In 2014 the Joint Ministerial Statement of the high-level review by the Commission of the implementation by Member States of the 2009 Political Declaration and Plan of Action: (…) called for “continued cooperation between Member States, the International Narcotics Control Board and the World Health Organization to ensure the adequate availability of narcotic drugs and psychotropic substances under international control, including opiates, for medical and scientific purposes, while concurrently preventing their diversion into illicit channels, pursuant to the international drug control conventions, and to provide recommendations on the scheduling of substances”;
- Access to controlled medicines
WHO estimates that 5.5 billion people (83% of the world’s population) live in countries with low or non-existent access to controlled medicines for the treatment, for example, of moderate-to-severe pain (5). Each year in these countries tens of millions of patients do not have access to adequate treatment – including an estimated 1 million people with advanced HIV disease, 5.5 million terminal cancer patients, 0.8 million patients suffering injuries caused by accidents and violence, patients recovering from surgery, women in labour (110 million births each year) and paediatric patients with painful conditions.
- Access to controlled medicines
Equally, despite strong evidence of efficacy (6), treatment of opioid dependence with long-acting opioids – known as opioid maintenance therapy (OMT)1 – is frequently unavailable. To ensure the availability and appropriate use of controlled medicines, WHO recommends that governments should enable and empower health-care professionals to prescribe, dispense and administer them in keeping with WHO policy and treatment guidelines, according to the individual medical needs of patients, and ensuring that a sufficient supply is available to meet those needs. While misuse of controlled substances poses a risk to society, the system of control is intended neither to be a barrier to availability for medical and scientific purposes nor to interfere with their legitimate medical use for patient care. WHO provides guidance and support to countries to assist them in achieving balance in national policies on controlled substances and in ensuring availability and accessibility of controlled medicines.
- Access to controlled medicines
WHO is one of the four treaty bodies to the international drug control conventions. The ultimate goal of the Single Convention on Narcotic Drugs, 1961, as amended by the 1972 Protocol, and the Convention on Psychotropic Substances, 1971, is to protect the health and welfare of humankind. Parties to the conventions consider that “co-ordinated and universal action” is required. (…)
- Access to controlled medicines
Implementation of the conventions should aim to fulfil the “dual obligation of governments to establish a system of control that ensures the adequate availability of controlled substances for medical and scientific purposes, while simultaneously preventing abuse, diversion and trafficking”
- Access to controlled medicines
WHO is the only treaty body with a mandate to carry out medical and scientific assessment of substances. According to the Convention on Psychotropic Substances (Article 2, paragraph 5), the CND, taking into account the information received from WHO “whose assessment shall be determinative as to medical and scientific matters, and bearing in mind the economic, social, legal, administrative and other factors it may consider relevant” makes a scheduling decision with regard to the substance. The official commentary to the Single Convention on Narcotic Drugs states that the CND should in principle accept the pharmacological and chemical findings of WHO and should be guided by other considerations such as those of an administrative or social nature when it does not follow WHO’s advice.
- Access to controlled medicines
Through the Expert Committee, WHO has reviewed more than 400 substances since 1949. Between 1948, when WHO was established, and 1999 the number of narcotic drugs under international control increased from 18 to 118, and the number of psychotropic substances from 32 to 111. (…)
- Access to controlled medicines
The Organization views drug control measures as means to protect the health and welfare of humankind, as required by the preambles to the conventions, and works towards improving access to controlled medicines for medical and scientific needs in line with the objectives of the conventions.
- Access to controlled medicines
Controlling psychoactive substances and giving patients access to essential medicines which are under international control is a balancing act. In 2005 the World Health Assembly adopted resolution WHA 58.22 on cancer prevention and control. Subsequently WHO, together with the INCB, assessed the feasibility and relevance of a programme to assist countries in improving access to controlled medicines. As a result, WHO established the Access to Controlled Medicines Programme (ACMP). Through the ACMP, WHO promotes access to medicines under international control and supports countries in making their drug control policies balanced, on the basis of the principle that policies should facilitate access to needed medicines while preventing nonmedical use and the diversion of controlled substances. WHO policy guidance on ensuring such balance provides numerous possibilities for improving patient access without increasing risks of nonmedical or harmful use.
- Access to controlled medicines
The WHO Model Lists of Essential Medicines are regularly updated using an evidence-based selection approach. The Model Lists serve as a basis for the development and review of national essential medicines lists by countries. At the last review of the WHO Model Lists, an evidence-based approach was used to create special sections on pain management, treatment of mental and neurological disorders and management of substance dependence, including the use of controlled medicines. Effective selection of essential medicines is important for achieving improved access to medicines.
- Access to controlled medicines
In May 2014, the Sixty-seventh World Health Assembly adopted resolution WHA67.19 on “Strengthening of palliative care as a component of comprehensive care throughout the life course”. This provides strong support to WHO’s work at global and country levels for improving access to, and use of, medicines for palliative care.
- Access to controlled medicines
As part of its normative role, WHO is developing policy and treatment guidelines for pain management. The Organization assists countries to improve access to controlled medicines, including through review of legislation and policies and through assessing and addressing barriers to the accessibility of these medicines. WHO is also part of a multi-partner project on Access to Opioid Medications in Europe (ATOME) (2009–2014), funded by the European Commission and conducted in 12 European countries.
- Access to controlled medicines
WHO, the Union for International Cancer Control (UICC) and UNODC are carrying out a joint global programme on access to controlled drugs for medical purposes with the objective of coordinating a worldwide response by Member States to improving policies and procedures on access to controlled medicines, particularly pain medication, for medical purposes. Activities have begun in selected countries. WHO is also collaborating with UNODC on revision of the Model Laws – in particular in relation to access to controlled drugs for medical purposes.
- Access to controlled medicines