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Overview

Healthcare funding

In general terms, how is healthcare, including access to medicines and medical devices, funded in your jurisdiction? Outline the roles of the public and private sectors.

The funding of Swiss healthcare rests on three pillars.

The main contributions is made from social insurance programmes. These consist of mandatory health insurance, accident insurance, pension and disability insurance, and military insurance. Private households and businesses pay insurance premiums, in some particular cases subsidised by the state - for instance, students’ healthcare premiums are subsidised by the cantons.

The second pillar consists of contributions by private households that pay services not covered by the mandatory insurance. These contributions are covered by private insurance. Additionally, private households contribute to the financing by normal insurance cost-sharing.

The third pillar consists of direct payments from state entities, primarily the cantons, to the healthcare system in various ways (eg, tax breaks for insurers or funding of healthcare providers). The state not only emerges as a source of financing but also acts as a service provider, mainly by operating hospitals and medical schools.

Taking into account all direct and indirect payments, the healthcare system is funded roughly by two-thirds from private households and by one-third from the state.

Delivery

In general terms, how is healthcare delivered in your jurisdiction? Outline the roles of the public and private sectors.

In principle, healthcare falls under the jurisdiction of the cantons. However, the federal government has taken over responsibility in many areas, so that competences are scattered through the different levels and are often intertwined. Healthcare delivery is not only spread across different governmental levels (Confederation, cantons and municipalities) but also across private and public entities. Thus, Switzerland’s healthcare delivery is a mix of a publicly and a competitively directed structure.

‘Healthcare’ is a wide term that can be broken down to treatment, prevention, education and supervision. The state is primarily responsible for prevention, education and supervision. Health services regarding treatment are delivered by public as well as by private entities. Outpatient services are mainly provided by the private sector. Inpatient services are organised both publicly and privately. Doctors’ offices, pharmacies and alternative medicine offices, for instance, are normally organised privately.

One particularity of Switzerland’s healthcare system is that every person in Switzerland must be mandatorily insured. This basic insurance covers a mandatory service catalogue, which is financed by a per capita premium. It is the Confederation that determines which services are covered by such basic insurance.

Key legislation

Identify the key legislation governing the delivery of healthcare and establishing the regulatory framework.

The key principles are anchored in the Swiss Constitution. Based on these principles, the following key acts, on which numerous ordinances and guidelines are based, can be identified:

  • the Code of Obligations (for the contractual relationship between doctor and patient);
  • the Swiss Civil Code (for contractual relationships);
  • the Swiss Criminal Code (for euthanasia, abortion and medical secrecy);
  • the Therapeutic Products Act (TPA);
  • the Federal Act on Health Insurance (AHI);
  • the Federal Act on University Medical Professions;
  • the Federal Act on Medically Assisted Reproduction (Reproductive Medicine Act);
  • the Federal Act on the Transplantation of Organs, Tissues and Cells (Transplantation Act);
  • the Federal Act on Research involving Human Beings (Human Research Act);
  • the Federal Act on Narcotics and Psychotropic Substances (Narcotics Act);
  • the Federal Act on Protection against Dangerous Substances and Preparations (Chemical Act);
  • the Federal Act on Foodstuffs and Utility Articles (Foodstuffs Act);
  • the Federal Act on Protection against Infectious Diseases in Humans (Epidemic Act);
  • the Federal Act on Non-Human Gene Technology; and
  • the Federal Act on Human Genetic Testing.

Legal stipulations regarding healthcare are scattered through various acts and are interlinked. International healthcare provisions can be added to this national set of regulations. For instance, Switzerland is member of different international conventions. In particular, it is a member of the World Health Organization. It also adheres - although with some reservations - to the Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, which sets a minimum standard for human rights in relation to biomedicine.

Please note that the TPA was revised in spring 2016, whereby the new provisions will enter into force on 1 January 2019. The necessary ordinances implementing the revised provision are currently being finalised under the label ‘Therapeutic Products Ordinance Package IV’.

Responsible agencies

Which agencies are principally responsible for the enforcement of laws and rules applicable to the delivery of healthcare?

In general, healthcare falls under the jurisdiction of the cantons. However, the federal government and its departments have taken over responsibility in many areas. In some areas, municipalities are also competent.

On the federal level, the Federal Office of Public Health (FOPH) is the competent authority with regard to health. As part of the Swiss administration, the FOPH is mainly sourced by public funds.

A further important authority is the Swiss Agency of Therapeutic Products (Swissmedic), a public institution of the Swiss government (for more details see question 6).

On the cantonal level, each of the 26 cantons has its own health department with the relevant agencies. Funding is regulated according to the diverse cantonal regulations. Activities related to healthcare can be funded by fees for such activities.

Scope of enforcement

What is the scope of their enforcement and regulatory responsibilities?

The Swiss healthcare system is characterised by the federal system of Switzerland. Specific enforcement or regulatory responsibilities must therefore be examined on a case-by-case basis. Generally, the tasks are as follows.

As the federal health authority, the FOPH deals with social health and accident insurance, the regulations for chemicals and medicines as well as biosafety, the research on humans and transplantation medicine, health promotion, strategies with regard to combating addiction and sexually transmitted diseases and radiation protection. It is further responsible for the regulation of university medical and health professionals. The FOPH is also the responsible authority with regard to international issues and representation. Besides informative and regulatory competences, it can issue administrative decisions on specific matters within its scope of responsibilities.

The cantonal health departments are responsible for the authorisation and education of non-doctor personnel, for funeral services and for the implementation of regulations with regard to medicinal products and devices as well as to foodstuffs. They control public hospitals, psychiatric clinics and care homes as well as physicians and pharmacies. To this end they can make inspections, ask for samples or information and issue administrative decisions. With regard to health insurance, they grant individual premium reductions.

Regulation of pharmaceutical products and medical devices

Which agencies are principally responsible for the regulation of pharmaceutical products and medical devices?

Swissmedic is the agency responsible for the regulation of pharmaceutical products and medical devices at the federal level. It is mainly funded by fees and payments from the Confederation. Fees are levied for licences, controls and services provided in relation to the TPA. They also cover costs for developing quality standards, monitoring the market, informing the public and taking measures against abusive or incorrect use. In general, the scale of fees is set in such a way that the costs for fulfilling Swissmedic’s service mandate are covered.

Scope of enforcement

What is the scope of their enforcement and regulatory responsibilities?

Together with the cantons, Swissmedic is entrusted with the implementation of the TPA. It is responsible for the authorisation of pharmaceutical products and the supervision of pharmaceutical products and medical devices. In particular, it grants licences and the authorisation for the manufacturing, import, export of and commerce with medicinal products. It further verifies and monitors the conformity of medicinal products and medical devices with the legal requirements and grants the required authorisations.

Swissmedic is authorised to issue guidelines and pamphlets, which have the characteristic of administrative ordinances. Based on legal delegation competence, it is further competent to enact specific regulations. It has the power to take all kind of administrative measures and to impose fines (see question 15).

Other agencies

Which other agencies have jurisdiction over healthcare, pharmaceutical and medical device cases?

In addition to Swissmedic, the FOPH and the cantons, the Federal Price Regulator has certain competences to monitor the pricing of therapeutic products and services provided by the healthcare providers. He or she can make recommendations and decisions with regard to price reductions.

Unlike the mandatory social insurance observed by the FOPH, complementary insurers and any complementary insurance activity are subject to the supervision of the Swiss Financial Market Supervisory Authority (FINMA).

In relation to any criminal proceedings with regard to healthcare, in physician-patient relationships, public prosecutors are typically responsible for procedural measures.

The Competition Commission (ComCo) supervises the Federal Act on Cartels. Thus, the ComCo has jurisdiction in case of competition restraints. In particular, it also combats harmful cartels or anticompetitive conduct in the pharmaceutical and healthcare industry.

In addition to these governmental agencies, there are private entities or self-regulation bodies, such as professional associations, imposing certain regulations on its members. The Swiss business association for chemical, pharmaceutical and biotech industries (scienceindustries Switzerland), the Federation of Swiss Medical Devices Trade and Industry Association (FASMED) and the Swiss Academy of Medical Sciences (SAMS) have developed different codes and guidelines, which provide different competences to such bodies.

Simultaneous investigations

Can multiple government agencies simultaneously conduct an investigation of the same subject? Does a completed investigation bar another agency from investigating the same facts and circumstances?

It is possible that the same set of facts affects different authorities. Therefore, it is possible for agencies to simultaneously conduct an investigation of the same subject within their competences. However, according to the principle of ne bis in idem, measures with a punitive character must not be cumulated.

Regulation of pharmaceutical products and medical devices

Monitoring powers

What powers do the authorities have to monitor compliance with the rules on drugs and devices?

Market surveillance occurs by periodic inspections that allow the verification of compliance with different regulations. In order to monitor the safety of therapeutic products, the authority shall further collect mandatory notifications and evaluate them. Based on this evaluation, they can take necessary administrative measures, such as the closing down of establishments, or prohibiting the distribution of therapeutic products. To this end, they are also allowed to take samples and to request essential information and documents.

Investigation time frames

How long do investigations typically take from initiation to completion? How are investigations started?

Investigations can be started in different ways, for example, with an inspection, a notification or based on any other ground of suspicion. The length of any investigation depends on the individual circumstances.

Access to investigation materials

What rights or access does the subject of an investigation have to the government investigation files and materials?

Depending on the subject of the investigation, the responsible authority may vary between Swissmedic and the cantons.

According to the Federal Act on Freedom of Information in the Administration (FoIA), which is applicable to Swissmedic, in principle any person has the right to inspect official documents. Exceptions to such inspection can be justified if, for example, the access to official documents significantly impairs the free opinion-forming and decision-making process of an authority or is likely to reveal professional, business or manufacturing secrets. Further, the Act is not applicable in relation to any civil, criminal or administrative judicial proceedings. In case of administrative judicial proceedings, such as investigations conducted by Swissmedic, the Federal Act on Administrative Procedure (APA) is applicable. Based on the constitutional right to be heard, a party has the right to inspect any submissions, documents serving as evidence or copies of rulings already issued to his or her case. This right can only be opposed by any essential public or private interest, as well as by required interests of an official ongoing investigation. According to jurisprudence, one further key limitation is the access to purely internal documents of an administrative body. Internal documents cannot serve as evidence. The limitation can often only be determined on a case-specific evaluation.

When a cantonal body is involved, the right to access any files is regulated in the different cantonal administrative procedural laws. The constitutional right to be heard serves again as the overarching principle. Therefore, even though the modalities may slightly differ in the different cantons, the right to access any files in a cantonal administrative proceeding follows the principles of the APA.

Outside any administrative proceedings, a person may ask for information based on the Federal Act on Data Protection, which grants certain information rights to persons whose data is gathered.

Investigations abroad

If pharmaceutical products or medical devices are made in a foreign country, may the authorities conduct investigations of the manufacturing processes in that other country?

With regard to medicinal products, Swissmedic has the competence to inspect the manufacturing at the expense of the importing company, who must be informed in advance. There are different international mutual agreements in relation to good manufacturing practices (GMP). The recognised good manufacturing practice within a country guarantees that a GMP-control system recognised in Switzerland is provided in the manufacturing place. Thus, such recognition facilitates import, because only an official confirmation instead of an actual inspection by Swiss authorities is required in such cases. Nevertheless, inspection remains possible in substantiated cases and after consultation with the responsible foreign authority.

The Agreement between the Swiss Confederation and the European Community on mutual recognition in relation to conformity assessment specifically regulates such mutual recognition of GMP-control systems for medicinal products and the certification of batches. In addition, it also contains such rules with regard to medical devices. Similar agreements exist between European Free Trade Association countries and Switzerland. Switzerland is also party to the Pharmaceutical Inspection Convention. Further, Swissmedic is part of different international commissions and working parties such as the Pharmaceutical Inspection Cooperation Scheme, which is an informal agreement between different responsible national agencies. Switzerland also observes the tripartite harmonised ICH Guidelines on Clinical Practice.

In practice, foreign authorities mainly carry out inspections in Switzerland. Since 2018, foreign authorities wishing to carry out an inspection in Switzerland need to notify Swissmedic at least 30 days prior to the planned beginning of the inspection - a formal authorisation of Swissmedic is no longer required. In 2017, 94 inspections were carried out in Switzerland involving authorities from Belarus, Brazil, China, Iran, Jordan, Kazakhstan, Korea, Libya, Mexico, Russia, Turkey and the US.

With regard to medical devices, the above-mentioned agreement between the EU and Switzerland also contains regulations on mutual recognition with regard to the conformity assessment of medical devices. Swissmedic focuses on the monitoring of the conformity assessment bodies.

Enforcement proceedings

Through what proceedings do agencies enforce the rules?

Agencies can take all administrative measures necessary to enforce the rules as long as the proportionality principle is met. Any such administrative decision can be appealed before the competent court. Subsidiary to the Criminal Code and to the Narcotics Act, the TPA also contains specific criminal provisions. In particular, Swissmedic is authorised to conduct penal investigations that involve fines or financial penalties. In relation to custodial sentences or any appeal to any sanction imposed by the agencies, an application to a court is required.

Sanctions

What sanctions and other measures can the authorities impose or seek in enforcement actions against drug and device manufacturers and their distributors?

The TPA provides a non-exhaustive list of administrative measures. For example, Swissmedic can raise objections and set an appropriate time period for restoring the state of law. It can suspend or revoke licence and marketing authorisations as well as close down establishments. Furthermore, it can prohibit the distribution, dispensing, import, export and foreign trade from Switzerland of therapeutic products, order their immediate recall from the market, or order the publication of recommendations of conduct to prevent damage. It can seize, hold in official storage, destroy or prohibit the use of illegal advertising media, and publish the prohibition at the expense of the responsible parties. It is also conceivable that Swissmedic will temporarily or permanently prohibit the advertising of a specific therapeutic product in the event of serious or repeated infringement of the rules, and publish the prohibition at the expense of the responsible parties.

Swissmedic is further authorised to provide the general public with any information of general interest about the therapeutic products sector within which the revocation decisions fall.

With regard to any penal investigations under the TPA, misdemeanours are sanctioned by imprisonment or by a fine not exceeding 200,000 Swiss francs. Contraventions are sanctioned by detention or fines not exceeding 50,000 Swiss francs. In case the person acts in his or her professional capacity, the fines will be raised to 500,000 Swiss francs for misdemeanour and to 100,000 Swiss francs in case of contraventions. The criminal provisions of the Federal Act on Technical Barriers to Trade remain reserved.

Actions against employees

Can the authorities pursue actions against employees as well as the company itself?

Administrative measures are generally directed towards the addressee of any previous application, in other words the authorisation holder, which in general is the company or a natural person.

In relation to any criminal proceedings, it is primarily the responsible natural person or the person in charge of any duties that have been violated who is addressed by an action. However, if the perpetrator cannot be identified, the company can be made responsible subsidiarily.

Defences and appeals

What defences and appeals are available to drug and device company defendants in an enforcement action?

The general defences usually made in administrative proceedings are also available to drug and device companies. For example, it is the parties’ right to be heard. The parties also have the right to access any files, which serve as basis for any decision, and offer additional proof. They can attend the examination of witnesses and ask supplementary questions. Defences can be based on or supplemented by information gathered through exercising such rights. Furthermore, the company can ask for a reconsideration of a decision in the presence of any legitimate reason. A decision must be appropriate, effective and proportional to accomplish the required results. Besides these material requirements, defences cannot be listed on an abstract level, but need to be evaluated on a case-by-case basis.

Any decision rendered by Swissmedic can be appealed before the Swiss Federal Administrative Court (FAC). Subsequently, a decision of the FAC can be brought before the Swiss Federal Supreme Court (FSC) with an appeal in matters of public law or with a subsidiary constitutional complaint.

A decision rendered by a cantonal authority can be appealed before the respective cantonal courts. A final cantonal decision can be brought before the FSC with an appeal in matters of public law or with a subsidiary constitutional complaint.

Minimising exposure

What strategies should companies adopt to minimise their exposure to enforcement actions and reduce their liability once an enforcement action is under way?

Generally, a company should comply with all legal requirements. It may be worthwhile to set up an internal unit monitoring the change of any legislation or issuance of new guidelines. Furthermore, all legal obligations and notification duties should be fulfilled in a timely manner. A clear and complete documentation ensuring the transparency of any steps may further minimise any risk before and during any enforcement action. Compliance with the applicable business code may also strengthen the company’s position. In case of unclear situation it may be positive to approach the regulatory authority voluntarily and seek an early collaboration prior to any potential issues.

Recent enforcement activities

What have the authorities focused on in their recent drugs and devices enforcement activity and what sanctions have been imposed?

With regard to medicinal products, the authorities have focused on illegal imports of narcotics. Since the international scandal on manufactured breast implants, the monitoring of medical devices and in particular of notified bodies has been intensified in accordance with the trend in the EU. In this context, inspections of conformity assessment bodies by foreign authorities considerably increased in recent years.

Self-governing bodies

Are there self-governing bodies for the companies that sell pharmaceutical products and medical devices? How do those organisations police members’ conduct?

In Switzerland, private associations have developed different standards and guidelines with a certain self-regulatory effect.

The Swiss business association for chemical, pharmaceutical and biotech industries (scienceindustries Switzerland) has adopted a Pharma Code and a Pharma Cooperation Code. The Pharma Code provides a code of conduct for the pharmaceutical industry. The Pharma Cooperation Code provides guidelines on cooperation with healthcare professional circles and patient organisations. The Code Secretariat is responsible for the implementation of both codes. There is an institutionalised procedure of investigation in case the guidelines are not complied with. The Code Secretariat acts on its own initiative or on notification. It can request documents from the concerned companies, set deadlines for compliance, initiate negotiations, set deadlines for remedial measures and ask for a guarantee to desist from such conduct in the future. In case of continuing contempt, the Code Secretariat has the right to transfer the matter to the official governmental body.

FASMED developed a Code of Business Conduct by providing guidelines for the interaction with healthcare professionals. It contains, among other things, rules with regard to corruption, product training, conferences, marketing meetings, gifts and donations. In terms of enforcement, the code only provides for a reporting system to FASMED in case of misconduct.

SAMS has also issued guidelines for collaboration between the medical profession and industry. These measures are binding for all members of the Swiss Medical Association (FMH). Any disrespect of the guidelines will be investigated by a consultancy agency, which can bring the issue to the attention of the Consultancy Commission of Training and Continuing Education of the FMH.

Relationships between healthcare professionals and suppliers

Relationship rules

What are the rules prohibiting or controlling the financial relationships between healthcare professionals and suppliers of products and services?

The TPA prohibits making promises of and accepting material benefits in relation to medicinal products. In particular, it is prohibited to grant, offer or promise material benefits to persons who prescribe or dispense medicinal products or to the organisations employing them. Furthermore, persons prescribing or dispensing medicinal products and organisations employing them are not allowed to solicit or accept material benefits.

There are two exceptions to these rules:

  • material benefits of modest value and which are related to medical or pharmaceutical practice are permitted; and
  • commercially and economically justified discounts, directly reflecting on the price, can be granted. The term ‘commercially and economically justified discounts’ is, however, not clearly established.

Note that the revised TPA, which is not yet in effect, will bring some significant changes and clarifications in this respect. Under the new TPA, the rules will apply to persons who prescribe, supply, use or (for these purposes) buy prescription drugs and organisations employing such persons. In this respect, the group of persons covered by the new rules is narrower on the one hand, as only prescription drugs are concerned, but broader on the other, because all dependent professional users (ie, purchasing members of hospital drug commissions and buyers for medical networks) are subjected to the rules.

Additionally, the Ordinance on Advertising for Medicinal Products contains some limited regulations on small quantities of free samples, and on scientific congresses and promotional meetings, which must be addressed only to professionals and subordinated to the main purpose of the congress.

The Unfair Competition Act (UCA) further contains certain rules with regard to bribes in the private sector. Bribery of officials, such as may occur in public hospitals, is, however, regulated by the Swiss Criminal Code.

In addition to these legal requirements the guidelines of the SAMS, the Pharma Code and the Pharma Cooperation Code contain further rules with regard to the relationship between healthcare professionals and suppliers. The SAMS guidelines provide for the duty of public hospitals to internally regulate payments in cash or in kind. In particular, such internal regulations must contain rules on which gifts must be reported and specify limits for form requirements with regard to agreements on acceptance of payments in cash or in kind as well as permitted purposes of donation payments.

Enforcement

How are the rules enforced?

With regard to enforcement of the TPA, see questions 14 and 15.

Any person in breach of the UCA can be sued before the competent courts by clients, a competent government authority or any other person infringed in its rights. Bribery of an official will be pursued ex officio according to the criminal proceeding principles.

The Code Secretariat supervises compliance with the Pharma Code and the Pharma Cooperation Code. There is an institutionalised procedure of investigation in case the guidelines are not followed. In case of continuing contempt, the Code Secretary has the right to transfer the matter to the official governmental body.

Any disrespect of the SAMS guidelines will be investigated by a consultancy agency, which can bring the issue to the attention of the Consultancy Commission of Training and Continuing Education of the FMH.

The developed Code of Business Conduct of FASMED only provides for a system of reporting to FASMED in case of misconduct.

Reporting requirements

What are the reporting requirements on such financial relationships? Is the reported information publicly available?

The TPA does not provide for a specific reporting system. However, the self-governing bodies contain some reporting requirements.

According to the Pharma Cooperation Code, the pharmaceutical industry adhering to the Pharma Cooperation Code has to disclose any pecuniary benefits provided to professional or healthcare organisations on their website.

The SAMS guidelines require that public hospitals only provide for internal regulations with regard to such payments.

The Business Conduct Code of FASMED includes a documentation requirement in order to combat corruption.

Regulation of healthcare delivery

Authority powers

What powers do the authorities have to monitor compliance with the rules on delivery of healthcare?

According to the Federal Act on University Medical Professions, physicians, dentists, chiropractors, pharmacists veterinarians, and psychologists (according to the Federal Act on Psychological Professions) are supervised by cantonal supervisory authorities. The latter can take appropriate measures in order to assure compliance with the legal professional duties. Therefore, the detailed measures are regulated in each canton. Generally, the authorities can carry out (unannounced) inspections and take administrative measures, including confiscation of relevant items, closing down of services or requesting additional training certificates. Certain notification duties of professionals may further facilitate the monitoring. In addition, cantonal courts and administration as well as the federal agencies have the duty to notify any potential breaches of professional duties to the competent cantonal authority.

With regard to non-university professions such as occupational and speech therapists, nutritional advisers, midwives, naturopaths, nurses, physiotherapists or dental technicians, the cantons are competent. Therefore, the powers of the authorities to monitor compliance are regulated in the cantonal legislations. Generally, they also encompass the right of inspection and controls. Currently, a new act on healthcare professions is being elaborated which will regulate professionals graduating from higher educational institutions (as opposed to universities).

Healthcare institutions such as hospitals, care homes, and Spitex services (which are services in relation to patient care and assistance at home) are regulated on the level of the cantons. In general, the competent cantonal authorities can inspect and control these institutions. When municipalities are in charge, for example for Spitex services, they dispose of similar competences.

In relation to healthcare delivery covered by the mandatory insurance, compliance is particularly important with regard to the quality and financial aspects of these services. Special independent medical officers monitor whether services fulfil the conditions in order to be covered by the insurance. In relation to the quality and financial aspect, scientific controls or the consultation of special units for quality assurance or of medical officers is required in order to benefit from insurance coverage.

Swissmedic and the cantons supervise the distribution of therapeutic products. With regard to their monitoring powers, see question 10.

Investigation time frames

How long do investigations of healthcare providers typically take from initiation to completion? How are investigations started?

Investigations can be started in different ways; for example, with an inspection, a notification or based on any other ground of suspicion. The length of any investigation depends on the individual circumstances.

Access to investigation materials

What rights or access does the subject of an investigation have to the government investigation files and materials?

See question 12.

Enforcement agencies

Through what proceedings do agencies enforce the rules?

See question 14.

Sanctions

What sanctions and other measures can the authorities impose or seek in enforcement actions against healthcare providers?

According to the Federal Act on University Medical Professions and the Federal Act on Psychological Professions, warnings, reprimands and fines of up to 20,000 Swiss francs can be issued for physicians, dentists, chiropractors, pharmacists and veterinarians. Temporary prohibitions from practice for up to six years or definitive prohibitions for the complete or partial field of activities are further conceivable. For psychologists a definitive prohibition concerns only the private practices under their own authority.

In relation to sanctions with regard to institutions and the non-university professionals, cantonal regulations contain fines and administrative measures such as closing down institutions or confiscating items.

In addition, see question 15.

Defences and appeals

What defences and appeals are available to healthcare providers in an enforcement action?

See question 17.

Minimising exposure

What strategies should healthcare providers adopt to minimise their exposure to enforcement actions and reduce their liability once an enforcement action is under way?

See question 18.

Recent enforcement activities

What have the authorities focused on in their recent enforcement activity and what sanctions have been imposed on healthcare providers?

Enforcement competences majorly lie with cantonal authorities with the consequence that authorities may emphasise various aspects of enforcement. However, recent developments show that the focus has been, among other things, on the harmonisation of procedures in institutions whose services are covered by the mandatory health insurance. For example, harmonisation on quality control has been envisaged.

There have been no recent noteworthy sanctions. However, some individual cases of malpractice of doctors and dentists have obtained national attention. In severe cases the delinquent was sanctioned with an occupational ban.

Self-governing bodies

Are there self-governing bodies for healthcare providers? How do those organisations police members’ conduct?

There are different codes or professional standards for different healthcare providers, mainly for professions requiring a university degree. For example, the FMH has developed a code of conduct (statute) for physicians. The competent cantonal professional committees deal with any breach upon notification by any member or third party. Similar regulations exist for dentists, chiropractors, pharmacists, etc.

Remedies for poor performance

What remedies for poor performance does the government typically include in its contracts with healthcare providers?

See question 28.

Private enforcement

Causes of action

What private causes of action may citizens or other private bodies bring to enforce a healthcare regulation or law?

A citizen must be affected by the implementation of a healthcare regulation or a law in order to enforce it or seek any action regarding it. Civil and criminal actions are conceivable. Although public law is applicable to various legal relationships within the healthcare sector, because of references in the public regulations or subsidiarity of civil law clauses, in most cases private law or criminal law is relevant. Nevertheless, certain cantonal regulations provide for state liability in case of any treatment in public hospitals. Proceedings are regulated according to such cantonal regulations. However, jurisprudence has established that any appeal before the FSC based on such public cantonal acts will be in civil matters. In the absence of such cantonal regulations on state responsibility, civil extra-contractual liability applies.

Possible claims under civil law can be based on breach of contract, agency without authority, tort, product liability or breach of the due care of a physician or his or her auxiliary personnel. Criminal proceedings are initiated upon request or ex officio by the public prosecutors. Under criminal law the following acts are relevant: intentional homicide, homicide through negligence, different forms of assault, breach of official secrecy or breach of professional confidentiality.

Besides citizens and private bodies, other parties may bring any issues in relation to healthcare to the attention of the competent authorities, which may investigate further on the subject. For example, the TPA stipulates that consumers, patient organisations or any interested third parties have the right to notify of unintended side effects of drugs.

Framework for claims

What is the framework for claims of clinical negligence against healthcare providers?

A successful civil claim of clinical negligence has to show:

  • that the negligence is unlawful;
  • that the negligence caused a loss;
  • that the loss was causally caused by the negligence; and
  • that the party alleged to be negligent was at fault.

For a contractually compliant course of action, an objective (as opposed to subjective) standard of care is applicable. Doctors have to act with due care, following the current best practice in the field. High demands are made on due care, including for example the use of a balanced risk and benefit relation of a treatment, the necessity to possess a level of knowledge which is up to date with recent medical developments and the obligation to inform patients, among others, about their state of health, drugs and procedures used.

Within criminal actions, homicide through negligence and different forms of assault are the most relevant cases when dealing with clinical negligence. A successful action has to show:

  • a breach of duty of care;
  • the predictability of the outcome;
  • that prevention of the loss was possible; and
  • a risk correlation between the breach of duty and the outcome.

Damages are only granted if an actual loss occurred; for example, to cover costs caused by additional required medical care or financial loss caused by inability to work. Compensation for personal suffering is granted restrictively.

Seeking recourse

How and on what grounds may purchasers or users of pharmaceuticals or devices seek recourse for regulatory and legal infringements?

Purchasers or users may seek recourse by a civil law action based on tort (see question 35). Furthermore, recourse can be sought on the grounds of product liability. Product liability is applicable to both pharmaceuticals and devices. The requirements for such claim are the proof of:

  • a loss;
  • the defendant being producer of the pharmaceutical or device;
  • the product being defective; and
  • the loss being casually caused by the defective nature of the product.

Compensation

Are there any compensation schemes in place?

No, there are no compensation schemes in place since Swiss law does not require such an instrument. As mentioned in question 35, damages are granted in the amount of actual loss occurred and paid by the opposing party.

Class and collective actions

Are class actions or other collective claims available in cases related to drugs, devices and provision of care?

Under current Swiss legislation, neither collective claims nor class actions are possible, since these types of claims do not (yet) exist under Swiss law. However, on 2 March 2018, the Federal Council sent concrete proposals for the collective enforcement of claims for damages into consultation.

The Federal Council proposes two new instruments: a repair association action, intended to facilitate the enforcement of mass and low-value damages, and a group settlement procedure, to enable the settlement of disputes collectively by mutual consent. However, the Federal Council continues to reject the introduction of class-action suits, based on the US model.

Review

Are acts, omissions or decisions of public and private institutions active in the healthcare sphere subject to judicial or administrative review following a complaint from interested parties?

A complaint can be reviewed by an action to a court. The injured party may submit a civil claim to court. In general, the person who suffered a loss because of an infringement is entitled to such action, which means that an interest itself is not enough. The conditions of a successful claim are laid out in questions 35 and 36. Stipulated claims for damages are subject to a limitation period depending on the type of claim involved. Claims based on contractual obligation become time-barred after 10 years. Extra-contractual claims become time-barred after one year and product liability claims after three years since the injured party became aware of the damage. The absolute limitation period is - in any case - 10 years. In case of any compensation based on state liability, cantonal regulations should be consulted. The time limitation period for filing an appeal of the first instance court decision is 10 or 30 days, depending on the type of procedure.

There are also some extrajudicial proceedings available. An interested party may contact the hospital’s internal complaints office. Interested parties may also forward a procedure in front of an ombudsman (ie, a specialised centre organised by the cantons). The centres primarily function as mediation bodies and cannot issue enforceable judgments.

The revised TPA, once in force, will introduce additional administrative complaint mechanisms.

Whistleblowers

Are there any legal protections for whistleblowers?

The legal protection for whistleblowers in Switzerland is rather weak. Generally speaking, a whistleblower might face charges based on criminal law or the Federal Data Protection Act when revealing internal information.

Currently, Swiss law addresses whistleblowing only in specific areas, namely in competition law, which provides for an immunity and leniency programme. Further applicable regulations are found in employment law. Employees have a secrecy obligation and, thus, are not allowed to release internal information to a third party that could harm the employer. An exception to this rule has been established by jurisprudence. If the higher-ranking interests of a third party or the public are touched, a complaint can be filed to the responsible authority. However, such ‘higher-ranking interests’ are not defined; a judge has to weigh up the interests of the employer with the public’s interest on a case-by-case basis. The Federal Council wants to lay down the conditions for a legal reporting of abuses at the workplace in the Swiss Code of Obligations. However, a corresponding draft was rejected by the councils and has to be newly processed. The revised TPA, once in force, will explicitly introduce an exception for employees of healthcare organisations and pharmaceutical companies, who will be entitled to report to the competent authorities any observations that indicate a violation of the TPA.

Does the country have a reward mechanism for whistleblowers?

There are no general reward mechanisms in place. In some specific areas, however, provisions for reward mechanisms exist. For example, in competition law, immunity or a reduction of competition law fines is granted to a company that notifies the competition authority of an illegal restraint of competition and cooperates in the subsequent investigation.

Are mechanisms allowing whistleblowers to report infringements required?

As mentioned under question 40, the revised TPA will introduce a specific right of employees of healthcare organisations and pharmaceutical companies to report infringements to the competent authorities. Currently, a general reporting mechanism is only established by jurisprudence. The course of action has to follow the predefined order of the legal practice. First, notice has to be given internally (internal whistleblowing). If there is no reaction within a reasonable timeframe, the employee may inform the responsible authority. The media shall only be contacted as a last resort.

Under competition law aspects, it is advisable for undertakings active in Swiss markets to implement an internal antitrust compliance programme, and as part of such programme consider adequate procedures for internal whistleblowing.

Cross-border enforcement and extraterritoriality

Cooperation with foreign counterparts

Do prosecutors and law enforcement authorities in your country cooperate with their foreign counterparts in healthcare cases?

Generally, Switzerland provides international mutual assistance in civil, administrative and criminal matters.

In relation to medicinal products and medical devices, Switzerland cooperates with foreign counterparts. The cooperation focuses on information exchange along the complete process from authorisation to supervision of the therapeutic products. In particular it gives international administrative assistance by respecting the national data protection regulations. It has concluded numerous information agreements, both binding and non-binding, with other countries and authorities.

Triggering investigations

In what circumstances will enforcement activities by foreign authorities trigger an investigation in your country?

An investigation by foreign authorities will trigger an investigation in Switzerland if Switzerland is requested to provide administrative or legal assistance. Switzerland will further become active if such enforcement activities by foreign authorities are relevant in Switzerland, in particular, if public health is at risk.

Pursuing foreign entities for infringement

In what circumstances will foreign companies and foreign nationals be pursued for infringements of your country’s healthcare laws?

In case the infringement occurs on Swiss territory, foreign companies and foreign nationals will be pursued according to Swiss healthcare laws.

In particular, the scope of application of Swiss administrative law is generally limited to the Swiss territory (principle of territoriality). However, according to the practice of the FSC, Swiss administrative law may also be applied to cases taking place in a foreign territory but having considerable effects in Switzerland (‘effects doctrine’), or if explicitly stated in the relevant law. However, Swiss authorities cannot directly become active against foreign entities outside Swiss territory. The authorities need to initiate a foreign administrative assistance procedure and request assistance of the competent foreign authorities. Similar concepts are applicable to criminal matters.

Update and trends

Current developments

What are the authorities’ enforcement priorities likely to be in the coming year? Are there any noteworthy cases pending? Are there any current developments or emerging policy or enforcement trends that should be noted?

No updates at this time.