Swissmedic Annual Report 2018

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74 Stakeholder management Stakeholder management Information Swissmedic is quick to provide targeted information on new findings concerning therapeutic products if there is a potential risk to health. In addition to safety-relevant information, new authorisation decisions or major changes to medicinal product information are of considerable interest. General enquiries Swissmedic responds to general enquiries submitted by consumers, patients and specialists on a wide range of subjects associated with therapeutic products. Generally speaking, such enquiries are answered within ten days. Enquiries related to specific applications or cases, and information and advice provided by Swissmedic’s Legal Affairs staff do not fall within this category. Activities • Significantly more enquiries – both general and medical device-related – were received during 2018 than in previous years. • The most popular subjects were the impurities found in antihypertensives (the “valsartan scandal”), cannabis products and the associated accountabilities, and information on importing medicinal products for personal use. • Additional enquiries were sparked by the new EU Regulations on medical devices and in vitro diagnostics, as well as by reporting on the “Implant Files”. • The uncertainty surrounding the consequences of Brexit for Switzerland created further demand for information. 8381 7076 7041 6064 5237 4912 3854 2317 2210 1990 3565 1839 1672 1600 3375 2129 1817 1537 327 239 312 2018 2017 Total responses to enquiries General enquiries – from specialists – from the general public 2016 Enquiries concerning medical devices – from specialists – from the general public Performance indicator 95 % 99 % General enquiries: percentage of responses sent within 10 days Target Result
Stakeholder management 75 Press relations The media managers at Swissmedic are responsible for a large proportion of the Agency’s public relations work. The Media Unit responds to enquiries from media representatives, puts them in touch with the right experts to provide background information or give interviews, and publishes releases for the media and the public. Swissmedic provides open, transparent information about the benefits and risks of therapeutic products and about the Agency’s tasks and areas of competence in a form that laypeople in medical matters can understand and within the permitted boundaries of the law. 2018 5 2017 7 2016 5 Media enquiries Press releases 519 581 615 Activities • Requests for information on the new features of the therapeutic products legislation that entered into force on 1 January 2019 were received throughout 2018. In particular, communications concerning medicines that had been assigned to new dispensing categories as part of the revision of the Therapeutic Products Act received a lot of coverage. There were regular reports on the possible impact of a disorderly Brexit on therapeutic product supplies. • Cases involving the Penal Division also made the headlines. In addition to reporting on the court proceedings against Alkopharma, which was accused of falsifying the expiry dates on cancer medicines, there was also extensive coverage of certain hospitals’ breaches of duty in reporting serious incidents involving medical devices. • Towards the end of the year, the “Implant Files” became the centre of public interest. New disclosures appeared on an almost weekly basis, and Swissmedic gave several statements and interviews. • Reporting on medicinal products revolved around the issue of impurities in sartan products. • Several media outlets reported on the changes in practice regarding HIV self-test kit issuing after Swissmedic approved self-testing on the basis of a recommendation by the Federal Commission for Sexual Health (FCSH).
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Annual Report 2018
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3 Contents Foreword by Stéphane Ro
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5 Standards Legal framework Legisla
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7 Raimund Bruhin, director “Not t
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9 The situation subsequently calmed
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11 Basis for development cooperatio
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13 Better protection against defect
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15 undercover investigations in one
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17 Autologous transplant products T
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19 Temporary authorisation: rapid a
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21 Number of authorisations by disp
Page 23 and 24: Market access | Marketing authorisa
Page 35 and 36: 35 Variations requiring approval an
Page 39 and 40: Market access | Licensing 39 Licens
Page 41 and 42: Market access | Licensing 41 Clinic
Page 43 and 44: Market access l Inspections 43 Insp
Page 45 and 46: Market access l Inspections 45 GLP
Page 47 and 48: Market access | Licensing 47 Licens
Page 49 and 50: Market access | Licensing 49 Analys
Page 51 and 52: Market access | Medicinal products
Page 61 and 62: Market access | Medical devices 61
Page 67 and 68: Standards 67 Standards Legal framew
Page 69 and 70: Standards 69 Pharmacopoeia The phar
Page 71 and 72: Penal law 71 Investigative measures
Page 73: Penal law 73 Decisions / verdicts b
Page 77 and 78: Stakeholder management 77 Events Sw
Page 79 and 80: Stakeholder management 79 Collabora
Page 81 and 82: Stakeholder management 81 • Swiss
Page 83 and 84: Stakeholder management 83 Special a
Page 85 and 86: Information technology and telecomm
Page 87 and 88: Corporate Governance 87 Agency Coun
Page 89 and 90: Corporate Governance 89 Chair Stép
Page 91 and 92: 91 Remuneration Remuneration for th
Page 93 and 94: Organisation 93 Members of the Vete
Page 95 and 96: Organisation 95 Nicole, Messi Mara,
Page 97 and 98: Balance sheet 97 Balance sheet (in
Page 99 and 100: Erfolgsrechnung 99
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Swissmedic Annual Report 2018

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