FAQs on integrity, transparency and discounts

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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Note

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 [e-mail].

Only the provisions of the relevant laws and ordinances are legally binding.

Legal framework

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

1. Do the integrity provisions apply to drugstores?

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.

2. Do the integrity provisions apply to combined pharmacies/drugstores?

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).

3. Do the integrity provisions apply to medical laboratories?

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.

4. Do the integrity provisions apply to purchasing companies even if they don't employ any professionals but purchase therapeutic products on their behalf?

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).

5. Do the integrity provisions apply to vets?

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.

6. Which products are affected by the integrity provisions?

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.

7. Do the new regulations regarding medical devices have an impact on the integrity provisions?

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 (e.g. chemists and drugstores). 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 opening of the consultation for the partial revision of the TPITO is planned for 2025.

8. The legislator approved a revision of the integrity provision (Art. 55 TPA) on 22 March 2019. In future this will also apply to medical devices; however, the Federal Council may exempt certain medical device categories. What exemptions are expected?

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 opening of the consultation for the partial revision of the TPITO is planned for 2025.

B. Due/undue advantages

1. How many «advantages of modest value» is a professional allowed to accept?

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.

2. How many «advantages of modest value» may be granted?

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.

3. What is the necessary relevance to practice for «advantages of modest value»?

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.
  

4. Is it permitted for professionals to be given personal gifts?

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.

5. What are due advantages in the purchase of therapeutic products?

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).

6. What is deemed a «discount»?

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).

7. What is deemed a «standard price»?

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.

8. Can medicinal products be supplied at the ex-factory price without a surcharge for logistics and other service costs?

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).

9. Can prescription or OTC medicinal products and medical devices be supplied as a discount in kind together with the purchase of prescription medicinal products?

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.

10. Is the exchange of expired products for non-expired products permitted under the integrity provisions?

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.

11. Is a credit note for expired products permitted under the integrity provisions?

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.

12. How long before the expiry date are product returns permitted within the scope of the integrity provisions in the legislation on therapeutic products?

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.

13. Do the delivery costs have to be charged for returns?

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.

14. How should losses in stock value be handled within the framework of the TPITO if the FOPH reduces the price of prescription medicinal products?

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)

1. What are the conditions of permissible compensation for a service of equivalent value?

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.

2. When is a service deemed «of equivalent value»?

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)

1. Under what conditions can professionals be supported in their continuing education and training and their continuing professional development?

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).

2. Which professionals are covered by Art. 5 and Art. 6 TPITO?

Professionals are persons who prescribe or dispense prescription medicinal products, use these professionally at their own responsibility, 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. 53 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.

3. What does “continuing education and training” mean?

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”).

4. What does “continuing professional development” mean?

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”).

5. What types of continuing education and training and continuing professional development may be supported?

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.

6. What types of continuing education and training and continuing professional development may not be supported?

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.

7. What scenarios are regulated by Art. 5 TPITO (support for the continuing education and training and continuing professional development of professionals)?

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.

8. What are the prerequisites for Art. 5 TPITO?

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.

9. What scenarios are regulated by Art. 6 TPITO (support for participating in events for the continuing education and training or continuing professional development of professionals)?

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.

10. What are the prerequisites for Art. 6 TPITO?

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. Compensation for services of equivalent value

1. What are the conditions of permissible compensation for a service of equivalent value?

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.

2. When is a service deemed «of equivalent value»?

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).
  

II. Transparency (Art. 56 TPA/Art. 8 and 10 TPITO)

A. Scope

1. Does the duty of transparency apply to drugstores?

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.

2. Does the duty of transparency apply to combined (pharmacy/drugstore) operations?

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.

3. Does the duty of transparency apply to medical laboratories?

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.

4. In terms of the duty of transparency, is there a difference between individual companies, groups and chains? Who needs to be able to provide evidence of what?

No, there is no difference. Everyone is required to implement the duty of transparency equally when purchasing therapeutic products.

5. Does the duty of transparency also apply to vets?

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).

6. Which products are included in the duty of transparency?

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).

7. Are IVDs subject to the duty of transparency?

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

1. What is a rebate?

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).

2. When are discounts and rebates on purchases of therapeutic products permitted?

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.

3. How should discounts and rebates be disclosed (minimum requirements)?

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).

4. Can medicinal products be obtained at their ex-factory price without any surcharge for logistics or other services costs?

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).

5. Does the manufacturer have to disclose discounts given to procurement companies or wholesalers?

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.

6. How can the buyer ensure that the prices demanded by manufacturers/suppliers are customary in the market?

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)

1. To whom and by when must the person be designated in accordance with Article 11 letter a 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.

2. How must the list of professionals or organisations be kept in accordance with Article 11 letter c TPITO?

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.

3. How does the FOPH monitor the observance of the integrity and transparency provisions under administrative law?

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).

4. What happens if the FOPH finds a possible violation of Art. 55 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)

1. Does the obligation to pass on discounts apply to hospitals, regardless of the setting (inpatient or outpatient)?

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).

2. Do discounts granted to service providers by procurement companies/intermediaries need to be passed on?

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).

3. What happens if a procurement company/intermediary receives an advantage from a manufacturer (e.g. a discount on the price of a medicinal product) but does not pass it on to the service provider purchasing from them?

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).

4. What is the situation regarding medical laboratories that grant direct or indirect advantages to doctors? Do these advantages have to be passed on?

Yes. The duty to pass on advantages is the responsibility of doctors (Art. 56 para. 3 let. a HIA).

5. What about medical laboratories that grant direct or indirect advantages to doctors? Is it possible to only pass on these advantages in part and use the rest for quality improvement (Art. 56 para. 3bis 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.

6. The FOPH must be notified without delay of agreements concluded between insurers and service providers (Art.76b para. 4 HIO). What is meant by «without delay»?

The contracting parties must notify the FOPH within one week of conclusion of the agreement.

7. For which therapeutic products (medicinal products or medical devices) must an advantage be passed on?

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).

8. How is the loss in stock value compensated if the FOPH decides to reduce the price of a medicinal product in the LS?

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.

9. Is the granting of an early payment discount deemed a discount and does it therefore have to be passed on by the service provider to the payment debtor?

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). 

10. How are returns or exchanges of therapeutic products that are covered by the compulsory health insurance handled? What happens about delivery costs?

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.

Change history

Change history and updates (PDF, 110 kB, 16.05.2024)

Last modification 21.11.2024