The U.S. healthcare system continually confronts the challenge of controlling costs, improving quality and patient safety, and increasing or maintaining patient access to care. Payors and purchasers of healthcare (both public and private) strive to develop mechanisms to guarantee that they are purchasing the highest-value care – seeking to ensure that amounts paid take into account and provide incentives encouraging the delivery of high-quality, cost-efficient care. Through “value-based purchasing” (“VBP”) strategies, healthcare payors and purchasers are transforming from passive payors of claims (as in a traditional fee for service system) to active purchasers of quality care. To date, employers, health plans, and the Centers for Medicare and Medicaid Services (“CMS”) have implemented well over 100 VBP programs. However, progress is slower than anticipated. As the Institute of Medicine (“IOM”) and others have noted, adoption of VBP reforms may be hampered by legal barriers arising from a number of state and federal laws. The goal of this paper is to identify potential state and federal legal impediments to implementing VBP in healthcare.

The purpose of this paper is to provide a comprehensive review of the work of the World Health Organization (WHO), begun a decade ago in Europe, in the field of health legislation. This program is the result of the interaction between two important factors: the trends in national health policy and legislation at the country level, and the implementation of the Health for All policy, which has been collectively adopted by the European Member States in various WHO fora.

Health legislation has proved to be a valuable tool in supporting National Health Policies in European countries and a key element in international health activities. The paper will be presented in three main parts. The first examines the legislative implications of the Health for All policy and strategy. The second gives an overview of developments in health legislation in Europe, focusing on national achievements in three areas in which change is necessary to achieve Health for All: health care systems, the environment, and lifestyles. The third part gives an account of activities carried out by the Regional Office for Europe of WHO in the health legislation field, recalls the organization of the first WHO medium-term program in this field, and summarizes its four current subprograms on health policy, health situation, exchange of information, and training. The conclusion briefly outlines the prospects for further developments in Europe.

The COVID-19 pandemic has revealed myriad and complex challenges for our national health care system spanning preparedness, response, access, costs, infrastructure, coordination, and medical innovation. These challenges implicate federal, state, and local agencies and actors, as well as international collaborative bodies. One constant throughout the pandemic has been the pressing need for safe and effective diagnostics, prophylactic vaccines, and drug treatments to counter the virus.1 Inarguably, significant problems with the multi-faceted system of drug and vaccine innovation and regulation manifested long before the COVID-19 pandemic.2 The pandemic, however, has laid bare the inextricable connections among federal funding, patents, product review and approval mechanisms, and the eventual medical products and resulting costs.

Society benefits from physicians who seek truth and healing for the good of humanity. Despite ethical admonishments to “do no harm,” however, physicians have caused some of the most appalling human rights abuses of the twentieth century. Physicians, alone or in concert with the state, have willfully abused their medical knowledge and debauched their profession in furtherance of human rights violations. Compounding their crimes, physicians often have been complicit in following oppressive regimes in abusive practices against their citizens. Ironically, it is their knowledge of this healing art that allows physicians to take part in this injurious conduct; and it is this knowledge that states seek to harness in buttressing violative policies. In fact, for nations bent on violating human rights, it is “much easier for governments to adopt inherently evil and destructive policies if they are aided by the patina of legitimacy that physician participation provides.”

The scope of product liability for prescription drug injuries is a highstakes matter. As the recent Vioxx litigation illustrates, drug manufacturers can face numerous lawsuits when users are injured by risks discovered only after the drug reaches the market. The extent to which Food and Drug Administration (FDA) decisions preempt tort liability has emerged as a major issue. The agency itself has issued a policy that favors preemption when a drug manufacturer consults with the agency about a new risk. The Supreme Court has found liability preempted for medical devices based on an express preemption provisions and is expected to make an important ruling on drug preemption this term in Wyeth v. Levine. Some believe that the Court will rule in favor of preemption even though there is no express statutory provision for drugs.

Behavioral scientists have understood for decades that when it comes to food, we are anything but fully autonomous. One's choice of what and how much to eat is strongly influenced by environment and context. Give someone a larger bowl and serving spoon, and he will unwittingly eat more ice cream than if he used a smaller bowl and spoon. A person will eat more if out with friends, and may eat less if eating at a leisurely pace. The food industry has been fully aware of this science for decades; indeed, its scientists have been among the leading researchers in the area. Using this science to its advantage, the industry has manipulated the appearance, smell, taste, texture, and packaging of food to get Americans to eat more of the foods the industry sells, with often devastating consequences for the public health.