IDPC Side event on Scheduling and how to respond to the new challenges of new psychoactive substances

Scheduling at the core of the drug control system. Flashpoint for drug control system.  At CND scheduling issue has been given a great deal of importance.  Two thematic debates, one on scheduling and one on the UNGASS.  Also a personal issue with two resolutions, one on ketamine and one on dronabinol.  For the first time UK seeking scheduling of mephedrone under provisions of 1971 Convention.






Chris Hallam.  Situation re NPS and scheduling.  Work on WHO and rebalancing of scheduling.  Sudden proliferation of NPS has brought to the foreground.  Many countries feeling besieged.  Fluid and dynamic.  Difficult for many countries to regulate.  Tool of conventions that hasn’t been used before.  Provisional controls measure.  UK wants to use with respect to mephedrone.  Danger that concern or alarm about NPS could prove problematic for rebalancing of  UN drug control system that has been underway for past two years, to some extent rhetorically but also practically.
Will focus on problem of rebalancing of the system.  If countries do panic danger that health concerns and scientific procedures of conventions written into the system will be sidelined.  In spite of the discourse about rebalancing away from criminlization.  Naming and shaming, punishment, etc.  If we actually look at the issue of scheduling we can see continued marginalization of health principle and WHO.  Many countries highly critical of WHO s previous decisions, scientific and public health decisions not to schedule.  But WHO not there to respond.  Very unfortunate.  Within the mandate given by the conventions, WHO given the task of scheduling.  Core task that goes to the health principle rather than enforcement that goes to INCB.

Detailed work is Expert Committee on Drug Dependence.  This recommendation goes to CND.  Can reject recommendations.  Has broad discretion to do so.  WHO remit is to look at public health consequences of drug and risk assess with that in mind.  CND can look at social, administrative, economic and other factors.  Gives CND a broad remit to make its decision.

In recent decades WHO has been starved of funding and resources more generally.  Program of substance abuse with six staff has one part time staff member.  Expert committee on drug dependency has faced criticism but has not had funding to meet.  Went six years for lack of funds.  Recommendations on tramadol and ketamine have been criticized by delegations and rejected by CND.  WHO also hampered in its work by structural incoherence built into conventions.  1961 convention refers to narcotic drugs (narcotic = sleeping) but includes cocaine – stimulus.  Plant based drugs. Psychotropics has no scientific  meaning at all.  Drugs that affect central nervous system.  Lack of conceptual coherence.  Bupenorphine, LSD, and others.

Expert committee has told us that trying to schedule under which convention is a major problem for it because of incoherence in definition.  Alcohol and tobacco are not classed as drugs at all by the conventions.  Consequences for availability of EM.  Some of WHO lists are also controlled as precursors by INCB.

Many countries are more restrictive than they need to be in interpretation of conventions.  Recognized by WHO and INCB as well.  Ketamine and tramadol are cases in point.

Anxieties about psychoactive substances should not make governments lose sight of the health principles of conventions or value of scientific evidence about values of certain drugs.  The position of Expert Committee on Drug Dependence Treatment needs strengthening as part of the overall rebalancing of the system, which INCB has spoken in favor of.

UK this morning mentioned use of provision controls.  Under 1961 convention these can be mandatory or discretionary.  Under 1971 only discretionary.  Possible result of this could be a circumventing of the conventions themselves and the WHO for new drugs.  Like INCBs call for domestic scheduling could result in de facto global ban on something like tramadol.  If every country bans domestically, could become and international convention by stealth.

Dr. Dave Bewley Taylor.  Swansea University and IDPC.  Evidence around that suggests INCB greatly exceeds its mandate with regard to scheduling.  Mandates on scheduling are very clear.  WHO is assigned unambiguous responsibility for making recommendations to CND.  Can attend as observer.  INCB only has mandate for 1998 convention with regard to precursors.  Board can be seen to engage in behavioral process, mission creep.  Perilously close to exceeding its mandate.  Selective reticence.  Reluctance to engage in an area that its mandate suggests it should engage in.  Ensuring access to essential medicines.  Advocate of restrictive rather than enabling provisions.  Aversion to diversion.  Board stands on problem to essential medicines is ambivalent.  Tension between WHO and Board.

Ephedrine an essential medicine by WHO but Table One of 1988, controlled.  Structural tension and inconsistency and lack of clarity.  See other more proactive examples of this tendency on the issue of scheduling.  Raises issue of mandate of CND itself.  Board is quite careful  not to openly call for international scheduling of substances.  More passive active approach in specific examples including khat.

Useful to focus on dronabinol and ketamine.  Detail will contextualize current discussions to ongoing resolutions this week.  As you are all aware cannabis controlled under strictest provisions of SC.  One of its most active agreement is listed in Schedule ON of 1972 convention.  Moved from original schedule One to two in 1991 and another critical review in 2002 where WHO said it should go to schedule 4.  Midterm review after 1998 session.  Dronabinol fate tied up with cannabis.  Debate about sending the wrong signal with regard to cannabis.  Issue kicked into long grass and not taken to CND.

Reviewed again in 2006.  Expert committee recommended move to Schedule 3.  Abuse liability low.. other available drug with similar properties – cannabis.  Commission decided not to vote on the issue.  CND did not allow science to prevail over politics.  In terms of mandate what is appropriate in asking the Board?  INCB positioning itself as an expert in scheduling.  INCB has bad attitude to WHO scheduling.  Annual Report 2006 and Plenary 2007 spoke out against WHO scheduling.  Set tone for debate.  Hiatus resulting from lack of funding.  Revisited critical review and decided recommendation should stand.

INCB used procedural arguments to delay.  Netherlands put forward resolution to be discussed this week.

Ketamine.  INCB has had hostile approach.  Generated a certain momentum in MS to schedule at national level.  Pre-review of WHO found that reports of dependence very limited and a very widely used anaesthetic.  Part of WHO list of Essential Medicines.  Insufficient evidence to schedule ketamine.  Members learned that 2006 session of CND, resolution tabled to schedule.  CND requested that WHO secretariat produce an updated critical review of expert committee.  Again repeated the recommendations reached on medical and public health grounds.  Access would be limited and would constitute a public health crisis where no alternative anaesthetic available.  Why does INCB consider this controversial?  For some time Board had been very energetically expressing alarm about ketamine and saying it should be placed under control.  Trying to schedule under national network.  Mentions year after year its concerns.  INCB writing letters to WHO to persuade about misuse of drug.  Board spokesman at 2006 WHO was “astonished” that INCB should call on states to do this and referenced negative public health aspects.

INCB campaign continued and widespread abuse of ketamine among youth and linked with commission of crimes.  Familiar discourse.  Several calls for scheduling at national level that INCB backed up.  Issue of ketamine in particular raises serious questioning in relation to scheduling not only in relation to board but to CND.  Quotes WHO—section called “current international controls and their impact.”  De fact system has emerged due to CND resolutions and INCB continuous pressure on MS.  CND has no mandate to control without WHO recommendation.  INCB has no mandate at all.  Expert peer review of critical report.  Notes “Strict procedures required for procurement of scheduled substances likely to create a public health crisis in several African countries.”

Danilo Belotta, EMCCDA.  Responding to the challenge of NPS in the EU.  1995-96 issue of “designer drugs”.  Potency same as what we have today.  Find a way to modify chemical structure.  Market still illicit.  1997 EU put legislation that had two objectives.  Much quicker than UN system.  Would take two or four years to schedule.  At the same time respond to scientific evidence.  Producers have realized that they didn’t have to compete in the legal market.  Consumers liked that. Not perceived as associated with bad stuff.  In the last five years lost control through internet and fancy smart shops.  From 2005 , 14 new compounds, 2009 24, 2010 turning point, doubled to 41 new compounds.  48 2011, 73 2012.  Last year over 80.  There is a demand for legal highs.  They like to enjoy recreational drug use if that is legally possible.  Smart shops grow up as mushrooms in many capitals.  Hundreds.  Poland invaded by shops.  The answer was panic.  All of a sudden, ministers of health saw press releases and news of people with strange substances.  Their phones ring, what are these things and how can we stop them.  First measure criticized by civil society was to shut the shops.  Kids would go and perceive at legal, end up in ER in big numbers and some were dying.

Decision of shutting shops one measures.  Some substances go underground into illicit market, at the same time we know those most of the market is migrating on internet.  Much more complicated to assess.  Internet as a possibility to offer more substances.  Not just NPS but medicines, fake medicines, licit drugs as well.  We think that new market is internet and we don’t have the tools to act on that.  Monitoring more than 360 substances.  Have assessed 13 substances by beginning of system.  In 11 subject to control.   Ketamine not under control .  We understand that when we meet elsewhere we have a system that is based on science and available for decision making.  Might not be perfect or elegant but this is the direction we want to go.

Phenomenon has clearly continued to evolve.  How are we going to have an effective system that includes balance?  Risk and danger of these substances that should be under control or not?  Might be declared not dangerous later and can go back to the market.  From our point of view we need to increase capacity to detect and assess serious adverse consequences.  When we are notified we have no idea what is inside.  Have to have chemical idea of substances.  Or when someone dies and we analyze.  Can only activate the system after.  Go out in the market buy the substances or have in seizures, then test.  Now behind the market.  We have to get ahead.

Ross Bell NZ drug foundation.  Heresy or Pragmatism?  Overview of model.  IDPC has published a paper on the technical specificities of the model.  Not speaking on behalf of the model.  From an NGO that advocates for changes in the law.  Used to think that NZ had a unique problem with NPS.  Very small and far away.  Good at cooking up own substances because can’t get heroin and coke.  Now we know all countries are dealing with it.  Had a new product that came onto the market because sellers realized that because of outdated drug laws could be on the market because not scheduled.  Had no idea what it was or risks.  Because no controls could be sold from anywhere – -“dairies” milk bars, 7-11s.  Created rapid rise in use and consumption.  With in 3 years ¼ adult population had tried.  Parents would see that kids could buy.  Media covered the story and politicians were under pressure.
First thing they did was ban the product.  Industry behind said, if you ban, we have a product to replace.  Same cycle that you have all experienced.  Thought the bans would work. Didn’t.  Ban them faster.  Some delegations think they can do that.  Doesn’t work.  Pressure on government to crack this nut.  Government turned to an independent organization called the Law Commission, an autonomous legal organization that can give government advice about reviewing laws.

Government said go away and review our drug law and come back with a new law that can fix this problem.  Not because they are reforming politicians.  Did it because they ran out of patience and were embarrassed.  Law Commission conducted a review and identified obvious weaknesses.  Recommended not to pursue old prohibitionist response but try something new.  Differentiated between convention and non-convention drugs.  Current drug law had no mechanism for effectively regulating before they reached market.  Onus on government to demonstrate harm before banning.  Industry had to demonstrate low risk before they put goods on the market.  Law passed in 2013.  Have 122 politicians in our country.  121-1 votes passed.  Rare event of cross party political pragmatism. Regulates all parts of NPS system.  Manufacture to selling.  Onus on industry to demonstrate that products are low risk before they can be sold.  Authority will set various hurdles before they can be approved for sale.

Regulate marketing.  No TV, age restrictions, health warnings on packaging.  Whole range of flexible regulations can be put in place.  Starting position is strict.  Because industry has to jump through all these hoops much information is available for consumers.  Finally consumers have good info about what they are taking.  No form of diversion for other drugs…so decriminalization model.  Caught in possession of unapproved substance, no criminal conviction.  Huge reduction in number of outlets where products sold.  Can no longer sell in corner stores.  4000 outlets to 150.  Fewer products.  Only 30 have interim license.

Politics.  NZ government didn’t do it because they are drug loving people.  Sold under a we are clamping down on these things.  Widespread public and media support.  All got sick of industry getting new products on the market. Communities have a store in their neighborhood protest.  Single vote against because of provision in law as part of risk assessment process because can be tested on animals.  Focus debate on new ways to control this challenge.

Dave, asks question of the floor.  Asked about dronabinol.  Mark of Netherlands.  Will be a vote in plenary.  Pre-precursors also being voted on tomorrow.  1971 convention has very high threshold – 2/3 of CND members have to vote to block.  Interest in access to medication issue definitely growing.  Delegations considering very seriously and coming with questions.  Dronabinol used for pain relief, HIV Aids, not abused much.  Latin American countries support.

Tom Blickman, TNI.  Endless war between producers and regulators.  Is there not a system where you at a certain point allow a less harmful substance counter the more harmful substances.  A lot of these products are in fact Ecstasy replacements.  Know it is not addictive.  So why not allow?  Answer – risk system a problem…why not schedule other risky substances.  Going in the direction of NZ.  Allow to circulate until too dangerous.  Still too reactive.  Best way to control is regulation with evidence… monitoring centers and government… not very clear.  Ketamine is only anaesthetic that can be used in low resource environment.  In high resource countries abused the most.  In low resource settings a beautiful anaesthetic.  Doesn’t require additional equipment.  Many concerns about more controls because will absolutely disappear.  Need to be paying very close attention to.  Not legally binding but quite a bit of work that needs to be done discussing with countries that are going to be affected by.  Medical community was not consulted.  We understand the potential for abuse.  But negative impact on surgical care very limited.
here as a proponent of access to essential medicines.  Morphine largely inaccessible.  Ketamine is accessible because it is not under control.  We use it all the time.  Very effective.  Really emphasize the gravity of this resolution.

Dave.  In re countries where you work.  It is powerful when CND builds momentum by passing resolutions requesting countries to schedule.

Comment to Chris on provisional controls.  Comment that you think provisional controls might circumvent conventions.  Put into place and commentaries expand on them.  Where process might take to long and lead to abuse of substances.  Emphasis on pending control by WHO.  Not supposed to be alternatives to WHO.  Where the fear emanates from…mandatory provisional controls and voluntary based on likelihood of abuse.
Chris. fear is that if a lot of countries introduce them they may be reluctant to go back.  While controls are in place people could be criminalized.  Plenty of research shows that criminalization very harmful.  Does more harm than drugs that have been criminalized.  Potential harms to essential medicines.  If ketamine controlled.  5.5 billion people living in countries that WHO says have inadequate countries to painkillers including anaesthetics.  Serious impacts from these measures.  Whole idea of doing this without scientific review needs to be treated with caution.  Atmosphere of suppressive panic at CND.  Concerned that this be done carefully.

Martin Jelsma.  Ketamine is the perfect example of the risk of provisional measures.  First call in CND resolution to start controlling it at national level started in 2006.  45 countries have done on a voluntary basis.  2012 WHO critical review asks not to control.  Ketamine resolution should ask countries that have imposed control, awaiting critical review of WHO should reconsider their decision because there is now a scientifically valid review saying to be very careful and give clear priority to access over risks of diversion.  Good example how it could work with provisional measures.  Once countries implement measures, and WHO comes with a recommendation, there will be very few that are going to review it.  Ketamine resolution a scandalous example of neglect of WHO scientific advice.  Clear example of talk of evidence based policy and putting into health based approach is hollow.  Taking serious evidence based policy and health as a priority doesn’t do that.

Comment. UK case.  Widespread use of opioids in UK, but government accepted upscheduling but understanding medical use.  Not just in response to Canadian point.  Also important for field medicine and the military…government’s concern for low income country.  Over interpretation of what is implied by various agreements.  There were interventions by four states parties during Yans talk, not about increasing access, but about increasing controls.  “No therapeutic value” misunderstood.  “As yet no therapeutic value”.

Jamie Bridge.  Question about provisional scheduling.  Mephedrone issue.  With NPS, poster boy.  If it does go through this week, will we have 80 of these things to deal with?  Ban it faster…what is the impact on innovative models?

Chris.  Distinct possibility that it may be the case.  Anxiety driven trend.
Boticelli.  Experience of NPS discussion today.  Need for someone in the room to put risk of substances into the text – default mindset.  More reassured if there were a risk assessment.  Clearly we are lacking??

Ross Bell.  Mephedrone already scheduled as illicit drug in NZ.  NZ a good treaty partner.  Scheduling of NPS would make NZ nervous.
Dave. I echo Chris’ interpretation.  Let’s wait and see.  Symbolically powerful.  UK statement implied that usage had gone down so should be banned at international level.  Prevalence not always related to policy.  Direct link that UK delegation did should be challenged.
UNODC  We would all agree that what we want is to save lives, to make sure that no one dies, or suffers.  Harder to make a judgement.  Only talking about scheduling.  Call for scheduling because there is a health problem, people are affected and there is a dangerous substance.  How do we weight one without the other?  WHO doing the best they can in a scientific context. Not God.  Scientific process works once there are the tools.  Often there is no research on use of NPS.  Let’s work on prevention, not just supply.  Need a more balanced view.  Not only from research side.  Serious study of who is at risk for using NPS.  What has been done in prevention?  Part of keeping at scientific level.

WHO.  Various groups dealing with it.  Essential medicines program.  Expert committee on drug dependence.  Also have colleagues in HIV/AIDS and substance abuse departments, etc.  Clearly there has been increasing interest and focus expert committee on drug dependence and cases of dronabinol and ketamine show what we have done within mandate assessing risks and benefits.  Work around NPS is clearly taking us to new territory.  We are all struggling with it.  Next expert committee will meet in June this year and look at NPS. Lack of data an issue.  One third of countries respond to surveys.   Also committed to how we can make cycle of meetings of expert committees more fit for purpose.  Lapse…how many substances we should look at.  Did create perception of loss of institutional memory.

Resolutions being passed in CND…important to signal that drugs were not discussed in WHA for fifteen years.  Has not got the attention of WHO.  A lot of debates have been taken on board in CND but not through a health lens.  Not all have a balanced approach in how we take things forward.  In WHO through a public health lens and would forget about law enforcement.  CND does the opposite.  Increasingly countries are getting interested in taking up debate at WHO.  Work in progress.

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