The National Council and the Council of States have adopted the revised Therapeutic Products Act during the federal parliament's spring session of 2016. In particular, the provisions on the prohibition of undue material benefits, the acceptance and use of discounts as well as the statutory regulation of minimum requirements regarding medical prescriptions were highly controversial. The necessary implementing ordinances will now be drafted, and the public consultation is planned to be initiated in spring 2017. Once the public consultation will be completed, the effective date of the revised statute and its implementing provisions will be determined.
On November 7, 2012 the Federal Council presented its draft of the revision of the Therapeutic Products Act (TPA) to the federal parliament. While the core elements of the Federal Council's draft were accepted by the National Council and the Council of States, some issues remained highly controversial until the very end. Particularly, the problems surrounding discounts granted on medicines almost led to a failure of the revision. After a conciliation, the final draft of the Therapeutic Products Act has been adopted by the National Council and the Council of States during the spring session of 2016.
The revision aims for improving the human and animal health in the field of therapeutic products. To this end, the revision wants to improve supervision and transparency of the market. Moreover, the revision is part of the federal government's master plan to foster biomedical research and technology.
Major Amendments in a Nutshell
Prohibition of Undue Material Benefits
The present art. 33 TPA regarding material benefits will be replaced by the new art. 55 et seqq. TPA. The prohibition of undue material benefits will only apply to prescription drugs. The Federal Council may, however, extend the scope of the provision to other categories of therapeutic products.
Additionally, the list of exceptions has been amended: Besides material benefits of modest value, contributions to research and advanced training, compensation in return for services of equal value as well as discounts and refunds on therapeutic products which do not affect the choice of treatment, will no longer be considered undue material benefits. During the conciliation, the present statutory rule stating that discounts must have a direct effect on the prices (art. 33 para. 3 lit. b TPA) has been abrogated.
The requirement of the...