European Ethical-Legal Papers
Biomedical ethics and law are rapidly evolving disciplines. Although a great number of specialized peer reviewed journals and series of books already exists in both disciplines we felt a growing need for a medium through which the results of our research can directly be presented to the research community and the interested community at large.
To meet this need we decided to start the "European Ethical-Legal Papers". Such papers will also contribute to the transparency we owe to society that finances our research efforts. We also hope that it will contribute to the discussion and the exchange of information and ideas among researchers in Europe and elsewhere.
More information can be found on the CBMER
- H. NYS, et al., "Patient Rights in the EU – Czech Republic", European Ethical-Legal Papers N°1, Leuven, 2006.
- H. NYS, et al., "Patient Rights in the EU – Denmark", European Ethical-Legal Papers N°2, Leuven, 2007.
- P. BORRY, et al., "Genetic Testing & Counselling - European Guidance", European Ethical-Legal Papers N°3, Leuven, 2007.
- European Ethical-Legal Papers N° 4 Removal of Organs in the EU
- H. NYS, et al., "Patient Rights in the EU- Estonia”, European Ethical-Legal Papers N°5, Leuven, 2007.
- T. GOFFIN, et al., "Patient Rights in the EU- Greece”, European Ethical-Legal Papers N°6, Leuven, 2007.
- T.GOFFIN, et al., “Patient Rights in the EU – Bulgaria”, European Ethical-Legal Papers N°8, Leuven, 2007.
- T.GOFFIN, et al., “Patient Rights in the EU – Cyprus”, European Ethical-Legal Papers N°10, Leuven, 2007.
- S.DEFLOOR, et al., “Patient Rights in the EU – Hungary”, European Ethical-Legal Papers N°11, Leuven, 2007.
- S.DEFLOOR, et al., “Patient Rights in the EU – Lithuania”, European Ethical-Legal Papers N°12, Leuven, 2007.
- H.NYS, et al., “Patient Rights in the EU - Portugal”, European Ethical-Legal Papers N°13, Leuven, 2008.
- H.NYS, et al., “Patient Rights in the EU – Slovakia”, European Ethical-Legal Papers N°14, Leuven, 2007.
- S.DEFLOOR, et al., “Patient Rights in the EU - Spain”, European Ethical-Legal Papers N°15, Leuven, 2008.
- V.ZNIDARSIC SKUBIC, "Patient Rights in the EU- Slovenia”, European Ethical-Legal Papers N°16, Leuven, 2008.
European Ethical-Legal Papers N° 1 Czech Republic
- The Czech Republic has signed and ratified the Biomedicine Convention which entered into force on 22 June 2001. The ratification of the Convention was neither preceded nor followed by substantial changes in the legislation concerning patient rights.
- At the moment, a comprehensive legislative framework of patient rights does not exist in the Czech Republic. Important patient rights such as the right to informed consent and the right to information about his or her health status, the right to protection of private life and confidentiality have only been incorporated fragmentally and incompletely into legislation. The Health Care Act 1966 contains some basic patient rights but it is quite old and although it has been amended many times it cannot be considered as an adequate framework for the protection of patient rights.
- It would be unfair however not to consider the constitutional background that has dramatically changed after 1989 and the many international treaties on human rights to which the Czech State is now party.
- Moreover there are recent developments within Czech society that may contribute to a climate that is much more favorable to real respect for patient rights than the former paternalistic habits that were so deeply enshrined in this society. We want especially mention the following ones.
First the role of the so called Czech Public Defender of Rights or Ombudsman. Relentlessly he has defended fundamental respect for physical integrity and autonomy of patients in his inquiry on the forced sterilization of Roma women. The importance of the Ombudsman interpreting article 23 of the Health Care Act 1966 on informed consent in the light of the Biomedicine Convention may not be underestimated. We also expect that the decisions of the Ombudsman in the cases concerning the vaccination of minors against the will of their parents, the right of a patient to access and copy his medical file and the right of the relatives to post mortem access of the medical file will contribute to a growing awareness of patients and physicians of their rights and duties towards each other.
Secondly, Czech judges seem to have started to take up their responsibility in the protection of patient rights. In November 2005 the Regional Court of Ostrava decided that a medical intervention without the proper consent of the patient infringes the patient’s personality rights. In April 2006 a district court stated that a patient has a right to copy his medical file. In both cases appeal has been lodged which demonstrates that the protection of patient rights is a process that should not be rushed.
- Regarding the rights of users of genetic services, the general rights of patients are applicable, supplemented by the relevant articles of the Biomedicine Convention and some specific domestic rules.
- Drafts for an act on patient rights have been announced several times after the ratification of the Biomedicine Convention but until now none succeeded to pass the legislative process. Also the draft Act N° 1151/0 on health care has been repealed after the parliamentary elections held in 2006. However, to the extent that we had the opportunity to become acquainted with the contents of this draft, it looked promising. We dare to express the hope that in the near future a modern legal framework for the protection of patient rights will be elaborated.
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European Ethical-Legal Papers N° 2 Denmark
- Denmark has signed and ratified the Biomedicine Convention which entered into force on 1 December 1999. Denmark has expressed a reservation in respect of article 10 §2 of the Convention concerning the right to know any information collected about his or her health.
- The manner in which Denmark has formalized patient rights is in common with other Scandinavian countries. A number of initiatives have been introduced to strengthen the rights of patients in the Danish health care system and this process started already years before the ratification of the Biomedicine Convention. In 2005 the Danish Parliament adopted the Health Act - Law No. 546 of 24 June 2005 – putting together different acts related to patient rights, especially Law No. 482 of 1 July 1998 on patient rights and a number of other acts which contain patient rights provisions (e.g. the Act on Abortion, the Act on Assisted Reproduction, the Act on Transplantation). This new act on patient rights has come into force on 1 January 2007.
- Danish law contains elaborated rules with regard to the protection of the right of patients to give or refuse informed consent either actually or through previously expressed wishes. Regarding the latter however, Danish law is not completely in accordance with article 9 of the Convention as there are only rules regarding previously expressed wishes in specific circumstances.
- In Denmark minor patients who have attained the age of 15 are – as a general rule – considered to be capable to provide informed consent. Parents must however be informed and be included in the decision-making process. If a minor of 15 years or older is unable to provide informed consent his parents are competent to do so. Under the age of 15 years parents must always consent to a medical intervention.
- With regard to incompetent adult patients Danish law distinguishes between permanently incompetent patients and temporarily incompetent patients. When a patient is permanently unable to provide informed consent the closest relative or when the patient is under guardianship, the guardian can provide informed consent. For persons who are temporarily incompetent Danish Law does not permit informed consent by the closest relative. Apart from the situation where a guardian is appointed who is allowed to take decisions in health matters as well, the law does not regulate who may give informed consent during the period that someone is temporarily incompetent.
- Danish law does not regulate the right to information about his or health as a separate right. The right to receive information regarding one’s state of health is mentioned in the Health Act 2005 as part of the right to informed consent. The right not to know has to be respected. A peculiarity of Danish law is that the therapeutic exception is illegal since 1998 although it is possible to refuse a patient access to his health record if this is considered to be harmful to the patient.
- Another interesting feature of Danish law relates to access to the medical file of an (permanently) incompetent patient. If a guardian has been appointed, he has the right to access the medical file of the patient. The closest relatives of an incompetent patient are only competent to provide consent to treatment. In other matters – like access to the medical file – the closest relatives cannot make a decision on behalf of the patient. Minor patients who are 15 years or older are entitled to have access to their medical file autonomously.
- With regard to the right to medical secrecy and confidentiality, Danish law is particularly elaborated regarding the transmission of medical information to colleagues, other health care workers and social services. As a general rule, consent of the patient is required. However, under certain conditions forwarding confidential medical information is allowed without the consent of the patient.
- Although not comprehensively regulated in the Danish Constitution the right to privacy is protected in the Criminal Code which demonstrates the importance attached to privacy protection in Danish law. The Act on Processing of Personal Data prohibits the processing of personal data concerning health except for the circumstances and purposes mentioned.
- The right to complain (to the Patient Offices, the Patient Complaints Board and the Parliamentary Ombudsman) and the right to compensation (by the Patient Insurance Scheme) are among the strongest protected patient rights in Danish law.
- In Denmark genetic testing is mainly regulated through the legal framework that applies to the Danish national health care system as a whole. The Health Act 2005 and its provisions on the rights of patients are mutatis mutandis applicable to users of genetic services.
- In connection with insurance and employment there are special rules regarding the use of genetic information. Section 3a of the Act on Insurance Agreements and Pension Funds as amended by the Act of 10 June 1997 prohibits for insurance companies to demand or make use of information regarding a person’s genetic predisposition. Accordingly, it is against the law to demand a genetic test or to ask whether a person has had a genetic test. It is furthermore prohibited to make use of the result from a pre-symptomatic genetic test – even in situation where the person voluntarily would like to reveal information (e.g. because the test shows that there is no predisposition). The use of health information in employment relations is regulated by Act No. 286 of 24 April 1996 on the Use of Health Information in Employment Relations.
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European Ethical-Legal Papers N°3 Genetic Testing and Counselling - European Guidance
Research into the identification of genes and their mutations correlating with diseases or inherited disorders has resulted in the availability of genetic tests. This has led to intense debates about the potential psychological, social, legal and ethical consequences of genetic testing and the question of an appropriate framework of regulation, information, guidance and education to guarantee a careful and beneficial application of this promising technology.
The Independent Expert Group, who developed 25 recommendations on the ethical, legal and social implications of genetic testing, stressed in its fourth recommendation of the report Ethical, legal and social aspects of genetic testing: research, development and clinical applications that (4a) “materials and resources should be developed and made available at the EU, national and local level to provide information about genetic testing, genetic screening, and pharmacogenetics” and that (4d) “concerted efforts to promote dialogue, education, information and debate should be encouraged.”
The ethical workpackage of the Eurogentest project took as one of its objectives to answer this need of information and education about the ethical and legal aspects of genetic testing and genetic counselling. This European Ethical – Legal Paper 3 provides an overview of existing guidance about ethical issues in genetic testing and counselling. It is mainly constituted of policy statements, guidelines, position papers, recommendations or reports that have been issued by professional associations and societies (for example genetic societies; medical and paediatric associations), national bioethics committees, national institutes of health, European associations, and NGOs.
Documents were only selected for this publication if they were (at least partly) dealing with ethical issues regarding genetic testing, genetic screening and genetic counselling. In particular, documents were included if, for example, they were discussing and providing recommendations on issues as confidentiality or informed consent in genetic counselling, genetic testing of minors; prenatal diagnosis; preimplantation genetic diagnosis; sex selection; paternity testing; genetic testing and insurance; genetic testing and employment. Documents providing recommendations regarding DNA banking, patents, therapeutic and reproductive cloning, stem cell research or pharmacogenetics were not considered for inclusion. In addition, only documents that were published since 1990 have been included.
Only documents coming from European countries (the 27 E.U. members states and members of the European Economic Area (Norway, Iceland, Liechtenstein and Switzerland), European associations and international organisations, have been integrated in this booklet. After a short presentation of the guideline provider, we present shortly the content of each document, and the original name if the document has been elaborated in another language than English, together with information about the availability if it is not or only partly available online. Documents that have been issued by public bodies receive the symbol , private bodies the symbol . For every country, we presented first the public bodies, followed by the private bodies.
We hope that this European Ethical – Legal Paper will provide a useful guide to all health care providers and the general public, as it would contain the major documents tackling the ethical dilemmas and conflicts that arise in the context of the patient-physician relation in the framework of a genetic test. Although we have tried to include as many relevant position papers, statements, opinions, guidelines, reports and recommendations as possible, a language bias and a selection bias might have led to the absence of some useful and relevant documents.
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European Ethical-Legal Papers N° 4 Removal of Organs in the EU
At the request of mrs. F. BREPOELS, Member of the European Parliament a comparative study has been made during the months May and June 2006 concerning the legal rules governing post mortem removal of organs in the different EU member states.
The aims of this study are to:
(a) present and compare the legal rules actually governing the removal of organs from a deceased person (also called: post mortem removal) in the at the moment of writing 25 Member States of the European Union;
(b) pay special attention to the position of the next of kin in this rules
(c) draw conclusions from the comparative study and suggest recommendations for improvement with special attention to the role and responsibility of the European Union
In the next section I will briefly explain the methodology and the sources used during this study.
The third section contains a presentation of the relevant pieces of the national laws governing post mortem removal. Most of the times we have cited literally the translated text, possible mistakes and inaccuracies included. The sources are indicated in footnotes.
In the fourth section we have put the national laws on a so called opting in/opting out scale. In order to facilitate comparisons we have only focused on the following topics: Explicit consent. Explicit refusal. No decision and the position of the next of kin. Special situations such as the position of minors and incapacitated persons, of non-residents, the methods to determine (brain) death, the registration of consent and refusal etc have deliberately left out of the study.
In the final section conclusions are drawn and recommendations suggested.
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European Ethical-Legal Papers N° 5 Patient Rights in Estonia
- Estonia has signed and ratified the Convention which entered into force on 1 June 2002.
- Estonia belongs to three Central-East EU Member States Member States where the Biomedicine Convention already had a significant impact upon patient rights legislation and policies before the ratification: Estonia, Hungary and Lithuania. The first attempts to legislate on patient rights date back to 1993. These attempts failed but in 2001 the rights and obligations of patients have been incorporated in the Law of Obligations Act. A privileged witness has testified that the Convention was already before its ratification “an inspiration for Estonia to legislate in this field”.
- Compared to other EU Member States the available information in English on the status of the rights of patients and users of genetic services is rather limited. Nonetheless we may conclude that Estonian law on the protection of patient rights is in general in concordance to the Biomedicine Convention. This is not a surprise given that the Law of Obligations Act has been inspired by the Dutch Medical treatment Contract Act.
- A serious deficiency in Estonian law exists regarding the protection of incapacitated adults. There is no regulation about proxy decision-making for these adults. The practice varies a lot: most of the times the treating physician takes the decision on behalf of the patient. In more rare cases a relative of the patient intervenes.
- Estonian law does not regulate the right to information about his or her health as a separate right. The right to receive information regarding one’s state of health is mentioned in §766(1) of the Law of Obligations Act 2001 as part of the right to informed consent. There is no provision in Estonian law regarding the therapeutic exception.
- Independent review of complaints of patients and compensation for damage due to malpractice is only possible through the court system which is expensive and time consuming.
- Estonia has no specific law on genetic testing. The Human Genes Research Act of 2000 intentionally left genetic testing unregulated. The Law on Obligations Act and its provisions on the rights of patients are mutatis mutandis applicable to users of genetic services.
- The Human Genes Research Act explicitly prohibits employers and insurers from collecting genetic data on employees, job applicants, insured persons or persons applying for insurance cover and from requiring employees, job applicants, insured persons or persons applying for insurance to provide tissue samples or descriptions of DNA. Employers are also prohibited from imposing discriminatory working and wages conditions for people with different genetic risks while insurers are prohibited from establishing different insurance conditions for people with different genetic risks and from establishing preferential tariff rates and determining insured events restrictively.
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European Ethical-Legal Papers N° 6 Patient Rights in Greece
- Greece signed the Convention on Human Rights and Biomedicine on 4 April 1997 and ratified it by Law 2619/1998. As article 28 (1) of the Constitution lays down the principle of the openness of the Greek legal order to international law, the provisions of the Convention form an integral part of domestic Greek law since 1 December 1999 and prevail over any contrary provision of the law. Greece has not made restrictions based on article 26 of the Convention. Generally spoken, Greek law is in conformity with the Convention.
- In Greece the relation between patients and physicians is regulated by provisions in various legal acts and not by specific legislation. The development of legislation relating to patient rights in Greece has in the last fifteen years undergone four major phases. In the period up to 1992, patient rights in Greece were indirectly addressed through relevant provisions in Civil, Penal, Administrative and Disciplinary Law. In 1992, based on the European Charter of Hospital Patients’ Rights of 1979, broader health care reform legislation contained provisions directly addressing the rights of hospital patients. In 1997 further provisions extended the rights of patients granted in 1992 to the entire population, and in addition provided for the implementation of the legislative provisions. In 2005 the most important change in medical law in Greece in the last years took place. The new Code of Medical Ethics was promulgated in that year by law.
- The right to informed consent is protected by the Greek Constitution and other Greek legislation under which the Penal Code, the Hospital Act and the Code of Medical Ethics. If no consent is obtained by the physician, he violates the Penal Code and will therefore be medical liable. Consent can be presumed in case of trivial diagnostic or therapeutic procedure without any risks or commonly practiced. In these cases there rests no obligation on the physician to inform the patient preceding the consent. In the event that the patient’s life is in danger, the doctor is obligated to intervene against or in spite of the patient’s wishes as well as in urgent cases which require surgery and in case of extended operations. The information that needs to be provided preceding the consent of the patient is under Greek law wider than what the Convention of Oviedo dictates. The specific addition of social and economic factors, as crucial to patient decisions is also an achievement.
- According to the Order of Physicians in Greece a distinction has to be made between two categories of minors: those who have attained the age of sound mind, and the others. It is not expressed in terms of an age limit. The physician should decide considering the personality of the child, the medical treatment proposed, the family and social background etc. A mature minor may give his consent alone, but the consent of his parents may also be required. The physician has always to evaluate the situation and to judge whether the consent of the parents will also be required. If the parents of a minor refuse to consent and the life of the minor is in danger, the Greek common medical practice on youth protection allows an ultimum remedium. The duty to rescue the minor obliges the physician to act on his own initiative.
- Article 11 (2) of the Code of Medical Ethics of 2005 stipulates for the patient a right not to know and for the physician an obligation to respect this right. In these cases, the patient is entitled to ask the doctor to inform exclusively other persons, suggested by him.
- Article 14 (7) stipulates that “the medical files may not contain any judgments or comments about patients except when they concern his illness. So no notes on any other matter than a patient’s disease shall be recorded in his file.” These documents are accessible only by persons to whom the information therein refers, and then only with the presence and assistance of a physician. The exact role of the physician remains unclear.
- The physician has a legal obligation not to disclose confidential information on patients which he has learned in the course of his medical practice, not only from patients themselves but from other sources too. Physicians cannot be released from the duty of secrecy by the circumstances that the patient has consented to the disclosure of confidential information, though the consent or the request of the patient enables a physician to disclose confidential information to a third party.
- Medical data are listed as ‘sensitive data’ in the privacy protection of Act 2472/97 (article 7 (1)). The processing of all sensitive data, medical data too, is according to article 7, section 2, only allowed under strict conditions. All data subjects of should, be able to inspect the recorded data relating to themselves. This right, however, needs to be exercised through a physician, for the protection of the subject.
- In Greece genetic testing is mainly regulated through the legal framework that applies to the Greek national health care system as a whole. The regulations on patient rights are mutatis mutandis applicable as rights of users of genetic services. The Bioethics Commission completes the legislation on genetic testing with some important recommendations. Because of the direct applicability of the provisions of the Biomedicine Convention related to genetic testing, these provisions are also applicable in Greece.
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European Ethical-Legal Papers N° 8 Patient Rights in Bulgaria
- Bulgaria ratified the Convention on Human Rights and Biomedicine on 1 August 2003. The national legislation is in conformity with the contents of the Convention, except for some fundamental questions, such as “previously expressed wishes”.
- The legislative framework of patient rights is based on several acts endorsed in the period 1995-2005. The Constitution, which was revised in 1991, contains some basic civil rights concerning medical care. Beside the regulations concerning health in the Constitution, patient rights are protected in several different acts. The most important Act is the Health Act of 2004 which is also called “the Constitution of the health care”.
- The rights of patients are compensated by their obligations. They have correlative links. A possible violation of obligations leads to deprivation or incapability of protecting the rights. The patient can be refused to be treated if he/she did not fulfill his/her obligations and irrespectively of the fact that he/she has paid its health insurance contributions.
- The medical activities shall be performed upon the informed consent expressed by the patient. The question for giving “informed consent” must be separated in two stages: 1. a stage “before” initiation of the treatment; and 2. a stage “during” the treatment. Both stages are characterized by different components of the contents of the information provided by the physician and of the contents of the consent given by the patient.
- The form of the given consent can be oral or written. The law explicitly enumerates the cases in which written form or written form with notary certification) is required. The oral form shall apply to the cases not explicitly mentioned by the law. The status of implied consent is disputed.
- The patient has a right not to know. This right is not absolute. The refusal of information should be given by the patient in writing. It will be reflected in writing in the patient’s medical documentation.
- There is no legal regulation of the therapeutic exception in Bulgarian Health Law. Therefore the physician cannot restrict the right to information in any way.
- In the Health Act a patient right regarding the medical file is not included in the Section “Patient’s Rights and Obligations”. The articles can be found in the first Chapter of the Act, in Section V “Health Information and Documentation”.
- The physician is obliged not to disclose confidential information concerning a patient which he learns in the process of the diagnosis and the treatment. The patients and their relatives can specify what these facts and circumstances can be. The physician has a right but not an obligation to break his duty of medical secrecy and to notify the competent authorities of the criminal acts committed by his patient.
- The Ombudsman is a special authority established in Bulgaria by the Act on the Ombudsman in force since 1 January 2004. The Ombudsman shall stand for the persons, when their rights and liberties are affected or offended by the state and the municipal authorities and their administrations, as well as by the persons assigned to provide public services. The health law doctrine calls the ombudsman a “patient's advisor”.
- The civil liability of the physician takes generally two forms: contractual and delictual. Under both types of liability the patient claims indemnity for damages of his health from the author of the damages. Contrary to the criminal law the guilt is always presumed until proven otherwise.
- Since the Health Act of 2004 genetic services have their own regulation in Bulgarian legislation. Section IV of the Health Act is named “Genetic Health and Genetic Tests”. Informed consent of the patient is necessary to conduct a genetic test. Discrimination on grounds of genetic heritage is forbidden. Preventive genetic tests shall only be conducted in a limited number of cases defined by law.
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European Ethical-Legal Papers N° 10 Patient Rights in Cyprus
- Cyprus has signed and ratified the Convention on Human Rights and Biomedicine on 20 March 2002. The Convention has entered into force on 1 July 2002. According to the Cypriot Constitution the Convention has immediately superior force to any municipal law. Cyprus has not made any restriction on the exercise of rights and provisions contained in the Convention.
- The Act on the Protection of the Rights of Patients and Related Issues was tabled to the House of Representatives in 2004 and passed on 7 January 2005. The Act safeguards among others the good quality and continuous care of health; the choice of physicians and institutions; and treatment that does not violate the integrity of the person. This Act forms a comprehensive regulation of patient rights.
- The Patient Rights Act is in conformity with the Convention on Human Rights and Biomedicine of 1997 and also with the Declaration of Amsterdam of 1994.
- Consent is only valid when it is retrieved after the necessary information was given to the patient. Without a valid consent, no medical treatment may be started. It may be given in writing or orally, but orally given consent has to be put in writing as soon as possible. This is also the case in emergency situations.
- A minor cannot give consent to a treatment him-/herself. Consent of a parent is always required. The opinion of the minor shall be taken into consideration as an increasingly determining factor in proportion of his/her age and degree of maturity.
- A physician is allowed to make use of the therapeutic exception. He/she is entitled to withhold information from the patient, when there is a valid reason to believe that this information may cause serious harm to the patient’s mental or physical health.
- The reasons for not allowing the patient to have access to his/her medical file are strictly stipulated in the Patient Rights Act. Access cannot be denied for privacy reasons. Minors and incapacitated adults do not have a right of direct access. Their right is guaranteed through a legal representative.
- Under certain strictly stipulated conditions the medical institution or the competent health care services provider may disclose medical information to a third party.
- Processing and collection of data concerning health, so called sensitive data, is prohibited. It is only permitted when one or more conditions stipulated in the Processing of Personal Data Act are fulfilled.
- A patient has a right to complain. This right is not directly stipulated in the Patient Rights Act, but can be deduced from articles in different acts, regulating the committees of complaint.
- Cyprus has no specific act on genetic testing and the rights of users of genetic services. Therefore the Patient Rights Act has to be used as an umbrella act, which covers also treatments such as genetic services. The regulations on patient rights are mutatis mutandis applicable as rights of users of genetic services.
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European Ethical-Legal Papers N° 11 Patient Rights in Hungary
- Hungary ratified the Convention on Human Rights and Biomedicine on 9 January 2002. The Convention entered into force on 1 May 2002. Hungary has made a restriction based upon article 26 of the Convention concerning the right of refusal of a medical intervention. A female patient may not refuse a subsistence treatment or a life-saving intervention if she is pregnant and she is presumably able to carry the pregnancy to full term.
- The draft text of the Convention has been taken into consideration while the Health Care Act of 1997 was being prepared. The primary legal sources of patient rights are the Parliamentary Act No. CLIV of 1997 on health care and the Parliamentary Act No. XLVII if 1997 on the processing and the protection of health care data and associated personal data.
- The patient’s informed consent is a precondition of all medical interventions, unless the Health Care Act provides otherwise. The information that has to precede the consent is comprehensive, individualized and disclosed in such a manner which is comprehensible for the patient.
- Unless the Health Care Act or another Act stipulates otherwise, the form of the given consent can be verbally, in writing or it can even be deducted from his behavior.
- The patient has the right to refuse medical treatment unless the lack of this treatment would endanger the lives or physical integrity of others. If the lack of the refused medical treatment would result in serious or permanent damage to his own health, the patient may only refuse the treatment if he makes a statement in a notarial deed, a fully conclusive private deed or in a declaration made before two witnesses in the case of inability to write. Life-supporting or life-saving interventions may only be refused if the patient suffers from a serious illness which will lead to death within a short period of time and is incurable according to the current state of medical science.
- A competent person may draw up an advance directive that might be relevant if later on he becomes incompetent. In such a statement he can refuse certain medical treatment or name the person who shall be entitled to exercise the right to draw up an advance directive in his stead. The previously expressed wishes have to take form of a notarial deed. A qualified psychiatrist has to confirm in a written opinion that the person made the decision in full awareness of its consequences.
- Hungarian law provides the right to information about his health as a right independent of the right to informed consent. The patient also has the right not to know. He may waive the right of being informed unless his doctor decides that the patient has to be aware of the nature of his illness in order not to endanger the health of others.
- There is no legal regulation of the therapeutic exception in Hungarian Health Law. However, the Health Care Act stipulates that the physician has to be circumspect in informing the patient and has to do so gradually when necessary, considering the patient’s condition and circumstances.
- The patient has the right to access the medical file. If personal notes of the physician are included, they are also accessible. If the medical record contains data which could compromise the privacy of other persons, the right to access can only be exercised with regard to the data referring to the patient.
- The Data Protection Act 1992 is applicable to any instance of data handling unless the handling of specific data is covered by the Health Data Protection Act of 1997.
- The patient has the right to file a complaint with the health service provider regarding the provided health care service. The Data Protection Commissioner can investigate when human rights and the rights of patients overlap. The Health Care Act has also created the institution of patients’ right representatives. Their main task is to provide information on the patient rights and how to enforce them.
- Hungary has no specific law on genetic testing. The regulations on patient rights are mutatis mutandis applicable as rights of users of genetic services.
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European Ethical-Legal Papers N° 12 Patient Rights in Lithuania
- Lithuania has signed and ratified the Convention on Human Rights and Biomedicine which entered into force on 1 February 2003.
- Lithuania belongs to three Central-East EU Member States where the Biomedicine Convention already had a significant impact upon patient rights legislation and policies before the ratification: Estonia, Hungary and Lithuania. A privileged witness has testified that the Convention was already before the ratification “an inspiration for Lithuania to legislate in this field”.
- Compared to other EU Member States the available information in English on the status of the rights of patients and users of genetic services is rather limited. Nonetheless we may conclude that Lithuanian law on the protection of patient rights is in general in accordance to the Biomedicine Convention. This is not a surprise given that the provisions in the new Civil Code, that came into effect in July 2001, have been inspired by the Dutch Medical Treatment Act. The Law on the Rights of Patients and Compensation of the Damage to their Health (1996) is still applicable but its significance is belittled by the fact that patient rights are governed by the new Civil Code.
- The implementation of laws is a complicated process and requires resources, time and the fulfillment of preconditions necessary for legislation to function in a specific country. A major proportion of Lithuanian respondents from a representative sample believed that patient rights had not been implemented and more than 40% said that the rights to information and privacy had not been implemented. There is no independent mechanism to defend the rights of patients. Also the independence of the State Inspectorate for Data Protection has been questioned.
- Lithuania has no specific law on genetic testing . The patient rights provisions in the Civil Code are mutatis mutandis applicable to users of genetic services.
- Article 100 (1) of the Law on Insurance of 18 September 2003 prohibits an insurer from requesting in any form the policy holder, the insured person and other persons to provide him genetic data.
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European Ethical-Legal Papers N° 13 Patient Rights in Portugal
- Portugal has signed the European Convention on Human Rights and Biomedicine on 4 April 1997 and has ratified the Convention on 13 August 2001. The Convention entered into force on 1 December 2001. Portugal has not made restrictions on the exercise of rights contained in the Convention.
- Several bills have been introduced in the Portuguese Parliament to replace the Law on Health 48/90 of 1990 by new legislation containing also more detailed prescriptions regarding the rights of patients. The most important one is probably Law n° 12/2005 of 26 January 2005 on personal genetic information and health information.
- Interventions or treatments which, according to the state of knowledge and medical experience, are considered appropriate and are carried out lege artis, by a doctor or another legally authorized person, with the intention of preventing, diagnosing, healing or alleviating illness, suffering, injury of bodily pain or mental perturbation, are not considered an offence upon personal integrity.
- Portugal has no specific legislation on previously expressed wishes. However, such advanced declarations of will would seem acceptable under the existing Portuguese law. Advanced declarations should be given only an indicative value.
- In Portugal medical majority is fixed at 14 years as a minor of 14 years of age and more can give valid consent to medical treatment if he has the ability to fully understand what is involved in the medical treatment in question.
- The right to information about his or her health is not provided as a right independent from the right to informed consent in Portuguese law. The physician can withhold information which, if the patient were to know about them, would endanger his life or would cause serious harm to his physical or mental health.
- The Law n° 12/2005 of 26 January 2005 concerning personal genetic information and health information contains provisions regarding medical information and medical records and obliges the treating physician to record the medical information on the medical records or to computerize the information.
- Within the Portuguese legal framework, personal data protection has legal and also constitutional protection. The right of access to information relating to health data, including genetic data, is exercised by means of the doctor chosen by the data subject. Only an indirect access is possible.
- Genetic testing in Portugal is in the first place governed by specific legislation: the Law n°12/2005 of 26 January 2005 on personal genetic information and health information. It is also covered by the general principles of medical law.
- No person can be prejudiced, in any way, due to the presence of a genetic disease or due to is genetic heritage. Discrimination on grounds of genetic heritage is prohibited explicitly on Portuguese legislation on genetic testing.
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European Ethical-Legal Papers N° 14 Patient Rights in Slovakia
- Slovakia ratified the Convention on Human Rights and Biomedicine on 15 January 1998 as the first Eastern European country. The Convention entered into force on 1 December 1999. Slovakia has not made restrictions based upon article 26 of the Convention.
- According to the Constitution of the Slovak Republic the Convention on Human Rights and Biomedicine has a superior force to any national legislation and is directly applicable in Slovakia.
- The Slovak Constitution, the health care reform package of six Acts from 2004 and subsequent legislation create a comprehensive legal framework of patient rights in Slovakia. However, patient rights as such are laid down in the Act No. 576/2004 Coll. on health care and health care-related services and on the amendment and supplementing of certain laws as amended.
- The right of a patient to informed consent is one of the basic patient rights in Slovakia. The informed consent shall be given by the patient or by his legal representative if he is incapable to give his informed consent. The information that has to precede the consent should be given in a comprehensible, understandable manner without any restraint, with sufficient time and with the possibility to opt freely for informed consent. The information should also be given in a way that is adjusted to the intellect, the will and the health condition of the patient.
- Previously expressed wishes relating to a medical intervention are not regulated in Slovak health law. As the European Convention on Human Rights and Biomedicine is directly applicable in Slovakia, the previously expressed wishes relating to a medical intervention by a patient should be taken into account according to article 9 of the Convention.
- Slovak law provides the right to information about his health status as a right independent of the right to informed consent. The right not to know is not recognized as such by the Slovak health law. As the European Convention on Human Rights and Biomedicine is directly applicable in Slovakia, the right not to know according to article 10 of the Convention should be respected.
- The maintaining of a medical file is an integral part of health care provisions. The health care provider has not only to process and provide the medical file of the patient, but also to enable its access. The Act on Health Care enumerates those persons who have the right to access the patient’s medical file. The health care provider is allowed to refuse access to a medical file if the patient is provided with the health care in the specialized field of psychiatry or clinical psychiatry and the access to the medical records would negatively affect his treatment.
- The processing of personal data and the protection of the rights of data subjects are regulated by the Act No. 428/2002 Coll. on Protection of Personal Data.
- Slovakia has no specific law on genetic testing. The regulations on patient rights are mutatis mutandis applicable as rights of users of genetic services. As a result of its direct applicability, the provisions of the Convention related to genetic services are applicable.
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European Ethical-Legal Papers N° 15 Patient Rights in Spain
- Spain has signed the Convention on Human Rights and Biomedicine on 4 April 1997 and has ratified it on 1 September 1999. The Convention entered into force on 1 January 2000. Spain has made several restrictions based on article 26 of the Convention for reasons that concern the public health or the health of a patient.
- According to the Spanish Constitution the Convention on Human Rights and Biomedicine has a superior force to any national legislation and is directly applicable in Spain.
- The primary legal sources of patient rights at national level in Spain are the General Law on Public Health of 1986 and the Patient Rights Law of 2002. The latter has partially repealed the General Health Law of 1986, particularly as regards the provisions on patient rights.
- The right of a patient to informed consent is one of the basic patient rights in Spain. The consent must be obtained once the patient has received prior information. This information has to be truthful, has to be communicated to the patient in a manner that is comprehensible and suited to his needs and has to help him take decisions in accordance with his own free will.
- The Patient Rights Law establishes as a general rule that the informed consent must be given orally, unless otherwise stipulated by law.
- A capable and free person of age (18 years) can declare his will in advance as regards the care and treatment of his health or the destination of his organs or his body in case of death by means of the document of prior instructions, so that his wishes are complied with at the moment he is not capable of expressing his will personally.
- Spanish health law provides the right to information about his health as a right independent of the right to informed consent. The patient also has the right not to know. The right of the patient to health information can be limited by the accredited existence of a state of therapeutic necessity.
- The patient or his legal representative have the right to access the medical file. The right to access the medical file can not be exercised to the prejudice of a third party’s right to confidentiality of the data noted in the medical file for the therapeutic interest of the patient, nor to the prejudice of the right to confidentiality of the subjective annotations made by the professionals who elaborate the clinical record
- The processing of personal data is regulated by the Organic Law 15/1999 on the Protection of Personal Data.
- Spain has no specific law on genetic testing. The regulations on patient rights are mutatis mutandis applicable as rights of users of genetic services. As a result of its direct applicability, the provisions of the Convention related to genetic services are applicable.
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European Ethical-Legal Papers N° 16 Patient Rights in Slovenia
- Slovenia signed the Convention on 4 April 1997, whereupon it was ratified by the National Parliament on 5 November 1998. The document entered into force in the Republic of Slovenia on 1 December 1999. In accordance with Article 8 of the Constitution of the Republic of Slovenia, ratified and published treaties are applied directly. This means that as of its enforcement, the Convention became part of the Slovenian internal law and can be applied directly in all legal procedures. The Republic of Slovenia adopted the Convention in whole, meaning it did not declare any reservations regarding its content.
- The provisions of the Convention were taken into account when drafting the new Act on Patients Rights, the fundamental legal source in the field of patient rights protection in Slovenia. The act was passed on 29 January 2008, it entered into force on 26 February 2008 and will become effective in practice on 26 August 2008. The act lays down the rights of the patient as a user of health care services at all providers of such services, the procedures to enforce these rights when they get violated and the obligations stemming from these rights. The purpose of the act is to enable an equal, adequate, quality and safe health care of a required standard that is based on trust and respect between the patient and the doctor or any other medical professional and other co-workers.
- The patient’s consent is decisive in the performance of any type of health treatment or service. The act sets the principle of the patient’s right to a free decision on treatment under the conditions, set by the act. The act forbids any medical treatment or health care to be administered to a patient with disposing capacity without his/her free and wilful consent, made on the basis of received explanations.
- It usually suffices that patient gives his/her consent verbally or by performing an act from which it can be deduced with certainty that it means acquiescence. Consent can also be delivered in writing, a form sometimes demanded by the act, especially in case of operations linked to a greater risk or heavier consequences.
- In cases where the patient does not have the disposing capacity or cannot expressing his/her will, emergency medical treatment can be administered without his/her consent.
- A patient with disposing capacity has the right to turn down proposed medical treatment or medical care unless doing so would threaten his/her life or the lives of others. In cases where the attending doctor deems that the decision of the patient runs against his/her health interests or that denial of treatment could threaten his/her life or result in irreparable damage to his/her health or cause a grave worsening of his/her condition, the doctor must attempt to convince the patient of the need to proceed with treatment. The doctor, if required, can turn to the patient’s immediate family for assistance or can propose to the patient to seek a second opinion.
- A patient who has reached 18 years of age and has a full disposing capacity can assign a representative who will act on his/her behalf in the event that he/she is unable to decide on medical treatment or other rights stemming from this law. The patient also has the right to put down in writing (on a special form) his/her will regarding what types of treatment he/she rejects if in a position where he/she is incapable of expressing his/her will.
- The right to information about one’s own health is guaranteed in Slovenia. The right of those who do not wish to know is also protected. The therapeutic privilege, which excuses the doctor in exceptional circumstances from revealing information to a patient if he feels that the disclosure should pose serious and immediate harm to the patient, is also established.
- The patient has the right to take a look into his/her health information, a right provided by both the Act on Patients Rights and the Personal Data Protection Act. Selected other people or entities also have this right in certain cases. The act also regulates the issue of medical data on the patient’s health condition after his/her death.
- One of the major patient’s rights, which are dealt with by the new law extensively and in detail, is the right to appeal and the right to proceedings in cases of violation of the patient's rights. The act lays down a two-stage (extra-judiciary) procedure and also introduces the important post of the patient's rights representative. The act also tasks the Human Rights Ombudsman with monitoring the implementation of the act and to issue warnings to responsible bodies to make sure that the conditions for carrying out the act are met.
- Because no special act on execution of genetic testing exists in Slovenia, these procedures fall under the general provisions on patient rights.
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