ATOME Access to Opioid Medicines Europe

Side event organised by the International Association for Hospice and Palliative Care and co-sponsored by Germany and Lithuania

Marlene Mortler  

German Drug Controller welcome.  Access to Opioid meds an issue of high relevance to our country.  As Drug Commissioner my role is to reduce drug and addiction problems in Germany.  Our national strategy includes 4 levels, prevention, counselling treatment, and harm reduction Improving access doesn’t seem to be part of this goal.  Phyisicans have a wide range of opioids available to treat pain.  Legislation has been revised repeatedly to facilitate adequate use of opioids.  Very low consumption of opioids in many countries worldwide.  Similar to German strategy CND strategy has focused on prevention of abuse to ensure that barriers are in place to make sure barriers are in place.  Raising the barriers for use of prescription opioids may have determinental effects on patients who need for pain releif.  Recogniseing need to balance between abuse and facilitation for use for medical and scientific purposes, WHO has revised the guidelines on ensuring access.  Guidelines provide guidelines for availability and accessibility, balancing between need to control and preven abuse and the need to ensure access for all px who need them.  Has been part of ATOME project, which aimed to improve access to opioids in Europe, including Lithuania and other countries.  PC experts and HR experts, main goal to ensure access.  Bringing these groups together might be the best way to ensure access under national policy.  Will hear about the project.  Germany, Netherlands, UK, as well as NGOs and Partners.  As Federal Drug Commissioner for Germany I am happy to open this event.  Those who want to prevent abuse, and those who recognise opioid tas an important treatment option. 

Lithuania Representative Gediminas Kliukas introduction 
Greetings honorable guests and panelists from Germany, Lithuania, Uganda and the Netherlands.  It is Lithuania’s privilege to co-sponsor this event on improving access to essential medicines for palliative care and opioid substitution treatment in the context of the ATOME project, which included Lithuanian participation and a very informative country report. 

This is the second time Lithuania has sponsored a CND side event on this topic of improving access to essential medicines controlled under the UN conventions.  Lithuania supports the conventions’ concern to protect “the health and welfare of mankind” and recognises, in the words of the Preamble of the Single Convention, “that the medical use of narcotic drugs continues to be indispensable for the relief of pain and suffering and that adequate provision must be made to ensure the availability of narcotic drugs for such purposes.”

We are also very honoured to welcome our fellow countryman Dr. Dainius Puras, the Special Rapporteur on the Right of Everyone to the Highest Attainable Standard of Health at the Human Rights Council in Geneva. It is past time for Geneva and Vienna to join forces on placing drug policy in a human rights perspective.  Dr. Puras is a Lithuanian psychiatrist, who is bringing to life the aspiration of the 2014 Joint Ministerial Statement to “review and update legal frameworks and law enforcement institutions, taking into account applicable international human rights obligations.”  The Republic of Lithuania welcomes you to this side event and thanks the Federal Republic of Germany for co-sponsoring.

Dr. Puras. Special Rapporteur, Highest Attainable Standard of Health I represent the right to health.  We use a shortened version.  A pleasure to attend this session.  This theme is very relevant to my right to health medicines.  Access to PC and controlled medicines should be considered as a human right and my predecessors, and the third reporter Paul Hung and Anand Grover were working a lot on different important issues and I am ready to continue this important issue.  My different experience is that I am not a lawyer  abut a medical doctor.  As UNGASS is approaching we all need to think what could be done differently to reach some more balanced approach and to place human rights, including the right to health at the center of the drug control debate.  Current debate and in some political declarations what I see is persistent problem is imbalance, not so much about formulating policies but implementation phase — goes to unbalanced approach, and right to health and public health approach often losing.  In other fields also, but also especially relevant is the issue of access to controlled medicines and palliative care. 

Also this issue ketamine is about lack of balance and evidence based approach.  We all understand that evidence is needed especially in the field of medications.  But they should be reasonable and not send threatening messages.  When they are perceived so even medical doctors are afraid to prescribe even if it sot forbidden but they think it is better not to do.  Side effects of legal regulations can sometimes bring even more problems.  This is about context and this field is trapped for so many years.  So my I will go on to continue what my predecessor was coin, including so many organisations that you represent to put human rights dimension and public health as evidence instead of irrational fears and myths and false interpretations that sometimes prevail in this field which is close to my field, which is mental health, which also suffers from same myths.  As a SR on th Right to hHealth, they inform and study report to UN bodies usually HR council and General and general assembly, different aspects and challenges worldwide, I will do my best and start from this statement Failure to ensure access to controlled medicines threatens fundamentals right to health and human rights in general.  There is no justification and excuse.  Short comment on ketamine is that imbalance.  When interpreting public health, not placing in Schedule I but any other schedule will limit accessibility — already against access to essential medications.  Yes, we know about non-medical use and we know all about possibilities and diversion and party drugs, and they may have some harmful effects, but if we compare harm non-medical use and compare to harm for placing on schedule cannot be compared.  Rational evidence based arguments.  Important for us to convince.

Willem Scholten, D. Pharm Independent Consultant Presentation on ATOME.  We had 10 partner organisations from 6 countries and WHO — some working on PC.  Some working in harm reduction, some in law and health policy.  Organisations could bring on their staff and we had the workforce we needed. 

Main content of project is shown in Work Package slide.  Country involvement.  Legislation review.  Each country had one legal officer from MoH — Trained in a 2 day workshop in Bucharest.  To familiarise themselves with barriers identified in the literature and what type of legislation to look for.

Policy review.  representatives from the government, like MoH, substance control office, health care inspectorate. Representatives from health care, like oncologists, palliative care, pharmacists.  Ideally 3 plus 3.  Lowest was two.

Policy guidelines.  Was translated in languages of most European countries.   

Overly restrictive laws often did not prevent abuse, dependence and diversion but created a barrier for medical access.
Medical education

Guidelines based on principle of balance.  Obligation of governments to establish a system of drug control that ensures the adequate availability fo controlled substances for medical and scientific purposes  while simultaneously preventing diversion and abuse and trafficking.  Derived from preambles of international drug control conventions for optimal public health.

21 Guidelines.  Content of drug control legislation and policy.  Different topics.  See
Legislation review looked at potential barriers.  Rules stricter than normal rules that poly to non-controlled medicinal products?  If yes, justification?  Necessary to prevent harmful use and divers?  If yes, proportional?  Often many more rules than treaties required.

9 categories.
9 barriers.  1. Prescribing, 2. Dispensing 3. Usage 4. Trade and distribution 5. See guidelines.

Policy reviews.  Process overview:
2 six country workshops — 6 participants per country,
National symposia – National and international speakers
Final report – Reviewed by country teams.  then reported back to plenary and included in final report.  A lot of input from country teams and people attending national symposium.  About 30 participants in smaller countries, and 75-80 in larger countries.  Also included patients — many giving their stories, some of which were heartbreaking.

A few recommendations.  

  • Address restrictions on prescribing
  • Decrease administrative burden — so much paperwork that it was a barrier
  • Remove the obligation for pharmacies to collect unused opioids for destruction
  • Ensure that patients in prison or patients living in remote areas can access controlled medicines.
  • Avoid language that stigmatises the medical use of opioids or reefs to patients with dependence in a disrespectful way.
  • Use of the word “drugs” — Same to refer to substances of misuse — if you want to promote access it is not very useful to say I want to improve access to medicine. 

Is it applicable to other countries.  Comprehensive model is effective.  Involve many stakeholders.  Announce regulations will be amended.  Follow up may be different from one country to another.

Presentation of Hospice Africa Uganda, Dr. Anne Merriman. See  
Problem of compassion in the world.  Countries need a heart transplant to ensure access to medicines.  We don’t want to promote Access to Opioids Medicines Africa (ATOMA) but ATOMW (To the World).  

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