Title II - RULES OF PROCEDURE FOR THE CONTROL BODIES
CHAPTER IV - Procedures
33. PROCEDURE FOR COMMUNICATING EVENTS AND SCIENTIFIC MEETINGS
The provisions of this article only result of application to article 11 of the Code.
The communication of meetings and Events of a scientific and promotional nature that are subject to mandatory communication in accordance with the provisions of article 11.8 of the Code must be notified according to the following conditions:
Companies must provide prior notification of the hold- ing of any scientific or promotional meeting or Event when the following three circumstances concur:
a) that they are organized – directly or indirectly – or sponsored – exclusively or in the majority – by the reporting company;
b) they include at least one overnight stay; and
c) they involve the participation of at least 20 Health- care Professionals practicing in Spain.
Nevertheless, when a company organizes the attendance of a group of more than 20 Healthcare Professionals who practice in Spain to a conference or meeting organized by a third party (scientific societies, professional organizations, etc.), it must be communicated as if the Event were organized by the company itself. This communication will not be obligatory for Events that have been reviewed by the Code of Practice Surveillance Unit. To this end, the Unit will provide a system through which the list of Events organized by third parties, both at national and international levels, that have been reviewed by the Unit can be consulted.
The communication shall be addressed to the Code of Practice Surveillance Unit at least 10 working days before its beginning.
33.3. Information to be Provided
The communication must contain the following data:
a) Name and address of the company.
b) Nature of the participation: organizer or sponsor.
c) Title of the meeting or Event.
d) Healthcare Professionals to whom it is directed (specialty and place of residence – local/regional, national or international scope).
e) Number of Healthcare Professionals Invited.
f) Approximate number of participants at the Event.
g) Location and dates (if held at a hotel, name and rating and number of overnight stays).
h) Scientific programme, with an indication of the number of hours.
i) Social programme and parallel activities.
j) Other entities involved in the organization and sponsorship of the Event (scientific societies, professional organizations, foundations, etc.).
A procedure will be put in place to present these communications through electronic media to ensure the agility of the process, its efficacy and the confidentiality of data.
The Code of Practice Surveillance Unit must confirm receipt of the communications to the respective companies, at the same time may also request additional information or corrective measures for compliance with the Code, if necessary. In the latter case, if the company holds the Event without meeting the corrective measures, the Unit may initiate the corresponding complaint procedure.
The Unit will have five working days from receipt of the report to make any pronouncements on international Events that, according to the stipulations of article 11.10 (b) of the Code, require previous authorization. The absence of such a pronouncement within the stipulated time period will imply that the Event has been authorized.
33.4. Person Responsible
Each company will designate through their legal representative one or two persons responsible for communicating Events who will be the intermediary in these matters and who shall be assigned personal passwords for communicating Events via the Inter- net/electronic mail. This will also be the person who will contact the Code of Practice Surveillance Unit for any clarifications on the reported Events. The Code of Practice Surveillance Unit will maintain a database in which all reports received will be collected. This will be kept strictly confidential. This database must comply with current regulations on the protection of personal data.