Source: http://blog.vischer.com/en/integrity-and-transparency-for-therapeutic-products-6-common-myths
Timestamp: 2020-08-10 16:26:29
Document Index: 527865624

Matched Legal Cases: ['Art. 55', 'Art. 3', 'Art. 56', 'Art. 10', 'Art. 55', 'Art. 56', 'Art. 76']

Integrity and Transparency for Therapeutic Products – 6 Common Myths
On 1 January 2020, the new provisions on integrity and transparency and on the passing on of discounts and benefits in the therapeutic products sector entered into force. The former provision on the promise and acceptance of monetary benefits was replaced by a new provision on integrity. In addition, a new provision on transparency in dealing with discounts and rebates is introduced.
The relevant legal and regulatory bases are the (revised) Therapeutic Products Act (TPA) and the Ordinance on Integrity and Transparency in the Therapeutic Products Sector (VITH). Specifically, the new rules are stipulated in Art. 55 TPA (Integrity) and Art. 3-9 VITH and Art. 56 TPA and Art. 10 VITH (Transparency).
During the revision of the TPA and the drafting period of the VITH, both the healthcare and the pharmaceutical sectors have uttered concerns about the implantation of the new rules, given that they are, in some respects, rather restrictive and can also lead to an increased workload in terms of administration and bureaucracy.
While many of the concerns are legitimate, there are also numerous misinterpretations circulating with respect to the required implementation and the permissibility of monetary benefits and discounts. The purpose of this article is to highlight some of the most common misinterpretations and to provide a differentiated explanation of the new rules in place.
Myth No. 1: The new rules only apply to HCPs; their implementation or potential sanctions do not apply to pharmaceutical companies
The duties of integrity, transparency and disclosure apply to all healthcare professionals who prescribe, dispense or use medicinal products or medical devices (with differentiations; see myth no. 2) on their own responsibility for their own professional use, purchase for these purposes or have a say in their purchase (hereinafter jointly referred to as "HCPs"), as well to any persons or organizations offering discounts or benefits to HCPs, such as e.g. pharmaceutical companies. A certain limitation of scope applies in that generally, the last level of trade, i.e. the level between the entity selling medicinal products or medical devices to HCPs. However, the duties of integrity, transparency and disclosure still apply to both parties to such trade level, i.e. the buyer and seller.
Myth No. 2: The duties of integrity, transparency and disclosure only concern prescription drugs
This is only partly correct: While the duties of integrity in the current Art. 55 TPA apply to prescription drugs (i.e. not to OTC drugs and medical devices), the transparency and disclosure obligations according to Art. 56 TPA apply to all medicinal products and medical devices, except for medicinal products of the dispensing category E (e.g. cough drops) and class I medical devices (according to the EU Directive 93/42/EEC concerning medical devices).
Myth No. 3: HCPs can no longer accept gifts of any kind
The offering and acceptance of personal gifts to HCPs is prohibited under the new law. However, gifts which are related to the professional activity of a medical professional and which do not exceed the value of CHF 300 per HCP per year are permitted. Moreover, such gifts must be related to professional activity or directly benefit the patients. This is the case, for example, with furniture for the waiting room or new fever meters for the medical practice. However, personal gifts such as wine for Christmas or invitations to sports, cultural or other leisure events are prohibited.
Myth No. 4: Sponsoring from pharmaceutical companies for teaching and research purposes may no longer be accepted
The acceptance of external support contributions (sponsoring) for teaching and research projects is, in principle, permissible. However, such contributions must be regulated in a written agreement and the purpose must be clearly defined. The sponsoring contributions may not be paid to the HCP personally, but must be transferred to an account designated by the organization (e.g. University) in question.
Myth No. 5: Sponsoring from pharmaceutical companies for contributions to further education and training may no longer be accepted
The payment of participation fees in further education ("Fortbildung") and further training ("Weiterbildung") events is generally permissible, provided that the attending HCP pays a certain cost contribution, whereby no payment should be made to the HCP himself, but rather to the organization employing him. The cost contribution to be borne by the HCP must cover at least one third of the costs for further education courses ("Fortbildungsveranstaltungen") and one fifth of the costs for further training events ("Weiterbildungsveranstaltungen"). The organization employing the HCP must decide on the type and selection of further education or further training as well as on the participating HCPs. Luxurious supporting programs and the assumption of the costs of accompanying persons, the reimbursement of the cost price as well as the assumption of the loss of income of the respective HCP during his absence are expressly forbidden.
Myth No. 6: Discounts on drugs and medical devices are no longer permitted
The acceptance of price discounts and rebates on prescription drugs is permissible if the price discounts and rebates do not influence the choice of treatment. An inadmissible influence on the choice of treatment is assumed when a medicinal product is prescribed or dispensed although such treatment is not medically indicated. The same applies if a prescription drug (or medical device) is prescribed or supplied in excessive quantities or in place of a more suitable product.
For medicinal products on the list of pharmaceutical specialities (SL), a discount is to be assumed if the price actually paid is below the factory selling price (ex factory price) of the manufacturer. For all other medicinal products and due to the lack of price regulation for medicinal products outside the SL, a discount is to be assumed if the price deviated from the price usually paid (to be disclosed by the supplier).
So-called natural discounts, i.e. the delivery of a larger quantity of products than effectively invoiced, are not permitted. Sample packs provided by the manufacturer to the specialist may be accepted but not sold.
In principle, the receiving organization must pass on all discounts and refunds granted to the insurers or the patients. However, discounts may now be partially retained, provided that the retained portion is used to improve the quality of treatment e.g. within the hospital. However, this requires a written agreement with the health insurers (Art. 76a et seqq. of the Ordinance on Health Insurance).
The new transparency obligation was introduced to verify and enforce integrity and disclosure obligations. According to the transparency obligation, all discounts and rebates granted for the purchase of therapeutic products must be documented in the invoices and business records both on the part of the manufacturers and distributors (manufacturers, distributors, wholesalers) as well as on the part of the purchasers. The transparency obligation applies to all therapeutic products, i.e. to all medicinal products as well as medical devices (with the exception of category E medicinal products and class I medical devices).
The Federal Office of Public Health (FOPH) is responsible for monitoring the compliance with integrity and transparency obligations as well as the passing on of discounts and benefits. With the new VITH, the FOPH gains extensive competence. It may not only demand information about any accepted discounts or refunds, but may also oblige service providers (such as hospitals or medical practices) to pass on discounts. Failure to comply with the duties of integrity, transparency and disclosure may result in severe penalties for the offenders (imprisonment for up to three years or monetary penalties).
If you have any questions regarding the new integrity and transparency rules, please contact Stefan Kohler or Ann Sofie Benz.
Topics: Life SciencesVITHIntegrityTherapeutic ProductsDiscounts