INTERM4TIONAL. DIGEST OF HEALTH LEGISLATION, 1999, 50 (1)

DENMARK. law No. 482 of 1 July 1998 on patients’ rights. (Lottidende, 1998, Part A, 2

July 1998, No. 99, pp. 2883-2888) Den. 99.1

This Law repeats Secs. 6 (points 2.5) and 6a of the Law on the practice of medicine as promulgated by Order No. 632 of 20 July 1995 (see IDIsfL, 1995, 46, 460, Den. 95.25), as amended by Law No. 463 of 10 June 1997 on the advertising of health services (see ibid., 1997, 48, 358, Den. 97.26), and will repeal or replace, in due course and as specified, Order No. 782 of 18 September 1992 on living wills (see ibid., 1992, 43, 767, Den. 92.34) and Sec. 31 of the above-mentioned Law on the practice of medicine. Chapters 1-5 read substantially as follows:

“Chapter 1

Purpose, scope definitions; etc.

1. The Law shall contribute to ensuring that the patient’s dignity, integrity, and autonomy are respected. The Law shall also contribute to ensuring that the relationship between the patient and the health care provider is one of confidence and confidentiality.

2. The Law shall be applicable to patients who, within the health system or in other places in which health services are provided, receive or have received a treatment from a health care provider, subject to other specific provisions laid down by legislation.

3. Within the meaning of this Law, treatment’ means examinations, diagnosis, the treatment of disease, rehabilitation, therapeutic and preventive care, etc., in connection with a particular patient.

4. Within the meaning of this Law, ‘health care provider’ means a person authorized by virtue of specific legislative provisions to dispense health care on a professional basis and also persons acting under his responsibility.

5. If a patient is unable personally to ensure that his interests are protected, the person or persons thus authorized by legislation shall intervene to uphold the patient’s rights under the law, to the extent necessary in order to ensure that his interests are protected in the situation concerned.

Chapter 2

Self-derennination

Informed consent

6. (1) No treatment may be begun or continued without the patient’s informed consent, unless otherwise provided for by this Law or in regulations made for its implementation or in pursuance of Sections 8 to 10.

(2) The patient may at any time withdraw the consent referred to in subsection 1.

(3) Within the meaning of this Law, ‘informed consent’ means consent given on the basis of adequate information provided by the health care provider, in accordance with Section 7.

(4) Under the terms of this Chapter, informed consent may be written, verbal, or tacit.

(5) The Minister of Health shall be empowered to lay down specific rules on the form and content of consent.

7. (1) The patient shall have the right to obtain information on his state of health and on the Possibilities of treatment offered to him, including that relating to the risk of complications and side-effects

(2) The patient shall have the right to refuse the information referred to in the preceding subsection

(3) Information shall be communicated as and when available and present the disease, examinations, and the envisaged treatment in comprehensible terms, Information shall be communicated in a considerate manner and shall be appropriate to the particular situation of the patient: his age, maturity, experience, etc.

(4) The information communicated shall include details concerning the relevant possibilities with regard to prevention, treatment, and care, including other medically justifiable possibilities of treatment and information on the consequences of nor carrying out any treatment. Information shall be more comprehensive if treatment entails the immediate risk of serious complications and side-effects.

(5) If it is considered that the patient is unaware of elements that are important to him in taking the decision referred to in Section 6, the health care provider shall undertake to inform hini accordingly, unless the patient has expressed the wish not to be informed, in accordance with subsection 2.

(6) [Competence of the Minister of Health]

Minors

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

15 years may personally give informed consent to treatment, The person holding parental authority shall also receive information in accordance with Section 7, and shall participate in the decision taken by the minor.

(2) If the health care provider considers, after carrying out an assessment of the individual concerned, that the 15-year-old patient is nor capable on his own of understanding the consequences of his decision the person holding parental authority shall be empowered ro give informed consent.

(3) A patient who has attained the age of 15 years shall have the right of access to the files concerning him, in accordance with the provisions of Chapter 4, and may give his consent to the disclosure of information relating to his health etc. in accordance with the provisions of Chapter 5.

Patients who are permanently incapable of giving informed consent

9. (1) If a patient is permanently incapable of giving informed consent, the person most closely relared to him may give informed consent to treatment. In cases where the patient is placed under guardianship that encompasses his persona! circumstances including his health as referred to in Section 5 of the Guardianship Law, the guardian shall be empowered to give informed consent.

(2) If a patient who is permanently incapable of giving informed consent has no next-of- kin or guardian, a health care provider may carry out the envisaged treatment if another health care provider competent in this field gives his agreement, provided that this person has not previously participated in the treatment of the patient concerned and will nor be called upon to participate in such treatment in the future.

(3) In the cases referred to in subsection 2, the health care provider may however, without involving another health care provider carry out the envisaged treatment if such treatment is nor of a very radical nature with regard to its extent or duration.

(4) If he considers that the patient’s next-of-kin or guardian, in accordance with subsection 1, carries out his duties with regard to consent in a manner that is obviously detrimental to the patient or the outcome of the treatment, the

health care provider may carry our the treatment, provided that the competent State medical institution has given its agreement.

Need for immediate treatment

10. If a patient, who is temporarily or permanently incapable of giving informed consent or who is under 15 years of age, finds himself in a situation in which he requires immediate treatment in order to survive or in order to improve his chances of survival or considerably improve the outcome of the treatment, a health care provider may begin or continue such treatment without rhe consent of the patient, the person holding parental authority, the next-of-kin, or the guardian.

 

Participation of the patient

11. A patient who is incapable of giving informed consent himself shall be kept informed and involved in the discussions relating to his treatment, to the extent that he is able to understand the situation with regard to treatment, provided that such involvement is not detrimental to him. Importance should be attached to the information provided by the patient, insofar as it is current and relevant.

  • Responsibility of the health care provider
  • 12.The health care provider responsible for the treatment shall be required to ensure that:

    1. informed consent is obtained in accordance with Sections 6-8 and subsection 1 of Section 9;

    2. the agreement of another health care provider has been obtained in accordance with subsection 2 of Section 9;

    3. the agreement of the appropriate State medical institution has been obtained in accordance with subsection 4 of Section 9; and

    4. the patient has been informed and involved in the discussions relating to his treatment in accordance with the provisions of Section 11.

    Chapter 3

    Self-determination in special cases

    13. Sections 6 and 7 on informed consent, Section 8 on minors, Section 11 on the participof the patient, and Section 12 on the responsibility of the health care provider shall also be applicable to the provisions of this Chapter. However, Section 8 on minors shall nor be applicable to Section 17 on living wills.

    Hunger strike

    14. If it is clear that a patient has begun a hunger strike and has been informed of its consequences for his health, the health care provider shall not have the right to terminate it.

    Refusal to receive blood

    15. (1) A treatment involving the transfusion of blood or blood products may not be begun or continued without the patient’s informed consent.

    (2) The patient’s refusal to receive blood or blood products shall be expressed in connection with the current state of the disease and based on information supplied by the health care provider concerning the health-related consequences of omitting to provide blood or blood products as part of the treatment.

    (3) If the administration of a treatment without the use of blood or blood products is contrary to his ethical convictions, the health care provider shall not be under an obligation to provide such treatment and the patient may be referred to another health care provider, unless his case is such that it urgently requires the intervention of a physician, in accordance with subsection 1 of Section 7 of the Law on the practice of medicine.

    Treatment of patients whose death is inevitable

    16. (1) A patient whose death is inevitable may refuse a treatment the sole purpose of which is to postpone the moment of death.

    (2) If a patient whose death is inevitable is no longer in a position to exercise his right to self-determination, a health care provider may refrain from beginning or continuing a life-prolonging treatment, in accordance with subsection 3 of Section 17.

    (3) A patient whose death is inevitable may receive the analgesics, tranquillizers, or similar medicaments necessary in order to alleviate the patient’s condition, even if this may precipitate the moment of death.

    Living wills

    17. (1) Any person who has attained the age of 18 years and is not under guardianship that encompasses his personal circumstances, including health, as referred to in Section 5 of the Law on guardianship, may draw up a living will. The person concerned may express in the will his wishes concerning treatment in the event of his being in a situation where he is no longer able to exercise the right of self-determination by himself.

    (2) In a living will, the patient may stipulate:

    1. that he does not wish to have recourse to life-prolonging treatment in a situation in

    which his death is inevitable; and

    2. that he does not wish to have recourse to life-prolonging treatment in a case where disease, advanced infirmity trough old age, an accident, cardiac arrest, or the like result in such severe incapacity that he is permanently unable to take care of himself both physically and mentally.

    (3) Life-prolonging treatment means treatment that offers no prospect of cure,

    improvement, or alleviation, but merely the

    prolongation of life,

    (4) If, in a case where a patient is unable to exercise his right of self-determination by himself, a health care provider envisages commencing life-prolonging treatment for a person whose death is inevitable or continuing such treatment in a situation such as that referred to in point 2 of subsection 2, the health care provider shall contact the Living Will Register, referred to in Section 18, in order to ascertain whether a living will exists.

    (5) The testator’s wishes under point 1 of subsection 2 shall be binding for the health care provider, whereas any wishes expressed in accordance with point 2 of subsection 2 shall merely serve as a guide for the health care provider and shall form part of the latter’s considerations with regard to treatment.

    18. (1) The Minister of Health shall establish a living Will Register and lay down specific rules on the drawing up, formulation, registration, and revocation, etc., of living wills.

    (2) [Registration fees]

    Chapter 4

    Right of access to files

    19. (1) The rules laid down in this Chapter shall be applicable to patients’ files, etc., prepared by health care providers and kept in public or private hospitals, clinics, Outpatient centres, in a private practice or in connection with treatment in private homes, or in other public or private establishments, etc., whose activities in the field of health include the treatment of patients,

    (2) The rules laid down in this Chapter shall not be applicable to the registers covered by the law on the registers of public authorities or to registration carried out purely for scientific or Statistical purposes.

    (3) [Competence of the Minister of Health}

    20. (1) If a patient so requests, he shall be informed of the extent to which use is made of the health data concerning him and contained in his file, etc. If use is made of such data, the patient shall be informed, at his request and in easily comprehensible terms, of:

    1. the nature of the data used;

    2. the purpose of such use;

    3. the categories of recipients of the data; and

    4. any information available on the origin of such data.

    (2) The right referred to in subsection 1 may, however, be restricted to the extent that the patient’s interest in being informed of the data must be sacrificed in favo,: r of considerations that are of crucial importance to the person concerned or to other private interests.

    21. (1) Decisions concerning the right of access to files shall be taken by the authority, establishment, or health care provider holding the patient’s files, etc.

    (2)The competent authority, establishment, or health care provider shall decide as rapidly as possible whether a request to consult a file can be complied with, and whether such consultation should take the form of on-the-spot examination of the patients file, etc., or whether a transcript or copy of the file should be communicated to the person concerned.

    (3) If a request to consult a file has not been complied with or refused within 10 days of its reception by the competent authority, establishment, or health care provider, the authority, establishment, or health care provider shall inform the patient of the reasons for this delay and shall indicate when a decision can be expected to be taken-

    (4) In cases in which a health care provider, in accordance with subsections 1 to 3, is authorized to this end, overall responsibility for authorizing consultation of the file, in accordance with this Law, shall lie with the authority responsible for the management of the establishment concerned.

    22. (1) [Competence of the Minister of Health I

    Chapter 5

    Professional confidentiality and the

    disclosure of health data, etc

    Right of the patient to have the

    confidentiality of the data

    concerning him respected by

    health care providers

    23. (1) A patient shall have the right to demand that health care providers respect the confidentiality of the data that have come to their knowledge during the practice of their profession or the assumptions that they may make concerning his state of health, as well as the confidentiality of other strictly private or confidential information, subject to the rules laid down In this respect by this Chapter.

    (2) In cases where a health care provider referred to in this Chapter is authorized to this end in pursuance of specific provisions, the overall responsibility of communicating the data, in accordance with this Law, shall lie with the authority responsible fur the management of the establishment concerned.

  • Disclosure of health-related data, etc, in connection with the treatment of patients
  • 24. (1) Subject to the patient’s consent, the health care provider may disclose to other health care providers data concerning the health of the patient, as well as information of a strictly private or confidential nature in connection with the patient’s treatment.

    (2) The data referred to in subsection I may be disclosed without the patient’s consent if:

    1. such disclosure is necessary with regard

  • to the current development of the treatment dispensed to the patient and due consideration is taken of the patient’s interests and needs;

    2. such is necessary for the protection of an obvious common interest or of important interests of the patient, health care provider, or other persons; or

  • 3. such disclosure is made to a general practitioner treating the patient by a beam

    tenens operating on the former’s behalf.

    (3) In the case of the disclosure referred to in point 1 of subsection 2, the patient may at any time during the course of the treatment dispensed to him request that the data are not disclosed.

    (4) The health care provider in possession of confidential data shall determine to what extent the disclosure of such data is justified under subsection 2.

    (5) If data are disclosed in accordance with item 2 of subsection 2, the person to whom the data relate shall be informed of such disclosure and of the reasons for this.

    (6) [competence of the Minister of Health]

    25. (1) The consent referred to in subsection I of Section 24 shall be given verbally or in writing. Consent may be given to the health care provider who divulges or to the health care provider who is the recipient of such data. Consent shall be recorded in the patient’s file.

    (2) [competence of the Minister of Health]

    Disclosure of health-related data, etc, for other purposes

    26. (1.) Subject to the patient’s consent, the health care provider may disclose to authorities, organizations, private persons, etc., data relating to the health of the patient, as well as strictly private or confidential information concerning him, for purposes other than therapeutic ones.

    (2) The data referred to in subsection I may be disclosed without the patient’s consent if:

    1. under the Law or provisions made for its implementation, the said data must be disclosed and must be considered as having considerable importance for the authority responsible for examining the file;

    2. their disclosure is justified for the protection of an obvious common interest or for the protection of important interests of the patient, health care provider, or other persons; or

    3. disclosure is necessary in order to permit the authority to carry out its inspection and control functions.

    (3) The health care provider in possession of confidential data shall determine to what extent their disclosure is justified under subsection 2.

    (4) If data are disclosed, in accordance with point 2 of subsection 2, the person to whom the data relate shall be informed of their disclosure as soon as possible and of the reasons for such action.

    27. (1) The consent referred to in subsection 1 of Section 26 shall be given in writing. Exceptions may be made to the requirement for written consent if indicated by the nature of the file or the circumstances involved. Consent shall be recorded in the patient’s file.

    (2) The consent referred to in subsection 1 shall cease to be valid at the latest one year after the date on which it was given.

    (3) [Competence of the Minister of Health]

    Disclosure to next-of-kin of data relating to

    the health of deceased patients

    28. (1) A health care provider may disclose data to the next-of-kin of a deceased patient concerning the development of the latter’s disease and the causes and manner of his death, provided that this is not perceived as running counter to the deceased’s wishes and that the respect due to him or other private interests do not strongly suggest that this is inappropriate. Data may also be disclosed to the deceased’s next-of-kin in accordance with item 2 of subsection 2 of Section 26.

    (2) The general practitioner treating the deceased or the physician responsible for the deceased’s treatment may obtain from a hospital or a health care provider the same data as those referred to in point 1 of subsection 1, provided that the deceased’s next-of-kin have expressed the wish to receive such data from the physician concerned.

    Disclosure of/wa/tb-related data for special purposes (research, statistics; etc.)

    29. (1) Data concerning the state of health of private persons, as well as strictly private or confidential information recorded in patients’ files, etc., may be disclosed to a researcher for use as part of a concrete biomedical research project, provided that the project has been authorized in pursuance of the Law [No. 503 of 24 June 19921 on the scientific ethics committee system and the examination of biomedical research projects [as promulgated by Order No. 221 of 4 March 1997 (see ibid., 1997, 48, 354, Den- 97.19].

    (2) If the Law on the scientific ethics committee system, etc. is not applicable to a research project, the data referred to in subsection 1 may be disclosed tO a researcher for use as part of a concrete research project of substantial interest for the community, after approval has been given by the National Board of Health, which shall be responsible for determining the conditions governing such disclosure.

    (3) ....

    30. (1) The data referred to in Section 29 may be disclosed for statistical use or planning after approval has been given by the National Board of Health, which shall be responsible for determining the conditions governing the use of such data, etc,, in accordance with subsection 2.

    (2) The data referred to in subsection 1 may be disclosed without the approval of the National Board of Health if the disclosure of such data is mandatory under the law.

    31. (1) Data collected under Sections 29 and

    30 for use in research, statistics, or planning shall not be subsequently used for purposes other than scientific or statistical ones.

    (2) The data referred to in subsection 1 may only be published in a form that guarantees the anonymity of the persons concerned.

    (3) [Competence of the Minister of Health]

    Disclosure to third countries

    32. [Competence of the Minister of Health]

    DENMARK. Guidelines No. 155 of 14

    September 1998 on the right to inspect

    documents in connection with health

    information. (Ministerialtidende, 1998, 24

    September 1998, No. 20, pp. 1715-1725)

    Den. 99.3

    These Guidelines, which are a follow-up to Law No. 482 of 1 July 1998 on patients’ rights (see supra), repeal Guidelines No. 193 of 7 December 1993 on the same subject (see IDHL, 1995, 46, 63, Den. 95.2). They implement Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data (see ibid., 1996, 47, 47, EC 96.3). The topics covered include: the purpose and scope of the right of inspection; the purpose of the guidelines; the procedure for submitting a request to inspect documents; the procedures for granting the right of inspection; the conditions governing the refusal to grant requests to inspect documents; appeals to the Board authorized to receive patients’ complaints; and the keeping of files,

     

    NETHERLANDS. Law (Stb. 365) of 5 July

    1997 promulgating provisions intended to strengthen the legal position of persons undergoing medical checks (the Medical Checks Law).a (Staatsblad van bet Koninkrijk derNeder/anden, 1997, 6 pp.)

    Net. 99.1

    Sec. 1 of this Law defines “medical check” as follows: “enquiries regarding the health of a subject and medical tests, made or performed in connection with the establishment or amendment of any of the following: (1) a civil contract of employment recognized under or pursuant to the Sickness Benefits Law or the Disability Insurance Law; (2) a contract of public service; (3) a civil pension or life insurance contract; (4) a commitment as referred to in Section 2 of the Pension and Savings Funds Law; (5) a civil occupational disability insurance contract; or (6) a contract of insurarice, as referred to in subsection 5 of Section 4, against a risk which exists in the Netherlands”,

    Secs, 2-13 of this Law, which entered into force on 1 January 1998, read substantially as follows:

    “2. (1) Medical checks shall be limited in their nature, content and extent to that which is necessary fur fulfilment of their purpose.

    (2) Medical check findings shall not be used for any purpose other than that for which they were obtained.

    3. (1) Neither the enquiries made nor the medical tests performed as part of a medical check shall unreasonably infringe the subject’s priv.

    (2) No medical check shall involve either of the fbllowing:

     

    a The extract published here is from the official English tmnslatbon, prepared by the Ministry of Health, Welfare and Sport, and is reproduced with a minimum of editorial changes—ED,

     

    (a) a test which entails a level of risk for the subject which is disproportionate to the likely usefulness of the test to the commissioning party (such as a test intended to provide information regarding the likelihood of developing a serious condition for which there is no known treatment or which cannot be prevented or stabilized by medical intervention, or regarding the presence of a serious, untreatable condition which might not become manifest until some time after the medical check);

    a test which otherwise involves unreasonable discomfort for the subject.

    4. (1) No employee, prospective employee, public servant or prospective public servant shall be required to undergo a medical check in connection with the establishment or amendment of a civil contract of employment recognized under or pursuant to the Sickness Benefits Law or the Disability Insurance Law, or in connection with the establishment or amendment of a contract of public service, unless the duties to which the contract relates are such that any person undertaking them must meet special medical fitness requirements. Medical fitness shall be deemed to include the individual’s ability to perform his or her duties without risk to his or her own health or safety or to the health or safety of others.

    (2) No prospective employee or prospective public servant shall be required to undergo a medical check in connection with the establishment of a civil contract of employment recognized under or pursuant to the Sickness Benefits law or the Disability Insurance Law, or in connection with the establishment of a contract of public service, until assessment of his or her suitability for employment on other criteria is complete and until the prospective employer has decided to appoint the individual in question, provided that the medical requirements are met. If the assessment referred to in the first sentence of this subsection includes investigation of the background of the prospective employee or prospective public servant, or if a security check of the kind referred to in the Security Checks Law is required, the medical check in connection with the establishment of a civil contract of employment recognized under or pursuant to the Sickness Benefits Law or the Disability Insurance Law or in connection with the establishment of a contract of public service, may, at the prospective employee’s or prospective public servant’s request, take place before the said investigation. A medical check in connection with admission to the military or police services may always be performed before any associated check of the individual’s background or any associated security check. Information shall not be sought regarding the health or sickness absenteeism record of a prospective employee or prospective public servant, either from the said individual or from other sources, except in the context of a medical check.

    (3) No person shall be required to undergo a medical check pzior to admission to a pension scheme, as referred to in Section 2 of the Pension and Savings Funds Law, unless an undertaking has been mad~ to a person, as referred to in subclause 1 of clause c of subsection 3 of Section 2 of the said Law. However, where a pension scheme offers individual participants certain options, if a permanent employee wishes to change the basis of his or her participation, a medical check may be required.

    (4) No person shall be required to undergo a medical check prior to admission to a scheme, which provides occupational disability insurance cover separate from that provided by a pension scheme as referred to in subsection 3 of this Section 4, and which is linked to a civil contract of employment recognized under or pursuant to the Sickness Benefits Law or the Disability Insurance law, or to a contract of public service.

    (5) No person covered by a civil contract of employment recognized under or pursuant to the Sickness Benefits Law or the Disability Insurance Law, or by a contract of public service, shall be required to undergo a medical check in connection with an insurance contract which the individual’s employer has closed or intends to close to cover the risk arising out of the employer’s statutory sick pay obligations, as specified in clause 1 of Article 629 of Book 7 of the Dutch Civil Code, or the risk arising out of the employer’s disability benefit payment obligations, as specified in Section 75a of the Disability Insurance Law.

    (6) Under circumstances where, pursuant to this Section 4, a medical check may not be required, if an employee wishes to participate in a scheme as referred to in subsection 3, or if an employer wishes to close or amend an insurance contract as referred to in subsection 4 or subsection 5, the insurer shall not exclude or diminish any right on the grounds of sickness, medical condition or disability.

    5. (1) No medical check connected with the closure or amendment of an insurance contract shall involve questioning the proposer’s blood relatives or, unless the condition is manifest the proposer, regarding a medical condition, as referred to in clause a of subsection 2 of Section 3, insofar as the condition is hereditary, or regarding tests which the proposer or the proposer’s blood relatives have undergone with a view to determining genetic predisposition to a medical condition or conditions, or regarding the results of such tests, unless the sum insured exceeds the enquiry limit. In the assessment of a proposal regarding the closure or :.mendment ot’ an insurance contract, and in the course of any related medical check, no use may be made of genetic information held by the commissioning party, the performing physician or the medical adviser, regarding the proposer or the proposer’s blood relatives, which has not been obtained in connection with that proposal.

    (2)

    6. Contraiy to the provisions of Section 5, a medical test to determine the presence of AIDS or AIDS antibodies may be required in connection with the closure or amendment of an insurance contract as referred to in Section r,, under either of the following circumstances:

    (a) if the sum insured exceeds the enquirY limit referred to in subsection 2 of Section 5; (b) if, although the surn insured does not exceed the enquiry limit referred to in subsection 2 of Section 5, such a test is justified by the subject’s responses to enquiries made as part of a medical check permitted by the provisions of Section 2 and subsection 1 of Section 3.

    7. Contrary to the provisions of Section 3, our Minister of Health, Welfare and Sport may, if a pressing public need should arise, regulate to bring under the scope of Section 6 any new medical condition of the kind referred to in clause a of subsection 2 of Section 3, until arrangements can be made in accordance with Section 9. A draft of any Order in Council prepared in accordance with the first sentence of this Section 7 shall be submitted to both houses

    of the States General at least four weeks before it is enacted.

    8. (1) Pursuant to Sections 2,3,4,5,6 and 7, the party commissioning a medical check shall specify in writing the purpose of the medical check and the nature of any associated enquiries and/or medical tests.

    (2) In good time before a medical check, the subject shall be notified, in writing and in a readily understandable form, of the purpose of the medical check and the nature of any associated enquiries and/or medical tests, as referred to in subsection 1 of this Section 8, as well as of his or her rights in relation to medical checks.

    9. Organizations representing employers or insurers, organizations representing employees or consumers and patients and organizations representing physicians may make agreements regarding the specification of the purpose of the medical check, as referred to in subsection 1 of Section 2, regarding the conduct of medical checks, as referred to in subsection 1 of Section 4, and regardinassociated enquiries and medical rests, as referred to in Sections 3, 5, 6, 7 and 8.

    10. (1) In the conduct of their duties, the performing physician and the medical adviser shall remain autonomous in their respective areas of competence and independent from the commissioning party.

    (2) The performing physician and the medical adviser shall treat as confidential information regarding the subject and shall ensure that any records retained pertaining to the subject are not accessible to third parties.

    (3) The performing physician and the medical adviser shall pass on to the commissioning party only that information which is strictly relevant to the purpose of the medical check.

    11.The subject shall be entitled to refuse to

    participate in a medical check or part of a

    medical check if the medical check or part-

    medical check does not comply with Sections 2,

    3, 4, 5, 6, 7, or 8.

    12, (1) If the findings of a medical check ae disadvantageous to or restrictive for the subject, the latter shall be entitled to a second medical check. A subject who wishes to exercise his or her right to a second medical check shall notify the commissioning party of this wish, stating his or her reasons, within a week of learning of the

    findings. The commissioning party shall then arrange for a second medical check to be performed by an independent medical practitioner.

    (2) If a subject exercises his or her right to a second medical check, the commissioning party shall postpone deciding the matter in connection with which the medical check was commissioned until the outcome of the second medical check is known.

    (3) The cost of any second medical check shall be borne by the commissioning party. The latter may, however, ask the subject to make a reasonable contribution to the said cost.

    13. (1) The organizations referred to in Section 9 may establish an independent complaints committee.

    (2) The said committee may receive complaints regarding matters regulated by or pursuant to this law or regarding the agreements referred to in Section 9, and may communicate its findings to the complainant and to the party who is the subject of the complaint.

    (3) The remit of a committee established in accordance with this Section 13 shall be defined by the organizations referred to in Section 9.”

    Sec. 14 lays down, inter a/ia, that further regulations concerning the matters dealt with in Sees 2-8 and 13 may be introduced by Order in Council,