Guidelines of the Regional Regulation of scientific information on drugs pursuant to article 48 paragraphs 21, 22, 23, 24 of Law No. 326 of 11.24.2003. “Advertising to doctors, health professionals and pharmacists” (art.7 Legislative Decree 541/92).
1. Pharmaceutical companies intending to carry out scientific information activities on drugs in the (Region or Autonomous Province), communicate to it:
name, surname, tax code, start date of their scientific representatives (ISF), specifying any therapeutic area they represent and the territorial area in which they carry out their activity (specify the provincial and/or ASL and/or AO area);
identification code of the Company itself and any associated/associated pharmaceutical companies;
self-certification of compliance with the provisions of art. 9 of Legislative Decree 541/92, with particular reference to:
– educational qualification;
– the name of the scientific manager on whom the ISF depend;
– company manager of pharmacovigilance
the ISF must be equipped with an identification card (including photo), which bears the following data:
- name and surname;
- Tax ID code;
– start date of activity at the pharmaceutical company;
logo and name of the pharmaceutical company;
identification code of the pharmaceutical company (source Italian Medicines Agency - AIFA);
therapeutic area in which the ISF operates;
territorial area and/or ASL and/or AO in which the ISF operates.
Said card will be provided by the respective pharmaceutical companies and authenticated by the Region or Autonomous Province, on the basis of the lists of names received, to be shown for access to the SSR structures, including those with special agreements. Any subsequent change to the list of names must be promptly (30 days) communicated to the Region or Autonomous Province;
in the event of termination of the employment relationship, the card must be withdrawn immediately by the pharmaceutical company.
2. The performance of the activities of the ISFs within the SSR structures is ensured and facilitated by the Managements of the aforementioned structures through the identification of suitable premises (for example doctors' room, ward library, doctor's office) in time slots agreed with the head of the operating unit, raising awareness of the availability of doctors and pharmacists and promoting the sharing of a company policy for the scheduling of scientific information meetings on drugs through individual visits by appointment or preferably collective meetings organized by the Managements themselves and/or by the head of the department/ operating unit. Therefore, it will not be permitted to carry out medical and scientific information activities within the hospitalization wards as well as in specialist outpatient clinics during patient visiting hours, with the exception of doctors' surgeries. The performance of the activity of the ISF in the affiliated medical studies (GPs, PLS and Guardia Medica) takes place at a specific time, agreed with the doctor.
3. In order to facilitate the scheduling of meetings, a special sign must be affixed in the affiliated medical offices and in the SSR structures in which the times and methods of receiving the ISFs are clearly identified.
4. The number of individual visits by each ISF to individual doctors can be quantified in an annual number of visits indicatively between 3 and 5 for each doctor interested in the prescription, according to the choices of the individual Regions. In any case, the same product containing the same active principle can be presented by the pharmaceutical company for a number of times equal to that identified for the above visits defined by the Region. If an ISF is responsible for the scientific information service of several products, the maximum number of visits is still determined, on the basis of regional choices, from 3 to 5 per year per doctor, without prejudice to the need to convey new relevant information on the appropriate use of medicines (modifications to the SPC - e.g. new therapeutic indications - or new safety information - e.g. warnings, adverse events, contraindications, side effects).
5. ISFs must carry out their work with doctors alone; the presence of the area manager or other professional figures not related to the scientific information activity is allowed only for functions other than scientific information.
6. 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.
7. Pharmaceutical companies are obliged to communicate to the Regions and Autonomous Provinces every six months, by 31 January to 31 July of each year, the number of doctors and pharmacists operating in the Region or Autonomous Province involved in scientific information activity on the drug;
TRANSFER AND ACQUISITION OF FREE SAMPLES (art. 13 Legislative Decree 541/92)
1. The free samples referred to in art. 13 of Legislative Decree 541/92 can be delivered by the ISF, to the doctors authorized to prescribe the medicine, according to the criteria outlined below:
two samples per visit for each dosage or pharmaceutical form of a medicinal product, exclusively in the eighteen months following the first marketing of the product and within the maximum limit of ten samples per year for each dosage and form;
for drugs on the market for more than eighteen months, on the other hand, the ISF can deliver to the doctor no pins of five total samples per visit within the maximum limit of twenty-five samples per year, chosen from the company price list;
The aforementioned quantitative limits do not apply to the supply of non-reimbursable drug samples from the NHS.
2. The free delivery of medicinal samples to doctors authorized to prescribe them is subject to a written request - which legibly reports the date, name and surname, stamp and signature of the requesting doctor, the number of samples per drug of each dosage and pharmaceutical form. Pharmaceutical companies are required to have every medical request delivered by the ISF, keep it for 18 months, and to provide the aforementioned documentation in the event of a request from the Regions and Autonomous Provinces.
The doctor who requested the samples according to the methods described above and according to the qualities indicated, is directly responsible for the management and correct conservation of the samples themselves.
3. Without prejudice to the provisions for free samples, the free transfer of medicinal products is not permitted. For drugs intended for "compassionate use" or clinical trials, reference is made to the specific legislation in force (Decree 8.5.2003 and Legislative Decree 211/2003).
INFORMATION MATERIAL (art. 8 Legislative Decree 541/92)
It is permitted to use only material authorized by the Ministry of Health (now the Italian Medicines Agency) for information to the doctor pursuant to art. 8 of Legislative Decree 541/92.
At each visit, the ISFs must deliver to the doctor, for each medicinal product presented, the summary of the product characteristics, complete with information on the price and, if necessary, the conditions under which the product can be prescribed with a charge to be borne by the National Health Service, without prejudice to the provisions of art. 9, paragraph 5, of Legislative Decree 541/92.
No other documentation can be provided to the doctor until 45 days have passed from the date of filing of the documentation with the Italian Medicines Agency. This date must be reported in the disclosed material.
In any case, the information contained in the aforementioned documentation must comply with the documentation submitted for the purpose of issuing or modifying the Marketing Authorization (AIC).
Therefore no other material, such as e.g. documentation for internal use by the pharmaceutical company can be used for scientific information purposes by the ISFs. The fulfilments envisaged in the field of pharmacovigilance are without prejudice.
GRANT OF FREE PROMOTIONAL PRODUCTS OF NEGLECT VALUE (art. 11 Legislative Decree 541/92)
The art. 11 of Legislative Decree 541/92 in the framework of the information and presentation of medicinal products carried out with doctors or pharmacists provides for the prohibition of granting, offering or promising prizes, pecuniary or in-kind advantages, unless they are of negligible value and are in any case connected to the activity carried out by the doctor and pharmacist.
The quantification of the aforementioned negligible value is fixed at a maximum of € 20.00 per year per pharmaceutical company for each individual doctor or pharmacist.
Considering that the cost value of subscriptions to scientific journals, texts, documents on computer support, etc., connected to the activity carried out by the doctor and pharmacist is generally higher than € 20.00, thus exceeding the limits set by the determination of the quantification of the "negligible value", it is established that the free transfer of said material can only be made in favor of the operating units of the AO/ASL. In this case, the pharmaceutical company is required to notify the company departments of the local ASL/AO, as said products are a common good for all healthcare professionals, employees or affiliated, of the healthcare company of the Region or Autonomous Province.
For general practitioners and paediatricians of free choice, the transfer of said material is carried out at the competent district, unless otherwise agreed between contracted doctors and the health company.
CONFERENCES AND CONGRESSES CONCERNING MEDICINES (art. 12 Legislative Decree 541/92 as amended by art. 48, paragraph 23 of Law 326/2003)
The art. 48, paragraph 23, of Law 326/2003 modified the art. 12, paragraph 6, of Legislative Decree 541/92 and provides that pharmaceutical companies, which organize or contribute to the realization of congresses, must be previously authorized by the Ministry of Health (now the Italian Medicines Agency) after consultation with the Region or Autonomous Province where the event is located.
With regard to the definition of the ways in which the operators of the National Health Service notify the Regions and Autonomous Provinces of their participation in initiatives promoted or financed by pharmaceutical companies and companies supplying medical devices (art. 48, paragraph 21, letter d), it is believed that the provision should be framed within the context of an organic revision of the Legislative Decree. 541/92 which also takes into account the advertising of medical devices similarly to that of medicines for human use.
Healthcare professionals who participate in events organized and/or promoted and/or financed, in any capacity, by pharmaceutical companies are required to notify their respective healthcare companies.
The Regions, in order to reduce some critical issues of the current scientific information system such as:
insufficient primary and secondary information on the risk-benefit ratio of drugs;
insufficient guarantees that scientific information is guaranteed, in a uniform way, to all doctors;
insufficient guarantees that scientific information is guaranteed, in a uniform way, on all medicines;
independence of scientific information;
marginality of public scientific information;
the lack of scientific information aimed at therapeutic strategies according to drug categories;
they can provide for the issuing of provisions for the establishment, at a provincial, company or inter-company or regional level, of special commissions where, indicatively, the following should be represented:
the Order of Doctors;
the Order of Pharmacists;
the paediatricians of free choice;
doctors employed by the NHS;
the Health Authority;
the Associations of scientific representatives.
In addition to the scientific information produced by the pharmaceutical industry, these commissions must be entrusted with the planning and implementation, also in collaboration with the pharmaceutical industry, of meetings with all the healthcare professionals operating in the catchment area, on specific issues related to the use of medicines.
SUPERVISION AND CONTROL
The Regions initiate continuous monitoring processes for the identification of tools, methods and actions aimed at verifying compliance with the provisions of this provision as well as at defining indicators of appropriateness of the scientific information activity, also in relation to the trend of pharmaceutical expenditure.
The Regions will be able to regulate the type and seriousness of the non-compliances relating to this provision with their own disciplinary provision, indicating any sanctions against the Pharmaceutical Company holder of the AIC or the non-compliant healthcare professionals.
For all the other scientific information activities referred to in Legislative Decree 541/92, the provisions on the subject of Legislative Decree 541/92 itself remain in force.
All violations of this provision and those relating to Legislative Decree 541/92 will be communicated not only to the competent authorities but also to the Ministry of Health and the Italian Medicines Agency, each for the matter of its own competence.
The adoption of guidelines for the regulation of scientific information on medical devices at regional level is desirable.