introduction to the medical and health care law (fall ...ffffffff-abbe-0b59... · on embryos and...

Universität Luzern

Rechtswissenschaftliche Fakultät

Prof. Dr. Bernhard Rütsche

made on 21.09.2010

PhD BmEL / Medical Track

INTRODUCTION TO THE

MEDICAL AND HEALTH CARE LAW

(Fall Semester 2010)


PhD BmEL / Medical Track / Introduction 2010

2

I. Subjects for presentation

1. Significance of international soft law for the new Federal Statute on research in-

volving human beings.

2. Convention of the European Council on Human Rights and Biomedicine: Influ-

ence on the Swiss legal system.

3. The jurisdiction of the European Court of Human Rights (ECHR) in the field of

reproductive medicine.

4. The jurisdiction of the Federal Supreme Court of Switzerland and the European

Court of Human Rights (ECHR) concerning assisted suicide.

5. Legal framework for the development of medicinal products for children in the

European Union and in Switzerland.

6. Authorization of products of complementary medicine in Swiss law.

7. Off label use of medicinal products in Swiss law.

8. Health Claims according to European Union law.

9. Criteria for the allocation of donated organs in Swiss law.

10. The prohibition of commercialising transplant products.

II. Powerpoint slides

Contents (I)

1. Health Care, Medical and Biomedical Law

− Definitions

− Diagram

2. Sources of National Health Care Law

− Overview

− Federal Powers

− Fundamental Rights

− Substantive Constitutional Norms

− Federal Laws

− Cantonal Laws

− Soft Law



3

Contents (II)

3. Sources of International Health Care Law

− Overview

− Treaties

− Soft Law

4. Protection of Public Health

− Overview

− Medicinal Products and Medical Devices

5. Medical and Biomedical Law

− Overview

− Transplant Medicine

1. Health Care, Medical and Biomedical Law:

Definitions

• Health care law

� All legal provisions concerning the prevention and treatment of

diseases and its consequences as well as the promotion of public

health

• Medical law

� All legal provisions concerning the exercise of medical

professions, particularly the doctor-patient-relationship

• Biomedical law

� In the wide sense: all legal provisions concerning the application

of medicine and biology to human beings

� In the narrow sense: all legal provisions concerning a subarea of

medicine in which biological methods (cell and molecular biology)

are applied



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1. Health Care, Medical and Biomedical Law:

Diagram

• Transplantation medicine

• Reproductive medicine

• Human gene technology

(gene therapies, genetic screening)

• Biomedical research on human beings, esp.

on embryos and embryonic stem cells

• Public health protection- Medicaments - Drugs - Chemicals - Food - Safety at work- Radiation protection- Non-human gene

technology- Etc.

• Social insurances- Health insurance- Disability insurance- Etc.

• Hospital organisation and planning

• Research on human beings in health care matters

• Informed Consent

• Medical due diligence

• Coercive treatment and examination

(in cases of emergency, pandemia, preventive

detention)

• Assisted Suicide

• Abortion

• Data protection (esp. professional secret)

• Medical professions: formation and admission

• Medical research on human beings

A. Pandemic Act

Facts:

The Federal Act of 18. Dec. 1970 on the control of pandemic human diseases (Pandemic Act; SR 818.101) regulates inter alia:

� Federal measures:

• Information of the population

• Education and formation of professional staff

• Recognition of laboratories

• Supply with medicaments

� Cantonal measures:

• Providing for installations appropriate for isolation and treatment

• Ordering isolation, medical observation, examination and vaccination

• Prohibiting public events, closing schools and other public as well as private institutions

Question:

To which legal discipline does the pandemic act belong to?



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2. Sources of National Health Care Law:

Overview

Federal powers Fundamental rightsSubstantive

constitutional norms

Case law

(Federal Court)

Federal laws and

ordinances

Cantonal laws and

ordinancesSoft law


Federal Powers

General powers

� Art. 95 Cst.: professional activities in the private sector

� Art. 111-117 Cst.: social insurances

� Art. 122 Cst.: civil law

� Art. 123 Cst.: penal law

Specific powers

� Art. 118 Cst.: health protection

� Art. 118b Cst.: research on human beings

� Art. 119 Cst.: reproductive medicine and gene technology involving

human beings

� Art. 119a Cst.: transplant medicine

� Art. 120 Cst.: non human gene technology



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B. Complementary Medicine

Facts:

On 17 May 2009, People and Cantons have adopted the constitutional initiative "Future with complementary medicine". The new constitutional article 118a reads as follows:

"The Confederation and the Cantons shall within the scope of their

powers ensure that consideration is given to complementary medicine."

Question:

Does this article provide new federal powers?

C. Research on Human Beings

Facts:

On 7 March 2010, the Swiss People and the Cantons have adopted a new constitutional article regarding research on human beings (art. 118b Cst.). Section 1 provides a new federal power and reads as follows:

"The Confederation shall legislate on the research on human beings, as far as it is required in order to protect human dignity and personality. In doing so, it shall respect the freedom of scientific research and take account of the importance of research for public health and society."

Question:

Compare this federal power with those conferred in art. 119 and 119a Cst. Are there some structural differences between these powers?



7


Fundamental Rights

• Human dignity

• Equality before the law and prohibition of discrimination

• Right to life

• Personal freedom

• Right to assistance when in need

• Right to privacy

• Freedom of religion and conscience

• Freedom of scientific research

• Economic freedom

Physical and mental integrity

Fundamental aspects of personhood

Freedom of movement

Respect for private and family life

Protection against misuse of

personal data

Acces to data relating to ancestry

D. Organised assisted suicide

Facts:

The Federal Council intends to restrict the activity of euthanasia organisations by revising the Penal Code (Consultation proposition of 28. Oct. 2009). The proposition contains two options. One of them has the following wording:

"A person who, for selfish reasons or as a member of an assistedsuicide organisation, incites someone to commit suicide or who assists that person in doing so shall, if the suicide was carried out or attempted, be sentenced to a term of imprisonment of up to five years or a monetary penalty."

Questions:

1. Which fundamental rights are being restricted by this provision?

2. Which fundamental rights are being protected by this provision?

3. Does this provision comply with the Constitution?



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E. Hunger strike

Facts:

Mr. X, a Swiss farmer, has been sentenced to five year imprisonment for repeatedly having planted and harvested cannabis plants on his fields. After some months in prison, X begins a hunger strike. As he communicates to the prison staff and the present media, he is only willing to stop the hunger strike if he is allowed to serve his sentence at home wearing electronic tags.

After several days, X's state of health has worsened so much that a artificial feeding is necessary to save his life. Hereupon, the director of the prison orders the prison doctor to undertake artificial nutrition and hydration of X, thereby using force when necessary.

Question:

Is the artificial feeding of X a violation of fundamental rights?

F. Compulsory vaccination for doctors and nursing staff

Facts:

Even though the Swiss Federal Office of Public Health recommends the use of antiviral drugs for doctors and nursing staff as a prophylaxis of pandemic influenza (H1N1-virus), a majority of the medical staff refuses to follow this recommendation. In many hospitals only 20 to 30% of the medical staff have had the H1N1-vaccination. The newly elected Head of the Federal Department of Home Affairs, Didier Burkhalter, commented in a recent radio interview that the Federal Council should impose a compulsory vaccination for all doctors and nursing staff.

Questions:

1. Would the Federal Council be competent to impose a compulsory vaccination for all doctors and nursing staff?

2. Is this compulsory vaccination in conformity with the fundamental rights?



9

G. Prohibitions of Reproduction

Facts:

The Federal Act of 18 Dec. 1998 on medically assisted human reproduction (Reproductive Medicine Act; RMA; SR 810.11) contains in Art. 3 under the title "welfare of the child" a number of reproductive prohibitions:

1 Procedures involving medically-assisted procreation may only be used if the wellbeing of the child is ensured.2 These procedures should only be used by couples:

a. where a relationship with the child can be established according to Articles 252–263 of the Swiss Civil Code (CC) and

b. who, based on their age and personal relations seem able to take care of and bring up a child until it becomes an adult.

3 Only married couples may use donated sperm.4 After the death of a person, gametes or impregnated ova from that person may no longer be used.

Question:Do these prohibitions of reproduction comply with the Fundamental Rights?


Substantive constitutional norms (I)

• Art. 119 Abs. 2 FC:

� Prohibition of cloning and prohibition of interference with the genetic material of human reproductive cells

� Prohibition of creation of hybrids

� Restriction of the scopes of procedures for medically assisted reproduction; requirement of a basis in a federal act for in-vitro-fertilisation; prohibition of a methodical creation of surplus embryos

� Prohibition of the donation of embryos and all forms of surrogate motherhood

� Prohibition of trade in human reproductive material and in products obtained from embryos

� Requirement of a basis in a federal act for the collecting and editing of human genetic data

� Right of access to data relating to ancestry

• Art. 119a Abs. 3 FC:

� Donation of human organs, tissues and cells is free of charge

� Prohibition of trade in human organs



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Substantive constitutional norms (II)

• Art. 118b Abs. 2 (new) FC:

For research on human beings concerning the fields of biology and

medicine the following applies:

� Informed consent; requirement of a basis in a federal act for exemptions;

objection as an absolute limit

� No inadequacy between risk/burdens and benefits of a research project

� Subsidiarity of research on persons lacking mental capacity; minimal risk and

burden of research on persons lacking mental capacity

� Independent examination

H. "Reasonable regulation of reproductive medicine"

Facts:

An action group "for a reasonable regulation of reproductive medicine" would like to launch with the help of members of Parliament an approach regarding a total revision of the Reproductive Medicine Act. Thereby – among other things – the following is claimed:

• Creation of a necessary (essential) legal basis regarding the adoption of supernumerary embryos.

• Authorisation of preimplantation genetic diagnosis (PGD)

� for couples with hereditary burden

� for couples with fertility problems (issues)

� for couples of advanced age and

� for the selection of immune-compatible embryos

• Authorisation of human embryo research with the intention to improve the success rate of the procedure for reproductive medicine.

Question:How far is the Federal Legislator authorized to implement the abovementioned requests without having to change the Constitution?



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Federal Laws (I)

Protection of Public Health

• Federal Act of 3 Oct. 1951 on Narcotics and Psychotropic Substances

• Federal Act of 15 Dec. 2000 on Medicinal Products and Medical Devices

• Federal Act of 15 Dec. 2000 on Protection against Dangerous Substances and Preparations

• Federal Act of 22 March 1991 on Radiological Protection

• Federal Act of 21 March 2003 on non human Gene Technology

• Federal Act of 9 Oct. 1992 on Foodstuffs

• Federal Act of 18 Dec. 1970 on Epidemic Diseases

• Federal Act of 19 March 1976 on Security of Technical Equipment and Devices

• Federal Labour Act of 13 March 1964

• Federal Act of 20 March 1981 on Accident Insurance


Federal Laws (II)

Medical and Biomedical Law

• Federal Act of 18 Dec. 1998 on Medically Assisted Human Reproduction

• Federal Act of 8 Oct. 2004 on the Genetic Testing of Humans

• Federal Act of 8 Oct. 2004 on the Transplantation of Organs, Tissues and Cells

• Federal Act of 19 Dec. 2003 on Research Involving Embryonic Stem Cells

• Federal Act of 23 Jun. 2006 on Academical Medical Professions

• Federal Act of 17 Dec. 2004 on the Requirements and Procedures of Sterilizations

• Swiss Civil Code of 10 Dec. 1907:

Protection of Personage, Parental Rights, Protective Confinement inter alia.

• Swiss Code of Obligations of 30 Mar. 1911:

Tort Law, Employment Contract, Mandate and others

• Swiss Penal Code of 21. Dec. 1937:

criminal acts against life and integrity, professional secrecy and others



12


Cantonal Laws

Selection of Acts of the Canton of Zurich:

• Act on Public Health of 2 April 2007

• Ordinance of 28 Mai 2008 on Academical Medical Professions

• Ordinance of 8 Jan. 1992 concerning Health Care Professions

• Ordinance of 1 Dec. 2004 concerning non-medical Psychotherapists

• Ordinance of 21 Mai 2008 on Therapeutic Products

• Patient Act of 5 April 2004

• Liability Act of 14 Sep. 1969

• Law of 27 Sep. 1998 concerning the Personnel of the Canton of Zurich

• Executive Ordinance of 19 Mar. 1975 concerning the Federal Act on Epidemic Diseases

• Ordinance of 21 Mai 2008 on the Combating of Substance Abuse

• Ordinance of 7 March 1963 on Funerals


Soft Law (I)

• Medical-ethical guidelines and recommendations of the Swiss Academy of Medical Sciences (SAMS), particularly

� Guidelines for research on humans

� Testaments of patients (2009)

� Live solid organ donation (2008)

� Collaboration between medical professionals and industry (2006)

� Coercive measures in medicine (2005)

� The Determination of Death in the Context of Organ Transplantation (2005)

� Care of patients in the end of life (2004)

� Somatic gene therapy in humans (1998)

• Professional code of conduct FMH (Swiss Medical Association), original version of 1998, amended version of 2008, particularly in regard to the following areas:

� Conduct towards patients

� Conduct towards colleagues

� Conduct towards funding agencies (cost items)



13


Soft Law (II)

• Opinions of the Swiss National Advisory Commission on Biomedical Ethics (NEK), in particular

� On research with children (16/2009)

� Preimplantation Genetic Diagnosis II (14/2007)

� Duty-of-care criteria for the management of assisted suicide (13/2006)

� Research involving human embryos and fetuses (11/2006)

� Preimplantation Genetic Diagnosis (10/2005)

� Assisted Suicide (9/2005)

� Sterilisation of persons incapable of making a rational judgment(7/2004)

� On the regulation of living donoation in the transplantation law (6/2003)

� On human reproductive cloning (4/2003)

� On embryonic stem cell research (3/2002)

� On term regulation (2/2002)

I. Significance of national Soft Law

Questions:

1. What is the legal function and meaning of

a) the SAMS-Guidelines?

b) the Professional code of conduct FMH

c) the opinions of the NEK?

2. Can or should soft law supplement or replace national law? If yes, in

which areas?



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3. Sources of International Health Care Law:

Overview

Courts

International treaties

Implementation Bodies

National law

Soft law

Committees

Self-

executing

Non-self-

executing

International

Organizations

International

NGO‘s


Treaties (I)

• International Health Regulations of the WHO of 23 Mai 2005 (IHR)

• Convention on Human Rights and Biomedicine of 4. April 1997

(Biomedical Convention; SR 0.810.2)

� Additional Protocol of 12 January 1998 on the Prohibition of Cloning

Human Beings (SR 0.810.21)

� Additional Protocol of 24 January 2002 on Transplantation of Organs

and Tissues of Human Origin (SR 0.810.22)

� Additional Protocol of 25 January 2005 on Biomedical Research (ETS

195; signed, not yet approved by the Parliament)

� Additional Protocol of 27 November 2008 on Genetic Testing for Health

Purposes (ETS 203; not yet signed)



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Treaties (II)

• International Covenant of 16. Dec. 1966 on Economic, Social and Cultural Rights (CESCR; SR 0.103.1)

� Right to the enjoyment of the highest attainable standard of physical and mental health (Art. 12)

• International Covenant of 16. Dec. 1966 on Civil and Political Rights(CCPR; SR 0.103.2)

� Prohibition of medical or scientific experimentation without free consent (Art. 7 phrase 2)

• Convention of 20. Nov. 1989 on the Rights of the Child (SR 0.107)

� Consideration of the views of a child (Art. 12)

� Right of the child to the enjoyment of the highest attainable standard of health (Art. 24)

• Agreement of 21. June 1999 on the free movement of personsSwitzerland-EU (SR 0.142.112.681)

� Mutual recognition of medical paramedical professions (Annex III Section A.C)


Soft Law

• UNESCO

� Universal Declaration on the Human Genome and Human Rights (1997)

� International Declaration on Human Genetic Data (2003)

� Universal Declaration on Bioethics and Human Rights (2005)

• The World Medical Association:

� Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (original version of 1964, amended version of 2008)

• Council for International Organizations of Medical Sciences (CIOMS), in collaboration with the World Health Organization (WHO):

� International ethical guidelines for biomedical research involving human subjects (CIOMS-Guidelines, original version of 1982, amended version of 2002)

• The International Conference on Harmonisation (ICH)

� Guideline for Good Clinical Practice (GCP-Guideline, 1996)



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K. Internationalisation of Medical Law

Questions:

1. In what way is an international regulation of Medical Law required?

2. In what way does the internationalisation of Medical Law involve

disadvantages and threats?

3. In which fields of Medical Law on an international level can you find

legal gaps and/or overregulations?

4. Can Soft Law be assigned to law or ethics?

4. Protection of Public Health:

Overview (I)

• Modalities of public health protection

� Prevention of diseases

� Combating diseases

� Promotion of Health

• Standard functions of public health protection

� Upholding of fundamental rights (Rights to life and integrity et al.)

� Upholding of other public interests (public order, economic interests et al.)

Protection of Public Health

by the public administration



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Overview (II)

Protection against threats to health caused by substances

• Narcotics

• Therapeutic products

• Chemicals

• Foodstuffs

• Radioaktice substances

Protection against threats to health caused by goods

• Medical goods and commodities

• Technical facilities und gadgets

Protection against threats to health caused by humans and animals

• Epidemic Diseases

• Interments

• Slaughterings

Protection against threats to health caused by activities

• Employment safety and security

• Accident avoidance

Protection against threats to health caused by environmental influences

• Noise, air and water pollution, beams, changes of DNA of organisms and the biological diversity et al.


Medicinal Products and Medical Devices (I)

Scope of the Law • Handling of therapeutic products

– Medicinal products: products of chemical or biological origin, which are intended to have, or are presented as having, a medicinal effect on the human or animal organism (incl. Blood and blood products)

– Medical devices: products, including instruments, apparatus, in vitro diagnostics, software and other goods or substances which are intended to have, or are presented as having, a medical use and whose principal effect is not obtained with a medicinal product

• Handling of narcotics, insofar as they are used as therapeutic products

• Therapeutic treatments, insofar as they directly relate to therapeutic products (such as gene therapy)



18


Medicinal Products and Medical Devices (II)

Requirement of

authorization

• Manufacture of medicinal products

• Authorization of placing medicinal products on the market

Exemptions for medicinal products

– which are prepared according to a doctor‘s

prescription or which are prepared in small quantities

for customers

– which cannot be standardized (Off Label Use)

Simplified procedure for

– certain categories of medicinal products, in particular

� medicinal products in which the active agents are

known, in particular Generica

� medicinal products of complementary medicine

� Orphan Drugs

� important medicinal products for rare diseases

– medicinal products which are imported from

countries with an equivalent authorization system


Medicinal Products and Medical Devices (III)

Conditions for the granting of a marketing authorization:

Physical, chemical and biological tests

– Documentation of the composition, manufacturing process, quality and stability et al.

Pharmacological and toxicological tests

� Clinical trials on animals

– Documentation of the compliance of the animal protection provisions

– Documentation of the effectiveness of a medicinal product, its processing in the human body as well as undesirable effects

Clinical tests

� Clinical trials on human beings: Phase I (safety), II (effectiveness), III (Comparison with standard therapy)

– Documentation of the compliance of the human clinical trials provisions

– Documentation of the effectiveness of a medicinal product, its clinical compatibility and its undesirable effects on the human body

Quality, safety and effectiveness (Art. 10 Par. 1 lit. a LTP)



19


Medicinal Products and Medical Devices (IV)

Parallel imports:

patent owner A

admission for A

manufacture by A‘

distribution by A‘‘

distribution by B‘

admission for A

manufacture by A‘

distribution by A‘‘

acquisition by B

export

parallel import


Medicinal Products and Medical Devices (V)

Patent protection

Revision Swiss Patent Act, in force since 1. Jul. 2009:

– Principle of regional (EC) exhaustion

– Exemption: medicinal products

Amendatory protection certificates

Initial applicant protection

Exclusive right of commercially using a patented invention for up to 20 years

Exclusive right of using medicinal products in which the active agents areknown for up to 5 years after expiration of the patent protection

Exclusive right of using data of the application for a marketing authorizationfor up to 10 years



20


Medicinal Products and Medical Devices (VI)

Mandatory notification • Placing on the market of certain medicinal products

– Co-Marketing-Medicinal Products (only new

brand name and package)

– Not medicinal products subject to prescription

for domestic animals

• Placing on the market of certain medical devices

– Implantible medicinal products

– In-vitro-Diagnostics

• Undesirable effects and incidents as well as quality

defects

Conformity evaluation • Placing on the market of medical devices

L. Distribution of a Liquid Inhalant

Facts:

The regional inspectorate for therapeutic products of north-west Switzerland has been assigned by Swissmedic to investigate the working environment of X Ltd. Company. Thereby the investigation shows that a liquid inhalant was found in the storage room of the company, which did not have the necessary authorization required by the Law on therapeutic products. Therefore Swissmedic forbids X Ltd. Company the distribution of liquid inhalants with immediate effect.

X Ltd. Company has filed an appeal against the decision of Swissmedic. The Company claims that the liquid inhalant was manufactured according to a doctor‘s prescription and only small amounts were made. Therefore the distribution doesn‘t require an authorization.

Question:

Will the X Ltd. Company be successful with its appeal?



21

M. "Cow-Lovely-Advertisement"

Facts:

In the second half of the year 1999 the Association of Swiss Milk Producers (SMP) placed in several newspapers and magazines the advertisement with the slogan "Milk promotes strong bones". The advertisement-text had the following wording:

"Drinking Milk will make you big and strong. And it maintains that way. The calcium contained in the milk helps to prevent bone fractures, the so-called osteoporosis. Today every third woman over the age of fifty suffers from this disease and the cases of men suffering from osteoporosis have increased. Every Person‘s diet should therefore contain at least three portions of milk a day: for instance one glas of milk, one cup of yoghurt and one piece of cheese."

On 25 Oct. 1999 the Federal Office of Public Health requested of the laboratory of the canton of Berne to take the necessary measures. Therefore the lab forbid the SMP to continue using the abovementioned text with this wording.

Question:

What is the present legal position?

N. Provision of Natrium-Pentobarbital

Facts:

X. (born 1953) suffers from a heavy bipolar affective disorder. He tried to commit suicide twice and has been repeatedly in stationary treatment. On 1 Jul. 2004 he joined the association "Dignitas". On 8 Nov. 2004 he requested for the arrangement of an assisted suicide since he considered his life due to his illnes as no longer humane. Because no doctor‘s prescription could be issued for the necessary 15 grams of Natrium-Pentobarbital (NaP) X requested of the Federal Office of Public Health to grant "Dignitas" the authorization to provide 15 grams of Natrium-Pentobarbital (NaP) without any doctor‘s prescription.

X. justified his request with the argument that as a person, who has the capacity to act, he has the right according to Art. 10 Par. 2 FC and Art. 8 EMRK to end his life without any risks and any pain and without harming other persons.

Question:

Does X. have the right to get 15 grams of Natrium-Pentobarbital?



22

5. Medical and Biomedical Law:

Overview (I)

• Objects of legal protection

� Human dignity

� Right to life

� Physical and mental integrity

� Right to privacy

• Objects with restricted legal protection

� Economic freedom, in particular the freedom to choose an occupation

� Freedom of research

Protection of patients, donors and trial subjects by the Law


Overview (II)

General Medical Law • Contract Law

• Tort Law

• Protection of personage

• Protection of the child and adults

• Rights and duties of patients

• Data protection

• Admission to a profession

• Criminal Law

Special fields • Reproductive medicine

• Gene technology, in particular genetical tests

• Transplant medicine

• Human Genetic Research, incl. Human Embryo Research



23


Transplant Medicine (I)

Scope of the Law • Handling of organs, tissues or cells of human or animal

origin and products obtained from them (transplant

products) intended for transplantation into humans

Exemptions:

– Artificial or devitalised organs, tissues or cells

(Applicability LTP)

– Blood and blood products, with the exemption of

blood stem cells (Applicability LTP)

– Germ cells, impregnated egg cells and embryos in

the context of medically assisted human

reproduction (Applicability Act on Reproductive

Medicine)


Transplant Medicine (II)

Removal of organs, tissues or cells from deceased persons

a) Requirements of consent

– consent before death

� written or oral declaration of intention to donate

� individuals who have reached the age of 16

– consent by the next of kin or by a trusted person

� no refusal by the deceased person

� consideration of what the deceased person would have wanted

� individuals who have reached the age of 16

b) Determination of death

− Brain death

− Determination of death according to guidelines (in particular SAMS-Guidelines of 2005)

− Independence of persons involved in the removal or transplantation of organs, tissues or cells



24


Transplant Medicine (III)

Removal of organs, tissues or cells from living persons

a) Persons who are mentally competent and have reached majority

– Informed consent

– No serious risk to life or health

– Subsidiarity towards any other therapeutic methods

b) Persons lacking mental capacity and minors

− Tissues or cells capable of regeneration

− Minimal risk and minimal burden

− Subsidiarity

− Parent, child or sibling as recipient

– Lifesaving through donation

– Informed consent by

� legal representative

� Person who is mentally competent but has not reached maturity

– Involvement of persons lacking mental capacity and no indication of objection

– Permission given by an independent authority


Transplant Medicine (III)

Removal of organs, tissues or cells from living persons

a) Persons who are mentally competent and have reached majority

– Informed consent

– No serious risk to life or health

– Subsidiarity towards any other therapeutic methods

b) Persons lacking mental capacity and minors

− Tissues or cells capable of regeneration

− Minimal risk and minimal burden

− Subsidiarity

− Parent, child or sibling as recipient

– Lifesaving through donation

– Informed consent by

� legal representative

� Person who is mentally competent but has not reached maturity

– Involvement of persons lacking mental capacity and no indication of objection

– Permission given by an independent authority



25


Transplant Medicine (IV)

Prohibitions and

Duties of behaviour

• General duty of care (art. 4)

• Prohibitions of commercialism

– Non-commercialism of donation of organs, tissues and cells (art. 6)

– Prohibition of trade in organs, tissues or cells (art. 7)

• Duty to bear costs on living donations (art. 14)

• Recording, evaluation and publication of the outcome of transplantations (art. 27 Abs. 3)

• Examination of the donor (art. 30)

• Mandatory testing of organs, tissues and cells (art. 31)

• Mandatory labelling of organs, tissues or cells (art. 33)

• Documentation to ensure traceability (art. 34)

• Mandatory archiving of the records for 20 years (art. 35)


Transplant Medicine (V)

Allocation of Organs

a) Waiting list

− Medical indication of a transplantation

− No permanent medical reasons, which are capable of endangering the transplantation success

b) Allocation

− Decision by the national organ allocation office (foundation Swisstransplant) through rulings (restricted right of appeal!)

− Certain organs, which the donor has not donated for a specific person

− Requirements:

1. Medical urgency of a transplantation (imminent danger to life)

2. Medical benefit of a transplantation

3. Combined transplantation or multiple transplantation

4. Rare blood types

5. Waiting time



26

O. Questions regarding the Transplantation Act

1. The cantonal hospital X offers all donors of organs, tissues and cells a flat rate compensation. Intention of this flat rate compensation is to equalize the undergone intervention in the physical integrity of the donors and to motivate potential donors. The payment for an organ donation is SFr. 2000.-, for a tissue- or cell donation SFr. 200.-. Is such a flat rate compensation allowed?

2. The 17 year old Z could probably save the live of her brother suffering from lucemia with a removal of blood stem cells. Is such a donation allowed?

3. B would like to donate a kidney to his wife, who is suffering from a kidney disease. Therefore he admits himself to a transplant centre. Is it mandatory for the transplant centre to inform the national organallocation office about this transplantation? Has the wife of B at all any right for the kidney?

4. Is it allowed to transplant cells of a superfluous in vitro embryo for the regeneration of tissue for a patient suffering from heart disease?

P. Removal of a Liver for Transplantation

Facts

After doctor A has determined the death of Y, he takes the necessary

preparatory medical measures for the removal of the liver. As there is no

consent available for the removal A asks the widow of Y whether she

consents to an organ removal. Y‘s widow declares, that her husband

probably would have been against a removal of the liver due to his

religious beliefs. She herself however considers a liver transplant as a

very reasonable act and therefore gives her consent. Hereupon A

removes the liver and gets it conserved for the purpose of a transplant.

Question

Is the procedure of A legal?



27

Q. Allocation of a Liver for Transplantation

Facts

John W, 67 years of age and heavy alcoholic has refused all his life to fill out an ID as an organ donor. Since 1999 he is unable to perform a normal work duty and therefore is dependent of social aid. His state of health has worsened in the past few months dramatically and a month ago his doctor told him, that he is suffering of cirrhosis of the liver and thus is in immediate need of a liver transplantation. With the consent of John W. his doctor puts him on the waiting list of the transplant centre.

One month later, the 35 year old Samuel R., father of 3 kids and a successful businessman is also put on the waiting list. He suffers from an auto immune liver disease which also makes him in need of a liver transplantation. As a donors liver becomes available, the doctors notice, that John W. and Samuel R. have the same priority and the same blood group.

(Facts Gächter/Vollenweider, Gesundheitsrecht, 2008, S. 235)

Questions

1. Will the transplant centre put John W. on the waiting list?

2. If yes: who will get the liver?

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