EU Statement on CND68 thematic session 5: “Low to Non-Existent Availability of Internationally Controlled Substances for Medical and Scientific Purposes in Many Parts of the World; Legal, Scientific, and Regulatory Challenges in Scheduling Substances”

Distinguished Chair, Excellencies, Ladies and Gentlemen,

I have the honour to speak on behalf of the European Union and its Member States. 

Albania, Bosnia and Herzegovina, Georgia, Iceland, Montenegro, North Macedonia, Norway, Republic of Moldova, and Ukraine align themselves with this statement.

We continue to attach great importance to ensuring access to and availability of internationally controlled substances for medical and scientific purposes while preventing their diversion. We underline the need to implement last year’s CND resolution 67/2, which was tabled by Belgium on behalf of the EU and by Ivory Coast with the aim of addressing the existing barriers and accelerating progress on access and availability, with particular attention to the needs of children[1]

As underlined in the latest INCB Annual Report 2024, there is still an insufficient availability of narcotic drugs and psychotropic substances for medical and scientific purposes in many countries, which needs to be addressed. The EU legal framework does not preclude the marketing authorisation of medicinal products based on controlled substances for medical purposes.[2] It remains crucial to improve the prescription and use of opioids and psychotropic substances for rational medical purposes, accompanied by targeted public policies on access and availability while preventing non-medical use and diversion to illicit markets.

These efforts should be supported by Governments and the international community, but also require active engagement and participation of other stakeholders, such as health-care professionals, the scientific community, academia, non-governmental organisations, civil society, and community-led organisations, which can all contribute to raising awareness and improving the acceptance and understanding of the rational use of controlled substances for medical and scientific purposes, as well as to promoting non-stigmatising attitudes towards such use, including for children. 

Another aspect underlined by the INCB is the availability of controlled substances for the treatment of opioid use disorder by ensuring that people suffering from such disorder have easy access to opioid agonist therapy and substances such as methadone and buprenorphine. Globally, it is estimated that only 10 per cent of people living with opioid use disorder have access to opioid agonist therapy. According to the European Drug Report 2025, an estimated half a million clients received opioid agonist treatment in the EU in 2023. There is an uneven coverage among the EU Member States, and in some it is below levels recommended by the WHO, and therefore further efforts are required to enhance access to therapy. Minimising barriers of entry into treatment is also important; including bureaucratic, legal and financial barriers and stigma-related obstacles.

Making available or expanding sufficient access to opioid antagonist treatment and related supports, as well as needle and syringe programmes, as appropriate in line with national legal frameworks is particularly important to improve preparedness to the appearance of highly potent substances and increased polysubstance use as well as related negative health and social consequences. Providing sufficient access to opioid antagonists, such as naloxone contributes to preventing overdose deaths.

As highlighted by the INCB, the rational use of psychotropic substances to address mental health conditions while preventing misuse is also essential. It is important that medical practitioners and other healthcare providers have the necessary tools to improve the rational prescribing, use and monitoring of psychotropic substances.

Last, the availability of controlled substances and the provision of medical care during humanitarian emergencies caused by armed conflict is one of the most pressing challenges faced by the international community. Therefore, the EU and its Member States underscore their grave concern for those populations that do not have adequate access to essential controlled medicines in emergency situations caused by natural disasters and armed conflicts, such as the Russian aggression against Ukraine.

Mr. Chair,

Despite all efforts and commitments, a significant imbalance globally in the access to and availability of controlled substances persists. In line with the EU Drugs Strategy, we remain committed to promote and implement capacity building and awareness raising activities regarding access to and availability of controlled substances for medical and scientific purposes, and to make further efforts in enabling adequate medical use linked to the fundamental human right to health and medical care.

Thank you. 


 

[1] Resolution 67/2 „Promoting awareness-raising, education, training and data collection as part of a comprehensive approach to ensuring access to and the availability of controlled substances for medical and scientific purposes, including for the treatment of children, and ensuring their rational use”

[2] Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, OJ L 311, 28.11.2001, p. 67