Legal Regulation of Transplantation in
Czech Republic
Karel
Schelle[1]
Introduction
The long-expected complex and special legal
regulation of donation, collection and transplantation of tissue and organs was
adopted by the Parliament of the Czech Republic on May 30, 2002, coming into effect on
September 1, 2002. The reason for such a regulation derived from the total
revision of the former system of donation, collection and transplantation of
tissue and organs in the Czech Republic. The new legal regulation replaced the
former insufficient and brief regulation of this topic included in the only
one provision of par. 26 of the Act no. 20/1966 on Health Care as amended
by following acts resuming by other subregulations. The new regulation conforms
the Constitutional Order of the Czech Republic and international agreements
binding the Czech Republic, while the EC acts are not connected with this
sphere.
The main source of the new regulation represents the Act no. 285/2002
on donation, collection and transplantation of tissue and organs and on a
change of several acts (the Transplantation Act). The amendment to the Act no. 140/1961 The Criminal Code,
Act no. 48/1997 on public health insurance and on a change and addition of
several associated acts as amended by
following acts, Act no. 200/1990 on
offences, as amended by following acts, Act no. 20/1966 on Health Care as
amended by following acts (hereinafter Act on Health Care), and Act no.
160/1992 on Health Care at non-public health institutions as amended by
following acts.
The following contribution deals with the medical and legal aspects of
the new regulation of donation, collection and transplantation of tissue and
organs in the Czech Republic, however, not going through the whole agenda.
The
Basic Purpose of the Transplantation Act
The aim of the Transplantation Act is to strengthen the legal
guarantees of a proper process within the collection and transplantation of
tissue and organs and to ensure the protection of rights of living and
dead donors‘ tissues and organs and patients, whom the tissue and organs are
transplanted.
The Concept of the Transplantation Act
The concept of the Transplantation Act and its certain provisions is
comparable to similar regulations within the European countries, mainly in the
European Union countries, respecting The Convention of the Council of Europe
no. 164 on Human Rights and Biomedicine Concerning Transplantation of Organs
and Tissue of Human Origin including its additional protocol on transplantation
of organs and tissue of human origin (hereinafter Convention).
The conception of the transplantation act further derives from the fact
that the personal data of the donor of organs and tissue and their recipients
have to be handled intimately with respect to the professional secrecy
(The Act on Health Care) and to the regulations dealing with the protection of
personal data (Act no. 101/2000 on protection of personal data).
The demand reflecting the secrecy of such information is not to be the
obstacle for the transplantation medical team to obtain necessary information
concerning the donor and is not to be the limit for getting the vital data on
transplantation itself. This all must happen in a manner that respects the
regular data protection. For instance, one donor can in fact provide more
organs and pieces of tissue, which are to be subsequently transplanted to more
recipients. If it is additionally recognised that the donor suffered from
certain disease, the possibility of donor and tissue and organ identification
must always exist. Similarly when the recipients‘ transplant is found to be
diseased and this can be transferred within the transplantation, the person,
who provided the tissue and organ and other relevant persons whom the tissue
and organs were implanted to, must be identified. To be impartial it is
necessary to state that every donor and recipient in the Czech Republic has to
undergo a wide variety of examinations and tests that minimize the possibility
of transplanting damaged or malfunctioning organ or transplanting serious
blood-bound diseases.
The basic principles of the Transplantation Act
The transplantation Act is based on a row of the basic principles
which are mainly the following ones:
·
the
presupposition of the consent with the post-mortal collection of tissue and
organs,
·
the
existence of the register of persons who do not agree with he post-mortal
collection of tissue and organs,
·
obligatory
registration of persons waiting for the transplantation, donors and recipients
of tissue and organs,
·
rule
that the organs and tissue are to be collected from, if possible, the dead persons
and not from the living ones,
·
justice
within the allocation of tissue and organs,
·
the
principle of medical urgency,
·
the
principle of claimants’ equality,
·
the
principle of anonymous donors and recipients,
·
the
existence of the independent Centre for Transplantation Coordination,
·
the
principle of international cooperation in the sphere of tissue and organs
transplantation exchange.
Taxonomy of the Transplantation Act
The Act on donation, collection and transplantation of tissue and organs
and on a change of several acts (transplantation act) consists of 39 paragraphs
divided into eight parts.
Part one - donation, collection
and transplantation of tissue and organs (par. 1 –
32) is formed by:
·
chapter
one – The general provisions (par. 1 and 2) containing the subject of
the regulation and defining several basic terms;
·
chapter
two – The collection of tissue and organs (par. 2 to 16) divided into
three parts – The collection of tissues and organs from the living donors
(par. 3 – 9), The collection from the dead donors (par. 10 – 14) and The
Information for the Relatives of the Supposed Collection and Disapproval with
Post-Mortal Collection (par. 15 and 16);
·
chapter
three – Recipient (par. 17);
·
chapter
four - The National medical register connected with transplantations
(par. 18)
·
chapter
five – The responsibilities of the medical institutions during providing
health care associated with the donation and transplantations of tissue
and organs (par. 19 to 25);
·
chapter
six – The international cooperation (par. 26);
·
chapter
seven – other activities connected with the donation, collections and
transplantations (par. 27 and 28);
·
chapter
nine – the common and temporal provisions (par. 31 and 32)
Part two – the amendment to the
Criminal code (par. 33)
Part three - the amendment to the Public health Insurance
Act (par. 34)
Part four – the amendment to the Act
on Offences (par. 35)
Part five – the amendment to the Act
on health care (par. 36)
Part six - the amendment to the Act
on health care at the non-public medical institutions
(par. 37)
Part seven –
the amendment to the Act on the Czech medical Chamber, Czech Stomatological
Chamber and the Czech Apothecary Chamber (par. 38)
Part eight –
The date of taking effect
The subject of the regulation
The Transplantation Act deals
with the requirements of donation, collection and transplantation of tissue and
organs of the human origin performed exclusively for the purpose of
providing health care while the legal provisions connected with tissue are
valid for cells, too.
The transplantation of
haematopoiesis cells problems is also regulated by the transplantation act.
The
transplantation act does not include the legal regulation of blood donation
because this issue - with respect to its extent of activities and legal
solution – differs from the very delicate and specific sphere regulated by this
act. The donation and collection for the medical science, research and
educational purposes and transplantation within the verification of new medical
procedures is not provided under the transplantation act as well.
The basic terms
For the purpose of
transplantation act the following terms according to par. 2 mean:
a) organs – parts of the human body consists of structural formations of tissue that can not
be substituted by organism if removed from body,
b) tissue and cells – structural parts of human body including
the remnants collected during the surgery, haematopoiesis cells collected from
the bone marrow, from peripheral and umbilical blood with the exception of
organs, blood and its components, genital cells, embryonic and foetal tissue
and organs, hair, nail, placenta and waste products of the body metabolism
(hereinafter „tissue“)
c) the possible donor – the patient who is – with respect to
his/her health status – supposed to die and provide the possibility of
collecting the tissue and organs, or the body of a dead person that was proved
to be dead and that is presupposed to be the object of tissue and organs
collection
d) donor – the person or the body of a dead person who/that is
the object of collection of tissue or organ for the purpose of transplantation,
e) death – the irreversible loss of function of the whole brain
including brainstem,
f) claimant – the person registered in the national register of
persons waiting for the organs transplantations,
g) recipient – the person whom the tissue or organ of the human
origin is implanted
h) collection – all the surgical procedures necessary for the
collection of human tissue and organs designated for transplantations including
examination for the purpose of the donors health capability assessment and
his/her preparation for the collection,
i) donation - the
collection from the living donor including the health care provided for the
purpose of convalescence after the collection
j) transplantation – the process aimed at the collected tissue or
organs preservation in the stable quality for implantation and the implantation
of the tissue and organ to the recipient itself including all the procedures of
preparations, autopsy and necropsy and preservation of tissue and organs.
Note: If the transplantation Act deals with the term Donor and
donation it has another meaning than in
the general legal regulations concerning the donation.
The tissue and organs collection from the living donors
The strict general
conditions under which it is possible to collect the tissue and organs from the
living person are defined in the par. 3/1 of the transplantation act. These
conditions derive from the basic principle that organs and tissue are to be,
if possible, collected from the dead persons and not from the living ones.
The collection from the living persons is always associated with certain
risk and can cause consequences (from less serious such as the healing of
the operation wound malfunction, the complications connected with the surgery
performance itself, to the serious and live threatening
complications connected with the malfunction of the remaining kidney or
parts of the liver). That is why the surgery procedures during the tissue and
organs collection from the living donors are modified to minimise the risks in
the Czech Republic. Despite this fact there is no reasonable argument for
getting the transplant from any living donor if there is another way which
brings the same benefit to the recipient. The reason for such transplantation
can be justified only in the case when there is no other way that would
bring comparable result (e.g. dialysis is not considered from the point
of view of the patients’ life quality comparable to the transplantation of the
kidney although the first enables long-lasting survival of patients with kidney
malfunction).
The paragraph 2 determines
other special conditions for the collections of organs which is compliant with
the Convention. The collection of the living-donor organs for the recipient who
is the so-called close person is only possible when the donor expressed free,
informed and certain consent.
However, the instances when
it is necessary to enable donation to the person who does not belong to
the sphere of the so-called close persons may occur (e. g. in case of patients
with a rare blood type, patient of an abnormal habit, i. e. in the cases when
waiting for the dead donor would be long enough that the patient could die
before the transplantation). This cases are however exceptional and may be
associated with the speculative motive for the organs donation. Therefore the
legal regulation tightens the conditions for the donation and requires:
1. the explicit written declaration of the
donor’s will
to donate the organ to the recipient with his/her signature attested by a
notary and
2. the consent of the ethic commission
(par. 5) and its supervision over the transplantation.
The collection from the living donor is not allowed (par. 3/3) if the
projected collection is too dangerous for the health or life of the living
donor or if there is a reasonable suspicion that the donor suffers from disease
or condition which could harm the health or life of the recipient (e. g. the
donor has malignant tumour or blood-bound disease). It is not so if the risk of
harming the recipient’s health is negligible compared to the life-saving
transplantation.
Note: The certain risk of disease transmission is acceptable only in
case if the consequence, when the transplantation does not take place, means a
greater risk for the recipient. If the sure death is the alternative, it is in
some cases acceptable to transplant even being aware of disease transmission.
For example in case of rapidly developing liver malfunction, the patient can
have only several hours of life left; that‘s why the transplantation of a risky
organ should be preferred. Life-saving procedure is also the transplantation of
haematopoiesis cells. The performing of these transplantations is ruled under
the principle of medical urgency while the recipient is thereafter preferred in
the list of claimants after using the transplantation centres within the
international cooperation.
The par. 4/1 defines the strict
conditions under which it is possible – in the exceptional situations
– to provide the collection of recoverable tissue from the persons who
are not able to prove the consent such as the minor persons, the persons
without legal capacity or persons with limited legal capacity (hereinafter
person without legal capacity) and persons who are – with respect to their
mental and health conditions – unable to express their competent permission
(hereinafter person unable to express permission). In general, the collections
from these persons are not allowed according to the Convention.
Note: These exceptions are legitimate because the recoverable tissue,
mainly bone marrow, can be transplanted only among genetically compatible
persons. Nowadays, this paragraph deals mainly with the bone marrow
transplantations. The term recoverable tissue has been formulated with respect
to the future development of medical science.
According to par. 4/1 the following conditions have to be fulfilled:
a) there is no other proper donor who is able to give the explicit and
certain consent,
b) the recipient is a donor’s brother or sister,
c) donation represents the only possibility of saving recipient’s life,
d) legal representative of the donor who is a minor person or a person
without legal capacity expressed the permission with the collection,
e) the ethic commission expressed its consent with the collection, and
f) this donor does not disagree.
Compliant
with the requirement of the Convention is in addition to permission
expressed by the legal representative of the person unable
to express permission as well as the consent of the ethic commission.
The aim of this dual permission is to ensure that the intended decision
concerning the collection of recoverable tissue is impartial.
In some cases, the procedure represents almost no risk or great stress
for the donor (e.g. collecting limited amount of dermal cells or small amount
of bone marrow). In such cases of cell collection from the persons specified in
par. 4/1 this is not necessary to fulfil the conditions that the
recipient is brother or sister of the donor or that the donation is the only
way to save the recipient’s life. (par. 4/2).
The ethic commission (par. 5) is an independent
commission which is constituted and dissolved by the statutory body of the
medical institution providing the collection of the organs for the benefit of
the recipient who is not the so-called close person or recoverable tissue for
the benefit of minor persons, persons without legal capacity or persons unable
to express the permission (par. 4/1). The ethic commission can be constituted
as a permanent commission or an ad hoc commission. The ethic commission
comprises at least five members; it is formed by physicians, a clinical
psychologist and by a lawyer. The members of the ethic commission can be only
individuals without any personal concern or participation in the collection
procedure.
The ethic commission provides after proving its consent the supervision
over the procedure and protection of the rights of donor, minor person or
person unable to express his/her permission. The commission should observe -
before getting the consent - whether the donor is not under pressure or whether
he/she did not decide with the promise of profit for him/herself or e. g. for
other close persons.
It is necessary to validate the health capability of the living donor before
the collection itself (par. 6). Pursuing this task, such medical
examinations and procedures which can evaluate the health condition of the
living donor (aimed at searching for the diseases that could mean a risk of
damage to health for the recipient - e. g. malignant tumours or blood-bound
infections) and possible risks for health and life of the recipient connected
with donation of tissue or organs have
to be taken. The main risk for the donor is represented by a surgical procedure
during the collection or adaptation of the organism after the organ collection
(e. g. kidneys or part of the liver). There are, however, some psychological
risks (abnormal sense of ownership attitude between the donor and the recipient
or the recipients feeling in debts to the donor); therefore it is necessary to
assess the psychological condition of the donor as well.
The collection from the living donor can be realised after the donor or
his/her legal representative gave the written permission based on free will
that can be cancelled any time (par. 7).The donor or his legal representative
has the right to information covering the tissue or organ donation. The
information have to be presented in a proper and understandable way for the
donor or the legal representative in order to clarify the purpose, character
and results of the tissue and organ donation and associated possible risks
including the long/term ones.
The provision of par. 8/1 stresses the condition that the
collection of organs from the living donor can be performed only for the
benefit of the explicitly determined
person (par. 3/2) and the condition to respect the will of the living
donor of tissue who qualified their collection only for a certain individual.
The procedure in the case that the collected tissue or organ cannot be
implanted to a designated person (e. g. this person has died or its health
status has changed or the impossibility to perform the transplantation has been
recognised during the surgery itself) to respect the will of a donor even in
this cases is defined in the par. 8/2.
The provision of par. 9 deals with cases when tissue and organ collection
is done for other reasons than for transplantation and later on there is a
need for their donation. For example in case of combined transplantation of
heart and lungs the recipient’s heart or his/her valves are in such a good condition
that can be used as a transplant for another claimant. Or during the surgery
the tissue that can be modified and later transplanted to the third person are
collected even if considered useless during the procedure (e. g. bone tissue
from the femur heads that was gained during the substitution hip joint or use
haematopoiesis from the umbilical blood).
It is necessary to instruct in such cases the person
(par. 9) whose tissue or organ has been collected from other reasons
than the transplantation about the consequences and possible risks which the
implantation of tissue and organs to recipients body carries (about the
necessity of another detailed examination and of recording all the information
in order to monitor the tissue and organs, sometimes even about the necessity
to at least change the procedural duration slightly to gain the tissue and
organ in the best possible quality) and to ask for his/her permission for
using them for transplantation. The transplant gained in this way are
usually applied with a lap of time and therefore preserved in tissue banks.
The dead donors’ collection
The sphere of tissue and organs donation after death is regulated in various countries differently; that is why
the Convention that was the main source for the legislator does not provide the
general valid regulation. The Convention admits the existence both the
presupposition of the permission to and the presupposing of disapproval with
the post-mortal collection of tissue and organs.
The application of the presupposition of disapproval principle in
the legal regulation (the patient must express his/her permission with the
post-mortal collection during his/her life) leads to the result that in the
cases when the person does not indicate any attitude towards the
transplantation, however not willing to deny the post-mortal transplantation
makes it impossible. Implementing such principle would significantly limit the
possibilities of transplantations and thus saving lives.
Therefore the presupposition of permission principle was chosen
in the Transplantation Act (par. 16). The National register of persons who
disagree with the post-mortal collection of tissue and organs is created in
order to strengthen the legal safeguard.
The collection of tissue and organs from the dead person can be only
performed if the person or the legal representative of minor person or the
legal representative of a person without legal capacity did not provably
expressed disapproval. Disapproval is obvious when the dead is registered
in the National register of persons who disagree with the post-mortal
collection of tissue and organs or this disapproval expressed in the statement
(the legal representative of minor person or the legal representative of person
without legal capacity similarly) made in the health institution which is
obliged to send the statement to the National register of persons who disagree
with the post-mortal collection of tissue and organs. It is necessary to record
the statement in the health care documentation. The permission or the
disapproval with post-mortal collection is always univocally expressed and
simultaneously the health care institution providing the collection has this
information always available and the undesirable possible delay caused by
acquiring the evidence of such statement will not occur.
The collection from the dead donor can be performed only in case of
death certification (par. 10/1). That’s why the
transplantation act states in its par. 10 the conditions for impartial,
independent and objective death certification; the physicians who certify the
death cannot participate in collection and transplantation and cannot be the
doctor taking care of the potential recipient. Further specification for the
death certification regulates according to the Transplantation Act the Ministry of Health order. Such form has been
chosen due to its flexibility to reflect the development of medical science;
this would be impossible through the legislative process.
Per.
11/1 regulates the situation when the collection of tissue and organs from the
dead persons (e.g. the dead person cannot be identified) is prohibited.
Another
situation when the collection from the dead donor is inadmissible emerges in
the par. 11/4 stating the collection from the deceased foreigner can be
performed only under the conditions provided in the international agreement
binding the Czech Republic.
The
physician who realised the collection of tissue or an organ records the list of
collected tissue and organs and the presumptive purpose of their application to
the donor’s health care documentation.
The
body of a deceased which was the object of collection has to undergo the
necropsy according to special legal regulation (Act on Health Care).
The
legislator avoids in par. 14 in accordance with the ethic principles the
situation when the bodies of the deceased would be delivered undignified to the
survivors after the collection or necropsies. Therefore the act regulates the
obligation to handle the body of the dead during the collection process and
during the necropsies with respect and, if possible, to put the body into
the original condition after performing these procedure.
The
interest of the so-called close persons, mainly their emotional attitudes
towards the patient, is respected by par. 15 which regulates the obligation
of the doctor to inform such persons about supposed collection and
simultaneously give them relevant explanation if the person proves to be
interested in the patient’s condition. The close persons are to be informed
but are not to be considered to give the substitutional permission;
in these cases the individual’s rights to decide is preferred. Regulating the substitutional
permission would cause when the close persons would express their own
wishes instead of the will of the deceased.
Recipient
The
selection of the most appropriate recipients is based according to par. 17/1 on
the principles of medical urgency and equality of the claimants; the
total duration of claimant’s registration in the National register of persons
waiting for transplantation is also taken into account. This provision is not
applied in the case of collection from the living donors, because this method
is regulated by par. 3/2.
The
recipient or the legal representative of minor persons or persons without legal
capacity has to be informed in advance about the reason and character of
transplantation, its consequences and associated risks as well as alternative
ways of treatment. This information is to be precise and provided in the way understandable
for the recipient. Subsequently the recipient or the legal representative has
to grant consent to realization of the transplantation. This consent is
supposed if it is not possible to request the recipients or legal
representatives’ permission and the transplantation is inevitable.
According
to par. 17/4 the medical documentation of a donor connected with the collection
(particularly the data concerning the health condition) is part of the recipient’s medical documentation
in order to find out the source of the collected tissue and organs any time.
The records must keep the anonymity of an individual donor.
The National medical registers related to transplantations
The
national registers consist according to par. 18/1 of:
·
The
National
register of persons who disagree with the post-mortal collection of tissue and
organs administered
for the possible conflict of interests
by another organisation – Coordination centre for the department of
medical information systems (formed by the Ministry of Health),
·
The
national register of tissue and organs donors (includes all the registered living and dead donors),
The National register of persons waiting for organ transplantation
(involves all the patients indicated for renal, hepatic, pulmonal, cardial,
pancreatic transplantation and for combined renal and pancreatic
transplantation), The National register of tissue and organ transplantations
performed that is administered by the independent Coordination centre for
transplantations.
The duties of the medical institutions within the issue and organs
donation and transplantation.
The
transplantation act provides in its special provisions of par. 20/1 the
principle of donor’s and
recipient’s anonymity; it respects the anonymity of:
a)
the dead donor towards the recipient,
b)
the living donor towards the person specified in par. 3/2 if it is the wish of
the donor,
c)
the living donor of recoverable tissue if not
a person defined in par. 3/2.
The
provision of par. 20/2 introduces the responsibility of the medical staff to
inform the nearest transplantation centre about the patients who are to become
donors in case of their supposed death.
The transplantations centres (par. 22/1) can be founded only with
the permission of the Ministry of Health as a part of a hospital. The
transplantation centres are institutions of highly specialised care
performing collections and transplantations of haematopoiesis cells and
organs in the extent defined in the decision of medical institutions
licence.
The medical institutions that are not the
transplantations centres realise the tissue collections and
transplantations (e.g. cornea, lens, vascular grafts, cordial valves, osseous
grafts) in the extent defined in the decision of medical institutions licence
(par. 21/1).
The tissue bank (par. 23/1) is determined to provide
the transplantation, further processing, examination, conservation , storage
and distribution of tissue grafts for transplantation. The tissue bank can only
be founded with a permission of the Ministry of Health as part of a hospital offering specialised or
even more specialised care.
The centre for searching for the haematopoiesis cells donors (par.
24/1) is designated for searching non-relative donors of haematopoiesis
cells, their examination and
mediates the transplantation of haematopoiesis cell from non-relative donors. The centre for searching
the haematopoiesis cells donors can only be founded with a permission of the
Ministry of Health. The centre for searching the haematopoiesis cells donors is
authorised to perform activities connected with searching the potential donors
of haematopoiesis cells, to administer the register of potential donors of
haematopoiesis cells and to support the international cooperation within
performing the exchange of haematopoiesis cells for transplantation.
The coordination centre for
transplantations (par. 25/1) was created by the Ministry of health to
ensure and mediate the transplantations; the activities are subsidised from
the ministerial budget directly. The coordination centre for transplantations
is absolutely independent on transplantations centres from the material,
spatial, personal and technical point view.
International cooperation
The
transplantation act regulates relations connected with the international
cooperation in the tissue and organs exchange as well. The conception of the
legal regulation derives from the two points of view:
1. the information covering the
organisation of the transplantation system and the efficiency of the provided
services should be freely accessible that all countries are able to reach the
most effective transplantation programmes reflecting the sources they possess,
2. the problems connected with the
tissue compatibility or with serious patient status may require the
collaboration of a major part of population if the transplantation is to be
successful (e. g. finding a proper non-relative donor of the bone marrow
requires extensive group of donors). That is why if a country that does not
have a proper recipient on the claimant list, posses the suitable organ, it is
necessary to offer it quickly to patients registered in other countries; to
avoid the event the organ will not be used.
According
to par. 26/1 the international exchange of tissue and organs for
transplantations is tolerable only in case when the task is to find the most
proper recipient or to save the claimant whose live is directly endangered;
another condition includes the membership in the international transplantation
organisations or such an obligation coming out from the international agreement
binding the Czech Republic.
According
to par. 26/2 the offer of tissue and organs abroad within the international
exchange of tissue and organs is possible only if the is no suitable claimant
registered in the Czech Republic or if it is a procedure emerging from the
membership in the international organisations.
When
accepting the tissue or an organ from abroad the state has to guarantee that
the tissue or the organ has been acquired in compliance with the legal
regulation of the state of origin (in a legal way) and to prove that the health
condition of the donor has been examined before the collection and the medical
documentation of a donor connected with the collection has to be accessible
(the donors must be fully identifiable in accordance with the Convention).
Making the information public
Although
the tissue and organs transplantations are part of health care offered to
patients with the effort to save human lives and to improve their quality it is
essential to take special steps to advertise the tissue and organs donation.
Therefore
the Ministry of Health arranges the public awareness of the importance and
possibilities of tissue and organs donation, particularly donation of
haematopoiesis cells, of the way how to express the disapproval with the
post-mortal collection and of the importance of transplantations. It
simultaneously cooperates with other administrative bodies and local
authorities, health insurance institutions, medical institutions, professional
organisations and other bodies and institutions.
Note: Regarding the deficiency of organs it is necessary to permanently
and systematically inform the general and professional public about the successes
and contributions of transplantations. It is inevitable to popularise the
donation of tissue and organs from dead persons as well as the voluntary
donation of haematopoiesis cells.
The prohibition of financial profit or other benefits and tissue and
organs business
The
legislator explicitly presents in par. 28 numerous clauses of prohibited acts
in order to avoid the abuse transplantations:
(1) human body and its parts must not
be the source of financial benefit and other privileges,
(2) donor or other persons must not
assert any claims towards the recipient,
(3) advertising with the purpose of
demand and offer of tissue and organs is prohibited; the procedure in
accordance with par. 27 is not considered advertising,
(4) tissue and organs business is prohibited.
Sanctions against illegal acts
Non-performing
or breaking the numerous clauses of duties or prohibitions given by the
transplantation act can be fined under this law. This fine is imposed on
the medical institution by the administrative authority that licensed this
institution. The fine on legal persons and individuals - not being a medical
institution - conducting a business on their own is imposed by municipal
authorities of the person’s residence.
Note: E. g. the medical institution is fined up to 100.000 CZK and legal
persons and individuals conducting their business on their own up to 500.000
CZK for breaking the provision of par. 28/3.
The common and temporal provisions
According
to par. 32/1 the medical institutions providing the collections and
transplantations, transplantations centres, tissue banks and centres for
searching for donors of haematopoiesis cells and parts of medical registers must
(par. 18) meet the conditions given by the transplantation act after
2 years maximum from its coming into effect.
Amendment of the Criminal Code
The
transplantation act brought a following amendment of the criminal code that
allow to criminalize the illegal collection of tissue and organs from the
body of a dead or illegal handling with collected human tissue or collected
human organ. New rei gestae of the criminal act “illegal handling with tissue
and organs” mentioned in par. 209a of the criminal code do not include the
cases of the illegal collection of tissue or organ from the living person
because these instances have already been persecuted in the criminal code with
wide range of provisions depending on the form of mens rea and caused result
(from blackmail or oppression, via intentional
or negligent bodily harm, intentional or negligent cause of damage of
ones heath, to murder).
Act on offences amendments
The
transplantation act brought a following amendment of the act on offences which
define new rei gestae of offences in the sphere of health care regarding the
breach of duties and prohibitions specified in par. 18 and 28 of the
transplantation act.
Financial sustaining of donation, collection and transplantation of
tissue and organs
The
medical care for living donor connected with the collection of tissue and
organs, the collection itself, necessary handling with collected issue and
organs and the transport of living donor and transport of dead donor is covered
by the health insurance institution where the donor has been registered (par.
35 of the amended Act on public health insurance).
Note: The public funds are the main source for covering the
procedures connected with donation,
collection and transplantation. Par. 35a clarified the former uncertainty and
frequently heterogeneous practice of carrying the expenses on collections and
transplantations in the Czech Republic.
Concluding summary
Although
some reservations about the accepted transplantation act still do exist there
is no need to doubt its current
significance. Even during the legislative process the voices of some
legislators stressing the need for quick amendment could be heard.
The
new amendment should be created on the grounds of multidisciplinary and
multidimensional attitude. It must in particular:
1. meet the needs for the further increase
of efficiency and organisation of the transplantation system in the Czech
Republic and for the requirement of financial and personal optimization for its
best performance,
2.
meet the current level of medical science,
3. to be compliant with the constitutional
order of the Czech Republic and international agreements binding the Czech
Republic,
4. follow the objectified and
generalised experience from other countries with advanced transplantation
systems.
[1] Doc. JUDr. Karel Schelle, CSc., Faculty of Law of Masaryk University, Brno, Czech Republic (e-mail: karel.schelle@schelle.cz). Co-authors: MUDr. Tomáš Ostøížek, JUDr. et RNDr. Vlastislav Man