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6 Written information from pharmaceutical companies KCE reports 55 material, except brochures. The French drug regulatory agency (AFSSAPS) has a Department of studies and pharmaco-economic information, including a unit Publicité et bon usage, which is in charge of the secretariat of the Committee for advertising control concerning drugs for human use, and for dissemination of recommendations on good use of medications. Article R. 5122-2 of the French Public health code relating to advertising of drugs and health products for human use states that every drug marketing company shall have a department devoted to advertising, which ensures the scientific validity of information which is disseminated . Article R. 5122-8 states that any promotional material disseminated towards health professionals should include all particulars contained in the SPC. It should not quote the position taken by an administrative or consultative authority towards a drug in a way that would be susceptible to alter the meaning or objectivity of this position, and any written mention should be perfectly readable. 1.1.4 Regulatory framework in the Netherlands b In the Netherlands, besides information required from the European Directive, the Decree on drug advertising b states that advertising must mention the drug price. The law of 8 February 2007 on pharmaceuticals is not implemented yet but it states in addition to the Decree that advertising should mention the composition, therapeutic indications, contra-indications, activity and secondary effects of the drug that are in agreement with the SPC of the drug; the texts in the documents containing advertisement(s), except the titles, should be written in the same letter size. The control of advertising towards health professionals is based on a combined system of self-regulation and c monitoring of activities by the governmental healthcare inspection. Self-regulation is performed by the Stichting Code Geneesmiddelenreclame (CGR) for advertising directed to health professionals, the Keuringsraad Openlijke Aanprijzing Geneesmiddelen / Keuringsraad Aanprijzing Gezondheidsproducten (KOAG/KAG) for advertising directed to the general public (the functioning will be evaluated in the spring of 2008) and the Stichting Reclame Code (SRC) –for advertising in general- and her Reclame Code Commissie (RCC) and Professional College. The CGR has established a guidance code for drug advertising. The most relevant points of this code, besides information already given in the European Directive, are given below. The use of vague terms or superlatives should be avoided as well as the exaggeration of drug properties in another way. Cited publications must reflect the current state of the science and of the technique. A lot of rules concerning the comparison of a drug with another one (where a competitor is explicitly or implicitly mentioned) are given in the code. Important points are that the comparison must not be misleading; compared drugs must fill the same gap or must be intended for the same purpose; the comparison must objectively concern one or more real, relevant, verifiable and representative drug characteristics, e.g. the (clinical) efficacy; the comparison must not unnecessarily harm the value of the other drugs; the comparison should not present the drug as an imitation of a drug with a protected brand name; the comparison must be accurate -scientifically demonstrable- and in agreement with the most recent state of the science; the comparison is complete concerning efficacy, side effects, indications, contra-indications and other relevant data of the drug to be compared with. Advertising (excluding reminders or advertisements intended for practical information containing no pharmaco-therapeutical claim) must contain the drug name, the name and address of the marketer, the qualitative and quantitative composition of active ingredients, the conditioning, the main indications and clinical effectiveness according to registration data, the most important side effects and warnings, all contra-indications and the supply classification. The governmental healthcare inspection controls the application of the above-mentioned Decree; it also monitors the functioning of the CGR and controls the compliance to the CGR code by means of three inspectors. Also studies on request of the Minister on e.g. the way the pharmaceutical industry tries to influence guidelines are one of the Inspection roles. In a http://wetten.overheid.nl/cgibin/sessioned/browsercheck/continuation=27050002/session=0391310028664 15/acton=javascript-result/javascript=yes consulted on 10 May 2007
KCE reports 55 Written information from pharmaceutical companies 7 report of August 2006, the governmental healthcare inspection pointed out that the CGR is not proactive, only reacting in case of complaints and it does not control if its decisions are observed. Since a control regarding regulations and ethics is already made on advertisements otherwise, the objective of the study is to assess content agreement with most recent evidence-based medicine (EBM) data. 1.2 OBJECTIVES The objectives are formulated as research questions as follows: 1.3 METHODOLOGY • What does (inter)national scientific literature tell us concerning content and agreement with regard to EB-value of written information distributed by the pharmaceutical industry? • Which written information coming from the pharmaceutical industry is sent to physicians or put to their disposal in Belgium? • Is written information coming from the pharmaceutical industry and sent to general practitioners (GPs) based on reliable scientific data? In case of positive answer, is this evidence-based information presented in such a way that GPs can analyse it critically in order to use it to base the choice of their treatments? • Which information does a physician need, except from EB-information, to perform an adequate therapeutic choice? In order to answer the first research question, a literature search was performed. A first contribution of the study of scientific literature was to give a methodology for the inventory and for the content analysis of written information. The second contribution was to give an overview of existing knowledge on EBM value of information from the pharmaceutical industry. Literature study is detailed in chapter 2. The second research question was answered by performing an exploratory inventory consisting of the collection by a sample of physicians (GPs and specialists) and pharmacists of all written information received from the pharmaceutical industry during one month. Material was classified according to the type and a descriptive analysis of material collected was performed, allowing choice of the field (drug classes) for content analysis. The exploratory inventory is detailed in chapter 3. The answer to the third question was given by the content analysis of classes of drugs selected at the time of the exploratory inventory. This analysis concerned prescription drugs only and SPCs were not part of information studied. Messages were classified according to specific criteria and content analysis was performed by means of a standardized plan. The content analysis is detailed in chapter 4. Finally, the last question was answered by the qualitative analysis of focus group interviews. Physicians with good experience of general practice but not interested in EBM information searching were interviewed on the one hand and physicians knowing well principles of EBM work and having developed activities on the subject (training, research…) were interviewed on the other hand. These interviews were performed separately in French and in Dutch. The qualitative analysis of focus group interviews is described in chapter 5. ‘Instruction leaflet’ is legally not the correct name, although it is used in this report as more readable term for ‘summary of product characteristics’.
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Dépôt légal : D/2007/10.273/13
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35. Etude relative aux coûts poten
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