Tensions Between Policy and Practice in Finnish Biobank Legislation

Introduction

Anumber of recent commentaries have identified some of the challenges and ethical dilemmas in developing policies surrounding the return of individual research results in biobank research.^1–4 Some have argued that participants have a right to access information regarding research results, noting that they have the potential to affect the lives of participants.^5,6 Access to personal and medical information is also seen as a cornerstone of patient rights, as well as the right to autonomy over their personal information that is stored. There appears to be little consensus, however, on the policies regarding the disclosure of genetic information of research participants. Some organizations have sought to develop guidelines and criteria for the conditions under which incidental findings ought to be reported back to patients, such as with clinical exome and genome sequencing. ⁷

Some have also argued that it is unethical for researchers to absolve themselves from clinical responsibilities to report significant and actionable findings to research subjects, since the data was collected for the purposes of research and not clinical studies. ⁸ This has led to ethical and legal dilemmas over the extent to which people whose samples and data are collected and used in biobanking have the right to know for what their samples and information are used, as well as the question of what responsibilities and duties biobanks have towards those whose information is used in relation to reporting back the significance of the findings made in various studies utilizing those samples. Furthermore, it has also raised questions as to what genetic information produced from biobanking studies can be seen as relevant and significant for participants.

The Finnish Biobank Act

Amidst such debates and discussions regarding the rights and duties of various stakeholders, a more dramatic and substantial development has occurred in Finland, relatively unnoticed by the international biobanking community. In 2012, a new Biobank Act (688/2012) ⁹ granted research subjects the right to receive information upon request, concerning their health, including information derived from their tissue sample which has been used in research. The new Biobank Act is considered by some to be one of the most comprehensive biobanking legislations in the world, covering both clinical and research biobanks within its scope and allowing for the transfer of existing clinical and research collections under the auspices of a biobank. ¹⁰

The act sets the conditions and requirements under which biobanks may be set up, as well as the process by which existing collections (both clinical and research) may be transferred into an official biobank with its rights and duties. This transfer process may take place without having to gain re-consent from individuals, but rather includes a general process of informing the public through various media outlets, such as newspapers. In practice, this will allow hospitals and large cohort studies to move their large collections of clinical and research samples into an institutional biobank, after an appropriate national ethical approval and licensing process. In the biobank, the uses of the samples and related information will be covered by a broad interpretation of consent and be more readily available for research in general.

Along with most other Nordic countries, which have extensive biomedical tissue collections and registers, as well as good quality healthcare records, Finland is seeking to leverage its collections of tissue and health information in a more systematic way under the new Biobanking Act. ¹¹ As part of this legal reform process, the attitudes of Finns were studied in an attempt to get a better idea of the hopes and concerns of the population.^12,13 These studies suggested that Finns were generally positive towards biobanking and the use of their samples.

In addition, however, the study also revealed that Finns were, in general, interested in receiving all types of information regarding increased health risks based on findings in biobank research. ¹⁴ In addition to the views of the Finnish population, the drafters of the new legislation have had to draw on broader EU Directives and Conventions in developing a comprehensive national legislation that would both respect the rights of the individual, but also facilitate efficient biomedical research.

Among the legal changes that the new Act included, one of the most controversial has been the inclusion of a section that allows the person whose sample is stored in a biobank and used for research to receive, upon request, information regarding his or her health in relation to what has been studied with their sample. ¹⁵ According to the Act:

The drafters of the legislation have reasoned that the impetus for including such a section within the Act draws and follows logically from the personal data legislation in Finland and the EU Directive on Personal Data (Directive 95/46/EU). Within the Finnish legislation and the Directive, individuals have the right to know for what purposes information gathered and stored on them is being used. This logic follows the reasoning found in the Council of Europe's Convention on Human Rights and Biomedicine, which states in Article 10 that “Everyone is entitled to know any information collected about his or her health.” This interpretation of EU Directives and Conventions has led, however, to tension between policy and practice in relation to biobanking in Finland.

In its reasoning in the drafting of the Act, Finland has drawn on the European Data Directive, as well as the Oviedo Convention to ensure patient rights to access on personal information. The Finnish Act, however, goes even further in that it requires the biobank to determine and explain to the person whose sample has been used for research the significance of whatever research has been performed on the sample. The cost of doing so must be covered by the person seeking this information. This raises two types of challenges for each biobank.

The first concern relates to how each biobank will arrange and provide this information in practice. In many cases biobanks serve as handling and distribution centers for biomedical tissues, and may not necessarily possess the necessary qualification to provide genetic counseling to individuals. Furthermore, they may not fully understand the study parameters and output that each study using said samples has produced. In addition, the law does not describe the basis for interpretation of the significance of the findings on an individuals' health. For example, are genetic counselors supposed to base their counseling on the publications that each biobanking study produces, or are they expected to analyze the raw data that each study produces and provide their own analysis of that data in relation to the individual?

A second problem relates to what protocols and procedures genetic counselors are to adopt in deciding what information ought to be passed on to the individual. For biobanks, it is difficult to assess and interpret the significance of research findings in relation to the health of individuals within that study. Biobanks will also grapple with what policies to adopt with regard to what risk levels and conditions ought to be reported to individuals. Should it include all findings, findings whose significance is above a certain risk level, only actionable findings, or some other criteria regarding relevance to individual health? In addition, many countries, such as Finland, may have different types of disease burdens with regard to genetic diseases and conditions, whereby international norms and standards may not always be applicable.

Although to date no biobank in Finland has had to provide such information to any individual, it is clear that the inclusion of such a provision has, on the one hand, sought to interpret European Directives and Conventions in a way that respects patient autonomy, but at the same time it has created an interpretive dilemma for Finnish biobanks. The problematic provisions are being discussed within the Governmental Steering Group on the Biobank Act, but it is still unclear how the legislation will be changed.

Conclusion

Although the recent developments in Finland regarding biobank regulation may seem limited in relation to its impact on biobanking more generally, it also raises a more significant problem globally, namely the emergence of what can be called interpretive regulatory dissonance, whereby different countries will interpret broader Directives and Conventions in different ways, giving rise to vastly different legal applications and practices related to biobanking. Although there are a number of broader international initiatives that are seeking to harmonize biobanking practices across state borders, such as BBMRI-ERIC, the case of the Finnish Biobank Act relates to a more general policy level problem related to Directives and Conventions, namely how different member states will interpret and implement them in various fields including health and “biolaws.” Although there is a need for harmonization within larger political contexts, the Finnish Biobank Act shows that member states may interpret and implement vastly different formulations through which patient rights become enacted in national legislation.

It is imperative for international biobanking networks such a BBMRI-ERIC and P3G to assume a more rigorous role in discussing the limits and consequences of interpretive regulatory dissonance, as well as to support various biobanking initiatives to address concerns in the drafting process of biobanking legislation. On a policy level, the aspiration to secure patient rights are fundamental, but regulatory tools must also reflect a more pragmatic approach in terms of what is doable and reasonable in relation to research using biobank material.