Expert Advisory Committee on Drugs & Minutes
BACKGROUND INFORMATION ON DECISION
GHB and 1,4-Butanediol Classification
Expert Advisory Committee on Drugs
Terms of Reference
This document sets out the terms of reference for the Expert Advisory Committee on Drugs (¡§the EACD¡¨), the underlying principles of the classification procedure, the working arrangements of the EACD, and the EACD¡¦s agreed outputs.
The EACD is a specialised committee established under the Misuse of Drugs Act 19752 (¡§the Act¡¨) to provide the Minister of Health (¡§the Minister¡¨) with expert advice on the risk of harm to individuals or to society from any drug, substance, preparation, mixture, or article (¡§drug¡¨). The EACD will advise on drug classification issues. The specific functions of the EACD are outlined in section 5AA of the Act (see below).
2.1 Appointment and reappointment of members
Members of the EACD will be appointed by the Minister in accordance with section 5AA of the Act. Members will be appointed by notice in writing by the Minister for a term of three years, but can be reappointed for a further term(s) by the Minister. It is envisaged that, as a general rule, members will serve for one or two terms.
The Minister shall appoint one member as Chairperson of the EACD. The Chairperson shall not have the right of a casting vote to break deadlocked decisions.
2.3 Resignation and removal of members
Any member can resign from the EACD by giving written notice to the Minister and the EACD Secretariat.
Any member who has resigned may continue in office until their replacement is appointed, if this is agreed upon by the EACD.
The Minister can remove any member from the EACD, and the Chairperson from his/her position as Chairperson, by notice in writing.
3. Meetings of the EACD
It is envisaged that the EACD will meet three to four times a year, although more meetings may be held if required. All EACD members should endeavour to attend meetings in person. However, the use of additional ¡¥out of session¡¦ communications, such as teleconferences, may also be employed if appropriate.
If one or more members cannot make an EACD meeting, the EACD and EACD Secretariat may agree to hold the meeting in the members¡¦ absence and forward background papers and notes of the EACD¡¦s preliminary deliberations to the absent member(s).
The EACD may decide to establish a working group to further investigate a particular issue.
Decisions on the next meeting time will be agreed between the EACD and the EACD Secretariat at the end of the current meeting. Otherwise, a meeting can be called with the agreement of the Chairperson. If this is the case the EACD Secretariat will endeavour to accommodate the members existing schedules.
The EACD is assisted by a Secretariat (¡§the EACD Secretariat¡¨) comprised of Ministry of Health officials and temporary advisers, as required. The EACD Secretariat¡¦s contact details are: EACD Secretariat, National Drug Policy Team, Public Health Directorate, Ministry of Health, PO Box 5013, Wellington [Fax: (04) 496 2340].
EACD members are expected to act in a professional manner.
5.1 Notice of Conflict of interest prior to appointment
Before members can be appointed to the EACD they must give the EACD Secretariat a statement completed by the member in good in good faith that¡X
(a) discloses any conflicts of interest
that the person has with the EACD as at the date on which
the statement is completed, or states that the person has no
such conflicts of interest as at that date;
(b) discloses any such conflicts of interest that the person believes are likely to arise in future, or states that the person does not believe that any such conflicts are likely to arise in future.
5.2 Conflicts of interest arising after appointment
If during the course of the EACD¡¦s business any member finds he/she has a conflict of interest in any matter being considered by the EACD, he/she must disclose the nature of the conflict of interest to the EACD as soon as practicable after the facts have come to the member¡¦s knowledge. To aid this process the Secretariat will circulate a conflict of interest form with subsequent agendas to allow members to disclose new potential conflict of interests, if they arise (and have not previously been disclosed).
Any conflict of interest disclosure will be recorded in a register maintained by the EACD Secretariat.
If a member has disclosed a potential conflict of interest he/she may still participate in the discussions and decisions of the EACD, subject to approval of a majority of the EACD. If this is the case the Minutes shall reflect the situation.
5.3 Ministry of Health conflict of interest protocol
Before being appointed to the EACD, members will be provided with the Ministry of Health¡¦s Conflict of Interest Protocol for Statutory Bodies and Other Committees, which is based on the State Services Commission¡¦s Board Appointments and Induction Guidelines, 1999. The protocol provides more information and guidance on conflict of interests.
5.4 Disclosure of confidential information
To the extent it does not interfere with the functions of the EACD (set out in section 5AA(2) of the Act ¡V see below) members must not disclose any confidential information (eg, submissions to the EACD) obtained in the course of the EACD¡¦s activities without the prior written approval of the Minister. If a member is in doubt as to whether information should be treated as confidential he/she should consult the EACD Secretariat in the first instance.
5.5 Media releases
Any media release by EACD
must be issued under the authority of the Committee¡¦s
Chairperson. The Chairperson will clear any media release
with the Minister office prior to making the media
Section 5AA(2) of the Act sets the functions of the committee, which are:
(a) to carry out medical and scientific evaluations of controlled drugs, and any other narcotic or psychotropic substances, preparations, mixtures, or articles; and
(b) to make
recommendation to the Minister about-
(i) whether and how controlled drugs or other substances, preparations, mixtures, or articles should be classified; and
(ii) the level at which any presumption for supply, as provided for in section 6(6), should be set for any substance, preparation, mixture, or article that is, or is proposed to be classified as , a controlled drug; and
(c) to increase public awareness of the Committee¡¦s work, by (for instance) the timely release of papers, reports, and recommendations.
When considering a particular drug, EACD should recommend how that drug should be classified in accordance with section 3A of the Act, which states that classification of drugs is to be based on the risk of harm to individuals or society;
„h Drugs posing a very high
risk of harm should be scheduled as ¡¥Class A.¡¦
„h Drugs posing a high risk of harm should be scheduled as ¡¥Class B.¡¦
„h Drugs posing a moderate risk of harm should be scheduled as ¡¥Class C.
The Act contains three schedules where drugs are listed and one schedule where precursor substances (ie, substances used or involved in the illegal processing or manufacturing of drugs) are listed. The EACD Secretariat will provide members with information clarifying the details of the Act¡¦s classification framework.
In the future, the Minister may request the Committee to consider specific or broader issues around drug classification.
7.1 Drugs referred to EACD for consideration
There are two paths by which a drug may be formally considered by the EACD.
First, the Minister of Health or the EACD Secretariat may refer a drug to the EACD for consideration. Members of the public can also feed into this process. If a member of the public considers the EACD should examine a particular drug¡¦s classification status they can make such a request to the EACD Secretariat. The EACD Secretariat will prioritise such requests against other drugs, and if appropriate refer the request onto the EACD for consideration. However, the EACD Secretariat will also provide the EACD with a schedule of all requests received.
Second, the EACD may itself decide to examine the classification of a particular drug.
As soon as practicable, the EACD Secretariat should publish information on the National Drug Policy Web Site about the substances being considered by the Committee, and the process for making written submissions. Submissions made to the Committee are to remain confidential, however, they would be noted in the minutes of the meeting.
The EACD will decide whether to invite oral presentations from submitters on a case-by-case basis.
7.2 EACD is to conduct an evaluation of each drug referred to it
For each drug to be considered by the EACD (under the procedure set out in sections 4, 4A, and 4B of the Act), the EACD Secretariat will compile a report incorporating relevant information, including scientific evidence and international assessments. This report will address the following matters:3
„h substance identification (International
Nonproprietary Name; chemical and common names, including
trade names; other identifying characteristics, Chemical
Abstracts Service registry number)
„h the drug¡¦s similarity to known substances
„h current classification (if any)
„h proposed classification
„h likelihood or evidence of abuse, including prevalence of the drug, seizure trends, and potential appeal to vulnerable populations
„h specific effects of the drug, including pharmacological, psychoactive and toxicological effects of the drug
„h risk, if any, to public health
„h therapeutic value of the drug, if any
„h potential for death upon use
„h ability to create physical or psychological dependence
„h international classification and experience of the drug in other jurisdictions
„h potential presumption for supply (section 6(6) of the Act refers) and justification for this
„h Other matters considered relevant by the EACD Secretariat or the Minister.
The EACD will consider these reports (which will include copies of relevant research/studies discussed) and other relevant background provided by the EACD Secretariat, along with relevant information and expertise brought to the meetings by EACD members.
The EACD¡¦s expert input regarding the above matters, along with additional issues such as:
„h potential risks/implications of adopting
the EACD¡¦s recommendation to the Minister
„h whether there is a significant body of scientific/academic literature contrary to the EACD¡¦s recommendation(s)
„h other matters the EACD considers relevant
will be incorporated into a final report to the Minister, which includes the EACD¡¦s recommendation(s) on the drug(s) in question.
7.3 Consultation with other groups
When considering a drug, the EACD may wish to consult other groups, as it deems necessary, before making a recommendation to the Minister of Health.
7.4 EACD will endeavour to form a consensus position
The EACD will endeavour to form a consensus position on the risk of harm to individuals and society posed by each drug under consideration. If the EACD cannot reach a consensus position (even after consulting with such other groups as it deems necessary) the Committee may make majority and minority submissions to the Minister, which clearly specify the reasons why the EACD could not reach a consensus position on the drug. However, such split submissions should only be advanced as a last resort and after all avenues for reaching a consensus have been exhausted.
7.5 EACD¡¦s recommendation(s) to the Minister
The EACD will prepare a formal written report on each drug that it considers. The report will make a recommendation on the appropriate classification of the drug in question, and the appropriate level for a presumption for supply, if any. The report will also include a summary of the information on each drug that forms the basis of the Committee¡¦s recommendation to the Minister.
8. Communication of Recommendations
EACD reports and, where appropriate, any supporting background papers, will be made publicly available. In cases where EACD reports recommend to the Minister that a particular drug should be classified or reclassified, public release of the reports will be sufficiently delayed to allow the Minister to formulate a response to the Committee¡¦s recommendation(s).
It is envisaged that relevant EACD reports and papers will be posted on the National Drug Policy website http//:www.ndp.govt.nz, which is serviced by the Ministry of Health.
9. Consequential Drug Classification Changes
After receiving advice from the EACD on a particular drug, the Minister may decide to recommend that the Governor-General makes an Order in Council, which amends the Schedules in the Act (by either classifying a drug that is not already in the Schedules, or by reclassifying a drug currently classified in the Schedules). However, before any Order in Council can come into force it must be approved by resolution of the House of Representatives.
The EACD is an advisory body. Any recommendations that the EACD makes to the Minister about drug classification issues are not binding on the Minister. In any cases where the Minister declines to follow the recommendations of EACD, the Minister will seek to communicate the reasons for that decision to the Committee.
In carrying out its functions the EACD will meet the aforementioned outputs on time, and within budgets.
EXPERT ADVISORY COMMITTEE ON DRUGS MEETING
Tuesday 29 May 2001, Conference Room CO1, Ministry of Health, 133 Molesworth Street
The meeting commenced at 10:08 am
Dr Bob Boyd
Dr Helen Moriarty
Dr Tim Maling
Det. Inspector Harry Quinn
Dr Doug Sellman
Dr Geoffrey Robinson
Dr Stuart Jesamine
Dr Keith Bedford (via teleconference)
Item 1: Welcome and Introductions
1.1 The Chair welcomed members to the first meeting of the Expert Advisory Committee on Drugs (¡§EACD¡¨) and noted that the EACD is a statutory advisory committee to the Minister of Health (¡§the Minister¡¨).
1.2 Members introduced themselves and outlined the expertise and experience they brought to the Committee.
1.3 The members of the Committee were asked to confirm their contact details and to sign the register of attendance.
1.4 The Secretariat advised the EACD that the Minister had not issued any formal instructions to the EACD (other than the terms of reference of the Committee).
Item 2: Terms of Reference
2.1 The Committee discussed the terms of reference of the EACD. Concerns were raised about the ability of the Committee to establish working groups, and the requirement that all members of the Committee must be consulted on the papers before a final recommendation can be made to the Minister.
The terms of reference be amended to:
Remove the requirement that ¡§EACD¡¦s final decisions or recommendations to the Minister about a particular drug should not be submitted to the Minister without input from all EACD members¡¨.
Confirm that working groups can be established by the EACD.
2.2 The issue of appointing substitute members was raised. However, It was noted that EACD appointments are made by the Minister and any substitutes would need the Minister¡¦s approval.
2.3 The Committee raised concerns about the practicality of the conflict of interest protocol.
The terms of reference be amended to allow members with a conflict of interest to participate in discussions and decisions, subject to approval of the EACD. The member may be asked to leave the room while the committee discusses the conflict.
The Secretariat will circulate the Ministry of Health¡¦s Conflict of Interest Protocol for Statutory Bodies and Other Committees, which provides more information and guidance on conflict of interests.
The Secretariat will circulate a conflict of interest form with subsequent agendas to allow members to disclose, to the Chair, new potential conflict of interests if they arise (and have not previously been disclosed).
2.4 Members of the EACD discussed the manner in which confidential information provided to the Committee would be managed.
All information provided to EACD members before each meeting should be treated as confidential (although members can consult their respective peer groups on the ¡¥general flavour¡¦ of the material or to clarify specific points etc). However, following EACD meetings, submissions and minutes will be subject to the Official Information Act. External requests for such information under the Official Information Act will be processed by the Secretariat in accordance with the provisions of the Act (even if marked confidential).
Confidential items discussed by the EACD should be marked as confidential in the minutes of the meeting and on any relevant documents produced by the EACD to assist members who refer or use the information ¡¥down the track¡¦. Submissions to the EACD are to be classed as confidential information by members. It was also noted that if a member was in doubt as to whether information was confidential he/she should consult the EACD Secretariat in the first instance.
The chair is the spokesperson for the committee and will issue all media releases relating to the Committee.
2.5 The EACD discussed the referral process for drugs that could potentially be considered by the EACD.
The EACD Secretariat will receive any written submissions from the public requesting that a drug(s) be considered for scheduling. At each meeting the Secretariat will provide the EACD with a schedule of all requests received.
2.6 The Committee discussed the preliminary assessments made by the Secretariat. Some members were satisfied with the length of the papers, whereas others preferred shorter summaries when appropriate.
The Secretariat is to provide copies of appropriate research materials that provided the basis of the preliminary evaluations to allow for independent consideration. This may involve preparing shorter summaries of the drugs under evaluation.
2.7 The EACD discussed the decision making process.
EACD should endeavour to make consensus decisions. However, in situations where EACD is divided the numbers voting for and against the recommendations would be recorded. Members would also be able to have their votes recorded in the minutes. Majority and minority positions may be put to the Minister. The chair will not have a casting vote (the draft Terms of Reference will be amended to reflect this).
2.8 The EACD discussed public notification of substances being considered and subsequent publication of papers on the web.
Information be publicised on the National Drug Policy (NDP) Web Site (www.ndp.govt.nz) about the issues being considered by the Committee, and the process for making written submissions. Submissions made to the Committee are to remain confidential, however, they would be noted in the minutes of the meeting.
The EACD adjourned at 12:05 pm.
[A sub-committee of the EACD was established to hear three oral presentations. The presenters had been invited by the EACD Secretariat (see attached minutes of the Sub-Committee below).]
The meeting reconvened at 1:45 pm.
2.9 The EACD discussed the appropriateness of receiving submissions from members of the public.
The EACD have the right to decide whether to invite future oral presentations (on a case-by-case basis). Generally, submissions will only be received in writing unless the Committee invites a person or group to attend. Written submissions should follow the Ministry of Health¡¦s EACD paper template (this template will be placed on the NDP website).
Item 3: Acetic Anhydride
3.1 EACD discussed the proposed reclassification of Acetic Anhydride as a Schedule 4 (Part 2) substance. This change is required to bring New Zealand into line with the United Nations international drug classification framework. New Zealand Police and Customs service reported no enforcement problems associated with the rescheduling of the substance.
Consideration of the reclassification of acetic anhydride be deferred so that acetic chloride, a precursor with a similar purpose (and equal relevance to the New Zealand situation), can be considered at the same time as acetic anhydride.
Item 4: Potassium Permanganate
4.1 EACD discussed the proposed reclassification of potassium permanganate. It was noted that this substance was readily available in New Zealand and there was no domestic manufacture of cocaine. This change is required to bring New Zealand into line with the United Nations international drug classification framework. It was noted that the memorandum of understanding between the National Drug Intelligence Bureau and the New Zealand Chemical Industry Council Inc may also need to be amended to reflect any change in classification. This issue could be work through by officials once any change has occurred
To recommend to the Minister of Health that potassium permanganate be reclassified as a Schedule 4 (Part 2) substance.
Item 5: Misuse of Drugs Schedules
5.1 The Secretariat outlined the explanatory paper on the current classification framework in the Misuse of Drugs Act. The Committee discussed the classification framework in the Act, in particular the lack of clarity of the schedules.
EACD members would endeavour to become more familiar with the classification framework in the Misuse of Drugs Act. The Secretariat would develop a proposal to review the schedules in the Act for future consideration by the Committee.
Item 6: Gamma-Hydroxybutyric Acid (GHB) and related compounds
6.1 The Committee discussed a preliminary paper prepared by the Secretariat on GHB and three related substances:
„h Gamma butyrolactone (¡§GBL¡¨)
„h Gamma-aminobutyric acid (¡§GABA¡¨).
6.2 The Committee also considered five written submissions, by or on behalf of:
„h The Brenner family
„h Outerspace Limited
„h The Department of Critical Care, Auckland Hospital
„h The New Zealand Drug Rape Trust
„h Dr Allan Pelkowitz.
6.3 The Committee sat as a Sub-Committee to hear verbal material provided by three submitters. This took the form of prepared statements and responses to questions put by members.
6.4 The Committee agreed to consider all four substances together, while noting the limited amount of evidence on which to compare their physical characteristics, potency, duration of action, and pharmacodynamics (the biochemical and physiological effects and mechanism of their action).
6.5 It was noted that in March 2001 the United Nations Commission on Narcotic Drugs had recommended that GHB be placed in Schedule 4 of the Convention on Psychotropic Substances 1971 (¡§the 1971 Convention¡¨). This decision has yet to be ratified by the United Nations Economic and Social Council (ECOSOC). If this recommendation is endorsed, New Zealand as a signatory to the 1971 Convention is obligated to include GHB within its domestic drug control regime in a manner consistent with its obligations under the 1971 Convention. However, New Zealand retains the discretion as to how it classifies the substance under its domestic legislation and what additional controls it might wish to place on GHB, or any other substance.
6.6 GHB has had limited use in anaesthesia. There is no evidence that it had ever been used for such a purpose in New Zealand and its use has been discontinued in most overseas countries.
6.7 There are reports that GHB, at prolonged high doses, can cause physical dependence and that its discontinuation can cause withdrawal symptoms. The Committee noted that there appears to be a steep dose-response curve ¡V i.e., there is a small difference in the dose required to give a ¡¥desired effect¡¦ and that required for an overdose, causing coma, convulsions, respiratory depression, and death. The effect of potentiation by other drugs taken concurrently is not clear.
6.8 The Committee concluded, on the evidence before it, that GHB and related substances had some similar properties to ethyl alcohol, while there was also some evidence of differences. The evidence provided on behalf of Outerspace Limited on the packaging of sachets containing 10 ml of diluted 1,4-B, and a suggestion that it might in future be sold diluted even further in fruit juice, compared with reported effects from consuming neat 1,4-B, heightened the perceived similarities.
6.9 It was noted that there is apparently a large number of people prepared to consume this group of substances. After emphasising the risk of harm from unknown or variable concentrations or doses, the EACD then discussed the other possible effects of classifying these substances in the Schedules to the Misuse of Drugs Act. As with other scheduled substances, there is a potential for driving the drugs ¡¥underground¡¦; increasing the attractiveness of the substances to some young people; potentiating the introduction of alternative un-regulated substances, and the illicit manufacture of inferior ¡¥home produced¡¦ versions of the controlled substances, that have a risk of unknown harmful contaminants. Such effects would impact on harm minimisation principles. However, the Committee concluded that it did not currently have sufficient evidence to weigh up these risks against the deterrent effect of scheduling these substances under the Misuse of Drugs Act.
6.10 Only one of the substances, GHB, has been used as a medicine and there has already been an attempt to control it as a prescription medicine, as its sodium salt, sodium oxybate. This has had limited success. 1,4-B has been marketed as a dietary supplement, which would make such products subject to the Dietary Supplements Regulations 1985 and the Food Act 1981. The Ministry has seized a substantial amount of product containing 1,4-B and is investigating whether to prosecute under the Food Act or Medicines Act. Alcoholic beverages, with which 1,4-B has some similarities with its toxicity, are subject to the Food Act (the Food Act empowers the development of food standards by the Australia New Zealand Food Authority). However, the Committee considered that GHB and its related substances could not be considered as foods or medicines and that existing regulatory frameworks under the Food act or Medicines Act would not be appropriate to regulate these substances.
6.11 Members requested that they receive copies of the scientific papers, which were used in the preparation of the Secretariat¡¦s preliminary paper on GHB and its related substances and that the Secretariat endeavour to obtain the background papers to the European Monitoring Centre for Drugs and Drug Addiction¡¦s risk assessment report on GHB.
6.12 There was discussion on the need to commission a literature search and report before the next meeting, but this decision was left until after the scientific papers noted in paragraph 6.11 had been examined by a working party of members with pharmacology and toxicology backgrounds.
GHB and related substances do require regulation and the Misuse of Drugs Act appears to be the most suitable available vehicle.
The Committee deferred a recommendation on the specific scheduling classification until members had more information.
The Secretariat should distribute to members, as speedily as possible, the background scientific papers used to prepare the Secretariat¡¦s preliminary paper on GHB and its related substances. Additionally the Secretariat should endeavour to obtain the technical Annexes which provided the foundation for the European Monitoring Centre for Drugs and Drug Addiction¡¦s risk assessment Report on GHB.
When such material has been circulated to members, a working group, comprising Dr¡¦s Bedford, Maling, Boyd, and Jessamine should be established to consider primarily the obtainable toxicology and pharmacology information and advise the Secretariat whether there is sufficient information to allow the full Committee to make a recommendation on scheduling.
Andrew Coleman would also provide further import/export information, and obtain Australian Customs ¡¥before and after¡¦ classification data.
Item 7: Prescription medicine-type substances
7.1 The papers on aminorex, pemoline, and zolpidem were not discussed in detail. Although there is no apparent abuse of these substances in New Zealand, New Zealand is obliged to apply domestic controls that are consistent with our obligations under the United Nations Conventions.
The Secretariat will initiate an ¡¥out-of-session¡¦ decision making process for these substances in a way that does not duplicate effort by EACD members.
Item 8: Next meeting
8.1 The Committee noted that it will take some time to complete the outstanding work from this meeting. The date of the next meeting will depend on the evaluation of scientific data requested under item 6, and any Ministerial imperative for the resolution of that item.
Subject to 8.1, the next meeting will be held on Thursday 30 August 2001. The venue will be room CO2 at the Ministry of Health, 133 Molesworth Street Wellington (between 10am and 5pm).
meeting concluded at 4.35pm
Meeting of the Sub-Committee of the Expert Advisory Committee on Drugs
Tuesday 29 May 2001, Conference Room CO1. Ministry of Health, 133 Molesworth Street
The meeting commenced at 12:05 pm
Dr Bob Boyd
Dr Helen Moriarty
Dr Tim Maling
Det. Inspector Harry Quinn
Dr Doug Sellman
Dr Geoffrey Robinson
Dr Stuart Jesamine
Dr Keith Bedford (via teleconference)
Item 1: Public Submissions
1.1 The EACD Sub-Committee heard verbal presentations from Outerspace, the New Zealand Drug Rape Trust and Brenner family. Each of these groups had lodged written submissions about GHB.
To recommend to the EACD that oral submissions be heard on a case by case basis in the future.
The meeting closed at 1.45 pm.