Policymaking is a complex art of accessing, analyzing, and interpreting numerous information sources within the context of limited resources, social pressures, legal requirements, and narrow timeframes. Despite a growing recognition of the importance of evidence-based policymaking, evidence alone is not sufficient for complex decision-making processes and in many cases there is limited or insufficient evidence. In the case of medical cannabis use, policymakers are faced with a limited evidence base due to prohibitive national and international laws, and mounting social and political pressures to provide access to patients. As a growing majority of U.S. states adopt medical cannabis policies, there is a clear need to identify best practices in medical cannabis policymaking processes, as well as core elements of effective policies and intended outcomes to better evaluate health impacts. This study will utilize framework analysis, key informant interviews, content analysis, and discourse analysis to provide information on policymaking processes, core policy components, and intended outcomes. The findings from this study will be valuable as policymakers seek to improve current medical cannabis policies, or develop new policies. This research will be of additional value to policymakers seeking to develop policies in areas with high controversy and limited evidence.
Background & Significance
Medical cannabis has a long and contentious history in the United States. Cannabis is classified as a Schedule 1 narcotic under federal and international laws, yet despite this over half of U.S. states have enacted some form of medical cannabis policy. As of December 2014, 23 U.S. states have implemented comprehensive medical cannabis policies (see Figure 1), and an additional 11 states have implemented restricted access policies. These policies target a range of regulatory issues, including cultivation, sale, access, and consumption. Due to restrictive federal cannabis research policies, state policymakers have developed medical cannabis policies without the benefit of a wide evidence base, and in highly contentious settings with competing stakeholder interests. Despite these challenges, state policies continue to evolve, and more states are considering legislation to legalize medical cannabis use; yet there is little guidance on the best practices for developing policies, the key elements of effective medical cannabis policies, or evaluation of outcomes and unintended impacts.
Figure 1. U.S. states with comprehensive medical cannabis policies as of December 2014
Cultivated in the U.S. as early as the 17th century, cannabishas historically been used for a range of medicinal purposes (Bostwick, 2012). Included in the United States Pharmacopeia from 1850 to 1942 (Mack & Joy, 2001) as treatment for multiple medical diagnoses, the use of medical cannabis declined as newer pharmaceuticals were brought to market, and as increasing social, legal, and economic pressures impacted policy (Sznitman & Zolotov, 2014). During the 1920s cannabis use peaked concurrently with a wave of Mexican immigrants fleeing the Mexican Revolution. These phenomena became intricately linked in the American psyche, and as immigrant relations deteriorated during the Great Depression, so too did views on cannabis use (Musto, 1991). By the time Congress passed the Marihuana Tax Act of 1937 (which regulated sales through transfer taxes that the Federal government never issued), cannabis possession and sale had already been criminalized in every state, with the exception of medical use. Arguing against the 1937 act, the American Medical Association asserted that although medical use of cannabis had declined, there was a need to produce more evidence on preparation, use, and effectiveness for medical purposes (Taxation of Marihuana, 1937). In 1961 the U.S. joined 72 other United Nation member states on the Single Convention on Narcotic Drugs that targeted cultivation, possession, use, and distribution of drugs, and classified THC (the active psychotropic compound in cannabis) as a “Schedule I” substance (United Nations, 2013). With the passage of the Comprehensive Drug Abuse and Prevention and Control Act of 1970, cannabis was further classified as a “Schedule I” controlled substance by U.S. standards, stating that it has “no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse” (U.S. Department of Justice, 2014).
Despite international and federal laws, there is a growing body of evidence on the therapeutic effectiveness of cannabis as treatment for a range of medical conditions (Borgetl, Franson, Nussbaum, & Wang, 2013; Lynch & Campbell, 2011; Martín-Sánchez, Furukawa, Taylor, & Martin, 2009; Mochado Rocha, Stéfano, De Cássia Haiek, Rosa Oliveira, & Da Silveira, 2008). The Institutes of Medicine concluded that, “scientific data indicate the potential therapeutic value of cannabinoid drugs, primarily THC, for pain relief, control of nausea and vomiting, and appetite stimulation” (Joy, Watson, & Benson, 2003, p. 4). More evidence is still needed on effective delivery mechanisms, the role of specific chemical compounds within cannabis and their therapeutic advantages, as well as a clear understanding of potential harms.
A growing evidence base, coupled with changing social perspectives has necessitated that policymakers respond to calls for access to medical cannabis. In the absence of national reform, states have developed individual policies to regulate and tax medical cannabis, creating a patchwork of legalization, with disparate policy frameworks and regulatory guidelines. State medical cannabis policies differ in their qualifying medical conditions, mechanisms for dispensing cannabis, safety and quality standards, rules for production and sale, and legal protections for users and caregivers. It is important to note that prior to 2009, state policies operated under enforced federal prohibition. In 2009 the U.S. Department of Justice issued a memorandum to its State Attorneys instructing them to “not focus federal resources in your States on individuals whose actions are in clear and unambiguous compliance with existing state laws providing for the medical use of marijuana” (Ogden, 2009, p. 1-2). This guidance further opened the door for policymakers to pursue state regulations without fear of federal reprisal.
Research has focused on the health impacts and unintended consequences of cannabis policies; however, there is a need to better understand the processes involved in developing policies to achieve positive outcomes. As Hall (2009) asserts, medical evidence alone will not suffice in the development of policies with fundamental differences between stakeholders regarding goals and intention. As the base of medical evidence continues to grow, so too must the evidence on policymaking processes and outputs. As Sznitman, Olsson, and Room (2008) assert, “in the absence of formal studies, estimation of the impact of law and policies remains a matter for ‘expert knowledge’” (p. 130). Further, while there are numerous guides to ideal policymaking practices that highlight critical components, there is little information on the barriers within policymaking processes and strategies to overcome them (Singleton & Rubin, 2014). To better understand the relationship between medical cannabis policies and public health, and accurately measure the impact of policies, it is critical to first understand how these policies are developed, the challenges and strategies for success, their intended outcomes, and identify appropriate metrics for evaluation. The proposed study is essential to help inform the development of safe and effective medical cannabis policies, as well as to inform policymaking process in areas with high levels of controversy and limited evidence.
Research Topic & Aims
The research aims to provide a comparative analysis of the state medical cannabis regulatory models, and identify the processes utilized by policymakers to develop these policies, as well as identify the intended outcomes of the policies in order to evaluate the effectiveness of policies and ultimately determine best practices in the development of medical cannabis policy. The study will identify key aspects of medical cannabis policy, including policy assumptions, collaborators and opponents, information sources and pathways, processes to synthesize disparate information streams, results of these processes, and intended outcomes.
Aim 1: Provide a comparative content analysis of state medical cannabis policies
The comparative analysis of state medical cannabis policies will identify the types of policies, core components, legislative intent, and potential impacts. The resulting framework will provide a comprehensive guide to medical cannabis regulation in the U.S., and serve as a tool to assist policymakers and researchers in the modification of current policies, development of new policies, and evaluation of the policy impacts and effectiveness.
Research Question 1: What are the types of medical cannabis policies and how are they different?
States have developed a range of policies, each responsive to the context, culture, and unique policy drivers of the state. The study will determine if there are different types of policies (e.g., medical, path to legalization), and the key differences, including differences in legislative intent.
Research Question 2: What are the core components of medical cannabis policy?
Although states have developed different types of policies, there are similar components contained across policies. The study will identify the core components common to state medical cannabis policies. This information will be used to develop a framework for analyzing policies, and will be directly relevant to states attempting to create and implement new policies. This information will also be able to inform changes to existing policies.
Aim 2: Describe the processes used to develop state medical cannabis policies
The analysis of policymaking processes will highlight why policies have been developed, how they were developed, and what they were intended to address. Additionally, the analysis will identify the types of information that inform policy development, the role of collaborative and opposing relationships, challenges and strategies for mitigating barriers in the policy development arena, and legislative intentions. This information can ultimately be used to identify best practices in medical cannabis policymaking, and may help policymakers in other highly contentious areas where there is limited evidence.
Research Question 3: What decision-making processes are used in the development of state medical cannabis policies? What are the benefits and challenges?
Medical cannabis policies are often highly contentious, with advocates and opponents presenting disparate evidence. Policymakers must develop sound policies that address the needs of stakeholders, with limited evidence and tight timeframes. Understanding the decision-making processes used, the unique challenges and strategies for success will provide other policymakers with tools for developing policies in similar situations.
Research Question 4: What are the intentions of policymakers developing state medical cannabis policies?
In order to evaluate effectiveness of policies, it is critical to first understand policymaking intentions, including the initiating intent and intended outcomes. Once policy intent has been identified, it will be possible to evaluate implementation processes and actual outcomes.
Aim 3: Describe the role of public discourse and information framing in the development of policy, and identify areas of consideration for policymakers
The analysis of public and political discourse in relation to the development of state medical cannabis policies will further inform analysis of the policymaking processes. The resulting evidence will describe the role of specific types of discourse and how these impacted policymaking processes, and ultimately shaped policies. This information will be particularly valuable to policymakers developing new medical cannabis policies, as well as policymakers grappling with the development of controversial policies where there is limited or insufficient evidence.
Research Question 5: What are the types of information streams used in the development of state medical cannabis policies? How are policymakers accessing these information streams?
Policymakers must make decisions with limited time and resources. The information that they are able to access, or are provided, becomes critical to the development of policies. Understanding the types of information policymakers used in the development of medical cannabis policies (e.g., peer-reviewed literature, anecdotal evidence, stakeholder input), and how they accessed the information will illuminate gaps, or needs, in policymaking processes. This information can be used to inform future policymaking processes.
Research Question 6: How did the framing of information impact the development of state medical cannabis policies?
In addition to the types of information that policymakers accessed for the development of medical cannabis policies, it is important to understand how the information was framed, and how this impacted the final policies. This information will be essential for researchers and others that would like to provide information for policymakers and influence policy decisions.
Analysis of the policymaking process will rely on the Advocacy Coalition Framework (ACF) to provide insight into the policy change processes required to move from prohibition of cannabis as a Schedule I narcotic to state regulated use for medical benefits. Developed by Sabatier and Jenkins-Smith, the ACF aims to analyze policy by recognizing the complexity of subsystem relationships, the role of science and analysis, and the impact of individual perceptions in policymaking processes (Weible, Sabatier, Jenkins-Smith, Nohrstedt, Henry, & deLeon, 2011). The ACF is based on several assumptions, most relevant that participants in policy systems can be grouped into coalitions, and that policies represent the “translation of coalition beliefs” (Weible et al., 2011, p. 351). In conjunction with the ACF’s assertion that the design of policy is a representation of coalition beliefs and the successful advocacy of these beliefs (Kübler, 2001), critical discourse theory views policymaking as “an arena of struggle over meaning” and the resulting policy as the interpretation of these struggles (Taylor, 2006, p. 26). While the ACF will provide a validated framework for analyzing policymaking processes, use of critical discourse methods will bolster understanding of coalition motivation, beliefs, attitudes, and intentions, as well as the subsequent policy designs.
The study will utilize a three-phase process to address the research aims (see Figure 2). Each phase of the study will inform the subsequent phases to ultimately produce an in-depth analysis of how information streams, perceptions of evidence and information, policymaking processes, and political intent converge to create policies in situations with highly controversial topics and limited evidence. The study will focus on the 23 state policies that provide comprehensive legislation on access and use, and explicit legal protections for patients. Additional state policies include research, and limited therapeutic provisions; however, these policies are still highly restrictive and do not have the type of broad implications to public health as more comprehensive policies.
The study will rely on a framework analysis of current state medical cannabis policies, key informant interviews with policymakers and other stakeholders, and discourse analysis of policymaking documents (e.g., meeting summaries, public testimony), concurrent research, and media sources.
Figure 2. Research design
The study will utilize the following methods to address the research aims.
A comparative analysis of policies from 23 states will be conducted using an inductively formed coding template. The sample will include the original policy text from each state. For the purposes of this study, amendments and guidelines are considered part of the implementation process and will therefore be excluded from the analysis of policy development. Policies will be taken from State websites, when available. States that do not have their full policies available online will be contacted directly. Thematic analysis of state policies will be used to index and chart coded data. Policy data will then be mapped and interpreted to explore relationships and associations within the data, and provide insight into key policy concepts and innovative state strategies. Information garnered through the content framework analysis will additionally inform the development of a topic guide for key informant interviews related to policymaking processes.
Original policy texts that provide legal protections, provide access to cannabis (e.g., personal cultivation, licensed dispensary), and allow for cannabis consumption (e.g., smoked, vaporized, eaten).
Policy amendments, guidelines, administrative rules, or original policy texts limited to therapeutic research.
Key Informant Interviews
A topic guide will be developed for key information interviews based on findings from the content framework analysis of state medical cannabis policies. Semi-structured interviews will be conducted with key policymakers to ascertain participant perceptions of the policymaking processes in each of the 23 states with medical cannabis programs. Key informants will include state policymakers, advocates, and opponents directly involved in the development of medical cannabis policies. Key informants will be identified through literature and policy document searches, and recruited for participation through email and phone calls. Interviews will be conducted by phone, be recorded and transcribed, and coded using Atlas.ti™ (qualitative software). Interview data will be analyzed using a grounded theory approach to reach thematic saturation.
As part of the key informant interviews, snowball sampling will be used to identify additional stakeholder interviewees, such as other policymakers, influential state agency employees, key advocates and opponents, and others. The topic guide will be adjusted, as needed, for the specific type of stakeholder. These interviews will provide more comprehensive views on the policymaking processes, and lend additional insight into specific processes, challenges, and information streams
Key informant interviews will focus on policy intent, decision-making processes, the role of evidence and other information in decision-making (including types of information used and how it was accessed), and the role of stakeholders. Key informants will be provided the results of the framework analysis and will be asked to vet the findings.
Discourse analysis will be used to analyze additional process texts such as meeting summaries, public testimony, public announcements, anecdotal records, correspondence, and media coverage, editorials, and scientific publications. This analysis will draw on thematic network analysis (Attride-Stirling, 2001) and will provide additional insight into the policy development processes.
The discourse analysis will be utilized to provide contextual perspective using case studies of three states. States will be selected based on the generalizability of approach or innovative strategies within their medical cannabis policies and processes, as informed by the policy content analysis, key informant interviews, and discourse analysis of process documents. These case studies will illustrate the role of public and political discourse in the development of policy, and the impact of issue framing on the development of policy.
There are several limitations to this study; however, there are strategies and considerations to mitigate the impact to the validity of findings.
Key informant interviews rely on subjective participant memory recall. As a result, findings will be may not reflect actual policymaking processes or outputs. For the purposes of this study, participant perceptions are valuable in understanding the policymaking processes. Additionally, content analysis of policy documents, including meeting summaries and correspondence, will provide further detail on actual proceedings. Future studies may wish to use observational study methods to analyze policymaking process as they occur.
An additional limitation to the analysis is the lack of multiple researchers during the coding and analysis phase to provide inter-rater reliability. This study relies on the interpretation of a single researcher to translate, analyze, and synthesize document text and qualitative data produced from interviews. A single coder and analyst is not innately a limitation or threat to study reliability, however, it does warrant additional consideration. The research will utilize respondent validation to vet initial findings, identify inconsistencies, and challenge researcher assumptions.
A further limitation is that participant responses may be impacted by the highly controversial nature of the research subject, and the complex social, political, and legal issues involved in cannabis regulation. Participant responses will be anonymized, and no personally identifiable information will be included in findings or resulting research products; however, the depth of participant responses relies on the relationship and trust with the researcher.
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