spanish code of practice for the promotion of medicines confidential "international congresses,...

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



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.



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.


GOALS



CONFIDENTIAL

CODE COVERAGE


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



CONFIDENTIAL

ACTIVE

MONITORING

RESOLVES

AND

PUBLISHES

SEEKS FOR

CONCILIATION

THE CONTROL BODIES

Code of PracticeSurveillance

Unit

Code of Practice

Committee

Self-Regulation Jury




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




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




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



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?




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



CONFIDENTIAL


GENERAL STANDARDS APPLICABLE IN SPAIN: EVENTS & HOSPITALITY



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.




CONFIDENTIAL





CONFIDENTIAL

NON PERMITTED PARTICIPATION




CONFIDENTIAL

POSSIBLE PARTICIPATION WITH COMMENTS




CONFIDENTIAL

POSSIBLE PARTICIPATION




CONFIDENTIAL

ON STUDY BY THE SURVEILLANCE UNIT




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.





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




CONFIDENTIAL

GOLF TOURNAMENT DURING THE MEETING

CASE STUDY




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.




CONFIDENTIAL

CASE STUDY




CONFIDENTIAL

CODE COMPLIANCE NETWORK (CCN)




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

spanish code of practice for the promotion of medicines confidential "international congresses,...

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