general rapporteur. He prepares in liaison with the competent administrative authorities, decisions relative to the management of credits opened in the name of the Committee.
b) General reporter
The general reporter is responsible for the preparation of the Committee’s annual report and, more generally, reports and information forwarded by the Committee to relevant ministers. He is vigilant with regard to formalization and adherence to the Committee’s policy and proposes the means of ensuring its distribution to companies.
c) President and Vice-President
The agendas of the President and Vice-President are made available to other members, rapporteurs and agents with Committee functions by the Secretariat such that they might be informed, particularly of planned meetings with company staff and asked if they would like to be involved.
Candidates for the function of rapporteur, who are not permanent state employees, a Public Body, or an obligatory health insurance body, must give their agreement to the Committee not to seek or to obtain employment in the Pharmaceutical Industry during the exercise of these functions or during the two-year period following cessation of these functions.
a) Dossier registration
All dossiers forwarded to the Committee are subject to registration and an acknowledgement of receipt. The Secretary General of the Committee continuously keeps up-to-date non-finalized dossiers submitted by companies, with information for each of them of the deadline of the prescribed regulation, depending on the type of dossier and the texts in force. It ensures furthermore that re-registration dossiers have been submitted by companies at the date set out by the regulations.
b) Allocation of dossiers to rapporteurs and the preparation of reports
The rapporteur is designated from the time of submission of the dossier by the company or on the initiative of the company, following the discussions of the Committee. However, for dossiers that require an approval from the Transparency Commission, the rapporteur is only in contact with the company concerned after forwarding of the approval to the Committee.
Reports are compiled in accordance with one of the examples of the plans given in the appendix to the present regulation. The Secretary General fixes the deadline for the delivery of the reports and checks on the status of dossiers entered on the agenda.
When a dossier has already been entered on at least one occasion on the Committee’s agenda, and is subject to further examination, the rapporteur puts together a summary sheet recapitulating in particular the preceding proceedings of the Committee and their motives as well as, if needs be, the subsequent suggestions of the company.
c)The distribution of information between members of the Committee
Dossiers submitted by companies are forwarded to members of the Committee at the time of their deposition. The agenda, the reports and the documents required for the examination of the points entered on the agenda are forwarded to the members of the Committee at least seven days before the session. If this time period is not adhered to, any member of the Committee can obtain the report of the corresponding debate at the following session.
d) Relations with companies
For the investigation of specific dossiers relating to a drug or to a company convention, contacts with the company are prioritised by the rapporteur and then by the President or the Vice-President. If the other members of the Committee have a bilateral contact with companies on subjects entrusted to a rapporteur, he/she will immediately be informed of it.
a) Session dates
Committee sessions take place every Thursday and commence at 9 am. It is not subject to a written notification. The day or the time of the session can be modified or a supplementary session added on the decision of the President after consultation with the Committee.
The agenda consists of three parts :
Part A is given over to all questions other than the examination of dossiers relating to a drug to a company ;
Part B is given over to the examination of specific drug dossiers or to a company other than those examined in Part C ;
Part C is given over to the examination of specific drug dossiers treated in accordance with the simplified procedure described in d) below.
All members of the Committee can put a point on the agenda within a minimum time period compatible with the information or the preliminary consideration of other members on the point proposed.
c) Attendance at Committee sessions
Those permitted to attend the Committee’s sessions :
Members with voting rights. These can be accompanied by anyone of their choice under their authority ;
With consultative powers, if need be, persons designated in article D. 162-2-3-II of the Social Security Code ;
The Secretary General and the general rapporteur of the Committee as well as, on the agreement of the President, any agent in the service of the Committee the presence of whom is necessary for the satisfactory progress of the session.
The rapporteurs, in the case of the dossiers for which they are responsible, as well as, at their request and with the agreement of the President, in respect of the other points in Part B of the agenda for which their assistance in the discussions of the Committee is useful to the exercise of their functions.
d) Report and discussion
The points given in Part B of the agenda are added verbally by the rapporteur. The session President then gives permission to those members who wish to speak. The rapporteur assists in the discussion and answers questions from members of the Committee. The session President can consult with the Secretary General, the General Rapporteur as well as any agent in the service of the Committee taking part in the session, particularly on questions of Committee law, procedure or doctrine.
Entered in Part C of the agenda are dossiers which the President believes can be processed by means of a single written report of the rapporteur, without a preliminary verbal presentation. These are mainly certain re-registration dossiers as well as registration dossiers or relating to generic drug price changes or basically drugs similar to a drug which is already registered. The rapporteur is not allowed to participate in the session. Insofar as is possible, it is taken directly to a vote.
The hearings set out in article 162-2-4 of the Social Security Code are determined by the Committee. Company hearings are determined by the President, on his/her initiative or at the request of the company in question. When a company with an agreed hearing decides to bring with it an expert who is not an executive employee, the latter is nevertheless considered to speak in the name and on behalf of the company.
This constitutes a decision within the meaning of the present interior regulation resulting from a deliberation of the Committee in a matter in which the law and its regulation grant it competence, whether an actual decision, a ministerial opinion, a convention proposition or amendment, the acceptance or the refusal of a convention proposition or an amendment drawn up by a company or the decision to postpone a decision.
For the points entered in Parts B and C of the agenda, a vote is only taken on decision projects justified and drawn up in session.
For the application of article D. 162-2-6 of the Social Security Code, voting is expressed by yes, no, abstention or objection. The objection must be clearly justified.
The minutes relating to each decision taken in Part B or C of the agenda are prepared and approved forthwith at the same time as a vote is taken on this decision.
The minutes of each session are given to members at the time of the following session and formally submitted for the approval of the Committee one week later.
Furthermore, a register is kept of the questions entered in Part A of the agenda. An outcome given during the proceedings of the Committee on these questions is forwarded to it at least once a month.
h) Debate and voting confidentiality
The members of the Committee, the rapporteurs, agents in the service of the Committee and all other persons assisting in the session are subject to professional secrecy regarding the conduct of the debates, the meanings of the decisions of the Committee, the votes given by each member as well as, generally speaking, any other document or information of which they are aware, as a result of their participation in the session. This secrecy is not an impediment to informing other senior authority members, these then being subject to the same requirement.
Information on the decisions of the Committee is normally ensured by regulatory publications or through letters addressed to companies. The Committee can however mandate the rapporteur, President or Vice-President to ensure an immediate and verbal supply of information to the companies concerned. In this case it up to the representative to ensure the accuracy of the contents of the information passed on.
a) Company information
Within one week following Committee proceedings on a point entered in Parts B and C of the agenda, a letter is forwarded to the company in question to inform it of the result and the reasons for the proceedings. This letter is accompanied, if applicable, with the corresponding convention project or amendment, in duplicate.
b) Signatures and publications
The Secretary General of the Committee arranges the signature of the conventions and amendments, looks after, if applicable, the preparation of decrees or decisions submitted for signature to the competent ministers as well as the regulatory publications.
c) Disagreement reports
When the Committee, taking note of the absence of an agreement with a company, particularly on expiry of a set time, fixed, if applicable, by regulation, has to propose to competent ministers the signing of a decree or the notification of a registration or re-registration refusal, it first informs the company of this proposal.
d) Update of conventions
The Secretary General of the Committee looks after, in liaison with the companies concerned, the regular update of conventions lasting several years and concluded through the application of article L 162-17-4 of the Social Security Code and particularly appendices to these conventions in relation to the list of reimbursable drugs and to the directory of clauses applicable to these drugs.