A Google search for “patient
and public involvement” or “patient engagement” results in over six million
hits. This demonstrates that a widespread effort exists to involve patients and
the public in the entire development and life cycle of therapeutic products.
During the research and development stages, patient involvement can promote
projects that are geared to patients’ needs. Involving patients in the approval
process can help regulatory decision makers address any stakeholder needs that
have remained unmet. Moreover, the market surveillance process benefits from
user engagement: when product users identify warning signals early on,
regulatory authorities can quickly initiate safety measures.
Swissmedic’s
approach to patient engagement
Regulatory authorities in
different countries take different approaches to patient and public
involvement. Whereas US patients or their representatives have seats on
decision-making bodies at the Food and Drug Administration (FDA), other regulatory
authorities involve patients in decision-making through patient interest groups
or they consult patients during their decision-making processes. Compared to
other countries, Switzerland is still in the early stages of finding tangible
solutions that transform passive recipients and users of therapeutic products
into active, well-informed participants.
As Switzerland’s regulatory
authority for therapeutic products, Swissmedic considers collaboration with all
national and international stakeholders to be an essential part of fulfilling
its legal mandate and reaching the defined objectives set out in its strategic
goals. As the users and beneficiaries of safe therapeutic products, patients
are considered important stakeholders in Swissmedic’s national network.
Swissmedic’s cooperation with patients is rooted in the concepts of information
exchange and active involvement in specific areas of its activities.
Partnering
with patients: Ongoing and future projects
Early in 2014, Swissmedic
launched a pilot partnership project that established a regular dialogue with
patient and consumer organisations in order to more effectively take into
account the needs and concerns of this stakeholder group and to obtain timely
information on patients’ experiences with therapeutic products. The newly
formed Swissmedic Patient and Consumer Organisations Working Group met three to
four times a year to discuss a range of key regulatory topics, such as the
authorisation requirements and process for biosimilars, the legal basis for and
relevant characteristics of patient information leaflets, and various aspects
of the – at that time the new version (from 1 January 2014) – Human Research
Act, including stakeholders’ initial experience with its implementation.
In 2016, the project’s pilot
phase was extended for an additional two years based on the results of a survey
of the working group and members’ willingness to continue actively
participating in the working group. The survey indicated that the project’s
goal of exchanging information had been achieved. However, the involvement of
patient representatives in defined areas of Swissmedic’s activities still fell
short of expectations. After everyone involved in the
working group unanimously agreed that it had made a valuable contribution to
participation processes in the regulatory environment, Swissmedic decided to continue
this forum for exchanging information and experience beyond its four-year pilot phase. Between May 2014 and the end of
2020, the working group met a total of 25 times. It continues to meet
regularly and currently includes 18 active member organisations.
In the upcoming years,
Swissmedic will focus on the challenge of identifying in which regulatory
processes patient and consumer participation is feasible and worth pursuing. To
actively address this issue, Swissmedic launched a pilot project in July 2018
to incorporate patients’ perspectives into the process of reviewing patient
information leaflets. By the end of that year, the project’s first candidate
for a patient review had already been identified. In 2020, the pilot project
was expanded to include additional indications and variations. The project is
currently being fully implemented, giving all applicants an opportunity to
involve patient organisations in the review of their patient information
leaflets within Swissmedic’s assessment process.
In addition, Swissmedic will
relaunch a project in which patient representatives have the opportunity to
review summaries of Swiss Public Assessment Reports (SwissPARs) that should be easily understood
by laypeople (these Public
Summary SwissPARs are available on Swissmedic’s website).
Partnering
with like-minded organisations and initiatives
Two of the aims stated in the
updated 2021–2024
work plan of Swissmedic’s Patient and Consumer Organisations
Working Group are to raise awareness of the group and increase its visibility.
An additional goal is to partner with organisations and initiatives that are
working on participation projects in Switzerland in areas aligned with the
working group’s activities. Swissmedic’s partners include organisations such as
the European Patients’ Academy on Therapeutic Innovation Switzerland (EUPATI CH), the Patient
Involvement in Development and Safe Uses of Medicines working group from the
Council for International Organizations of Medical Sciences (CIOMS), and the Patient
Advisory Board of the Swiss Group for Clinical Cancer Research (SAKK), an organisation
that seeks to gather the experience and concerns of cancer patients and their
families and more effectively channel them into research. These partnerships
help to avoid duplication and to use existing resources and capacities as
efficiently as possible.
Like our partner authorities,
Swissmedic supports patient engagement activities of international forums. For
example, it contributed to the Reflection
Paper on Patient-Focused Drug Development issued by the
International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH). This reflection paper identifies key areas in which
incorporating the patient’s perspective could improve the quality, safety, and
efficiency of medicinal product development and thus inform regulatory
decision-making.
Informing
and engaging the public through social media
In response to social media’s
growing influence on public opinion, Swissmedic established its social media
presence in May 2020, which it continues to develop and expand. Swissmedic’s
social media platforms have become important sources of information for the
public, especially during the COVID-19 pandemic. In the future, these media
channels will include even more images, infographics, and videos and will be
more interactive. This will allow Swissmedic’s social media platforms to be
more than just another broadcasting opportunity – they can become key
tools for fostering a dialogue with the public and patients.
A framework
for the future
Patient and public involvement
in healthcare is increasingly being accepted as stakeholders’ right to
contribute to decision-making processes. For in the end, patients are the
beneficiaries of healthcare and are therefore important stakeholders in the
regulatory process. Plenty of work awaits Swissmedic in the next few years as
it continues to put into place its framework for partnering with patients and
the public and incorporate their perspectives into its processes. Swissmedic is
convinced that this work will lead to greater benefits for patients and the
public.
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