Proposal of Law n.1482
XIV LEGISLATURE
HOUSE OF REPRESENTATIVES
N. 1482
LAW PROPOSAL
d’iniziativa dei deputati
LUCCHESE, DORINA BIANCHI, EMERENZIO BARBIERI, ANNA MARIA LEONE, TUCCI, NARO
Nuova regolamentazione dell’attività di informazione scientifica farmaceutica e istituzione dell’albo degli informatori scientifici del farmaco
Presented on August 2, 2001
XIV LEGISLATURE
HOUSE OF REPRESENTATIVES
N. 1482
Onorevoli Colleghi! – Nella XIII legislatura e precisamente in data 7 marzo 2001 la XII Commissione Affari sociali della Camera dei deputati ha approvato la proposta di legge atto Camera n. 7567 recante “Nuova regolamentazione delle attività di informazione scientifica farmaceutica e istituzione dell’albo degli informatori scientifici del farmaco”. Tale proposta di legge riproduceva integralmente il testo del disegno di legge approvato all’unanimità dall’Aula del Senato della Repubblica il 25 gennaio 2001 (atto Senato n. 478).
Il testo del disegno di legge viene riproposto nella presente proposta di legge, che tiene conto del decreto legislativo 30 dicembre 1992, n. 541, di recepimento della direttiva 92/28/CEE sulla pubblicità dei medicinali per uso umano e che, senza alcuna sovrapposizione, ne integra alcuni aspetti particolari.
La proposta di legge intende evidenziare, in un settore così delicato come quello dell’informazione scientifica sui farmaci, il ruolo ed i compiti dell’informatore scientifico del farmaco e degli addetti al settore, nonché la natura giuridica del rapporto informatore scientifico-azienda farmaceutica.
Come stabilito all’articolo 2 della proposta di legge, l’informatore scientifico del farmaco “porta a conoscenza dei sanitari le informazioni scientifiche sui farmaci e ne assicura il periodico aggiornamento” a conferma della corresponsabilità di tale professionista, al pari del medico, nell’uso corretto del farmaco in terapia.
L’articolo 3 prevede che gli informatori scientifici del farmaci sono tenuti a rispettare il segreto professionale sulle notizie fornite loro dalle aziende per le quali operano, nonché dagli altri operatori sanitari, rimandando la disciplina del rapporto di lavoro alle contrattazioni collettive fra le categorie interessate ai sensi dell’articolo 6, ottavo comma, del decreto del Ministro della sanità 23 giugno 1981, pubblicato nella Gazzetta Ufficiale n. 180 del 2 luglio 1981, e successive modificazioni.
Dall’articolo 4 all’articolo 17 si disciplina la costituzione dei collegi degli informatori scientifici del farmaco in tutti i suoi aspetti: dai requisiti richiesti per l’iscrizione all’albo professionale alle procedure elettorali per la elezione del Consiglio nazionale dei collegi.
Dall’articolo 18 all’articolo 23 si disciplinano le sanzioni disciplinari e le modalità di tenuta dell’albo.
Si ritiene opportuno presentare la proposta di legge proprio per dare al più presto veste giuridica alla figura dell’informatore scientifico del farmaco, poiché, come già previsto dal citato decreto del Ministro della sanità 23 giugno 1981, all’articolo 10, questi soggetti “sono tenuti a collaborare con il Ministero della sanità, anche con suggerimenti e indicazioni, al fine di assicurare il corretto e ottimale svolgimento dell’attività di informazione sui farmaci”.
XIV LEGISLATURE
HOUSE OF REPRESENTATIVES
N. 1482
LAW PROPOSAL
Article 1.
1. Except as expressly established by this law, the provisions and definitions contained in 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 2.
1. Scientific informant of drugs is the person who, registered in the special register referred to in article 15, brings scientific information on drugs to the attention of healthcare professionals and ensures its periodic updating. By decree of the Minister of Education, University and Research, issued in agreement with the Minister of Health, the university qualifications required for the exercise of the profession of scientific sales representative of the drug are defined, taking into account the university qualifications acquired on the basis of the legislation in force prior to the date of entry into force of the regulation referred to in the decree of the Minister of University and Scientific and Technological Research November 3, 1999, n. 509, and subsequent decrees issued pursuant to article 17, paragraph 95, of the law of 15 May 1997, n. 127, and subsequent modifications.
2. It is the duty of the pharmaceutical sales representative to communicate, pursuant to article 9, paragraph 6, of the legislative decree of 30 December 1992, n. 541, to the manager of the scientific service of the company referred to in article 14 of the same legislative decree, the observations on the medicinal specialties that the operators report, guaranteeing a constant exchange of information between doctors and companies.
Article 3.
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.
2. Pharmaceutical industries, in order to carry out propaganda and dissemination activities, must draw from the register of scientific representatives and can also form associations in order to use the same scientific representative.
3. The employment relationship of the scientific informant is governed by the relative collective bargaining agreements between the categories concerned pursuant to article 6, eighth paragraph, of the decree of the Minister of Health of 23 June 1981, published in the Official Gazette no. 180 of 2 July 1981, and subsequent amendments.
Article 4.
1. Provincial colleges of drug sales representatives are established in each province, with functions relating to the maintenance of the professional register and the discipline of the members and with any other attribution provided for by law.
2. Pharmaceutical sales reps registered in the register referred to in article 15 and resident in the province belong to the provincial colleges.
3. If the number of drug sales reps residing in the province is small or if there are other reasons of a historical or geographical nature, it may be established, pursuant to letter d) of paragraph 1 of article 12, that a college has as its district two or more neighboring provinces.
Article 5.
1. The functions referred to in article 4 are exercised, for each province or group of provinces, by the councils of the provincial colleges of drug sales representatives elected in assembly among those registered in the register referred to in article 15 residing in the same territorial district, by relative majority of votes and by secret ballot.
2. The councils of the provincial colleges referred to in paragraph 1 are made up of nine scientific representatives of the drug, who have at least five years of activity effectively carried out.
Article 6.
1. The council of the provincial college elects the president, the vice president, the secretary and the treasurer from among its members.
Article 7.
1. The council of the provincial college has the following powers:
a) compile and keep the college register;
b) take care of the observance of the provisions of the law and of all other provisions on the subject by the members;
c) supervise for the protection of the drug sales representative in any place and carry out any activity aimed at the repression of the abusive exercise of the profession;
d) promote and encourage all initiatives aimed at the cultural progress of the members;
e) collaborate with public and private entities operating in the drug sector in the study and implementation of measures that may in any case affect the college;
f) exercise disciplinary power over members;
g) provide for the administration of the assets pertaining to the college and propose the budget and the final account for approval by the assembly;
h) exercise the other powers assigned to him by law;
i) designate the representatives of the college to the National Council.
2. Ogni consiglio provinciale, su indicazione del Consiglio nazionale, è tenuto annualmente, a promuovere, organizzare e sovraintendere un corso di formazione professionale, in collaborazione con le università, per gli informatori scientifici del farmaco iscritti all’albo del collegio.
3. The execution of the courses referred to in paragraph 2 and the relative programs are communicated in advance to the Ministry of Health, which provides the indications and guidelines aimed at giving homogeneity to these initiatives.
Article 8.
1. The president of the council of the provincial college of drug sales reps is the representative of the college itself, 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 9.
1. Each provincial college of drug sales representatives has a provincial college of auditors, made up of three members, which controls the management of the funds and verifies the budgets prepared by the council, reporting them to the assembly.
Article 10.
1. The National Council of Colleges of Pharmaceutical Representatives is hereby established. It includes a representative from each provincial or interprovincial college.
2. The provincial or inter-provincial colleges which have more than three hundred registered drug sales representatives elect an additional national councilor for every three hundred drug sales reps exceeding this number or fraction of it greater than half.
Article 11.
1. The National Council of Colleges of Pharmaceutical Representatives elects the president, the secretary, the treasurer and five councilors from among its members, who make up the executive committee.
2. The National Council also designates three scientific representatives of the drug to exercise the function of auditor.
Article 12.
1. The following powers are assigned to the National Council of Colleges of Pharmaceutical Representatives:
a) supervise the protection of the category of scientific representatives of the drug and take care of the deontological relations between the representatives and the corporate management on which they depend;
b) coordinate and promote the cultural activities of the councils of the provincial colleges to encourage initiatives aimed at improving and professionally perfecting for qualified and scientific information, as well as regulating and supervising the updating and permanent training of drug sales representatives;
c) expressing its opinion, when requested, on draft laws and regulations concerning the scientific information service on medicines and the profession of scientific information on medicines, as well as on any other matter pertaining to the provincial colleges;
d) decide on the establishment of interprovincial colleges in the cases provided for by paragraph 3 of article 4;
e) decide administratively on the appeals against the resolutions of the councils of the provincial colleges regarding registration and cancellation from the register, on the appeals in disciplinary matters and on those relating to the elections of the councils of the provincial colleges and of the provincial colleges of auditors;
f) draw up the regulations for the handling of appeals and matters within its competence;
g) determine the extent of the annual fees due by members.
Article 13.
1. The members of each council of the provincial college and those of the national council of drug sales reps remain in office for three years and can be re-elected for no more than two consecutive terms.
Article 14.
1. All drug sales reps are eligible for the positions referred to in articles 6 and 11, even if enrolled in other professional registers, without prejudice to the conditions of compatibility referred to in article 3.
Article 15.
1. A register of drug sales reps, who have their residence in the territory included in the district of the college itself, is established in each council of the provincial or inter-provincial college.
Article 16.
1. The register must contain the surname, first name, date of birth, residence and domicile of the members, as well as the date of registration and the title on the basis of which it took place. Seniority is determined by the date of enrollment in the register.
Article 17.
1. The following requirements are required for enrollment in the register:
a) citizenship of a member country of the European Union;
b) enjoyment of civil rights;
c) possession of one of the university qualifications defined by the decree referred to in paragraph 1 of article 2.
Article 18.
1. Scientific representatives of the drug incur the provision for cancellation from the register:
a) for loss of enjoyment of civil rights;
b) for criminal conviction;
c) for cessation of professional activity for at least five years;
d) for proven exercise of activity in another professional college.
Article 19.
1. The scientific representative of the drug canceled from the register can, at his request, be readmitted when the reasons that led to the cancellation have ceased.
2. If the cancellation from the register occurred following a criminal conviction, the application for new registration can be proposed when rehabilitation has been obtained.
Article 20.
1. A copy of the register must be deposited every year within the month of January, by the councils of the provincial colleges, at the chancery of the court of appeal of the capital of the region where the aforementioned councils are based, as well as at the secretariat of the National Council of colleges of drug sales representatives and at the Ministry of Justice and the Ministry of Health.
2. Any new registration or cancellation must be communicated within two months to the Minister of Justice and the Minister of Health, the Registry of the Court of Appeal, the Attorney General of the same Court of Appeal and the National Council.
Article 21.
1. Gli iscritti all’albo che si rendano colpevoli di fatti non conformi al decoro ed alla dignità professionali o di fatti che compromettano la propria reputazione o la dignità del collegio, sono sottoposti a procedimento disciplinare.
Article 22.
1. Disciplinary sanctions are pronounced with a reasoned decision by the council of the provincial college referred to in article 5 after hearing the interested party. They are:
a) the warning;
b) censorship;
c) suspension from practicing the profession for a period of no less than two months and no more than one year;
d) disqualification from the register.
Article 23.
1. Judicial appeal is permitted against decisions regarding registration, cancellation and election in the councils of provincial colleges and disciplinary measures.
Article 24.
1. In the first implementation of this law, all those who have carried out this activity continuously for at least two years, starting from the date of entry into force of the legislative decree 30 December 1992, n. 541, and subsequent amendments, even in the absence of the requirements referred to in paragraph 1 of article 2 of this law. They can be registered in the register, following a specific written request, accompanied by suitable documentation.
Article 25.
1. All expenses deriving from the implementation of this law are financed with the quotas referred to in letter g) of paragraph 1 of article 12 and consequently any burden on the State budget is excluded.
Article 26.
1. Il Governo, entro il termine di tre mesi dalla data di entrata in vigore della presente legge, emana il relativo regolamento di esecuzione. Con il medesimo regolamento sono dettate le norme relative alle assemblee degli iscritti e alle elezioni dei consigli dei collegi provinciali e interprovinciali