Analytical frame for public policy implementation

"I don't think we truly understand how to implement. What does it mean to truly implement? Not the command center type that our culture is very good at, but a thorough planned systematic approach" (HP, 9.28.2011). This important question is asked by a clinician who works in a health care setting and who has experienced the implementation of a public policy. This case study applied the lessons learned from three generations of public policy research to a health care setting. As a result of the study an analytical frame was created as a guide to assess an organization's readiness for the implementation of a public policy.^

Household Hardships, Public Programs, and Their Associations with the Health and Development of Very Young Children: Insights from Children’s HealthWatch

America’s low-income families struggle to protect their children from multiple threats to their health and growth. Many research and advocacy groups explore the health and educational effects of food insecurity, but less is known about these effects on very young children. Children’s HealthWatch, a group of pediatric clinicians and public health researchers, has continuously collected data on the effects of food insecurity alone and in conjunction with other household hardships since 1998. The group’s peer reviewed research has shown that a number of economic risks at the household level, including food, housing and energy insecurity, tend to be correlated. These insecurities alone or in conjunction increase the risk that a young child will suffer various negative health consequences, including increases in lifetime hospitalizations, parental report of fair or poor health,1 or risk for developmental delays.2 Child food insecurity is an incremental risk indicator above and beyond the risk imposed by household-level food insecurity. The Children’sHealthwatch research also suggests public benefits programs modify some of these effects for families experiencing hardships. This empirical evidence is presented in a variety of public venues outside the usual scientific settings, such as congressional hearings, to support the needs of America’s most vulnerable population through policy change. Children’s HealthWatch research supports legislative solutions to food insecurity, including sustained funding for public programs and re-evaluation of the use of the Thrifty Food Plan as the basis of SNAP benefits calculations. Children’s HealthWatch is one of many models to support the American Academy of Pediatrics’ call to “stand up, speak up, and step up for children.”3 No isolated group or single intervention will solve child poverty or multiple hardships. However, working collaboratively each group has a role to play in supporting the health and well-being of young children and their families. 1. Cook JT, Frank DA, Berkowitz C, et al. Food insecurity is associated with adverse health outcomes among human infants and toddlers. J Nutr. 2004;134:1432-1438. 2. Rose-Jacobs R, Black MM, Casey PH, et al. Household food insecurity: associations with at-risk infant and toddler development. Pediatrics. 2008;121:65-72. 3. AAP leader says to stand up, speak up, and step up for child health [news release]. Boston, MA: American Academy of Pediatrics; October 11, 2008. http://www2.aap.org/pressroom/nce/nce08childhealth.htm. Accessed January 1, 2012.

'Reform' of the British national health service after the election of a labour government: Understanding the policy development process

The policy development process leading to the Labour government's white paper of December 1997—The new NHS: Modern, Dependable—is the focus of this project and the public policy development literature is used to aid in the understanding of this process. Policy makers who had been involved in the development of the white paper were interviewed in order to acquire a thorough understanding of who was involved in this process and how they produced the white paper. A theoretical framework is used that sorts policy development models into those that focus on knowledge and experience, and those which focus on politics and influence. This framework is central to understanding the evidence gathered from the individuals and associations that participated in this policy development process. The main research question to be asked in this project is to what extent do either of these sets of policy development models aid in understanding and explicating the process by which the Labour government's policies were developed. The interview evidence, along with published evidence, show that a clear pattern of policy change emerged from this policy development process, and the Knowledge-Experience and Politics-Influence policy making models both assist in understanding this process. The early stages of the policy development process were characterized as hierarchical and iterative, yet also very collaborative among those participating, with knowledge and experience being quite prevalent. At every point in the process, however, informal networks of political influence were used and noted to be quite prevalent by all of the individuals interviewed. The later stages of the process then became increasingly noninclusive, with decisions made by a select group of internal and external policy makers. These policy making models became an important tool with which to understand the policy development process. This Knowledge-Experience and Politics-Influence dichotomy of policy development models could therefore be useful in analyzing other types of policy development. ^

Patenting genes and gene sequences: Analysis of public health implications and the law

At issue is whether or not isolated DNA is patent eligible under the U.S. Patent Law and the implications of that determination on public health. The U.S. Patent and Trademark Office has issued patents on DNA since the 1980s, and scientists and researchers have proceeded under that milieu since that time. Today, genetic research and testing related to the human breast cancer genes BRCA1 and BRCA2 is conducted within the framework of seven patents that were issued to Myriad Genetics and the University of Utah Research Foundation between 1997 and 2000. In 2009, suit was filed on behalf of multiple researchers, professional associations and others to invalidate fifteen of the claims underlying those patents. The Court of Appeals for the Federal Circuit, which hears patent cases, has invalidated claims for analyzing and comparing isolated DNA but has upheld claims to isolated DNA. The specific issue of whether isolated DNA is patent eligible is now before the Supreme Court, which is expected to decide the case by year's end. In this work, a systematic review was performed to determine the effects of DNA patents on various stakeholders and, ultimately, on public health; and to provide a legal analysis of the patent eligibility of isolated DNA and the likely outcome of the Supreme Court's decision. ^ A literature review was conducted to: first, identify principle stakeholders with an interest in patent eligibility of the isolated DNA sequences BRCA1 and BRCA2; and second, determine the effect of the case on those stakeholders. Published reports that addressed gene patents, the Myriad litigation, and implications of gene patents on stakeholders were included. Next, an in-depth legal analysis of the patent eligibility of isolated DNA and methods for analyzing it was performed pursuant to accepted methods of legal research and analysis based on legal briefs, federal law and jurisprudence, scholarly works and standard practice legal analysis. ^ Biotechnology, biomedical and clinical research, access to health care, and personalized medicine were identified as the principle stakeholders and interests herein. Many experts believe that the patent eligibility of isolated DNA will not greatly affect the biotechnology industry insofar as genetic testing is concerned; unlike for therapeutics, genetic testing does not require tremendous resources or lead time. The actual impact on biomedical researchers is uncertain, with greater impact expected for researchers whose work is intended for commercial purposes (versus basic science). The impact on access to health care has been surprisingly difficult to assess; while invalidating gene patents might be expected to decrease the cost of genetic testing and improve access to more laboratories and physicians' offices that provide the test, a 2010 study on the actual impact was inconclusive. As for personalized medicine, many experts believe that the availability of personalized medicine is ultimately a public policy issue for Congress, not the courts. ^ Based on the legal analysis performed in this work, this writer believes the Supreme Court is likely to invalidate patents on isolated DNA whose sequences are found in nature, because these gene sequences are a basic tool of scientific and technologic work and patents on isolated DNA would unduly inhibit their future use. Patents on complementary DNA (cDNA) are expected to stand, however, based on the human intervention required to craft cDNA and the product's distinction from the DNA found in nature. ^ In the end, the solution as to how to address gene patents may lie not in jurisprudence but in a fundamental change in business practices to provide expanded licenses to better address the interests of the several stakeholders. ^