Biobank Law in Norway – Critical Reflections

1. Biobank Law in Norway – Critical Reflections Body Control – Legal Regulatory Perspectives on Biometrics and Biobanks, University of Oslo November 22-23, 2007 Henriette Sinding Aasen

2. Introduction • Focus: Trends rather than details in the legal regulation of biobanks, especially in relation to biomedical research • ”Biobanks are the tools of the doctors/medical scientists” (Marit Halvorsen, Norsk Biobankrett, 2006, p 2), especially with regard to • Diagnosis and treatment • New knowledge (research) • Development for industrial and financial purposes (pharmaceutical industry)

3. Biobank: Brief description • A systematic collection of biological material from human beings (often patients) • blood, tissue, hair, bone, sperm, eggs, hearts, kidneys, stemcells… • Prepared and stored (frozen, dried, in a chemical substance etc), for a certain period of time

4. Background and future • NOU 2001:19 Report on biobanks from a committee appointed by the government • Research interests and opportunities in focus • Disagreement on the definition (what is a biobank?) • Agreement on informed consent as a main principle for the use of biological material from human beings • Disagreement concerning the quality and requirements of informed consent in research (how open/wide should the informed consent be allowed to be?) • The Biobank Law (2003), changed in 2006 • NOU 2005: 1 and Ot prp nr 74 (2006-2007): New legislation for medical research

5. Clinical biobanks in Norway • Systematic collections of pathological material from 1930, stemming from 10 mill. patients (fetus, newborn, old people, men, women) over the last 4-5 generations • Used for diagnosis and re-diagnosis, quality control, research • 900.000 cell- and tissue samples are analyzed every year • 65 blood banks • Used for transfusions, production of blood products for treatment and plasma for sale to the pharmaceutical industry • Organ banks (transplantation) • 277 organ transplantations in 2000 (most kidney, but also heart-, liver- and lung transplantations) • Stemcell banks • Used in cancer treatment. Many possibilities in the future…

6. Research biobanks in Norway • The Janus project (Norwegian Cancer Society): Analysis of blood and data from cancer patients, both retro- and prospective studies • The Cohort Norway Project (CONOR, medical research groups): Analysis of data and biological material from the Norwegian population in all the regions • Mother and child project (Norwegian Institute of Public Health): Analysis of blood and data from pregnant women and offspring, as well as from fathers (more recent) • Many smaller biobanks (around 400 established every year)

7. Death register Cancer register Tuberculosis register Norwegian patient register Register for contagious diseases Newborn register Name, social security number and other characteristics can be processed without consent from the registered person, so far as this is necessary to achieve the purpose of the register, and as long as direct identifying characteristics are stored in a ”crypted” fashion (Health register law § 8) Health registers in Norway

8. Biobanks and datatechnology • Data technology adds to the potential of biobanks • The inherent information in the biological material is usually the most important aspect of the biobank • Data technology provides tools for advanced analysis of the inherent information in the biobanks, and • Makes it possible to connect different biobanks and the attached data, which opens up a world of research possibilities • The more biobanks, data and health registers, the bigger ”playground” for researchers …

9. The Norwegian Biobank Act (2003) • Regulates the collection, storage, use and destruction of material and data from human beings for both clinical and scientific purposes • Diagnostic biobanks • Therapeutic biobanks • Research biobanks • The Biobank Act regulates anonymous as well as non-anonymous material

10. Biobank regulation: Overview • Definition of biobanks • Establishment or destruction of biobanks must be reported • Requirements concerning responsibility for the biobank, storage and transportation of material abroad • Information and consent • New use of the material • Access to the material

11. Biobanks for diagnostic and therapeutic purposes • Legal definition • A collection of biological material from human beings which is given for the purpose of medical examination, diagnosis and treatment (§ 2) • Data is not included, due to sufficient regulation by other laws

12. Biobanks for research purposes • Legal definition • A collection of biological materialand data which is directly available through analysis of the material, and which is being used or will be used in research (§ 2) • Data is included, because the utilization of data in research biobanks is not sufficiently regulated by other laws • Prevention of commercial use of data (especially relevant for genetic research)

13. Biobanks: Alternative definitions • A systematic collection of human biological material • Anonymous and non-anonymous material (Norway, Iceland) • Non-anonymous material only (Sweden, Denmark) • Anonymous material only (not practical?)

14. Biobank Law § 1: Basic principles and values • The aim of the law is to secure that collection, storage and use of material in a biobank are ethically justified and that biobanks are utilized in the best interest of individuals and society, in accordance with basic data protection considerations, principles of respect for human dignity, human rights and personal integrity, and on the basis of non-discrimination of the persons from whom the material originate.

15. Overall interests and values • Health care purposes (public interests) • Protection of individuals • Human dignity and integrity • Human rights • Data protection • Non-discrimination

16. Non-anonymous material: Human rights issues • Right to privacy (ECHR art 8, Oviedo Convention art 10) • Concerning data that can be traced back to individuals • ”Crypted” • ”Hidden identity” • ”Open identity” • Right to self-determination/autonomy (informed consent, Oviedo Convention art 5) • Concerning use of human biological material • Concerning use of data

17. Anonymous material: Human rights issues • Right to self-determination/autonomy (informed consent) • Concerning use of the human biological material

18. In the following • Focus on the right to ”self-determination” and informed consent in relation to human biological material, including data • The right to privacy will be indirectly discussed

19. Right to self-determination • Traditionally: The right of the individual to make decisions concerning his or her own body (”informed consent”) • Medical research (Nürnberg Code, Helsinki Declaration, ICCPR, Oviedo Convention) • Health care (Oviedo Convention, Patient Rights Act)

20. ”An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it. This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks.” Interventions in the body Is the collection, storage and use of human biological material an ”intervention””? Not necessarily in the human body But could be ”in the health field” Non-anonymous material Anonymous material Oviedo Convention art 5

21. ”Self-determination” and human biological material • ”Self-determination”: What is the ”self”? • The material? • The information? • Better terminology: Right to determine over the material and the information …? • What is the ”intervention”? • Non-anonymous material: Distribution and use of sensitive data (and material) without the consent of the ”owner” • Anonymous material: Use of the biological material without the consent of the ”owner”

22. Biobanks and research: Consent issues and legal development in Norway • Distinction between different types of research, involving • The human body (”traditional” informed consent requirements) • Human biological material (consent requirements depending on anonymous or non-anonymous status) • Data (consent requirements according to data security) • ”Crypted” • ”Hidden identity” • ”Open identity” • From ”absolute” to more flexible and ”open” consent requirements, depending on the nature of the research • From very specific to broader consent forms • Inclusion of vulnerable groups (incompetence) in all types of research • Research in clinical emergency situations allowed by law

23. Changed, expanded or new use of material • No consent will be demanded for the use of human biological material and data that have been made anonynous (Biobank Law § 13, new Medical Research Law § 20) • However, the collection of material and data, even if it is later to be made anonymous, will still require informed consent • ”Self-determination” considerations

24. Persons not able to consent • Not excluded from research • Until 2006: Collection of human biological material from adults without consent competence not allowed • Today: Allowed on strict conditions • Insignificant risk • The person does not protest • Similar research cannot be performed on competent individuals • Potential benefit for the actual person or for others

25. Use of human biological material collected in the health care service • The regional committee on medical ethics may decide that human biological material collected in the health care service as part of diagnosis and treatment may be used for research purposes without consent from the patient (§ 28). Requirements: • The research is necessary in order to provide good services of common interest, and • The public interest in the research clearly exceeds the burdens on the individual patient (similar as for data) • The patient shall beforehand receive information about such use of human biological material, and must be given the right to reject

26. Finding the right balance … • … between individual and public interests