After discussions lasting several years, the two houses of parliament approved the second partial revision of the Therapeutic Products Act in the spring session of 2016. The deadline for the referendum passed without action. For the research-based pharmaceutical industry, this revision touched on four key areas:
1. RESEARCH INCENTIVES IN THE AREA OF INTELLECTUAL PROPERTY
The two houses of parliament (the National Council and the Council of States) decided that a ten-year period of data protection should be granted in the case of new indications for medicines with known active ingredients, provided that significant clinical benefit can be expected compared with existing treatments and that evidence of this can be shown through extensive clinical trials. It was further decided that, for paediatric medicines, either an extension of an existing supplementary protection certificate or a separate six-month protection certificate should be granted. The two houses disagreed on the question of medicines for rare diseases (orphan drugs). The National Council wanted to promote the development of such products by granting ten-year market exclusivity, as has been the case for some time already in the USA and the EU, whereas the Council of States wanted data protection of 12 years or 15 years in the case of paediatric indications. After the 2015 autumn session, signs of a possible compromise began to emerge: The National Council health commission proposed waiving the instrument of market exclusivity and providing for a general data protection of 15 years instead, thus accommodating the Council of States position. Before this, during the debate in the Council of States, the Federal Councillor responsible had signalled his support for a general data protection of 15 years for orphan drugs. Eventually, both houses decided the institute must publish applications for market authorization in future and thus establish transparency in the market.
In the run-up to and during the debate, Interpharma campaigned for greater research incentives in the area of intellectual property. With data protection for new indications with known active ingredients, Switzerland will assume a pioneering role and reinforce its position as a centre for research.
2. Tougher sanctions in cases of pharmaceutical crime
Both houses of parliament voted in favour of much tougher sanctions in cases of pharmaceutical crime and adopted an article that now makes pharmaceutical crime an abstract endangerment offence. In addition, a provision was explicitly introduced into law that also makes the imitation, falsification or false designation of human medicinal products and medical devices a criminal offence.
Interpharma has been engaged for years in the fight against pharmaceutical criminality and is also active in the STOP PIRACY association, which campaigns against counterfeiting and piracy. In terms of patient safety there has to be zero tolerance to the counterfeiting of medicines. To this extent Interpharma welcomes the tougher sanctions adopted in the fight against pharmaceutical crime.
3. REGULATION ON TRANSFER OF VALUE
The National Council corrected the unsuccessful article of the Federal Council, which provided for a ban on transfers of value and opted for a different approach by adopting an integrity article which rules that service providers may not accept or demand any undue advantages or accept the promise of such advantages. The Council of States largely followed this approach.
Interpharma has campaigned for a practicable regulation that is fit for purpose to be implemented in order to regularize relations between the pharmaceutical industry and other service providers.
4. PRODUCT INFORMATION
On the question of who should publish medicinal product information in future, the two houses of parliament approved a stakeholder solution, which Interpharma is/was actively involved in helping to elaborate. This means that responsibility for the publication of these data will no longer lie with Swissmedic, but with a foundation supported by the pharmaceutical industry, medical professions and patient organization. Interpharma welcomes this stakeholder solution.