1. Bylaw on drug demand reduction in Serbia

2. Bylaw(s) - principles  should be based on existing law(s)  should complement existing laws  should not be contradictory to existing legislation  should not repeat existing laws (for example definition of the same subject differently)

3. Bylaw(s) – principles (2)  make a disctinction between bylaw (legal regulation) and clinical guidelines (state of the art / lege artis procedures) – legal regulations concern public security, public interest, rights and obligations of individuals – clinical guidelines should be left to medical community

4. Legislative framework in the field of drug demand reduction in Serbia Essential acts:  law on psychoactive controlled substances (LPCS)  law on health care (LHC)  law on the protection of persons with mental health disorders (LMHD)  law on patient‘s rights (LPR)  law on medicinal products and medical devices (LMPMD)

5. Law on psychoactive controlled substances  Definitions: Art. 3 – § 11 dependence syndrom – § 12 abuse  VII. APPLICATION OF PSYCHOACTIVE CONTROLLED SUBSTANCES IN HEALTHCARE (art. 63 – 69)  VIII. PROGRAM ACTIVITIES FOR PREVENTION, TREATMENT AND REDUCTION OF ABUSE/DEMAND OF PSYCHOACTIVE CONTROLLED SUBSTANCES  IX. REPORTING AND RECORD KEEPING

6. VII. APPLICATION OF PSYCHOACTIVE CONTROLLED SUBSTANCES IN HEALTHCARE  Article 63: Application of psychoactive controlled substances  Article 64 – § 3 treatment of addiction versus symptomatic treatment – § 5 treatment institutions – § 6 methods to be prescribed by minister

7. Article 64, § 6 of LPCS – legal base for bylaw „Methods and conditions pertaining to the application of psychoactive controlled substances within healthcare institutions and private practices for the treatment of addiction diseases, as well as methods and conditions pertaining to the application of psychoactive controlled substances within healthcare institutions and private practices for the needs of treatment, or medical procedures or interventions, including symptomatic treatment, are prescribed by the Minister.“

8. VIII. PROGRAM ACTIVITIES FOR PREVENTION, TREATMENT AND REDUCTION OF ABUSE/DEMAND OF PSYCHOACTIVE CONTROLLED SUBSTANCES  Art. 70, § 1: elements and aim of drug demand reduction: „Program activities for prevention, treatment and decrease in demand of psychoactive controlled substances represent a group of comprehensive measures and activities aimed at the decrease in the number of users of psychoactive controlled substances, reduction of social and health consequences of psychoactive controlled substances use and assistance in the reintegration of former addicts into the society.“

9. VIII. PROGRAM ACTIVITIES FOR PREVENTION, TREATMENT AND REDUCTION OF ABUSE/DEMAND OF PSYCHOACTIVE CONTROLLED SUBSTANCES  Art. 70, § 2: actors and action in drug demand reduction: „... competent bodies, local self government bodies, healthcare institutions, private practice, educational institutions and other competent organisations are obliged to plan, organize and apply the prescribed measures, as well as to control the implementation of such measures or provide financial and other resources for their implementation, pursuant to the Law.“

10. VIII. PROGRAM ACTIVITIES FOR PREVENTION, TREATMENT AND REDUCTION OF ABUSE/DEMAND OF PSYCHOACTIVE CONTROLLED SUBSTANCES  Art. 71: programme activities and coordination of drug demand reduction: „Program activities in the field of psychoactive controlled substances must be in line with this Law. Coordination and carrying out of the program activities from paragraph 1 of this Article is monitored by the Committee“

11. VIII. PROGRAM ACTIVITIES FOR PREVENTION, TREATMENT AND REDUCTION OF ABUSE/DEMAND OF PSYCHOACTIVE CONTROLLED SUBSTANCES  Art. 72: Rehabilitation and social reintegration „Persons who had undergone treatment for addiction diseases are provided with rehabilitation and social reintegration with the objective of their inclusion in various forms of social life, improvement of quality of life and reduction of harmful consequences caused by the use of psychoactive controlled substances, pursuant to the Law. “

12. VIII. PROGRAM ACTIVITIES FOR PREVENTION, TREATMENT AND REDUCTION OF ABUSE/DEMAND OF PSYCHOACTIVE CONTROLLED SUBSTANCES  Art. 73: Institutes for public health „Institutes for public health, within their activities prescribed by the Law, participate in the implementation of program activities for the prevention of addiction diseases and reduction in demand of psychoactive controlled substances and monitor their realisation at the level of the local self- government unit, or autonomous province level, as well as at the level of the Republic of Serbia. “

13. IX. REPORTING AND RECORD KEEPING  Art. 74, No 9, 10: – 9) Register of healthcare institutions and private practices engaging in treatment of addiction diseases; – 10) Register of healthcare institutions that, for the needs of treatment, or medical procedures, including symptomatic treatment, apply psychoactive controlled substances classified in Lists nos. 1, 5 and 6 of the Schedule;

14. IX. REPORTING AND RECORD KEEPING  Art. 76: – Records on intoxications and deaths by drugs – Records on drug users  Art. 77: – Records on consumption of PCSs in addiction treatment  Art. 78: – Records on consumption of PCSs in symptomatic treatment

15. Other laws:  addiction treatment is integral part of health care (LHC, art. 11) – provisions for organisation of health care and division of responsibilities (art. 9-15 of LHC) – principles of health care (art. 19-24 of LHC) – rights of patients (art. 25-40 of LHC) – provision of health services (art. 46-66 of LHC)  addicted persons are subject of human and patients rights protection (LMHD, LPR in general)

16. Observations What should be avoided in this particular bylaw:  redundant definitions  area of symptomatic treatment with PCSs  area of administrative / controlled measures towards PCSs  area of human and patients rights in general  area of conditions for provision of health services

17. Observations (2) What should be included in this particular bylaw (?):  definitions of responsibilities and roles in organising and ensuring provision of drug services including financial mechanisms – state, local governments...  coordination  specific provision for prevention  specific provision for addiction treatment including substitution treatment  specific provision for harm reduction services  registration and monitoring

18. Thank You for your attention!

19. Coordination  Commission of art. 4 should consist of ministers and high level representatives – political level  It should be backed-up by the Office for Drugs (governmental department) – day to day coordination body  It should be complemented by expert working bodies (commissions) – expert commission on PCSs – expert commission for the supervision of incineration of drugs – expert commission for drug prevention and treatment (current republican commission...) – etc.  Law on psychoactive controlled substances should be amended