Title II - RULES OF PROCEDURE FOR THE CONTROL BODIES
CHAPTER IV - Procedures
32. COMPLAINT PROCEDURE
The procedure will commence by a complaint from any person who has a legitimate interest in action being taken with regard to a specific activity, or by a complaint from the Code of Practice Surveillance Unit.
Complaints made to the Code of Practice Committee will be directed to the Secretary of the Code of Practice Committee, preferably by electronic mail to email@example.com whenever the size of the file and the nature of the acts being reported allow for the use of this medium.
A registry book with all complaints received will be maintained.
The complaints must contain, at a minimum, the following data:
a) Name and address of the complainant and, where applicable, personal data of the representative, who must certify the power of attorney. In the case of complaints made by the Unit, it is sufficient that this appears as the complainant.
b) Name and address of the defendant.
c) A detailed explanation of the facts constituting the presumed breach of the Code that is being reported and the appropriate request for this to be investigated.
d) Documents, evidence on which the complaint is based and, where applicable, an original copy of the promotional materials that are the source of dispute.
In addition, the complainant may also propose any other means of evidence to certify the activities denounced, which shall be used if deemed necessary by the Code of Practice Committee.
If the written complaint is missing any required information, the Secretary of the Code of Practice Committee will address a communication to the interested complainant requesting provision of the information, within a period of three days, in order to complete the file
If the time elapses without the interested party providing the information, the file will be closed, with no other processing, and this will be communicated to the complainant.
Complaints received through EFPIA will follow the same procedure.
Complaints will only be processed if:
a) They relate to promotional materials that have been carried out in the previous twelve months.
b) They relate to activities that were carried out within the previous 3 years.
c) They do not relate to complaints related to a promotional activity that has been resolved or is undergoing a legal process or administrative procedure.
Letters a) and b) do not apply when they concern a presumed ongoing breach, construed as the realization of a plurality of actions or omissions that breach the same or similar precepts of the Code, in execution of a preconceived plan or taking advantage of an identical or similar occasion.
Once the file has been completed, the Secretary will inform the defendant, which can make any allegations it deems convenient within five days of receiving the complaint. Written allegations should preferably be presented by electronic means.
Afterward, the Secretary will transfer a copy of the file with a succinct informative note to the members of the Code of Practice Committee so that the matter can be discussed at the next scheduled meeting. The order of issues will be determined by the Secretary of the Code of Practice Committee, according to the timetable for meetings that will be periodically published by circular in the FARMAINDUSTRIA self-regulation system web http://www.codigofarmaindustria.es. If the matter is considered urgent because of its importance, then the Secretary, after a verbal consultation with the members, will call an extraordinary meeting. The Secretary of the Code of Practice Committee will formally convene the parties, with a minimum of two working days notice, to a mediation hearing before the Code of Practice Committee.
If the Code of Practice Committee succeeds in assisting the parties in reaching an amicable agreement, the complaint will be resolved without the need to be transferred to the Jury. The mediation agreement reached will be signed by the parties. If an agreement were not possible, the Secretary of the Code of Practice Committee will transfer the file to the Jury within a maximum period of two days. In addition, the Secretary, in coordination with the Code of Practice Committee and the complainant, may transfer the file to the Jury if it appears that the defendant is delaying the mediation process unnecessarily.
In order to facilitate achieving an amicable agreement, the complainant may propose the terms under which an amicable agreement can be reached to the accused company, which will include the recognition of the breach by the company, as well as the corrective measures that are considered necessary based on the severity of the acts and with the objective or repairing the damage caused and preventing recurrence in the future. The mediation agreements will be published monthly on the FARMAINDUSTRIA website, except when the Code of Practice Committee considers it necessary to maintain the confidentiality of the agreement.
In the same way as the resolutions by the Jury, the parties must immediately comply with the agreement reached.
32.4. Direct Resolution by the Jury
When there are reasons for urgency, direct resolution of complaints by the Jury may be requested. Once the complaint has been admitted for processing, in accordance with the stipulations of section 32.2, the Secretary of the Code of Practice Committee may transfer the complaint to the defendant so that the allegations he/she feels are appropriate can be presented within the five days following receipt of the complaint. Once the file is complete, it will be transferred to the Code of Practice Committee so that said request can be resolved within a maximum of 2 days. If appropriate, it will be sent immediately to the Jury, which will act according to its owns Rules of Procedure. In case of rejection of the request, the file will continue the ordinary process.