Question on Scientific Information of the drug
Very kind director Nicola Magrini
given the current legislation, given our ongoing commitment to representing the difficulties faced daily by the workers in question during the performance of a function necessary to the National Health Service, we would like to ask you a few questions regarding the profession of drug sales rep.
Given that:
• Article 31 of Law 833/78 on scientific information states that “The national health service is responsible for providing scientific information on drugs and for monitoring the scientific information activity of the companies that hold authorizations to place drugs on the market.". He also adds that "The Minister of Health, having heard the National Health Council, having seen the proposals of the regions, taking into account the Community directives and having evaluated the observations and proposals that will arrive from the Higher Institute of Health and from university and research institutes, as well as from pharmaceutical industry, prepares a multi-year program for scientific information on drugs, also aimed at health education initiatives and lays down rules for the regulation of the aforementioned service and the activity of scientific representatives.”
- The law 219/2006 in article 119, transposing the Community directive, in paragraph 2 states that "Without prejudice to the provisions of this title, scientific information to healthcare professionals must be carried out in compliance with the criteria and guidelines adopted by AIFA, subject to agreement with the Permanent Conference for relations between the State, the regions and the autonomous provinces of Trento and Bolzano after hearing the pharmaceutical industry associations.", continues in article 122 paragraph 1 stating that "Information on medicines can be provided to the doctor and pharmacist by scientific representatives." and adds that the training of the sales representative on medicines of the marketing authorization holder has no limits, if not sufficient knowledge because as stated in paragraph 2 "In all cases, the sales reps must receive adequate training from the companies from which depend, so as to be in possession of sufficient scientific knowledge to provide precise and as complete information on the medicines presented. The companies holding the AIC ensure the constant updating of the technical and scientific training of the scientific representatives.”
- In the conference of the Regions and autonomous provinces, with the guidelines launched on 20 April 2006, scientific information is regulated in such a way as to oblige companies to indicate who their Scientific Representative is, which drugs they will deal with and their area of competence. Adding that, "in carrying out their activity, operators of the NHS and affiliated pharmacies are not permitted to provide scientific representatives with information relating to the prescribing habits of doctors, or information relating to the procedures for purchasing medicines."
In recent years we have been witnessing a revolution in the world of scientific information, which risks accelerating due to the pandemic, with the attempt by some companies to interact with the doctor mainly remotely, without having defined the legal, nor contractual outlines; at the same time, in order to better achieve the objective, new figures are entering the system who, in an attempt to bypass the founding rules of the scientific information service, actually replace the activity of the scientific informant.
In this context, it becomes necessary to clarify who and how should carry out the activity of providing scientific information to the doctor, thus protecting, as you yourself underlined with the note dated 23/3/2021, the health of patients,"guaranteeing the freedom of the contents of scientific information, of which the direct relationship between the scientific representative and the doctor constitutes an irrepressible corollary, a relationship that must always take place in full freedom and autonomy”.
That said, we would like to raise the following questions:
- Is it possible to provide scientific information by telephone, commonly known as phone detailing, when the arguments put forward in support of one's theses, on the use of the drug, cannot be viewed in their entirety, AIFA authorization included?
- It may be possible for other company figures, probably doctors employed by the Medical Department, to "inform" the clinician freely, perhaps even on the use of the drug in indications not present in the AIC, effectively bypassing the Scientific Department, related informants and even AIFA , on arguments and materials that will use?
- In promoting the ethical use of the drug, the Scientific Representative uses information related to the indications present in the AIC, but can he also use any scientific material made available to the company, including ongoing trials, as long as it is authorized by AIFA?
- Can a doctor, an employee of a public health company, in the full performance of his duties, give consent to the processing of his data, without asking the authorization of his manager?
Dear director Magrini, your answers will be useful for clarifying the roles and duties of the Scientific Representatives, as well as regulating figures who propose themselves, straddling the roles, in the clumsy attempt to escape from rules and controls.
Awaiting your kind reply, available for any clarifications, best regards
Editor's note: We have received and published the query, reported above, from a territorial Filctem CGIL to Dr. Nicola Magrini, Director General of AIFA, on the activity of scientific information. The document was also shared and sent by the Filctem CGIL of Milan and Florence.
We hope that the questions raised will be a reason for reflection by all trade union organizations and will be the subject of a negotiation aware of the role of the ISF for the renewal of the CCNL
