Regulatory, Pricing and Reimbursement Overview
An insight into regulatory, pricing and reimbursement overview in Swiss Pharma. Prepared in association with Wenger Plattner, a leading law firm in Switzerland, this is an extract from The Pharma Legal Handbook: Switzerland, available to purchase here for USD 99.
1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country?
• Swiss Agency for Therapeutic Products (Schweizerisches Heilmittelinstitut [Swissmedic]):
The Swiss Agency for Therapeutic Products (hereinafter: Swissmedic) is the competent authority for various authorizations and licenses in the field of medicinal products and medical devices (e.g. marketing authorizations; manufacturing licenses; licenses for exporting, importing and distributing; authorizations for clinical trials). It is an institution under public law with its own legal personality located in Berne and was founded in 2002. Swissmedic is furthermore responsible for market surveillance in the area of therapeutic products and has also numerous competences in relation to law enforcement. It should be mentioned that Swissmedic may even adopt legislation, such as the Ordinance on simplified authorisation and marketing authorisation on the basis of a notification of medicinal products (Verordnung des Schweizerischen Heilmittelinstituts vom 22. Juni 2006 über die vereinfachte Zulassung von Arzneimitteln und die Zulassung von Arzneimitteln im Meldeverfahren; SR 812.212.23). Consequently, Swissmedic has an almost comprehensive competence with regard to medicinal products and medical devices.
• Federal Office of Public Health (FOPH) (Bundesamt für Gesundheit [BAG]):
The Federal Office of Public Health (hereinafter: FOPH) in Berne plays a key role especially in the legislative procedures in all sectors of the public health law (e.g draft legislations and ordinances). It is responsible for the coordination of the health policy and the supervision of the compulsory health insurance. While Swissmedic is competent for various authorizations and licenses in the field of medicinal products and medical devices, the FOPH mainly deals with questions concerning pricing and reimbursement of medicinal products within the framework of the Federal Act on Health Insurance (Bundesgesetz über die Krankenversicherung vom 18. März 1994 [KVG; SR 832.10]).
• Ethics committees (Ethikkommissionen):
There are 7 ethics committees in Switzerland, each of which is responsible for a specific canton or region (Ethics Committee northwest/central Switzerland EKNZ, Ethics Committee Bern, Ethics Committee Geneva, Ethikkommission Ostschweiz EKOS, Ethics Committee Ticino, Ethics Committee Vaud, Ethics Committee Zurich). For conducting a research project (e.g. concerning medicinal products), an authorization from the responsible ethics committee is required (in addition to Swissmedic’s authorization).
• Conformity Assessment Bodies (Konformitätsbewertungsstellen):
Medical devices do not require any marketing authorization by Swissmedic. However, a conformity assessment procedure (Konformitätsbewertungsverfahren) is required for certain types of medical devices. These procedures are carried out by private conformity assessment bodies (Konformitätsbewertungsstellen). They are approved and monitored by Swissmedic. Since the Swiss medical device law is currently undergoing a total revision and the draft of the new Medical Devices Ordinance is not yet final, no further details can be provided at this moment. However, the main elements of the new law are set out in Regulatory Reforms.
• Cantonal authorities:
In addition, there are also authorities in each canton responsible e.g. for certain types of inspections or the granting of professional licences for doctors. As these authorities are not of great importance below, they are not listed.
2. What is the regulatory framework for the authorization, pricing, and reimbursement of drugs, biologicals, and medical devices?
1. The regulatory framework for the authorization of medicinal products and biologicals
The legal framework for the authorization of medicinal products and biologicals is regulated by the Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act) (hereinafter: TPA) (Bundesgesetz über Arzneimittel und Medizinprodukte vom 15. Dezember 2000 [Heilmittelgesetz, HMG; SR 812.21]). According to the TPA, medicinal products means products of chemical or biological origin which are intended to have or are presented as having a medicinal effect on the human or animal organism, in particular in the diagnosis, prevention or treatment of diseases, injuries and handicaps; blood and blood products are also considered to be medicinal products (art. 4 para. 1 lit. a TPA). In addition, there are numerous ordinances governing the details (e.g. the Ordinance on Medicinal Products and the Ordinance on Licensing in the Medicinal Products Sector).
The TPA is divided into 8 chapters: General Provisions; Medicinal Products; Medical Devices; Common Provisions on Medicinal Products and Medical Devices; Swiss Agency for Therapeutic Products; Enforcement; Administrative Procedure and Rights of Appeal; Criminal Provisions; Final Provisions.
2. The regulatory framework for the authorization of medical devices
Same as medicinal products, medical devices are also regulated by the TPA. The Swiss legislator thus implements – contrary to other countries – both, medicinal products and medical devices, in one law. Medical devices means products, including instruments, apparatus, in vitro diagnostics, software and other goods or substances which are intended to have, or are presented as having, a medical use and whose principal effect is not obtained with a medicinal product (art. 4 para. 1 lit. b TPA). Medical devices are additionally regulated, among others, by the Medical Devices Ordinance (Medizinprodukteverordnung vom 17. Oktober 2001 [MepV; SR 812.213]). Since the Swiss medical device law is currently undergoing a total revision and the draft of the new Medical Devices Ordinance is not yet final, no further details can be provided at this moment. However, the main elements of the new law are set out in Regulatory Reforms.
The main difference, which will also apply under the new law, is that medical devices (contrary to medicinal products) do not require marketing authorization by Swissmedic before being placed on the market.
3. The regulatory framework of pricing and reimbursement of medicinal products, biologicals and medicinal devices
These aspects are outlined in questions 12 and 13 below.
3. What are the steps to obtain authorization to develop, test, and market a product?
The following overview is intended to cover two main aspects: First the authorization for clinical trials and second the marketing authorization. Any previous steps (such as pre-clinical trials and clinical trials with animals) are not outlined below.
1. Authorization for clinical trials
Clinical trials of therapeutic products require prior authorization from Swissmedic (art. 54 para. 1 TPA). Swissmedic verifies whether the medicinal products meet the requirements of Good Manufacturing Practice and of medicinal product safety or whether the medical devices meet the requirements specified in art. 45 TPA (i.e. the medical device does not endanger the health of the user or a third party when used in accordance with its intended use), the product risks are duly considered in the clinical trial, and the product data is in line with current scientific knowledge and correctly indicated in the protocol (art. 54 para. 4 TPA).
Art. 54a TPA provides the obligation to develop a paediatric investigation plan: For each medicinal product, a paediatric investigation plan shall be drawn up with a view to its marketing authorization which sets out the requirements for the development of the medicinal product in paediatrics and which must be submitted to Swissmedic.
For clinical trials of therapeutic products in humans, the Human Research Act (hereinafter: HRA) (Bundesgesetz vom 30. September 2011 über die Forschung am Menschen [Humanforschungsgesetz, HFG; SR 810.30]) applies in addition to the provisions of the TPA (art. 53 TPA). For conducting a research project, an authorization from the responsible ethics committee is required (art. 45 para. 1 lit. a HRA). The authorization is granted if the ethical, legal and scientific requirements of the HRA are met. This includes, for example, general requirements for research involving persons (such as protection of participants, information and consent), liability and coverage or additional requirements for research involving particularly vulnerable persons (art. 45 para. 2 HRA).
2. Marketing authorization
Ready-to-use medicinal products can be placed on the market only if they are authorized by Swissmedic (art. 9 para. 1 TPA). Any person or organization applying for a marketing authorization must prove that the medicinal products with indications or procedures are of high quality, safe and effective (art. 10 para. 1 lit. a TPA). High quality means that the medicinal product must meet certain conditions; anyone applying for marketing authorization has to show that the medicinal product complies with the requirements of the pharmacopeia and the applicable GMP-Standards. In order to prove that a medicinal product is safe and effective, clinical trials have to be conducted.
It is the general purpose of the TPA to protect the human (as well as the animal) health and to guarantee that only high quality, safe and effective therapeutic products are placed on the market (art. 1 para. 1 TPA). Swissmedic shall grant a marketing authorization if the conditions are fulfilled and may attach conditions and requirements to the authorization (art. 16 para. 1 TPA).
Swiss legislation provides different marketing authorization procedures, as outlined in their main aspects below (see also Marketing, Manufacturing, Packaging & Labeling, Advertising):
• “Ordinary” authorization procedure:
Ready-to-use medicinal products may be placed on the market only if authorized by Swiss medic (art. 9 para. 1 TPA). The requirements for the application for a marketing authorization according to the “ordinary” authorization procedure are regulated in art. 11 TPA. This provision mainly concerns medicinal products with new active substances. The ordinary authorization procedure is the longest compared to the other procedures.
• Simplified authorization procedure:
For the authorization of certain categories of medicinal products and where this is compatible with the quality, safety and efficacy requirements, among others, a simplified authorization procedure is provided (art. 14 TPA). It applies, for instance, in the following cases: medicinal products made with known active substances; medicinal products whose active substances are used in a medicinal product which, when the application was submitted, has been authorized as a medicinal product for at least 10 years in at least one EU or EFTA country and which is comparable in terms of indications, dosage and method of administration; non-prescription medicinal products with indications which, when the application was submitted, have been proven to have been used medically for at least 30 years, and for at least 15 years in EU and EFTA countries.
• Marketing authorization on the basis of a notification:
Complementary medicines without indications and medicinal products for which, due to their low risk potential, a simplified marketing authorization proves to be disproportionate, among others, may be placed on the market on the basis of a notification (art. 15 TPA). An “ordinary” or simplified marketing authorization procedure is not necessary in such case.
Medical devices, one the other hand, are not subject to a marketing authorization (see also Marketing, Manufacturing, Packaging & Labeling, Advertising).
4. What are the approximate fees for each authorization?
Swissmedic’s fees are regulated in an ordinance adopted by Swissmedic itself (Verordnung des Schweizerischen Heilmittelinstituts vom 14. September 2018 über seine Gebühren; SR 812.214.5). The fee for the authorisation of a medicinal product with a new active substance is 80 000 Swiss francs. The fee for the authorisation of a clinical trial is 5000 Swiss francs.
Swissmedic is mainly financed by means of fees, which are regulated individually and transparently in Annex 1 and 2 to the ordinance mentioned above. This is just one aspect ensuring Swissmedic’s independency from politics and other federal institutions such as the Federal Department of Home Affairs or the FOPH. Swissmedic decides without external influences and there is no “superior” authority that could influence a decision. Needless to say, Swissmedic’s decisions (e.g. decision of non-approval of a medicinal product) may be appealed to the Federal Administrative Court.
5. For how long are marketing authorizations/registrations valid? How are marketing authorizations/registrations renewed?
The first marketing authorisation of a medicinal product is valid for a limited period. According to art. 16 TPA, the marketing authorisation is issued for the first time for a period of five years. Swissmedic shall order a shorter period of authorisation if the authorisations are limited in accordance with art. 9a TPA (so-called Temporary authorisation) or this is necessary for the protection of health. The authorisation of medicinal products on the basis of a notification shall be valid for an unlimited period.
The renewal of the marketing authorisation is regulated in art. 16b TPA. According to this provision, a marketing authorisation shall be renewed upon application if the authorisation requirements continue to be met. As a rule, renewed authorisations are valid for an unlimited period. Swissmedic may, however, limit them in particular cases.
The detailed procedures are set out in the Ordinance on Medicinal Products (Verordnung über die Arzneimittel vom 21. September 2018 [Arzneimittelverordnung, VAM; SR 812.212.21]).
In this context, it should be emphasised that the TPA provides a special provision for revocation and transfer of the authorisation. For example, Swissmedic may revoke the authorisation for a medicinal product if it is not actually 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 successive years after it has been placed on the market (art. 16a para. 1 TPA). The purpose of this sunset clause is to ensure that medicinal products are effectively available on the market.
Since medical devices are not authorized by Swissmedic, the question of the duration of approval does not arise. Decisions and certificates taken or issued by conformity assessment bodies are valid for a period of five years. On application, the certificates may be extended for a maximum of five years at a time (art. 12 para. 1 Medical Devices Ordinance [Medizinprodukteverordnung vom 17. Oktober 2001, MepV; SR 812.213]). Since the Swiss medical device law is currently undergoing a total revision and the draft of the new Medical Devices Ordinance is not yet final, no further details can be provided at this moment. However, the main elements of the new law are set out in Regulatory Reform.
6. How does the authorization process differ between brand-name products and generic products? Are there differences for local manufacturers versus foreign-owned manufacturers?
The main elements of the authorization process for brand-name products are outlined in question 3. Requirements for approval of generic products are less stringent than for original or brand-name products.
To begin with, original preparation means a medicinal product that is authorised by Swissmedic as the first product with a specific active substance, including all dosage forms authorised at the same time or later (art. 4 para. 1 lit. asexies TPA). Generic medicinal product means a medicinal product authorised by Swissmedic which is essentially the same as an original preparation and which is interchangeable with the original preparation due to its identical active substances and its dosage form and dosage (art. 4 para. 1 lit. asepties TPA).
The documentation (e.g. documentation about preclinical and clinical trials) relating to a medicinal product containing at least one new active substance and authorised in an “ordinary” authorization procedure shall be protected for a period of ten years (art. 11a TPA). This so-called “Document protection in general” must be distinguished from patent protection under the Federal Act on Patents for Inventions (Patents Act, PatA) (Bundesgesetz über die Erfindungspatente vom 25. Juni 1954 [Patentgesetz, PatG; SR 232.14]).
The authorization process of generic products is regulated in art. 12 TPA (Authorisation of essentially similar medicinal products). The application for a marketing authorization for a medicinal product which is essentially the same as a medicinal product whose documents are protected may be based on the results of the pharmacological, toxicological and clinical tests if the holder of the marketing authorization for the medicinal product with document protection provides written permission or the protection period for the relevant documents has expired.
This means that generic products manufacturers have to wait until the protection period for the relevant documents has expired (unless the brand-name products manufacturer gives his written permission before). After this period, the documents from the “ordinary” authorization procedure can be used for the authorization procedure for the generic product. The manufacturer of the generic product therefore does not have to conduct any new (and expensive) clinical trials.
With regard to this procedure, there are no differences for local manufacturers versus foreign-owned manufacturers. However, any person or organization applying for a marketing authorization must have a registered address, registered office or a branch office in Switzerland.
7. How are combination products (drug + drug, drug + biologic, drug + device, biologic + device, drug + biologic + device) regulated?
Combination products are not regulated in the TPA and there is no official Swissmedic practice.
However, these kinds of products exist on the Swiss market, which means they are authorized by Swissmedic. The “Guidance document Formal requirements HMV4” (cf. https://www.swissmedic.ch/swissmedic/en/home/kpa/homeopathic-anthroposophic-medicines/information/anpassung_wl_formale_anforderungen.html, last visited on 27 January 2020) contains technical information concerning the application form for medicinal products with a medical device component. Since the legal situation is inconclusive, it is recommended to seek legal assistance.
8. How is compliance with regulation monitored and evaluated? Is the regulatory regime comparable with the U.S. Food and Drug Administration or the European Medicines Agency expectations and requirements?
Market surveillance and inspection procedures are also regulated in the TPA. Swissmedic and the other authorities entrusted with the implementation of the TPA (e.g. the FOPH) monitor, within the limits of their competences, whether the manufacturing, distribution, dispensing and presentation of therapeutic products are in accordance with the TPA. They verify by means of periodic inspection that the conditions for the licenses are still fulfilled (art. 58 para. 1 TPA). Swissmedic verifies the therapeutic products placed on the market. The Agency further verifies that medicinal products comply with the granted marketing authorization and that medical devices satisfy the legal requirements (art. 58 para. 2 TPA). Swissmedic is responsible for monitoring the safety of therapeutic products. To this effect, it in particular collects the notifications referred to in art. 59 TPA (mandatory notification, notification system and the right to notify), evaluates them, and takes the necessary administrative measures. Any person manufacturing or distributing ready-to-use therapeutic products must put in place a system of notification (art. 59 para. 1 TPA).
Even if Switzerland’s regulations are not identical to those of the U.S. Food and Drug Administration and the European Medicines Agency, they are nevertheless comparable.
9. What is the potential range of penalties for noncompliance?
The revised TPA, which came into force on 1 January 2019, contains stricter penal provisions than the previous version of the law. Art. 86 to 90c TPA regulate the criminal provisions in detail. Only an overview is given below:
First, the law distinguishes between Felonies and misdemeanours (art. 86 TPA) on the one hand, and Other Offences (art. 87 TPA) on the other hand. Any person who wilfully commits a felony or a misdemeanour (e.g. placing on the market, using, prescribing, importing or exporting, or trading in a foreign country medicinal products without the required marketing authorisation or licence) shall be liable to a custodial sentence not exceeding three years or to a monetary penalty (art. 86 para. 1 TPA). A custodial sentence not exceeding ten years, which may be combined with a monetary penalty, shall be imposed on any person who knows or must assume that the violation specifically endangers human health or achieves a high turnover or makes substantial profits through commercial activity (art. 86 para. 2 TPA).
Any person who willfully commits others felonies (e.g. manufacturing, placing on the market, importing or exporting, or trading in a foreign country therapeutic products or excipients which do not conform to the requirements stated in the pharmacopoeia) shall be liable to a fine not exceeding 50 000 Swiss francs (art. 87 para. 1 TPA).
Prosecutions at federal level are conducted by Swissmedic and the FOPH. Swissmedic may order covert surveillance measures (e.g. observations or undercover enquiries) pursuant to the Swiss Criminal Procedure Code (Schweizerische Strafprozessordnung vom 5. Oktober 2007 [Strafprozessordnung, StPO; SR 312.0]).
In addition, the Swiss Penal Code (e.g. if someone gets injured by a therapeutic product or in case of corporate criminal liability) and other private and public law provisions may also be applicable.
10. Is there a national healthcare system? If so, how is it administered and funded?
Basic health insurance is mainly regulated by two federal laws: The Federal Act on Health Insurance (hereinafter: HIA) (Bundesgesetz über die Krankenversicherung vom 18. März 1994 [KVG; SR 832.10]) and the Federal Act on the Supervision of Health Insurance (hereinafter: SHIA) (Bundesgesetz betreffend die Aufsicht über die soziale Krankenversicherung vom 26. September 2014 [Krankenversicherungsaufsichtsgesetz, KVAG; SR 832.12]).
Every person domiciled in Switzerland is obliged to conclude basic health insurance within three months of moving to Switzerland or from the birth of a child (art. 3 para. 1 HIA). The insurer can be freely chosen (art. 4 HIA), there is no “single public health insurance” (Öffentliche Einheitskrankenkasse).
Any person who offers basic health insurance is obliged to seek for an authorization from the FOPH. At the moment, there are 57 authorised insurance companies on the Swiss market offering basic health insurance (cf.https://www.bag.admin.ch/bag/de/home/versicherungen/krankenversicherung/krankenversicherung-versicherer-aufsicht/verzeichnisse-krankenundrueckversicherer.html, last visited on 27 January 2020). Insurers are legal entities (organized according to private or public law) which do not pursue a profit-making purpose; they offer basic health insurance (art. 2 para. 1 SHIA). They must treat all persons equally, regardless of age or state of health. For example, no insurer can refuse to insure a seriously ill person. There is a legal obligation to conclude a contract which each person (Kontrahierungszwang). Furthermore, it makes no difference which insurance is chosen when it comes to insurance benefits. Each insurer is obliged to reimburse the costs of treatment, medication etc. mentioned in the HIA and the applicable ordinances. However, there are qualitative differences, such as in terms of customer service or the duration of the reimbursement process. If someone does not conclude a basic health insurance timely, cantonal authorities are allowed to allocate such person to one of the insurers (art. 6 para. 2 HIA). It can therefore be concluded that every resident in Switzerland has basic health insurance.
The tariffs/premiums (Krankenkassenprämien) for the basic health insurance have to be approved annually by the FOPH (art. 16 SHIA). Unlike in other countries, the health insurance premium does not depend on wages. A person with a very high income must pay the same premium as a person living on the edge of the subsistence level. Persons, who do not have sufficient financial means, can request a premium reduction (art. 65 HIA). A certain amount is then paid by the canton to the insurer.
However, insurance premiums vary between the insurers and the cantons. The premium also depends on the deductible, which can be freely chosen by the insured (the higher the deductible, the lower the premium).
The Swiss healthcare system is, as outlined above, regulated by federal laws and ordinances. Nevertheless, the cantons are responsible for the provision and funding of healthcare. This will be illustrated by the example of a hospital: The majority of hospitals is controlled or owned by cantons and municipalities. Cantons co-finance the public hospitals together with the health insurers. Consequently, the canton has to pay at least 55% of the cost of inpatient hospitalisation (art. 49a para. 2ter HIA); the other 45% are covered by the insurer.
11. How does the government (or public) healthcare system function with private sector healthcare?
The main principles of public health insurance are outlined in question 10. In contrast to basic health insurance, there is no obligation for a person to conclude a private health insurance that provides additional benefits (e.g. a private room during a hospital stay). Insurance companies offering basic health insurance usually offer private health insurance products too. One of the main differences between these two forms is that private health insurances are governed by the Federal Act on Insurance Contracts (Bundesgesetz über den Versicherungsvertrag vom 2. April 1908 [Versicherungsvertragsgesetz, VVG; SR 221.229.1]). In private healthcare sector, the Swiss Financial Market Supervisory Authority (Eidgenössische Finanzmarktaufsicht FINMA) approves the tariffs/premiums. However, private health insurers can choose whether or not to conclude an insurance contract with a person, which means that persons can be refused due to their age or health condition. Consequently, discrimination that is prohibited within the scope of the HIA is permitted and practised within the scope of the Federal Act on Insurance Contracts. In contrast to the supervisory function of the FOPH over the public health insurance sector, the supervision of the private insurance sector is exercised by the FINMA. Most insurers offer both, basic and private health insurances.
12. Are prices of drugs and devices regulated and, if so, how?
As outlined in question 3, ready-to-use medicinal products may be placed on the market only if authorized by Swissmedic (art. 9 para. 1 TPA). This authorization does not cover pricing and reimbursement. The competent authority for pricing (and reimbursement) is the FOPH.
A medicinal product can only be reimbursed by the health insurance if it is listed by the FOPH on the so-called “specialty list” (Spezialitätenliste) (art. 52 para. 1 lit. b HIA). First, an application for a medicinal product to be listed on the specialty list has to be filed with the FOPH. In order to be listed, the Swissmedic approved medicinal product must satisfy the criteria of effectiveness, functionality and economic efficiency (art. 65 para. 1 and 3 of the Ordinance on Health Insurance [hereinafter: OHI] [Verordnung über die Krankenversicherung vom 27. Juni 1995, KVV; SR 832.102]).
In order to assess the effectiveness criterion, the same documents are used as those submitted to Swissmedic for marketing authorisation. However, the FOPH may require further documentation (art. 32 Ordinance on the Benefits of the Mandatory Health Insurance [hereinafter: OBHI] [Verordnung des EDI vom 29. September 1995 über Leistungen in der obligatorischen Krankenpflegeversicherung; Krankenpflege-Leistungsverordnung, KLV; SR 832.112.31]). With regard to the functionality of a medicinal product, the FOPH analyses its impact, composition and possible side effects (art. 33 OBHI). The economic efficiency of a medicinal product is evaluated by using a combination of different concepts:
First, the FOPH compares the price of the medicinal product with the average price of the same medicinal product in the reference countries Germany, Denmark, Great Britain, the Netherlands, France, Austria, Belgium, Finland and Sweden (Auslandspreisvergleich) (cf. https://www.bag.admin.ch/bag/de/home/versicherungen/krankenversicherung/krankenversicherung-leistungen-tarife/Arzneimittel/Mitteilungen-zur-Spezialitaetenliste.html, last visited on 27 January 2020). Second, the FOPH compares the price of the medicinal product with the price of other medicinal products in Switzerland used to treat the same disease (therapeutischer Quervergleich). Both results will be evaluated equally (art. 65b OHI; art. 34a et seqq. OBHI). The FOPH has a large discretion in the composition of the reference drugs. The calculation process is illustrated by the following example: the average price in the reference countries is 100 Swiss francs; the average price for other medicinal products in Switzerland used to treat the same disease is 150 Swiss francs; as a result, the price for the new medicinal product is set at 125 Swiss francs ([100+150] / 2).
However, the price determined by these criteria is not yet definitive. The FOPH takes into account costs for research and development (unless the original product is a successor product that does not bring any therapeutic progress). In case of significant therapeutic progress, a so-called innovation supplement (Innovationszuschlag) is granted for a maximum of 15 years (art. 65b para. 6 and 7 OHI).
Medicinal products do not remain on the speciality list indefinitely. A re-evaluation of the 3 criteria takes place every 3 years. In consequence, the FOPH may order a reduction of the price (art. 65d OHI).
Medical Devices, on the other hand, are not listed on the speciality list. There is a separate list for medical devices (among others) used by patients, the so-called Mittel-und Gegenständeliste (MiGel). However, this list does not apply to all medical devices.
13. How are drugs and devices used by patients paid for? What roles do public and private payers play?
The main principles of pricing are outlined in question 12. A medicinal product can only be reimbursed by the health insurance if it is listed by the FOPH on the so-called “specialty list” (Spezialitätenliste). In order to be listed, the Swissmedic approved medicinal product must satisfy the criteria of effectiveness, functionality and economic efficiency (art. 65 para. 1 and 3 OHI).
Consequently, medicinal products not listed on the “specialty list” have to be paid for exclusively by the patients themselves. If several equivalent medicinal products exist, doctors usually prescribe listed ones. If a medicinal product is not reimbursed by the health insurance, doctors must inform their patients of this fact before prescribing the medicinal product. It can therefore be essential for a pharmaceutical company that their medicinal product is listed.
In order to be reimbursed by the health insurance, medical devices have to be listed, for example, on the so-called Mittel- und Gegenständeliste (MiGel).
14. Who dispenses drugs and devices to patients and how are those dispensers compensated?
Medicinal products are classified into categories according to whether or not they are subject to prescription (art. 23 para. 1 TPA). Swissmedic categorizes each medicinal product for which it has granted a marketing authorization. It takes into account the professional competence of the professional groups entitled to dispense medicinal products (art. 23a para. 1 TPA).
Medicinal products in categories A and B are subject to a prescription, category D medicinal products require professional advice in advance (e.g. the consultation of a pharmacist) ( “Abgabe nach Fachberatung”) and category E medicinal products can be sold over the counter (e.g. in supermarkets). Category C was abolished on 1 January 2019.
The following persons are entitled to dispense prescription-only (categories A and B) medicinal products (art. 24 para. 1 TPA):
- Pharmacists, on presentation of a doctor’s prescription. They may dispense medicinal products without a doctor’s prescription if they have direct contact with the person concerned, if they document the product dispensed, and if the medicinal products and indications have been designated by the Federal Council (e.g. medicinal products for the continuation of a permanent medication) or if the case is justified and exceptional.
- All other medical professionals in accordance with the provisions on so-called pro-pharmacy (“Selbstdispensation”) and taking account of art. 1 para. 3 lit. c TPA.
- All duly trained professionals, under the supervision of a person specified in lit. a) and b).
The following persons are entitled to dispense non-prescription (categories D and E) medicinal products (art. 25 para. 1 TPA):
- Persons entitled to dispense prescription medicinal products.
- Druggists holding a federal diploma.
- All other duly trained persons, within the limits of their right to dispense medicinal products.
- All duly trained professionals, under the supervision of persons referred to in lit. a) and b).
Any person dispensing medicinal products must have a cantonal license (art. 30 para. 1 TPA). The requirements are regulated in the cantonal health laws and ordinances.
Cantonal law also regulates the question of whether doctors are allowed to dispense medicinal products themselves (“Selbstdispensation”). In Basel-Stadt, for example, only pharmacies are allowed to dispense medicinal products. To give another example, in Zurich, doctors are allowed to run a “private pharmacy” in their medical office, which means they can not only prescribe medicinal products, but also dispense them directly to their patients.
Dispensers are never compensated in any way by manufacturers if they prescribe or dispense a certain medicinal product (which would be highly illegal). This guarantees absolute independence in the choice of the medicinal product. Doctors (if allowed to dispense) and pharmacists are either compensated directly by their patients (after a consultation or treatment) or by the patients’ health insurance. The health insurance reimburses the costs for medicinal products only if they are listed on the “specialty list” (Spezialitätenliste).
These provisions do not apply to medical devices. For the protection of health, the Federal Council may, for certain medical devices: adopt provision that such medical devices can only be dispensed upon a medical prescription; lay down the necessary technical and operational conditions or a mandatory notification for their dispensing and use; attach to the dispensing of products the condition that the devices concerned must be traceable between their manufacture and their use and vice versa (art. 48 para. 1 TPA). Since the Swiss medical device law is currently undergoing a total revision and the draft of the new Medical Devices Ordinance is not yet final, no further details can be provided at the moment. However, the main elements of the new law are set out in Regulatory Reform.
15. What are the professional and legal responsibilities of those who dispense drugs and devices? What role do they play in providing patient care, information, and safety?
The recognized rules of pharmaceutical and medical sciences must be respected when prescribing, dispensing and using medicinal products, and the principles of the corresponding therapy approach must be respected when prescribing, dispensing and using complementary medicines without indications. A medicinal product may only be prescribed if the state of health of the consumer or patient is known (art. 26 para. 1 and 2 TPA).
Failure to comply with this obligation may be penalised: Any person who wilfully dispenses medicinal products contrary to the due diligence requirements stipulated in art. 26 TPA shall be liable to a custodial sentence not exceeding three years or to a monetary penalty (art. 86 para. 1 lit. a TPA). It is important to emphasize that this provision applies regardless of whether a person has been endangered or injured or not. A custodial sentence not exceeding ten years, which may be combined with a monetary penalty, shall be imposed on any person who knows or must assume that the violation specifically endangers human health or achieves a high turnover or makes substantial profits through commercial activity (art. 86 para. 2 TPA).
It is therefore essential for a doctor or pharmacist to be aware of the patient’s state of health before dispensing a medicinal product. To give one example, the Swiss Association of Cantonal Pharmacists (Kantonsapothekervereinigung) has issued a document “Rules of Good Dispensing Practice for Therapeutic Products” (cf. “Regeln der Guten Abgabepraxis für Heilmittel” vom 14. September 2009, http://www.kantonsapotheker.ch/fileadmin/docs/public/kav/posipapiere/regeln_der_guten_abgabepraxis_cgap_v1_maerz2010_d.pdf [last visited on 27 January 2020]) addressed primarily to pharmacists and doctors. In Switzerland, doctors and pharmacists are basically fully aware of these strict rules, which serve to protect the health of patients. It is widely accepted that many medicinal products cannot simply be bought “over the counter” like in other countries. The involvement of doctors and pharmacists in the course of dispensing helps to avoid medication errors and to actively inform patients about potential risks and side effects.
Art. 26 TPA also applies to medical devices (art. 48 para. 2 TPA). Since the Swiss medical device law is currently undergoing a total revision and the draft of the new Medical Devices Ordinance is not yet final, no further details can be provided at the moment. However, the main elements of the new law are set out in Regulatory Reform.