Rejection requested, not yet addressed in Council.
Submitted text
The Federal Council is instructed to draw up a Draft law on biobanks through which the protection of participants, freedom of science, and public health are ensured and international ethical principles and human rights are respected. This law should serve as Basis for networking population-based biobanks in Switzerland and for the Establishment of a national population-based biobank serve. The law should also define the minimum requirements that all biobanks in our country, both public and private, would have to meet. In this way, Switzerland secures its place in international research.
Justification
In order for us to address the challenges facing the healthcare system, the Collecting and processing large amounts of personal data and human samples essential. For this purpose, extensive population-based biobanks must be created. Biobank means the organized collection of human samples and the associated data.
Numerous federal laws that have been passed recently or will be passed soon refer to certain challenges we face in connection with biobanks: HFG, GUMG, KRG, EPDG, DSG etc.. However, none of these enactments provides a complete answer to the questions raised by biobanks.
In this context, the adoption of a federal law would make it possible to establish the general framework for biobanks. It would also guarantee fundamental rights and freedoms and establish minimum requirements in terms of quality and safety standards. Such a measure would be an indispensable step to address the justified concerns of the population, while promoting research.
Many countries have already anticipated this scientific and public health need. In this way, these countries are gaining a head start in research and in the exploitation of their results. Switzerland, whose cutting-edge research in biomedicine is internationally recognized, is lagging behind in this area. Admittedly: Numerous initiatives exist to network our country’s biobanks, for example the Swiss Biobanking Platform. The pharmaceutical industry also collects numerous samples as part of its own research. However, there is a lack of a clear legal framework to promote these measures.
Statement of the Federal Council of June 2, 2017
The Federal Council is aware that research with biological material and health-related personal data plays an important role in medicine. It recognizes the importance of biobanks for biomedical research and thus for Switzerland as a research location. At the same time, he also sees the challenges, particularly with regard to the protection of personality, which accompany the technological developments in the field of data processing.
Specific biobanking laws exist in Finland and Belgium, for example. In many other countries, the protection of individuals participating in research projects is regulated by general decrees, usually via data protection laws.
Many aspects that a “biobanks law” would cover are already regulated by the Federal Law on Research Involving Human Subjects (Human Research Act, HFG, SR 810.30). Its primary objective is to protect the dignity and personality of the participating individuals. In detail, the law and the implementing legislation prescribe the content of the information and the form of consent of persons who provide samples and data to a biobank for research purposes. The right to information about results is also stipulated, as is the encryption or decryption and anonymization of samples and data. In addition, it contains requirements for the storage of samples and data. With the HRA, Switzerland has a comparatively comprehensive regulation of human research.
However, there are no specific licensing requirements for the operation of biobanks.after a corresponding proposal in the preliminary draft of the Human Research Act was viewed negatively by research and industry circles. This was also on the grounds that the speed of technical developments in the field of biobanks is very high and therefore self-regulation was desired. At the international level, the Taipei Declaration was adopted by the World Medical Association in October 2016. By primarily addressing physicians as well as biobank employees, it strives for self-regulation of biobanks. The Declaration contains guidelines on patient rights, organization and operation of biobanks.
The Federal Council is of the opinion that there is currently no need for statutory regulation. On the one hand, there are no indications from enforcement that the protection requirements of the HRA are insufficient. On the other hand, it has been shown that both the establishment and operation of biobanks and the cooperation of individual biobanks at national level, e.g. within the framework of the Swiss Biobanking Platform, are possible even without a corresponding Biobanking Act.
As part of its legal mandate (Art. 61 HRA), the Federal Office of Public Health is currently reviewing the effectiveness and appropriateness of the HRA. In doing so, it is also examining the specifications for the collection and further use of samples and data. The evaluation will identify any need for action, also with regard to the regulation of biobanks. The Federal Department of Home Affairs will report to the Federal Council at the end of 2019 and submit proposals for action. Based on this and on further experience in dealing with biobanks, the Federal Council will decide whether or not there is a specific need for regulation, particularly in the area of research with biological material and health-related personal data.