Side event – Coordinated efforts to increase access to controlled drugs for medical purposes

Mr. David Lewis, Australian Permanent Mission.

Appreciates efforts of Dr. Gerra.  Panama’s efforts in  WHO EB resolution.  Drawing upon CND resolution on which Australia has led for relief of pain and suffering.  High priority on access to medical opioids for pain relief and palliative care.  Moral obligation to work for better access.  Guaranteeing access was rationale of drug conventions.  Addressing the issue is a collective responsibility.  Look to all to continue to work together.  Today’s discussion is timely and appropriate.  Brings together qualified experts around the world.
Practical contribution.  Delivering services in Ghana.  90% of px cannot be treated.  Ghana program has had a good start.  Practical project to address the broader issues.   Acknowledge crucial role of INCB on this issue.

Introduces Yuri Fedetov.  Executive Director of UNODC.  Welcomes us. Thanks Union for International Cancer Control (UICC).  Also Italy, India, and Panama who have gained a lot in implementing recent legislation to improve access to control drugs for relief of pain and suffering in particular for cancer.  Fundamental objective of international drug control conventions.  Reason opioids are controlled is harm of misuse.  Conventions seek to have a balance – preventing misuse and promoting availability.  Protection and promotion of health and public safety.  Increased issue and dialogue on this issue and meeting medical and health needs of patients.

New UNODC program to increase access and provide technical assistance and guidance to MS.  Discussion paper for UNODC after 54th session.  INCB 2010 Annual Report on availability and WHO Ensuring Balance Guidelines.  I welcome this work that has been done under joint global program including revision of parts of model laws.   Initiation of pilot effort in Ghana.  Together we can ensure that people get adequate treatment for conditions requiring the use of controlled medicines, painkillers.

Ms. Elizabeth Mathai.  WHO.  Estimates show that more than 90% of medical opioid use in 7% of population.  WHO as directing and coordinating authority is concerned about this inequality and avoidable suffering.  Global Atlas maps out unmet needs in palliative care.  Only 1/10 people receive such care.  Majority live in LMICs.  Support of PC report and Draft resolution in WHO is evidence of MS commitment to improve the situation.  Details of resolution will be explained later.  PC not just about pain relief but will be explained later.  Access for all indications.  Barriers differ in different parts of the world.  Insufficient education, economic reasons, undue fears of diversion, regulatory barriers.  Need responsible use and prevention of diversion and misuse.

After being invited to assess, WHO developed ACMP in consultation with INCB.  Developed tools, Ensuring Balance.  Guide on Estimating requirements.  To help with responsible use, treatment guidelines especially for pain in children.  All available free for children and in multiple languages.  Increasing action by joint stakeholders very encouraging.

Julie TorodeUICC.  Very happy that UICC is partnering with UNODC.  Hosted by all partners an innovative project to improve access.  800 plus member organization across the globe.  Involvement of civil society.  UICC just one organization in network of improving access to controlled medicines.  6 billion people living in pain around the globe with no access to pain relief!!

2009 first time UICC attended the meeting.  Many participants surprised by why we were here.  Landmark resolutions about balance of control and access.  Increasing momentum on the topic generated by MS actions in Geneva.  Global action plan on NCDs last year at WHA has core element about access to opioids.  Essential medicines list fit for purpose.  Two key messages: CS is ready and able to take a role in action on the ground.  Please include us.  Now is the time between collaborative action between regulators and public health – more access and less patients in pain.

Gilberto Gerratakes over.  Fedetov supporting strongly this “new approach”.  Becoming available for medical purposes.  Wants to use two words:
“Prohibited and indispensible.”  Considered by the conventions “indispensible”.   Not to permit that shadow of prohibition impairs important medical use.  We have also to consider pain and treating pain very seriously.  Pain is not a disease.  Affects a person with all her cultural, social religious, spiritual characteristics.  Not to be superficial.  We are no here to offer free morphine for everyone.  Have to stop the inequality between large part of the world not having access and small part having epidemic in terms of abuse and diversion.

Drug control operation involved in this…Ghana means something practical.  Drop in the ocean but not only with words but with facts.  Training policy makers and changing public opinion to impact availability.

Dr. Jim Cleary.  PPSG.  Honor to be part of effort in Ghana.  Use “medicines” rather than “drugs.”  Have heard about SC, dual pillars, Guidelines.  Global consumption of morphine slide.  Good relationship with INCB.  At least 6 billion people have inadequate access to opioids.  Clearly infogram.
All data and more available at http://www.esmo.org/Policy/Global-Opioid-Policy-Initiative

Multiple barriers.
1)   regulatory
2)   knowledge and attitudes
3)   cost
Lack of access in Eastern Europe – availability and cost.  Presence of a color and lack of black spaces in Cherny slides.  Ukraine has changed rules and now has access.  Africa, Asia, LAM and Caribbean, and India.  Presenting Cherny slides…link to.

Medicines available often, but not much used.
Went through barriers.
·      Who can write prescriptions
·      Days allowed for a prescription.
·      Prescription pads for opioids – ie Philippines
·      Restrictions on pharmacists.
·      Negative barriers? – negative language in the laws.  Esp Africa and the Middle East.  Message is that more pink and red is significant barriers.  (see slide set)
·      Next steps in access…Drug availability, Education and Policy…public health model.

Mr. Jorge Corrales, Permanent Mission of Panama UN, Geneva.
Updates related to the recent WHO EB Resolution on Palliative Care.
1.     why is palliative care in focus
2.     Strengthening of palliative care as a component of integrated treatment
3.     Implementation issues.  Why we need to emphasize implementation.

Cooperation between WHO, INCB, National Drug Reg authorities and health ministries needed to increase access.
Defines Palliative C – health service that ensures that people with serious illness do not suffer unnecessarily.  Opioid medicines essential, not just thinking about in Geneva but in Vienna.  Need is growing worldwide.  40 million every year.  About 21 million need PC at the end of their lives.  More than 90% as a result of NCDs.

Political commitments.  Positions of the states.  September 2011 adopted a political declaration that encouraged countries to ensure availability of PC.
WHO Global action plan for NCDs called for new models, policies and approaches for pain relief.
WHO Global Monitoring Framework implements new PC indicator
WHO EM list revised to include section on essential PC medicines.

Resolution.  EB on January 23 2014 adopted a resolution urging countries to ensure access to pain medicines and PC
First discussion by WHO about integrating PC into national health systems
Resolution drafted under leadership of Panama by Australia, Chile, Ghana Libya, Malaysia, S Africa, Spain, Switz, and US.  Interest was an interest in public health and technical issues.  Was not politicized.  More than a dozen additional countries from different regions co-sponsored.
Identified three key areas where governments need to take action to ensure adequate availability.
1)   Following health system policies to ensure integration
2)   Education and training of healthcare professionals
3)   Ensure availability and accessibility of essential pc medicines especially opioid analgesics.
Challenge for regulators and physicians is to balance risks and benefits of opioid use
Focus on prevention of abuse has led to overly strict rules in many countries.  As a result, the medical use has been hampered and this is not in line with conventions
Conventions consider public health as the cornerstone  and implementation of drug control measures should not compromise public health
Who as directing coordinating authority for health within UN systems promotes public health approach to the problems of drug use an ddrug use disorders
For now, nobody is reall taking responsibility in much of the world for the lack of access to adequate pain medicine.  Who better than WHO

We have to measure access to opioids continuously.  The indicator in NCD action Plan will do this.  And keep the issue on the agenda in Geneva and Vienna with an exchange of information
Geneve and Vienna must insist that national level authorities, both health and drug control officials, take coordinated measures…

Guido Fanelli – Chair of Italian Health Ministry.  Commission for Pain and Palliative Care.  Law safeguards right of all citizens to have access to PC and Palliative therapy.  Tried to move from pain as a symptom and patient alone with his pain.  Moved to patient at the middle of the field, pain as a disease.

This year, Italy will become president of EU in second half of 2014.  Our government put priority on pain management and palliative care – will share with other MS.  P. 108.
What about Cannabis?  Last January small region in Italy, Abruzzo, proposed use of medical cannabis.  Italian cannabis decided not to contest.  Is free for use in medical purposes in whole of Italy.  Very crucial for px.  Driving – from legal point of view, constitution safeguards health and fundamental right.. punishable by law to drive on opioids.   People on opioids are punished.  Difference between blood levels.  Also altered physical or mental status.  Police usually judge.  Our goal, using expert panels, is acceptable blood level according to prescribed doses.  Define objective performance requirements.
Pain in Children.  11K children need PC.  95% have pain as first symptom.  But in Europe drugs against pain are off label except for oral morphine.  Not for lack of studies or scientific knowledge.  EMA (European Medical Association) asks for a fee of 50K euros for drug use registration in children.  Possible not to pay fee if we article 9 – can be removed.  Convince pharmaceutical company to register drugs for pediatric palliative care.

Rajesh Srivastava.  India. Track record has not been good in the past.  1.2 billion people.  15-16% of humanity.  If pain medicine not available, as Jim Cleary says, I regulate for 1/6 of the world’s population.  Problem… shows Triangle of Policy, drug availability, and education.  Policy part addressed recently in India.  Regulatory barriers.  India a federal structures.  Divided between central and state governments.  Power to regulate manufacture etc. is central, transport, etc. state governments.  Multiple regulatory barriers, permits, many licenses.  Limited duration for one and then the other.  Consumption of morphine in India Dropped after NDPS act.  Global average 6mg.  India.  .09.  India has to increase 65X to get to global average.

Dr. MR Rajagopal’s photo pictures a man suffering in acute and needless pain.  Mentions Rajagopal contribution.  Any hospital – but only for cancer px in 1998, could get morphine if they had model regulations.  In states that did come up with operating procedures, position did not improve drastically.  We had moved an amendment to NDPS act in September 2011.  Did not incorporate provisions for access to pain relief.  In August 2012 we realized that time has come to make it obligatory that states change their laws through central legislation.  Created a new category of essential narcotic drugs.  Can keep adding to.  Finally had principle of balance.  Law captures.  And transfers powers of regulation for ENDs upon Central Government.
Restricts State Government’s powers.

Superlative involvement of palliative care organizations.  Cannot get done without them.  Process was not easy.  Changing laws not easy.  In three sessions could not be taken up.  Finally, this present stint got done.

INCB.  Beate Hammond.  Art. 9, para 4 of SC mandates INCB to ensure availability of drugs for medical and scientific purposes.  Also in 1971 Convention on use of psychotropic substances.  Not unduly restricted.  What has INCB been doing.  Engaged in dialog – mostly correspondence.  Photo of Yans meeting the pope.  Access to pain medication featured on top of the agenda.  Second focus is looking at the data.  Planned and actual consumption data.  Then published in annual reports.  Technical reports.  Core INCB mandate so publishes special report.  2010 latest.  Also based on special data provided by MS.  Planning another special report in 2016 in time for UNGASS.  Preparing survey at the moment.

Overview of availability.  Changed for the better in areas of South America, some parts of Asia, and Russia.  Far too many white spots on the map where low to no consumption.  Over 30 years, tremendous increase since 1980s.  INCB always increased in barriers to increased access.  Concern over addiction top reason.  Room for training and technical support.  Consequences of lack of access – unnecessary pain and suffering.  5.5 million terminal cancer – WHO statistics.  1 million end stage HIG AIDS.  Women, 110 million.  Equal to malaria and TB.  Moral and public health as well as legal and political imperative.

INCB recommendations.
Critically examine estimates and methods to estimate…
Identify potential impediments
Supports governments in carrying out the tasks
Kamran Niaz – Resaerch and Trend Analysis Branch, Statistics and Survey Section UNODC.  Misuse of prescription drugs.
Major disparity in global consumption.  Canada and US with 812 ME  Nigeria and Myanmar 0.014 and 0.015 per capital.  High income countries 17% of population has 92% of medical morphine.  Half of the countries consumed less than 1 mg per person morphine.

Three main factors.
Legislation and policy (ESMO data) – do not materially contribute to prevention of misuse.  Potential to prevent misuses, but disproportionately prevent availability.  Preventing diversion and misuse concern is the root.
Making opioid painkillers available would lead to higher degree of misuse.

Attitudes and Knowledge – health care professionals, px and their families and general public
Economic and procurement impediments
Looked at data on consumption across countries and compared with data on misuse.  At one end of the spectrum you see countries with high consumption?? At the bottom is prevalence data on misuse.  There is no correlation.  Where you see countries like Nigeria and Pakistan with low consumption levels, have comparable levels of abuse of prescription opioids.  Same thing found in the middle.  Ie Czech republic.  Paradigm shift.  National legislations, regulations and policies need reflect to rebalance priority of availability  … then secondarily  prevent misuse and diversion.

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