Proposal of Law n.1479

XIV LEGISLATURE
HOUSE OF REPRESENTATIVES
No. 1479

 

LAW PROPOSAL
on the initiative of the deputy MAURA COSSUTTA

Regulation of the pharmaceutical information activity and establishment of the register of scientific representatives of the drug

Presented on August 2, 2001

 

 

XIV LEGISLATURE
HOUSE OF REPRESENTATIVES
No. 1479
Ladies and Gentlemen! – The problem of the working condition and classification of drug sales reps has emerged for some time. In recent legislatures, attempts have been made several times to approve an organic discipline adequate to the delicacy and importance of the role of which this professional figure is invested.
Indeed, it is clear that informing healthcare professionals, on the basis of justified scientific justifications, about the characteristics and methods of use of drugs and, in particular, of new molecules, is a task that implies the assumption of a significant responsibility towards the healthcare system and citizens.
In contrast to the importance and delicacy of their role, drug sales reps operate in the absence of any law that specifically regulates their activity and, unlike most other professional categories in the health sector, they do not have a professional register. This implies that they are devoid of any guarantee of stability of their employment relationship and allows the pharmaceutical industries to benefit from complete discretion, making economic and commercial considerations prevail over technical-scientific ones.
The lack of adequate regulation causes a series of problems for both scientific representatives, health professionals and citizens. There is a lack of adequate guarantees regarding the employment relationship between whistleblowers and the pharmaceutical industries; there is a tendency towards the transformation of their activity from a technical-scientific information and support profession to health professionals, to a real activity exclusively promotional and commercial; the field opens up to the possibility of aberrant deviations, both in the relationships between informants, companies and doctors, and also in the seriousness of the information, which is often seen forced to derogate from the need to highlight, alongside the advantages, also the possible limitations and possible negative effects of the molecules, having to obey the absolute necessity of increasing sales in any case.
The present bill proposes to answer these problems.
Article 1 recalls the applicability of the provisions and definitions of the legislative decree n. 541 of 1992 which, transposing directive 92/28/EEC, currently contains the fundamental regulation on the subject of advertising of medicines for human use.
Article 2 defines the figure of the pharmaceutical sales representative as that of the person who brings scientific information on drugs to the attention of healthcare professionals, ensuring its periodic updating. It is also the duty of the informant to inform the head of the scientific service of the company for which he carries out his activity the observations of health professionals on medicinal products. In this way, the aim is to guarantee a continuous exchange of information between doctors and companies. This article establishes the need for informants to be registered in the register, governed by subsequent articles. Furthermore, the identification of the university qualifications required for the practice of the profession is left to subsequent measures.
Article 3 establishes that scientific representatives of the drug have an obligation of professional secrecy on the information received as a result of their work, and provides that the pharmaceutical industries must compulsorily draw on the register of informants to carry out their propaganda and information activities. Lastly, it establishes that the employment relationship of whistleblowers is governed by the collective bargaining agreement for the category.
Articles 4 to 9 establish and define the composition, organization and functions of the provincial colleges of drug sales representatives, whose essential task is to keep the relevant provincial register.
In detail, the possibility of setting up inter-provincial colleges deserves special mention, where the number of informants residing in the province is small or where there are other reasons of a historical or geographical nature.
It is also established that the councils of the provincial colleges are made up of nine scientific informants, elected by the members of the register, and that each council elects a president, a vice president, a secretary and a treasurer from among its members.
Among the various tasks of the colleges, in addition to compiling and maintaining the register, we note those of ensuring compliance with the rules by the members, of supervising the protection of the activity of informants and repressing any abusive exercise of the profession and of promoting and encouraging initiatives aimed at the cultural progress of the members. Each year, in collaboration with the universities, a specific professional refresher course must be promoted for those enrolled. The functions of the president are also identified and the establishment of the board of auditors is envisaged.
Article 10, on the other hand, establishes the National Council of Colleges of Pharmaceutical Representatives, made up of a representative from each provincial college. The organs of the National Council are identified by article 11, while article 12 defines their powers, among which stand out those relating to the care of deontological relations between scientific representatives and company management of companies, the expression of opinions on draft laws and regulations, the decision of appeals relating to registration in the register and disciplinary sanctions as well as the determination of the annual fees due by members.
After the rules on the term of office and eligibility of the members of the provincial and national councils, the professional register of pharmaceutical sales reps is established with article 15. The elements that must be indicated in the register are identified in article 16, while article 17 establishes the requirements for registration and article 18 identifies the causes for cancellation from the register, among which we note the cessation of the activity for at least five years.
Article 20 provides that copies of each register are filed with the clerk's office of the court of appeal, with the National Council as well as with the Ministries of Justice and Health, subjects to which the changes to the register itself are communicated.
Articles 21 to 23 deal with the matter of disciplinary sanctions. They may consist of warning, censure, suspension from the exercise of the profession for a period from two months to one year or removal from the register. They are pronounced by the council of the provincial college against informants who are guilty of acts that do not conform to professional decorum and dignity or that compromise their reputation or the dignity of the college.
Article 24 dictates transitional provisions for the first implementation phase of the law, providing that all those who have carried out this activity continuously for at least two years starting from 26 January 1993, i.e. the date of entry into force of the aforementioned legislative decree n. 541 of 1992, concerning the regulation of the advertising of medicines for human use.
Finally, article 25 provides that all expenses deriving from the implementation of the law are charged to the fees paid by the members of the registers, and article 26 provides for the issue, within three months from the date of entry into force of the law, of the related implementing regulation, also containing the rules relating to the meetings of the members and the elections of the councils.
XIV LEGISLATURE
HOUSE OF REPRESENTATIVES
No. 1479
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 informants.
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 a president, a vice president, a secretary and a 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. Each provincial council, on the indication of the National Council, is required annually to promote, organize and supervise a professional training course, in collaboration with the universities, for drug sales representatives registered in the college register.
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 a president, a secretary, a treasurer and five councilors from among its members, who form 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. Those enrolled in the register who are guilty of acts that do not conform to professional decorum and dignity or of acts that compromise their reputation or the dignity of the college are subject to disciplinary proceedings.
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. The Government, within three months from the date of entry into force of this law, issues the relative implementing regulation. The same regulation dictates the rules relating to the assemblies of the members and to the elections of the councils of the provincial and inter-provincial colleges.