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- Transitional provisions to the revision of the Stock Corporation Act of June 19, 2020
- Art. 808c CO
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- Art. 2 PRA
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- Vorb. zu Art. 1 FADP
- Art. 1 FADP
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- Art. 5 lit. f und g FADP
- Art. 6 Abs. 6 and 7 FADP
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- Art. 31 para. 2 lit. e FADP
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- Art. 2 CCC (Convention on Cybercrime)
- Art. 3 CCC (Convention on Cybercrime)
- Art. 4 CCC (Convention on Cybercrime)
- Art. 5 CCC (Convention on Cybercrime)
- Art. 6 CCC (Convention on Cybercrime)
- Art. 7 CCC (Convention on Cybercrime)
- Art. 8 CCC (Convention on Cybercrime)
- Art. 9 CCC (Convention on Cybercrime)
- Art. 11 CCC (Convention on Cybercrime)
- Art. 12 CCC (Convention on Cybercrime)
- Art. 25 CCC (Convention on Cybercrime)
- Art. 29 CCC (Convention on Cybercrime)
- Art. 32 CCC (Convention on Cybercrime)
- Art. 33 CCC (Convention on Cybercrime)
- Art. 34 CCC (Convention on Cybercrime)
FEDERAL CONSTITUTION
MEDICAL DEVICES ORDINANCE
CODE OF OBLIGATIONS
FEDERAL LAW ON PRIVATE INTERNATIONAL LAW
LUGANO CONVENTION
CODE OF CRIMINAL PROCEDURE
CIVIL PROCEDURE CODE
FEDERAL ACT ON POLITICAL RIGHTS
CIVIL CODE
FEDERAL ACT ON CARTELS AND OTHER RESTRAINTS OF COMPETITION
FEDERAL ACT ON INTERNATIONAL MUTUAL ASSISTANCE IN CRIMINAL MATTERS
DEBT ENFORCEMENT AND BANKRUPTCY ACT
FEDERAL ACT ON DATA PROTECTION
SWISS CRIMINAL CODE
CYBERCRIME CONVENTION
COMMERCIAL REGISTER ORDINANCE
FEDERAL ACT ON COMBATING MONEY LAUNDERING AND TERRORIST FINANCING
- I. General
- II. The concept of “supply”
- III. Purpose and manufacturer's information
- IV. Application by analogy of Art. 26 TPA
- Bibliography
- Materials
I. General
1 In contrast to medicinal products, the dispensing of medical devices is only regulated very superficially in the legislation on therapeutic products. Art. 48 para. 1 let. b and c TPA allows the Federal Council to define, for the protection of health, (a) professional and operational requirements or a reporting requirement for the dispensing of certain medical devices, and (b) to link the dispensing to the requirement that the products in question can be traced from their manufacture to their use and back. In addition, Art. 48 para. 2 TPA states that Art. 26 TPA, which regulates the principles for the prescription, dispensing and use of medicinal products, applies mutatis mutandis to the dispensing of medical devices.
2 The Federal Council has been very cautious in exercising its authority under Art. 48 para. 1 TPA, because only Art. 68 MedDO contains a regulation at the ordinance level for dispensing. According to Art. 68 MedDO, medical devices may be dispensed in accordance with their intended purpose and the manufacturer's instructions. Before the revision of the Medical Devices Ordinance in 2021, the dispensing of medical devices was regulated in detail in Art. 17 para. 1 aMepV. In contrast to the current regulation, under the aMepV, in particular, professional advice had to be provided by the point of care for devices for self-administration (see Art. 17 para. 2 aMepV). This requirement was dropped during the revision, as this provision proved to be unsuitable in practice and was almost impossible for the competent authorities to verify.
3 Paragraphs 2, 3 and 4 of Art. 17 aMepV, which concerned in vitro diagnostics, initially remained in force in accordance with the transitional provision of Art. 105 MedDO. However, Art. 105 MedDO was subsequently repealed by Annex 5 of the Ordinance on In Vitro Diagnostics (IvDO) of May 4, 2022, with effect from May 26, 2022. Since then, the provisions on in vitro diagnostic medical devices previously found in Art. 17 para. 2 and 3 aMepV can be found in Art. 61 IvDV. Now, the dispensing of medical devices is based only on the intended purpose of the device and the information provided by the manufacturer, whereby the medical devices must, of course, fulfill all other legal requirements for placing them on the market in order to be dispensed in accordance with Art. 68 MedDO.
II. The concept of “supply”
4 As already mentioned, the supply of medical devices in accordance with Art. 68 MedDO is based on the intended purpose and the manufacturer's information. The definition of the term “supply of goods” is therefore crucial for this provision. Art. 4 para. 1 MedDO does not contain a separate definition of the term “supply”, nor does Art. 4 para. 2 refer to the corresponding definition (“making available on the market”) in Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (“EU MDR”). However, a definition of this term can be found in Art. 4 para. 1 let. f TPA. According to this, dispensing is to be understood as the transfer or provision, whether in return for payment or free of charge, of a ready-for-use therapeutic product for use by the purchaser or for application to third parties or to animals. If we compare this with the definitions in Art. 4 para. 1 MedDO, it is noticeable that this definition corresponds to the term “putting into service” in Art. 4 para. 1 let. c MedDO. In fact, the term “putting into service” also refers to the point in time at which a ready-to-use medical device is made available to the end user for the first time on the Swiss market for use in accordance with its intended purpose. In summary, “dispensing with intent to sell” refers to the act of handing over a medical device to the end user, i.e. a medical professional or a patient.
5 The term “supply of a medical device” does not include the prescription of a medical device, i.e. the issuing of a prescription by an authorized medical professional. The supply of a medical device is only deemed to have taken place once a medical prescription has been filled. With the revision of the medical device legislation, Art. 16 of the MedDO, which regulated the prescription requirement for medical devices, was deleted without replacement and the corresponding ordinance repealed (Art. 99 no. 2 MedDO). According to the Federal Office of Public Health, the reason for this was that the medical devices listed in the Ordinance on the List of Prescription-Only Medical Devices of June 22, 2006 (VLvM) (intrauterine devices for contraception and saturation compressors) are no longer as risky today, which is why a prescription is no longer required. Therefore, there are no longer any medical devices that require a prescription by law. However, a prescription requirement may arise from the intended purpose or the manufacturer's information, which must be taken into account in the context of Art. 68 MedDO. Unlike the situation with medicinal products, it is not the Swiss Agency for Therapeutic Products that assigns medical devices to a dispensing category when they are officially authorized, and thus determines whether they are prescription-only or not, but rather the manufacturers themselves who can determine whether their products are prescription-only or not, provided this makes sense, for example, for safety reasons.
6 The application of medical devices must also be distinguished from their dispensing, although neither the TPA nor the MedDO contain a definition of the term “application of a”. In particular, the application is characterized by the independent decision to administer the device and the assumption of responsibility for this decision. The application is therefore to be equated with the use that occurs after the device has been dispensed and which means the specific use of the medical device for the intended medical purpose.
7 Possible actions that may fall under the dispensing of medical devices include, in particular, selling, distributing, delivering or making them available to patients. These actions can be carried out by doctors, healthcare institutions, pharmacies, drugstores, supermarkets, mail-order companies, web shops or self-service vending machines, among others. Making medical devices available to medical personnel or professional users also falls under the term “dispensing” if this medical device is intended for use by the medical personnel on patients. The execution of a medical prescription by an authorized person ultimately leads to the dispensing of the medical device. The case in which manufacturers provide their medical devices directly to patients is also to be evaluated as a dispensing in the sense of therapeutic products legislation.
8 In addition, the general regulations – such as their respective risk class – are also to be observed when dispensing medical devices. Consequently, only medical devices that are intended for use by the public, i.e. lay users, in accordance with the manufacturer's specifications, i.e. persons who cannot be assumed to have medical or technical expertise, may be supplied directly to end users (see also Art. 70 para. 2 and 3 and Annex 6 MedDO).
9 In principle, the distribution of medical devices does not require official authorization. However, if the costs for the distribution are to be covered by health insurance, a cantonal authorization is sometimes required.
III. Purpose and manufacturer's information
10 The distribution of medical devices is based on the intended purpose and the manufacturer's instructions. A uniform definition of the term “intended purpose” cannot be found in either the MedDO or the TPA. With regard to Art. 2 no. 12 EU MDR, the definition of which also applies to Switzerland in accordance with Art. 4 para. 2 MedDO, the intended purpose refers to “the use for which a device is intended, as specified by the manufacturer on the label, in the instructions for use or in promotional or sales material, or in promotional or sales information and in the clinical evaluation”. The labeling refers to written, printed or graphically displayed information affixed either to the device itself or to the packaging of each unit or to the packaging of multiple products (Art. 4 para. 2 MedDO in conjunction with Art. 2 no. 13 EU MDR). The instructions for use refer to information provided by the manufacturer in which the user is informed about the intended purpose and correct use of a product, as well as any precautions to be taken (Art. 4 para. 2 MedDO in conjunction with Art. 2 no. 14 EU MDR). Consequently, it is primarily the manufacturer who determines the purpose of his product, and he thus has a great deal of discretion. This is surprising in that the dispensing of medicinal products is strictly regulated by law. In any case, the limits of this discretion are set by Art. 70 para. 2 and 3 in conjunction with Annex 6 MedDO, which indirectly affect the dispensing of such products only to professionals – and thus not directly to patients. These are so-called long-term injectable products that are intended to remain in the human body for more than 30 days (no. 1 of Annex 6 MedDO).
11 According to Art. 4 para. 1 let. f MedDO, a manufacturer is any natural or legal person who manufactures a device or reprocesses a device, or who has a device designed, manufactured or reprocessed, and markets that device under his name or trademark. According to Art. 4 para. 1 let. f MedDO, the clarifications and exceptions listed in Article 16 para. 1 and 2 of the EU MDR – which particularly affect distributors and importers and the cases in which they do or do not have the obligations of a manufacturer – must also be taken into account.
12 Since the revision of the medical devices legislation in 2021, the MedDO applies both to medical devices and their accessories in accordance with Art. 3 para. 3 MedDO and to products without an intended medical purpose in accordance with Annex 1 MedDO (see Art. 1 para. 1 MedDO). Products without an intended medical purpose include, for example, contact lenses or hair removal products. Consequently, Art. 68 MedDO applies to both medical devices and products without an intended medical purpose (Art. 1 para. 2 MedDO).
IV. Application by analogy of Art. 26 TPA
13 According to Art. 48 para. 2 TPA, Art. 26 TPA applies by analogy to medical devices. Art. 26 TPA regulates the principles for the prescription, dispensing and use of medicinal products. These rules also apply by analogy to medical devices by virtue of the reference in Art. 48 para. 2 TPA. Since there are currently no legally prescribed prescription-only medical devices, the reference is (currently) without legal consequence with regard to prescription, unless a manufacturer voluntarily subjects its product to a prescription requirement. However, this reference and thus Art. 26 TPA must be observed in any case for dispensing and use, even if the Federal Council has not exercised its authority under para. 1 of Art. 48 TPA. Para. 2 of Art. 48 TPA is an independent provision, and thus separate from para. 1, which must be observed in any case. The analogous application for medical devices therefore means in particular that the recognized rules of medical and pharmaceutical science must be observed when dispensing and using medical devices (Art. 48 para. 2 in conjunction with Art. 26 para. 1 TPA).
14 Observing the recognized rules of medical and pharmaceutical science when dispensing means, in particular, a concretization of the duty of care arising from Art. 3 TPA. What exactly the term “recognized rules of medical and pharmaceutical science” means is not defined in more detail in the TPA. According to the Federal Supreme Court, a breach of due diligence on the part of the medical profession is deemed to have occurred if a doctor's actions no longer appear justifiable according to the general state of professional knowledge and do not correspond to the current state of scientific knowledge. The applicable standard of care is primarily based on special standards that prescribe a certain course of action. According to the Federal Court, this also applies to generally recognized rules of conduct issued by a private or semi-public association that do not constitute legal norms. These rules of conduct include, for example, the rules of good dispensing practice for therapeutic products of the Swiss Association of Cantonal Pharmacists and the FMH drug policy, which are covered by Art. 26 para. 1 TPA. These rules of conduct merely form the framework on the basis of which a breach of due diligence can be determined. Specific cases of breaches of due diligence must be examined on a case-by-case basis by means of medical reports. When dispensing medical devices, the rules of good dispensing practice for therapeutic products must be observed in particular, which define the basic due diligence to be observed when dispensing and using therapeutic products. However, it should be noted that the rules of Good Dispensing Practice for therapeutic products generally only apply to prescription-only medical devices. For non-prescription medical devices, which make up the majority of medical devices, the principles of the rules of Good Dispensing Practice for therapeutic products should therefore be consulted for reference only.
Bibliography
Bürgi Heidi, Kommentierung zu Art. 26 HMG, in: Eichenberger Thomas/Jaisli Urs/Richli Paul (Hrsg.), Basler Kommentar, Heilmittelrecht, 2. Aufl., Basel 2022.
Cortizo Juan, Kommentierung zu Art. 48 HMG, in: Eichenberger Thomas/Jaisli Urs/Richli Paul (Hrsg.), Basler Kommentar, Heilmittelrecht, 2. Aufl., Basel 2022.
Eggenberger Stöckli Ursula/Kesselring Felix, Kommentierung zu Art. 4 HMG, in: Eichenberger Thomas/Jaisli Urs/Richli Paul (Hrsg.), Basler Kommentar, Heilmittelrecht, 2. Aufl., Basel 2022.
Isler Michael, Direkte Beschaffung und Anwendung von Medizinprodukten aus dem Ausland, LSR 1 (2024), S. 22-32.
Regeln der Guten Abgabepraxis für Heilmittel, Kantonsapothekervereinigung Schweiz, 14.9.2009, Version 1.
Swissmedic, AW-Merkblatt vom 19.6.2018, Abgabe von Publikums-Medizinprodukten, https://www.ag.ch/media/kanton_aargau/dgs/dokumente_4/gesundheit_1/admin/berufsbewilligungen/MerkblattSwissmedic_Medizinproukdte.pdf, besucht am 22.8.2024.
Materials
Botschaft zu einem Bundesgesetz über Arzneimittel und Medizinprodukte (Heilmittelgesetz, HMG) vom 1.3.1999, BBl 1999 III 3453 ff., abrufbar unter https://www.fedlex.admin.ch/eli/fga/1999/1_3453_3151_2959/de, besucht am 19.8.2024.
Bundesamt für Gesundheit, Totalrevision der Medizinprodukteverordnung und Verordnung über klinische Versuche mit Medizinprodukten (neue Medizinprodukte-Regulierung), Erläuternder Bericht, Juli 2020.