I am happy to announce the publication of our collaborative paper with Helen Yu and Jakob Wested on “Innovation and intellectual property policies in European Research Infrastructure Consortia (part I)” in the Journal of Intellectual Property Law and Practice (Oxford University Press). Taking the European Spallation Source ERIC as an example, our paper investigates ERIC Regulations and EU policies and discusses what issues and perspectives ERICs need to consider in their IPR policies to balance the core-objectives of multiple stakeholders and achieve sustainability in various research areas, including the health and life sciences.
The authors would like to express their special gratitude to Dr. Ohad Graber Soudry, Head of Legal, European Spallation Source ESS-ERIC in Lund, Sweden, for all his support and valuable comments. This paper is supported by the CoNeXT project (see http://conext.ku.dk/ last visited July 23, 2016) under the University of Copenhagen’s Excellence Program for Interdisciplinary Research.
Research and innovation are key pillars of the EU’s strategy to create sustainable growth and prosperity in Europe. Research infrastructures (RIs) are central instruments to implement this strategy. They bring together a wide diversity of expertise and interests to look for solutions to many of the problems society is facing today, including challenges in the health and life sciences. To facilitate the creation and operation of such RIs, the EU adopted legal frameworks for European Research Infrastructure Consortia (ERIC). On August 31, 2015, the European Spallation Source (ESS) was established as an ERIC. Under the ERIC Regulations and ESS Statutes, the European Spallation Source ERIC is required to adopt various policy documents relating to the operation and management of the facility. These cover a wide variety of issues such as user access, public procurement, intellectual property rights (IPR), data management, and dissemination. One of the main goals of the ESS policies is to ensure that the research environment at ESS is compatible with a wide variety of international users’ obligations to multiple stakeholder-interests. But how can these policies best be aligned with the EU objective to achieve economic growth and scientific excellence by encouraging international research collaborations? The complex relationship between scientific excellence, innovation, and IPRs must be carefully considered. Taking the European Spallation Source ERIC as an example, this article investigates ERIC Regulations and EU policies and discusses what issues and perspectives ERICs need to consider in their IPR policies to balance the core-objectives of multiple stakeholders and achieve sustainability. In Part II, we will analyze and compare the different IPR policies of the various ERICs in a subsequent article.
According to the Centers for Disease Control and Prevention, more than 6.4 million US children 4-17 years old have been diagnosed with attention-deficit/hyperactivity disorder (ADHD). The percentage of US children diagnosed with ADHD has increased by 3-5 percent per year since the 1990s. Relatedly, the percentage of children in this age group taking ADHD medication also has increased by about 7 percent per year from 2007-2008 to 2011-2012.
In response, some state Medicaid programs have implemented policies to manage the use of ADHD medications and guide physicians toward best practices for ADHD treatment in children. These policies include prescription medication prior authorization requirements that restrict approvals to patients above a certain age, or require additional provider involvement before approval for payment is granted.
In a new article published this afternoon in MMWR, CDC researchers compared Medicaid and employer-sponsored insurance (ESI) claims for “psychological services” (the procedure code category that includes behavior therapy) and ADHD medication among children aged 2–5 years receiving clinical care for ADHD.
The article references a newly released LawAtlas map that examines features of state Medicaid prior authorization policies that pertain to pediatric ADHD medication treatment, including applicable ages, medication types, and criteria for approval.
States with Medicaid programs that have a policy that requires prior authorization for ADHD medications prescribed to children younger than 28 years old.
A team of researchers led by Jennifer Pomeranz, JD, MPH, Clinical Assistant Professor of the College of Global Public Health at New York University, have released a new set of resources that detail characteristics of laws related to workplace wellness programs and identify trends in these laws across the United States: interactive maps for public and private employers at LawAtlas.org and a paper published in the American Journal of Public Health.
A few key findings:
Thirty-three states and the District of Columbia have laws related to workplace wellness programs.
Four states (Georgia, Indiana, Maine and Massachusetts) provide tax incentives for work place wellness programs.
State laws addressed public and private employers differently, for example, five states permit rewards (e.g., discounts, rebates and waivers) by public employers, whereas 16 states expressly permit positive rewards for participation in programs by private employers.
The research was funded by the Robert Wood Johnson Foundation’s Public Health Law Research Program.
Peeling the Onion:
How to Promote Pharmaceutical Innovation and Access to Medicine
Speaking about frustrations over the IP system in pharmaceutical innovation, sometimes feels like – to lend the words of the late German Nobel Prize winner Günter Grass – “peeling an onion:” Continue reading →
The nature of today’s most vital challenges and funding policies are driving more and more researchers towards interdisciplinary work. But what are the essential tools for those breaking the silos and leaving the comfort zones of their own disciplines?
Cross-disciplinary collaborations have become an increasingly important part of science. They are seen as a key factor for finding solutions to pressing societal challenges on a global scale including green technologies, sustainable food production and drug development. This has also been realized by regulators and policy-makers, as it is reflected in the 80 billion Euro “Horizon 2020” EU Framework Programme for Research and Innovation. This programme puts special emphasis at breaking down barriers between fields to create a path breaking environment for knowledge, research and innovation.
However, igniting and successfully maintaining cross-disciplinary collaborations can be a delicate task. In this article we focus on the specific challenges associated with cross-disciplinary research in particular from the perspective of the theoretician. As research fellows of the 2020 Science project and collaboration partners, we bring broad experience of developing interdisciplinary collaborations [2–12]. We intend this guide for early career computational researchers as well as more senior scientists who are entering a cross disciplinary setting for the first time. We describe the key benefits, as well as some possible pitfalls, arising from collaborations between scientists with backgrounds in very different fields.
Knapp B, Bardenet R, Bernabeu MO, Bordas R, Bruna M, Minssen T, et al. (2015) Ten Simple Rules for a Successful Cross-Disciplinary Collaboration. PLoS Comput Biol 11(4): e1004214. doi:10.1371/journal.pcbi.1004214
On this, the last day of National Public Health Week 2015, we’re looking forward by looking backward. There is nothing new about using law and policy to promote healthier environments, products and behavior. There is no good future for public health that does not include even more, and more effective, legal interventions.
Evan Anderson and I wrote in 2012 about the legal regulation of health-related behavior over the past half-century. The story we told offered several reasons for unabashed optimism about what law can do for health. The record is clear that law works, and works across a wide range of different health threats. We pointed to CDC lists of Great Public Health Achievements from the last century and the first decade of the 21st. Every one of them — from high levels of vaccination, through motor vehicle safety and cancer prevention to maternal and child health – could not have been successful without law and policy. Continue reading →
As part of the Public Health Law Research program’s participation in National Public Health Week 2015, we have been sharing materials and resources under the daily themes. Today’s theme, Building Broader Connections, is about expanding partnerships and making connections to benefit public health.
We spoke with Laura Hitchcock, JD, Policy Research & Development Specialist for Public Health – Seattle & King County and the King County Executive/Department of Executive Services Partnerships Initiative Lead. We asked her to offer some insight from her work as a lawyer and researcher in a public health department.
PHLR: What role can researchers play in building partnerships with health departments and contributing to the policy-making discussion?
Laura Hitchcock, JD
LH: Public health researchers can help to support development and refinement of evidence-based policies. Because policies are created in a political process, it is important for public health departments to continue to offer their scientific knowledge to support creation of effective policies, including repeal of ineffective policies or refinement of existing policies to better result in a healthy population by 2030. Health departments may need help to define local or state-focused areas for policy evaluation by working together with researchers, and should contribute to development of research agendas by identifying areas where policy makers, communities, medical professionals and others have concerns about the public’s health, and are likely to need support from researchers to know how to ‘plug in’ to research agenda development. Continue reading →
In each piece, Keirns outlines the challenges she faced in vaginally delivering her son in a hospital environment that seemed committed to performing a caesarian section. Particularly given Keirns’ expertise in and familiarity with health care, the lack of patient-centered care in the story is striking. Several staff suggested that surgery was a foregone conclusion while others appeared unprepared for her son’s long-awaited arrival.
We may be living in a golden age of group-think. A weekly reminder is poor Paul Krugman railing against the apparently universal belief in America and Europe that we’ve got to cut budgets right now or disaster will strike. He calls this a Zombie idea, a false claim that has been falsified with plenty of stakes in the heart, silver bullets and blows to the head, but will not stay in the grave.
Closer to home for us in public health is the claim that Americans don’t like government rules regulating their behavior and meddling with their preferences. Cass Sunstein and Richard Thaler have delivered some solid blows to the idea that paternalism typically messes with solid preferences. As we celebrate Public Health Week, I want to highlight two recent papers that show that Americans, like the children in Mary Poppins, actually like their nannies, who do some pretty great things.
Public Health Law Research has recently posted the manuscript of a paper that Evan Anderson and I have prepared for the Annual Review of Law and Social Science. The paper describes the dramatic rise of law as a tool of public health since the 1960s in five major domains: traffic safety, gun violence, tobacco use, reproductive health and obesity. These topical stories illustrate both law’s effectiveness and limitations as a public health tool. They also establish its popularity by the most apt of metrics – the willingness of legislators to enact it. The one picture worth a thousand words, below, depicts the rapid adoption of a variety of interventions by state legislatures. (By the way, the five examples also show that public health law research can and does influence the development and refinement of legal interventions over time.)
According to officials, the worst of this year’s devastating flu season should be over in most parts of the country. But in early January, the flu had hit 47 of 50 states. According to the CDC, a total of 78 influenza-associated pediatric deaths have been reported. Throughout this terrible flu season, there’s been much talk about vaccination mandates for health care workers.
States have started passing legislation regulating health care worker flu vaccination, and an increasing number of hospitals have started implementing policies in attempt to reach the Healthy People 2020 goal of having 90 percent of health care workers vaccinated. Only two-thirds of health care workers were vaccinated against the flu last year. This can leave patients at risk and hospitals short-staffed because of absenteeism.
This past week, PHLR hosted 150 researchers, lawyers, public health practitioners and others for our fourth annual meeting. With our theme for the conference in mind, “Driving Legal Innovation,” our attendees shared results of evaluations of laws and regulations, offered up suggestions for new ways to use law to improve health, and attacked head on the issues facing the United States and our public health.
While you wait for more multimedia content, here are a few highlight moments: Continue reading →
The Congressional Budget Office just released a comprehensive new report investigating the budgetary effects of a hypothetical increase in the federal excise tax on cigarettes and small cigars from, $1.01 to $1.51 in fiscal year 2013. The report’s level of sophistication is unprecedented in its ability to evaluate the effects this change could have. Given the federal budget’s current state of affairs, perhaps the most significant finding from the analysis is that increasing the excise tax on cigarettes could reduce federal budget deficits by a total of about $42 billion through 2021. The value of the health costs and lives saved goes without saying.
Of course, the same could be said for some other products that can be harmful to health. Alcohol taxes also suppress consumption and reduce the harms associated with drinking, and thanks to inflation and the absence of indexing in state tax laws, they are generally now at real rates we had in the ’50s and ’60s. See Alex Wagenaar’s systematic review for more on the subject.
So, if a majority of Americans are seeing a need for revenue, why not raise it, in part, where the result will also include saved lives and saved health care costs?
There’s so much we still don’t know about the prescription opioid problem. The partial remedies advanced so far reflect this:
Prescription Drug Monitoring Programs, which in essence define the problem as doctor-shopping patients;
treatment guidelines, which define the problem as doctors without expertise; and
crackdowns on “pill-mills,” which see the issue as physician corruption. Each of these diagnoses has an element of truth, but not necessarily enough to make the treatments effective.
One huge part of the problem has gotten far too little attention: the pharmaceutical supply chain where all these drugs start and along which they are distributed. Now, John Coleman, a former DEA officer, has given us a thorough and compelling primer on the supply chain, describing it and showing where the pressure points are for action. He is not happy about what he sees: DEA is overwhelmed, and too secretive with its data; and the distributors are too interested in profits and far too unwilling to police paying customers. But he also sees room for action and even hope. This article is well worth a read if you are interested in the overdose problem and how to solve it:
P.S. — One of the hopeful signs he sees was Florida’s legislation beefing up state-level monitoring and controls. This takes me back to the successful Wisconsin Cancer Pain Initiative in the 70s and 80s, which articulated the Principle of Balance in drug control and demonstrated that it was possible to have good access to pain medicine and effective control. In those days, David Joranson, the state drug controller, worked closely with DEA, using state regulatory authority to shut down docs and pharmacies who were acting outside the law. The possibility of history repeating itself is a ray of sunlight in the cloudy skies of this issue. (If you are interested in the story, here’s one place to start: Joranson, D., and J. L. Dahl. “Achieving Balance in Drug Policy: The Wisconsin Model.” In Advances in Pain Research and Therapy, edited by CS Hill Jr. and WS Fields. 197-204. New York: Raven Press, 1989.)
Somewhere along the way, environmental law and public health law got separated. Despite the importance of clean air and water to public health – not to mention parks, recreation, salubrious zoning – the two fields developed independently in the law. That’s changing in a lot of ways, and one very good example is a study proceeding now in New York City.
The National Football League has given the National Institutes of Health $30 million for research on traumatic brain injury. There is much we don’t know about the causes, effects, prevention and treatment of sports-related brain injury – but that doesn’t mean that we should put all our eggs into the basket of biomedical research. Since Washington state pioneered its youth-sports brain injury prevention model-law in 2009, 40 states have passed laws setting out rules aimed at the problem (We’re tracking these on LawAtlas, the new PHLR policy surveillance portal). Most of these laws work by promoting identification of concussions, regulating the athlete’s return to play, and educating parents and coaches.
To put it another way, the nation, through a majority of its state legislatures, has embarked on a major initiative to reduce sports-related injuries. Tens of millions of people will be affected in some way – athletes, parents and coaches. Limited school-based resources will be consumed to comply with these laws. And, most importantly, people worried about the problem will, to some extent, rely on implementation of these laws to protect student athletes.
If this public health intervention were a drug or a new technique for changing behavior, its efficacy would be rigorously tested by government-funded research. Why should things be different because this possibly magic bullet happens to be based in the law? So far, the CDC has funded implementation case studies of youth sports concussion laws in Washington and Massachusetts. PHLR is funding a more in-depth study in Washington, with results expected next year.
It’s easy to see the value of including scientists in public health law research teams; most public health lawyers lack the training to conduct rigorous empirical research. It may be harder to see the need for adding lawyers to the research team, but their presence is no less critical. Sometimes scientists have as much trouble understanding the law as the lawyers have understanding the science.
The value of involving lawyers in public health law research became clear to me recently as I was working on a project relating to health policies affecting immigrants. One question I wanted to know was how the 1996 Personal Responsibility and Work Opportunity Reconciliation Act (PRWORA) affected immigrants’ access to health insurance in the United States. So I decided to review the scientific literature. The results were dismaying.
An article by Julia Costich, MPA, JD, PhD, and Dana Patton, PhD, in the October 2012 edition of the American Journal of Public Health reveals the tip of the iceberg on a highly discussed and yet insufficiently researched topic: the legal infrastructure. While the team reports a significant impact of the legal infrastructure of local health departments on population health outcomes, the paper also raises questions regarding the role of law more generally in the functioning of health departments.
While we “see” law all the time in action, we rarely “see” law as an important factor influencing the way health agencies operate. Sure, we understand law as a way to drive the behavior of individuals by regulating sugar-sweetened beverages or prohibiting texting while driving or preventing smoking in indoor spaces — this is called interventional law — but there is a lesser-known cousin, infrastructural law, that desperately needs our attention.
While public health officials, policy-makers, advocates and academics regularly discuss the funding and organization of health departments at both the state and local levels, they less often step back to think about what is driving the process — law. As states are facing significant fiscal crisis, funds are a major concern, but it is important to remember that appropriations are made through law. Additionally, in recent years, during natural disasters such as hurricanes in the south and major floods in New England, there were questions in the news about which agencies should be doing what and when. The authority for a health department to act and/or to act in concert with another agency is derived from law.