What will change
Following the revision of the Therapeutic Products Act (revTPA) and the correlating changes to the Health Insurance Act (revHIA) that entered into force on January 1, 2019, the Swiss Federal Council issued its Ordinance on Integrity and Transparency in the sector of Therapeutic Products (OITTP) as well as revisions to the Ordinance on Health Insurance (OIH) on April 10, 2019 which will enter into force on January 1, 2020.
What it means for you
The OITTP provides for a number of definitions of legal terms introduced by the revised Therapeutic Products Act and thus provides more details on admissible practices in the sale and purchase of prescription drugs. In addition, the ordinance lays down precise conditions for the admissibility of different forms of financial incentives, such as discounts and reimbursements, contributions to organizations and fees for services.
The scope of the OITTP provisions on integrity apply to all medical personnel who prescribe, supply, professionally use or purchase prescription drugs and to all legal entities employing such persons. The scope of beneficiaris is unlimited and therefore applies to everyone involved in the trade of prescription-only drugs.
All discounts and refunds granted for the purchase of therapeutic products must be documented in the company's business records and on request be disclosed to the Swiss Federal Office of Public Health (FOPH). This transparency obligation applies to all parties involved in the trade of therapeutic products, including, manufacturers wholesalers, purchasing cooperatives and service providers. The obligation applies to all medicines and medical devices. Exception is made for "low risk"- medicines (e.g. plasters etc.)
Passing on of Discounts
Insurers and service providers may now agree on not passing on discounts to patients in full but instead to use the funds to sponsor national programmes of public health. The revised HIO specifies the conditions under which such agreements are permitted and implements the additional obligation to disclose them to the FOPH.
New Compliance Standard
Companies must now designate a compliance manager responsible for integrity, transparency and for liaising with the FOPH. This obligation applies to all companies that manufacture or distribute therapeutic products.
The responsibility for the implementation of the revised legislation will pass on to the FOPH. It is to be expected that the FOPH will be more vigorous than the current enforcer Swissmedic.
Actions to take
The new compliance prerequisites are considerable and time until January 1, 2020 is limited. Companies ranging from manufacturers of therapeutic goods to hospitals will have to:
- appoint a manager in charge of integrity and transparency compliance;
- implement internal reporting processes; and
- review and amend existing discount and remuneration arrangements.
Read more here
Not sure whether and how these changes apply to you? Do contact us and we can help you find out.