Title I - PROVISIONS OF THE CODE
CHAPTER V – Rules of application, Monitoring, Breaches and Sanctions
22. BREACHES AND SANCTIONS
22.1. Breaches will be classified as minor, severe and very severe, according to the following criteria:
a) Magnitude of the breach and, in particular, its possible risk to patient health.
b) Repercussion on the medical or scientific profession, or on society in general of the act that generates the breach.
c) Unfair competition.
d) Generalization of the breach.
f) Damage to the image of the pharmaceutical industry.
Once the breach has been classified as minor, severe or very severe according to the above criteria, aggravating factors may be involved that will be taken into account by the Jury when imposing the corresponding sanctions according to the scale in section 2 of this article. Accumulation of aggravating factors may modify the initial classification of "minor" to "severe" or "severe" to "very severe". These aggravating factors are as follows:
i) Degree of intentionality.
ii) Non-compliance with prior warnings.
iii) Concurrence of several breaches in the same act or activity.
iv) Financial benefit for the company derived from the breach.
Additionally, for qualifying and determining the pecuniary sanction, the Jury may take into account the estimated total cost of the infringing activity.
22.2. In light of the criteria indicated above, the Jury and the Executive Board of FARMAINDUSTRIA, where applicable, in accordance with the stipulations of section 3 of this article, may impose the following pecuniary sanctions:
a) Minor breaches: From 6,000 to 120,000 Euro.
b) Severe breaches: From 120,001 to 240,000 Euro.
c) Very severe breaches: From 240,001 to 360,000 Euro.
In the case of breaches categorized in articles 11.9, 14.3 and 16.2, the first two times they occur, they will be subject to a warning by the Code of Practice Surveillance Unit and, in the Event of a third successive breach within a period of less than one year, the applicable sanctions will be 1,000 Euro for each obligatory communicating activity that has not been reported in due time and appropriate form to the Code of Practice Surveillance Unit.
In complaints presented by the Code of Practice Surveillance Unit, the Jury, in addition to pecuniary sanctions, may impose on the infringing company the corrective or rectifying measures proposed by the Unit in the mediation meeting, according to the severity of the acts and always with the objective of repairing the damage caused and preventing its recurrence in the future.
In cases in which the Jury detects the existence of a breach and the affected company has acted in good faith in accordance with a query as stipulated in article 20 of the Code made by the company itself, provided the facts and the terms of the query are identical, the Jury will request that the company cease this conduct but will not impose any other sanction.
22.3. FARMAINDUSTRIA will collect those contributions agreed during the mediation phase and execute the sanctions imposed by the Jury. The amount obtained from pecuniary sanctions will be used to constitute a special fund in FARMAINDUSTRIA that will be set aside for promoting the rational use of medicines. FARMAINDUSTRIA Board of Directors, as proposed by the Code of Practice Committee or the Code of Practice Surveillance Unit, will impose and execute the sanctions for non-compliance as stipulated in articles 11.9, 14.3, 16.2, 18, 21.5 and 22.8 of this Code. In these cases, companies that are directly affected by the matter analysed shall abstain from participating in the deliberations and agreements of the Executive Board.
22.4. In cases of severe or very severe breaches, or when the contents of a resolution issued by the Jury are not honored, the Code of Practice Committee and the Code of Practice Surveillance Unit – in cases in which the latter acts as a complainant – may propose to the Governing Council that FARMAINDUSTRIA proceed with issuing a complaint against the offending company to the competent health authorities and/or propose that the Executive Board of the Association expel the company from the association, following the procedure outlined in the Association bylaws. If the company is expelled for this reason, readmission cannot be considered for a period of at least one year.
22.5. Readmission of the company to the Association will only occur after this period has elapsed if the company expressly commits not to carry out practices prohibited by the Code and after all fees that would have applied during the expulsion period have been paid.
22.6. In all cases, in the resolution adopted by the Jury, a determination will be made as to which party or parties are responsible for the administrative costs incurred in processing the complaint to AUTOCONTROL. All of the fees accrued by AUTOCONTROL for processing the procedure, as well as the monetary costs of expert support, where applicable, as determined by the Jury — by ruling or at the request of the party — will be the responsibility of the party that has had all its claims rejected. If the ruling were partial, each party will pay its own costs and half the administrative costs mentioned above.
22.7. In the Event of repeated complaints that are clearly unfounded, the Jury may impose a pecuniary sanction as it sees fit. This sanction will be in proportion to the supposed severity of the alleged acts.
22.8. Repeated and unfounded reporting of presumed breaches to the Code of Practice Surveillance Unit may also be subject to sanctions by the Executive Board, at the proposal of the Code of Practice Surveillance Unit.