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THE STAGE 2 REPORT - AT LAST!
The report will be presented to Mrs Kate Carnell, Chief Minister and Minister for Health in the ACT on June 27, 1995.
This report is the culmination of four years of research into the question: Should a carefully controlled and rigorously evaluated trial be conducted to determine whether or not the prescription of pharmaceutical heroin (diacetylmorphine) is a useful addition to current maintenance treatment for dependent heroin users?
It recommends that two carefully controlled pilot studies should be conducted in Canberra. However, the addition of diacetylmorphine to maintenance treatment must not be linked with permissive attitudes to illicit drug use and must be coupled with continuing law enforcement and prevention activity against illicit drug use.
There is a sixteen-year history in Australia of government consideration of the issue of diacetylmorphine maintenance treatment. In 1991 the ACT Legislative Assembly Select Committee on HIV, Illegal Drugs and Prostitution asked the National Centre for Epidemiology and Population Health at the Australian National University to investigate the issue and, in collaboration with the Australian Institute of Criminology, research into in-principle and logistic feasibility was undertaken.
It was found that a trial would not place Australia in breach of international treaties. ACT and other laws will have to be changed for a trial to proceed and the Commonwealth must grant licences and permissions.
There is considerable community support, both in the ACT and nationally, for new approaches to the problem of heroin dependence and, although there is a degree of uncertainty about an ACT-based trial, there is more support than opposition to it, particularly in Canberra. There should now be a three-month consultation period to allow the feasibility study findings to be scrutinised and discussed as widely as possible.
Of all the interest groups, the police have the most concerns about a trial, and their concerns were carefully considered in the feasibility investigations. Limiting participant eligibility to restricted numbers of users registered with the ACT methadone program and resident in the ACT since 1993 will minimise the risk that dependent users might move to the ACT from elsewhere in Australia. There are also safeguards to prevent participants from driving while affected by diacetylmorphine and strict security provisions, including administration of diacetylmorphine only at the clinic under close supervision.
Other potential risks were carefully scrutinised and ways to minimise them determined. By minimising the risks, it becomes feasible to evaluate the potential benefits of expanding maintenance treatment to include diacetylmorphine. The potential benefits include decreased crime and improved health and social integration.
The pilots and trial will be of national significance. It is estimated that establishing and conducting an initial six-month pilot with 40 participants will cost around $800,000 and a second six-month pilot with 250 participants will cost $1.5 million. These pilot studies will determine whether or not a multi-centre two-year trial involving three Australian cities should be undertaken. Evidence is accumulating that treatment of illicit drug users is more cost-effective than leaving them in the community untreated or sending them to jail. Initial estimates suggest that expanded maintenance treatment which includes diacetylmorphine would cost the community less than one-tenth of the cost of an untreated illicit heroin user and would be substantially cheaper than some current treatments. The pilots and trial provide the possibility of significantly strengthening treatment options.
Recommendation 1. That two carefully controlled pilot studies are conducted in Canberra to assess the addition of injectable diacetylmorphine to maintenance treatment for registered dependent users. If these produce positive outcomes, that a full-scale trial of expanded maintenance treatment which includes injectable diacetylmorphine is conducted in at least three Australian cities.
Recommendation 2. That the exploration of expanding maintenance treatment to include injectable diacetylmorphine is coupled with continuing law enforcement and prevention activity to control illicit drug use. The addition of diacetylmorphine to maintenance treatment should not be linked with permissive attitudes to illicit drug use.
Recommendation 3. That the first pilot study is conducted with 40 established ACT resident volunteers who have either dropped out of ACT methadone treatment or who are current ACT methadone clients who would prefer the expanded treatment option. That, over a six-month period, the study examines the following questions:
Recommendation 4: Pilot study 1 will be deemed a success if the following criteria are met:
Recommendation 5: If pilot study 1 is a success, that a second pilot study is conducted with 250 dependent heroin users drawn from volunteers who have been resident in the ACT since 1993, and who have dropped out of ACT methadone treatment, or who are current ACT methadone clients who would prefer the expanded treatment option. That, over a six month period, this pilot address the following questions:
Recommendation 6: Pilot study 2 will be deemed a success if the following criteria are met:
Recommendation 7: If the pilot studies are shown to be successful, that a two-year trial with 1000 participants is conducted in three Australian cities. That it target three groups of dependent heroin users - those who have never been in treatment, those who have dropped out of treatment, and current methadone clients who would prefer the expanded treatment option. That it address the following questions:
Recommendation 8: That the service provision for the pilot studies and the ACT component of the trial is provided by the Alcohol and Drug Service of ACT Health. That the independent evaluation is conducted jointly by the National Centre for Epidemiology and Population Health at the Australian National University and the Australian Institute of Criminology. That a committee is established to oversee the running of the pilot studies and the ACT component of the trial. Its membership should include representatives from the clinical staff, participants and researchers; the police and judiciary; the medical profession and non-government treatment services; ACT Health and the ACT Attorney-General's Department; relevant Commonwealth departments; and an ethicist. That this committee will recommend to the ACT Legislative Assembly whether or not there should be progression from pilot 1 to pilot 2 and from pilot 2 to a trial or if the prescription of injectable diacetylmorphine should be stopped at any time.
Recommendation 9: That, noting the national significance of the ACT based pilot studies, there is extensive financial support from outside the ACT to fund the pilot studies.
Recommendation 10: That the ACT government institutes a three-month consultation period in which the results of the feasibility research are widely disseminated and discussed. That a committee is established to receive and consider the feedback from groups and individuals. That the committee includes representation from the ACT Health Alcohol and Drug Service; the police and judiciary; the ACT Attorney General's Department; relevant Commonwealth departments; illicit heroin users; the medical profession and non-government treatment services; an ethicist; and the Director of the Feasibility Research. That the committee reports to the ACT Minister for Health on the results of the consultation no later than 31 October 1995.
Recommendation 11: That the ACT Health Alcohol and Dug Service is proactive in disseminating information about eligibility criteria to drug treatment services and user advocacy groups around Australia.
Recommendation 12: That, to establish the first pilot study, the ACT Legislative Assembly either amend existing legislation or introduce special legislation to make diacetylmorphine available for carefully controlled and limited medical prescription. That the ACT government liaise with the Commonwealth and other States about the passage of relevant legislation and the provision of the necessary licences and permissions. That a service manager and a senior specialist are employed as soon as practicable to establish policy and procedures for the service delivery. That the service manager is also responsible for finding a suitable location for the new clinic; organising refurbishment; and hiring and training non-medical staff.
New Working Paper
Criminal liability issues associated with a "heroin trial".
Simon Bronitt
Working Papers Number 13.
This report covers four areas: drug law in Australia; criminal liability for causing harm to trial participants; criminal liability for the crimes committed by trial participants; and miscellaneous issues.
Drug Law in Australia:
The provision of heroin participants during the trial would give rise to criminal liability under various drug offences under Commonwealth and ACT legislation. It is recommended that the respective legislatures enact an exemption to permit the lawful possession, supply and administration of heroin for the purposes of the trial. The enactment of these exemptions would not infringe Australia's international obligations under the conventions dealing with narcotics.
Under the present law, medical practitioners are unable to prescribe and/or administer heroin to any person for the purpose of treatment or research. It is recommended that the Drugs of Dependence Act 1989 (ACT) be amended to permit the medical prescription of heroin.
As the heroin provided to participants during the trial has therapeutic use, researchers and clinical staff must comply with licensing and exemption requirements imposed by the Therapeutic Goods Act 1989 (Cth). The regulatory framework for therapeutic goods is complex, and the compliance requirements are costly and burdensome. It is recommended therefore that the Commonwealth legislature enact a special exemption which states that heroin provided to participants during the trial is not to be regarded as a "therapeutic good" under the Therapeutic Goods Act 1989 (Cth).
At present, heroin manufacture is absolutely prohibited in all jurisdictions except Victoria. Importation of heroin from abroad would require compliance with the terms of the Commonwealth legislation (and the obligations imposed by the international conventions on narcotic drugs) before the relevant licences and authorisation to import the drug could be granted.
Trial staff who arrange interstate transport of heroin may be guilty of aiding and abetting drug offences in those jurisdictions through which the heroin is transported. It is recommended that, in those jurisdictions through which heroin is transported, the rules governing accessory liability be amended in the following terms: trial staff who arrange the transport of heroin shall not, by reason only of that conduct, be taken to have aided and abetted the commission of specific drug offences in that jurisdiction. Furthermore, it is recommended that the Crimes (Narcotic Drugs and Psychotropic Substances) Act 1990 (Cth) be amended, creating a special exemption for the purpose of the trial, to permit the lawful interstate transportation of heroin by air.
Criminal Liability for Causing Harm to Trial Participants: No amendment of the law governing homicide is considered necessary or desirable. To avoid liability for homicide, researchers and clinical staff must ensure that both foreseen and reasonably foreseeable risks of death or serious harm to participants during the trial are minimised.
Failure to obtain an effective and valid consent from trial participants would give rise to criminal liability for assault and/or related offences, except where the treatment is provided in an emergency situation.
Consent in the criminal law requires participants to comprehend only the physical nature of the treatment and procedures. It is recommended that researchers and clinical staff should observe higher standards for consent (i.e., fully informed consent or free agreement). Failure to observe these higher standards for consent may (i) give rise to civil liability for battery or negligence, and/or (ii) constitute a breach of ethical guidelines. It is recommended that participants be fully informed, both in writing and orally, about the nature, purpose, significance and context of the treatment and procedures before and during the trial. In addition, participants should be informed that in situations of emergency it may be necessary to administer treatment without first obtaining their consent. The "public interest' places limits on consent where the activity involves the risk of bodily harm. It is unclear, under the present law, whether the treatment or procedures during the trial could be justified under the existing "medical treatment" exception, or some other "public interest" exception.
The provision of heroin to participants may give rise to liability under poisoning offences. It is unclear whether, and to what extent, the consent of participants would operate as a defence.
It is recommended that, in light of these uncertainties about consent, the ACT legislature enact a special "consent" defence for assault and related offences (including poisoning offences), which would clarify that staff who administer heroin during the course of the trial can raise the consent of the participants as a defence.
Criminal Liability for the Crimes Committed by Trial Participants: In the ACT the common law offence of misprision of felony is no longer available: mere knowledge that a participant has committed an offence, and failing to report that offence to the relevant authorities, is not sufficient to impose criminal liability on researchers or clinical staff. However, where that knowledge is accompanied by positive acts of assistance, which enable the perpetrator to escape punishment or to dispose of the proceeds of the offence, there may be liability as an accessory after the fact.
Clinical staff may "aid and abet" driving offences (i.e., driving under the influence or culpable driving) subsequently committed by participants, either through (a) the act of supplying the heroin or (b) the failure to take steps to prevent the participants from driving while under the influence of the drug. Clinical staff however would ordinarily lack the requisite intention to be guilty of aiding and abetting, and may in any event avoid liability by taking steps to disassociate themselves from the criminal purpose of the participant. The creation of a special "suppliers' defence" for clinical staff would not encourage responsible professional conduct. No amendment of the present law governing accessory liability is considered necessary or desirable.
Miscellaneous Issues: It is recommended that researchers and clinical staff deter the social congregation of participants in the immediate vicinity of the treatment centre. The conduct of groups of participants may attract police intervention through public order offences and the powers to deal with individuals who are intoxicated in public.
To avoid liability for public nuisance, which is both a crime and a tort, researchers and clinical staff must ensure that dangers to the general public are kept to a minimum - such steps would include, for example, the establishment of procedures for the safe disposal of used needles and syringes, and effective security for heroin kept on the premises.
There is some uncertainty over the scope of the powers of law enforcement agencies to search and seize confidential information gained during the trial. It is recommended that the scope of the power to search and seize confidential information gained during the trial be clarified in the Epidemiological Studies (Confidentiality) Act 1992 (ACT): information "concerning the affairs of another person" gained during the trial should not be subject to search and seizure by law enforcement authorities. It is further recommended that through cooperative arrangements with law enforcement agencies, procedures be drawn up to resolve disputes over the privileged nature of the information gained during the trial and whether that information can properly be the subject of a search warrant.
What's next?
There are a number of working papers still being prepared and newsletters will be produced to advise when they are ready. We will also be monitoring what happens to the recommendations and will report on that.
New Publications
*Bammer, G; June 1995 Report and Recommendations of Stage 2 Feasibility Research into the Controlled Availability of Opioids with a Foreword by Professor RM Douglas, Director, NCEPH, ANU and Dr Adam Graycar, Director, Australian Institute of Criminology.
Peer Review Papers
Bammer, G.; Stevens, A.; Dance, P.; Ostini, R.; Crawford, D. 1995 Controlled heroin availability in Australia? How and to what end?' Internationa1 Journa1 of the Addictions, 30, 991-1007.
Working Papers
*Bronitt, S. 1995 Criminal liability issues associated with a "heroin trial". Feasibility Research into the Controlled Availability of Opioids Stage 2 Working Papers Number 13.
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FURTHER INFORMATION
Dr Gabriele Bammer
NCEPH, ANU
Canberra ACT 0200
Phone:(02) 6125 0716
Fax: (02) 6125 0740