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The Document in PDF Format Ministry of Health and Care Services Report to the Storting No. 28 (2014–2015) Report to the Storting (Norwegian Parliament) _________________________________________________________ White Paper on Medicinal Products Correct use – better health Recommendations from the Ministry of Health and Care Services 22 May 2015, approved by the Cabinet the same day. (Solberg government) Table of contents 3 Development and approval of medicinal products ................................................................. 5 3.1 Development of medical products.................................................................................... 6 3.2 Marketing authorisation ................................................................................................... 7 3.2.1 Patents, patent protection, generics and biosimilars ............................................... 11 3.3 What medicinal products are currently on the market?.................................................. 13 3.4 What medicinal products can we expect in the future? .................................................. 17 4 Actors in the medicinal product market ................................................................................ 21 4.1 Patients and service users ............................................................................................... 21 4.2 The pharmaceutical industry .......................................................................................... 22 4.3 Health care personnel ..................................................................................................... 24 4.4 Pharmacy ........................................................................................................................ 27 4.5 Regional health authorities and municipalities .............................................................. 28 4.6 Public administration...................................................................................................... 28 4.6.1 The Norwegian Medicines Agency ........................................................................ 28 4.6.2 The Norwegian Directorate of Health ..................................................................... 29 4.6.3 Norwegian Knowledge Centre for Health Services ................................................ 30 4.6.4 Point of contact for interdepartmental medicine information ................................. 31 4.6.5 Norwegian Institute of Public Health ..................................................................... 32 4.6.6 Supervisory authorities ........................................................................................... 32 4.7 Other actors that compile and convey knowledge about medicinal products ................ 33 5 Health status and the use of medicinal products ................................................................... 35 5.1 Health status ................................................................................................................... 35 5.1.1 Communicable diseases .......................................................................................... 35 5.1.2 Non-communicable chronic diseases and NCD strategies ..................................... 35 5.2 Use of medicinal products .............................................................................................. 36 5.2.1 Adverse reactions .................................................................................................... 36 5.2.2 Children................................................................................................................... 37 5.2.3 The elderly .............................................................................................................. 38 5.2.4 Gender differences in the use of medicinal products .............................................. 39 5.3 Incorrect use of medicinal products ............................................................................... 40 5.3.1 Uncertainty regarding medicinal products in use ................................................... 42 5.3.2 User-friendly information about medicinal products for health care personnel ..... 43 5.3.3 Treatment adherence ............................................................................................... 43 5.3.4 Management of medicinal products ........................................................................ 44 5.3.5 General challenges .................................................................................................. 45 6 Quality treatment with medicinal products ........................................................................... 47 6.1 Quality and patient safety ............................................................................................... 47 6.2 Shared medicine lists ...................................................................................................... 50 6.3 Medication Review ........................................................................................................ 54 6.4 Correct use of medicinal products in specialist health care services ............................. 56 6.5 Correct use of medicinal products in municipal health and care services ..................... 60 7 The need for information about medicinal products among patients and health care personnel ....................................................................................................................................... 62 7.1 The patient’s need for information about medicinal products ....................................... 63 7.1.1 Patient involvement – shared decision making ....................................................... 64 7.1.2 Information about medicinal products to strengthen adherence to treatment ......... 65 7.1.3 Digital medicine information .................................................................................. 68 7.1.4 Pharmacy advice for enhancing adherence to treatment ......................................... 69 7.2 The need for medicinal product information for health care personnel ......................... 74 7.2.1 Electronic decision support function for health care personnel .............................. 75 7.2.2 Academic detailing ................................................................................................. 76 8 Medicinal product information for research, health analyses and quality assurance ........... 78 8.1 System for reporting adverse reactions .......................................................................... 80 9 Quality indicators .................................................................................................................. 82 10 The role of the Association of the Pharmaceutical Industry in Norway in providing information .................................................................................................................................... 83 11 Generic and biosimilar medicinal products .......................................................................... 87 11.1 Generic medicinal products and pharmacy substitution ............................................. 87 11.2 Biological and biosimilar medicinal products ............................................................ 89 12 Medicinal product management ............................................................................................ 90 12.1 Multidose .................................................................................................................... 91 13 Special groups ....................................................................................................................... 93 13.1 The use of antibiotics and antibiotic resistance .......................................................... 93 13.2 Use of medicinal products for mental illness and pain ............................................... 95 13.2.1 Use of psychoactive medicinal products................................................................. 96 13.2.2 Use of addictive medicinal products ....................................................................... 98 13.3 Medication-Assisted Treatment ................................................................................ 101 14 Veterinary medicinal products ............................................................................................ 103 14.1 Authorisation of veterinary medicinal products ....................................................... 103 14.2 Proposal on new EU regulations for veterinary medicinal products ........................ 104 14.3 Responsible use of medicinal products .................................................................... 106 14.4 Research and development ....................................................................................... 108 14.5 Medicinal products and environmental effects / environmental impact ................... 108 15 The need for price regulation .............................................................................................. 111 16 Current price regulations..................................................................................................... 111 16.1 Maximum price system ............................................................................................ 111 16.2 Reimbursement price and reimbursement contract .................................................. 112 16.3 Pharmacy markup ....................................................................................................
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