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RS 812.121.6 Order of 25 May 2011 on addiction to narcotic drugs and other addiction-related disorders (Narcotics addiction Ordinance, OAStup)

Original Language Title: RS 812.121.6 Ordonnance du 25 mai 2011 relative à l’addiction aux stupéfiants et aux autres troubles liés à l’addiction (Ordonnance relative à l’addiction aux stupéfiants, OAStup)

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812.121.6

Narcotics and Other Addiction Disorders Ordinance

(Narcotics addiction Ordinance, OAStup)

May 25, 2011 (State 1 Er July 2011)

The Swiss Federal Council,

Having regard to art. 3 B , para. 2, 3 D , para. 5, 3 E , para. 2 and 3, 3 F , para. 3, 29, para. 4, 29 C , para. 1 and 2, and 30, para. 1 and 2, of the Act of 3 October 1951 on Narcotic Drugs (LStup) 1 ,

Stops:

Chapter 1 General provisions

Art. 1 Purpose

This Order governs:

A.
Measures to prevent the problematic use of psychoactive substances and addiction-related disorders;
B.
Therapies and rehabilitation measures for people with addictive disorders;
C.
Measures to reduce risks in people with addiction-related disorders and help them to survive;
D.
The exceptional authorizations referred to in s. 8, para. 5, 6 and 8, LStup and related controls;
E.
Promotion of research, training, development, continuing education and quality assurance in the field of addictions;
F.
The Federal Commission on addiction issues.
Art. 2 Definitions

For the purposes of this order:

A.
Addiction or addiction: A combination of physiological, cognitive and behavioural phenomena that can develop after repeated use of psychoactive substances;
B.
Prescription of narcotic drugs or subst products I Tution: Replacement, on a medical prescription, of a narcotic consumed without authorization by way of medical and psychosocial treatment;
C.
Diacetylmorphine: Pharmaceutical derived from morphine legally manufactured in pharmacies for the medical treatment of people who are dependent on opiate;
D.
Treatment with diacetylmorphine prescription: Therapy for people who are severely addicted to heroin, using diacetylmorphine in medical and psychosocial treatment;
E.
Good laboratory practices: Quality assurance system including the organisation of the conduct of studies, the general conditions under which these studies are planned, carried out and controlled, the recording and dissemination of these studies and the archiving of their studies Records;
F.
Psychoactive substance: Substance that acts on the psyche of the human being;
G.
Person severely dependent on heroin: Person meeting the criteria for this diagnosis according to the International Classification of Diseases of the World Health Organization (WHO), International Statistical Class I Fication of Diseases and Related Health Problems , ICD-10 F11.2, version 2007, published January 2008 1 ;
H.
Health: Full physical, mental and social well-being as defined by WHO 2 .

1 The text of this classification may be obtained free of charge from the Federal Office of Public Health, Division National Prevention Programmes, 3003 Berne, and consulted on the Internet at the address http://apps.who.int/classifications/apps/icd/icd10online/
2 The WHO definition can be obtained free of charge from the Federal Office of Public Health, Division National Prevention Programmes, 3003 Berne, and consulted on the Internet at the address http://apps.who.int/gb/bd/PDF/bd47/EN/constitution-en.pdf

Chapter 2 Prevention

Art. 3 Prevention Goals

The goals of prevention are to:

A.
To prevent the unauthorized consumption of controlled substances and encourage abstinent;
B.
Prevent and prevent problematic substance use and dependence on psychoactive substances;
C.
To prevent the social and health problems that may be caused by problematic substance use and dependence;
D.
Create general conditions conducive to health promotion in relation to the consumption of psychoactive substances.
Art. 4 Encouragement of prevention programmes

1 The Federal Office of Public Health (OFSP) assists the relevant federal departments, cantons, municipalities, public institutions and private organisations in the design and implementation of prevention programmes in the field of substances Psychoactive.

2 In particular, it performs the following tasks:

A.
Collecting and analysing information on health risks related to addiction;
B.
Informing the public about the health, social and economic damage caused by the addiction;
C.
Providing scientific basis and methodological tools;
D.
It supports the cantons and third parties in the coordination of activities and in the creation and monitoring of networks in the field of addiction;
E.
Examines the effectiveness of supported programs and projects.

3 Within the limits of the appropriations approved, it may allocate financial aid:

A.
For prevention programmes of national importance carried out by public authorities or public utility organisations of private law;
B.
For information activities and offers for advice.
Art. 5 Advertising Skill and Early Detection

The FOPH may support the cantons in the implementation of Art. 3 C LStup.

Chapter 3 Therapy and reintegration

Section 1 General provisions

Art. 6 Goals of therapy

The goals of therapy for people with addiction-related disorders are:

A.
Establish a therapeutic relationship with them;
B.
Improving health, including by reducing the psychological, physical and social complications of substance use;
C.
Move them towards the consumption of low risk psychoactive substances;
D.
Encourage them to reintegrate socially and professionally;
E.
Encourage them to refrain from consuming substances subject to control without authorisation.
Art. 7 Offer of therapies

The FOPH develops recommendations for the funding of therapies and rehabilitation measures.

Section 2 Drug prescription

Art. 8 Treatment Goals with Drug prescription

1 The goals of the drug prescription drug treatment are:

A.
Remove the treated person from the drug environment;
B.
To prevent drug-related crime;
C.
Change the person treated to forms of substance use of low risk psychoactive substances;
D.
Cause the treated person to reduce his/her consumption of substitute products until they do not.

2 Drug prescription treatment is carried out by qualified people, including doctors, pharmacists, nurses, social workers and psychologists.

3 It may be provided in the residential sector, in an institution equipped for this purpose, or in the ambulatory sector. The provisions governing the prescription of diacetylmorphine are reserved.

Art. Indications to be provided for the granting of an authorisation

1 For the granting of an authorization to follow a prescription of narcotic drugs according to s. 3 E , para. 1, LStup, the canton must require the doctor treating the following particulars:

A.
Name and address of the attending physician;
B.
Patient's first and last name;
C.
Sex of patient;
D.
Patient's date of birth;
E.
Place of origin of the patient;
F.
Address of patient's home;
G.
Address of the patient's provisional residence, and
H.
Delivery organization.

2 In the case of residential treatment, it also requires the name and address of the institution.

Section 3 Special provisions for the prescription of diacetylmorphine

Art. 10 Admission Criteria

1 To be admitted to treatment with a prescription of diacetylmorphine, the patient must:

A.
Be 18 years of age;
B.
Have been severely addicted to heroin for at least two years;
C.
Have followed without success or interrupted at least two other ambulatory or residential therapy; and
D.
Present deficits of a psychic, physical or social nature.

2 In justified exceptional cases where treatment with other therapies is not a chance of success or is not possible, for example in the case of serious physical or mental illness, a patient may be admitted to treatment with Prescription of diacetylmorphine even if it does not meet the above conditions.

Art. 11 Indication

The responsible physician will provide the indication. It must first complete a comprehensive review of the patient's health status. In so doing, it takes into account the social context.

Art. 12 Therapeutic plan

1 The people who treat the patient (treatment team) establish a therapeutic plan in an interdisciplinary way. They define the individual objectives of the patient in the different areas of care.

2 During therapy, they regularly evaluate the therapeutic plan with the help of the patient. In particular, they study the possibility for the patient to switch to another suitable form of treatment.

Art. 13 Administration, remission and seizure of diacetylmorphine

1 In principle, the administration and taking of diacetylmorphine in the course of therapy must take place within the institution referred to in s. 16, under visual control of a member of the treatment team.

2 Exceptionally, in specified cases, diacetylmorphine can be administered at home under the visual control of the responsible physician or a person mandated by his or her care.

3 Exceptionally, a patient may be given up to two daily doses if the following conditions are met:

A.
The patient has been treated with a prescription of diacetylmorphine for at least six months without interruption;
B.
The patient has a sufficiently stable health and social condition;
C.
The last two urine tests did not show any narcotics except diacetylmorphine;
D.
There is no risk of abuse.

4 At the reasoned request of the attending physician, the FOPH may reduce the time limit laid down in para. 3, let. A.

Art. 14 Treatment institution with a prescription of diacetylmorphine

1 The following are entitled to dispense with the prescription of diacetylmorphine the institutions:

A.
Provide interdisciplinary treatment and care;
B.
Concentrating medical and other skills that are required;
C.
Have a sufficient number of staff and care staff;
D.
Whose premises have an appropriate infrastructure; and
E.
Which can ensure the safety and quality of operations related to diacetylmorphine.

2 The authorities responsible for the treatment institutions with the prescription of diacetylmorphine may be cantons, municipalities or private organisations.

Art. 15 Caregivers

1 The health care staff of an institution providing treatment with the prescription of diacetylmorphine must be at least:

A.
A physician who is authorized to prescribe diacetylmorphine and is responsible for medical management;
B.
A qualified person responsible for the provision of psychosocial care; and
C.
People who are competent to provide care and provide preparations and medications.

2 Caregivers must have the required professional qualifications and regularly undergo continuous training.

3 A qualified person can assume responsibility for two areas of care if he or she has the necessary training and has sufficient capacity to take charge.

4 In justified exceptional cases, where coordination of interdisciplinary care allows, certain areas of treatment and care can be delegated to qualified external persons or institutions. The prescription of diacetylmorphine cannot be delegated.

Art. 16 Authority issued to the institution

1 Any institution wishing to dispense with the prescription of diacetylmorphine must obtain an authorization from the FOPH.

2 The FOPH issues the authorization:

A.
If the institution has obtained the cantonal authorization referred to in s. 3 E , para. 1, LStup;
B.
If the conditions for dispensing with the prescription of diacetylmorphine and the requirements imposed on the health care personnel and the institution set out in this order are met.

3 Exceptionally, an authorisation may be issued to a non-specialist institution if that is the only way to allow the patient to continue the treatment with the prescription of diacetylmorphine. The authorisation issued is valid only for the duration of the patient's stay.

4 The authorisation shall be valid for no more than five years. It may be renewed upon request.

Art. 17 Withdrawal of the authorisation issued to the institution

1 The FOPH shall withdraw the authorisation issued to the institution if the conditions for its grant cease to be fulfilled.

2 He may withdraw the authorization at any time under s. 6 and 14 A , para. 2, LStup.

Art. 18 Authorization issued to the physician

1 The OFSP grants to any physician authorized to prescribe narcotic drugs the authorization to obtain, use and remit diacetylmorphine in the course of a treatment with a prescription of diacetylmorphine (authorization issued to the physician) Justifies experience in the treatment of people who are severely addicted to heroin.

2 The authorisation shall be valid for no more than five years. It may be renewed upon request.

Art. 19 Extinction of authorization issued to the physician

The authorisation issued to the doctor shall be extinguished as soon as the holder ceases to be engaged in the treatment with the prescription of diacetylmorphine.

Art. Withdrawal of the authorisation issued to the doctor

The FOPH withdraws the authorization issued to the physician if:

A.
No longer fulfils the conditions required for its grant;
B.
Committed an intentional or repeated negligent violation of the Stup or the related orders;
C.
Actually the request.
Art. Patient-issued authorization

1 The FOPH grants any patient the authorization to treat with the prescription of diacetylmorphine (authorization issued to the patient):

A.
If it meets the eligibility criteria set out in s. 10;
B.
Whether the medical management has submitted the application for the prescription of diacetylmorphine and the granting of an authorization to the patient within the meaning of para. 2;
C.
If the competent cantonal authority within the meaning of Art. 3 E , para. 1, LStup does not object, and
D.
If the prescription of diacetylmorphine is dispensed in an institution holding an authorization referred to in s. 16.

2 The application to the patient for authorisation to follow a treatment with a prescription of diacetylmorphine must contain the particulars listed in art. 9.

3 The authorisation shall be valid for no more than two years. It may be renewed upon request, provided that the conditions for its grant are fulfilled.

Art. Extinction of authorisation issued to the patient

The authorization issued to the patient is extinguished:

A.
At the patient's request;
B.
If the patient withdraws from the program on the indication of the attending physician.
Art. Withdrawal of authorisation issued to the patient

The FOPH may withdraw consent from the patient for the prescription of diacetylmorphine:

A.
It consumes narcotics without medical prescription within the institution;
B.
If it gives or sells to third parties preparations that have been given to it in the course of the therapy;
C.
If it acts as a threat or acts of violence against health care personnel or other persons within the institution;
D.
If it refuses in principle and repeatedly to follow the related treatments or if it refuses in general the assumption of responsibility;
E.
Contravens other legal or internal provisions of the institution.
Art. 24 Information

The FOPH publishes an annual report on the implementation, development and evolution of the prescription of diacetylmorphine.

Art. 25 Control

1 The FOPH oversees the institutions. It carries out regular checks in close cooperation with the competent cantonal authorities.

2 As part of the control of the prescription of diacetylmorphine, the OFSP can consult the anamnesis and the treatment plans of the patients concerned.

Chapter 4 Goals of Risk Reduction

Art. 26 Goals of Risk Reduction

The goals of risk reduction are as follows:

A.
Maintain or improve the health of people with problematic substance use or addiction to psychoactive substances;
B.
To provide access to the health system and social assistance services for people with problematic substance use or addiction to psychoactive substances;
C.
To inform people with problematic substance use or addiction to psychoactive substances of less risky forms of consumption;
D.
Encourage people with addiction-related disorders to initiate substitution treatment or treatment for abstinent;
E.
To encourage people with problematic substance use or addiction to psychoactive substances to refrain from consuming controlled substances that are not prescribed;
F.
Protect third parties and the public space from the negative consequences of addictions; and
G.
To ensure the best possible social integration of people with problematic substance use or addiction to psychoactive substances.
Art. 27 Tasks of the Confederation

The FOPH encourages coordination between the relevant services and their exchanges on the latest developments.

Chapter 5 Exceptional Authorizations

Art. 28 Conditions

1 In need of an exceptional authorization issued by the FOPH any person who:

A.
Wishes to cultivate, import, manufacture or trade prohibited drugs (art. 8, para. 5, 6 and 8, LStup);
B.
Wants to conduct research on prohibited drugs;
C.
Wants to develop drugs from banned drugs;
D.
Wants to make limited medical use of a prohibited narcotic;
E.
Intends to use an authorized drug containing prohibited drugs for an indication other than the authorized indication.

2 The following particulars must be provided:

A.
For the authorization referred to in para. 1, let. A:
1.
The applicant's personal data,
2.
The purpose of the narcotic's use, and
3.
The amount and place of supply of the narcotic;
B.
For the authorization referred to in para. 1, let. B, evidence that good laboratory practices are being followed;
C.
For the authorization referred to in para. 1, let. C, evidence of compliance with the rules set out in s. 4, para. 2, of the order of 17 October 2001 on authorisations in the field of medicinal products 1 As well as provisions applicable to clinical trials contained in the Therapeutic Products Act of 15 December 2000 2 And in the order of October 17, 2001, on Clinical Trials for Therapeutic Products 3 ;
D.
For the authorization referred to in para. 1, let. D and e, a written statement from the patient by whom the patient consents to the application.

Art. Control

The FOPH controls the holders of exceptional authorizations for prohibited drugs (art. 8, para. 5, 6 and 8, LStup).

Chapter 6 Tasks of the FOPH

Art. Training, development and continuing education

1 In particular, the FOPH works with the authorities and specialised organisations on measures to promote training, development and continuing education in the field of addiction to psychoactive substances.

2 Within the limits of the appropriations approved, it may grant financial aid in favour of measures to promote development and continuous training.

Art. Quality Assurance Recommendations

In particular, the FOPH works with the authorities and specialised organisations on quality assurance recommendations in the areas of prevention, therapy and risk reduction. In doing so, it takes into account the results and recommendations of research and practice.

Art. 32 Reference Laboratory

1 The reference laboratory referred to in s. 29 C LStup is led by the OFSP.

2 In collaboration with professional societies and competent cantonal services, it makes recommendations on quality assurance in the field of quantitative and qualitative detection of narcotic drugs.

Art. 33 National Observatory

1 The National Observatory of Addiction Problems is led by the OFSP.

2 Federal services and cantonal services provide the national observatory with the information and statistical data it needs.

Chapter 7 Commission, emoluments and data protection

Section 1 Federal Commission on addiction issues

Art. 34 Tasks

1 The Federal Commission for Addiction Issues (Commission) has the following tasks and competencies:

A.
It advises the Federal Council and the Federal Government on substantive issues concerning addiction policy and the problem of addiction;
B.
Observing and analysing national and international developments in the field of addictions;
C.
Developing plans and ideas for the future for a Swiss policy on addiction;
D.
Regular activity reports.

2 It is independent in the performance of its tasks.

3 It can obtain information from relevant federal departments on existing information.

Art. 35 Composition and Appointment

1 The committee is composed of 12 to 15 members.

2 When the members are appointed, the Federal Council ensures a balanced representation of the cantons and institutions as well as professionals involved in the field of addictions.

Art. 36 Internal organization and secretariat

1 The Commission defines its organisation and method of operation in a regulation.

2 It is administratively attached to the FOPH.

Art. Duty to Discretion

Members of the Commission are subject to the duty of discretion and the obligation to give evidence that are applicable to employees of the Confederation.

Section 2 Fees

Art. 38 General Fees

1 The following emoluments are collected:

A.
For decisions relating to exceptional authorisations according to Art. 8, para. 5, LStup: 200 to 2000 francs;
B.
For decisions relating to exceptional authorisations according to Art. 8, para. 6, LStup: 200 to 2000 francs;
C.
For inspections and controls under s. 8 LStup: based on time spent;
D.
For on-demand benefits: depending on the time spent.

2 Within the limits defined in para. 1, let. A and b, the emoluments shall be fixed according to the time spent.

3 The fees shall be calculated on the basis of an hourly rate of between 100 and 250 francs, depending on the competencies required and the hierarchical level of the staff who carried out the work.

4 Except as otherwise provided in this order, the provisions of the General Order of 8 September 2004 on emoluments 1 Are applicable.


Art. 39 Special emoluments

For administrative acts of extraordinary magnitude, with special or urgent difficulties, the FOPH may collect up to 50 % of the ordinary fee.

Art. 40 Exemption of emoluments

Are exempt from emoluments:

A.
Decisions relating to exceptional authorisations for limited medical application;
B.
Exceptional authorizations for scientific research funded by the Confederation;
C.
Exceptional authorisations in the context of measures to combat abuse according to Art. 8, para. 8, LStup;
D.
Authorizations and controls for the prescription of diacetylmorphine;
E.
Simple requests for information requesting little time.

Section 3 Data Protection

Art. Processing of personal data

The collaborators of the FOPH, the cantonal authorities and the institutions that are competent to monitor compliance with the conditions and the conduct of the treatment of persons addicted to narcotic drugs in the context of art. 3 F LStup processes the following personal data:

A.
The name and first name;
B.
Address and telephone number;
C.
Gender and date of birth;
D.
The country of domicile and nationality, the canton of domicile and the place of residence;
E.
Health data.
Art. Exchange of data between authorities and institutions

Persons subject to s. 41 exchange, upon request, only the personal data required to monitor compliance with the conditions and the processing of the treatment of persons who are addicted to narcotics.

Art. 43 Communication of personal data to third parties

The FOPH and the Institute shall have the right to communicate to third parties personal data only in anonymized form, in particular for statistical purposes, research, planning and evaluation without any link to persons.

Art. 44 Communication of personal data to foreign authorities as well as supranational and international organisations

1 The FOPH and the Institute have the right to disclose personal data in anonymized form to foreign authorities and institutions as well as to supranational and international organisations.

2 They have the right to disclose personal data if required by international conventions or decisions of international organizations.

Art. 45 Research and Statistics

1 Persons responsible for collecting data for research or statistical purposes shall be required to keep secret on all data concerning natural or legal persons brought to their knowledge in the course of their work.

2 The collection of personal data for research or statistical purposes is subject to obtaining the written consent of the data subject.

3 Personal data collected for research or statistical purposes shall not be used for any other purpose without the written consent of the data subject.

Chapter 8 Final provisions

Art. Repeal of the law in force

The following orders are repealed:

1.
The order of 8 March 1999 on the medical prescription of heroin 1 ;
2.
The order of 23 October 1978 fixing the emoluments levied by the Narcotics Laboratory of the Federal Public Health Service 2 .

1 [ RO 1999 1313 , 2009 2641]
2 [RO 1978 1622]

Art. Transitional provisions

Exceptional authorisations and authorisations issued prior to the entry into force of this Order shall remain valid until the expiry of their term of validity.

Art. 48 Entry into force

This order shall enter into force on 1 Er July 2011.



RO 2011 2639



State 1 Er July 2011