First, it addresses a problem of public health significance—a health condition involving a high burden of morbidity or mortality and thus a high social cost. Although not confined to measures targeting the top killers, critical opportunities target health problems that matter. Prevalence, severity of harm, and whether there are strongly disparate effects in a subpopulation are all relevant considerations. Second, the mechanisms underlying the public health problem are sufficiently well understood to support a conclusion that it is plausibly amenable to change through law. It is causally linked to behaviors, environmental conditions, or other determinants that should be modifiable through the influence of legal interventions.
Legal interventions may take any regulatory form—for example, new statutes and regulations, better use of existing regulatory processes, even litigation—and may be deployable at any jurisdictional level. Usually there is evidence about the etiology of the problem that can provide important insights concerning plausible legal interventions, even if direct evidence of the effectiveness of such interventions is lacking. Law works through generic mechanisms e. Third, 1 or more plausible legal interventions have been identified that could address the determinants of the problem but are not being used to maximum advantage.
There must be good reason to think that the intervention will be effective in achieving its goal, although the level of direct evidence of effectiveness may range from high to nonexistent. In addition to considering the merit of the intervention itself, policymakers may need to consider whether it is so far out ahead of prevailing social norms that it may provoke backlash, such that the net effect is to set back the broader mission.
Although well-intentioned public health laws sometimes fail and are not without cost, we do not hold that lawmaking need always be reserved as an intervention of last resort. In pressing matters of population health and safety, there may be opportunities for legal reform that should be advanced even before voluntary best practices have been fully deployed. At the same time, the intervention must be something that policymakers could realistically hope to implement without encountering insurmountable constitutional or political barriers.
The possibility that a law will be challenged in court is not necessarily a reason not to proceed, but such challenges add to the costs of an innovation in a way policymakers will want to consider. Similarly, an opportunity is illusory if there is no realistic prospect of giving it life, even over the long term. Legal and political barriers have played a large role in stymieing the progress of many otherwise promising public health legal interventions.
Examples that currently fail the criterion of feasibility include proposals for far-reaching restrictions on advertising and many gun control laws. Identifying critical opportunities for public health law provides pivotal support for evidence-based lawmaking—that is, lawmaking that draws priorities and designs interventions from the existing evidence and exhibits learning over time.
Fidelity to evidence-based lawmaking, then, simply requires a commitment to be led by the available evidence, evaluate new laws, and use additional evidence as it becomes available.
CRITERIA FOR CRITICAL OPPORTUNITIES
This is the rationale of the critical opportunities approach. On the basis of our own experience studying legal and policy interventions, we identified 5 exemplary critical opportunities Table These ideas by no means exhaust the range of critical opportunities in public health law, and there are undoubtedly others that eclipse them in public health significance. We selected them to illustrate the concept of critical opportunities and highlight a few intriguing and potentially impactful areas in which policymakers could focus.
In the sections that follow, we briefly summarize the rationale for each of these exemplars. A critical opportunity may arise because a large number of state and local governments have tested different forms of a legal intervention and their cumulative experience shows which form is most effective, creating an opportunity to fine-tune existing laws for maximum effect. Such is the case for GDL schemes. Every day, about 15 US adolescents die in motor vehicle crashes—more than from any other cause of death.
Adolescents have not fully developed the social and cognitive abilities required to comprehend and manage driving risks. Law has played a crucial role in creating conditions for safe driver development through GDL schemes, which now exist in all US states. During the learning permit stage, new drivers gain experience while under supervision. Next, drivers can operate their vehicles unsupervised but with restrictions e. In the last phase, drivers receive an unrestricted license. Nighttime and passenger restrictions should also be tightened. Numerous states restrict only intermediate drivers after midnight, but because the riskiest time period for adolescents is late evening, a nighttime restriction beginning at 9: Both sets of restrictions should remain until age 18 years.
GDL laws have proven political feasibility, as evidenced by their universal adoption by states and widespread public support. The feasibility and effectiveness of the laws may depend in part on the degree of voluntary compliance, but a modest body of survey research has consistently shown that supermajorities of parents support strengthening nighttime and passenger restrictions.
Only a third to a half of parents, depending on the state, support increasing the age of licensure beyond age 16 years, however. Strong, consistent scientific evidence supports the effectiveness of comprehensive GDL laws. A review of 27 American- and Canadian-based studies of numerous laws showed that GDL schemes are successful in reducing adolescent crashes.
Taxation of alcoholic beverages is an example of a legal intervention whose effectiveness is amply supported by evidence. Yet because it has been poorly implemented, the full potential of the intervention has not been realized. Injury and disease caused by excessive consumption of alcoholic beverages—either in a single episode or chronically—are the third leading preventable cause of death in the United States.
Since the repeal of Prohibition—a failed social experiment with some forgotten public health benefits 36 —alcoholic beverages have been subject to a host of regulations limiting sales and access, restricting who can sell and serve, and maintaining a floor on retail prices through either state-owned monopoly sellers or excise and sales taxes.
Price regulation through taxes has been a particularly important strategy; all states currently impose some type of tax. Taxes affect prices, consumers drink less when prices are higher, 37 and reduced drinking leads to reductions in population rates of alcohol-related diseases and injuries. During the past several decades, real tax rates on alcoholic beverages have steadily eroded.
This phenomenon occurred primarily because most alcohol-specific taxes are ad valorum a set amount per gallon and not automatically adjusted for inflation. Occasional legislated increases in alcohol tax rates have not compensated for inflation over the decades. Doubling current alcohol tax rates would restore rates to the real levels operating a few decades ago. Including automatic annual adjustments for inflation in alcohol tax legislation would solve the rate erosion problem.
Such a policy requires no new outlays, because the implementation mechanisms for alcohol-specific taxes are already in place. Alcoholic beverage sellers have successfully opposed tax increases in some states recently, but the strong evidence of health, safety, and economic benefits has carried the day in several others, clearly demonstrating feasibility of state alcohol tax increases.
Although the lobbying power of alcohol sellers appears even more formidable at the federal level, the federal alcohol excise tax was nevertheless increased a half dozen times over the 20th century. Voluminous, consistent evidence supports the expectation that increasing alcohol taxes would result in significant reductions in death, disability, and other health and social costs attributable to drinking.
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Scientific evidence on the public health effects of alcohol taxes spans half a century and numerous states and countries. A second, recent systematic review examined alcohol tax and price effects on alcohol-related morbidity and mortality, summarizing 50 studies containing estimates. Many other reviews have reached similar conclusions. Regulation by government agencies also affords critical opportunities. In some cases, as with regulation of the sodium content of foods, there exist regulatory pathways that can be triggered in the face of new evidence to act on a problem.
Sodium consumption has increased in the United States since the s and is now the second leading driver of cardiovascular disease. There is some debate over healthy consumption of sodium. Although a Cochrane review found insufficient power to determine a significant effect of reducing sodium, 48 national and international organizations have concluded that a reduction in sodium consumption would decrease cardiovascular disease. To date, law has not been used in the United States to reduce sodium in the food supply.
However, many potential legal approaches exist. The Food and Drug Administration FDA , state legislatures, or the Congress could require processed food manufacturers to reformulate food products and provide more meaningful disclosures about sodium content on labels. The FDA could also incentivize and coordinate voluntary action by food manufacturers—for example, by convening companies to agree on voluntary standards for sodium, as was done in Europe.
Voluntary standards clearly carry a risk of noncompliance. Several large food companies have already voluntarily taken steps to reduce levels of sodium in their products 55 ; by requiring such efforts, new regulation would create a level playing field for all food companies. Opposition to sodium reduction from food manufacturers appears moderate, relating largely to the food science needed to reduce sodium content while maintaining flavor and shelf life.
But concern may be eased by emphasizing that no ban on sodium is proposed. Although not uncontroverted, the evidence about the health effects of sodium is sufficient to have persuaded the IOM and World Health Organization to recommend policies to reduce sodium consumption and sodium content in foods.
Critical Opportunities for Public Health Law: A Call for Action
The broad health benefits of legally regulating sodium as a food additive are highly plausible and sufficient to justify a national policy of curbing dietary sodium intake once safe limits are scientifically established. Certainly, the existing evidence justifies the FDA initiating a process to obtain additional data on safe consumption levels and determine what regulatory actions, if any, are appropriate. As the evidence base regarding the deleterious effects of sodium on health grows in strength, so will the case for more assertive regulation.
Sometimes, a critical opportunity may lie in removing legal barriers, or offering legal support, to a nonlegal intervention that has shown promise. This approach could be used to respond to the rapidly escalating threat of opioid overdose. Recently, a dramatic increase in deaths among licit and illicit users of prescription opioids has put overdose squarely on the prevention agenda. A variety of legal approaches are being deployed to promote safer prescribing practices, better regulate pharmaceutical marketing, and limit diversion of prescription drugs into illegal markets.
An increasing number of states are recognizing an opportunity to facilitate reversal of overdoses. The critical opportunity is to change law from a barrier to a facilitator of overdose reversal programs. The main legal barrier to wider availability of naloxone is that it must be prescribed by a licensed health care provider to a patient with a medical need, and in many states it could be considered a crime for a layperson to administer the drug to another.
Leaving aside the long-term possibility of the FDA converting naloxone to over-the-counter status, states can facilitate overdose reversal by creating an exception to the legal requirements for distribution of prescription drugs. Specifically, legislation could 1 authorize prescription of naloxone to, and administration by, trained laypersons as have, for example, New Mexico and New York 62 ; 2 allow liberal use of standing orders for naloxone prescription as did Massachusetts before it passed an explicit authorization law ; and 3 create civil and criminal immunities for health care providers or laypersons participating in these programs as have, for example, Connecticut and California.
The passage of enabling legislation in several states without substantial opposition, support from families of young overdose victims, and an endorsement from the chief of the Office of National Drug Control Policy 66 suggests a reasonable degree of political feasibility. The fact that many overdose victims are medical users may help insulate the intervention from criticism that it facilitates illegal drug use. Authorizing the intervention does not necessarily require funding, although some states have tasked health departments to create materials, track reversals, or otherwise invest resources.
There is currently only suggestive evidence that enacting these measures leads to a reduction in overdose deaths. Observational studies have reported that trainees will retain naloxone provided to them, can accurately identify the signs of overdose, are willing and able to administer the drug to people in need, and succeed in reversing overdose without serious negative side effects.
The case for laws promoting overdose reversal interventions rests on the plausibility of the approach; its demonstrated feasibility; consistent reports that naloxone is being used by witnesses to reverse overdose; the lack of any reports of serious harm; and, even if the intervention has as yet unidentified risks, the fact that the alternative is death for many opioid users.
Considering the severity of the overdose epidemic, it makes sense to experiment with and evaluate legal interventions targeting every point in the process between prescribing and death. In recent years, tragic acts of violence by mentally disturbed students have focused national attention on the problem of untreated mental disorder in college students.
Legal approaches to college mental health issues vary across jurisdictions, tend to be poorly understood by stakeholders, 75 and are often not used or not well implemented. These laws protect important values but, properly understood, permit higher educational institutions to do considerably more than most currently do. State legislatures could require colleges to implement evidence-based campus safety measures that federal law does not forbid.
Virginia provides an example for other states. State laws therefore should require—and support through appropriations or incentives—the availability of mental health counseling, or at least referral services, at all public institutions of higher education. In states such as Virginia where a strong background norm favors self-regulation by private colleges, private institutions should be encouraged to voluntarily institute these policies.
In other states, legislation could cover all institutions of higher education. Although hundreds of campuses across the nation have successfully implemented threat assessment teams, most have not. The reason for this, in part, is that threat assessment teams and the mental health service capacities on which they depend cost money and are not required by law, except in Illinois and Virginia.
Legal mandates may thus be necessary. Because some colleges will struggle to implement new requirements without additional funding, legislative appropriations may also be needed. This requires difficult budgetary choices, but we are currently in a political moment when public concern may motivate action. Very few states have required parental notification of students experiencing mental health problems. Because widespread confusion about what the federal laws actually permit institutions to disclose may prevent colleges from acting prudently in notifying parents, legislative action should include guidance to eliminate misperceptions.
For the reasons we have outlined, the public would likely support these measures insofar as they do not conflict with federal law. High face validity and expert consensus support the view that threat assessment teams can help protect students with potentially dangerous mental health conditions from harming themselves or others.
Using the law to move these institutions toward best practices and eliminating misconceptions about what the law prohibits are critical steps. We have illustrated the application of our criteria for critical opportunities with 5 examples. We conclude with some reflections on the need for a national conversation to create a policy agenda for public health law.
The criteria we propose are not novel and should not be controversial. But the notion that policymakers should systematically apply a set of decision criteria to assess the relative merits of ideas competing for attention in the policy space is unconventional. Public health lawmaking has tended to be more ad hoc. Research in public health law has tended to focus either on the evidence concerning a specific legal intervention or on theories of what the law should do and has not supported policy prioritization.
Our framework provides a disciplined, pragmatic approach to making hard decisions about where to focus effort and resources. The 5 interventions we have discussed are but a few of the important opportunities for public health law. They merit serious consideration because they are potentially high impact, involve regulatory actions that are proportional to the available evidence, and can be accomplished with only modest changes or no changes to existing statutes and regulations. Just as important, however, is their illustrative function: Concerted deliberation by public health leaders, their legal counsel, and scholars can generate myriad other useful proposals.
There are several reasons it is important to pursue a national conversation to identify critical opportunities. First, it can enhance the legitimacy and perceived value of law as a tool for population health improvement. Public health officials face 2 important barriers to expanding the use of law to achieve health aims: Identifying critical opportunities can address both problems.
With regard to economic constraints, a critical opportunities initiative can help establish the level of investment a legal intervention requires and what the likely return on investment will be by identifying the costs and effectiveness of legal interventions.
INSIDE THIS SECTION
Public health officials are being asked to do more with less and are forced to confront hard questions about resource allocation and opportunity costs. In times of contentious politics and extreme strain on state budgets, it becomes very difficult to accomplish even sensible policy changes with mainly long-range expected benefits if they impose immediate costs. Lawmakers thus need evidence of the value of legal interventions to advance them on tightly constrained policy agendas.
Demonstrating the value of legal approaches to health problems can also help overcome ideological opposition to expanded use of public health law.
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In an era of calls for smaller government, there is a need to show that official action can succeed in producing population health benefits. A strong list of critical opportunities highlighting effective, feasible interventions can counter beliefs that regulation cannot work and carries too great a social cost. A second reason a critical opportunities conversation is needed is to support strategic choices in policymaking. Individual policymakers, too, must make hard choices about where to invest effort and resources.
Third, a critical opportunities movement could bridge informational gaps that may account for the lack of uptake of some promising legal interventions. Policymakers have both too much information and too little about opportunities in public health law. They may have far less access to objective, scientific information—especially comprehensible summaries of the strength of evidence for particular legal interventions. A critical opportunities initiative can supply reliable evidence syntheses and expert analyses where an evidence base already exists.
It can also identify lingering evidentiary gaps that require further research e. Consulting—or engaging a health agency to contribute to—a growing menu of critical opportunities could help health leaders find innovative legal interventions to meet state and local needs that will not wait for exhaustive research and a Cochrane, Campbell or Community Guide review. By bridging informational gaps, a critical opportunities initiative can also promote evidence-based lawmaking.
Generating consensus about critical opportunities can help make the case for policy experiments of promising ideas as well as the systematic evaluation of those experiments that is necessary to advance knowledge and improve laws over time. The best examples of public health law conforming to evidence—such as GDL laws, child safety seat laws, and clean indoor air laws—are ones in which early innovations at the state or local level were evaluated, adapted with evidence-based changes, and then further evaluated and tweaked in a cycle of innovation and assessment.
A conversation on critical opportunities can place policy ideas in this cycle and help policymakers understand where those ideas currently lie along the continuum of evidence. The critical opportunities approach is an exercise in the generation and diffusion of innovation. Many innovators in public health law have promising ideas, but there need to be pathways along which these ideas can reach important opinion leaders and thence move out across networks. The process of suggesting, vetting, and publicizing critical opportunities can create an easily accessible window for policymakers to see where the needs are and how they might be fulfilled through better use of law.
Of course, identifying good ideas does not remove the barriers to pursuing them. Policymakers will always struggle with interest group politics, opposition to regulation from industry, severe resource constraints, and other obstacles. But arming themselves with consensus-based, evidence-based policy recommendations may help policymakers make their case. Leaders and practitioners in public health are trying to make the best of challenging political and economic times by identifying what works and devising new ways to deliver essential services.
Accreditation, consolidation, and cross-jurisdictional sharing of public health programs and staff are all examples of this effort. More effective use of law should be part of this transformation, and a critical opportunities initiative can light the way.
2013 New York Consolidated Laws
We are grateful to Evan Anderson, Patrick Bernet, and Prabhu Ponkshe for helpful comments on the draft article and to Jillian Penrod for assistance with article preparation. Institutional review aboard approval was not needed for this work because no human participant research was involved. National Center for Biotechnology Information , U.
Am J Public Health. Published online November. Wagenaar , PhD, Jennifer K. Swanson , PhD, MA. Author information Article notes Copyright and License information Disclaimer. At the time this work was conducted, Michelle M. Correspondence should be sent to Michelle M. Senior Corporate Counsel, Pfizer Inc. Tackling the Opioid Crisis: Benesch Edward Rebenwurzel, Esq.
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Ruskin Moscou Faltischek, P. Converging Tailwinds for Cybersecurity: Looking for CLE opportunities online? The Health Law Section has three recordings available to purchase and view for CLE credit, any time that is convenient for you: New York State is facing a health care crisis: While a single donor can help save the lives of up to 8 people, potential donors are rare.
It is crucial that all of the participants in the process, legal, clinical, administrative and governmental are knowledgeable about the law and the process surrounding organ and tissue donation. Health Law Section Fall Meeting: Health Law Section Member: These innovative programs and the use of the technology necessary to support them do not come without legal barriers and challenges. Our diverse panel of speakers will describe innovative, collaborative initiatives that are disrupting the health care system, and the practical ways to overcome the real and perceived barriers to sustained implementation.