Informationsbeauftragter und Arzneimittelwerbung / Person designated responsible for information and advertising of medicinal products

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1 Informationsbeauftragter und Arzneimittelwerbung / Person designated responsible for information and advertising of medicinal products Sofie Regner BBSG Wien, Austrian Agency for Health and Food Safety

2 Advertising - Regulated by the Medicinal Products Act (AMG) o Part V o Enforcement: Federal Agency for Safety in Health Care 2

3 person designated responsible for information and ( 56 AMG) Should ensure that advertising material for medicinal products complies with Part V of this Act and that the advertising materials are made available on request by the BASG at any time. 3

4 Monitoring of advertising material for medicinal products Active Research in various media Öst. Apothekerzeitung, Ärztezeitung, Vetjournal, Internet Passive other market players patients, medical staff, competition company other authorities BMG, VKI, foreign authorities 4

5 - Advertising should be in compliance - for persons qualified to prescribe or supply: - 54 AMG essential information - 55 AMG Quotations, tables or other illustrations in correspondence with the referenced literature - for the public: - 53 ( 1) AMG - For both No promotion for POM medicines. - 50a Abs. AMG No statements that go beyond the SPC 5

6 What should be submitted - advertising documentation for all medicinal products of the requested indication(atc-code) This includes: o any promotion material distributed and lists of all recipient groups and the way of distribution & o any material for sales promotion events and occupational scientific events 6

7 How to submit: paper CD USB-Stick zip file eudralink 7

8 Where to - Bundesamt für Sicherheit im Gesundheitswesen - Traisengasse 5 - A-1200 Wien - z.h. Mag. Sofie Regner 8

9 monitoring of advertising material for medicinal products - Project Launch

10 The table below shows an overview of all advertising monitoring projects so far year Selection criterion 2011 representative cross-section of Austrian pharmaceutical companies 2012 medicinal products intended for gastrointestinal disorders 2013 medicinal products containing immunologicals or immunostimulants 2014 medicinal products containing non-opioid analgesics 2015 medicinal products influencing the cardiovascular system except lipid modifying agents 10

11 Selection criteria ATC-Code Companies (selected randomly) human/veterinary/herbal/homeopathic drugs 11

12 What is checked - Sent promotional material o compliant with the law - Corresponding homepage o Only OTC products o Password protected o Only disease information 12

13 deficiencies contact Hard to get into contact with the companies Information about every change person, address, company, 13

14 deficiencies - promotion material Advertising material for health care professionals - Missing essential information (relevant parts of the SPC) Group advertising - Missing essential information Incorrect advertising Promoting material for consumers - included clinical study results with claims going beyond the information of the labelling, SPC and patient information leaflet Promotion was not suitable 14

15 deficiencies - homepage - No password protected access for health care professionals - POM products - Patients experience reports 15

16 Important points to be considered for future projects: The data of the person designated responsible for information should be up to date. - For non-austrian MAH the contact person may be a representative of the Austrian provider. Advertising material for health care professionals should always include essential information. For the submission of the promotional material: - data should be clearly structured (e.g. Excel-sheets, referring to sub-folders). - Scientific references - held ready for retrieval (to be provided - within 1-3 business days). 16

17 Recommendation Advertisment should be - Balanced - Objective - No exaggeration compliant - Applicable - Fair 17

18 Advertising of medicinal products Thank you for your attention/compliance! For further information please contact us: Mag. Sofie Regner Mag. iur. Martina Hofmann, LLM 18

19 Back up slides Important points to be consisered : the LAW! 19

20 50. (1) "Advertising for medicinal products" defines all measures taken with the aim of information provision, market research and market development, or the creation of incentives to increase the volume of prescriptions, distribution, sales or consumption of medicinal products. business-to-layman advertising business-to-business advertising medical representatives' visits to professionals licensed to prescribe or dispense supply of medical samples, incentives for writing prescriptions or dispensing by giving, offering or promising financial or material advantages sponsoring of sales promotion events reimbursement of travel expenses, costs of room and board and attendance fees in connection with occupational scientific events for persons who are licensed to write prescriptions or dispense medicinal products 20

21 NOT: correspondence and, if applicable, all non-advertising documents required to answer a precise question on a certain medicinal product sales catalogues and price lists, unless they contain information on medicinal products, information on the health or illnesses of humans and animals, insofar as no reference, direct or otherwise, is made to an medicinal product summary of product characteristics (SPC), the patient information leaflet and the labelling insofar as they serve to meet the obligations laid down in 15ff 21

22 Advertising of medicinal products Advertising only for ( 50a): 1. authorised proprietary medicinal products, 2. registered traditional herbal proprietary medicinal products, 3. registered homeopathic proprietary medicinal products, 4. proprietary medicinal products that have been licensed for distribution via parallel trade, and 5. Pharmacy-proprietary medicinal products. No exaggeration No statements or images that: - attribute an effect of the medicinal product that is not in keeping with its true efficacy, - create the false impression that success may be expected regularly, - deviate from the labelling, the patient information leaflet or the summary of product characteristics (SPC) or exceed them 22

23 Advertising of medicinal products Business-to-layman advertising 51. (1) Business-to-layman advertising is not permitted for: 1. proprietary medicinal products subject to the prescription requirement 2. proprietary medicinal products not subject to the prescription requirement, where the name of the product contains the same imaginary word or the same scientifically used expression as a proprietary medicinal product of the same name that is subject to the prescription requirement and 3. registered homeopathic proprietary medicinal products. (2) The interdiction under section 1 subsection 1 shall not apply to vaccination campaigns carried out or supported by the local authorities. 23

24 Advertising of medicinal products Business-to-layman advertising 52. (1) Business-to-layman advertising shall be done in such a way that the purpose of advertising is evident and the product is clearly presented as a medicinal product. Advertising and other editorially reviewed texts shall be clearly separate. (2) Business-to-layman advertising shall include at least the following information, unless the provisions of section 4 state otherwise: 1. the trade name of the proprietary medicinal product and the customary scientific designation of the active agent, insofar as the medicinal product contains only one active agent, 2. the information indispensable for proper administration of the proprietary medicinal product and 3. a clearly visible notice that medicinal products may cause undesirable effects in addition to the desired effects and that the patient information leaflet should be observed or the advice of a physician or pharmacist obtained. If the medicinal product is advertised via acoustic or audio-visual media, this information must be made clearly evident acoustically. (3) Business-to-layman advertising for traditional herbal proprietary medicinal products shall additionally be accompanied by a notice that the medicinal product is a traditional herbal proprietary medicinal product for use for a specific therapeutic indication or specific therapeutic indications based solely on many years' experience. (4) Business-to-layman advertising need not meet the requirements of section 2 if the advertisement is solely composed of the trade name of a proprietary medicinal product (reminder advertising), unless the advertisement is for proprietary medicinal products that increase sports performance. The notice under section 2 subsection 3 shall be included insofar as the reminder advertisement is conveyed via placards, classified adverts or acoustic or audio-visual media. 24

25 53. (1) Business-to-layman advertising shall contain no elements that: 1. include pictorial representations in conjunction with members of the healing professions or healthcare institutions, 2. make a medical examination or a surgical operation appear superfluous, especially by offering a diagnosis or treatment by correspondence, 3. suggest that the effect of a medicinal product is guaranteed to be without adverse reactions or corresponds, or is superior, to another treatment or to another medicinal product, 4. suggest that the patient's normal good health could be improved by using the medicinal product, 5. suggest that the patient's normal good health could be compromised if he does not use the medicinal product, 6. are intended exclusively or mainly for children, 7. refer to a recommendation by scientists, persons working in healthcare, or persons who in view of their reputation could advocate the use of medicinal products, 25

26 8. equate the medicinal product with a foodstuff, a cosmetic or other consumer good, 9. suggest that the safety or efficacy of the medicinal product is attributable to its being a "natural product", 10. through a detailed description or representation of the medical history could induce a false self-diagnosis, 11. refer to attestations of recovery in an abusive, alarming or misleading way, 12. utilise pictorial representations of changes in the human or animal body as a result of illness or injury or of the effect of a medicinal product in the human body or in parts of the body in an abusive, alarming or misleading way, 13. are aimed at the procurement of prescription medicinal products by mail order. (2) Business-to-layman advertising may include a reference to the marketing authorisation or registration of the proprietary medicinal product, insofar as reference is made exclusively to the fact of marketing authorisation or registration and such a reference cannot serve the purpose of instilling in the consumer a false impression of the safety and efficacy of the proprietary medicinal product concerned. (3) The distribution of samples of, or coupons for medicinal products is prohibited. Similarly, the holding of lotteries is prohibited if they are in connection with the distribution of medicinal products. 26

27 Business-to-business advertising 54. (1) Medicinal product advertising that is targeted at persons licensed to use or dispense medicinal products shall state, in clearly legible form, the essential information on the proprietary medicinal product conforming to the summary of product characteristics (SPC), insofar as it: - 1. is carried out for a proprietary medicinal product for which a summary of product characteristics (SPC) must be published in accordance with 15 and - 2. appears in print media, electronic media or is transmitted via telecommunication. 55. (1) All documents on a proprietary medicinal product that is distributed to persons licensed for the prescription or distribution of medicinal products for the purpose of sales promotion shall state, in addition to the information required under 52 section 1, the date and time at which the documents have been drawn up or the date and time of their last modification. (2) All documents referred to in section 1 shall be sufficiently precise, up to date, verifiable and complete to enable the recipient to comprehend the therapeutic use of a proprietary medicinal product. (3) All quotations, tables and other depictions taken from the specialist literature and used in the documents named in section 1 shall be verbatim; the precise source must be stated. (4) If reference is made to the specialist literature in the documents named in section 1, their general meaning shall be rendered objectively and the source stated. 27

28 56a Austrian Medicinal Product Act (1) Part V [ ] shall be enforced by the Federal Agency for Safety in Health Care. On request by the latter, all documents shall be submitted that the Federal Agency deems necessary to enforce compliance with this part. This also comprises all documents on sales promotion events and occupational scientific events. Agents of the Federal Agency for Safety in Health Care and appointed experts are entitled to enter the entire premises of the company, gain access to and make copies of all documents, as may be necessary for the enforcement of the provisions within this Part V of the Act. These searches shall be carried out during regular business hours, unless there is imminent danger. (2) If, during a search in accordance with section 1, it is found that the provisions of this Part V have been contravened, or if the Federal Agency for Safety in Health Care otherwise gains knowledge of such contravention, it shall order all measures necessary to create a situation of compliance with the law. 28

29 56/2 The marketing authorisation holder or registration holder is obliged to appoint a person with the necessary technical knowledge and experience to carry out and take responsibility for the management of scientific information on the medicinal products placed on the market by the marketing authorisation holder (person designated responsible for information) and to give this person the necessary authority to go about the related tasks. The Federal Agency for Safety in Health Care shall be informed without delay when a person designated responsible for information is appointed or a different person is designated responsible for information. 29

on the advertising of medicinal products for human use

30. 4. 92 Official Journal of the European Communities No L 113 / 13 COUNCIL DIRECTIVE 92/28/EEC of 31 March 1992 on the advertising of medicinal products for human use THE COUNCIL OF THE EUROPEAN COMMUNITIES,