Ordinary Revision Of The Therapeutic Products Act (2nd Stage): More Child-Friendly Medicines And Simplified Access To Medicines

Author:Mr Kilian Schärli and Andreas Wildi
Profession:meyerlustenberger | lachenal

Changes to the Therapeutic Products Act will improve public access to medicines and conditions for biomedical research and industry. The aim is to make it easier for complementary and herbal medicines to enter the market and increase the availability of a wider range of medicines suitable for children. There are also amendments to regulations on discounts and kickbacks, on self-medication, on good corporate governance, on medicinal products information, on market surveillance and on regulatory data protection.

The Therapeutic Products Act ("TPA"), which came into force in early 2002, has been revised twice, in two stages. The 1st stage, the early partial revision of the TPA, already entered into force in October 2010, so that the urgent problem of the supply of medicines in hospitals could be resolved. The 2nd stage of the revision of the TPA involves mainly the following areas:

Medicinal products for pediatric use

The revision of the TPA seeks to promote the production of medicinal products for pediatric use by increasing research, development and authorization for this type of medicinal product. The lack of medicinal products specifically designed and developed for treating children is a Europe wide problem. Thus, the revised TPA aims to improve the health and quality of life of children by ensuring that new medicines for children and medicines already on the market are fully adapted to their specific needs. In order to fill the gaps in research on this type of medicinal product, the TPA lays down new obligations for the pharmaceutical industry accompanied by rewards and incentives, especially an additional extension of the patent protection term of six months. Therefore, the regulation also contributes to the competitiveness of the Swiss pharmaceutical industry.

Simplified authorization procedure of complementary and herbal medicinal products

The Federal Council has drafted concessions in drug authorization procedures, particularly concerning complementary and herbal medicinal products. Medicinal products which were approved at the cantonal level at the time of entry into force of the TPA and which are still distributed may also benefit from the proposed changes. However, due to a special provision, the aforementioned medicinal products may continue to be placed on the market - as in the past - only in the concerned canton.

Discounts and kickbacks

Being revised is also the current system of non-cash benefits such as bonuses or free...

To continue reading