Legal basis
of PPI in Switzerland
In 2015, the Federal Council
evaluated the participation rights of patient organisations and patient
involvement in health policy processes as part of its Health2020
strategy (Swiss Confederation 2015). One goal of Health2020
was to “empower insurees and patients” while focusing on “increasing the health
skills and individual responsibility of insurees and patients”, which would
lead to a promotion of patient involvement (see Objective 2.3, FOPH 2013).
However, it was concluded that no federal law for a central information point
about patient rights issues would be established due to the complicated nature
of shared competences between the cantons and the federal government. This
decision was affirmed after an interpellation in 2020 (Swiss Parliament 2020).
Nevertheless, the promotion of health literacy remained an objective of the
Federal Council in Health2030 in order to increase access to health literature
and information and to support patients’ decision-making in health-related
issues (FOPH 2019). Examples of this support are initiatives such as the
national license for the Cochrane Library and the information portal of the Swiss Red Cross (migesplus.ch). The
Federal Council supports the involvement of patient organisations in health policy processes but has not expressed any intention to legally anchor this
involvement (Swiss Confederation 2015).
Despite the lack of
legislation related to PPI in Switzerland, PPI guidelines exist, for example
the Pharma
Cooperation Code for the pharmaceutical industry, which focuses on
advisory activities of patient organisations and potential conflicts of
interest. According to the code, these advisory activities are only allowed “if
such consultancy tasks or services are provided to support healthcare or
research and cannot be interpreted as an incentive to recommend, prescribe,
acquire, deliver, sell or administer specific medicinal products”. The Swiss Ordinance
on Organisational Aspects of the Human Research Act (OrgO-HRA) sets
forth considerations regarding the work processes of ethics committees, which
may also include patient members.
PPI and
Swiss data protection legislation
As part of a political and
legal basis for addressing PPI, data protection needs to be taken into account.
Data generated in PPI processes are not typically covered by the Human Research
Act (HRA) but
may be protected by federal or cantonal data protection legislation. General
data protection principles such as lawfulness, data minimisation, purpose
limitation, transparency, accountability, integrity, accuracy, and data
security need to be followed. The main considerations for determining which law
is applicable and the extent to which it is applicable are firstly, whether the
data is anonymised and secondly, who processes the data (see Figure 2).
When processing personal data,
private organisations must comply with the Federal Act on Data Protection (FADP), whereas cantonal
institutions such as university hospitals must comply with their canton’s data
protection laws. According to the FADP, a data subject’s consent is, as a rule,
required for data processing within the scope of PPI. Cantonal data processors
usually require a legal basis, which varies between cantons. When health data
is processed, generally stricter requirements must be met, such as explicit
consent or express authorisation for data processing in a law. Unlike personal
data, anonymised data are not covered by any data protection legislation.
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