The regulatory regime
While medicines are tightly regulated by the TPA (Chapters 2 and 4) and numerous ordinances and must obtain a marketing authorisation, medical devices are governed by the principle of self-regulation. Medicines follow a genuine Swiss legislation, whereas medical devices are regulated in close accordance with EU law.i Classification
Medicines are products of chemical or biological origin that 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.
Medical devices are products including instruments, apparatus, in vitro diagnostics, software and other goods or substances that are intended to have or are presented as having a medical use and whose principal effect is not obtained with a medicine.
Foodstuffs are defined by the Federal Act on Foodstuffs and Utility Articles as all substances or products that are intended or may reasonably be expected to be consumed by human beings in a processed, partly processed or unprocessed state; medicines are not foodstuffs. Health claims in connection with foodstuffs must comply with, among others, the provisions of the Ordinance on Information on Foodstuffs.
Cosmetics, when used as normally intended, come into contact with the body externally, and with teeth or mucous membranes externally, and belong to the category of 'utility articles'. Health claims are prohibited for cosmetics.
With regard to chemicals, substances are defined by the Federal Act on Protection against Dangerous Substances and Preparations as chemical elements and their compounds in the natural state or obtained by any production process, while preparations are defined as mixtures or solutions composed of two or more substances. According to the Ordinance on Protection against Dangerous Substances and Preparations, said ordinance does not apply to medicines and medical devices.ii Non-clinical studies
The documentation of analytical, chemical and pharmaceutical test results in non-clinical trials – which is necessary to obtain a marketing authorisation for a specific medicine with a specific indication – must prove that the test procedures correspond with the current state of science and are validated. Studies carried out on animals or, where appropriate, on qualified or validated alternative models must (1) be in accordance with the rules and recommendations governing the protection of the animals used and ensuring impeccable test results; and (2) have been planned and implemented in accordance with the current state of science. Further, the marketing authorisation application for a new chemical entity must contain information and documents on pharmacodynamics, pharmacokinetics, toxicology and ecotoxicity.
Non-clinical studies are subject to the Federal Act on Animal Protection, the guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use and the Ordinance on Good Laboratory Practice.iii Clinical trials
Clinical trials are mainly governed by Articles 53 et seq. of the TPA, the HRA and the Ordinance on Clinical Trials in Human Research. Clinical trials of medicines and medical devices require prior authorisation from Swissmedic. However, clinical trials involving compliant medical devices applied in accordance with the intended use specified in the conformity assessment are exempted from mandatory authorisation.
In addition to Swissmedic's authorisation, an authorisation from the responsible ethics committee is required.
The sponsor is defined as a person or institution headquartered or represented in Switzerland that takes responsibility for organising a clinical trial, and in particular for the initiation, management and financing of the trial in Switzerland. The investigator on the other hand is the person responsible in Switzerland for the conduct of a clinical trial and for the protection of the participants at the trial site; an investigator who takes responsibility for organising a clinical trial in Switzerland is also a sponsor.
Clinical trials must be conducted in accordance with the rules of Good Clinical Practice.
The main principles in connection with clinical trials include the informed consent of the persons concerned, the primacy of individual interests over the interests of science and society, the requirement of a scientifically relevant topic, the principle of non-discrimination, the right of persons concerned to receive information on their health, the prohibition of the commercialisation of the human body and parts thereof, as well as compliance with certain scientific requirements. Furthermore, the person carrying out the clinical trial is liable for all damages suffered in connection with the project and must ensure that this liability is appropriately covered through insurance or in some other manner. In addition, the trial must be registered in a public registry and is subject to various notification and reporting obligations (e.g., completion or discontinuation of trial, adverse events, and safety and protective measures).iv Named-patient and compassionate use procedures
In Switzerland, there are two main possibilities to use non-authorised medicines. Swissmedic may authorise a medical professional to import non-authorised medicines, which are either authorised or part of a clinical trial in a comparable jurisdiction, for the treatment of an individual patient.
Furthermore, Switzerland defines and allows compassionate use, whereby it may temporarily authorise the sponsor of a clinical trial approved in Switzerland to use medicines used in clinical trials on certain persons or on a certain group of persons outside of the clinical trial.
A treatment with a non-authorised medicine is reimbursed by the compulsory healthcare insurance scheme if the medicine is authorised for the relevant indication in a country with an authorisation system recognised by Swissmedic as equivalent, and if either (1) the use of the medicine is an indispensable condition for another treatment covered by compulsory health insurance and if that treatment is clearly in the foreground; or (2) the use of the medicine is expected to have a great therapeutic benefit against a disease that is fatal or that could result in serious and chronic health impairments, and if no other effective and approved treatment is available owing to a lack of therapeutic alternatives.
The reimbursement requires prior approval by the healthcare insurance after consultation with the medical examiner, and the costs must be proportionate to the therapeutic benefit.v Pre-market clearance
The commercial distribution of medicines requires a marketing authorisation by Swissmedic, whereas medical devices may, in principle, be put on the Swiss market without a marketing authorisation.
A marketing authorisation for a medicine is granted by Swissmedic if it is of high quality, safe and effective, if the applicant is the holder of an authorisation to manufacture, import or conduct wholesale trade, and if the applicant has a registered address, registered office or a branch office in Switzerland.
The marketing authorisation is issued for five years. Its renewal is generally unlimited in terms of time.
A simplified procedure ensures fast access to certain categories of medicines:
- medicines with known active pharmaceutical ingredients;
- medicines whose active substances are used in a medicine that, at the time of submission of the application, has been authorised for at least 10 years in at least one EU or EFTA country and that is comparable in terms of indications, dosage and method of administration;
- non-prescription medicines with an indication that, at the time of submission of the application, has been proven to have been used medically for at least 30 years, of which at least 15 years have been in EU and EFTA countries;
- medicines that, at the time of submission of the application, are proven to have been authorised as medicines for at least 15 years in a canton;
- complementary medicines;
- herbal medicines;
- medicines prepared by a hospital pharmacy or in the hospital's own radiopharmaceutical unit for the needs of the hospital;
- medicines prepared by the army and used in the context of the coordinated army medical corps;
- important medicines for rare diseases; and
- veterinary medicines, which are intended exclusively for animals not kept for the production of foodstuffs.
Complementary medicines without indication, the active substances of which are included in lists of special therapeutic directions, may be placed on the market solely on the basis of a notification to Swissmedic. The same holds true for other medicines or groups of medicines for which, because of their low risk potential, a simplified marketing authorisation procedure proves to be disproportionate.
The fees as of 1 January 2019 are as follows:
- authorisation of a medicine with a new active substance: 80,000 Swiss francs;
- authorisation of a medicine with a known active substance: 50,000 Swiss francs;
- authorisation of a herbal medicine with a new active substance: 30,000 Swiss francs;
- authorisation of a medicine in the simplified procedure: 100 to 80,000 Swiss francs;
- renewal of an existing authorisation and change into authorisation unlimited in time: 500 Swiss francs; and
- authorisation of orphan drugs: fee is waived (grant of orphan drug status: 3,000 Swiss francs).
Medical devices may be put on the market if they do not endanger the health of users, consumers, patients or third parties when used in accordance with their intended use. Claims for their performance or effectiveness must be provable. The person placing a medical device on the market must be able to prove that the device satisfies the fundamental requirements set forth by the applicable EU Directives and that it has been submitted to the prescribed procedures for assessing conformity. Only a small group of medical devices is subject to a mandatory notification obligation before putting them on the market for the first time.vi Regulatory incentives
Upon application, the Intellectual Property Institution grants a supplementary protection certificate for medicines, which is valid after expiry of the maximum term of the patent for a period equal to the period that elapses between the date of patent filing and the date of the first marketing authorisation, minus five years. It is valid for five years at the most.
Document protection is granted for 10 years for medicines with a new active ingredient. Document protection is also granted for 10 years for a new indication in the case of a considerable therapeutic improvement and for three years for a new indication, application, dosage form, dose strength or dosage recommendation of a medicine with a known active ingredient. Document protection is also granted to paediatric medicines (10 years) and orphan drugs (15 years).
Medicines for paediatric use benefit from a six-month extension of the supplementary protection certificate, subject to certain conditions.
Patent-protected medicines may be manufactured and exported to developing countries to combat public health problems, subject to certain conditions (compulsory licences).vii Post-approval controls
Any person manufacturing or distributing therapeutic products (i.e., medicines or medical devices) must establish a notification system. He or she must notify Swissmedic of any adverse event or reaction that (1) is or may be attributable to the therapeutic product itself, its use or labelling; or (2) may endanger or damage the health of the consumer, the patient or a third party. That person must also notify Swissmedic of any quality defects and any further findings and assessments that could influence the basis of evaluation. Such notifications must be made in accordance with the recognised rules of good vigilance practice.
The marketing authorisation is transferable. The rules regarding amendments to approvals (known as variations) have been largely harmonised with EU law.
Swissmedic may revoke the marketing authorisation if the medicine is not actually placed on the market within three years of granting 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. If the authorisation holder intends not to place a paediatric medicine on the market, such intention is published by Swissmedic together with the information that the authorisation documentation can be obtained free of charge from the marketing authorisation holder.viii Manufacturing controls
Manufacturers of medicines require a licence from Swissmedic, whereas manufacturers of medical devices are not required to obtain such a licence.
Manufacturing licences are issued if the necessary technical and operational conditions are fulfilled and if an appropriate system of quality assurance exists.
The licence is unlimited in time in principle and specifies in particular the qualified person, the authorised activities and the business locations.
The manufacture of medicines must conform to the recognised rules of good manufacturing practice.ix Advertising and promotion
Whereas the TPA contains provisions regarding advertising of both medicines and medical devices, the ordinances applicable to advertising of medicines and medical devices differ. Advertising of medicines is subject to the Ordinance on Advertising of Medicinal Products (AWV), whereas advertising of medical devices is subject to Article 21 of the Ordinance on Medical Devices (MepV).
Advertising of medicines is defined in the AWV as all information, marketing and incentivising measures aimed at promoting the prescription, supply, sale, consumption or use of medicines. General information on health and diseases without any direct or indirect references to individual medicines is not, however, considered to be advertising. The packing material and the drug information do not fall within the provisions of the AWV either.
The provisions regarding advertising of medicines clearly distinguish between advertising directed at healthcare professionals (HCPs) and advertising directed at the general public. Generally speaking, it is permitted to advertise all types of medicines if the advertising is directed exclusively at HCPs. However, it is only permitted to advertise non-prescription medicines to the general public.
With regard to medical devices, Article 21 MepV states that advertising to the general public is prohibited for medical devices that are placed on the market for the exclusive use by professionals.
Advertising is deemed unlawful if it is misleading or contrary to public order and morality, if it may incite an excessive, abusive or inappropriate use of medicines or if it is for medicines that may not be placed on the market nationally or cantonally.
Furthermore, advertising directed at the general public is deemed unlawful for medicines that contain narcotic or psychotropic substances and for medicines that may not, on account of their composition and their intended use, be used without the intervention of a doctor for the necessary diagnosis, prescription or treatment, as well as for medicines that are frequently the object of abuse, or lead to an addiction or dependence.
The infringement of the regulations on the advertising of medicines may entail criminal sanctions.
In addition, Swissmedic may take all administrative measures necessary to enforce the TPA. In particular, it may 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 as well as temporarily or permanently prohibit the advertising of a specific medicine in the event of serious or repeated infringements of the provisions of the TPA, and publish the prohibition at the expense of the responsible parties.x Distributors and wholesalers
Any person engaged in the wholesale trade of medicines must possess a licence issued by Swissmedic, which is issued if the necessary technical and operational conditions are fulfilled and an appropriate system of quality assurance exists. The licence is also issued if the applicant already possesses a manufacturing or import licence for medicines.
Brokers and agents require a licence for the distribution of medicines as well.
The licence is unlimited in time in principle and specifies in particular the qualified person, the authorised activities and the business locations.
Furthermore, anyone who dispenses medicines in a pharmacy, a drugstore or another retail trade establishment requires a cantonal licence.
In principle, mail-order trade in medicines is prohibited. However, cantons may issue a licence under certain conditions.xi Classification of products
In connection with the marketing authorisation, Swissmedic classifies medicines into four categories (A, B, D and E) depending mainly on their safety and their undesirable effects. Generally speaking, categories A and B contain prescription-only medicines, whereas category D contains over-the-counter medicines in pharmacies and drug stores, and category E contains medicines sold without any restrictions.
Category A and B medicines may be dispensed by doctors or pharmacies. Category A medicines may, however, only be dispensed once. Certain category B medicines may, under certain conditions, be dispensed by pharmacists without a prescription.
Category D medicines may be dispensed by pharmacies and drug stores after professional advice, whereas category E medicines can be sold anywhere without restrictions.
The former category C (over-the-counter medicines that may be dispensed by pharmacies after professional advice by a healthcare professional) has been abolished, starting from 1 January 2019, and all the medicines that were in it are being reclassified into category D or B. However, until completion of said reclassification, category C will continue to exist until all reclassifications are legally binding, which may take several years if such reclassifications are appealed.xii Imports and exports
Any person who, in a professional capacity, imports or exports ready-to-use medicines intended for distribution or dispensing, requires a licence issued by Swissmedic. The same holds true for anyone who, in a professional capacity, trades medicines in foreign countries from Switzerland, without their entering into Switzerland.
The licence is unlimited in time in principle, and specifies in particular the qualified person, the authorised activities and the business locations.xiii Controlled substances
Advertising directed at the general public is deemed unlawful for medicines that contain narcotic or psychotropic substances as referred to in the Narcotics Act.
The import of medicines is generally limited to medicines that have been authorised or that are not subject to authorisation. As a general rule, opium for smoking and the residues created in its production or use, diacetylmorphine and its salts, hallucinogens such as lysergide (LSD 25) and narcotics containing an effective concentration of cannabinoids may not be cultivated, imported, produced or placed on the market. However, the FOPH may issue exceptional licences, subject to certain conditions. For the import, production and placing on the market of one of the mentioned narcotics that is an active ingredient in an authorised medicine, a licence from Swissmedic is required.
The export of medicines and their foreign trade from Switzerland is generally prohibited if they are prohibited in the target country or if circumstances suggest that they could be intended for illegal purposes.xiv Enforcement
As a general rule, both Swissmedic and cantonal authorities – in certain situations the FOPH – are responsible for market surveillance, for conducting inspections and for enforcing the TPA.
Swissmedic may take all administrative measures deemed necessary and institute criminal proceedings, which are conducted by Swissmedic and the FOPH, and which may involve further federal or cantonal authorities.
The Code Secretariat is the self-regulatory body that is responsible for the implementation of the Pharma Code and the Pharma Cooperation Code, which are relevant and often referred to self-governing codices by the pharmaceutical industry. Both codes contain provisions regarding procedures in case of a breach of a code.