FAQs on ITD
The FOPH has compiled a selection of answers to frequently-asked questions on integrity, transparency and the obligation to pass on discounts for therapeutic products.
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The FOPH publishes here a selection of frequently-asked questions on integrity and transparency in the context of therapeutic products legislation and the obligation to pass on discounts laid down in the health insurance legislation.
The FOPH only provides general comments on legal interpretation. The admissibility of an actual transaction always depends on the circumstances of the specific case. The legality can be evaluated only by means of a detailed analysis of the actual activities in the case concerned. Therefore, the answers provided here can only serve as a guide to lawful behaviour. Inquiries regarding specific cases or actions may be submitted to itw@bag.admin.ch.
Only the provisions of the relevant laws and ordinances are legally binding.
The integrity provision concerns the granting and acceptance of undue advantages when prescribing, dispensing, using or purchasing prescription medicinal products (Art. 55 TPA; Art. 86 para. 1 let. h TPA). The duty of transparency relates to the obligation to show all discounts and refunds granted on purchases of therapeutic products and to disclose them to the FOPH on request (Art. 56 TPA; Art. 87 para. 1 let. h TPA).
The FOPH is responsible both for enforcing the provisions on integrity and transparency under administrative law (Art. 82 para. 1 TPA) and for pursuing associated prosecutions (Art. 90 para. 1 TPA).
Under the Health Insurance Act (HIA; SR 832.10), care providers are required to pass on direct or indirect discounts from suppliers in their entirety (Art. 56 para. 3 let. b HIA). They are also criminally liable if they do not pass on such discounts to the payment debtors concerned (Art. 92 para. 1 let. d HIA). Service providers may agree with insurers, however, that discounts received are not passed on in their entirety, provided more than 50% of these discounts is passed on and the portion of the discounts that is not passed on is used to improve quality of care (Art. 56 para. 3bis HIA). The FOPH is responsible both for checking that discounts are passed on (Art. 82a HIA) and for criminal prosecution in the event of violations of the aforementioned provisions (Art. 92 para. 2 HIA).
These provisions of the Therapeutic Products Act were fleshed out in the Ordinance on Integrity and Transparency in relation to Therapeutic Products (TPITO; SR 812.214.31), while the corresponding provisions in the Health Insurance Act were set out in more detail in the Health Insurance Ordinance (Art. 76a–76c HIO).
I. Integrity (Art. 55 TPA / Art. 3-9 TPITO)
A. Scope
No: the integrity provisions only cover advantages in relation to prescribing, dispensing, using and purchasing prescription medicinal products.
For information on the extension of the integrity provisions to medical devices (which is yet to come into force), see ‘A. Scope’ Question 7 below.
The integrity provisions only cover advantages in relation to prescribing, dispensing, using and purchasing prescription medicinal products. Combined operations should therefore ensure that the advantages received are permitted (Art. 55 para. 2 TPA and Art. 3-9 TPITO).
The prohibition of advantages is limited to advantages that are related to prescription medicinal products or to their prescribing, dispensing, use or purchase. If there is no relation whatsoever – not even a very remote one – between the laboratory's activity and any potential influence with regard to the prescribing, dispensing, use and/or purchase of prescription medicinal products, then the integrity provisions in the TPA do not apply to the laboratory's activities.
For information on the extension of the integrity provisions to medical devices (which is yet to come into force), see ‘A. Scope’ Question 7 below.
Yes (Art. 55 TPA and Art. 2 TPITO): the integrity provisions also apply to anyone on the recipient side who purchases prescription medicinal products for the purpose of their prescription, dispensing and use. They also include all advantages that are offered, promised or granted to professionals for third parties (such as purchasing companies).
On the recipient side, the integrity provisions apply to the aforementioned persons and organisations without distinction between veterinary and human medicinal products. They therefore also apply to anyone who prescribes, dispenses or uses prescription veterinary medicinal products (or human medicinal products redesignated for veterinary use) or who purchases such products for these purposes, and to all organisations that employ such persons.
The integrity provisions only concern advantages that are linked to prescription medicinal products.
The following are not affected by the integrity provisions, provided there is no link to prescribing, dispensing, using or purchasing prescription medicinal products:
- Category E medicinal products
- Category D medicinal products
- Category C medicinal products (if still available on the market)
- medical devices.
For information on the extension of the integrity provisions to medical devices (which is yet to come into force), see ‘A. Scope’ Question 7 below.
Yes. As part of the revision of the Therapeutic Products Act (new regulations regarding medical devices), which was approved on 22 March 2019, the legislator decided to amend Art. 55 (BBl 2019 2589).
This amendment means that, in future, persons who prescribe, dispense or use medical devices or purchase them for such purposes will also be subject to the integrity provisions. This includes organisations that employ such persons. The Federal Council may make exceptions, however, for certain categories of medical devices.In order to implement this amendment, a partial revision of the TPITO is needed. The consultation for the partial revision of the TPITO will take place in 2026.
In order to implement this amendment (AS 2020 2961), a partial revision of the TPITO is needed. The FOPH is currently carrying out in-depth evaluations, the results of which will be incorporated in the partial revision of the TPITO. No details are therefore known at present. As part of the consultation procedure, there will be an opportunity to comment on this partial revision. The consultation for the partial revision of the TPITO will take place in 2026.
B. Due/undue advantages
In continuation of current practice, «advantages of modest value» that are of relevance to medical or pharmaceutical practice and have a maximum total value of CHF 300 per professional per year are permitted (Art. 3 para. 1 TPITO). On the recipient side, it is not permitted e.g. to multiply the maximum amount of CHF 300 by the number of employees of an organisation in order to receive advantages that are more than of modest value (e.g. a laptop worth CHF 900 for a medical practice with three doctors). The maximum annual limit of CHF 300 also continues to apply for such advantages granted to professionals regardless of any (additional) support contributions for continuing education and training and continuing professional development events in accordance with Article 6 TPITO.
In continuation of current practice, «advantages of modest value» that are of relevance to medical or pharmaceutical practice and have a maximum total value of CHF 300 per professional per year are permitted (Art. 3 para. 1 TPITO). Those concerned may therefore continue, for example, to grant advantages worth a maximum of CHF 300 a year to every professional in an organisation (e.g. a total of three laptops each worth CHF 300 to three doctors in a medical practice), provided they are relevant to medical or pharmaceutical practice in every case. By contrast, it is not permitted to multiply the maximum amount of CHF 300 by the number of employees of an organisation in order to grant advantages of more than modest value (e.g. a laptop worth CHF 900 to a medical practice with three doctors). The maximum annual limit of CHF 300 also continues to apply for such advantages granted to professionals regardless of any (additional) support contributions for continuing education and training and continuing professional development events in accordance with Article 6 TPITO.
In any event, only advantages that are of relevance to medical or pharmaceutical practice are permitted (Art. 3 para. 1 TPITO). An advantage is of relevance to medical or pharmaceutical practice if it
- is directly connected with the professional’s practice of their profession, i.e. it helps develop their knowledge and expertise (particularly specialist literature and training/continuing professional development via electronic media such as image, sound or data carriers) or it can be used in day-to-day practice (particularly equipment such as thermometers, computer software or a mobile phone for emergency services); or
- directly benefits the professional's customers (particularly as an integral part of the surgery’s facilities such as a water cooler or reading matter for the waiting room).
In continuation of current practice, the following are not deemed to be of relevance to practice:
- discounts on the purchase of therapeutic products
- cash payments and money transfers
- personal gifts.
- is directly connected with the professional’s practice of their profession, i.e. it helps develop their knowledge and expertise (particularly specialist literature and training/continuing professional development via electronic media such as image, sound or data carriers) or it can be used in day-to-day practice (particularly equipment such as thermometers, computer software or a mobile phone for emergency services); or
No: personal gifts for professionals (such as theatre tickets, boxes of chocolates or wine) are not permitted, as they are not relevant to medical or pharmaceutical practice.
In view of the exhaustive exceptions (Art. 55 para. 2 TPA) and current practice, an advantage is only permitted on purchases within the scope of the integrity provisions if it constitutes a discount or refund in accordance with Art. 55 para. 2 let. d TPA. In particular, discounts on deliveries of medicinal products do not constitute advantages of modest value as they are not of relevance to professional practice (Art. 55 para. 2 let. a TPA; see Federal Administrative Court rulings FAC C-4724/2010 of 10.03.2014, deliberation 3.6.1, C-1663/2007 of 28.06.2011, deliberation 4.1.2 and C-669/2008 of 17.12.2010, deliberation 4.8.1).
A «discount» on the purchase of therapeutic products is the difference between the standard price of a product and the price actually paid (Art. 55 para. 2 let. d and Art. 56 TPA in association with Art. 8 para. 1 TPITO).
A standard price can be described as the price that a manufacturer/supplier usually charges for a certain product:
For medicinal products on the specialities list (SL), the standard price can be considered:
- the ex-factory price for products purchased from warehouse stocks (cf. Art. 67 para. 3 HIO);
- the ex-factory price + value of logistics services for products purchased from warehouse stocks + logistics services (such as delivery) (cf. Art. 67 para. 4 HIO).
Otherwise, pricing complies with market rules, provided there are no government price controls in place. For medical devices the standard price will generally be the supplier's list price.
Under Article 55 TPA, the waiving of delivery costs is deemed an advantage which is only permitted if it is disclosed as a discount or refund in accordance with the provisions of Art. 55 para. 2 let. d TPA. Consequently, delivery at ex-factory price is only permitted if this advantage (waiving of delivery cost) does not have an influence on the choice of treatment. Such advantages (discount or refund) must be shown on invoices and in accounts in accordance with the applicable provisions, and must be disclosed to the FOPH on request (Art. 56 TPA and Art. 10 TPITO; see question block II).
No. The prohibition of discounts in kind (cf. Art. 8 para. 2 TPITO) is designed, among other things, to prevent prescription medicinal products being supplied free of charge with the purchase of therapeutic products (or over-the-counter medicinal products and/or medical devices), and to prevent the choice of prescription medicinal products being unduly influenced by other therapeutic products being given away for free.
No. If professionals and organisations return goods to the supplier that are no longer marketable, exchanging them for goods that are still marketable is not permitted. Exchanging products with no market value for products with full market value (without invoicing/payment) constitutes an advantage under Article 55 paragraph 1 TPA. Ultimately, this transaction equates to a prohibited discount in kind: the delivery of a larger quantity than ordered and invoiced (Art. 8 para. 2 TPITO).
For the compensation of losses in value of stocks due to a price reduction by the FOPH, see ‘B. Due/undue advantages’ Question 14 below.
No. If professionals and organisations return goods to the supplier that are no longer marketable, a credit note for products that are still marketable is not permitted. Exchanging products with no market value for products with full market value (without invoicing/payment) constitutes an advantage under Article 55 paragraph 1 TPA. This transaction would result in a prohibited discount in kind when the credit note is redeemed, as a larger quantity would be delivered than was ordered and invoiced (Art. 8 para. 2 TPITO).
For the compensation of losses in value of stocks due to a price reduction by the FOPH, see ‘B. Due/undue advantages’ Question 14 below.
The cut-off date for the permitted return of expiring products is the last day of the month preceding the month in which the prescription medicinal product expires. The professional or organisation concerned must be able to provide evidence that they returned the products in question to the manufacturer/supplier who sold them (i.e. they presented such products to a delivery service or post office) by this cut-off date. For example: in compliance with the integrity provisions set out in the legislation on therapeutic products, the last legal return date for a product expiring in December 2021 would be 30 November 2021. The professional or organisation concerned must therefore be able to prove that they handed the products in question over to a delivery service or the post office by 30 November 2021.
Please note: the FOPH stipulates such cut-off dates for returns exclusively with regard to the enforcement of the integrity provisions set out in the legislation on therapeutic products (i.e. with a view to a permitted exchange or credit note for the expired products concerned). These stipulations have no bearing whatsoever on the question of how long a therapeutic product that has not yet expired may still be used or dispensed.
For returns, the delivery costs must be invoiced in the same way as for purchases. If the delivery costs are waived, this constitutes a price reduction on the purchase of prescription medicinal products and thus a financial advantage. Such an advantage is only permitted for a return if it is shown as a discount or refund in accordance with the requirements set out under Art. 55 para. 2 let. d TPA and Art. 8 TPITO and provided it has no influence on the choice of treatment. In addition, in accordance with the applicable provisions, such a discount must be shown on the invoice and in the accounts, and must be disclosed to the FOPH on request (Art. 56 TPA and Art. 10 TPITO).
It is up to companies to decide whether and to what extent they wish to pay the delivery costs. For integrity and transparency provisions purposes, it is only important that the costs (and discounts) are correctly invoiced and disclosed.
In accordance with the provisions of Art. 55 para. 1 and para. 2 let. d TPA in conjunction with Art. 8 TPITO, refunds are generally permitted, and in accordance with Art. 56 TPA in conjunction with Art. 8 and 10 TPITO such refunds must be disclosed. So the purchase price actually paid will be subsequently adjusted to the updated lower standard price. In concrete terms:
- If the value of the refund corresponds to the loss in stock value suffered, there is no actual advantage as defined under Art. 55 para. 1 TPA. However, the duty of transparency still applies, in compliance with the applicable provisions.
- If the value of the refund is higher than the loss in stock value suffered, there is a due advantage per se (a rebate in the sense of a «subsequently granted discount» even on the new lower standard price), provided the conditions specified in Art. 55 para. 2 let. d TPA and Art. 8 TPITO are met. In this case, too, the duty of transparency still applies, in compliance with the applicable provisions.
C. Continuing education and training and continuing professional development (Art. 5 and 6 TPITO)
Compensation for services of equivalent value is permitted, in accordance with the requirements under Article 7 TPITO, i.e. the compensation must be based on a written agreement and must be commensurate with the service provided in return.
Under Article 7 paragraph 3 TPITO, compensation is not permitted for services that a professional/organisation
- provides for themselves: for instance to simplify their own working processes, such as the electronic transmission of medical prescriptions;
- provides in fulfilment of statutory obligations: such as compulsory activities related to pharmacovigilance (cf. Art. 59 para. 3 TPA) or professional postgraduate and further training (e.g. Art. 40 let. b Medical Professions Act);
- is otherwise remunerated for: in particular all reimbursed services (i.e. all those already reimbursed through tariffs such as Tarmed), by means of a salary if they are employed or by means of invoices to customers or insurers if they are self-employed.
When the applicable conditions of an equivalent service are met, its compensation is not deemed an 'advantage' even under the new legislation (but rather a quid pro quo of equal contractual value).
Since permissible compensation must by definition be of equivalent value to the service provided (Art. 55 para. 2 let. c TPA; Art. 7 para. 1 let. b TPITO), a percentage of the order amount, which is determined on the basis of the order amount and not a service provided, cannot usually be deemed a service of equivalent value. Pragmatic exception in implementation: in an overall assessment of the situation (such as low interest rates at present), a smaller discount (in the region of 1 or 2%) may be deemed appropriate compensation, provided the other conditions set out under Article 7 TPITO are met.
A service is defined as «of equivalent value» if its value corresponds to that of the compensation (cf. Art. 55 para. 2 let. c TPA; Art. 7 para. 1 let. b TPITO). In continuation of current practice, services that may be prepared and performed as part of usual professional activities should therefore be compensated less than those that require additional effort outside of this activity. In addition, the compensation should be based on a number of points, including:
- how demanding the service is compared with day-to-day work in the practice or organisation (e.g. workshop versus surgical activity) and
- to what extent the professional performing the service can be held accountable for the quality; to what extent they are liable for services performed outside of their usual activity (e.g. expert review) or must fear a loss of reputation – if that were ever to happen (e.g. advisory board activity).
C. Continuing education and training and continuing professional development (Art. 5 and 6 TPITO)
There are two scenarios in which professionals can be supported in their continuing education and training and their continuing professional development. The requirements for contributions supporting professionals’ continuing education and training and continuing professional development are specified in Art. 5 TPITO, while Art. 6 thereof stipulates the conditions for contributions supporting professionals’ participation in continuing education, training and professional development events (see ‘C. Continuing education and training and continuing professional development (Art. 5 and 6 TPITO)’ Questions 9 and 10 below).
Professionals are persons who prescribe or dispense prescription medicinal products, use them independently on a professional basis, purchase these for such purposes or are actively involved in the corresponding purchase decisions (Art. 2 let. a TPITO). The criterion of “at their own responsibility” also applies to such prescription, dispensing and (shared) purchase decisions. The aim and purpose of Art. 55 TPA is to prevent the influencing of persons authorised to make such decisions – primarily doctors and pharmacists with cantonal professional licences (in addition to further medical professions, this may also extend to the persons listed under Art. 52 para. 2 of the Ordinance on Medicinal Products). The applicability of Art. 55 TPA does not generally extend to employees at doctors’ practices or professional caregivers (unless they also bear decision-making responsibility for purchases of prescription medicinal products). In view of this, an organisation as specified under Art. 2 let. b TPITO may not be supported in the continuing education and training and continuing professional development of such practice personnel.
Art. 5 and 6 TPITO are concerned partly with the continuing education and training of medical professions as defined in Art. 3 para. 3 of the Medical Professions Act (“Continuing professional education and training serve to enhance competencies and specialisations within the individual’s specialist area”). They are also concerned with the continuing education and training of all other professionals as defined in Art. 3 let. a of the Federal Act on Further Education (“Further education [non-formal education]: structured education beyond formal education”).
Continuing professional development relates to the further professional development in the medical professions as defined in Art. 3 para. 4 of the Medical Professions Act (“Lifelong continuing professional development ensures that both knowledge and professional competencies remain consistently up to date”).
As a general principle, support may only be given to professionals for their continuing education and training and their continuing professional development if such activities promote the professional’s scientific knowledge and competencies in a way which improves their medical practices and their patients’ treatment results.
Any continuing education and training in continuing education programmes which are accredited under the Medical Professions Act and are conducted by recognised further education institutions may always be supported, as may any continuing professional development for which ECTS credits are awarded by the SIWF or another specialist organisation.
The permissibility of any other support for any other continuing education and training or continuing professional development must be verified on a case-by-case basis.
Support may not be given to professionals for their continuing education and training and their continuing professional development if such activities do not promote the professional’s scientific knowledge and competencies in a way which improves their medical practices and their patients’ treatment results.
Examples of this would be “certifications” or “quality labels” for a medical practice, because these generally do not entail any continuing education and training or continuing professional development, but consist solely in assessing existing processes or providing action recommendations.
Art. 5 primarily covers two scenarios:
- a pharmaceutical company supporting an organisation as defined in Art. 2 let. b in the conducting of continuing education and training or continuing professional development (e.g. a hospital conducting an internal or external event for which it receives support from a pharmaceutical company for the rental of the premises, speakers’ fees or similar).
- an organisation being supported via an “all-in contribution” that can be used by its professionals to participate in events.
Art. 5 (which specifically does not envisage any personal contribution to costs) may not be used to circumvent Art. 6. This means in particular that no “all-in contribution” may be made as envisaged under Art. 5 if it is evident that this will ultimately be used to enable certain professionals to participate in certain events.
Support may only be provided for the continuing education and training or continuing professional development of professionals if the conditions specified in Art. 4 let. a–f are met. Particular reference here is made to Art. 4 let. a, under which the support may not be offered, promised or given to an individual professional but may only be provided for the organisation employing them. This organisation must also be able to decide on the type and choice of continuing education and training or continuing professional development concerned and the professional to participate therein independently of the person or organisation providing such support.
Compared to Art. 5, Art. 6 should be viewed as a “special provision” that regulates the prerequisites for supporting participation in continuing education and training or continuing professional development events (for the delineation between this and Art. 5, see Question 7 above). Unlike Art. 5, Art. 6 also permits direct support of the professional concerned.
Support may only be provided for professionals to participate in continuing education and training or continuing professional development events if:
- this is agreed in writing, and
- the professionals participating or the organisations that employ them make an appropriate contribution to the costs of the event (a “personal contribution” to the costs).
This personal contribution to costs must amount to at least one third per person attending a continuing professional development event or at least one fifth per person attending a continuing education and training event of the costs specified in Art. 6 para. 2 let. a-d. A personal contribution to costs will not be required, however, under either of the conditions specified in Art. 6 para. 3, while Art. 6 para. 4 specifies certain further inadmissible payments (such as any refunding of personal contributions to costs).
D. Services of equivalent value (Art. 7 TPITO)
Article 7 TPITO specifies the conditions under which compensation for services of equivalent value is permissible: the compensation must be based on a written agreement (setting out the nature and extent of the service and the compensation) and must be commensurate with the service provided (Art. 7 para. 1 TPITO). Put simply, the commensurateness of the compensation, or the equivalent value of the service provided, is intended to ensure that the risk of influence associated with a financial contribution is “neutralised” by the service of equivalent value provided by the professional or organisation.
In the written agreement (Art. 7 para. 1 let. a) which is to be concluded in advance (i.e. before the service is provided), the compensation must be defined or calculated as precisely as possible, i.e. on the basis of comprehensible, objective criteria.
The commensurateness of compensation (Art. 7 para. 1 let. b TPITO) is usually assessed in connection with Art. 7 para. 4 let. b–d TPITO in accordance with hourly market rates.
Abstract rules for calculation are to be found in the relevant materials (cf. Explanatory Notes on TPITO/HIO, p. 17): thus, services which can be prepared and performed in the course of normal professional activity are to receive less compensation than those which require additional efforts outside of this activity. Likewise, compensation should be based on a number of points including:
- how demanding the service is compared to daily work in the professional’s own practice or organisation (e.g. workshop versus surgical activity), and
- to what extent the professional providing the service can be held accountable for the quality thereof and, for example in the case of an inadequate service, is legally liable (e.g. in the provision of expert opinions) or merely – if at all – faces a possible loss of reputation.
Compensation, or the level thereof, cannot be justified merely in terms of the “free market” argument. In particular, it would not be in accordance with the legislators’ wishes to provide exactly the same level of compensation for the “simplest activities” as for the performance of “intellectually complex” work. While physicians’ income (or statistical values) can in principle be “considered” or serve as a guide for calculation purposes, compensation for a “simple activity” could not be justified exclusively by citing a physician’s average hourly income. It should, however, be noted that an “exact” calculation of value is not necessary (and indeed often hardly possible): rather, the extent of and effort involved in the service provided must “roughly” correspond to the value of the compensation. The commensurateness of the compensation (or the equivalent value of the service provided) must always be assessed on a case-by-case basis, taking all the circumstances into account.
No. Payment of the actual costs of meals up to a maximum of CHF 100 is only permissible in the context of a “specialist discussion” (Art. 7 para. 2 TPITO). This specialist discussion must involve the provision of a genuine service by the professional. In this context, no written agreement is required in accordance with Art. 7 para. 1 let. a TPITO.
According to Art. 7 para. 3 TPITO, no compensation may be provided, in particular, for services which a professional or organisation:
- provides for themselves (example: the efforts involved are counted by a professional towards their mandatory continuing education and training or continuing professional development duties);
- performs in fulfilment of statutory obligations (example: a service has to be performed in any event as part of the exercise of professional activities in accordance with legal requirements, such as under Art. 59 para. 3 TPA concerning pharmacovigilance obligations); or
- is otherwise remunerated for (example: a service is already reimbursed through tariffs or under compulsory health insurance).
In connection with the purchase of prescription-only medicinal products, compensation is permissible for services provided in return by the professional or organisation; this applies, for example, to the payment of transport or storage costs, or the assumption of storage risks (Art. 7 para. 4 let. a TPITO).
Since permissible compensation must by definition be of equivalent value to the service provided in return (Art. 55 para. 2 let. c TPA; Art. 7 para. 1 let. b TPITO), a percentage of the order amount, for example, determined on the basis of the order amount and not of the service provided in return, cannot usually be deemed to be of equivalent value. A pragmatic exception in enforcement: in an overall assessment of the situation (such as current low interest rates), a small discount (in the region of 1 or 2%) may at present be deemed appropriate compensation, provided the other conditions specified in Article 7 TPITO are met.
Examples (“in particular”) of types of services of equivalent value generally eligible for compensation – outside of orders and deliveries of prescription-only medicinal products – are listed in Art. 7 para. 4 let. b–d TPITO and comprise teaching, expert and advisory activities or the conduct of scientific studies and clinical trials; reports on practical experiences; and participation in advisory bodies, workshops or market research projects, provided they serve no promotional purpose.
Participation in reports on practical experiences does not generally represent a service eligible for compensation, since such reports are usually of limited scientific value and are frequently undertaken for marketing reasons. Compensation is only permissible if practice experience reports are published in a recognised scientific medium.
The lists of (in)eligible services given in Art. 7 para. 3 and 4 TPITO are not exhaustive (cf. the expression “in particular”). In the context of enforcement, the FOPH may therefore define other types of eligible or ineligible services.
- Compensation for the transmission of sales data to pharmaceutical companies cannot be calculated according to the “value of the data”, since the sales data or statistics do not have a value eligible for compensation (cf. Federal Administrative Court ruling C-669/2008, especially deliberation 5.5.3).
- It is generally permissible for compensation to be calculated on the basis of the time required by the professional/assistant or organisation; for this, an agreement is necessary complying with the requirements of Art. 7 para. 1 TPITO. It must also be taken into account that modern inventory management systems permit the preparation and transmission of data with minimal effort.
- Compensation must not be provided for work arising, for example, from discussions between the professional and the pharmaceutical representative (cf. “D. Services of equivalent value (Art. 7 TPITO)”, Question 12 below). In the case of such discussions, it is generally also to be assumed that the professional will benefit themselves or be able to optimise their product range as a result; for this reason, compensation would also be prohibited from the perspective of Art. 7 para. 3 let. a TPITO (so-called prohibition of compensation for a service performed on one’s own behalf).
If payment is offered or requested for receiving a pharmaceutical representative who discusses a prescription-only medicinal product with the professional, this offer of a material advantage is closely linked to the prescription, dispensing or use of prescription-only medicinal products. However, there is not generally any discernible service provided by the physician for the pharmaceutical company if the pharmaceutical representative merely explains or promotes their product. Compensation would therefore generally be prohibited.
Compensation is not permissible even if the professional provides the pharmaceutical representative with feedback on the product: it is true that Art. 7 para. 4 let. d TPITO permits compensation for participation in advisory boards, workshops or market research projects, provided they serve no promotional purpose. However, in the case of visits from pharmaceutical representatives, a “promotional effect” of this kind is generally to be assumed.
- The placement of promotional measures (in accordance with “D. Services of equivalent value (Art. 7 TPITO)”, Question 14 below) in medical practices, pharmacies and other organisations represents a service provided by a professional or organisation for which compensation may be paid in accordance with Art. 55 para. 2 let. c TPA in conjunction with Art. 7 TPITO.
- For the placement of promotional measures, the only service eligible for compensation is the effort involved for the professional (or their assistants). This method of calculation reflects the rationale for Art. 55 TPA, insofar as commensurate compensation (usually a few hundred Swiss francs per year) is paid for the provision of a “simple” service (making advertising space available, turning promotional films on/off, filling or refilling brochure holders, etc.). The risk of influence in relation to the prescribing, dispensing, use or purchase of prescription-only medicinal products is thus neutralised.
In the present context, the term “promotional measures” is defined more broadly than the term “advertising” in the Medicinal Products Advertising Ordinance. For a promotional measure and compensation for the same to be covered by Art. 55 TPA, the measure must be related to prescription-only medicinal products (Category A and B). The providers of the benefit will primarily be the licence holders and the distributors of such medicinal products.
Such coverage extends in particular to the following promotional measures:
- Corporate image promotion by companies that include prescription-only medicinal products in their product range, be this in the form of “general” promotion of the company’s own product range or general promotion of the company;
- "Disease awareness campaigns" for therapeutic areas for which the company has prescription-only medicinal products in its product range;
- Information campaigns by companies with a connection to prescription-only medicinal products.
Compensation for all types of advertising is covered (e.g. screens, banners, other devices such as brochure holders, etc.).
Not covered, however, is compensation for such promotional measures as:
- Advertising for over-the-counter medicinal products (Category D and E), nutritional supplements, cosmetics etc.
- Corporate image promotion by companies that have no prescription-only medicinal products in their product range;
- Advertising in medical practices, pharmacies and other organisations for which professionals or the organisations receive no compensation from manufacturers;
- Information and disease awareness campaigns with no relation to prescription-only medicinal products.
II. Transparency (Art. 56 TPA/Art. 8 and 10 TPITO)
A. Scope
The duty of transparency (Art. 56 TPA and Art. 10 TPITO) applies to the purchase of all therapeutic products (except medicinal products in dispensing category E and class I medical devices).
Drugstores are required to show all discounts and refunds on invoices and to disclose them in their accounts and to the FOPH on request.
Drugstores must therefore ensure that invoices from suppliers (wholesalers or authorisation holders) show the discounts granted so that they can be correctly incorporated in the accounts.
The duty of transparency (Art. 56 TPA and Art. 10 TPITO) concerns the purchase of all therapeutic products (except medicinal products in dispensing category E and class I medical devices).
Combined operations are required to show all discounts and refunds on invoices and to disclose them in their accounts and to the FOPH on request.
Combined operations must therefore ensure that invoices from suppliers (wholesalers or authorisation holders) show the discounts granted so that they can be correctly incorporated in the accounts.
The duty of transparency set out in the legislation on therapeutic products (cf. Art. 56 TPA; Art. 8, 10 and 11 TPITO) in principle applies to all discounts and refunds that are given on the purchase of therapeutic products. If for example a laboratory purchases medical devices (with the exception of class I), then the relevant duty of transparency applies.
No, there is no difference. Everyone is required to implement the duty of transparency equally when purchasing therapeutic products.
The duty of transparency (Art. 56 TPA) in principle applies to all discounts and refunds that are given on the purchase of therapeutic products (i.e. also on the purchase of veterinary medicinal products) with the exception of (veterinary) medicinal products in dispensing category E and class I medical devices (see also the details under Art. 8, 10 and 11 TPITO).
The duty of transparency in principle applies to the purchase of all categories of therapeutic products, i.e. any medicinal products and medical devices, regardless of the persons prescribing, dispensing and using these therapeutic products. They also apply irrespective of whether and how such therapeutic products are listed (e.g. whether they feature on the list of specialities or the list of medical supplies and devices).
The Federal Council has exempted certain therapeutic products with a low risk potential from the duty of transparency: it does not apply to medicinal products in dispensing category E and class I medical devices, in accordance with Annex IX of Council Directive 93/42/EEC on Medical Devices (Art. 10 para. 2 TPITO).
Yes. In-vitro diagnostics (IVDs) fall under the duty of transparency set out under Art. 56 TPA and Art. 10 TPITO. The Federal Council has not exempted such products from the duty of transparency (Art. 56 para. 3 TPA in conjunction with Art. 10 para. 2 TPITO).
B. Discounts and rebates
Rebates as specified in Art. 56 TPA are price reductions on purchases of therapeutic products that are granted not at the time of the transaction but thereafter (e.g. volume discounts).
In accordance with Art. 55 para. 2 TPA, discounts and rebates are only permitted on purchases of therapeutic products if they do not have any influence on the choice of treatment. This must be verified in each individual case.
A discount or rebate is not permitted if it can mean that:
a) an inappropriate prescription medicinal product is prescribed, dispensed or used,
b) a prescription medicinal product is excessively prescribed, dispensed or used or
c) a prescription medicinal product is prescribed, dispensed or used when no medicinal product is required.All discounts and rebates given on the purchase of therapeutic products must be clearly and transparently disclosed on invoices and receipts and in accounts. This applies both on the buyer side (e.g. hospitals, care homes, doctors and pharmacists) and on the manufacturer and distributor side (e.g. manufacturers, distribution companies, wholesalers and retailers). A breach of the duty of transparency is punishable by a fine (Art. 87 para. 1 let. h TPA).
The Therapeutic Products Act (TPA) does not stipulate precisely in what form discounts must be disclosed on invoices. The minimum requirement is that this is done in a form that is clear and transparent for the supervisory authority. In continuation of current practice, transparency in the granting of discounts on specific product deliveries is designed in particular to prevent particular types of financial advantages in the form of discounts where the amount or calculation basis are not transparent. Discounts should therefore be transparently disclosed so that it is easy to discern whether they concern due advantages or further undue advantages (cf. Art. 33 para. 3 let. b old TPA, the Federal Supreme Court judgment 2C_92/2011 of 12 April 2012, deliberation 3.9 et seq, and summary deliberation 3.11).
In other words: if the manufacturer explicitly shows the standard price, the discount granted and the price actually paid on the invoice, it can be assumed that they have done everything to satisfy these requirements (cf. Swissmedic Journal 2003 980, p. 984 and 2012 1054).
Delivery costs may only be waived if they are presented as a discount or a rebate as specified in Art. 55 para. 2 let. d TPA (see the integrity questions). They must also be presented accordingly under the principles of transparency, and must be disclosed to the FOPH on request (Art. 56 TPA and Art. 10 TPITO):
- The seller may determine the value of the delivery costs waived on the basis of their operating accounts and declare this as a discount.
- The buyer may then take this invoiced/documented discount over into their own accounts.
In its capacity as the relevant enforcement authority, the FOPH may demand to examine the discount granted (or the estimation of the value of the delivery costs waived).
The duty of transparency currently only applies to the last stage in the commercial process, i.e. purchase by professionals/organisations/their procurement companies. Discounts offered by manufacturers to wholesalers are therefore not affected. But discounts given to procurement companies must be disclosed.
In the area of pricing according to market rules, the price a seller usually charges their customers for a certain product is deemed the standard price. It may be defined separately by the seller on the basis of their operating accounts (and verified accordingly by the FOPH). It is therefore the seller's responsibility to disclose the discounts granted (and thus also the "standard price") in a clear and transparent manner on invoices and receipts (Art. 56 TPA). The buyer can then transfer the discounts disclosed to their own accounts.
III.Market supervision by the FOPH (Art. 11 TPITO)
This person must be designated internally by the manufacturer/supplier concerned. If requested to do so, the manufacturer/supplier must be able to disclose the name of the designated person to the FOPH. This person must be able to supply the FOPH with all the required documents (e.g. a complete and up-to-date list as specified in Art. 11 let. c TPITO) and information (on processes since 1.1.2020). However, the designated person does not need to proactively notify the FOPH.
The TPA does not set out any formal requirements regarding the administration of the list. Manufacturers and distributors are free to decide how they ensure that they can supply a correct, transparent and complete list if requested to do so by the FOPH.
Under its duty to ensure due and full compliance with all transparency and disclosure requirements (Art. 56 TPA and Art. 10 TPITO), the FOPH holds an explicit mandate requiring all the parties subject to the same to due and full disclosure: the FOPH must be presented on demand with appropriate documentary evidence of all discounts and rebates granted in the procurement of therapeutic products to persons or organisations prescribing, dispensing or using therapeutic products or purchasing the same for such purposes (Art. 10 para. 1 TPITO).
The observance of the relevant integrity provisions of the Therapeutic Products Act is verified by the FOPH under its market supervisory remit. Art. 58 para. 4 TPA permits the FOPH to demand the information or documentation required to do so, and to demand any further assistance needed to such ends. The FOPH may, therefore, demand the provision of all requisite documentation (contracts, invoices, bank statements or similar) in the course of its supervisory checks. Any non-fulfilment of this duty of cooperation under the Therapeutic Products Act is a criminal offence (Art. 87 para. 1 let. d TPA).
If the FOPH finds a possible violation of the law in the course of its market supervisory activities (i.e. after analysing documents demanded and submitted) or via other sources, it will take the administrative measures envisaged under Art. 66 para. 2 TPA (informal objections, hearings, initiating administrative proceedings and/or similar). Such administrative actions will be primarily intended to restore compliance with the law. Alternatively or simultaneously, the FOPH may also elect to initiate criminal proceedings (cf. Art. 86 para. 1 let. h TPA, under which the violation of the provisions of Art. 55 TPA is a criminal offence).
IV. Obligation to pass on discounts (Art. 56 para. 3 and 3bis HIA / Art. 76a - 76c HIO)
It is the responsibility of service providers to pass on discounts (Art. 56 para. 3 HIA). This includes all hospitals without distinction (Art. 35 para. 2 HIA). The following applies:
- In outpatient settings, the direct or indirect discount received must be disclosed in the invoicing.
- In inpatient settings, if the discount is incorporated in the calculation of case rates (DRG) through lower costs, it no longer needs to be disclosed separately in the invoicing (Art.76a HIA).Yes. If a procurement company/ intermediary grants a discount to a service provider, the service provider must pass this discount on to the payment debtor (Art. 56 para. 3 HIA).
It is the responsibility of service providers to pass on the direct or indirect advantages received. Such an advantage could constitute an indirect advantage for the service provider and must therefore be passed on (Art. 56 para. 3 HIA).
Yes. The duty to pass on advantages is the responsibility of doctors (Art. 56 para. 3 let. a HIA).
No. The material scope of discounts that can be used for quality improvement is clearly defined (it concerns the discounts set out under Art. 56 para. 3 let. b HIA). The discounts a doctor receives from a laboratory therefore cannot be used for quality improvement.
The contracting parties must notify the FOPH within one week of conclusion of the agreement.
The law makes reference to medicinal products and medical supplies or devices used for examination or treatment; this concerns therapeutic products that are covered by the compulsory health insurance (Art. 56 para. 3 let. b HIA).
This is primarily medicinal products on the list of specialities (LS) and the items on the list of medical supplies and devices (MiGeL).
This also concerns prescription preparations that are manufactured as magistral formulas and whose active agents and auxiliary agents are included in the list of medicines with tariff (LMT). Medicinal products, the costs of which are covered by compulsory health insurance on the basis of Article 71a et seq HIO, are also included.The duty to pass on advantages also applies to medical supplies and devices that are e.g. implanted in the body or used by service providers and not featured in the list of medical supplies and devices (MiGeL) (Art. 20 para. 2 HIO).
The compensation of a loss in stock value due to a price reduction is a matter of goodwill of the parties.
If the manufacturer or distributor refunds the difference between the purchase price (the previous ex-factory price) and the new price defined by the FOPH, this refund does not constitute an advantage, provided the service provider is reimbursed within the framework of the FOPH's pricing system (Art. 52 para. 1 let. b HIA; Art. 64a et seq HIO). However, an excessive refund does constitute an advantage in accordance with Article 56 paragraph 3 letter b HIA, and must be passed on.
A discount granted for early payment or compliance with a short payment term constitutes an advantage and must be passed on by the service provider to the payment debtor (Art. 56 para. 3 let. b HIA) if it is not balanced and proportionate to the benefit (e.g. immediate liquidity or lower risk of bearing debtor's insolvency where applicable) to whoever granted it (creditor).
The exchange of goods without value for goods with value is not permitted under the TPA (see section I.B above). In this case, the duty to pass on advantages does not apply either.
If goods that still have market value are taken back and the service provider is credited with the same amount as they were originally invoiced or the same quantity of identical items are exchanged, this does not constitute an advantage as defined under Article 56 paragraph 3 letter b HIA. However, if the conditions when the items are returned (refund/exchange) are more favourable than those granted to the service provider when the items were originally purchased, this does constitute an advantage.If the delivery costs are covered by the supplier for returns:
- and they were covered to the same extent when the items were purchased, this does not constitute an additional advantage;
- and they were not covered when the items were purchased, this does constitute an advantage as the conditions are more favourable at the time of return.
V. ITD whistleblowing platform
You can report possible breaches of the provisions on integrity and transparency laid down in the Therapeutic Products Act and the obligation to pass on benefits in accordance with the Health Insurance Act using the FOPH’s ITD whistleblowing platform. Further questions and answers can be found on the ITW whistleblowing platform under FAQs.
Employees of individuals and organizations that manufacture, distribute, prescribe, or dispense medicinal products are legally entitled to report observations to the FOPH that suggest a violation of Articles 55 and 56 TPA (see Article 59, Paragraph 7 TPA).
Change history
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