Bulletin of the World Health Organization

Do national drug control laws ensure the availability of opioids for medical and scientific purposes?

S Asra Husain a, Marty Skemp Brown a & Martha A Maurer a

a. WHO Collaborating Center for Pain Policy and Palliative Care, Pain and Policy Studies Group, University of Wisconsin, 1300 University Avenue, 6152 MSC, Madison, WI 53706, United States of America.

Correspondence to S Asra Husain (e-mail: ahusain@uwcarbone.wisc.edu).

(Submitted: 14 March 2013 – Revised version received: 26 September 2013 – Accepted: 27 September 2013 – Published online: 26 November 2013.)

Bulletin of the World Health Organization 2014;92:108-116. doi: http://dx.doi.org/10.2471/BLT.13.121558

Introduction

In a report to the United Nations, the International Narcotics Control Board (INCB) stated: “One of the fundamental objectives of the international drug control treaties is to ensure the availability of narcotic drugs and psychotropic substances for medical and scientific purposes and to promote the rational use of narcotic drugs and psychotropic substances.”1 Countries that signed the 1961 Single Convention on Narcotic Drugs as Amended by the 1972 Protocol, hereafter referred to as the Single Convention, are expected to abide by the Convention’s provisions on the control of certain drugs while ensuring that these drugs are available for medical purposes. The Single Convention established a medicolegal principle of balance: governments have a dual obligation to prevent the diversion and abuse of narcotic drugs and to ensure adequate provision of opioid analgesics for legitimate medical and scientific purposes.2 In this paper, we use the word “balance” in the way it is used by international organizations, such as the United Nations Economic and Social Council, the INCB,3 the World Health Organization (WHO)2 and the Commission on Narcotic Drugs.4 Drug availability is ensured most effectively in the context of balance and drug control is achieved most effectively when carried out with availability in mind. Table 1 lists the principal measures proposed by the Single Convention to ensure the availability and control of Schedule I drugs in situations in which a closed drug control system has been established to give a government authority over other involved parties, thus preventing the diversion and nonmedical use of these substances. Schedule I drugs belong to one of four schedules of drugs classified by the Single Convention according to their potential for abuse and medical value. These drugs are recognized as being essential for medical and scientific purposes but, since they are also the most susceptible to abuse, are subject to the most stringent control of all medical drugs. Drugs may be added to Schedule I by the Commission on Narcotic Drugs on the recommendation of WHO if they have the same potential for abuse as other drugs on the schedule.5

“One of the fundamental objectives of the international drug control treaties is to ensure the availability of narcotic drugs and psychotropic substances for medical and scientific purposes and to promote the rational use of narcotic drugs and psychotropic substances.”1

“One of the fundamental objectives of the international drug control treaties is to ensure the availability of narcotic drugs and psychotropic substances for medical and scientific purposes and to promote the rational use of narcotic drugs and psychotropic substances.”1

WHO has estimated that tens of millions of people worldwide experience pain associated with late-stage cancer, acquired immunodeficiency syndrome (AIDS) and other painful diseases and conditions.6 However, despite WHO’s long-standing designation of morphine as an essential medicine for the relief of pain, much of the world still does not have access to this drug or to other opioid medications commonly used for the treatment of pain and dependence syndrome,3 such as hydromorphone, fentanyl, morphine, methadone and oxycodone. Moreover, WHO estimates that over 80% of the world’s population lives in countries with little or no access to controlled opioid analgesics.68 Indeed, most patients in developing countries with cancer, AIDS and other painful conditions are not treated with opioid medicines because access to these controlled drugs is severely restricted.3,7,9,10 According to United Nations’ bodies, there are a number of reasons for the poor availability of, or limited access to, essential opioid medicines, such as concerns about patients developing dependence, insufficient training for health-care professionals and problems with procurement, manufacture and distribution.2,3,11,12 In addition, the availability of these substances for medical use has also been severely limited by administrative requirements that are much stricter than the control measures proposed by the Single Convention (i.e. “regulatory impediments”, Box 1).3,20

Box 1. Examples of regulatory impediments to the availability of Schedule I drugsa for medical and scientific purposes

  • inadequate national drug availability policy
  • limits on the amount of a drug that can be prescribed13
  • limits on the maximum drug dose14
  • short time limits on the validity of prescriptions15
  • prescription of opioids limited to specialists16,17
  • opioid prescriptions permitted for certain diagnoses only17
  • barriers to obtaining official prescription forms18
  • unreasonably severe penalties for inadequate record-keeping19
  • restrictions on prescribing practices that may seem contrary to medical indications but that may be legitimate19

a Schedule I drugs, such as opioids, cannabinoids and cocaine, are defined in the Single Convention on Narcotic Drugs.

In 2009, the Pain and Policy Studies Group at the University of Wisconsin in the United States of America examined the model law, model drug regulation and model drug abuse bill proposed by the United Nations Office on Drugs and Crime (UNODC) – the body responsible for preparing national model legislation and regulations – to determine whether these models provide governments with language they can use to implement their obligations under the Single Convention. The Group found that these model instruments did not reflect all the requirements of the Single Convention.21 Table 2 compares UNODC model legislation provisions with measures proposed by the Single Convention. Overall, the Group concluded that the UNODC models do not establish an obligation on national governments to ensure the availability of opioid drugs for medical use. In fact, the control recommended by these models is excessively stringent.

Despite their stated intent, UNODC model laws do not provide a framework for ensuring medication availability, as implied by the Single Convention. What is more, implementation of UNODC model legislation is likely to result in unbalanced national regulation of narcotic drugs, which may lead to limited availability of opioids for medical use.25 An increasing number of experts now recognize that governments are not taking measures to ensure the adequate provision of opioid drugs and it is, therefore, an opportune time to assess the extent to which countries’ laws reflect the need for balanced drug control laws encapsulated in the Single Convention.26 The aim of this study was to examine a sample of national drug control laws to determine whether they contain provisions ensuring that opioid drugs are available for medical and scientific purposes.

Methods

This pilot study involved a convenience sample of laws from 15 countries. Countries were selected on the basis of our experience and contacts and because their drug laws were available in English. Four policy evaluation criteria were developed in consultation with the Center for Health Law, Policy and Practice at the Temple University Beasley School of Law in the United States. Previous Pain and Policy Studies Group analyses emphasized that evaluations of policy and legislation should have a clear rational basis that is derived from authoritative sources.27,28 Consequently, the criteria we developed used the plain language of the Single Convention and were based on interpretations of the Convention and recommendations made by competent international authorities, such as this statement from a report by the INCB:

“Governments should determine whether their national laws include elements of the 1961 Convention and the 1972 Protocol that take into account the fact that the medical use of narcotic drugs continues to be indispensable for the relief of pain and suffering and the fact that adequate provision must be made to ensure the availability of narcotic drugs for such purposes and to ensure that administrative responsibility has been established…”20

“Governments should determine whether their national laws include elements of the 1961 Convention and the 1972 Protocol that take into account the fact that the medical use of narcotic drugs continues to be indispensable for the relief of pain and suffering and the fact that adequate provision must be made to ensure the availability of narcotic drugs for such purposes and to ensure that administrative responsibility has been established…”20

Our four criteria concern: (i) recognition that the medical use of opioid drugs is indispensable for the relief of pain and suffering; (ii) government responsibility for ensuring adequate provision of opioid drugs for medical and scientific purposes; (iii) designation of a special administrative body with responsibility for implementing international drug control conventions; and (iv) a government’s intention to implement international drug control conventions, including the Single Convention (Table 3). The first three criteria directly reflect relevant objectives within the Single Convention, whereas the fourth relates to whether or not a country’s laws express the intention to conform to the provisions of the Single Convention.

Several members of the Pain and Policy Studies Group with experience in evaluating legislation reviewed each national law. We evaluated only statutory drug control legislation that had been adopted by the country’s law-making body and which was currently in force. We excluded sections relating to drug classification, scheduling or penalties as well as commentaries and footnotes. For inclusion in this evaluation, a provision had either to use wording that was substantially the same as that used in the criterion or to express clearly the main intent of the criterion.

Results

Table 4 lists the policy evaluation criteria that were fulfilled by the laws of each of the 15 countries. Two of the 15 countries (13%) had a drug control law that recognized that the medical use of opioid drugs continues to be indispensable for the relief of pain and suffering. Australia is unique because its drug control law includes the entire Single Convention verbatim.31 Consequently, the term “indispensable” appears just as it does in the preamble to the Single Convention. In the United States, the term “indispensable” does not appear but the preamble to the Controlled Substances Act states:

“The Congress makes the following findings and declarations: (1) Many of the drugs included within this subchapter have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people.”32

“The Congress makes the following findings and declarations: (1) Many of the drugs included within this subchapter have a useful and legitimate medical purpose and are necessary to maintain the health and general welfare of the American people.”32

Three countries (20%) had a drug control law that established the government’s responsibility for ensuring adequate provision of opioid drugs for medical and scientific purposes: Australia, Georgia and Uganda. The national drug control law in Uganda clearly states:

“A Statute to establish a National Drug Policy and a National Drug Authority to ensure the availability, at all times, of essential, efficacious and cost-effective drugs to the entire population of Uganda, as a means of providing satisfactory health care and safe-guarding the appropriate use of drugs.”33

“A Statute to establish a National Drug Policy and a National Drug Authority to ensure the availability, at all times, of essential, efficacious and cost-effective drugs to the entire population of Uganda, as a means of providing satisfactory health care and safe-guarding the appropriate use of drugs.”33

Five of the 15 (33%) national drug control laws acknowledged that government had an administrative responsibility for implementing international drug control conventions. India’s law, which states that “the International Conventions” include the Single Convention, is an example:

“Chapter II Authorities and Officers...the measures which the Central Government may take...include...(b) obligations under the International Conventions.”34

“Chapter II Authorities and Officers...the measures which the Central Government may take...include...(b) obligations under the International Conventions.”34

National drug control laws in 7 of the 15 countries (47%) specifically acknowledged that the government intends to implement international drug control conventions. As noted above, Australia clearly accepted its obligations under the Single Convention. In addition, the law in Uganda states:

“The National Drug Policy shall be… (h) to comply with the international regulations on drugs including the conventions on Narcotic Drugs and Psychotropic Substances under International Control…”33

“The National Drug Policy shall be… (h) to comply with the international regulations on drugs including the conventions on Narcotic Drugs and Psychotropic Substances under International Control…”33

In the United States, the Controlled Substances Act fulfils this last criterion by acknowledging that the country accepts the Single Convention:

“The United States is a party to the Single Convention on Narcotic Drugs, 1961, and other international conventions designed to establish effective control over international and domestic traffic in controlled substances.”35

“The United States is a party to the Single Convention on Narcotic Drugs, 1961, and other international conventions designed to establish effective control over international and domestic traffic in controlled substances.”35

The other countries whose laws met the last criterion were Armenia, India, Serbia and Viet Nam. Often the language used in legislation was unclear. In Viet Nam, for example, the relevant statute mentioned drug control conventions without specifically naming the Single Convention.

Discussion

Once ratified by national governments and incorporated into national law, treaties such as the Single Convention gain substantial legal force.36 To date, 184 countries have ratified the Single Convention.37 The results of this pilot study support the conclusions of the INCB and WHO that there is a need for more balanced model and national laws on drug control and availability. Although the Single Convention and interpretations of the Convention made by competent international authorities are clear about national governments’ obligation to ensure that opioid drugs are available for medical and scientific purposes, balanced legal provisions were scarce among national laws. Less than half the countries we studied had laws that acknowledged an intention to implement international drug control conventions. Even fewer acknowledged responsibility for ensuring drug availability. Several countries had laws that seemed to reflect the balanced intent of the Single Convention but placed no obligation on government to ensure that drug availability and control measures were balanced. Without laws that ensure the availability of controlled medicines, countries may not have a balanced drug control policy that can guide the actions of agencies that control drugs and satisfy the expectations of patients and caregivers.

Among the few national laws that did fulfil Single Convention criteria on drug availability, there was little uniformity in the language used or the intent expressed, which underlines the need for appropriate legislative models on balancing drug availability and control. It is likely that a systematic evaluation of laws and regulations from around the world would uncover similar impediments to drug availability. The Pain and Policy Studies Group is currently developing criteria that can be used to perform a more complete assessment of national laws. One aim is to provide guidance to governments on how to align national policies with the balanced approach to drug availability and control implicit in the Single Convention, thereby helping ensure adequate opioid availability.

Even though a country may have ratified the Single Convention, the absence of legislation establishing the government’s responsibility for ensuring drug availability means that health professionals may find it difficult to convince government agencies that drugs should be made available for medical needs, especially if government officials believe that, for example, pain medicine should be strictly controlled. In contrast, drugs are readily available in some countries without clear legislative authority. Many government representatives do accept the need for balanced legislation on drug availability and control and have pursued this objective in national workshops and United Nations meetings.38,39 However, other government representatives are more familiar with drug control, which has sometimes prompted resistance to balanced legislation. Encouragingly, once governments become aware of WHO and INCB recommendations on improving drug availability, change can, and often does, take place (EL Krakauer, personal communication, 2013). Recently, United Nations drug control bodies have been examining the need for model policies and national drug control laws that deal with both preventing the diversion and abuse of controlled medicines and ensuring the availability of these medicines for medical and scientific purposes. With the passage of Resolutions 53/4 and 54/6 by the Commission on Narcotic Drugs in 2010 and 2011, respectively,4,40 and with the drafting of a document on ensuring drug availability, UNODC has an opportunity to become a central force in establishing balanced legislation in this area. Resolution 53/4 on drug availability encourages Member States to work with the INCB and UNODC to “update policies and legislative frameworks, as appropriate, to ensure adequate availability of internationally controlled substances”40 in addition to preventing diversion and abuse. Resolution 54/6 provides similar encouragement and requests UNODC to create a technical guide to help Member States incorporate model legislation into their own national laws. The Commission on Narcotic Drugs also supported the INCB’s call for Member States, as a priority, to promote the availability, accessibility and rational use of drugs for medical purposes4 and to identify impediments to opioid availability and access for pain relief, as recommended by WHO.2,12

This pilot study has a number of limitations. Regulations and other administrative decrees were not evaluated. However, ordinarily these policies implement statutory laws and neither exceed nor broaden them. Although achieving a balance between opioid drug availability and control is arguably a goal of the Single Convention, it is an implied goal since the Convention does not use the term. However, bodies with the authority to interpret the Single Convention have repeatedly discussed the need for balance. The study did not aim to identify provisions in national laws that were overly restrictive (i.e. regulatory impediments), though knowledge of these provisions is essential for obtaining a complete picture of all factors affecting drug control and availability. Moreover, we did not investigate how model and national laws were developed, reviewed, approved or promulgated. Hence, we are unable to explain why they appear so unbalanced. Finally, although a country’s laws may have satisfied our four study criteria, there is no guarantee that opioids will be available for medical purposes in sufficient quantities. Actions must also be taken to improve access to medications within the health-care system, for example, through national workshops, physician training and public education.

The findings of our analysis of national legislation can be used by countries to adjust their laws to ensure they fully embrace the Single Convention’s goals of preventing the diversion and abuse of opioid drugs while ensuring their availability for medical and scientific purposes. In particular, government ministers and their staff can assess their own national laws using the criteria proposed in this study and can ask UNODC to provide model laws that would help increase drug availability.

The study’s findings also indicate directions for additional policy research, such as determining whether the Single Convention’s provisions on drug availability have been applied in a larger sample of national legislation, regulations and administrative policies. Another area of inquiry is to investigate the extent to which governments are able to manage policies and systems that prevent the diversion and abuse of controlled medicines without interfering with their availability for medical purposes. The results would provide the evidence needed for guiding the assessment, planning and systematic improvement of drug control and availability policies and for consolidating our understanding of how such policies affect medication availability and patient care. Research could also be carried out on why United Nations’ guidance on ensuring drug availability has not been accessible to governments until recently, whereas guidance on the strict control of drugs has been thoroughly investigated. In addition, it would be useful to understand why ensuring the adequate availability of narcotic drugs was included in the preamble to the Single Convention after it was amended by the 1972 Protocol but was not mentioned in the original version of the Convention.

The limited availability of opioid medications combined with the increasing number of people with cancer and other noncommunicable diseases has widened the gap between the amount of medication available for the relief of pain and suffering and the amount needed.30,41,42 United Nations’ bodies and civil society have expressed deep concerns about this gap. However, the necessary progress cannot be achieved within the current weak and contradictory international drug control policy framework. There is an urgent need to reform United Nations’ model drug legislation. This would require the INCB and UNODC to expand their work with governments for a number of years in order to increase drug availability within the constraints of existing drug control policies.4 Otherwise, generations of patients may continue to suffer.

We propose a number of goals for revised model drug legislation. First, revised model legislation should carefully follow international drug control conventions and should provide specific language that governments can use in updating relevant laws and regulations while bearing in mind the need to adapt legislation to national conditions. Second, new model drug legislation should offer commentaries on the purpose of the legislation, the meaning of balancing control and availability, the obligation to ensure that drugs are available, safeguards for supply chains, the identification of unduly strict provisions and ways of estimating the amount of drugs needed for medical and scientific purposes. Finally, after a Member State has requested model drug legislation, the resulting national legislation should be developed collaboratively with the INCB, WHO and civil society, including individuals involved in health care, patient care and drug control. The adoption and promulgation of UNODC model laws, which are effective in establishing a balance between drug control and availability, can lead to a drug regulatory system that takes into account public health needs. However, without the commitment of governments to enact laws that ensure the drugs they control are available for medical purposes, it will be difficult to improve access for those with legitimate medical needs and set-backs are likely.


Acknowledgements

The authors would like to thank Zipporah Ali, Snezana Bosnjak, Rosa Buitrago, Scott Burris, Liliana DeLima, Eva Duarte, Pati Dzotsenidze, Verna Edwards, David E Joranson, Irina Kazaryan, Eric Krakauer, Marta Leon, Jonathan Liberman, Gabriel Madiye, Bishnu Dutta Paudel, Nguyen Thi Phuong Cham and MR Rajagopal.

Funding:

The University of Wisconsin received support from the Open Society Foundations and the United Kingdom Department for International Development via a subcontract with Temple University.

Competing interests:

The University of Wisconsin Carbone Cancer Center received an unrestricted educational grant from Purdue Pharma in 2010 to support the work of the Pain and Policy Studies Group.

References

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