Spanish Code of Practice for the
Promotion of Medicines
CONFIDENTIAL
"International congresses, including booth materials and panels, controls related to non-CME medical presentations, and interactions between
commercial associates and health care professionals before/after CME events:
Which guidelines apply?"
Dr. José F. Zamarriego IzquierdoParis, May 29th 2008
Spanish Code of Practice for the
Promotion of Medicines
CONFIDENTIAL1991: Adoption of the Spanish Code on the basis of EFPIA Code (adapted
in 1992).2002: Approved a much more stringent and precise new version of the Code.2004: New version with additional measures to reinforce this self-regulation system. 2005: New adaptation, incorporating elements from EFPIA Code new
version (Nov 04). 2008: Code New Version & New Code: Interaction with Patient Organizations (July 08).
INTRODUCTION
DOCUMENTS (www.farmaindustria.es)
Spanish Code Of PracticeRules of Procedure for the Control BodiesImplementation Guide Queries (Questions And Answers) on the Interpretation of the Code
The Code covers all promotional actions addressed at Spanish healthcare professionals wherever they may take place (i.e. Spain, USA, South Africa, China....).
THE SPANISH CODE OF PRACTICE
Applicable to members of Farmaindustria and to the pharmaceutical companies adhered to the Code.
Spanish Code of Practice for the
Promotion of Medicines
CONFIDENTIAL
GUARANTEE
Information available and distributed to healthcare professional able to prescribe and dispense medicines, being accurate, balanced, fair, objective and complete.
That such promotion is done respecting the most stringent ethical principles of professionalism and responsibility.
ESTABLISH
Establish a framework for the conduct of promotional activities by the industry, offering guidance and facilitating compliance by pharmaceutical companies of applicable rules.
THE SPANISH CODE OF PRACTICE
GOALS
Spanish Code of Practice for the
Promotion of Medicines
CONFIDENTIAL
CODE COVERAGE
THE SPANISH CODE OF PRACTICE
FARMAINDUSTRIA MEMBERS (ASSOCIATES)
- NATIONAL COMPANIES: 98 (Large 10, Medium 6, Small 82)
- INTERNATIONAL COMPANIES: 118 (Large 27, Medium 27, Small 64)
Approximately 250 Pharmaceutical Companies representing the 98% total sales of prescription medicines in Spain
ADHERE COMPANIES (National & International)
- Companies that voluntarily submit their promotion activities to the Code
- Companies that are EFPIA members
Spanish Code of Practice for the
Promotion of Medicines
CONFIDENTIAL
ACTIVE
MONITORING
RESOLVES
AND
PUBLISHES
SEEKS FOR
CONCILIATION
THE CONTROL BODIES
Code of PracticeSurveillance
Unit
Code of Practice
Committee
Self-Regulation Jury
THE SPANISH CODE OF PRACTICE
Spanish Code of Practice for the
Promotion of Medicines
CONFIDENTIAL
Prepares answers
Control actions
THE CONTROL BODIES
FARMAINDUSTRIABoard of Governors
PharmaceuticalCompanies
Code of Pr.Surveillance
Unit
Code of Practice
Committee
Self-regulation Jury
Appointment and reporting
Surveillance
Complaints
Biding Querires
Appoints the Director
Other Stakeholders
Inititate procedures
Ask for clarification
(queries)
Resolv
es
qu
eir
es
Seeks conciliation…if
no agreement...
Submits complaints (as party)
Com
mu
nic
ate
p
ossib
le
infr
i ng
em
en
ts
Communicate Events Info
Supervises
Communicate possible
infringements
Prepares Surveillance Plans
and Reports every 3 months
An
nu
al
Rep
ort
Ap
poin
ts
Sets ruling,
sanctions (if
applicable) and
publishes rulings
Electronic Inf. 3rd parties events
Subm
its
com
pla
ints (a
s
party)
Control Bodies
THE SPANISH CODE OF PRACTICE
Spanish Code of Practice for the
Promotion of Medicines
CONFIDENTIAL
1 MARKETING AUTHORIZATION
2 INFORMATION TO BE MADE AVAILABLE
3 INFORMATION AND ITS SUBSTANTIATION
4 ACCEPTABILITY OF PROMOTION
5 TRANSPARENCY OF PROMOTION
6 USE OF REFERENCE QUOTATIONS
7 DISTRIBUTION OF PROMOTIONAL MATERIAL
8 PROMOTION VIA INTERNET
9 SCIENTIFC SERVICE AND REVIEW OF PROMOTIONAL MATERIAL
10 GIFTS AND INDUCEMENTS
11 HOSPITALITY AND MEETINGS
ARTICLES
INTRODUCTION, PURPOSE AND SCOPE OF THE CODE
THE SPANISH CODE OF PRACTICE
Spanish Code of Practice for the
Promotion of Medicines
CONFIDENTIAL
12 PHARMACEUTICAL COMPANY STAFF
13 SAMPLES
14 STUDIES
15 RULES OF APPLICATION OF THE CODE
16 REQUEST FOR QUERIES
17 CONTROL OF THE BODIE COMPLIANCE
18 INFRINGEMENTS AND SANCTIONS
19 IMPLEMENTATION GUIDES AND COLLABORATION AGREEMENTS
20 DISCLOSURE AND COMPLILATION OF DECISIONS
21 DATE OF ENTRY INTO FORCE OF THE CODE
THE SPANISH CODE OF PRACTICE ARTICLES
Spanish Code of Practice for the
Promotion of Medicines
CONFIDENTIAL
HOSPITALITY AND MEETINGS
CONGRESSES AND SCIENTIFIC EVENTS FUNDED BY THE INDUSTRY
88.
11.
The behaviour of the pharmaceutical companies must be guided by this principles:
Scientific goals must represent the main focus in the organization of such meetings
Hospitality should be reasonable at all times, and must always be secondary to the main purpose of the meeting
A useful criterion
Would the company like that all details of the organization of the event to be widely disseminated?
THE SPANISH CODE OF PRACTICE
Spanish Code of Practice for the
Promotion of Medicines
CONFIDENTIAL
LAB THIRD PARTIES
4* YES YES
NO NO
BUSINESS HOTEL BUSINESS HOTEL>200 PARTICIPANTS >200
VENUE VENUE OR USD NOT AVAILABILITY
S. 5* / L. 5* / G.L.5* / SPORTS / THEMES / WINERY
NO NO
5*
NO: To lodge, stands, rooms, auditorium, facilities, meals…
INTERNATIONAL EVENTS: safety, security, image and local rankings additional criteria
National and International Events
THE SPANISH CODE OF PRACTICE HOSPITALITY AND MEETINGS: HOTELS CRITERIA
Spanish Code of Practice for the
Promotion of Medicines
CONFIDENTIAL
THE SPANISH CODE OF PRACTICE
GENERAL STANDARDS APPLICABLE IN SPAIN: EVENTS & HOSPITALITY
Spanish Code of Practice for the
Promotion of Medicines
CONFIDENTIAL
Located on Farmaindustria intranet there is a useful tool, available to all its members, through which the national and international events organized by third parties that have been reviewed by the Unit can be consulted.
EVENTS ORGANIZED BY THIRD PARTIES
System available to companies Compliance Officers only.
THE SPANISH CODE OF PRACTICE
Spanish Code of Practice for the
Promotion of Medicines
CONFIDENTIAL
EVENTS ORGANIZED BY THIRD PARTIES
THE SPANISH CODE OF PRACTICE
Spanish Code of Practice for the
Promotion of Medicines
CONFIDENTIAL
NON PERMITTED PARTICIPATION
THE SPANISH CODE OF PRACTICE
Spanish Code of Practice for the
Promotion of Medicines
CONFIDENTIAL
POSSIBLE PARTICIPATION WITH COMMENTS
THE SPANISH CODE OF PRACTICE
Spanish Code of Practice for the
Promotion of Medicines
CONFIDENTIAL
POSSIBLE PARTICIPATION
THE SPANISH CODE OF PRACTICE
Spanish Code of Practice for the
Promotion of Medicines
CONFIDENTIAL
ON STUDY BY THE SURVEILLANCE UNIT
THE SPANISH CODE OF PRACTICE
Spanish Code of Practice for the
Promotion of Medicines
CONFIDENTIAL
Positive effects: When a national event is marked as non permitted:
- Laboratories contact the organisers to let them know that there are some items that do not comply with the Code.
- Organisers contact the Surveillance Unit for advise, make the correct changes for an approval qualification and send a signed letter certifying it.
- Surveillance Unit changes the non permitted mark for the possible participation with comments marked and send an email to the laboratories to let them know the new conditions.
EVENTS ORGANIZED BY THIRD PARTIES
THE SPANISH CODE OF PRACTICE
Spanish Code of Practice for the
Promotion of Medicines
CONFIDENTIAL
Procedure followed once an event which might; (i) cause an infringement of the Code of Practice or (ii) represents a material risk for pharmaceutical industry image; is identified:
Contact with the organizers (Scientific Society or Technical Secretary),
If necessary give a brief explanation of our self-regulation system (Article 11) and the role of the Surveillance Unit,
Indicate aspects related with the meeting that do not allow pharmaceutical industry collaboration. Explain why,
Propose solutions, alternatives, recommendations, modifications,
Inform companies about the result of this process and qualify the event.
CASE STUDY
THE SPANISH CODE OF PRACTICE
Spanish Code of Practice for the
Promotion of Medicines
CONFIDENTIAL
GOLF TOURNAMENT DURING THE MEETING
CASE STUDY
THE SPANISH CODE OF PRACTICE
Spanish Code of Practice for the
Promotion of Medicines
CONFIDENTIAL
CASE STUDY
Hereby confirm that the golf tournament has been cancelled and that no golf tournament will take place. The President of the Organization Committee.
THE SPANISH CODE OF PRACTICE
Spanish Code of Practice for the
Promotion of Medicines
CONFIDENTIAL
CASE STUDY
THE SPANISH CODE OF PRACTICE
Spanish Code of Practice for the
Promotion of Medicines
CONFIDENTIAL
CODE COMPLIANCE NETWORK (CCN)
THE SPANISH CODE OF PRACTICE
Spanish Code of Practice for the
Promotion of Medicines
CONFIDENTIAL
CODE COMPLIANCE NETWORK (CCN)
THE SPANISH CODE OF PRACTICE
Spanish Code of Practice for the
Promotion of Medicines
CONFIDENTIAL
CONCLUSIONS
KEEPING AND REINFORCING THE CRITICAL ASPECTS, THE SELF-REGULATION SYSTEM IS
A STRENGTH OF THE PHARMACEUTICAL INDUSTRY TO POSITIVELY IMPROVE ITS
IMAGE BEFORE THE WHOLE SOCIETY (PUBLIC ADMINISTRATION, HEALTHCARE
PROFESSIONALS AND PATIENTS)
THE SPANISH CODE SURVILLANCE UNIT
Velázquez 109E - 28006 Madrid - SpainTel. +34 91 7452050Fax +34 91 [email protected]
www.farmaindustria.es