CODE OF CONDUCT DATEN & FAKTEN 2012 .coc committees of experts of the 1st and 2nd instance daten

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Transcript of CODE OF CONDUCT DATEN & FAKTEN 2012 .coc committees of experts of the 1st and 2nd instance daten

  • CODE OF CONDUCTPHARMIG CODE OF CONDUCT ANDCODE OF PROCEDURE OF THE COC COMMITTEES OF EXPERTS OF THE 1ST AND 2ND INSTANCE

    DATEN & FAKTEN 2012 ARZNEIMITTEL UND GESUNDHEITSWESEN IN STERREICH

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  • DATEN & FAKTEN 2012 ARZNEIMITTEL UND GESUNDHEITSWESEN IN STERREICH

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    Coming into force on 01/07/2007 Last amendment at the General Assembly on 25/04/2014 coming into force on 01/07/2014

    CODE OF CONDUCTPHARMIG CODE OF CONDUCT

    AND

    CODE OF PROCEDURE OF THE COC COMMITTEES OF EXPERTS OF THE 1ST AND 2ND INSTANCE

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  • CODE OF CONDUCT

    IMPRINT

    IMPRINT

    OWNER AND PUBLISHER

    Pharmig Association of the Austrian Pharmaceutical Industry

    Garnisongasse 4/1/6, 1090 Vienna, Austria

    Phone. +43/1/40 60 290

    Fax +43/1/40 60 290-9

    E-mail: office@pharmig.at

    Web: www.pharmig.at

    This edition can also be downloaded from our homepage.

    In any case the German version prevails.

    PRODUCED BY

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    Druckhausstrae 1, 2540 Bad Vslau, Austria

    GENDER NEUTRALITY

    All terms referring to individuals are generic and refer to both genders.

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    CODE OF CONDUCT

    FOREWORD

    5

    PHARMIG DATEN & FAKTEN

    VORWORT

    LIEBE LESERIN, LIEBER LESER!

    Vor Ihnen liegt eine neue Ausgabe Daten & Fakten: uerlich aufgefrischt und inhaltlich aktuell ergnzt. Die Ausgabe 2012 enthlt neue Themen wie Rahmen-Pharmavertrag, Arzneimittelberwachung oder Biophar-mazeutika im Erstattungsmarkt. Im ebenfalls neuen Teil Gesundheitsverhalten und Prvention gehen wir schwer-

    punktmig auf die alarmierenden Zahlen ein, die den knftigen Handlungs-bedarf im Hinblick auf Kinder- und Jugendgesundheit zeigen. Einzelne Bereiche wurden neu strukturiert, um die Inhalte noch kompakter und bersichtlicher zur Verfgung zu stellen. Ihnen ist sicher auch aufgefallen, dass die Daten & Fakten erstmals nur noch halb so umfangreich sind wie in den Jahren zuvor. Das liegt daran, dass die bisher enthaltene englische Version Facts & Figures ab nun als Download-Dokument auf unserer Homepage www.pharmig.at im Bereich Publikationen verfgbar ist.

    Viel Freude mit den neuen Daten & Fakten!

    Herzliche Gre,

    Dr. Jan Oliver HuberGeneralsekretr der Pharmig

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    LADIES AND GENTLEMEN,

    Medicinal products are precious, technologically well developed products, which provide an essential part for the public healthcare of our society. Effective medicinal therapies guarantee the efficient use of recourses within the public health care system. Medicinal products help to save costs in the public healthcare system. A successful research into medicinal products is not conceivable without the cooperation between pharmaceutical enterprises and healthcare professionals. Therefore it is essential to define the basic rules of this cooperation in a transparent and fair manner.

    The trust in this cooperation is strenghtened and continually enhanced by common shared transparency. A separate provision requires the pharmaceutical companies to disclose the transfers of value made to healthcare professionals or institutions. Transparency is a strength and self-regulation ensures the right balance.

    In addition to research and marketing of medicinal products, it is of high importance for the pharmaceutical industry, to provide support for a highly developed public healthcare system on supplying appropriate and balanced information. To highlight the value and potential risks of medicinal products is an indispensable and necessary duty of the pharmaceutical companies. It is the pharmaceutical industrys social obligation, even its social responsibility to communicate relevant information on medicinal products to patients as well as to specialist circles of the public health care system. Therefore it is of general importance to consider the principles of exactitude, objectivity, fairness and transparency, in order to guarantee a safe use of medicinal products for physicians and for patients. In addition to the scientific information on medicinal products, advertising is an essential element of market economy and expression of intensive competition. Therefore not only the principles of the Pharmig Code of Conduct have to be met, but also the competition regulations have to be followed.

    The voluntary restraint of the Pharmig Code of Conduct bears witness to a strong sense of responsibility and to the declared intention of our members, to represent the ethic standards of the pharmaceutical branch. The pharmaceutical industry gives actively a clear sign to support the reasonable and responsible use of medicinal products.

    Thus: Our aim remains to provide all patients in Austria with the appropriate medicinal products to bear our responsibility within the Austrian public health care system to the best of our knowledge.

    The current version of the Pharmig Code of Conduct and the Code of Procedure of the CoC Committees of the 1st and 2nd instance came into force on 01/07/2007 with the last amendment as by 01/07/2014.

    Jan Oliver HuberSecretary General of Pharmig

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    CODE OF CONDUCT

    TABLE OF CONTENTS

    PHARMIG CODE OF CONDUCT

    Article 1 Introduction 7

    Article 2 Scope 7

    Article 3 General principles 8

    Article 4 Information on medicinal products 8

    Article 5 Advertising medicinal products 11

    Article 6 Information and advertisement via the Internet 12

    Article 7 Events for healthcare professionals 14

    Article 8 Cooperation with healthcare professionals and institutions 15

    Article 9 Transparency 18

    Article 10 Cooperation with patients organisations 21

    Article 11 Benefits 24

    Article 12 Raffles 25

    Article 13 Pharmaceutical company employees 25

    Article 14 Clinical trials 26

    Article 15 Violation of the MPA 26

    Article 16 CoC ordinance 26

    ORDINANCE 1/2010 OF THE PHARMIG BOARD REGARDING NON-INTERVENTIONAL STUDIES (VO-NIS 1/2010)

    Artikel 1 Scope of Application 27

    Artikel 2 Definitions 28

    Artikel 3 Purpose of NIS 28

    Artikel 4 Distinction from Clinical Studies 29

    Artikel 5 Designing a NIS 29

    Artikel 6 Reviewing a NIS 31

    Artikel 7 Approving a NIS 32

    Artikel 8 Commencement and Transitional Provisions 32

    ORDINANCE 1/2014 ADOPTED BY THE BOARD OF PHARMIG ON ARTICLES 7 AND 8 OF THE PHARMIG CODE OF CONDUCT (VALUE LIMITS FOR BOARDS AND HOSPITALITY) 33

    Ordinance on Articles 7 and 8 CoC 33

    ORDINANCE 2/2014 ADOPTED BY THE BOARD OF PHARMIG ON ARTICLE 9 OF THE PHARMIG CODE OF CONDUCT (TRANSPARENCY) 35

    Ordinancy on Article 9 CoC 35

    COC Ordinance on Article 9 Standardized template for the documentation of data to be disclosed 37

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    CODE OF CONDUCT

    TABLE OF CONTENTS

    CODE OF PROCEDURE OF THE COC COMMITTEES OF EXPERTS OF THE 1ST AND 2ND INSTANCE

    Article 1 Tasks and responsibilities of the Committees of Experts 1st and 2nd Instance 39

    Article 2 Language of correspondence / Language of proceedings 40

    Article 3 Venue for proceedings 40

    Article 4 Rights of defence 40

    Article 5 Complainant 40

    Article 6 Object and admissibility of the complaint 41

    Article 7 Content and form of the complaint Article 8 42

    Article 8 Rights and liabilities of the complainant 42

    Article 9 CoC Committee of Experts of the 1st Instance 43

    Article 10 Simplified proceedings before the CoC Committee of Experts of the 1st Instance 43

    Article 11 Continuation of the proceedings before the CoC Committee of Experts of the 1st Instance 44

    Article 12 Oral proceedings 45

    Article 13 Representation of the company concerned 46

    Article 14 Decision of the CoC Committee of Experts of the 1st Instance 46

    Article 15 Sanctions of the CoC Committee of Experts of the 1st Instance 47

    Article 16 Appeal 49

    Article 17 CoC Committee of Experts of the 2nd Instance 49

    Article 18 Decision of the CoC Committee of Experts of the 2nd Instance 50

    Article 19 Non-appealability of the decision of the CoC Committee of Experts of the 2nd Instance 51

    Article 20 Partiality 51

    Article 21 Deadlines, deliveries and notifications 52

    Article 22 Pharmig Office 53

    Article 23 Secrecy 53

    Article 24 Members of the CoC Committee of Experts of the 1st Instance 53

    Article 25 Members of the CoC Committee of Experts of the 2nd Instance 54

    Article 26 Common regulations for the appointment of members to the CoC Committees of Experts of the 1st and 2nd Instance 55

    Article 27 Costs of the CoC Committees of Experts of the 1st and 2nd Instance 55

    Article 28 Cost of the simplified proceedings before the CoC Committee of Experts of the 1st Instance 56

    Article 29 Cost of continuation of the proceedings before the CoC Committee of Experts of the 1st Instance 56

    Article 30 Costs of the proceedings before the CoC Commi