Life Sciences 2024 – Healthcare

 1. Life Sciences Regulatory Framework

 1.1 Legislation and Regulation for Pharmaceuticals
and Medical Devices

Swiss healthcare regulation is spread over various statutes,
ordinances and guidelines, including self-regulatory instruments
such as best practice codes and references to international
provisions. This makes navigating the life sciences landscape
depend in large part on legal and regulatory expertise, as well as
extensive practical industry experience.

The following key acts provide the principles of the national
regulation of pharmaceuticals and medical devices, whereby the
legal terminology in Switzerland refers to “therapeutic
products” as the generic term encompassing both
“medicinal products” (pharmaceuticals) and
“medical devices”.

• Medicinal products – Therapeutic Products Act (TPA),
  Ordinance on Medicinal Products (OMP), Medicinal Products Licensing
  Ordinance (MPLO), Ordinance on the Requirements of Marketing
  Authorisation of Medicinal Products (OMAMP), Ordinance on
  Advertising of Medicinal Products (OMPA), and the Ordinance on
  Integrity and Transparency (OIT).




• Medical devices – TPA, Medical Devices Ordinance (MedDO)
  and Ordinance on In Vitro Diagnostic Medical Devices (IvDO).
  Switzerland recently revised its medical devices law to align it
  with Regulation (EU) 2017/745 on medical devices (EU-MDR) and
  Regulation (EU) 2017/746 on in vitro diagnostic medical devices
  (EU-IVDR).

Duties and responsibilities for Swiss healthcare are divided
among the federal, cantonal and municipal authorities, whereas this
practice guide focuses on the federal level. As part of the Federal
Department of Home Affairs (FDHA), the Federal Office of Public
Health (FOPH) is responsible for public health in Switzerland. The
Swiss Agency for Therapeutic Products (Swissmedic) is the Swiss
authority responsible for the authorisation and supervision of
therapeutic products. As a federal public law institution,
Swissmedic is autonomous with respect to its organisation and
management.

 1.2 Challenging Decisions of Regulatory Bodies
That Enforce Pharmaceuticals and Medical Devices
Regulation

Administrative decisions of regulatory bodies are usually issued
in the form of a ruling and can be challenged in administrative
procedures or administrative court proceedings. The appropriate
legal action depends on whether a federal or a cantonal regulatory
body has issued the decision. If issued by a federal authority,
decisions can be appealed to the Federal Administrative Court.
Decisions of the Federal Administrative Court are subject to
further appeal to the Federal Supreme Court.

These challenge procedures in general also apply to other
regulated products. In certain areas, such as public procurement or
social security, special provisions may apply. Besides, criminal
procedure rules may apply to administrative and criminal sanctions
issued by regulatory bodies.

 1.3 Different Categories of Pharmaceuticals and
Medical Devices

Medicinal products are divided into four dispensing
categories:

• category A – medicinal products that may be dispensed on
  a one-time basis on a physician’s prescription (Article 41
  OMP);




• category B – medicinal products that require a
  prescription and can be obtained several times, whereby medicinal
  products on list B+ can also be dispensed without a prescription
  (Article 42 OMP);




• category D – medicinal products that may be dispensed
  without a prescription, but after specialist advice (Article 43
  OMP); and




• category E – medicinal products that may be dispensed
  without a prescription and without specialist advice (Article 44
  OMP).

The assignment to a particular category determines who is
authorised to dispense, prescribe and use the medicinal product
(Articles 24 et seq TPA). Non-prescription medicinal products,
known as “over-the-counter” medicinal products, are
intended for self-medication. The classification into the different
categories is made by Swissmedic (Article 23a TPA).

The TPA further contains special provisions for blood and blood
products (Articles 34 et seq TPA) as well as for veterinary
medicinal products (Articles 42 et seq TPA).

Medical devices are divided into different categories (classes
I, IIa, IIb, III) for which different conformity assessment
procedures apply. The classification follows the respective
regulation in the EU-MDR (Article 16 paragraph 1 MedDO) and is
based on the intended purpose and the associated risk. Certain
medical devices may be classified as intended for use by healthcare
professionals (HCPs) only.

 2. Clinical Trials

 2.1 Regulation of Clinical Trials

Clinical trials are mainly governed by the TPA, the Human
Research Act (HRA), the Human Research Ordinance (HRO), the
Clinical Trials Ordinance (ClinO) and the Ordinance on Clinical
Trials with Medical Devices (ClinO-MD). In principle, clinical
trials with therapeutic products require prior authorisation from
Swissmedic (Article 54 paragraph 1 TPA) and the competent ethics
committee (Articles 24 et seq ClinO and Articles 9 et seq
ClinO-MD). Regarding medicinal products, Swissmedic examines
whether the Good Manufacturing Practice and safety requirements are
met (Article 54 paragraph 4 lit a TPA); regarding medical devices,
the assessment includes the conformity of the products with the
safety requirements (Article 54 paragraph 4 lit b, Article 45
paragraphs 1 and 3 TPA).

Clinical trials must be conducted in line with the rules of good
clinical practice as set out, with regard to medicinal products, in
the ICH Guideline on Good Clinical Practice of 9 November 2016 and
the WMA Declaration of Helsinki on Ethical Principles for Medical
Research Involving Human Subjects (Article 5 paragraph 1 ClinO;
Article 3 ClinO-MD). With regard to medical devices, the applicable
rules on good clinical practice were incorporated into Swiss
legislation by way of reference to Article 72 and Annex XV Chapters
I and III of Regulation (EU) 2017/745 on medical devices (MDR) as
well as in EN ISO 14155.

 2.2 Procedure for Securing Authorisation to
Undertake a Clinical Trial

In order to secure authorisation for the conduct of a clinical
trial, the investigator must submit an application to the ethics
committee in the canton in whose territory the study is conducted
(Articles 24 et seq ClinO; Articles 10 et seq ClinO-MD):

• acknowledgment of receipt/possible deficiencies’
  notification within seven (medicinal products) or ten (medical
  devices) days respectively; and




• decision within 30 (medicinal products) or 40 (medical devices)
  days respectively and information of Swissmedic in case an
  authorisation by Swissmedic is necessary; in case of multi-centre
  clinical trials with medicinal products, the deadline is extended
  to 45 days.

The submission of the application to Swissmedic is made by the
sponsor:

• acknowledgment of receipt/possible deficiencies’
  notification within seven (medicinal products) or ten (medical
  devices) days respectively;




• as a general rule, decision within 30 (medicinal products) or
  45 (medical devices) days respectively; and




• in certain circumstances, Swissmedic must obtain the opinions
  from the Swiss Expert Committee for Biosafety (SECB), the Federal
  Office for the Environment (FOEN) or the FOPH before granting the
  authorisation.

 2.3 Public Availability of the Conduct of a
Clinical Trial

Sponsors of authorised clinical trials with medicinal products
are subject to registration obligations (Articles 64-67 ClinO).
Before conducting a clinical trial with medicinal products, the
sponsor must enter the clinical trial either in a primary register
recognised by the World Health Organisation (WHO) or in the
register of the National Library of Medicine of the United States
of America as well as in the supplementary Swiss federal database
using a Swiss national language. The publicly accessible portal
SNCTP (Swiss National Clinical Trials Portal) displays studies that
are being conducted in Switzerland as soon as they have been
approved by the cantonal ethics committee and released for
publication by the researchers. The data originates from (i) the
cross-cantonal application submission platform BASEC and (ii) the
international study database ICTRP (WHO database comprising 17
worldwide primary registers). The operation of the portal –
as well as the supplementary federal database – is guaranteed
by the co-ordination office Kofam (Article 67 paragraph 3 ClinO).
The following data may be accessed publicly: a brief description of
the clinical trial, the site(s) where the clinical trial is
conducted, the criteria for the participation in the clinical
trial, the disease category and the health condition investigated,
as well as an indication of whether the clinical trial includes
rare diseases.

Sponsors of clinical trials with medical devices are subject to
analogous registration obligations (Article 41 ClinO-MD). Public
access to the results of the clinical trials is ensured by
publication in one of the above-mentioned registers (Article 42
ClinO-MD).

Generally, the results of clinical trials are not publicly
available. However, physicians that are member of the Swiss Medical
Association (FMH) are subject to a publication obligation contained
in the ethical guidelines of the Declaration of Helsinki (2013)
regarding the results of human research.

 2.4 Restriction on Using Online Tools to Support
Clinical Trials

Personal data held for research purposes must be protected by
appropriate operational and organisational measures (cf. Article 5
paragraph 1 HRO). The applicable ICH Guideline explicitly refers to
the increasingly widespread use of electronic data handling and
remote electronic trial data systems and outlines the additional
requirements that must be met by the sponsor when using such tools
(see Section 5.5.3 of the Guideline for Good Clinical Practice
EG(R2) of 9 November 2016). In addition, the use of online and
electronic tools is subject to the limitations imposed by Swiss
data protection law (in particular the Federal Act on Data
Protection (FADP) and the respective Ordinance (DPO) both of which
have been completely revised as of 1 September 2023).

 2.5 Use of Data Resulting From Clinical
Trials

Health data is considered personal data requiring special
protection. The HRA regulates in detail the further use and
disclosure of health data that falls within its scope of
application. In principle, the disclosure of health data is
permissible both within an organisation and to third parties
depending on the type of health data, the intended further use and
the assignability to a specific person. The data protection
provisions do not apply to anonymised and pseudonymised data,
insofar as the data subjects are no longer identifiable.

 2.6 Databases Containing Personal or Sensitive
Data

According to the HRA and its implementing provisions (Article 43
HRA; Article 5 HRO), anyone who stores biological material or
health-related personal data for research purposes must take
appropriate technical and organisational measures to prevent the
unauthorised use thereof, and must fulfil certain operational and
professional requirements.

Since 2016, the Declaration of Taipei on Ethical Considerations
regarding Health Databases and Biobanks has complemented the
Declaration of Helsinki.

 3. Marketing Authorisations for Pharmaceuticals or
Medical Devices

 3.1 Product Classification: Pharmaceuticals or
Medical Devices

The decisive criterion for the classification of a product as a
therapeutic product – ie, as a medicinal product or as a
medical device, is the intended purpose of the product, which
– considering all objective (nature of a product) and
subjective (designation and promotion of a product) circumstances
of the individual case – must be the medical effect or
application on the human organism.

As regards the distinction between medicinal products and
medical devices, the decisive factor is not the material
composition of the product, but whether its intended main effect in
or on the human body is caused by pharmacological, immunological or
metabolic means (medicinal products), or rather through mechanical,
physical or physico-chemical effects (medical devices; Article 4
paragraph 1 lit a and b TPA; BVGE C-2093/2006, E. 3.5).

 3.2 Granting a Marketing Authorisation for
Biologic Medicinal Products

No specific requirements need to be met for the authorisation of
biological medicinal products (Article 2 paragraph 1 lit d
Ordinance on the Simplified Marketing Authorisation Procedures
(OSMA)). It is, however, necessary that an equilateral black
triangle standing on its apex is included in the package leaflet
and information, which is accompanied by the statement that this
medicinal product is subject to additional monitoring (Article 14a
lit b OMAMP).

 3.3 Period of Validity for Marketing Authorisation
for Pharmaceuticals or Medical Devices

The authorisation of medicinal products is initially valid for a
period of five years and is subject to subsequent renewal upon
application (Article 16 paragraph 2, Article 16b paragraph 1 TPA).
If a medicinal product is not placed on the market within three
years of the granting of the authorisation, or if it is no longer
actually on the market during a period of three consecutive years
after it has been placed on the market, Swissmedic may revoke the
authorisation (Article 16a paragraph 1 lit a TPA). Medicinal
products must fulfil their authorisation requirements for each
production unit during the entire distribution period, whereby such
requirements may only be modified, extended or restricted by a
formal amendment procedure. Swissmedic may at any time review the
authorisation, adapt it to changed circumstances or revoke it
(Article 16c TPA).

Regarding medical devices, the necessary certificates of
conformity (see 3.4 Procedure for Obtaining a
Marketing Authorisation for Pharmaceuticals and Medical
Devices) are valid for a maximum of five years and are
extended following a re-assessment (Article 26 MedDO). If a
designated body finds that a manufacturer no longer fulfils the
requirements of the MedDO, it must set a deadline for correction
and otherwise suspend, revoke or restrict the certificate (Article
27 MedDO).

 3.4 Procedure for Obtaining a Marketing
Authorisation for Pharmaceuticals and Medical Devices

An authorisation to place medicinal products on the Swiss market
is granted based on a respective application (Article 11 TPA) and
after a detailed examination by Swissmedic. Applicants must hold a
manufacturing, import or wholesale licence issued by Swissmedic
(see 4. Manufacturing of Pharmaceuticals and Medical
Devices), have a registered address, office or branch
office in Switzerland and must prove that the medicinal product is
of high quality, safe and effective (Article 10 TPA).

Different authorisation procedures apply depending on the
characteristics and the application of the medicinal product.

• Ordinary procedures for first authorisations of new active
  pharmaceutical ingredients (APIs) and major deviations (Article 9
  paragraph 1, Articles 11 et seq TPA).




• Compassionate use authorisations (in a simplified procedure,
  Articles 14 et seq TPA) for a limited period – ie, for
  life-threating or debilitating diseases if they are compatible with
  the protection of health, their use is expected to have a major
  therapeutic benefit, and no authorised, alternative or equivalent
  medicinal product is available in Switzerland (Article 9a TPA;
  Articles 18 et seq OSMA).




• Fast-track procedures for first authorisations of new APIs and
  major deviations on request, available for promising therapies for
  the prevention or therapy of a severe, debilitating or
  life-threatening disease with a high therapeutic benefit and where
  the standard treatment is either unavailable or unsatisfactory
  (Article 7 OMP).




• Simplified procedures for certain categories of medicinal
  products where this is compatible with the quality, safety and
  efficacy requirements and where there is no conflict with Swiss
  interests or international agreements, in particular for generics
  (but not for biosimilars), orphan drugs and certain categories of
  medicinal products authorised and/or used in foreign countries
  (Articles 14 et seq TPA; Articles 12 et seq OSMA).




• The authorisation procedure on the basis of a notification, in
  particular for certain complementary medicines without indications
  and other medicinal products with a low-risk potential (Article 15
  TPA).

Changes to an authorisation that have no or only minimal
consequences for the quality, safety or efficacy of a medicinal
product must be communicated to Swissmedic within 12 months of
their implementation (Article 21 OMP). Substantial variations
require an additional marketing authorisation procedure. Marketing
authorisations are in principle transferable upon approval of a
respective application by Swissmedic.

Medical devices do not require an authorisation by a public
authority prior to being placed on the Swiss market. Instead, they
must bear a respective conformity (MD or CE) marking testifying the
conformity of the device with the general safety and performance
requirements.

The conformity assessment procedure is based on Articles 52 and
54 and Annexes IX-XI of the EU-MDR (Articles 21 et seq MedDO;
Articles 17 et seq IvDO). Depending on the risk qualification of
the medical device (see 1.3 Different Categories of
Pharmaceuticals and Medical Devices), the conformity is
either to be declared by the manufacturer or by a private body
certified to conduct conformity assessments.

 3.5 Access to Pharmaceuticals and Medical Devices
Without Marketing Authorisations

In principle, ready-to-use medicinal products may only be placed
on the market after they have been authorised (Article 9 paragraph
1 TPA). However, there are a number of exceptions to this general
rule.

• Medicinal products for which a review of the ordinary approval
  requirements (of high quality, safe and effective) is not necessary
  or useful – eg, formula magistralis, officinalis and
  hospitalis products or products intended for clinical trials
  (Article 9 paragraphs 2 et seq TPA).




• Orphan use – the use of medicinal products for the
  treatment of diseases that are so rare that there is hardly any
  incentive for a regular marketing authorisation to be approved in
  Switzerland for a limited period in a simplified approval procedure
  (Article 9a, Article 14 paragraph 1 lit f TPA).




• Temporary authorisation for use outside of clinical trials
  – Swissmedic may temporarily authorise the use of yet
  unauthorised medicinal products intended for clinical trials
  outside the scope of a clinical trial (Article 9b paragraph 1 TPA;
  Articles 52 et seq MPLO).




• Temporary authorisation to bridge temporary unavailability
  – medicinal products may be temporarily or quantitatively
  authorised by Swissmedic to bridge the unavailability of an
  identical medicinal product in Switzerland, provided that they are
  authorised in another country with an equivalent medicinal product
  control and no essentially identical medicinal product is
  authorised and available in Switzerland (Article 9b paragraph 2
  TPA).




• Off-label use – off-label use – eg the use of a
  (properly) authorised medicinal product for other indications, is
  generally permissible within the scope of Articles 3 and 26
  TPA.




• Unlicensed use – an unlicensed medicinal product may be
  imported under the restrictive requirements of Article 20 paragraph
  2 TPA and Articles 48 et seq MPLO.

Manufacturers of medical devices must generally carry out a
conformity assessment before placing the device on the market
(see 3.4 Procedure for Obtaining a Marketing
Authorisation for Pharmaceuticals and Medical Devices).
However, in the interest of public health or patient safety or
health, Swissmedic may, upon application, grant an authorisation
even though the relevant conformity assessment procedure has not
been carried out (Article 22 paragraph 1 MedDO; Article 18
paragraph 1 IvDO).

 3.6 Marketing Authorisations for Pharmaceuticals
and Medical Devices: Ongoing Obligations

Holders of marketing authorisations for medicinal products, as
well as medical device manufacturers, must have a post-market
surveillance system (ie, pharmacovigilance and materiovigilance
plans) in place (Article 11 paragraph 2 lit a no 5 TPA; Article 56
MedDO; Article 49 IvDO).

Holders of marketing authorisations for medicinal products with
a new API or a biosimilar must periodically and automatically file
safety update reports (PSURs) with Swissmedic on the safety and
risk-benefit ratio for four years after authorisation (Article 60
OMP). With its marketing authorisation, Swissmedic may impose
additional conditions or obligations on the applicant, including
further product evaluations (eg, in Phase IV clinical trials).
Depending on the classification of a medical device, its
manufacturer has similar trend report, periodic summary report and
PSUR obligations to the designated body involved in the conformity
assessment (Articles 59 et seq MedDO; Articles 52 et seq IvDO).

As for incident notification requirements, manufacturers of
medicinal products, distributors of ready-to-use medicinal products
and HCPs must notify Swissmedic of adverse events, adverse drug
reactions and quality defects within 15 days in case of serious
adverse reactions and within 60 days of non-serious reactions.
Similarly, anyone placing medical devices on the Swiss market must
report to Swissmedic all serious incidents as well as all field
safety corrective actions that are undertaken in Switzerland
(Article 66 MedDO; Article 59 IvDO).

 3.7 Third-Party Access to Pending Applications for
Marketing Authorisations for Pharmaceuticals and Medical
Devices

Authorities must in principle treat all data collected within
the framework of the TPA and its implementing regulations as
confidential, including all data communicated to the authorities in
the context of a marketing authorisation application (Article 62
TPA). Granted marketing authorisations for medicinal products are
published in the monthly Swissmedic Journal, together with
essential information about the medicinal product. Swissmedic
publishes an assessment report (SwissPAR) for all medicinal
products with a new API, as well as for transplant products, for
which a decision to approve or reject authorisation has been
issued. The SwissPAR includes the evaluation results of the
application for new authorisation or additional indication of a
medicinal product, but not the applicant’s commercial or
manufacturing secrets or personal data.

Regarding medical devices, the conformity assessment procedures
by Swiss or European assessment bodies are not accessible to third
parties. The successful completion of a conformity assessment is
made public together with the issuance of the declaration of
conformity for the respective product (Article 90 lit f MedDO).

 3.8 Rules Against Illegal Medicines and/or Medical
Devices

Switzerland has signed and ratified the Council of Europe
Convention on the counterfeiting of medical products and similar
crimes involving threats to public health (Medicrime-Convention).
Accordingly, several provisions were introduced into the TPA,
including mandatory licensing for persons trading medicinal
products in foreign countries from Switzerland or acting from
Switzerland as brokers or agents for medicinal products (Article 18
paragraphs 1 and 2 TPA), the designation of Swissmedic as the
national contact point under the Medicrime Convention (Article 69
paragraph 4 TPA), and criminal provisions (Articles 90 et seq
TPA).

 3.9 Border Measures to Tackle Counterfeit
Pharmaceuticals and Medical Devices

Customs authorities are involved in monitoring the importation,
the transit and the exportation of therapeutic products. In
particular, they monitor whether the medicinal products are
authorised or compliant and whether the quantity lies within the
maximum limit. In the case of suspicious shipments of goods, the
customs office notifies Swissmedic and holds back the products in
question. Decisions in application of healthcare regulations are,
however, made exclusively by Swissmedic.

Following the ratification of the Medicrime-Convention
(see 3.8 Rules Against Illegal Medicines and/or
Medical Devices), the Federal Office for Customs and
Border Security (FOCBS) was granted the competence, alongside
Swissmedic, to order secret surveillance measures (Article 90a
TPA).

 4. Manufacturing of Pharmaceuticals and Medical
Devices

 4.1 Requirement for Authorisation for
Manufacturing Plants of Pharmaceuticals and Medical
Devices

The manufacture of medicinal products in Switzerland is subject
to a mandatory licence (Article 5 paragraph 1 lit a TPA). The same
applies to anyone withdrawing blood from humans for the purpose of
transfusion or the manufacture of therapeutic products or for
supply to a third party (Article 34 TPA). The licence is issued if
Swissmedic has successfully verified during an inspection that the
necessary technical and operational conditions have been fulfilled
and an appropriate system of quality assurance exists (Article 6
TPA; Articles 3 et seq MPLO). The licence is issued for an
unlimited period of time, whereby Swissmedic performs periodic
inspections and may revoke licences if the requirements are no
longer fulfilled.

Manufacturers of medical devices are not subject to licensing
requirements in Switzerland. However, if a manufacturer is not
established within Switzerland, its devices may only be placed on
the market if it has appointed an authorised representative in
Switzerland that is responsible for the related formal and
safety-related aspects and is registered with Swissmedic (Articles
51 and 55 MedDO; Articles 44 and 48 IvDO; Article 11 EU-MDR/
EU-IVDR).

 5. Distribution of Pharmaceuticals and Medical
Devices

 5.1 Wholesale of Pharmaceuticals and Medical
Devices

Any person engaged in the wholesale trade of medicinal products
must possess a licence (Article 28 paragraph 1 TPA). The licence is
issued following an inspection by Swissmedic (Article 28 paragraph
2 TPA; Articles 11 et seq MPLO).

No licences are required for the wholesale (Article 4 paragraph
1 lit i MedDO; Article 4 paragraph 1 lit h IvDO) of medical
devices. Foreign manufacturers, however, need to appoint an
authorised representative domiciled in Switzerland
(see 4.1 Requirement for Authorisation for
Manufacturing Plants of Pharmaceuticals and Medical
Devices).

 5.2 Different Classifications Applicable to
Pharmaceuticals

See 1.3 Different Categories of Pharmaceuticals and
Medical Devices.

 6. Importation and Exportation of Pharmaceuticals and
Medical Devices

 6.1 Governing Law for the Importation and
Exportation of Pharmaceuticals and Medical Devices and Relevant
Enforcement Bodies

Importation and exportation of medicinal products and medical
devices are mainly governed by the TPA, MPLO, MedDO and the Swiss
customs legislation. At the point of entry, the responsibility for
the application and enforcement of the respective regulations lies
with the FOCBS. The competent governmental authority for any
subsequent market surveillance is Swissmedic. FOCBS and Swissmedic
co-operate closely in their joint areas of competence (cf. Article
65 MPLO).

 6.2 Importer of Record of Pharmaceuticals and
Medical Devices

Any person that professionally imports medicinal products
intended for distribution or dispensing must possess a licence
issued by Swissmedic (Article 18 paragraph 1 lit a TPA) following
an inspection confirming that the necessary technical and
operational conditions have been fulfilled and that an appropriate
system of quality assurance exists (Article 19 paragraph 1 TPA;
Articles 11 et seq MPLO).

Importers of medical devices (Article 4 paragraph 1 lit h MedDO;
Article 4 paragraph 1 lit. g IvDO) are not subject to licensing
requirements in Switzerland. However, if a manufacturer is not
established within Switzerland, its devices may only be placed on
the market if it has appointed an authorised representative in
Switzerland that is responsible for the related formal and
safety-related aspects and if the importer is registered with
Swissmedic and is assigned a CHRN (Article 55 MedDO; Article 48
IvDO; see 4.1 Requirement for Authorisation for
Manufacturing Plants of Pharmaceuticals and Medical
Devices).

 6.3 Prior Authorisations for the Importation of
Pharmaceuticals and Medical Devices

In principle, only medicinal products that have been granted a
marketing authorisation by Swissmedic can be imported into
Switzerland (Article 9 TPA), and importation is subject to a
specific licence (Article 18 paragraph 1 lit a TPA). Subject to
certain exceptions, in particular in connection with an official
batch release from a foreign control authority belonging to the
Official Control Authority Batch Release Network (OCABR), anyone
wishing to import immunological medicinal products or blood and
blood products generally requires a special licence for each
individual shipment (Article 44 MPLO). Under certain circumstances,
ready-to-use medicinal products without a marketing authorisation
in Switzerland may be imported in small amounts by persons for
private use or by HCPs (cf. Articles 48 and 49 MPLO).

While no licence for the import of medical devices is required
(see 6.2 Importer of Record of Pharmaceuticals and
Medical Devices), medical devices must, prior to their
placing on the Swiss market, undergo a conformity assessment to
ensure that general safety and performance requirements are met
(Articles 6, 21 et seq MedDO; Articles 6, 21 et seq IvDO).
Certifications of conformity (CE markings) issued by bodies from
EU/EEA countries are unilaterally recognised in Switzerland
(Article 25 paragraph 4 MedDO; Article 21 paragraph 4 IvDO).

 6.4 Non-tariff Regulations and Restrictions
Imposed Upon Importation

Non-tariff restrictions are set forth in the Swiss customs
tariff. The entries in the relevant Harmonised Tariff Schedule
(HTS) line will determine which market surveillance authority is
competent to examine and approve import. The product-related laws
and implementing ordinances set out the restrictions in detail.

 6.5 Trade Blocs and Free Trade
Agreements

Switzerland is a member of the European Free Trade Association
(EFTA) and is, amongst others, signatory to the Free Trade
Agreement with the EU of 1972 as well as to a network of currently
33 free trade agreements with 34 partners. The EU has unilaterally
ceased the application of the Mutual Recognition Agreement as
regards medical devices. As a result, exportation of medical
devices from Switzerland into the EU has become more burdensome.
Negotiations are currently taking place between the USA and
Switzerland on a free trade agreement concerning the pharmaceutical
sector, which is intended to facilitate market access for Swiss
pharmaceutical companies.

 7. Pharmaceutical and Medical Device Pricing and
Reimbursement

 7.1 Price Control for Pharmaceuticals and Medical
Devices

Under Swiss law, prices of therapeutic products are controlled
to the extent that they are reimbursed by the compulsory health
insurance. With regard to therapeutic products not reimbursed by
compulsory health insurance, manufacturers, wholesalers and
retailers are, in principle, not restricted in their pricing.

Pharmaceuticals are reimbursed subject to a listing on the
Specialties List (SL) where ready-to-use medicinal products are
included. Medicinal products that are manufactured in a pharmacy
are reimbursed if their APIs are included in the List of Medicines
with Tariff (LMT). The requirements for price fixing are mainly
contained in the Health Insurance Act (HIA), the Health Insurance
Ordinance (HIO) and the Ordinance on the Benefits under the
Mandatory Health Insurance (OBHI). The SL determines the ex-factory
price as well as the public price, which is the maximum amount
(including VAT) that must be reimbursed by health insurers.

The FOPH decides on the inclusion of a medicinal product on the
SL after consultation with the Federal Drugs Commission (EAK),
except in case of certain medicinal products, such as generics and
new galenic forms or package sizes of already listed medicinal
products (Article 31 paragraph 2 OBHI). An accelerated procedure
applies in case of an accelerated market authorisation (Article 31a
OBHI). The procedure is initiated by the market authorisation
holder (Article 31 paragraph 1 OBHI). Medicinal products can only
be included in the SL if the criteria of efficacy, appropriateness
and cost-effectiveness are met (Article 32 paragraph 1 HIA). The
prices are reviewed every three years (Article 65d HIO), and
additional reviews take place upon patent expiry and in case of the
authorisation of further indications.

The List of Items and Tools (LIT) determines which devices are
covered by the compulsory health insurance. Unlike the SL, the LIT
does not fix the ex-factory and public price, but only sets the
maximum reimbursement amount. In principle, higher prices may be
charged and the difference is borne by the patient. There are
specific provisions governing the application for inclusion on the
LIT. The FDHA decides upon consultation of the Federal Commission
for Analyses, Instruments and Tools (FCAIT) on the addition,
change, or delisting (cf. Articles 21 et seq OBHI). The criteria of
efficacy, appropriateness and cost-effectiveness also apply to
medical devices.

 7.2 Price Levels of Pharmaceuticals or Medical
Devices

When setting and reviewing the prices of the medicinal products
included in the SL, the FOPH relies on the following comparisons:
(i) a therapeutic comparison in which the effectiveness of the
medicinal products is assessed in relation to other medicinal
products used for the same indication (Article 65b paragraph 4bis
HIO); and (ii) a price comparison with the same medicinal product
abroad (cf. Article 34a and 34b OBHI). The two comparisons are
given the same weight. The latter comparison is carried out
according to the guidance of the EAK taking into account foreign
countries whose pharmaceutical sector is economically comparable
with Switzerland.

 7.3 Pharmaceuticals and Medical Devices:
Reimbursement From Public Funds

Under the compulsory health insurance, insurers must reimburse
costs for prescribed medicinal products listed in the SL and the
LMT at the maximum amount set out therein. The reimbursement may be
restricted to specific indications, quantities or durations.
Reimbursement is, in general, only granted for listed medicinal
products under the condition that they are used in connection with
indications approved by Swissmedic and within approved quantities.
Exceptions from this general rule apply on a case-by-case basis
subject to the conditions set out in Article 71a HIO. In addition,
there is also room for reimbursement in individual cases of
medicinal products not yet authorised, not yet included in the SL
or used outside their marketing authorisation (Articles 71b-d
HIO).

Medical devices applied by the patient are reimbursed under the
condition that they belong to a specific group of medical devices
in the LIT, are prescribed by a physician or chiropractor and are
dispensed by an authorised provider. The reimbursement of listed
medical devices may be restricted to specific medical indications,
quantities or durations. Case law has not yet addressed the
question of whether the provisions of Article 71a-d HIO are also
applicable to medical devices by analogy.

 7.4 Cost-Benefit Analyses for Pharmaceuticals and
Medical Devices

Among the conditions for the inclusion of medicinal products on
the SL are their efficacy, appropriateness and cost-effectiveness,
and the existence of these conditions must be periodically reviewed
(Article 32 HIA). Medicinal products that no longer meet these
criteria are removed from the SL by the FOPH. The same applies to
medical devices (to be) included on the LIT.

It is usually undisputed that an authorised medicinal product is
effective and appropriate. In practice, the main focus is therefore
on the criterion of cost-effectiveness, including the respective
comparisons with other medicinal products and markets
(see 7.2 Price Levels of Pharmaceuticals or Medical
Devices).

 7.5 Regulation of Prescriptions and Dispensing by
Pharmacies

While the main purpose of the prescribing and dispensing
regulations is to safeguard patient welfare and safety in the
dispensing and use of medicinal products by requiring that only
HCPs with sufficient education, training and continuing education
are involved (Articles 24-26 TPA), HCPs are required by their
professional duties and corresponding provisions in their
self-regulations to also observe the aspect of economic efficiency.
Furthermore, the legal provisions on the advertising of medicinal
products explicitly provide for the inadmissibility of advertising,
including to HCPs, which may encourage the excessive use of
medicinal products (cf. Article 32 paragraph 1 lit b TPA). Lastly,
the integrity provisions (cf. Article 55 TPA; OIT) prohibit the
excessive prescribing of medicines.

In general, physicians may prescribe any authorised medicinal
product for a given indication without regard to its price, and
they are not obliged to propose a more affordable (generic)
alternative. That said, if the SL contains different medicinal
products containing the same API, the cost share that must be borne
by the patient may vary. Physicians must inform their patients
accordingly. Equally, for medicinal products that are not included
in the SL or that are used off-label or off-limitation, HCPs must
inform the patients that the costs might not be reimbursed under
the compulsory health insurance. According to Article 52a HIA,
pharmacists are allowed, but not obliged, to substitute a
prescribed original medicinal product listed on the SL with a
generic unless there is an explicit request by the prescribing
physician or chiropractor to dispense the original.

 8. Digital Healthcare

 8.1 Rules for Medical Apps

Medical apps are not subject to specific regulation in
Switzerland, but are considered medical devices provided that the
app is intended to be used for a medical purpose as set out in the
TPA (see 3.1 Product Classification: Pharmaceuticals
or Medical Devices; Federal Administrative Court decision
C-669/2016 of 17 September 2018). Therefore, such apps must comply
with the legal requirements for medical devices, including
regarding conformity assessments.

 8.2 Rules for Telemedicine

While telemedicine is established in Switzerland, only few
cantons have issued specific regulation (eg, § 8 Health Care
Act of the Canton of Basel-Landschaft). Thus, telemedicine is
governed by general healthcare law and the medical code of ethics.
As soon as the treating physician can no longer assume that a
patient can be treated carefully by means of telemedicine, the
treatment must be adjusted and the patient must be either
physically examined or referred to another physician. The
provisions of data protection and medical secrecy (Article 321
Swiss Criminal Code (SCC)) are also applicable to treatments using
telemedicine methods.

 8.3 Promoting and/or Advertising on an Online
Platform

Electronic advertising of medicinal products, such as via online
portals and social networks, without any access restriction,
qualifies as advertising to the general public (Article 15(c)
OMPA), which is prohibited for prescription medicines (Article 32
paragraph 2 lit a TPA). Access to professional advertising via
electronic means must be restricted by appropriate technical and
password protection to professionals authorised to dispense or
apply medicinal products (Article 5a OMPA). The same applies to
media releases and press kits which directly or indirectly
reference the prescription of specific medicinal products
(Swissmedic Guidance “Advertising of medicinal products on
the internet”).

There are no specific regulations governing online promotion and
advertising of medical devices. The promotion to the general public
of products intended solely for the use by HCPs is prohibited
(Article 51 TPA; Article 69 paragraph 3 MedDO; Article 62 paragraph
3 IvDO).

 8.4 Electronic Prescriptions

Rules on electronic prescription are part of the regulation on
the electronic patient record. The FMH and the Pharmacists
Association “Pharmasuisse” announced in a 2022
statement that they intend to create an electronic prescription,
and initial pilot tests have already been launched. The most recent
draft revision of the TPA, for which consultation was opened in
December 2023, intends to create a legal basis for electronic
prescriptions and their digital transmission.

 8.5 Online Sales of Medicines and Medical
Devices

The online sale of medicinal products is, in principle,
prohibited (Article 27 TPA). By exception, a licence may be granted
by the competent cantonal authorities to persons already in
possession of a cantonal retail authorisation to run a public
pharmacy if (Article 27 paragraphs 2 and 4 TPA; Article 55
paragraph 2 OMP):

• there is a physician’s prescription for the medicinal
  product (irrespective of whether it qualifies as a
  prescription-only product);




• no safety requirements oppose it; and




• appropriate consultation and sufficient medical supervision of
  the effect of the medicinal product are guaranteed.

The online sale of medical devices is, in principle, permitted
(Article 7 MedDO; Article 7 IvDO).

 8.6 Electronic Health Records

In 2017, the Federal Act on the Electronic Patient Record (EPR)
and the related ordinances came into force and regulate the
conditions for the introduction and implementation of the
electronic patient dossier (EPD). The EPD is a filing system for
treatment, with relevant information containing copies of medical
records, whereby the decision whether to open an EDP is left to the
patients (opt-in). The data is stored in encrypted form and can
only be viewed by the patients and authorised HCPs. The EPR is
currently being revised.

Health-related data is regarded as sensitive data pursuant to
the FADP and the DPO, provided that the data directly or indirectly
references an identified or identifiable person’s physical or
mental health. This means that, in principle, anonymised data is
not regarded as sensitive data.

More stringent requirements apply to sensitive data, including
requiring data controllers to:

• inform the person concerned about the collection of their
  data;




• ensure that the disclosure of sensitive data to third parties
  is based on a legal justification; and




• comply with specific registration and notification obligations
  with the Federal Data Protection and Information Commissioner
  (FDPIC).

Moreover, the general provisions of the FADP must be complied
with. The transfer and storage of health data on a cloud platform
is, in principle, permitted under the FADP. However, this is only
possible if, among others, no legal or contractual confidentiality
obligation prohibits such transfer. Physicians are bound by
professional secrecy regarding the medical history or the contents
of the patient file (Article 321 SCC). They remain responsible for
keeping confidentiality even when transferring the data and
therefore must ensure that the patient data is protected against
unauthorised processing. The FMH recommends that physicians do not
store health data of their patients in clouds located abroad.

 9. Patents Relating to Pharmaceuticals and Medical
Devices

 9.1 Laws Applicable to Patents for Pharmaceuticals
and Medical Devices

The Federal Act on Patents and Inventions (PatA) and the
Ordinance on Patents and Inventions (PatO) apply to patents in
Switzerland. Further, Switzerland is a member of the major
international patent treaties, such as the European Patent
Convention (EPC) and the Patent Co-operation Treaty (PCT).

Most patents in Switzerland are granted within a harmonised
procedure under the EPC. Generally, patents are granted for new
inventions with an industrial application.

Certain inventions, such as gene sequences, are excluded from
patent protection. Accordingly, the patentability of medicinal
products developed from human gene sequences is subject to a
scrutinous examination. Methods for medical treatment and
diagnostics are also excluded from patent protection. While it is
in essence undisputed that the exclusion from patentability only
refers to the methods, and not to products used in such methods, it
can be difficult to draw a clear distinction between device-related
methods and functional device features.

 9.2 Second and Subsequent Medical
Uses

Pharmaceutical substances or compositions that – even
though they are part of the state of the art as such – do not
yet form the state of the art in relation to a specific use in a
surgical, therapeutic or diagnostic method are deemed to be new
and, hence, patentable, provided they are intended for use in the
manufacture of a means to a surgical, therapeutic or diagnostic end
(Article 7c PatA). Any subsequent new surgical, therapeutic or
diagnostic use for which the substance or composition is not
considered state of the art can also be claimed as new (Article 7d
PatA). Consequently, the use of a substance or composition for the
manufacturing of a means for a medical procedure is patentable.
Such claims are referred to as Swiss-type claims.

New dosage regimes and the indication for a new or selected
patient population as such cannot be patented. However, if a dosage
regime or indication is new and based on an inventive step, such
new dosage regime or new indication can be patented. In most cases,
however, a new dosage regime will be considered obvious and, hence,
not patentable.

To date, it is unclear what activities constitute infringement
of second and subsequent patents of medicinal products. More
specifically, it has yet to be decided whether and to what extent
the exclusive rights conferred by a traditional substance claim, by
a claim for second and subsequent medical use under Articles 7c and
7d PatA and by a purpose-oriented substance claim under Article
54(5) of the EPC differ from each other.

 9.3 Patent Term Extension for
Pharmaceuticals

In principle, patent protection is granted for a term of 20
years from the filing date of the application and cannot be
extended. Unlike other jurisdictions, Switzerland does not have a
patent linkage system. However, for medicinal products, the Swiss
Intellectual Property Institute (IPI) can grant a supplementary
protection certificate (SPC) for a patent-protected API or
combination of APIs (or manufacturing process or use of such API or
API combination) contained in a medicinal product authorised in
Switzerland. An SPC takes effect on expiry of the maximum patent
term for a period equal to the period which elapses between the
date of filing and the date of the first authorisation of the
medicinal product in Switzerland minus five years, but for a
maximum term of five years. Subject to statutory conditions, the
SPC’s term of protection may be extended once for a period of
six months. The application for an SPC must be filed with the IPI
(i) within six months of the first marketing authorisation of a
medicinal product containing the API or API combination in
Switzerland; or (ii) within six months of the grant of the patent
if the patent was granted later than the first marketing
authorisation. On certain conditions, patent holders can also apply
for a paediatric SPC or extension of a non-paediatric SPC with a
term of six months.

 9.4 Pharmaceutical or Medical Device Patent
Infringement

Medicinal products and medical device patents confer the
exclusive right to commercially use the invention in Switzerland.
This exclusive right can be infringed through direct or indirect
misconduct. A direct infringement occurs when an unauthorised party
uses a patent commercially by, inter alia, manufacturing, storing,
offering, advertising to Swiss customers, placing on the market,
importing, exporting and carrying in transit a patent-protected
product, or by possessing the patent-protected product for any of
these purposes. An indirect infringement occurs if a party
contributes to a direct patent infringement – ie, if a party
instigates, participates in, favours, facilitates or contributes in
other ways to a direct patent infringement (aiding or abetting).
Such contribution must have an adequate causal link to the direct
patent infringement.

Apart from actual patent infringements, the mere threat of
infringement is actionable as well. In such cases, the claimant
must deliver proof of a sufficient interest in legal protection.
Such an interest exists if the unlawful act is imminent – ie,
if the alleged infringement of rights is to be seriously
expected.

 9.5 Defences to Patent Infringement in Relation to
Pharmaceuticals and Medical Devices

In practice, key defences to patent infringement relate to the
invalidity of a patent as well as the lack of an infringement.

Further, defendants may invoke statutory exemptions, such as the
so-called “experimental use exemption”, according to
which the effect of a patent does not extend to acts undertaken for
research or experimental purposes under Swiss law (Article 9
paragraph 1 lit b PatA). Additional exemptions and respective
defences are, inter alia, provided for:

• acts necessary for obtaining a marketing authorisation for a
  medicinal product in Switzerland or in countries with equivalent
  medicinal product control – ie, EU/EEA countries, USA,
  Singapore, New Zealand, Canada, Japan, and Great Britain (Article 9
  paragraph 1 lit c PatA);




• acts undertaken as part of a medical activity by legally
  authorised persons concerning an individual person and involving a
  medicinal product (compassionate or off-label use) (Article 9
  paragraph 1 lit g PatA); and




• the direct individual preparation of medicinal products in
  pharmacies in accordance with a physician’s prescription
  (Article 9 paragraph 1 lit h PatA).

 9.6 Proceedings for Patent
Infringement

Patent infringement proceedings may be initiated by the patent
owner and by a patent licensee who holds an exclusive licence and
whose right to initiate an infringement action is not explicitly
excluded in the licence agreement. Exclusive and non-exclusive
licensees are eligible to join a pending infringement proceeding in
order to claim their own losses or damages.

Through a patent infringement proceeding, a claimant may seek a
variety of remedies, such as injunctive relief, the remedying of an
unlawful situation, damages or a declaratory judgment. Further
statutory remedies are the provision of information and accounting,
the destruction of infringing goods, the recall of patent
infringing goods or the publication of the decision.

Typical patent infringement actions are carried out in the form
of inter partes preliminary injunction proceedings for interim
relief, followed by ordinary proceedings on the merits.

A defendant may raise the defence of invalidity in preliminary
injunction proceedings. If such a defence is raised, the Federal
Patent Court examines both the question of validity and the
question of infringement in almost as much detail as in ordinary
proceedings on the merits. In ordinary proceedings on the merits,
the invalidity may be invoked either as a defence or by way of a
counteraction. Unlike courts in other jurisdictions, the Federal
Patent Court is competent to rule on both the validity and the
infringement of a patent. Accordingly, plaintiffs need not bring
validity and infringement actions before different courts.

 9.7 Procedures Available to a Generic
Entrant

There is no requirement of a declaratory action for a generic
product to enter the Swiss market. While a prior marketing
authorisation is required for a medicinal product to enter the
market, the authorisation procedure as such is not considered to
constitute a patent infringement.

At the same time, the simplified authorisation procedure used
for generic entry in Switzerland (Articles 14 et seq TPA; Articles
12 et seq OSMA) is based on references to the marketing
authorisation documents of the medicinal product with the known
APIs. These documents can benefit from regulatory data protection
for a certain period. Accordingly, the marketing authorisation for
generic entrants can, in principle, only be granted upon expiry of
the regulatory data protection.

For medical devices, Swiss law does not provide for a marketing
authorisation procedure. It is for the competitor to decide on its
market entry, and for the holder of a patent in the original
medical device to take legal action.

 10. IP Other Than Patents

 10.1 Counterfeit Pharmaceuticals and Medical
Devices

In Switzerland, various intellectual property laws and
procedures are in place to combat the counterfeiting of medicinal
products and medical devices, including the following: the PatA,
the Trade Mark Protection Act (TmPA), the Federal Design Act, the
Federal Act on Copyright and Related Rights, and the Federal Unfair
Competition Act (UCA).

In case of infringements, these statutes grant civil law
remedies such as injunctions, damages and account of profits.

In addition to civil law remedies, under criminal law,
counterfeiting medicinal products and medical devices constitutes a
criminal offence. The Swiss intellectual property laws provide for
criminal penalties against counterfeiters, including custodial
sentences of up to five years and monetary penalties.

Under customs laws, the FOCBS is responsible for enforcing
intellectual property rights at the Swiss border – eg, by
withholding goods and notifying the proprietor of the intellectual
property right if there is a suspicion that the import, export or
transit of such goods infringes rights in Switzerland.

 10.2 Restrictions on Trade Marks Used for
Pharmaceuticals and Medical Devices

In principle, trade marks for medicinal products and medical
devices are subject to generally applicable trade mark and unfair
competition laws.

Notably, the IPI can refuse the registration of a trade mark if
the registered sign is (i) in the public domain, (ii) misleading,
(iii) contrary to public policy, morality or applicable law, (iv)
technically necessary or representing the nature of the goods
themselves (Article 2 TmPA). Inter alia, trade mark protection can
be withdrawn for lack of use or infringement of a prior trade
mark.

In addition to generally applicable standards, the name of a
medicinal product (unlike the name of a medical device) is subject
to prior authorisation by Swissmedic as part of the marketing
authorisation proceedings. Swissmedic can reject or request
amendments to a contemplated name if there is a risk of confusion
between medicinal products or if the name is considered (i)
misleading about the product’s composition, quality,
efficacy, risks, or safety, or (ii) promoting improper
consumption.

 10.3 IP Protection for Trade Dress or Design of
Pharmaceuticals and Medical Devices

In principle, the design of medicinal products and medical
devices, as well as their packaging, are eligible for trade mark,
design and/or copyright protection, as well as protection under the
UCA. The scope of protection will generally depend on the
(intellectual property) right that is being claimed and on the
level of distinctiveness of the specific design or trade dress.

Upon registration, trade mark protection is granted in
Switzerland to protect the use of a registered sign for a specified
class of products and/or services. The trade mark can, in
principle, consist in packaging or trade dress elements. In order
to be protected, the trade mark must be distinctive.

Upon registration, design protection is granted in Switzerland
to protect the appearance of a product and/or its packaging. A
design is protected to the extent that it is new and has an
individual character.

Copyright protection is granted as of the moment of the creation
of a design. No registration is required. To benefit from
protection, the design must, however, qualify as an original work
of authorship.

Where an imitation of a medicinal product or medical device
trade dress violates fairness principles (eg, if the user is
intentionally misled about a product’s origin or if the
imitator intentionally exploits the reputation of a competing
product), protection can be sought under the UCA.

 10.4 Data Exclusivity for Pharmaceuticals and
Medical Devices

The documents that are submitted to obtain marketing
authorisation for new active substances are generally protected for
a period of ten years from the granting of the marketing
authorisation in Switzerland (Article 11a TPA). New indications,
modes of administration, dosages or dosage forms can benefit from
regulatory data protection of three years. Further document
protection can be granted for important orphan medicinal products
(15 years), medicinal products specifically and exclusively for
paediatric use (ten years), and medicinal products that are
expected to have a significant clinical benefit compared to
existing therapies (ten years) (Article 11b TPA).

During the respective data protection period, the simplified
procedure allowing for a reference to marketing authorisation
documents of a known API is unavailable and a marketing
authorisation for another product cannot be granted based the
protected data, including trial data for the protected authorised
product, unless the marketing authorisation holder consents. Unlike
jurisdictions providing for market exclusivity, the Swiss system
only protects the data and does not prevent other manufacturers
from entering the market based on independently generated data.

 11. COVID-19 and Life Sciences

 11.1 Special Regulation for Commercialisation or
Distribution of Medicines and Medical Devices

Numerous (temporary) regulations were issued in connection with
the COVID-19 pandemic, also affecting the marketing and
distribution of therapeutic products. As of today, the key
regulation in this respect is the Ordinance 3 on Measures to Combat
the Coronavirus (COVID-19 Ordinance 3), which is intended to ensure
that Switzerland can maintain adequate medical care for the
population and sufficient essential medical supplies. To this end,
the COVID-19 Ordinance 3 establishes notification requirements for
stocks of essential medical supplies, procurement and distribution
requirements and simplifying exemptions for the placing on the
market and importation of medicinal products and medical devices
for the prevention and control of COVID-19. The COVID-19 Ordinance
3 will cease to apply as of 1 August 2024.

 11.2 Special Measures Relating to Clinical
Trials

Swissmedic and Swissethics issued joint recommendations for the
handling of clinical trials with medicinal products during the
COVID-19 pandemic (“Joint Guidance”). The Joint
Guidance provided, among other things, that applications for
clinical trials related to COVID-19 were prioritised and that
applications for clinical trials could be submitted electronically
and in bundles of multiple applications. Furthermore, for the
period of the pandemic, specific amendments regarding the
distribution of investigational medicinal drug products and the
monitoring of clinical trials were provided.

 11.3 Emergency Approvals of Pharmaceuticals and
Medical Devices

During the pandemic, different exemptions from the general
authorisation requirement for medicinal products were issued.

• Certain medicinal products used for the treatment of COVID-19
  patients, can already be placed on the market during the approval
  process (Article 21 paragraph 1 of the COVID-19 Ordinance 3).




• The same applies to medicinal products that prevent the
  COVID-19 infection of immunosuppressed persons under certain
  conditions (Article 21 paragraph 1bis COVID-19 Ordinance 3).




• Variations to the authorisation for certain authorised
  medicinal products can be implemented immediately upon application
  (Article 21 paragraph 2 COVID-19 Ordinance 3).




• Swissmedic was enabled to approve the import of essentially
  identical medicinal products as a short-term solution for any
  temporary non-availability of medicinal products (Article 22
  paragraph 3 COVID-19 Ordinance 3).

Likewise, certain exemptions were introduced for medical
devices.

• Subject to approval by Swissmedic, medical devices that have
  not (yet) undergone the required conformity assessment procedure in
  Switzerland or in a recognised third country (eg, the EU) may
  nevertheless be placed on the Swiss market under certain
  requirements (Article 23 paragraph 1 COVID-19 Ordinance 3).




• Face masks that have not undergone a conformity assessment
  procedure can be placed on the market, provided that they are not
  used in the medical field and are labelled accordingly (Article 23
  paragraph 4 COVID-19 Ordinance 3).

 11.4 Flexibility in Manufacturing Certification as
a Result of COVID-19

No simplifications regarding manufacturing licences were
introduced in connection with the pandemic. However, for a short
period of time, Swissmedic inspections were suspended or modified,
and Swissmedic confirmed that all GMP certificates issued in
2017/2018 would remain fully valid until the end of 2021 or the
next routine inspection. In January 2023, Swissmedic provided an
update according to which all planned routine inspections in
Switzerland were carried out and that it was no longer necessary to
generally extend GMP certificates. Extended EU GMP certificates
are, however, accepted by Swissmedic.

 11.5 Import/Export Restrictions or Flexibilities
as a Result of COVID-19

Different regulations were introduced during the pandemic to
facilitate the import of medicinal products.

• Following the submission of an authorisation application
  according to Article 21bis COVID-19 Ordinance 3, the applicant can
  import the medicinal product before the decision on the
  authorisation or entrust a company carrying a wholesale or import
  licence with the import (Article 22 paragraphs 1 and 2bis COVID-19
  Ordinance 3).




• Pharmacists who have pharmaceutical responsibility in a
  hospital pharmacy are authorised to import certain medicinal
  products (Article 22 paragraph 1bis COVID-19 Ordinance 3).




• For the temporary non-availability of a medicinal product,
  Swissmedic may allow the temporary import of an identical medicinal
  product, provided no other essentially identical medicinal product
  is authorised and available in Switzerland (Article 22 paragraph 3
  COVID-19 Ordinance 3).




• Article 22 paragraph 4 Covid-19 Ordinance 3 permits the import
  and storage of COVID-19 vaccines before their authorisation, under
  certain conditions.

 11.6 Drivers for Digital Health Innovation Due to
COVID-19

Under the pandemic, a wider range of remote services delivered
by HCPs was reimbursed by the compulsory health insurance in order
to comply with the requirements of social distancing.

 11.7 Compulsory Licensing of IP Rights for
COVID-19-Related Treatments

Applicants may bring action before Swiss courts for a compulsory
non-exclusive licence for the manufacture of patent-protected
medicinal products and for their export to a country that has
insufficient or no production capacity of its own in the
pharmaceutical sector and which requires these products to combat
public health problems, in particular those related to epidemics
(Article 40d paragraph 1 PatA). However, no such licence has been
granted to date in the medicinal products area, including for
COVID-19-related treatments or vaccines.

 11.8 Liability Exemptions for COVID-19 Treatments
or Vaccines

No liability exemptions were introduced for COVID-19 treatments
and vaccines in Switzerland, and the general product liability
rules continue to apply.

In addition to these general rules, the Epidemics Act (EpA)
provides a special ground for liability claims for vaccines.
Accordingly, anyone who is harmed by an officially ordered or
officially recommended vaccination is entitled to damages, and also
to moral compensation of maximum CHF70,000, if the severity of the
impairment justifies it (Articles 64 et seq EpA). However, the
Swiss State only grants compensation if the damage cannot be
covered otherwise with reasonable efforts – eg, by the
vaccine manufacturer. While this compensation scheme existed
already prior to the COVID-19 pandemic, it has attracted greater
attention since.

 11.9 Requisition or Conversion of Manufacturing
Sites

There was no requisition or conversion of manufacturing sites
due to COVID-19.

 11.10 Changes to the System of Public Procurement
of Medicines and Medical Devices

The Swiss Armed Forces Pharmacy has been granted extended rights
in connection with the procurement of essential medical goods if
requirements cannot be covered through the normal procurement
channels (Article 14 COVID-19 Ordinance 3).

Originally Published by Chambers and Partners

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.