Title II - RULES OF PROCEDURE FOR THE CONTROL BODIES
CHAPTER IV - Procedures
33. PROCEDURE FOR COMMUNICATING SCIENTIFIC MEETINGS
The provisions of this article only result of application to article 11 of the Code.
The communication of meetings 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:
33.1. Conditions
Pharmaceutical companies must provide prior notification of the holding of any scientific or promotional meeting when the following three circumstances concur:
- that they are organised – directly or indirectly – or sponsored – exclusively or in the majority – by the reporting pharmaceutical company;
- they offer at least one overnight stay; and
- they involve the participation of at least 20 Healthcare Professionals practicing in Spain.
Nevertheless, when a company organises the attendance of a group of more than 20 Healthcare Professionals who practice in Spain to a conference or meeting organised by a third party (scientific societies, professional organisations, etc.), it must be communicated as if the meeting were organised by the pharmaceutical company itself. This communication will not be obligatory for meetings 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 meetings organised by third parties, both at national and international levels, that have been reviewed by the Unit can be consulted.
33.2. Deadlines
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 pharmaceutical company.
b) Nature of the participation: organiser or sponsor.
c) Title of the meeting.
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 meeting.
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 organisation and sponsorship of the meeting (scientific societies, professional organisations, 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 pharmaceutical 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 meeting 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 meetings 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 meeting has been authorized.
33.4. Person Responsible
Each pharmaceutical company will designate through their legal representative one or two persons responsible for communicating meetings who will be the intermediary in these matters and who shall be assigned personal passwords for communicating meetings via the Internet/electronic mail. This will also be the person who will contact the Code of Practice Surveillance Unit for any clarifications on the reported meetings. 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.