Biobank Law in Norway

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 200119 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
Health registers in Norway

• 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)

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 material and 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
Oviedo Convention art 5

• 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

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