Ingen bildrubrik

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Associate Professor Elisabeth Rynning Faculty
of Law, Uppsala University
Legal Issues on Biobanking Privacy Versus
Freedom of Research and Property Rights...
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International trend towards more legal rules in
biomedicine

• Developments in biotechnology and IT
• new possibilities and new risks
• International awareness of need for protection of
  human rights and human dignity
• Advancement of science and industry requires
  regulations to be predictable and preferably
  uniform...

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European law making demands...

• The Council of Europe
• Convention on Human Rights and Biomedicine
  (1997), into force since December 1, 1999
• The European Union
• Directive (95/46/EC) on the protection of
  personal data
• Directive (98/44/EC) on the protection of
  biotechnical interventions
• Directive (2001/20/EG) on the implementation of
  GCP in the conduct of clinical trials...

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The European Convention on Human Rights and
Biomedicine

• An international legally binding document
• A framework of common minimum standards in health
  care and biomedical research
• Parties must adjust internal law and provide
  appropriate judicial protection against
  infringements
• Sweden is preparing for ratification

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Convention on Human Rights and Biomedicine
(continued)

• Article 2 Primacy of the human being
• Requirements concerning information and consent
  in general, special safe-guards for research
  subjects
• Article 21 prohibition of financial gain from
  parts of the human body as such
• Article 22 disposal of removed parts of the
  human body only in accordance with appropriate
  information and consent procedures

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What are the legal issues?

• Balancing the interests involved
• Protecting privacy and personal integrity of
  donors (relatives and other groups concerned?)
• consent/withdrawal
• confidentiality
• Facilitating justifiable use of human tissue
• provision of good health care
• freedom of research
• access to information and biobank materials
• protection of property rights...

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Regulating biobank activities in the Nordic
countries

• Iceland - Act on Biobanks since January 1, 2001
• Finland - new rules introduced in the Act on Use
  of Human Organs and Tissue for Medical Purposes,
  September 1, 2001
• Sweden - the new Act on Biobanks in Health Care
  will enter into force on January 1, 2003
• Norway - proposal for a new Act on Biobanks
  presented in March 2002, to be passed later this
  year?
• Denmark - govermental report presented in June
  2002

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The scope of the Swedish Act

• Two types of biobanks
• . Banks established by health care providers
• . Secondary banks, consisting of samples that
  originate from banks in category A.
• Collections of biological material from
  identifiable humans - organs and tissue samples
  as well as the smallest parts of DNA
• To be stored and used for health care purposes or
  other medical activities (research, production of
  pharmaceuticals etc)
• Old collections as well as new ones

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Not covered by the Act

• Samples taken without any connection to health
  care, e.g. at a research institution or a
  pharmaceutical company
• Anonymous samples (that cannot be traced to the
  donor)
• Routine samples taken for diagnosis or treatment
  of the donor, if not preserved more than two
  months
• Collections of pure data (without any
  biological materials)

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What is being regulated?

• Registration and monitoring of biobank activities
• Information and consent requirements
• Role of research ethics committees
• Transfer and use of biobank samples, including
  coding requirements
• Authorisation requirements to discontinue or
  transfer a biobank
• Prohibition of transfer in view of financial gain

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Consent requirements

• Mandatory explicit informed consent from live
  donors, also for health care related storage
• Sweden more strict than the other Nordic
  countries, stricter rules for samples than for
  personal data
• If consent is withdrawn, the sample must be
  destroyed or de-personalised...
• New consent required for new purposes
• (for research, RECs may agree to exceptions)

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Transfer of biobank samples

• A biobank as such, or part of it, must not be
  transferred to a recipient in another country
• General restrictions on sending samples abroad,
  but international co-operation may take place
• within research projects
• between companies, for clinical trials
• for health care related analysis
• on the following conditions
• donor consent
• samples must be coded or rendered anonymous
• samples must be returned or destroyed after use

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Access to biobank samples

• Biobank samples valuable and limited sources of
  information
• Who gets access to biobanks in the public sector?
• Swedish law provides no right of access to
  biological samples
• stricter rules than for medical records, health
  data registers and other official documents
• human tissue not fully comparable to other
  sources of information?

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Concepts of anonymity and identifiability

• Anonymity
• A criterion of reasonableness or the absolute
  anonymity criterion?
• In Sweden, the latter, as regards personal
  data...
• What degree of anonymity is at all conceivable
  for human tissue samples?
• If anonymous, should samples be used regardless
  of donors wishes?

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Sample or product?

• Human tissue as raw material
• When does the sample turn into a product?
• Is a stem cell line part of a sample, that must
  be destroyed or de-personalised at the donors
  request? Or is it a product, the results of
  research...
• If the original donor is still identifiable, how
  is privacy and personal integrity protected?
• The new Swedish Act does not provide any
  answers...

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Commercial interests and criminalised financial
gain

• Prohibition of handling human biological material
  (certain exceptions) with a view to gain
• How is this legal concept defined?
• Parts of the human body as such may not be
  commercialised, but services, knowledge and
  products follow different rules...
• Clarifications are called for!

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Regulating biobanks - a difficult task

• Biological material from humans information
  carrier and raw material of extraordinary
  potential, not comparable to any other...
• Still a need for legal harmony in related areas
• Definitions of legal concepts involved must be
  clarified
• anonymity...
• sample or product...
• with a view to gain...
• A careful balance of interests required,
  international standards to be considered...