INCB, WHO and UNODC statement on access to internationally controlled medicines during COVID-19

Scope (COVID-19 and non-COVID-19patients affected by the pandemic)

The International Narcotics Control Board (INCB), the WorldHealth Organization (WHO) and the United Nations Office on Drugs and Crime (UNODC)call on governments to ensure that the procurement and supply of controlledmedicines in countries meet the needs of patients, both those who have COVID-19and those who require internationally controlled medicines for other medicalconditions.

There is a need to ensure access to controlled medicines such assedatives and analgesics for intubation protocols for the treatment of patientswith COVID-19. Non-COVID patients continue to require controlled medicines forthe management of pain and palliative care, surgical care and anaesthesia,mental health and neurological conditions, and for the treatment of drug usedisorders.

It is important to remember the needs of existing patients whorequire controlled medicines for the management of these health conditions.These patients faced barriers to accessing controlled medicines before theCOVID-19 pandemic. The COVID-19 pandemic has further resulted in interruptionsof the medicines supply chain, and it is critical that access to essentialhealth services and medications not be forgotten or de-prioritised during thispandemic.

Need for equitable access

As the pandemic increasingly affects countries withunder-resourced health infrastructure and services, it is an ethical imperativeto ensure that all people in all countries of the world are able to accessessential medicines. This includes those medicines that are under internationalcontrol.

Governments should ensure that sufficient quantities ofinternationally controlled medicines, of assured quality, are available andaffordable to people under medical care.   Throughout the duration of thepandemic and beyond the acute phase of burden on the healthcare infrastructure,it is critical that governments work cooperatively to ensure that no country,no region, no district, no city and no patient is left behind. Competentnational authorities, manufacturers, suppliers and distributors play a crucialrole in ensuring that internationally controlled medicines urgently needed formedical treatment are available within and across national borders.   Thesupply chain is the foundation of quality medical care because without thenecessary supplies, including essential controlled medicines, patients willsuffer.

Solutions to address barriers

Governments are reminded that in acute emergencies, it ispossible under the International Drug Control Conventions to utilize simplifiedcontrol procedures for the export, transportation and supply of medicinalproducts containing controlled substances, especially in those cases where thecompetent authorities in the importing countries may not be operating at fullcapacity. Competent national authorities may permit the export of medicinescontaining narcotic drugs and/or psychotropic substances to affected areas evenin the absence of the corresponding import authorizations and/or estimates.Urgent deliveries do not need to be included in the estimates of the receivingcountries affected by emergencies. When possible, competent nationalauthorities are also encouraged to issue electronic import and exportauthorizations through the INCB International Import and Export AuthorizationSystem (I2ES), PEN Online and share related contingency measures in the forumtherein.

Countries should ease COVID-19 related transport restrictionsfor controlled medicines and consider local production solutions when feasible,to meet the COVID-19 driven demand spikes.

To assist countries as they work to find solutions to the lackof access and availability of controlled medicines, the three organizations suggestthe following technical assistance and support documents:

• Countries     are encouraged to refer to the Guide on Estimating Requirements for     Substances under International Control developed by the International     Narcotics Control Board and the World Health Organization for use by     Competent National Authorities.

• Countries     are encouraged to refer to WHO’s toolkit on the clinical care of severe     acute respiratory infections, which includes guidance on the use of     controlled medicines for the treatment of COVID-19 patients.

• Countries     are further advised to utilize WHO’s operational guidance for maintaining     essential services during an outbreak to balance the demands of responding     to the COVID-19 pandemic whilst simultaneously ensuring that essential     health services and provision of medication for other ongoing medical     conditions are maintained.

• Countries     are encouraged to refer to normative guidance such as the WHO List of     Essential Medicines and guidelines for the pharmacological and     radiotherapeutic management of cancer pain in adults and adolescents.

• Countries     are further advised to refer to and utilize the strategies presented in     UNODC’s Technical Guidance: Increasing Access and Availability of     Controlled Medicines developed in collaboration with experts, civil     society partners and other international partners.

• Under     the UNODC-WHO-UICC Joint Global Program, countries are encouraged to reach     out to UNODC and WHO for technical assistance and support at the national     level that also involves civil society partners.

Conclusions

The work of doctors, nurses, and health care professionals ingeneral, who provide treatment and care to people including the mostvulnerable, needs to be supported and safe and effective medicines should beavailable, accessible and affordable at all times for people who need them.

INCB, WHO and UNODC are committed to continue to work togetherto address this critical issue and will expand joint efforts to engage withother partners and increase advocacy and technical assistance to countries forimproving access to controlled medicines during the COVID-19 pandemic andmitigate barriers to ensure that both patients affected by COVID-19 or by othernon-COVID-related conditions requiring medicines under international controlhave access to these medicines when they need them.