E/INCB/1999/1 I. Freedom from pain and suffering A. Ensuring an adequate supply of controlled Convention. In discharging its functions, the Board has drugs for medical purposes: a principal regularly monitored the status of national compliance with objective of the international drug control the international drug control treaties and the functioning of treaties the treaty system. In 1994, the Board reviewed the operation and effectiveness of the three main international drug control treaties and highlighted in its report the principal areas where the treaty provisions had not been wholly effective or adequate.6 Among the identified shortcomings was the fact 1. The principal objective of the Single Convention on 1 that the treaty objective of ensuring an adequate supply of Narcotic Drugs of 1961 and previous international con- narcotic drugs, especially opiates used for medical purposes, ventions to limit the use of narcotic drugs to legitimate had not been universally achieved.7 The Board suggested medical and scientific purposes reflects the consensus specific remedial measures at the national and international among all Governments that the medical use of narcotic levels. At the same time, the Board voiced its concern over drugs continues to be indispensable for the relief of pain and the easy availability of psychotropic substances, in particular suffering and that adequate provision must be made to ensure 2 their indiscriminate and excessive use in many countries and the availability of narcotic drugs for such purposes. Guided their diversion into illicit channels as a result of inadequate by a similar principle, States recognized in the Convention control measures. on Psychotropic Substances of 1971 that the availability of psychotropic substances for medical and scientific purposes 3 should not be unduly restricted. Adequate availability and limitation were considered by the States parties to the 1961 B. Progress and constraints Convention and the 1971 Convention as two complementary, not mutually exclusive, aims and were thus incorporated in the control provisions of those conventions. In adopting such aims, Governments were motivated by two complementary humanitarian considerations, namely the The significance of controlled drugs in alleviating need to provide optimal help and relief for pain and suffering pain and suffering and the need to protect the individual and society from drug dependence and its detrimental consequences.4 4. During the past few decades, significant progress has 2. Success in this endeavour depends to a large extent on been made in health care throughout the world. The avail- the degree to which those aims are understood, accepted, ability of increasingly effective and safe therapeutic agents supported and implemented by Governments, by the has played a large role in this process. Pharmaceutical professionals involved in the complex task of operating a research and industrial manufacture have led to the discovery national licit drug supply system and, ultimately, by the and commercialization of many new psychoactive general public. In developing and implementing national medicines. A better understanding of the working mecha- drug control laws and regulations, it is particularly important nisms of the human body has enabled many new derivatives to maintain an optimal balance between restriction and of already known drugs or entirely new types with even facilitation efforts. higher specificity, efficacy and safety to become important tools of modern medicine. Older and less effective drugs 3. Pursuant to article 9 of the Single Convention on with lower benefit-risk margins have, in turn, gradually lost Narcotic Drugs as amended by the 1972 Protocol,5 the their therapeutic significance. Narcotic drugs and psycho- International Narcotics Control Board endeavours to limit tropic substances used in medicine are no exception. the cultivation, production, manufacture and use of drugs to an adequate amount required for medical and scientific 5. Virtually all new narcotic drugs and psychotropic purposes and to ensure their availability for such purposes substances with accepted medical use represented progress and facilitates national action to attain the aims of that in therapy at the time that they were introduced; however, their dependence potential became apparent during their 1 E/INCB/1999/1 large-scale therapeutic use. Thus, there was a need for spe- and actual use. After a few decades, that process led to a cific administrative restrictions regarding their manufacture, number of changes in each category of controlled drugs with trade and medical use. Growing concern over their abuse medical use. potential led to a reassessment of their therapeutic usefulness 6. Most semi-synthetic and synthetic opioids8 under past 20-30 years, mostly in developed countries, document international control today were developed before the the fact that such conditions affect large segments of society. adoption of the 1961 Convention. It was originally hoped that the therapeutic qualities of morphine could be improved 9. According to WHO projections, two thirds of the by separating its desirable (central analgesic, estimated 15 million new cancer cases per year will occur in cough-suppressant, anti-diarrhoeal) effects from its unde- developing countries by the year 2015. Some 70-80 per cent sirable (addictive) properties. Unfortunately, that goal has of cancer patients suffer severe pain, whether acute or not been achieved to date; consequently, several opioids chronic, in the late stages of the disease. There is broad initially welcomed as safer alternatives to older drugs have consensus today that, for the treatment of severe pain related failed to live up to expectations. Some opioids, primarily to cancer, opioids, above all morphine, are indispensable due morphine and codeine, have not only been essential thera- to their affordability and analgesic efficacy. peutic tools with a range of applications for more than 100 years, but have also gained in importance in recent times. Both codeine and morphine have been on the Model Progress List of Essential Drugs of the World Health Organization (WHO) since 1977, when the list was first published, and morphine is among the drugs proposed by WHO for the New 10. There has been notable progress in achieving the aims Emergency Health Kit 1998. of the international drug control treaties, including the provision of narcotic drugs and psychotropic substances for 7. Expansion and diversification of the licit opioid medical purposes. The ever-increasing variety of new market have been somewhat slow during the past 20 years; therapeutic agents and the multitude of preparations on the there has been a relatively small increase in the number of global pharmaceutical market offer health-care professionals scheduled narcotic drugs used for licit purposes. Global licit and patients alike a growing number of treatment options. opioid consumption has therefore continued to grow slowly, Such new medicines can make the relief of human pain and the total volume reaching approximately 240 tons in suffering more universally available and qualitatively better; morphine equivalent in 1999.9 This is because the demand however, they may also offer new opportunities for misuse. for pure opium alkaloids, mainly morphine and codeine, has increased slowly while the consumption of raw opium, its 11. Governments have placed substantial groups of concentrates and opium tincture has gradually decreased. psychoactive substances, currently marketed and used as Codeine is now the most widely used natural opioid; it is medicines, under international control because of their used as a cough suppressant and as an analgesic. Its average recognized abuse and dependence potential and the risk that annual consumption has been around 170 tons in recent they may pose to public health; that should be acknowledged years, representing about 75 per cent of total opiate as a significant achievement. Thus, the scope of international consumption. Between 1978 and 1998, global codeine drug control, especially the control of psychotropic consumption rose at an annual rate of only about 1-2 per substances, has expanded considerably since the 1971 cent. Global consumption of morphine for medical purposes Convention entered into force. The scope of control under was relatively low and stable for many years before 1984, the 1961 Convention has evolved much more slowly, when it amounted to about 2.2 tons, but since then it has risen reflecting both the more comprehensive initial coverage of almost tenfold. Other semi-synthetic or synthetic opioids that Convention and the slower development of the with significant or increasing consumption levels are pharmaceutical opioid market. buprenorphine, hydrocodone, hydromorphone, oxycodone and fentanyl. 12. The voluntary implementation of certain regulatory and reporting provisions by many Governments has been a 8. In the absence of cross-national comparative data, it is welcome development. The Commission on Narcotic Drugs, difficult to arrive at valid estimates of the aggregate number in its resolution 7 (XXXIX), endorsed the position of the of people on a global scale affected by any health problem Board that the distribution of narcotic drugs and requiring treatment with a narcotic drug or psychotropic psychotropic substances needed for humanitarian aid in substance. Although pain and suffering are difficult to assess acute emergencies justified the application of simplified