Bill n.630
SENATE OF THE REPUBLIC
———– XIV LEGISLATURE ———–
No. 630
BILL OF LAW
on the initiative of Senator TOMASSINI
COMMUNICATION TO THE PRESIDENCY ON 18 SEPTEMBER 2001
———–
Regulation on scientific information: establishment of the Guarantor Authority and of the Register of scientific representatives of the drug
———–
Honorable Senators. – This bill intends to regulate some specific aspects of the scientific information of medicines, in harmony with the provisions of the legislative decree 30 December 1992, n. 541, which transposed directive 92/28/EEC concerning the advertising of medicines.
Given the importance of scientific information, which represents the fundamental element for guaranteeing correct prescription by doctors, and therefore the protection of public health, the text that I submit for your approval establishes the Authority for scientific information with the task, among other things, of supervising the information activity of companies and of defining a code of ethics.
As a further guarantee, the establishment of the Register of scientific representatives is also proposed.
The fundamental objectives of the bill are therefore those of further regulating scientific information, of making it compliant with rigorous deontological principles, of verifying the behavior of operators in the drug sector through inspections by means of a special inspection body headed by the Guarantor Authority itself.
The establishment of the National Register and the related Regional Commissions are entrusted with further supervisory activities as well as the promotion of initiatives aimed at the cultural progress of drug sales representatives.
The substantial elements of section I of the articles concerning the establishment of an Authority guaranteeing medical-scientific information are described below (Articles 1 to 7).
Article 1 establishes, with a decree of the President of the Republic, on the proposal of the President of the Council of Ministers, the Authority for medical-scientific information, with headquarters in Rome.
Article 2 defines the Authority's responsibilities, including that of developing and updating a code of ethics and verifying compliance with it by operators.
Article 3 introduces the possibility of using state bodies (Anti-adulteration unit and finance police) for institutional purposes.
Article 4 lists the bodies of the Authority: President, General Manager, Board of Directors, Inspection Body, I and II degree Deontological Commissions.
Article 5 obliges the Authority to prepare and submit, by 31 January of each year, a report on its activities to the Prime Minister, the Minister of Health and the Parliament.
Articles 6 and 7 respectively concern the issue by the Minister of Health of a specific regulation and the internal regulation of the Authority.
Section II concerns the establishment of the Register of drug sales representatives (Articles 8 to 30).
Article 8 refers to the existing national and Community provisions on scientific information.
Article 9 establishes the requirements and duties of scientific representatives. Article 10 obliges whistleblowers to maintain professional secrecy.
Article 11 establishes in each region the Regional Commission for the register of scientific representatives.
Article 12 and Article 13 concern the composition of the Commission and its bodies.
Article 14 lists the tasks of the Regional Commission.
Article 15 identifies the functions of the president of the regional commission and of the vice president.
Article 16 introduces the Board of Auditors for each Regional Commission.
Article 17 establishes the National Register of drug sales representatives.
Article 18 describes the National Commission of the National Register, specifying its composition.
Article 19 lists the powers of the National Commission.
Articles 20 and 21 contain provisions on the term of office and the eligibility requirements of the members of the Commission.
Article 22 defines the information and characteristics of each member of the National Register and the Regional Register.
Article 23 describes the requirements for registration in the Register of scientific representatives.
Article 24 lists the cases in which cancellation from the Register is envisaged, while article 25 defines the conditions for readmission.
Article 26 provides that the list of members of the National Register must be filed annually by the National Commission to the Directorate for the Evaluation of Medicinal Products and Pharmacovigilance.
Article 27 concerns the headquarters of the National Register.
Article 28 concerns the transitional rules for registration in the national and regional register.
Article 29 establishes that the charges relating to the maintenance of the National Register and the Regional Registers are to be borne by the members.
Article 30 provides for the Government to issue an implementing regulation within three months of the date of publication of the law in the Official Gazette.
I hope that this proposal can be approved as quickly as possible in order to improve the activity of scientific information in our country and to make it increasingly adherent to scientific and ethical criteria.
BILL OF LAW
Section I
CONSTITUTION OF AN INFORMATION GUARANTEE AUTHORITY
MEDICAL-SCIENTIFIC
Article 1.
(Establishment of the Authority)
1. The Authority for medical-scientific information, hereinafter referred to as the "Authority", with headquarters in Rome, is established by decree of the President of the Republic, on the proposal of the President of the Council of Ministers, in agreement with the Minister of Health.
2. The Authority has financial, hierarchical and functional autonomy and is subject to the supervision of the Ministry of Health.
3. The Authority may set up decentralized offices in the regional capitals for the purposes of the optimal exercise of the inspection activity.
Article 2.
(Competencies of the Authority)
1. The Authority is responsible for:
a) verify that the medical-scientific information of companies is carried out in compliance with current legislation;
b) to monitor, in particular, the activity of pharmaceutical sales reps on the national territory;
c) develop and periodically update, in agreement with the medical and pharmaceutical industry associations, a code of ethics relating to the activity of medical-scientific information;
d) verify compliance with the code referred to in letter c) in the conduct of companies and pharmaceutical sales reps;
e) set up an inspection body with the function of ascertaining the compliance of the conduct of companies and pharmaceutical sales reps with the legislation in force and with the code referred to in letter c);
f) impose administrative and pecuniary sanctions on scientific representatives, in the event of ascertaining violations of the law or ethically incorrect conduct, without prejudice to the obligation to notify the Ministry of Health and the judicial authority of cases in which it is ascertained or suspected that the administrative or criminal violations of current legislation have been violated;
g) monitor the evolution of the regulations and ethical codes that regulate the information activity in the countries of the European Union and in the other more industrialized countries, comparing them with the Italian situation;
h) propose to the Minister of Health amendments to the regulations on medical-scientific information, in relation to the evolution of the Italian and international situation.
Article 3.
(Possibility of using State Bodies for institutional purposes)
1. The Authority, for its institutional purposes, may use, in addition to the members of the inspection body referred to in article 4, paragraph 1, also the anti-sophistication unit and the finance police.
Article 4.
(Bodies of the Authority)
1. The following are organs of the Authority:
a) the President of the Authority, appointed by the President of the Council of Ministers on the proposal of the Minister of Health, who has the legal and political responsibility of the Authority and imposes the sanctions;
b) the Director General, appointed by the President of the Authority after hearing the opinion of the Governing Council referred to in letter c) of this paragraph, who is responsible for internal organisation;
c) the Governing Council, made up of seven members appointed by the Minister of Health, of which two on a proposal from the regions and two on a proposal, respectively, from the order of doctors and from the pharmaceutical industry association, which defines and proposes the lines of activity to the President;
d) the Inspection Body, appointed by the President, on the proposal of the Director General, having consulted the Governing Council;
e) the First Instance Ethics Commission, appointed by the President, on the proposal of the Director General, having consulted the Governing Council, which examines the infractions and imposes sanctions;
f) the Second Instance Deontological Commission, appointed by the President, on a proposal from the Director General, having consulted the Governing Council, made up of three members chosen from the ordinary or retired administrative Judiciary, which judges on any appeals.
2. The President, the Governing Council and the Deontological Commissions remain in office for five years and their members cannot be re-elected immediately. The Minister of Health, in exercising his supervisory power over the Authority, may propose to the President of the Council of Ministers, suitably motivating it, the revocation of the President's mandate, even before the normal deadline.
Article 5.
(Annual report on the Authority's activity)
1. By 31 January of each year, the Authority draws up a "report" on the activity carried out in the previous year and forwards it, signed by the President, to the Presidency of the Council of Ministers, to Parliament and to the Minister of Health.
Article 6.
(Regulations)
1. Within three months from the date of entry into force of this law, the Minister of Health issues a regulation which establishes:
a) the general guidelines of the Authority's operational structure;
b) the characteristics of the inspection body;
c) the type of sanctions payable by the Authority.
2. Within three months from the date of entry into force of this law, the Minister of Health, in agreement with the Minister of Economy and Finance, issues a regulation which establishes the methods of financing the Authority.
Article 7.
(Internal regulation of the Authority)
1. Within three months from the date of issue of the regulation referred to in article 6, paragraph 1, the President of the Authority, on a proposal from the Director General, having heard the Governing Council, approves the internal regulation which establishes the organizational chart, functions and responsibilities relating to the structure of the Authority itself.
Section II
ESTABLISHMENT OF THE REGISTER OF SCIENTIFIC INFORMANTS
OF THE DRUG
Article 8.
(Regulatory provisions)
1. The regulatory provisions and definitions relating to scientific information on drugs are those established by the legislative decree of 30 December 1992, n. 541, and subsequent amendments, implementing directive 92/28/EEC, concerning the advertising of medicines for human use.
Article 9.
(Requirements and duties of the informant
drug science)
1. The scientific representative of the drug must be in possession of the appropriate qualification as per legislative decree 30 December 1992, n. 541, and subsequent amendments, must be registered in the National Register referred to in article 17 and must carry out scientific information activities with doctors, according to company directives and in compliance with current legislation, illustrating to them the pharmacological, tolerability and therapeutic characteristics of the drugs, as well as the related pathologies of reference, in order to ensure their correct use and the possibility of disbursement at the expense of the National Health Service.
2. It is the duty of the scientific representative to communicate, pursuant to article 9, paragraph 6, of the aforementioned legislative decree n. 541 of 1992, to the head of the scientific service referred to in article 14 of the legislative decree itself, the observations on the medicinal specialties that the operators report, guaranteeing a constant exchange of information between doctors and companies.
Article 10.
(Professional secret)
1. Pharmaceutical representatives are required to respect the professional secrecy of the information provided to them by the companies for which they work, as well as by other healthcare operators.
Article 11.
(Regional Commission of the Register of scientific representatives of the drug)
1. In each region, the Regional Commission of the Register of Scientific Representatives of the drug, hereinafter referred to as the "Regional Commission" is established.
2. The scientific representatives of the drug residing in the region are entered in the regional register referred to in paragraph 1.
Article 12.
(Election and composition of the Regional Commission)
1. For each region, the Regional Commission is elected by the Assembly of members of the Regional Register, by majority vote and secret ballot.
2. The Regional Commission referred to in paragraph 1 is made up of nine scientific representatives of the drug, who have at least five years of activity actually carried out.
Article 13.
(Bodies of the Regional Commission)
1. The Regional Commission elects a president, a vice president, a secretary and a treasurer within its ambit.
Article 14.
(Attributions of the Regional Commission)
1. The Regional Commission has the following powers:
a) take care of the maintenance of the Regional Register of scientific representatives of the drug;
b) ensure compliance with the provisions of the law and with all other provisions concerning scientific information on the part of the members;
c) supervise for the protection of the drug sales representative through any activity aimed at repressing the abusive exercise of the profession;
d) promote and encourage all initiatives aimed at the cultural progress of the members;
e) collaborate with the public and private bodies of the region operating in the drug sector, in the study and implementation of the provisions inherent to the activity of drug sales reps;
f) propose the budget and the final account for approval by the Assembly of members of the Regional Register;
g) designate their own representatives in the National Commission referred to in Article 18.
Article 15.
(Duties of the President and the Vice-President)
1. The President of the Regional Commission convenes and presides over the Members' Assembly and exercises the other powers conferred on him by law.
2. The vice president replaces the president in case of absence or impediment and performs any functions delegated to him.
Article 16.
(Board of Auditors)
1. Each Regional Commission has a board of auditors, made up of three members, which controls the management of the funds and verifies the budgets prepared by the Commission, reporting them to the Assembly.
Article 17.
(National register of whistleblowers
drug scientists)
1. The National Register of drug sales representatives is established. All those who carry out or intend to carry out the scientific information activity referred to in article 9 and who meet the requirements established by this law must be registered in the National Register.
Article 18.
(National Commission)
1. The National Register is kept by a National Commission elected by the Assembly of members by majority vote and secret ballot.
2. The National Commission referred to in paragraph 1 is made up of:
a) three members chosen from among the drug sales representatives registered in the national register who have carried out five years of effective activity as drug sales representatives, upon designation by the regional commissions referred to in article 12;
b) a representative for each regional commission.
3. The National Commission set up pursuant to paragraph 2, elects from among its members the president, the vice president, the treasurer and the secretary who make up the Executive Committee.
4. The National Commission evaluates the applications presented to the Regional Commissions and proceeds with the registration in the National Register of scientific representatives of the drug. Registration in the National Register determines the simultaneous and automatic registration in the Regional Registers. The National Commission also provides for the updating of the National Register and has the powers referred to in article 19.
5. The National Commission provides for a board of auditors, made up of three members, which controls the management of the funds and verifies the budgets. The auditors are elected by the members' assembly by majority vote of the members and by secret ballot.
Article 19.
(Attributions of the National Commission)
1. The National Commission referred to in article 18 has the following powers:
a) to protect the category of pharmaceutical sales reps;
b) coordinate and promote cultural activities to encourage initiatives aimed at improvement and professional development for qualified and scientific information;
c) expressing an opinion, when requested, on draft laws and regulations concerning the information service on medicines and the activity of scientific informant on medicines;
d) update the national register of drug sales representatives registered in the regional registers;
e) transmit annually to the Ministry of Health, Directorate for the Evaluation of Medicinal Products and for Pharmacovigilance, the list of those registered in the National Register, in accordance with the provisions of article 26;
f) determine the extent of the annual fees due by members;
g) promote, organize and supervise professional training courses for drug sales representatives registered in the national register, in collaboration with the Minister of Health and the University. The execution of these courses and the related programs are communicated in advance to the Ministry of Health, which provides the indications and guidelines required to give homogeneity to these initiatives.
Article 20.
(Duration of offices)
1. I componenti di ciascuna Commissione regionale e quelli della Commissione nazionale durano in carica tre anni e sono rieleggibili per non più di due mandati consecutivi.
Article 21.
(Eleggibilità)
1. Sono eleggibili alle cariche di cui all’articolo 20 tutti gli informatori scientifici del farmaco iscritti al Registro sia nazionale sia regionale, che abbiano svolto cinque anni di effettiva attività quali informatori, purché non sussistano per essi i divieti previsti dalla presente legge.
Article 22.
(Dati del Registro)
1. Il Registro, sia regionale sia nazionale, contiene oltre al nome e cognome, il luogo e la data di nascita, la residenza, il titolo di studio, l’azienda per la quale viene svolta l’attività, il tipo di contratto secondo il quale è fornita la collaborazione.
Article 23.
(Requisiti)
1. Per l’iscrizione al Registro degli informatori scientifici del farmaco sono necessari i seguenti requisiti:
a) cittadinanza italiana o di un paese membro dell’Unione Europea ovvero cittadinanza di un paese extraeuropeo, purché il richiedente abbia la residenza nel territorio della Repubblica Italiana;
b) enjoyment of civil rights;
c) possesso del titolo di studio di cui al decreto legislativo 30 dicembre 1992, n. 541, e successive modificazioni.
Article 24.
(Cancellazione)
1. La Commissione nazionale adotta il provvedimento di cancellazione dal Registro, sia nazionale sia regionale, nei confronti dell’informatore scientifico del farmaco nei seguenti casi:
a) perdita del godimento dei diritti civili;
b) condanna penale;
c) cessazione dell’attività professionale da almeno cinque anni.
Article 25.
(Riammissione)
1. L’informatore scientifico del farmaco cancellato dal Registro, sia nazionale sia regionale, può, a sua richiesta, essere riammesso quando siano cessate le ragioni che hanno determinato la cancellazione.
2. Se la cancellazione dal Registro sia nazionale sia regionale, è avvenuta a seguito di condanna penale, la domanda di nuova iscrizione può essere proposta quando si è ottenuta la riabilitazione.
Article 26.
(Aggiornamento del Registro nazionale)
1. L’elenco degli iscritti al Registro nazionale aggiornato deve essere annualmente depositato dalla Commissione nazionale presso la Direzione per la valutazione dei medicinali e per la farmacovigilanza del Ministero della salute.
Article 27.
(Sede del Registro nazionale)
1. Il Registro nazionale degli informatori scientifici del farmaco ha sede in Roma.
Article 28.
(Disposizioni transitorie)
1. In sede di prima applicazione della presente legge sono considerati, di diritto, informatori scientifici del farmaco tutti coloro che hanno svolto tale attività in modo continuativo per almeno due anni nel periodo compreso tra la data di entrata in vigore del decreto legislativo 30 dicembre 1992, n. 541, e la data di entrata in vigore della presente legge. Essi possono essere iscritti al Registro di cui all’articolo 17 previa apposita richiesta scritta corredata di idonea documentazione.
2. Per essere iscritti al Registro nazionale e a quello regionale, gli informatori scientifici del farmaco che si trovano in tale situazione devono presentare domanda corredata di idonea documentazione alla competente Commissione provinciale del Registro degli informatori scientifici del farmaco entro e non oltre sei mesi dalla data di entrata in vigore della presente legge.
Article 29.
(Oneri)
1. Gli oneri relativi alla tenuta del Registro nazionale ed ai Registri regionali, di cui agli articoli 11 e 17, sono a carico degli iscritti.