Proposal of Law n.1572

XIV LEGISLATURE
HOUSE OF REPRESENTATIVES
No. 1572

 

LAW PROPOSAL
on the initiative of the MILANESE deputy

New regulation of pharmaceutical scientific information activities and establishment of the register of drug scientific representatives

Presented on September 13, 2001
XIV LEGISLATURE
HOUSE OF REPRESENTATIVES
No. 1572
Ladies and Gentlemen! – According to current legislation, the scientific information service on drugs has the purpose of periodically making all health professionals aware of their characteristics and properties, in order to ensure their use according to the appropriate indications and dosages, also with reference to the need to contain the related consumption, which is of great concern to the Government and the regions.
This service also has the purpose of collecting in a capillary way every element on the therapeutic and side effects deriving from the use of drugs, consequently promoting their constant improvement.
If it is true that prevention and rehabilitation constitute the most qualifying aspects of the health reform law, one cannot therefore fail to state that correct information and adequate updating of those in charge of prescribing medicines are also indispensable for the protection of public health.
Today the doctor's update, as regards the knowledge of medicinal products for human use produced by pharmaceutical companies, is largely ensured through the interview with the scientific representative, so it is impossible not to consider a co-responsibility of both in the use of the drugs in therapy.
The responsibility of scientific representatives was also sanctioned by the decree of the Minister of Health of 23 June 1981, which obliges them (article 10) to collaborate with the Ministry of Health, also with suggestions and indications, in order precisely to ensure the correct and optimal performance of the information activity on drugs.
The role of scientific representatives in the knowledge and use of the drug is therefore important and delicate, so it must be performed with full professional dignity.
The legal recognition of the profession of scientific representative of the drug is to be considered, therefore, right and necessary, so that these operators can be held accountable for their work and can thus offer the community the maximum guarantee as regards their ethics and professionalism.
Professional systems are, in fact, specific to certain intellectual professions, to which the legislator has decided to devote particular attention, since the private interests involved in the profession are indirectly relevant also for the State.
Just as enrollment in the register of surgeons becomes an essential condition for the exercise of the professional activity of the doctor and guarantees, at the same time, the community on the possession of the obligatory requisites by the attending physicians, as well as their ethics and professionalism, similarly, enrollment in the register of the board of scientific representatives of drugs would constitute the essential condition for the exercise of the professional activity (automatically eliminating any form of abuse by outsiders for the specific purposes of the scientific information service on drugs) and would guarantee the doctor and the community on the possession of the mandatory requirements by drug sales reps, as well as their ethics and professionalism.
It could be argued that a professional is someone who provides, for a fee, services with mainly their own activity, without subordination constraints and that therefore such an attribution would be badly suited to drug sales reps (with the responsibilities and related implications), being the same, predominantly, holders of a full-time subordinate employment relationship. There are, however, some professionals, who find themselves in an anomalous position with respect to the generality, in the sense that they practice the profession, despite being subordinate workers, employed by public and private bodies.
Just think of the various categories of lawyers, who are not freelancers, such as the lawyers of the state and other public bodies. Some of them are registered in the so-called "special registers", while others are an integral part of the administration. Think of certain categories of health professionals, in particular pharmacists.
The example is even more fitting, with reference to the order of journalists, in which all members are legally holders of an employment relationship. The Constitutional Court (sentence n. 11 of 1968) did not find the presence of this order illegitimate, not even insofar as it constitutes a violation of the sphere of freedom of those who want to devote themselves professionally to journalism. In fact, the justification for the presence of the order of journalists was found by the Court in an argument completely unrelated to the real function of the order and of the professional colleges: the argument of the opportunity for journalists to be associated in a body which "with respect to the opposing economic power of the employers, can contribute to guaranteeing respect for the personality and, therefore, for their freedom".
The public value attributed to the activity of scientific information on drugs by the health reform law is confirmed by the legislation indicated by the decrees of the Minister of Health of 23 June 1981, 23 November 1982, 26 February 1985, 4 December 1990, and 3 July 1992 (all on the regulation of scientific information on drugs), as well as by the decrees of the Minister of Health of 20 March 1980 and 28 July 1 984 (on drug monitoring), by Legislative Decree 30 December 1992, n. 541, and subsequent amendments, (in implementation of directive 92/28/EEC concerning the advertising of medicines for human use), by law 6 February 1996, n. 52, and by the regulation referred to in the decree of the President of the Republic 7 December 2000, n. 435 (both, among other things, on the involvement of drug sales representatives in pharmacovigilance activities).
Finally, it should be remembered that the characteristics of professional orders exclude that, in a democratic and non-corporate system, they can be bearers, in an exclusive manner, of the representation and protection of the general and particular interest of the members, since their configuration as persons governed by public law, while it is an essential requirement for the attribution of public powers aimed at protecting the dignity of the profession, in the interest not only of professionals but of the community, prevents orders endowed, in the public interest, with powers of supremacy over all members of the profession, to be at the same time a free expression of the particular interests of the category (Cassation, United Sections, 2 February 1965, n. 164), which is achieved instead only through union organization pursuant to article 39 of the Constitution (Council of State, V, 25 September 1963, n. 767).
On the basis of this reality, the conviction has therefore matured that the activity of the scientific informant constitutes a "new profession", which does not find obstacles in constitutional rules and finds, instead, comfort and exemplification in the laws governing other professions. It is no coincidence, in fact, on 7 March 2001, in the XIII legislature, the XII Commission for Social Affairs of the Chamber of Deputies approved, in the referring office, the draft law Chamber act n. 7567 containing "New regulation of pharmaceutical scientific information activities and establishment of the register of pharmaceutical sales reps", which reproduced in full the text of the bill unanimously approved by the Senate of the Republic on 25 January 2001 (Senate act n. 478).
The text of the aforementioned bill is reproposed in this bill, which takes into account the legislation in force on the subject and which, without any overlap, integrates some particular aspects.
The bill aims to highlight the role and duties of the pharmaceutical sales rep, as well as the legal nature of the sales rep-pharmaceutical company relationship. It also wants to be a serious and convincing start of a process of moralization in the field of drug trade. The pharmaceutical companies themselves will gain both in image and in investments, being able to have qualified personnel capable of enhancing the scientific aspect of the pharmaceutical product among health professionals.
As for the establishment of the register of drug sales reps, this instrument will not only give greater dignity to these operators, but will place them in a clear and transparent deontological condition, as a greater defense and guarantee of professionalism, having a positive impact on corporate philosophies and strategies, as well as on the qualification and containment of pharmaceutical expenditure
XIV LEGISLATURE
HOUSE OF REPRESENTATIVES
No. 1572
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 Council Directive 92/28/EEC of 31 March 1992 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 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 related programs are communicated in advance to the Ministry of Health, which provides the indications and guidelines intended to give 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 filed 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 the term of three months from the date of entry into force of this law, shall issue the related 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.