Swissmedic Annual Report 2018

Stakeholder management 79
Collaboration
In accordance with its legal mandate, its service mandate
and the strategic plan, the Agency pursues a policy of including
external stakeholders, with their often-diverging
interests, in Swissmedic’s various fields of activity as a fundamental
principle. Collaboration is structured in such a
way as to preserve Swissmedic’s independence as an authorisation
and supervisory authority. It is based on a relationship
that creates long-term trust and fosters mutual
understanding.
National collaboration
National network
National-level collaboration is fundamental in enabling
Swissmedic to achieve the objectives set out in its legal and
strategic foundations. These objectives are geared first and
foremost to guaranteeing the safety of therapeutic products.
The following stakeholder groups are part of Swissmedic’s
national network:
• Patients/consumers and their associations/organisations
• Healthcare professionals and their associations/organisations
• The therapeutic products industry and its associations/
organisations
• Service providers from the therapeutic products industry
• Cantonal and federal authorities and parliament
• Media representatives (see Press relations section)
Activities
• Meetings of the Swissmedic patient/consumer organisations
working group
The patient/consumer organisations working group
continued its customary work, holding four meetings
during the course of the year. Activities focused on the
“Involvement in the assessment of patient information”
pilot project, which kicked off on 1 June 2018. By the
end of the year, the first candidate for the pilot project
had already been identified. In addition, Swissmedic put
various issues forward for discussion, including the first
draft of a template for layperson-friendly summaries of
SwissPARs. The meeting records are published on the
Swissmedic website at https://www.swissmedic.ch/
swissmedic/en/home/about-us/collaboration/national-collaboration/collaboration-with-patient-and-consumer-organisations.html.
• Collaboration with the Association of Cantonal
Pharmacists (KAV)
The annual meeting between Swissmedic and the
Association of Cantonal Pharmacists (KAV) took place
on Friday 16 March. Swissmedic gave KAV representatives
a briefing on legal matters (including the status of
consultation proceedings for the TPA ordinance
package), authorisations (supplying medicinal products
to doctors for their own use) and market monitoring
(including the issue of distinguishing medicinal products
from medical devices, reviewing the status of CBD
products and hospital inspections during 2017). In turn,
the KAV raised the issue of access to inspection reports.
On 29 November, Swissmedic gave Cantonal Pharmacists
another full briefing on the changes resulting from
HMV IV at their training day in Bern. The briefing
focused on the reclassification of medicinal products in
different dispensing categories, the changes to the
MPLO and other enforcement-related issues.
• Swiss Medtech conference
Along with representatives of the FOPH and SECO,
Swissmedic participated in the national conference held
by Swiss Medtech on 28 March 2018 to discuss the
impact of the new EU Regulations governing medical
devices and in vitro diagnostics (MDR/IVDR). The
conference highlighted the challenges arising from the
new Regulations, while the breakout sessions provided
an opportunity to discuss specific issues. The attendance
figure of 450 is a reflection of the strong interest in the
subject.
• Regulatory Affairs round table meetings with pharmaceutical
industry associations
Three Regulatory Affairs round table meetings with
industry association representatives took place during
2018. The round tables are an opportunity to share
information on current issues and for each side to ask
and discuss questions. The subjects covered included
applications for vaccines, the IDMP technical data
scheme, the new practice for positive and negative
declaration of excipients, and changes resulting from
HMV IV.
• Meetings with complementary and herbal medicine
(CHM) stakeholder associations
The annual meeting between Swissmedic and CHM
stakeholders took place on 23 May 2018. It focused
mainly on a review of the outcomes of the CHM
division’s activities during 2017 and the changes
associated with HMV IV.