Proposal of Law n.342
XIV LEGISLATURE
HOUSE OF REPRESENTATIVES
No. 342
LAW PROPOSAL
on the initiative of MEPs from BOLOGNESI, PETRELLA, CORDONI, MAGNOLFI, DI SERIO D'ANTONA, PUSINI
New regulation of pharmaceutical scientific information activities and establishment of the register of drug scientific representatives
Presented on May 30, 2001
XIV LEGISLATURE
DRAFT LAW - No. 342
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Ladies and Gentlemen! – For many years, the problem of the working condition and classification of drug sales reps has emerged. 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. It is evident, in fact, 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, in particular, 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 suitable regulation causes a series of problems for both scientific representatives, health professionals and citizens. Firstly, there is a lack of adequate guarantees regarding the employment relationship between whistleblowers and the pharmaceutical industries. Furthermore, there is a tendency to transform their activity from a technical-scientific profession providing information and support to health professionals, to a real and proper exclusively promotional and commercial activity. Finally, the field is thus opened 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 forced to deviate 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 provision under examination proposes to respond to these problems, elaborated by the Senate of the Republic over the last few years and examined in this branch of Parliament, in the referent seat, by the Social Affairs Commission in the last part of the past legislature.
Article 1 of this bill recalls the applicability of the provisions and definitions of the legislative decree 30 December 1992, n. 541 and subsequent amendments which, in transposition of directive 92/28/EEC, establishes 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. Furthermore, it is 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 exercise of the profession is referred to subsequent measures.
Article 3 establishes that scientific representatives of the drug have the obligation of professional secrecy on the information received as a result of their work and provides that the pharmaceutical industries must compulsorily draw from the register of informants to carry out their propaganda and information activities. In order to facilitate smaller companies, it is envisaged that the pharmaceutical industries can associate in order to use the same informant. Finally, it is established that the employment relationship of whistleblowers is governed by collective bargaining 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.
Among the detailed provisions of this discipline, it is worth mentioning the possibility of setting up inter-provincial colleges, where the number of informants residing in the province is small or where there are other reasons of a historical or geographical nature. Furthermore, it is 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 provincial 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 favoring initiatives aimed at the cultural progress of the members. Each year, in collaboration with the university, a specific professional refresher course must be promoted for the students enrolled. The functions of the president of the council of the provincial college are also identified and the establishment of the provincial college 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 bodies 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 ethical 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 and the determination of the annual fees due by members. Articles 13 and 14 establish rules regarding the term of office and eligibility of the members of the provincial and national councils.
Article 15 establishes the register of scientific representatives of the drug.
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 19 regulates readmission to the register. Article 20 provides that copies of each register are filed with the chancery of the court of appeal, with the National Council as well as with the Ministry of Justice and the Ministry of Health, subjects to which the changes that have occurred in 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 provincial college council 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 phase of first application of the law, providing that all those who have carried out this activity continuously for at least two years starting from the date of entry into force of the aforementioned legislative decree n. 541 of 1992, concerning the advertising of medicines for human use.
Finally, article 25 establishes that all the expenses deriving from the implementation of the law are to be borne by 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 a regulation implementing the law, also to dictate the rules relating to the meetings of the members and the elections of the councils.
As mentioned, in past legislatures the Parliament has tried several times, without success, to approve a specific discipline on the subject of scientific representatives of the drug. In the XIII legislature, after the conclusion of the examination in the referent seat at the Hygiene and Health Commission, which lasted from July 1996 to October 1999, the Assembly of the Senate of the Republic came to dismiss the provision, in first reading, only at the end of January 2001.
The times for the examination in the referring office at the Social Affairs Commission of the Chamber of Deputies were consequently compressed. Given the prospect of the dissolution of the Chambers, the debate in the Commission essentially concentrated on the preliminary question of the actual need and degree of urgency for the approval of the new regulations before the end of the legislature. Closely connected to this preliminary question was the debate on the opportunity to proceed with the establishment of a new professional register, both in reference to the compatibility of this instrument with the Community principles on the free movement of workers and professionals, and in relation to the broader reflection underway in recent years on this type of legal institution, mainly oriented towards its overcoming. Several of the opinions given by the competent Commissions in the consultative forum also focused on this aspect. The Social Affairs Commission of the Chamber of Deputies, while expressing a plurality of positions, considered the prevailing interest in rapidly approving a regulation that would give certainty to sector operators and citizens. Once this choice was made, the question of the advisability of establishing a new register was resolved positively, both because the limited time available would have made it difficult, in the event of a modification of the text, to pass it again to the Senate of the Republic, and above all in the consideration that, until an overall reorganization of the matter has actually been achieved, there seemed to be no reasons why the protection guaranteed by this legal institution to most professional categories should be excluded for drug sales representatives.
Among the particular aspects which, despite the rapidity of the examination, were explored in depth during the debate, it is worth noting in particular the provision that companies can join together to hire the same informant. In contrast to the opinion of some groups, who have read in this regulation a possible harm to competition between companies, it has been underlined that it is aimed primarily at facilitating the activity of smaller companies, which could have difficulty in hiring a highly qualified individual on their own. Finally, useful elements for reflection also emerged from the discussion on the transitional rules. Also in this case, however, the opinion prevailed that it was advisable not to modify the text of the Senate of the Republic.
This choice, despite some aspects that cannot be fully shared, did not, however, lead to the definitive approval of the measure. This negative result was certainly contributed to by the fact that the opposition groups of the last legislature did not deem it appropriate to express their assent to discuss the provision in the legislative session, as perhaps it would have been appropriate, given the need to regulate this delicate matter in certain times. However, the impossibility of definitively approving the measure certainly depended above all on the scarcity of time available to the Chamber of Deputies to fully examine its contents and reach the definition of a widely shared political agreement.
Therefore, the regret remains that the accumulated delays have forced an examination in a short time and close to the dissolution of the Chambers. The hope is that the work carried out in the XIII legislature, which led to the approval of the provision in one of the two houses of Parliament, will facilitate a more rapid examination by the current Chambers, in the awareness of the need to intervene as soon as possible to adequately regulate the delicate and important professional activity carried out by scientific representatives of the drug.
XIV LEGISLATURE
DRAFT LAW - No. 342
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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 Universities and Scientific and Technological Research, issued in agreement with the Minister of Health, the university qualifications required for the exercise of the profession of scientific information 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 decree of the Minister of Universities and Scientific and Technological Research November 3, 1999, n. 509, and the subsequent decrees referred to in 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 legislative decree itself, 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 actually 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, will take care of annually promoting, organizing and supervising a professional training course, in collaboration with the university, for drug sales reps 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 referred to in paragraph 1 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 referred to in article 15 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 referred to in article 15 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 have their headquarters, 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 of drug scientific representatives 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 panel 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 application 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 referred to in article 15 of this law, upon 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 the term of three months from the date of entry into force of this law, adopts the related implementing regulation. With the aforesaid implementing regulation the rules relating to the assemblies of the members and to the elections of the councils of the provincial and inter-provincial colleges are dictated.