Legal framework of the Finnish Cancer Registry

The legal framework has three main, interlinked components:

1) legislation concerning personal data and medical registries,
2) legislation and ethical norms concerning research, and
3) general administrative norms and other legislation
with implications on registry activities.

1.1. Act on National Personal Records Kept under the Health Care System (1989)
(Act on National Health Care Registries with Personal Data)

    • authorises Board of Health to have medical registries
    • authorities, institutions and health care personnel must submit data (overruns confidentiality)
    • data can be used for research purposes
    • data cannot be used for individual decision making (hospitals, insurance ...)

1.1.1. Decree on National Personal Records Kept under the Health Care System (1989)

    • cancer registry among 9 other specified registries
    • mass screening registry is a part of the cancer registry
    • describes purpose of registration
    • describes types of data collected Instructions by Board of Health (administrative norm, 1990)

    • a notification must be made concerning each tumour that is identified, even if someone else may also make a notifification
    • defines sources
    • instructs in filling in the notification form (data items listed)
    • describes the types of neoplasms to be notified

1.2. Personal Data Act (1999)

    • follows EC Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data
    • allows cancer registration without consent
    • allows use of data for scientific and statistical research
    • restricts right of access to data by individuals

2.1. Act on the Medical Use of Human Organs and Tissues (2001), i.e., biobanks

    • always informed consent (except if analysis performed and registered before 1 Sept. 2001)
    • National Authority for Medicolegal Affairs can lift the consent if
      • samples were collected for diagnostic or therapeutic purposes AND number of samples is large, samples are old or patients are dead
      • samples were collected for medical research purposes AND patients are dead

2.2. Act on the National public Health Institute (modified in 2001)

    • exempts informed consent for research using Institute's biobanks

2.3. Act on Medical Research (1999)

    • if intervention
    • always informed consent
    • ethical committees obligatory
    • contact with patient via treating physician or institute

3. Other Acts

    • Act on the Openness of Government Activities (1999)
    • Act on Patients' rights (1992, modified)
    • Act on the Use of Radiation (1991, modified) - related to mammography screening