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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Legal framework
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 answers cannot simply be applied ‘as is’ to other situations.
The FOPH only provides general comments on legal interpretation, not legal advice. The admissibility of an actual transaction always depends on the circumstances of the respective individual case. The legality can be evaluated only by means of a detailed analysis of the actual activities in the specific case. Therefore, the published answers can only serve as a guide to lawful behaviour.
Only the provisions of the relevant laws and ordinances are legally binding.
As a preliminary point, please note that the amendment of the Therapeutic Products Act (TPA; SR 812.21) of 18 March 2016 led to a series of new provisions being added to the TPA as of 1 January 2020. 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 is the obligation to show all discounts and refunds granted on purchases of medicinal products and to disclose them to the FOPH on request (Art. 56 TPA; Art. 87 para. 1 let. h TPA).
The FOPH is now responsible both for enforcing the provisions on integrity and transparency (Art. 82 para. 1 TPA) and for prosecutions conducted at federal level (Art. 90 para. 1 TPA).
As part of this revision of the TPA, the Health Insurance Act (HIA; SR 832.10) was also amended. Since 1996, care providers have been required to pass on direct or indirect discounts from suppliers in their entirety (Art. 56 para. 3 let. b HIA); they are criminally liable if such discounts are not passed on to payment debtors (Art. 92 let. d HIA). This provision was qualified during the aforementioned revision: as of 1 January 2020, discounts received by care providers still have to benefit insurers or patients (payment debtors). But now service providers can agree with insurers that discounts received are not passed on in their entirety, provided that 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 now 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 new provisions in the Therapeutic Products Act were fleshed out in the new Ordinance on Integrity and Transparency in relation to Therapeutic Products (TPITO; SR 812.214.31), and the new provisions in the Health Insurance Act were set out in more detail in the Health Insurance Ordinance (new Art. 76a–76c HIO) (AS 2019 1395).
I. Integrity (Art. 55 TPA / Art. 3-9 TPITO)
A. Scope
1. Do the new integrity provisions apply to drugstores?
2. Do the new integrity provisions apply to combined pharmacies/drugstores?
3. Do the integrity provisions apply to medical laboratories?
4. Do the new integrity provisions apply to purchasing companies even if they don't employ any professionals, but purchase therapeutic products on their behalf?
5. Do the integrity provisions apply to vets?
6. Which products are affected by the integrity provisions?
* 7. Do the new regulations regarding medical devices have an impact on the integrity provisions?
* 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?
No, because the applicable integrity provisions only cover advantages in relation to prescribing, dispensing, use and purchasing of prescription medicinal products.
For the modification regarding medical devices that was approved on 22 March 2019 and will enter into force at a later date, please see the relevant question and answer.
The applicable integrity provisions only cover advantages in relation to prescribing, dispensing, use and purchasing of prescription medicinal products. Combined operations should therefore ensure that the advantages received are permitted (Art. 55 para. 2 TPA and Art. 3-9 TPITO).
Medical laboratories are affected by the integrity provision (Art. 55 TPA; Art. 1-9 and 11 TPITO) in the following ways:
- as potential recipients of advantages if they employ professionals in accordance with the definition under Art. 2 let. a TPITO (i.e. the laboratory is an organisation, as defined under Art. 2 let. b TPITO).
- as potential givers of advantages if they offer, promise or grant advantages to such professionals or organisations.
The prohibition of advantages is currently limited to advantages that are related to prescription medicinal products or to their prescribing, dispensing, use or purchase. Therefore, if there is no relation whatsoever – not even a very remote one – between the laboratory's activity and potential influence with regard to prescribing, dispensing, use and/or purchasing of prescription medicinal products, then the integrity provisions in the TPA do not apply to the laboratory's activities.
For the modification regarding medical devices that was approved on 22 March 2019 and will enter into force at a later date, please see the relevant question and answer.
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 prescribing, dispensing and use. They also include all advantages that are offered, promised or granted to professionals for third parties (e.g. purchasing companies).
On the recipient side, the integrity provisions concern the aforementioned persons and organisations without distinction between veterinary and human medicinal products. They therefore also concern anyone who prescribes, dispenses, uses or purchases prescription veterinary medicinal products (or human medicinal products redesignated for veterinary use) for this purpose, and all organisations that employ such persons.
The applicable 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, use or purchase of prescription medicinal products:
- Category E medicinal products
- Category D medicinal products
- Category C medicinal products if still available on the market.
- Category I medical devices
- Category II medical devices
- Category III medical devices
For the modification regarding medical devices that was approved on 22 March 2019 and will enter into force at a later date, please see the relevant question and answer.
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, use and purchase medical devices for this purpose will also be subject to the integrity provisions. This includes organisations that employ such persons (e.g. chemists and drugstores). However, the Federal Council may make exceptions 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 OITTP is planned for 2025.
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 OITTP is planned for 2025.
B. Due/undue advantages
1. How many advantages of modest value is a professional allowed to accept?
2. How many advantages of modest value may be granted?
3. What is the necessary relevance to practice for «advantages of modest value»?
4. Is it permitted for professionals to be given personal gifts?
5. What are due advantages in the purchase of therapeutic products?
6. What is deemed a «discount»?
7. What is deemed a «standard price»?
8. Can medicinal products be supplied at the ex-factory price without a surcharge for logistics and other service costs?
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?
10. Is the exchange of expired products for non-expired products permitted under the provisions on integrity?
11. Under the provisions on integrity, is a credit note for expired products permitted?
12. How long before the expiry date are product returns permitted within the scope of the integrity provisions in the legislation on therapeutic products?
13. Do the delivery costs have to be charged for returns?
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 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 therefore 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 grant advantages worth a maximum of CHF 300 a year e.g. to every professional in an organisation, 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 therefore 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 practice of the profession by the professional, i.e. helps develop knowledge and expertise (e.g. 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 (e.g. equipment such as thermometers, computer software or a mobile phone for emergency services); or
- directly benefits the professional's customers (e.g. as an integral part of the surgery equipment, 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 transfer of money
- personal gifts.
No, personal gifts for professionals (such as invitations, boxes of chocolates, 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. 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. 1 ter HIO);
· the ex-factory price + value of logistics services for products purchased from warehouse stocks + logistics services (such as delivery) (cf. Art. 67 para. 1 quater HIO).
Otherwise, pricing complies with market rules, provided there are no government price controls in place. In principle, the supplier's list price is the standard 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 under 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 accounts in accordance with the applicable provisions, and disclosed to the FOPH on request (Art. 56 TPA and Art. 10 TPITO; see question block II).
No. The prohibition of discounts in kind 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 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 in accordance with 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).
Concerning the compensation of losses in value of stocks due to a price reduction by the FOPH, see the corresponding question and answer.
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 in accordance with Article 55 paragraph 1 TPA. This transaction would result in a 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).
Concerning the compensation of losses in value of stocks due to a price reduction by the FOPH, see the corresponding question and answer.
The permitted cut-off date for the 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 by the cut-off date (presentation to a delivery service or post office). 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 this cut-off date for returns exclusively with regard to 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). The question of how long a therapeutic product that has not yet expired may be used or dispensed is the responsibility of the cantons.
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 invoices and accounts and 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. However, within the framework of the integrity and transparency provisions, it is important that the costs (and discounts) are correctly invoiced and disclosed.
In accordance with the conditions under 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, must be disclosed. The purchase price actually paid is therefore 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 (rebate in the sense of a «subsequently granted discount» even on the new lower standard price) provided the conditions under 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. Compensation for services of equivalent value
1. What are the conditions of permissible compensation for a service of equivalent value?
2. When is a service deemed «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.
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?
2. Does the duty of transparency apply to combined operations (pharmacy/drugstore)?
3. Does the duty of transparency apply to medical laboratories?
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?
5. Does the duty of transparency also apply to vets?
6. Which products are included in the duty of transparency?
7. Are IVDs also exempt from the duty of transparency?
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).
Since 1 January 2020, drugstores have been 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).
Since 1 January 2020, combined operations have been 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).
No. In-vitro diagnostics (IVD) fall under the duty of transparency set out under Art. 56 TPA and Art. 10 TPITO. There is no exemption for such products; the Federal Council has not exempted them from the duty of transparency (Art. 56 para. 3 TPA in conjunction with Art. 10 para. 2 TPITO).
B. Disclosing discounts
1. How should the discount be disclosed?
2. Can medicinal products be purchased at the ex-factory price without a supplement for logistics or other service costs?
3. How should discounts be disclosed on an invoice (minimum requirements)?
4. How should refunds be disclosed?
5. How can the buyer ensure that the prices demanded by manufacturers/suppliers are customary in the market?
6. Does the manufacturer have to disclose discounts given to procurement companies or wholesalers?
A discount must be shown by the seller on invoices and by the seller and buyer in receipts and accounts and disclosed to the FOPH on request (Art. 56 TPA and Art. 10 TPITO).
The waiving of delivery costs is only permitted if it constitutes a discount or refund in accordance with Art. 55 para. 2 let. d TPA (see question on integrity provisions). As such, it must be indicated in accordance with the transparency principles and disclosed to the FOPH on request (Art. 56 TPA and Art. 10 TPITO):
- The seller may define the value of the waived delivery costs on the basis of their operating accounts and disclose it as a corresponding discount;
- the buyer can then transfer this discount from the invoice/receipts to their accounts;
- finally, the FOPH, as the authority responsible for enforcement and criminal prosecution, may check the discount granted (or the estimated waived delivery costs) where necessary.
All discounts and refunds 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).
Refunds as defined under Art. 56 TPA are rebates on the purchase of therapeutic products (e.g. volume discounts) that are not granted at the time of the transaction, but subsequently. As soon as the refund is actually made, it must be recorded in the accounts. The provisions on the obligation to pass on advantages in accordance with health insurance legislation apply.
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 checked accordingly by the authorities). 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 disclosed discounts to their accounts.
For now, the duty of transparency 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 currently affected. Discounts given to procurement companies must be disclosed, however.
III. Controls (Art. 11 TPITO)
1. To whom and by when must the person be designated in accordance with Article 11 letter a TPITO?
2. How must the list of professionals or organisations be kept in accordance with Article 11 letter c TPITO?
The manufacturer/supplier had to designate the person internally before the ordinance entered into force (1.1.2020). 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. since 1.1.2020 complete and up-to-date list in accordance with 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.
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)?
2. Do discounts granted to service providers by procurement companies/intermediaries need to be passed on?
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?
4. What is the situation regarding medical laboratories that grant direct or indirect advantages to doctors? Do these advantages have to be passed on?
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)?
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»?
7. For which therapeutic products (medicinal products or medical devices) must an advantage be passed on?
8. How is the loss in stock value compensated if the FOPH decides to reduce the price of a medicinal product in the LS?
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?
10. How are returns or exchanges of therapeutic products that are covered by the compulsory health insurance handled? What happens about delivery costs?
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.
Change history
Last modification 11.04.2024
Contact
Federal Office of Public Health FOPH
Team Integrity, transparency and discounts
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