VITH - Integrity and Transparency in the Therapeutic Products Sector
With this Q&A we answer your questions about the new Ordinance on Integrity and Transparency in the Therapeutic Products Sector (VITH) and show you what you have to do in order to comply with this new regulation.
1. What is the VITH?
VITH is the German abbreviation for the Ordinance on Integrity and Transparency in the Therapeutic Products Sector (German: "Verordnung über die Integrität und Transparenz im Heilmittelbereich", in short: VITH; we will continue to use the German abbreviation in this document).
The ordinance regulates financial benefits to healthcare professionals (HCPs), especially in connection with the promotion or sale of therapeutic products. In dealing with financial benefits, the ordinance addresses three fundamental principles: Integrity, transparency and the obligation to pass on benefits to the health insurance companies. The ordinance has entered into force on 1 January 2020.
2. What has changed?
The VITH stipulates new obligations on transparency in relation to therapeutic products. It requires that all discounts are documented on the invoices and in the financial records of the purchaser and seller. The transparency obligations apply to both medicinal products and medical devices, with the exception of Class I medical devices. The transparency obligations in particular also apply to non-prescription drugs (OTC, except category E).
The Federal Office of Public Health (FOPH) is now responsible for the enforcement of the regulation on undue benefits to HCPs in the therapeutic products sector. Thus, the competent authority is the same authority that is also responsible for setting the reimbursement price for medicinal products and its periodic evaluation.
The transparency obligations empower the FOPH to request certain information and documents from suppliers and purchasers of therapeutic products and oblige HCPs to pass on discounts and other benefits to health insurance companies.
3. What has remained the same?
The prohibition of payments for the prescription or dispensing of prescription only medicines (POM) remains unchanged. However, this prohibition had previously been wider and included non-prescription medicines (OTC). The fact that payments for the prescription or dispensing of POM are prohibited does not preclude all forms of cooperation between the industry and doctors or pharmacists. The VITH clarifies, for example, in which cases remuneration for services is permissible and which conditions must be fulfilled.
4. To whom does it apply?
The VITH applies to HCPs and organisations employing HCPs, as well as to manufacturers and wholesalers of therapeutic products.
While the integrity obligations are limited to prescription only pharmaceuticals, the transparency obligations are wider and apply to medical devices as well. The obligation to pass on discounts and other benefits to health insurance companies applies also to medical laboratories to the extent that the Federal Health Insurance Act (KVG) reimburses their services. The obligation to pass on discounts applies also to benefits given to medical laboratories and X-ray institutes and to benefits that they give to HCPs.
5. Who's an HCP according to the VITH?
According to the VITH, an HCP is any person who, in the course of his or her professional activities, may prescribe, purchase, supply, dispense or administer a therapeutic product. Hence, an HCP according of the VITH may be a member of the medical, dental, or pharmacy profession.
6. What is prohibited under the VITH?
The VITH in general prohibits undue benefits to HCPs in connection with therapeutic products. Undue benefits may occur in cash, cash equivalents, or in kind.
7. When are discounts inadmissible?
While discounts in kind are always prohibited, financial discounts are permitted if they do not affect the choice of treatment. This requires that a drug is not prescribed or dispensed in situations where a pharmaceutical treatment is not suited, or if the drug is prescribed or dispensed in excessive quantities or in lieu of a more suitable drug.
8. What discounts are allowed?
Financial discounts and refunds are permitted. Discounts in kind, on the other hand, are not permitted. This is the case if a larger quantity of products is delivered than what is actually invoiced. The sale of sample packs provided by a manufacturer to HCPs is also prohibited.
9. What applies to outpatient care?
In the outpatient sector, discounts must be disclosed transparently and passed on to the insurance companies. Hospitals must therefore ensure that the reimbursement price is reduced in accordance with the discounts. This requires that different billing methods and pricing schemes are implemented in the outpatient and inpatient sectors, especially when purchasing is carried out jointly for both sectors.
10. Does the obligation to pass on discounts apply also in the inpatient sector of a hospital?
No. In the inpatient sector, the rules on disclosure and transparency have been relaxed. If discounts have already been included in the tariff for acute-care hospital services such as the tariff for Diagnosis Related Groups (DRG), they must not be disclosed separately.
11. Are there any other exceptions?
Yes, in addition to the inpatient sector of a hospital, further exceptions apply to other tariffs, where medical services are billed on a flat-rate basis. For instance, in the case of managed care models, discounts must not be disclosed separately.
12. What should a pharmacist or a hospital do if they are offered a discount?
A pharmacist or a hospital should first seek clarification whether there is a discount. If the discount is admissible, the discount must be passed on to the insurance companies.
13. How is it assessed whether there is a discount?
With respect to therapeutic products that are reimbursed under the compulsory health insurance, in particular listed drugs, a discount exists in any case if the price actually paid is lower than the ex-factory price. For all other medicinal products and medical devices, there is a discount if the price is lower than what is usually paid ("standard price"). Since there is no price regulation for non-listed drugs, the assessment is based primarily on the information provided by the supplier or manufacturer, for example, a manufacturer's price list.
14. Do discounts always have to be passed on?
No. If the HCP provides services of equal value with respect to the discounts in question, such (functional/trade) discounts do not have to be passed on. This is the case, for instance, if the HCP undertakes some logistical tasks for the manufacturer or wholesaler. Another example are early payment discounts where a shorter payment period is remunerated.
In addition, the VITH now provides that the HCP can retain a part of the discounts. While the majority of the discounts must still be passed on to insurance companies, the remainder can be used to finance projects dedicated to the improvement of treatment quality, and shall include nationally oriented programs as those managed by the Foundation Patient Safety Switzerland or any other quality development organization in Switzerland.
15. What conditions must be met in order to retain discounts?
An agreement with the respective insurance companies is required for a partial retention of discounts. Such agreements should primarily be concluded between the trade associations of HCPs and insurance companies. However, individual hospitals or networks of doctors also have the possibility of concluding such agreements with insurance companies on the use of discounts to improve the quality of treatment.
16. It is permissible to invite HCPs to a lunch or other meals?
Yes, provided that the costs do not exceed CHF 100 per person and per meal. Furthermore, the invitation must serve the exchange of medical information or education. The exchange must be documented and kept on record. It is irrelevant whether the invitation is for lunch or dinner.
17. Are personal gifts permitted?
No. Only gifts that are related to the practice of a doctor or pharmacist are permitted. Such gifts may not exceed the value of CHF 300 per HCP and year. The VITH requires that the gifts are related to the professional activity of the doctor or pharmacist, or that they benefit the patients directly. According to the FOPH's guidelines, this is the case with a rocking horse or a water dispenser for the waiting room. By contrast, smoked salmon for Christmas, a flower bouquet or a bottle of wine are not permitted because they benefit the HCP personally.
18. Are donations or grants for teaching and research permitted?
Yes, it is permissible to support hospitals or university clinics financially. These institutions rely on third party contributions to fund research, training, and infrastructure projects. There must be a written document setting out the purpose of the donation clearly. It is not permitted to combine a donation with the dispensing or prescription of medicinal products.
19. Are contributions to postgraduate medical training and continuing medical education permissible?
Yes, contributions to postgraduate medical training and continuing medical education are permitted, provided that the HCP makes an appropriate financial contribution. The contribution is adequate if the HCP pays at least one fifth of the costs for the postgraduate medical training, and at least one third for continuing medical education. It is forbidden to provide a compensation for the time that the HCP attends an event, to offer luxurious social programmes or to contribute to the costs of accompanying persons.
20. May HCPs be compensated for their participation in advisory boards?
Yes, provided that remuneration is reasonable and corresponds to the value of the services effectively delivered by the doctor. The scope of the services must be defined in an advisory board or consulting agreement. The Swiss tariff system for doctors (TARMED) gives indications whether the stipulated hourly rate is adequate. The engagement shall not be an incentive to recommend or prescribe, sell or administer a particular therapeutic product.
21. Which services may not be compensated?
Services which an HCP provides in his own interest or which he is legally obliged to provide may not be remunerated. For example, an HCP may not be remunerated for exercising his or her legal duty of care. Also inadmissible is the remuneration of services that are already compensated elsewhere (e.g. TARMED, LoA).
22. What are the obligations of the responsible person?
Manufacturers and distributors of medicinal products or medical devices must designate a contact person for the communication with the FOPH. The responsible person's duties relate to the obligation of the respective manufacturer or distributor to keep all agreements with HCPs and respective organizations for at least 10 years and to keep a register with the names of all HCPs and organizations who have received benefits. Upon request, the responsible person shall submit the requested documentation and information to the FOPH. The responsible person does not incur any personal liability for the company’s compliance with the VITH.
Subject to these obligations to designate a responsible person are also intermediaries, such as purchasing organizations of pharmacy groups or health maintenance organizations (HMOs).