REPORT OF THE BILL 336

 

 

Honorable Senators. – 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.

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 relevance 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 adequate 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 information and support profession to health professionals into a real activity exclusively promotional and commercial. 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 contents of the bill.

The provision under examination, elaborated by the Senate over the last few years and examined, in the referent seat, by the Hygiene and Health Commission in the last part of the legislature, proposes to respond to these problems.

Article 1 recalls the applicability of the provisions and definitions of the legislative decree 30 December 1992, n. 541, which, in implementation of 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. The aim is thus to ensure 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 the 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. 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, the possibility of setting up inter-provincial colleges deserves 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 university, a specific professional refresher course must be promoted for the students 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 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.
After regulations on the term of office and eligibility of members of the provincial and national councils, with article 15 the register of scientific representatives of the drug is established. 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 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 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 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 ninety days from the 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.

Preliminary examination of bills.

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 this legislature, the examination of the numerous bills presented to both the House and the Senate was started in good time by the latter House. Moreover, after the conclusion of the examination in the referent seat at the 12th Commission, which lasted from July 1996 to October 1999, the Senate Assembly 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 imminent prospect of an early dissolution of the Chambers, the debate in the Commission essentially focused 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 Commission, while expressing a plurality of positions, considered the prevailing interest in quickly 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, and above all in the consideration that, until an overall reorganization of the matter has actually been achieved, there do not seem to be 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 provision a possible harm to competition between companies, it has been underlined that it is primarily aimed 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 appropriate not to modify the text of the Senate.

Conclusions.

The decision not to modify the text of the Senate, despite some aspects that are not fully acceptable, 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 did not deem it appropriate to express their assent to discuss the measure in the legislative session, as would perhaps 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 last 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 next 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.