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(1)

THE

MDEON CODE

OF

ETHICS

interactionS between HeaLtHcare

ProFeSSionaLS and the PHarMaceUticaL

and MeDicaL DeViceS inDUStrY

(2)

Why a Code of Ethics?

The relationship between the Pharmaceutical and Medical Devices industry and Healthcare Professionals is legitimate and important in order to optimize patient care.

It is paramount to preserve and to support the obligation of Healthcare Professionals to make independent decisions regarding the treatment of their patients. Only ethical interactions between Companies and Healthcare Professionals can guarantee such independence.

Anchored within a European legal framework, the Mdeon Code of Ethics develops principles which govern the inter-actions between the Pharmaceutical and Medical Devices Industry and Healthcare Professionals and, in particular, the three types of grants and advantages which may be offered by Companies.

1. Rewarding of scientific acts

Healthcare professionals may receive compensation from pharmaceutical or medical devices companies in exchange for legitimate scientific activities carried out on behalf of those companies.

“Activities of a scientific nature” should be interpreted as being the collaboration of healthcare professionals taking part in clinical trials, the presentation of scientific papers during teaching lectures, seminars, symposiums or congresses and the execution of consultancy agreements of a scientific nature.

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2. Allowances and Benefits

It is acceptable to offer healthcare professionals benefits or allowances of low monetary value. Such gifts, however, must be in relation with the practice of the profession. The offering or receiving of personal gifts is not acceptable.

3a. Payment of costs of participation in a scientific event

Support for continuing education of Healthcare Professionals by companies requires that different ethical principles be adhered to, which are applicable to any sponsored event, independent of its duration, ie:

the event must be of an exclusively scientific nature

the hospitality provided must be reasonable and remain of a subsidiary nature in terms of the scientific aims of the event

the hospitality provided must not include any sporting or leisure events or other kind of entertainment

the place, date and duration of the event must not lead to any confusion regarding its scientific nature

the hospitality provided must be limited to the official duration of the scientific event payments of costs of participation is limited to healthcare professionals only

costs related to lengthening of stays must be paid-for by the healthcare professionals themselves.

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3b. Preliminary visa obligation for events that extend over several

days

When an event takes place over several days the level of sponsoring is subject to the granting of a visa beforehand.

The Mdeon Bureau of visas will check that the ethical principles governing the financial sponsoring for a scientific event are adhered to.

The visa number provided is a guarantee that the project sponsorship is consistent with current legislation and ethics. This is of key importance as both companies and the healthcare professionals are legally responsible that visa obligation be strictly adhered to. For more details concerning visa obligations see www.mdeon.be and the flyer «Visa for the sponsoring of continuing education».

The offering of benefits and allowances is in principle prohibited

Points 1 to 3 are exemptions to a legal disposition* which prohibits in general the offering of benefits andallowances by the industry to healthcare professionals, and the solicitation of benefits and allowances. If a sponsorship doesn’t enter in one of those three legal exemptions it consequently falls into the general prohibition and cannot be neither offered, nor accepted, nor solicited.

The Federal Agency for Medicines and Health Products (F.A.M.H.P.) is the competent body controlling the observance of this general prohibition.

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The 19 Mdeon members (2012)

Medical Associations

Association Belge des Syndicats Médicaux asbl/Belgische Vereniging van Artsensyndicaten vzw (ABSyM-BVAS)

Cartel asbl/Kartel vzw Domus Medica vzw

Groupement des Unions Professionnelles Belges de Médecins Spécialistes, Union professionnelle reconnue/Verbond der Belgische Beroeps- verenigingen van Geneesheren-Specialisten, erkende beroepsvereniging (GBS-VBS)

Société Scientifique de Médecine Générale asbl (SSMG) Syndicaat van Vlaamse Huisartsen vzw (SVH)

Associations of Pharmacists

Association Pharmaceutique Belge, Fédération nationale des Unions professionnelles pharmaceutiques/Algemene Pharmaceutische Bond, Nationale federatie van Belgische Apothekersverenigingen (APB)

Instituut voor Permanente Studie voor Apothekers vzw (IPSA)

Office des Pharmacies Coopératives de Belgique, Union professionnelle reconnue/ Vereniging der Coöperatieve Apothekers, erkende beroepsvereniging (OPHACO)

Société Scientifique des Pharmaciens Francophones asbl (SSPF) Veterinary Associations

Formavet asbl

Union Professionnelle Vétérinaire asbl (UPV) Dental Associations

Vlaamse Beroepsvereniging Tandartsen, erkende beroepsvereniging (VBT)

Associations of Nurses

Nationaal Verbond van Katholieke Vlaamse

Verpleegkundigen en Vroedvrouwen vzw (NVKVV) Associations of paramedicals

Fédération Belge des Podologues asbl/Federatie van Belgische Podologen vzw (FBP) Associations representing the Industry

Bachi asbl FeBelGen asbl pharma.be asbl Unamec asbl

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Editor: Ph. M-H. Cornély • Av. du Roi Albert Ier, 64 à 1780 Wemmel • 2012.

etHicaL HeaLtHPLatForM

Do you require further details?

Various types of information are available on our Internet site. Do not hesitate to get in touch with us:

Asbl Mdeon

Avenue du Roi Albert Ier, 64 - 1780 Wemmel T. +32 2 609 54 90

F. +32 2 609 54 99 info@mdeon.be

https://www.mdeon.be

For any further questions concerning the a posteriori control, please get in touch with the « Contact-Point » set up by the authorities: Agence Fédérale des Médicaments et Produits de Santé/ Federaal Agentschap voor Genees-middelen en Gezondheidsproducten (A.F.M.P.S./ F.A.G.G.)

Eurostation II

Place Victor Horta, 40 boîte 40 - 1060 Bruxelles www.afmps.be

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