The drug agency is waiting to understand what the new minister Speranza will decide to do with the top management. Meanwhile, many of the announced actions have not even been started
The Republic – 12 September 2019
The review of the pharmaceutical handbook is at a standstill, the executives leave and are not replaced, releases such as the one on single-dose drugs to be distributed to save money are a dead letter. Aifa, the Italian agency 
of the drug, is experiencing a phase of stasis, which risks worsening during the period of change of hands of the Ministry of Health. The director Luca Li Bassi (right photo), chosen by Giulia Grillo after evaluating a few dozen resumes, will now have to deal with a new health manager and probably hopes to stay in his position. It is not yet clear what Roberto Speranza will do, who has 90 days to exercise the spoil system and replace him but who for now seems busy choosing ministry collaborators.
It is a fact that Grillina's drug policy, which had announced itself as free, independent and for the savings of citizens to the detriment of the large profits of industry, has not made great progress in this sense. Proof of this is the famous "pharmaceutical governance" table. A group of personalities in the sector or in any case of technicians, from Silvio Garattini of Mario Negri to the former Emilian councilor and among other things former member of the Aifa board of directors Giovanni Bissoni (among other things belonging to the Mdp area like Minister Speranza), had written a detailed document that Grillo submitted to Li Bassi at the end of 2018 so that he could start applying it. There was talk of increasing the use of generics and biosimilars, of therapeutic equivalence (i.e. the possibility of giving the same reimbursement price to different but equally effective drugs for the same pathologies), of supra-regional tenders for hospital drugs, of the appropriateness of prescriptions and adherence to treatments. Of all this, and more, practically nothing has been done. Above all, the eagerly awaited work on the pharmaceutical handbook has not yet begun, which in the idea of the grillini and their advisors who are experts in drug policies, would finally make it possible to reduce the enormous number of medicines on the market in our country, many of which are old and no longer used, or useless, or finally "duplicates". A game that has been stagnant for years that the new health managers intended to unblock but did not start in their government period
At the same time, Aifa appears to have backed down on a number of promised things. Striking the one on 
paracetamol. For a few hours, a few months ago, a proposal appeared on the agency's website to pass this drug, which is generally paid by the patient, free of charge in certain cases. In the space of an afternoon, however, Dr. Li Bassi changed his mind. It is not well known what happened to another announcement, that of having single-dose drugs or better with the dosage based on the therapy. It would have served to reduce the waste caused by packages with more pills than necessary, which remain abandoned in the lockers of Italians. Another promise made by management was to add a specification on the adverse effects of drugs to the report on the pharmacovigilance of vaccines, i.e. the damage caused by them. The vaccine document, moreover drawn up largely by the ministry's experts, was released at the beginning of August, the Aifa document on drugs was not seen.
Li Bassi, and Grillo, rightly rejoiced for having brought to the WHO a resolution which demands transparency on the price of medicines from multinationals. Quite right, given that it is known that pharmaceutical companies play different games in various countries to extract the best price based on the economic situation. And in any case, many medicines have enormous costs for health systems. However, the results of the meritorious action promoted by Italy are not visible at the moment.
Rather, we can clearly see the situation that Aifa is experiencing internally in recent weeks. There are vacant directorates, governed by acting functions, which cannot be filled. There are 12 sectors without a dedicated guide, 
that is, entrusted ad interim, most of it to the capable doctor Giovanna Romeo, who arrived in Aifa from the ministry, it is said, precisely to lend a hand to Li Bassi when Grillo realized that he couldn't do it alone. Among other things, the minister thus inaugurated a season of interference by Lungotevere Ripa in the agency that had never been seen in recent years. Among the managements in the hands of acting officials, some are central, such as the personnel, the legal office or the HTA, which is in charge of working on the prices of the medicines that Aifa approves. Precisely for the HTA area, a tender was even made last November, which was subsequently closed without being assigned.
Li Bassi is therefore not appointing the top management of the agency. And moreover in September another 6 or 7 senior figures expire (among these the authorization area, lscientific information, the office for economic evaluations, drug innovation and strategy) and no acts have yet been made, i.e. interpellations, to choose successors. Finally, imagine that the director according to the Calabria decree should appoint two new figures, two deputy directors who support him from an administrative and scientific point of view. Two more appointments to be made that are not on the horizon for now. All to accentuate the inaction of the national agency which should deal with quickly approving the really useful drugs for Italian patients.
Michael Bocci
Ed: Legislative Decree 219/06 gives AIFA control over the regularity of scientific information on medicines. Since 2006 she has been in charge of drafting guidelines on scientific information. 13 years later they still have to be done. It seemed imminent a few months ago after hearing from the pharmaceutical industry associations, obviously the scientific representatives have not been considered, but as of today they are not there yet.
The "multiple mandated" ISF must be authorized by a Ministry Decree subject to the opinion of AIFA. There are no positive opinions from AIFA in this sense and yet there are unpunished companies that hire "multi-mandate" ISFs (the last request of today).
The scientific service on which the ISF depend must be independent from marketing, which rarely occurs. The ISF with an agency contract paid with the commissions on the drugs it "sells" is also common. The inclusion in the CCNL of chemists in the marketing functional area of the ISFs whose hierarchical referent is an Area Manager wholly dependent on marketing is also incredible. AIFA obviously knows nothing.
There are no sanctions from AIFA to pharmaceutical companies on scientific information carried out irregularly since Legislative Decree 2019 of 2006 has been in force which, moreover, has incorporated a previous decree of 1992, the Legislative Decree 541. That is, in 27 years, no infractions! We may have missed it, but it's probably a model sector!
Certainly there will have been some sanctions, such as the samples held irregularly by the ISF or the lack of written requests by some ISF for the delivery of samples of medicines.
Below are some articles of Legislative Decree 219/06
Art.119: 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, having consulted the pharmaceutical industry associations.
If the promotional information to healthcare professionals is carried out in violation of the provisions and criteria and directives adopted by AIFA pursuant to paragraph 2, the Agency itself:
a) orders the immediate cessation or suspension of the promotional information;
b) orders the dissemination, at the offender's expense, of a correction and clarification press release, the drafting of which will be handled according to the methods established by AIFA. This press release may be inserted by AIFA in the Bulletin of information on drugs and on the institutional website of the same and, by and at the expense of the Company, on the latter's website or even in national newspapers.
Article 120: AIFA may, at any time, with a motivated provision, also taking into account the guidelines referred to in paragraph 2 of article 119, prohibit or suspend the disclosure of the documentation referred to in paragraph 1, if it considers it to be in conflict with the provisions and principles of this decree.
Art.122: Information on medicines can be provided to the doctor and pharmacist by the scientific representatives. In January of each year, each pharmaceutical company must notify AIFA, on a regional basis, of the number of healthcare professionals visited by its scientific representatives in the previous year, specifying the average number of visits made. To this end, within the month of January of each year, each pharmaceutical company must communicate to AIFA the list of scientific representatives employed during the previous year, with an indication of the educational qualification and the type of employment contract with the pharmaceutical company.
The activity of scientific representatives is carried out on the basis of an employment relationship established with a single pharmaceutical company. With decree of the Minister of Health, on the proposal of the AIFA, derogations from the provisions set out in the previous period may be envisaged, due to the size and characteristics of the companies.
Article 124: in Italy or abroad, a congress, convention or meeting on issues relating to the use of medicines produced or marketed by the same company must be sent to the competent AIFA office
