General provisions
Content and objectives of the proposal
section 1 of this Act contains provisions on the quality and
safety standards for human organs intended for
transplantation to the human body.
The aim of the Act is to protect human health.
Definitions
paragraph 2 of this law the following definitions below
the specified importance.
"Serious adverse event" event that occurs in some
step in the chain from donation
to transplant and can
1. lead to the transmission of a
contagious disease or to
death,
2. be life-threatening or
Disabling or cause
significant loss of functionality
for the patient, or
3. cause or extend
disease or need
hospital care.
Serious adverse reaction unintended response,
including infectious disease,
of the living donors or
the receiver may be related
with any step in the chain from
donation to transplantation,
and as
1. can result in death or
to a life-threatening or
disabling condition,
2. result in significant
disability, or
3. results in or prolongs
disease or need
hospital care.
The competent authority or
delegated institution the authorities or
establishments referred to in the
list of European
the Commission shall provide
Member States in accordance with
Article 8 of the Commission's
implementing directive 2012/25/EU
of 9 October 2012
information procedures for
Exchange between Member States of
human organs intended for
transplant.
Organ 1. Differentiated part of
the human body consists of
different tissues and
maintains its structure,
vascularisation, and capacity to
develop physiological
features with a significant
degree of autonomy, or
2. part of such bodies
referred to in 1 and which is intended
to be used for the same purpose
as the whole body of the
the human body and which
satisfying the requirements of the structure
and vascularisation.
Health care providers government agency, County
in the case of such
Healthcare
authority, the County Council or
the municipality is responsible for and
other legal entity or
individual traders
engaged in health care.
Law (2014:358).
Scope of the directive
section 3 of the Act apply to the donation, testing, characterization,
procurement, preservation, transport and transplantation of
human organs intended for transplantation.
Relationship to other laws
§ 4 subject to this Act or the regulations
has been notified pursuant to the law, personal data Act
(1998:204) in the treatment of personal data.
Notification of serious adverse events and serious
side effects
5 § The caregivers responsible for safeguarding a body
should immediately to the health care provider responsible for the
Transplant agency notify and stated
serious adverse events and serious adverse events
that could affect the Agency's safety and quality.
In the cases of such adverse events or reactions
referred to in the first paragraph is suspected to be linked with a donor
whose bodies were sent to a country within the European economic
area (EEA), the health care provider responsible for
to protect this donor organs immediately notify these
events or adverse reactions to the competent authority or
delegated institution in the country that received the donor's
bodies. Law (2014:358).
5 a § The caregivers responsible for transplanting a
agencies should immediately to the health care provider responsible for
to protect the Agency notify and stated
serious adverse events and serious adverse events
that could affect the Agency's safety and quality.
In the cases of such adverse events or reactions
referred to in the first paragraph is suspected to be linked with a body
received from a country within the European economic
area (EEA), the health care provider responsible for
to transplant body immediate notification of these events
or adverse reactions to the competent authority or delegated
establishment in the country where the Agency murals.
Law (2014:358).
section 6 If a caregiver reporting suspected or actual
serious adverse event or serious adverse reactions
According to 5 or 5 a § or receive notification of such
events or reactions from the competent authority or
delegated establishment located in a country within the European economic
area (EEA), must immediately notify the health care provider
These events and side effects to the Inspectorate for health
and care. Law (2014:358).
Registry
section 7 of the Inspectorate for health and long-term care will be using
automated data processing, keep a register of
activities of health care providers who serve or
transplanting organs. The registry is intended to provide
publicity activities including procurement and
transplantation of organs.
The registry may also be used for monitoring, research and for
production of statistics.
The register may, in the case of personal data include information
only if the healthcare provider and business manager.
Inspectorate for health and long-term care is responsible for
the registry.
Government Announces rules on which authority should have
direct access to the data in the inspection for health and
care records. Law (2012:960).
§ 8 the provisions of the Swedish personal data Act (1998:204) about
rectification and damages shall apply in the case of treatment of
personal information under this Act.
Appropriations
9 § Government or authority the Government determines may
provide for an obligation for health care providers to provide
information to the Inspectorate for health and long-term care for treatment
in the register referred to in section 7. Law (2012:960).
section 10 of the Government or the authority, as the Government determines
may announce further provisions for the protection of the life and
health care providers who serve or transplanting organs
and on the management of bodies.
