INTERNATIONAL DIGEST OF HEALTH LEGISLATION. 1999. 50 (1)

DENMARK. Order No. 665 of 14 September 1998 on information and consent and the communication of information relating to health, etc. (Lovtidende, 1998, Part A, 22 September 1998, No. 133, pp. 3877-3880)

Den. 99.8

This Order, which has been made in pursuance of Law No. 482 of 1 July 1998 on patients’ rights (see IDHL, 1999, 50, 62, Den. 99.1), repeals Circular No. 163 of 22 September

1992 on information and consent, etc. “Physicians’ duties and patients’ rights” (see ibid., 1993, 44, 57, Den. 93.11). Chapter 1 reads as follows:

“Chapter 1

Informed consent

Consent to treatment

1. (1) ‘Informed consent’ means consent given on the basis of adequate information provided by a health care provider.

(2) Consent to treatment shall be given by a patient who has attained 15 years of age. The patient shall be capable of grasping the implications of his actions.

(3) Consent may be given by a representative provided that the requirements laid down in subsection 2 of Section 8 and subsection 1 of Section 9 of the Law on patients’ rights are satisfied.

2. (1) Consent to treatment must be freely given.

(2) Consent shall be explicit (see, however, subsection 4). Verbal consent shall be sufficient (see, however, subsection 3).

(3) The health care provider responsible for the treatment (see Section 17) may request written consent if the intervention concerned is a major one and complicated treatment is involved, or if there is any possibility that doubts might be raised with regard to the granting of consent and its extent.

(4) Tacit consent may, according to the circumstances, be considered sufficient if there is no doubt that the patient is in agreement with the treatment.

(5) Consent given by a representative shall always be explicit.

3. (1) A patient shall give consent to a specific treatment in connection with his current state of health.

(2) If further explanations have to be provided or if changes are made to the treatment protocol, fresh consent shall be obtained.

(3) A patient may at any time withdraw his consent.

Information

4. (1) A patient who has attained the age of

15 years shall have the right to be informed concerning his state of health and the possibilities of treatment available to him, including the risk of complications and side-effects.

(2) The information shall include explanations of the relevant prevcntion, treatment, and care possibilities, as well as explanations with regard to other possibilities of treatment and also explanations concerning the consequences of not providing any treatment. The information shall be more comprehensive if treatment involves an immediate risk of serious complications or side-effects.

(3) If he considers that the patient is unaware of circumstances that are of importance in order to take a decision concerning him, the health care provider shall provide him with the necessary information, unless the patient has expressed the wish not to be informed, in accordance with Section 6.

5. (1) The information shall be communicated verbally and supplemented by written information in the case of major interventions and complicated treatments.

(2) The information shall be communicated with sufficient time for the patient to ask questions and weigh up the situation.

(3) The information shall be communicated in such a way that the patient has the necessarv understanding of its content and significance.

The right not to know

6. The patient shall have the right not to be informed concerning his current state of health and the treatment dispensed to him and concerning any diseases that he is likely to suffer from at a later stage in his life.”

Chapters 2 (Sees. 7-14) and 3 (Secs. 15-16) are entitled, respectively: Consent to the dissemination of health-related information, etc.; and Dissemination of health-related information, etc., to third countries (States that are not members of the European Union and which have not concluded an agreement with the latter). Secs. 17 and 18 of Chapter 4 (Responsibility, etc.) read as follows:

“17. It shall be the responsibility of the health care provider in charge of administering the treatment to obtain informed consent to the treatment and consent to the dissemination of health-related information, etc.

18. The National Board of Health has drawn up guidelines concerning information and consent and the dissemination of health-related information, etc.”

Sec. 19 (Keeping of files) indicates the responsibilities of the health care provider in charge of the treatment with regard to the recording in the patient’s file of information communicated and disseminated, in accordance with Circular No. 235 of 19 December 1996 on the duty of physicians to keep organized records (Keeping of files) (see ibid., 1997, 48, 354, Den.

97.14).

 

LITHUANIA. Law (Text No. 1-1562) of the Republic of lithuania of 3 October 1996 on the rights of patients and compensation of the damage to their health.” Lith. 99.6

The following are the principal provisions of this Law.

chapter 1. General provisions (Articles 1-2). Article 1 defines various terms, including “patient” (“denotes a person who avails himself of health care irrespective of whether he is in poor health or well”) and “patient documents” (“denotes documents containing the case history of illness and other documents, which assess the health condition of [a] patient and the kinds and methods of health care applied to him”). Article 2 (Purpose of the Law) reads as follows:

“2. (1) The purpose of the 12w on the Rights of Patients and Compensation of the Damage to their Health shall be to establish the rights of patients and the procedure of assessing and compensating the damage inflicted on the health thereof through the legitimate actions of a physician or nursing staff member (through no fault of their own).

(2) This and other laws of the Republic of Lithuania and legal acts shall regulate the special rights of patients in performance of tissue and organ transplantation and also the rights of mentat patients.”

Ghapter II. The rights of patients (Articles 3-10,). This Chapter includes the following Articles:

3. The right to health care; 4. The right to accessible health care; 5. The right to select a physician, nursing staff member, health care institution; 6. The right to information; 7. The patient’s participation in an instruction process, scientific and medical experiments; 8. The right to refuse treatment; 9. The right of complaint; and 10. Inviolability of personal privacY.

Chapter 111. Patients’ documents (Articles 11-13). This Chapter comprises the following Articles: 11. Necessity of patients’ documents:

12. Confidentiality of the information contained in the documents of patients; and 13. Use of the information contained in patients’ documents for scientific research and student instruction.

The remaining Chapters are as follows: IV. Principles and procedure for compensation of damage inflicted upon the patients’ health (Articles 14-24); and V. Final provisions (Article 25).

 

 

 

TURKEY. Regulations of 1998 of the Ministry of Health on patients’ rights. ([Ti) rkiye Cumhurzjveti] Resmi Gazete, 1 August 1998, No. 23420, pp. 67-76) Turk. 99.1

These regulations have been made in pursuance of See. 9 (paragraph c) of Basic Law No. 3359 on the health services and Sec. 43 of Decree No. 181 implementing the Law on the organization and functions of the Ministry of Health. The following are among its principle provisions.

Chapter I. Purpose, scope, legal basis, definitions, and principles (Secs. 1-5). Secs. 1 and 2 read as follows:

“Purpose

“1. The purpose of these Regulations is to present patients’ rights in a concrete manner, such rights reflecting basic human rights in the field of the health services and being recognized in the first place in the Constitution of the Turkish Republic as well as in other Turkish legislative texts and in international legal instruments, and to establish a system, through formulating the principles of the same, whereby every person is able to enjoy patients’ rights, to be protected against any violation of his rights, and to implement, if necessary, the means of legal protection, thus ensuring that the dignity of the human being is respected in all establishments and facilities in which health services are dispensed as well as in places other than health establishments and facilities in which such services are dispensed.

Scope

2. These Regulations shall be applicable to public or private establishments or facilities dispensing health services, the staff having the qualifications and skills required to provide such services within or outside these establishments or facilities, and all persons entitled to benefit from such services.”

Sec. 4 defines various terms, including “patient” (person needing to have recourse to the health services), “health establishment or facility” (any establishment or facility, whether public or private, in which health services are dispensed, as well as any place in which medical procedures are performed, with the exception of those coming under the Ministry of National Defence), and “patients’ rights” (rights which all persons needing to have recourse to the health services enjoy as human beings, and which are guaranteed by the Constitution of the Turkish Republic, international treaties, laws, and other legislative texts). Sec. 5 reads as follows:

“Principles

5. The dispensing of health services shall comply with the following principles:

(a) at each stage of the dispensing of services

the right shall be respected of every person,

as a basic human right, to live in a state of complete physical, mental, and social wellbeing;

~b) every patient must be treated as a human being, every person having the right to the protection and full development of his life and existence both physically and intellectually and no authority or person shall be empowered to abolish this right;

(c) health services shall be dispensed to the patient without distinction as to race, language, religion or denomination, sex, political opinion, philosophical conviction, social or economic situation, or any other form of discrimination. Health services shall be planned and organized in such a way that they are easily accessible to all persons;

~ except in cases of medical necessity or in cases provided for by law, there shall be no infringement of the physical integrity of a person or of other rights inherent in the individual without the consent of the person concerned;

(e) fl() one may be subjected to medical research without his consent or without an authorization from the Ministry; and

(~ except in the cases provided or authorized by law or in the event of medical necessity, there shall be no infringement of the confidentiality of the patient’s private or family life.”

Chapter II. Right of access to the health services (Secs. 6-14). This Chapter reads as follows:

“Access in keeping with equity and justice

6. Every patient shall have the right of access, in accordance with his needs, to health services, including activities intended to promote a healthy lifestyle and preventive services, in keeping with the principles of equity and justice. This right implies that the staff practising in an establishment or facility in which health care is dispensed or in any health service shall dispense care in keeping with the principles of equity and justice.

Request for information

7. The patient may request to be informed concerning the modalities for access to the health services. This right includes the right to be informed concerning the conditions

governing access according to the type of facility involved, the services and possibilities offered by health establishments and facilities, and the modalities governing access to the health services dispensed in consultation centres.

Each health establishment or facility shall constitute a unit with the necessary technical equipment for informing patients in accordance with the first paragraph. Such a unit shall possess, on a permanent basis, qualified and competent staff capable of providing patients with reliable and adequate information and of ensuring that measures are taken such as the displaying of notices, brochures, and instructions for information purposes in appropriate places in the facility, thereby enabling units to respond easily to patients’ needs.

Right to choose and change health facilities

8. The patient shall have the right to choose his health establishment or facility and to have access to the health services dispensed in his chosen health facility, in accordance with the modalities and conditions laid down in the relevant legislation.

The patient may change his health facility subject to compliance with the transfer system determined by legislation. However, it will not be possible to change the health facility if the patient’s physician considers that such a change would endanger the patient’s life or aggravate his disease.

Except in an emergency, every person shall be dependent upon a facility covered by the social security system and shall personally bear the cost of the difference in price corresponding to the transfer process, in accordance with the law.

In cases where it is useful for medical reasons during the patient’s stay in a health facility or when necessary for his transfer to another health facility, the patient or persons referred to in the second paragraph of Section 15 shall be informed of the situation. Before transfer, all the necessary information shall be provided by the facility to which the patient is transferred or by the competent persons designated by law to the health facility which is the subject of the request for transfer or which is indicated for medical reasons. In both cases, it is essential to ensure the proper provision and continuity of care.

Acceptance, choice,

and replacement of personnel

9. The patient may request to be informed concerning the identity, functions, and qualifications of the physicians and other staff members who are to dispense care to him or who dispense care to him.

Subject to compliance with the procedures indicated by law, the patient shall have the right to freely choose the staff called upon to dispense care to him, to change his attending physician, or to request consultations with other physicians.

If he exercises his right to choose staff, to change his physician, or to request a consultation, the patient concerned shall incur the extra costs laid down by law for the exercise of these rights.

Request for the establishment

of an order of priority

10. If a health facility is unable to satisfy a request for care on the grounds that its possibilities for dispensing services are insufficient or limited, the patient shall have the right to request the establishment of a right of priority on the basis of medical criteria drawn up in an objective manner.

The establishment of an order of priority concerning elderly or disabled persons, in urgent and legitimate cases, shall be in accordance with the applicable legislation.

Appropriateness of diagnosis, treatment,

and care to medical requirements

11. The patient shall have the right to request that he benefit from diagnosis, treatment, and care that are in keeping with the knowledge of modern medicine and technological requirements.

It shall be prohibited to give a diagnosis or apply a treatment that runs counter to the principles of medicine or the legal provisions governing medicine, or which is of doubtful quality.

Prohibition of intervention

without a medical need

12. It shall be prohibited to practise or request any intervention likely to result in a person’s death or which endangers his life, constitutes an affront to his physical integrity, or diminishes his mental or physicial faculties, without diagnostic, therapeutic, or preventive purposes.

Prohibition of euthanasia

13. Euthanasia shall be prohibited.

It shall be prohibited to take life, by medical methods or in any other manner whatsoever. The taking of a person’s life shall not be permitted, either at his request or at the request of another person.

Dispensing of medical care

14. Staff shall dispense the medical care necessitated by the patient’s state of health. To the extent that it is possible to save the patient’s lifehis health, staff shall endeavour to reduce of alleviate his suffering.”

Chapter III. The right to be informed concerning one’s state of health (Secs. 15-20).

This Chapter reads as follows:

“Request for general information

15. The patient shall have the right to request to be informed, orally or in writing, concerning his state of health, the medical treatments it is envisaged to administer to him, as well as the foreseeable advantages and disadvantages, alternative medical procedures, the probable consequences of the non-acceptance of a treatment, and the development of his disease and its effects.

Any necessary information concerning the state of health of the patient may be requested by the patient himself or, if the latter is a minor incapable of discernment, or subject to guardianship, by his guardian or legal representative. The patient may also authorize a third party to receive information concerning his state of health. If necessary, the power of attorney may be requested.

The patient may be informed about his state of health by a physician other than his attending physician.

Checking of records

16. The patient may check, directly or through the intermediary of his agent or legal representative, his medical file and the data contained therein and make a copy thereof. The said data may only concern the patient’s treatment.

Request for the rectification of records

17. The patient may request that incomplete, inaccurate, or erroneous medical or personal data contained in the files kept by health establishments and facilities be supplemented, clarified, rectified, or made consistent with his state of health or personal situation.

This right shall include the right to contest reports on a patient’s state of health and to request that a new report on his state of health be drawn up by the same or another health establishment or the same or another health facility.

Method of information communication

18. Information shall be communicated to the patient in a manner that he finds comprehensible, if necessary with the aid of an interpreter, using the fewest possible medical terms, without giving rise to uncertainties or doubts, taking account of the patient’s physical state, and with due consideration for the patient’s feelings.

 

 

 

Cases in which the communication of

information is not authorized

and measures must be taken

19. The diagnosis may be kept from the patient in order not to jeopardize he mental state if revealing the diagnosis is likely to aggravate his disease or if the development or effects of the disease are considered to be serious.

It is the physician’s duty to assess whether or not the patient or his associates should be informed of the patient’s state of health, under the conditions referred to in the preceding paragraph.

A diagnosis that does not result in a treatment may not be referred to or revealed to a patient other than by a physician, who must exercise considerable tact. If the patient has not expressed his opposition or has not personally expressed his intention in advance, such a diagnosis shall be communicated to his family.

Prohibition of the disclosure of data

20. With the exception of cases where measures have to be taken by the competent authorities in accordance with the relevant legislation and in the light of the nature of the disease, the patient may request that data concerning his state of health are not communicated to himself, to his family, or his associates.

 

Chapter IV. Protection of patients’ rights (Secs.21-23). This Chapter reads substantially as follows:

“Respect for privacy

21. Respect for a patient’s privacy is a fundamental principle. The patient may also expressly request that his privacy be protected. Every medical procedure shall be carried out in such a way that the patient’s privacy is respected.

The right to respect for privacy and the right to demand this respect shall include:

(a) the right to undergo medical examinations in a confidential manner in accordance with the patient’s state of health; ~b) the right that an examination, diagnosis, treatment, or procedures requiring direct contact with the patient take place in a sufficiently confidential setting;

(c) the right that the presence of a close associate be authorized in cases where such a presence is not inconvenient from a medical standpoint;

(d) the right that persons not directly associated with the treatment are not present at a medical intervention;

(e) the right of non-interference in the patient’s private and family life if the nature of the disease so demands; and

(I) the right to confidentiality with regard to the origin of health expenditure.

In the event of death, the right to confidentiality shall maintained.

If, within a health establishment or facility in which training is provided, it is necessary for persons who are not directly associated with the patient’s treatment to be present during a medical procedure, the express consent of the patient concerned to such presence shall be obtained prior to or during the treatment.

Prohibition of the subjection of a person to a medical procedure without his consent

22. No person may be subjected to a medical procedure without his consent or in a manner that is not in keeping with the consent that he is given, subject to exceptions laid down by law.

[Recourse to a court decision for the carrying out of a medical procedure in the event of an offence or a presumed offence]

In cases where delay would be detrimental, such a procedure may be carried out at the request of the State Prosecutor.

Confidentiality of data

23. Data obtained during the provision of health services may not be disclosed under any circumstances, other than where permitted by law.

[Provisions relating to legal and criminal liability]

Even in the context of activities carried out for the purposes of research or teaching, it shall be prohibited to disclose data relating to a patient’s identity without the patient’s consent.”

chapter V Patient’s consent to a medical

procedure (Secs. 24-31). Under Sec. 24 (Patient’s consent and authorization), the patient’s consent to a medical procedure is necessary. If the patient is a minor or incompetent, the authorization of his tutor is required. If the patient’s guardian is unavailable or if the patient is not able to express his wishes, this condition is not required. A medical procedure may be carried out on a patient subject to guardianship in the absence of consent from his legal representative if such procedure is medically necessary, following a court decision in accordance with Sees. 272 and 431 of the Turkish Civil Code. If a person’s life is in danger or if a vital organ is threatened, the authorization of the legal representative or the court is not required. Except in a case of an emergency as referred to above, consent may be withdrawn at any time. Withdrawal of consent implies that a patient refuses the treatment. Sees. 25-28 are entitled as follows: 25. Refusal and suspension of treatment; 26. Participation of a minor or incompetent person in a medical procedure; 27. Application of non-traditional therapeutic methods; and 28. Form and validity of consent. Sec. 29 (Consent to the removal of organs and tissues) prohibits the removal of organs or tissues from persons under 18 years of age or those incapable of discernment. Such removal for diagnostic, therapeutic, or scientific purposes is governed by the provisions of Sec. 6 of Law No. 2238 of 29 May 1979 on the removal, storage, and transplantation of organs and tissues (see IDHL, 1980, 31, 866). The conditions governing the removal of organs and tissues from a deceased person and the modalities concerning the storage of cadavers intended for scientific research are covered by the provisions of Sec. 14 of the above-mentioned Law No. 2238 of 1979. Under Sec. 30 (Family planning services and pregnancy termination), it is prohibited to use, with or without the consent of the person concerned, medicaments or procedures that are not recogniby the Ministry. Pregnancy terminations are covered by the provisions of Law No. 2827 of 24 May 1983 on family planning (see i., 1983, 34, 759, Turk. 83.1). In cases of sterilization or pregnancy termination, the consent of the patient’s spouse, if there is one, is also required. Sec. 31 (Implications of consent) lays down, inter alia, that the patient or his legal representative must, before giving consent, have been informed and instructed concerning the object and consequenes of the proposed medical procedure.

Chapter VI. Medical research (Secs. 32.36). Sec. 32 (Consent to medical research) lays down that no person may be subjected to a medical procedure for the purposes of experimentation, research, or teaching without the authorization of the Ministry and his own consent. The other Sections of this Chapter are entitled as follows: 33. Protection and provision of information to the voluntary subject; 34. Modalities and form of consent; 35. Cases involving minors and incompetent persons; and 36. Use of medicaments and compounds for research purposes.

Chapter VII. Other rights (Secs. 37-41). The Sections of this Chapter are entitled as follows:

37. Assurance of safety; 38. Access to a place of worship and religious services; 39. Respect for human values and visits; 40. Availability of persons to provide support to the patient; and

41. Access to services outside health establishments or facilities.

chapter VIII. Liability and means of legal protection (Secs. 42-47). The Sections of this Chapter are entitled as follows: 42. Right to appeal, lodge complaints, and bring actions; 43. Liability of health establishments and facilities;

44. Liability of officials and other personnel in the public sector; 45. Method of determining the liability of personnel in the public sector; 46. Sanctions concerning personnel in the public sector; and 47. Liability of personnel not belonging to the public sector.

Chapter IX. Final provisions (Secs. 48-51). Sec. 51 charges the Minister of Health with the implementation of these Regulations.