Happy Birthday to our National Health Service (NHS)

By John Tingle

Our National Health Service turns 70 in July and has made remarkable achievements since its inception on July 5, 1948. The NHS is quite rightly an institution to be proud of, and it is envied across the world. Admittedly, the NHS does have its problems, but these should not detract from an overall appreciation of its core value to our society.

In 70 years a lot has happened. Nursing and medicine have evolved, new treatments, and medicines have been developed to cope with new diseases, and our concept of health has also changed.

Health is no longer just the absence of disease; it’s a far more holistic concept today.

Since its inception, the NHS has had to deal with clinical negligence claims. Today there is mounting concern that the high level and costs of clinical negligence claims threaten the very existence and fabric of the NHS.

Exactly what must be done to reduce levels and costs remains a topic of intense speculation and conjecture.

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Making “Meaningful Access” Meaningful: Equitable Healthcare for Divisive Times

By Leslie Francis

Another anniversary of President Bush’s signing of the Americans with Disabilities Act (ADA) is coming up in late July, yet the nation remains far from offering even a semblance of equitable societal opportunity to most individuals with disabilities.

For them, full social participation is dismissed as merely an idealistic dream. With its focus on restoration of full functioning for patients, the health care delivery system might be supposed an exception, but a closer look shows the opposite is true.

Physicians’ offices, clinics, and hospitals too often have not been made accessible. Too frequently, these facilities have diagnostic or treatment equipment that some people, due to disability, cannot use. Health care provider staff are not trained to interact with or assess disabled individuals, and may be swayed by implicit biases that target disability, just as are non-medical personnel or laypersons in the population.

disability rights protest sign

Photo by The Leadership Conference on Civil and Human Rights/Flickr

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Scott Burris and Abraham Gutman on ‘The Week in Health Law’ Podcast

By Nicolas Terry

Special guest host Wendy Mariner from Boston University and I welcome Scott Burris and Abraham Gutman from Temple University’s Center for Public Health Law Research. We discuss the failures associated with the Fair Housing Act, including the delayed implementation of the Affirmatively Furthering Fair Housing rule, the eviction epidemic highlighted in Matthew Desmond’s book Evicted: Poverty and Profit in the American City, the tragedy of the silos in public health interventions, and the application of the concept of “health in all policies” to the housing crisis. Continue reading

Patient Safety, Health Quality and Learning Disability

By John Tingle

Tragic stories of mental health care failings leading to injury and in some cases death have featured strongly in the English media in recent years. The reports reveal common threads such as poor resources, inadequate staffing levels, limited service availability, poor inter-agency cooperation, poor patient engagement, poor understanding of the Mental Capacity Act 2005 and so on. This care area seems to largely remain a Cinderella health care service provision, existing in the shadows, with the focus being predominantly on physical acute care. There are however now welcome and firm Government commitments to drive improvement into mental health care supported by a raft of promising initiatives.

When patient stories of learning disability and autism care failings are read from several reference sources a picture emerges. Care for people with learning disability and autism can be seen to share many of the patient safety and health quality problems that beset patients who are classified as being mentally ill: Continue reading

World Trade Month: Trade’s impact on domestic drug prices

By Oliver Kim

Happy World Trade Month! While health policy is often seen as something particularly domestic, trade can have an impact on health policy here at home.

Just a day before President Trump’s speech outlining the administration’s approach to rising drug costs, the Pharmaceutical Research and Manufacturers of America (PhRMA) declared May as a time to “celebrate the many American companies exporting products around the world.” However, PhRMA also warned that “Americans should not subsidize the medicine costs in other wealthy countries.”

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2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics

2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics
June 1, 2018 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

“Congress acknowledged that society’s accumulated myths and fears about disability and disease are as handicapping as are the physical limitations that flow from actual impairment.” Justice William J. Brennan, Jr., School Bd. of Nassau, Fl. v. Arline, 480 U.S. 273 (1987).

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2018 annual conference, entitled: “Beyond Disadvantage: Disability, Law, and Bioethics.” This year’s conference is organized in collaboration with the Harvard Law School Project on Disability.

Conference Description

Historically and across societies people with disabilities have been stigmatized and excluded from social opportunities on a variety of culturally specific grounds. These justifications include assertions that people with disabilities are biologically defective, less than capable, costly, suffering, or fundamentally inappropriate for social inclusion. Rethinking the idea of disability so as to detach being disabled from inescapable disadvantage has been considered a key to twenty-first century reconstruction of how disablement is best understood.

Continue reading

Thad Pope on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

Our guest this week is Thaddeus Mason Pope, Director of the Health Law Institute and Professor of Law at Mitchell Hamline School of Law. Thad is also a Ph.D. with multiple global academic posts. This week we discuss grave and complex problems in end of life care, focusing on the tragic case of Jahi McMath. Thad recently published “Brain Death Forsaken,” and offers a wealth of insight on this and similar situations. The definition of death has complex implications for insurance, reimbursement, malpractice, and even criminal law.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at Apple Podcasts, listen at Stitcher Radio Tunein, or Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on Twitter @nicolasterry @FrankPasquale @WeekInHealthLaw.

Monthly Round-Up of What to Read on Pharma Law and Policy

By Ameet Sarpatwari, Michael S. Sinha, and Aaron S. Kesselheim

Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.

Below are the abstracts/summaries for papers identified from the month of April. The selections feature topics ranging from experience with the FDA breakthrough drug designation pathway; to the impact of off-patent drug acquisitions on prices; to the Indian pharmaceutical patent prosecution. A full posting of abstracts/summaries of these articles may be found on our website.

  1. Corrigan-Curay J, McKee AE, Stein P. Breakthrough-Therapy Designation—An FDA Perspective. N Engl J Med. 2018 Apr 12;378(15):1457-1458.
  2. Darrow JJ, Avorn J, Kesselheim AS. The FDA Breakthrough-Drug Designation – Four Years of Experience. N Engl J Med. 2018 Apr 12;378(15):1444-1453.
  3. Desai RJ, Sarpatwari A, Dejene S, Khan NF, Lii J, Rogers JR, Dutcher SK, Raofi S, Bohn J, Connolly J, Fischer MA, Kesselheim AS, Gagne JJ. Differences in rates of switchbacks after switching from branded to authorized generic and branded to generic drug products: cohort study. BMJ. 2018 Apr 3;361:k1180.
  4. Goldman AL, McCormick D, Haas JS, Sommers BD. Effects of the ACA’s Health Insurance Marketplaces on the Previously Uninsured: A Quasi-Experimental Analysis. Health Aff. 2018 Apr;37(4):591-599.
  5. Gupta R, Henkel A, Forman HP, Ross JS. The Impact of Off-Patent Drug Acquisitions on Prices. J Gen Intern Med. 2018 Apr 23. [Epub ahead of print]
  6. Hwang TJ, Franklin JM, Chen CT, Lauffenburger JC, Gyawali B, Kesselheim AS, Darrow JJ. Efficacy, Safety, and Regulatory Approval of Food and Drug Administration-Designated Breakthrough and Nonbreakthrough Cancer Medicines. J Clin Oncol. 2018 Apr 24. [Epub ahead of print]
  7. Sampat BN, Shadlen KC. Indian pharmaceutical patent prosecution: The changing role of Section 3(d). PLoS One. 2018 Apr 2;13(4):e0194714.

Jessica Roberts on ‘The Week in Health Law’ Podcast

By Nicolas Terry and Frank Pasquale

Subscribe to TWIHL here!

Jessica Roberts, the Director of the Health Law and Policy Institute and a George Butler Research Professor at the University of Houston Law Center, returns to the pod. In her research, Jessica has offered compelling and innovative perspectives on a range of issues in heatlh care research, finance, privacy, and ethics.

Jessica’s book on “Health-ism,” co-authored with friend of the pod Elizabeth Weeks Leonard, is forthcoming from Cambridge University Press. We begin by discussing health discrimination before, during, and after the ACA. Then, we discuss Jessica’s take (admirably articulated in a recent Michigan Law Review book review) on the nudging at the center of healthcare’s version of behavioral economics.

The Week in Health Law Podcast from Frank Pasquale and Nicolas Terry is a commuting-length discussion about some of the more thorny issues in Health Law & Policy. Subscribe at Apple Podcasts, listen at Stitcher Radio Tunein, or Podbean, or search for The Week in Health Law in your favorite podcast app. Show notes and more are at TWIHL.com. If you have comments, an idea for a show or a topic to discuss you can find us on Twitter @nicolasterry @FrankPasquale @WeekInHealthLaw.

The Notable Absence of Regulating Cannabis in FDA Commissioner Scott Gottlieb’s Keynote Address to FDLI 2018

by Tara Sklar

At the Food and Drug Law Institute (FDLI) 2018 Annual Conference, the Commissioner of Food and Drugs, Scott Gottlieb, gave the Keynote Address to kick-off the largest turnout yet for this event of over 900 attendees. Commissioner Gottlieb’s remarks started off with how previous FDA Commissioners used this opportunity to recap the past year, but he would be different, he would lay out the strategic priorities for next year.

The room went nearly silent, as Commissioner Gottlieb steadily went through the many sectors the agency oversees, and where he believes the FDA will play a larger leadership role, including in the epidemics of addition (opioid crisis), drug costs, and greater access to generic competition. He laid out a vision that most people in the room would probably subscribe to, including “You’re public health minded, and work hard to deliver innovations that’ll advance human health. The problem is that a few bad apples, that game the system, can tarnish the entire brand of an otherwise principled industry.”[1] Close to the end of his thirty-minute speech, Commissioner Gottlieb firmly addressed the companies that produce e-cigarettes, and said, “If you target kids, then we’re going to target you.”[2]

Indeed, Commissioner Gottlieb mentioned so many FDA strategic priorities, and in such unequivocal detail for how they plan to regulate, that when the President & CEO of the FDLI, Amy Comstock Rick, thanked him and introduced the follow-up panel to discuss the issues Commissioner Gottlieb raised, she said, “We reserved one-hour in the conference to discuss Commissioner Gottlieb’s Keynote Address, but we may need five.” However, there was an area that was not brought up in Commissioner Gottlieb’s wide-ranging speech, despite its very active place in the media and scientific journals calling for the FDA to have a greater role, and more consistent guidance, and this prominent area is the future regulation of cannabis. Continue reading

REGISTER NOW! Ordeals in Health Care: Ethics and Efficient Delivery

Ordeals in Health Care: Ethics and Efficient Delivery
May 10-11, 2018 1:00 PM
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA
 

Economic ordeals are interventions that deliberately make access to products or services more difficult in an effort to improve resource allocation. In this vein, making patients wait in long lines to schedule an appointment with a specialist might discourage patients with needs that could be met by less qualified personnel from taking up the specialist’s time, thus freeing up time for those with complex needs. Similarly, putting brand-name medications at the bottom of a long list of options on clinicians’ computers might encourage them to prescribe a generic brand listed closer to the top.

Recent research in development economics, behavioral economics, and health policy suggests that some economic ordeals could help target health resources to patients who are more likely to utilize these resources, without the regressive effects of co-pays and other forms of financial participation on the part of patients. However, making health care deliberately less accessible raises ethical challenges. Is it not the case that ordeals discourage utilization by patients with acute needs? Do these ordeals affect some disadvantaged populations disproportionately? And do deliberate obstacles to health resource utilization violate the human right to health?

This workshop will bring together leading scholars in economics, ethics, health policy, public health, medicine, sociology, and law to explore these questions.

This event is organized by Nir Eyal, PhD, Associate Professor of Global Health and Population, Harvard T. H. Chan School of Public Health, and Anders Herlitz, PhD, Visiting Scientist, Harvard T. H. Chan School of Public Health and Researcher, Department of Philosophy, Linguistics and Theory of Science, University of Gothenburg, Sweden.

This event is free and open to the public, but seating is limited and registration is required. Register now!

Co-sponsored by the Harvard T.H. Chan School of Public Health; the Edmond J. Safra Center for Ethics at Harvard University; the Petrie-Flom Center for Health Law, Biotechnology, and Bioethics at Harvard Law School; the Mossavar-Rahmani Center for Business and Government at the Harvard Kennedy School of Government; and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund at Harvard University.

Register for and learn more about the event here!

Join us- we are hiring: Postdoctoral position in Biomedical Innovation Law with a focus on Biologics

Having a PhD and specialized in biomedical innovation law & legal/regulatory issues in biologic drug development? Interested in empirical legal research and data analysis?Then join our international research collaboration at the University of Copenhagen with core partners from i.a. the UK (University of Cambridge) and the US (Harvard Medical School, Harvard Law School (PFC) & Michigan Law School). Apply for a PostDoc position at the Center for Advanced Studies in Biomedical Innovation Law right here  .

Elder abuse is not substantiated

Philip C. Marshal is an elder justice advocate and founder of Beyond Brooke. The remarks below were prepared for Our Aging Brains: Decision-making, Fraud, and Undue Influence, part of the Project on Law and Applied Neuroscience at Harvard Law School; April 27, 2018. The complete version of Decision-making, fraud, and undue influence—illustrated through the lens of the Brooke Astor story was published April 28, 2018 in Medium.

The meaning of elder abuse remains misunderstood, even by professionals.

I know—from hard-learned experience—when I, and many others, worked to save my grandmother from abuse by my father.

In a December 2006 court decision, my grandmother’s guardianship judge authorized reimbursement of my legal fees for bringing a guardianship petition for my grandmother, stating, “Although this matter voluntarily settled before the hearing, I find the petitioner Philip Marshall was the prevailing party…”

But the judge also decided to award my father a portion of his legal fees, writing, “I make this ruling based on the conclusion of the court evaluator that the allegations in the petition regarding Mrs. Astor’s medical and dental care, and the other allegations of intentional elder abuse by the Marshalls, were not substantiated.” [italics added]

Decision—In the Matter of the Application of Philip Marshall for the appointment of a Guardian for the Person and Property for Brooke Astor, an Alleged Incapacitated Person. Judge John A. Stackhouse, Supreme Court of the State of New York. December 4, 2006 Continue reading

2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics

2018 Petrie-Flom Center Annual Conference: Beyond Disadvantage: Disability, Law, and Bioethics
June 1, 2018 8:00 AM – 5:00 PM
Wasserstein Hall, Milstein East ABC (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

“Congress acknowledged that society’s accumulated myths and fears about disability and disease are as handicapping as are the physical limitations that flow from actual impairment.” Justice William J. Brennan, Jr., School Bd. of Nassau, Fl. v. Arline, 480 U.S. 273 (1987).

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is pleased to announce plans for our 2018 annual conference, entitled: “Beyond Disadvantage: Disability, Law, and Bioethics.” This year’s conference is organized in collaboration with the Harvard Law School Project on Disability.

Conference Description

Historically and across societies people with disabilities have been stigmatized and excluded from social opportunities on a variety of culturally specific grounds. These justifications include assertions that people with disabilities are biologically defective, less than capable, costly, suffering, or fundamentally inappropriate for social inclusion. Rethinking the idea of disability so as to detach being disabled from inescapable disadvantage has been considered a key to twenty-first century reconstruction of how disablement is best understood.

Continue reading

Tertiary Patents: An Emerging Phenomenon

By Jonathan J. Darrow

Brand-name pharmaceutical manufacturers have long been known to try to protect and extend their market exclusivity periods by obtaining patents on a drug’s substance (“primary patents”) and also on its peripheral features, such as formulations or methods of manufacture (“secondary patents”). A new study describes an emerging phenomenon of “tertiary patents,” which have the potential to further delay and discourage market entry in the context of drug-device combination products.

Combination products are defined by the U.S. Food and Drug Administration (FDA) to include therapeutic products that combine a drug with a device, such as an inhaler or injector pen. These products can sometimes offer life-changing or life-sustaining treatment, as with naloxone (Narcan) for opioid overdose or epinephrine (EpiPen) for severe allergic reactions. In recent years, these and other similar products have been the subject of substantial controversy related to their prices and prolonged lack of generic competition.

To investigate the potential role of patents on the prices and exclusivity periods of drug-device combination products, two researchers at the Program On Regulation, Therapeutics, And Law (PORTAL) at Brigham and Women’s Hospital and Harvard Medical School (where I hold a faculty appointment) conducted a comprehensive evaluation of drug-device combination patents registered with the FDA. They found that patents related to drug delivery devices have tripled since the year 2000 and contribute a median of five years of additional market exclusivity to those products (subject, of course, to potential judicial or administrative patent invalidation). Furthermore, the researchers identified a subset of 31 products having only device patents (i.e., having no primary or secondary patents), and found that these patents were scheduled to expire a median of 17 years after FDA approval. Continue reading

Diseases of Despair on ‘The Week in Health Law’ Podcast #2

By Nicolas Terry and Leo Beletsky 

Subscribe to TWIHL here!

In April, 2018 the Northeastern University School of Law held a conference titled “Diseases of Despair: The Role of Policy and Law.” TWIHL was asked to be the event’s podcast partner and we roped in Leo Beletsky, our friend and one of the conference organizers, to act as co-host for two special TWIHL episodes. Professor Beletsky, holds a joint appointment with the Northeastern University School of Law and Bouvé College of Health Sciences. His research examines the use of law to improve health, with a focus on drug policy, reducing the spread of infectious disease, and the role of the criminal justice system in shaping public health outcomes. Continue reading

Call for Proposals: Symposium – Serving the Needs of Medicaid Populations

The Beazley Institute for Health Law and Policy at Loyola University Chicago School of Law and Annals of Health Law invite original research paper submissions for presentation at our Twelfth Annual Health Law Symposium: Serving the Needs of Medicaid Populations. The Symposium will take place at Loyola University Chicago School of Law on Friday, November 16, 2018.

The Symposium will explore whether the current Medicaid system is adequately serving the needs of its target population, and how social determinants of health affect access to care in the context of Medicaid. The Symposium is intended to touch upon a wide variety of areas responsive to this overall theme.  Accordingly, we invite submissions addressing any and all aspects of Medicaid and/or its impact upon accessible, quality patient care. Possible approaches to this Call for Proposals include, but are not limited to:

  • Medicaid’s impact on the financial viability of hospital systems and physician practices and the effect this has on access to health care. Topics may explore the financial burdens and/or benefits faced by health systems after Medicaid expansion, economic viability of health systems in states that did not expand Medicaid, and corporate restructuring in the wake of Medicaid reform.
  • The current status of Medicaid in relation to access to health care. Topics may include the health access trends within states that expanded or shrunk Medicaid, state use of Medicaid waivers, Medicaid work requirements, and shifts in DHHS practices and policies.
  • Populations underserved by Medicaid. Topics may explore immigrant access to care in Medicaid, access problems surrounding individuals with medical complexities, and children with disabilities in Medicaid.
  • Proposals to reform Medicaid in order to increase access and reduce social disparities. Topics may include new proposed models that increase access to care, the ACA’s role in expanding access under Medicaid, and bridging the disconnect between health care spending and health outcomes in the United States through Medicaid reform.

Submission Information: Those interested in participating, please send a 1000-word abstract to  health-law at luc.edu by June 16, 2018.  Authors will be notified of decisions no later than July 14, 2018. It is our hope presenters will submit papers for publication in the Annals of Health Law. Papers submitted for publication will be due by January 8, 2019.

TOMORROW! Our Aging Brains: Decision-making, Fraud, and Undue Influence

Our Aging Brains: Decision-making, Fraud, and Undue Influence
April 27, 2018 7:30 AM – 12:30 PM
Wasserstein Hall, Milstein East (2036)
Harvard Law School, 1585 Massachusetts Ave., Cambridge, MA

With over 70 million Baby Boomers retiring, elder financial exploitation has been labeled the “Crime of the 21st Century.” In this half-day event, we will explore the neuroscience, psychology, and legal doctrine of financial decision-making in older adults. How does the aging brain make financial decisions, and when is it uniquely susceptible? How can courts best use science to improve their adjudication of disputes over “competency”, “capacity”, and “undue influence”? Is novel neuroimaging evidence of dementia ready for courtroom use? This conference will bring together experts in medicine, science, and law to explore these important questions and chart a path forward for dementia and the law.

Part of the Project on Law and Applied Neuroscience, a collaboration between the Center for Law, Brain & Behavior at Massachusetts General Hospital and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

Learn more about the event here!

A Roadblock in Maryland

By Zack Buck

In a 2-1 decision, a three-judge panel of the Fourth Circuit Court of Appeals has struck down Maryland’s pharmaceutical price-gouging law.

The law, which went into effect on October 1 of last year, prohibited drug manufacturers from imposing “unconscionable” price increases, empowering the state attorney general to assess civil penalties against drug manufacturers and to enjoin the sale of such drugs in Maryland.  The law applied only to essential off-patent or generic drugs, and specifically allowed the attorney general “to intervene if a generic or off-patent drug’s price increased by 50 percent or more in a single year,” in addition to acting on other “unjustified” increases.

The court, writing through Judge Stephanie Thacker, found that the law ran afoul of the “dormant” commerce clause, in that it empowered Maryland to regulate transactions that occurred completely outside of the state.

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Patient Safety Failings in Independent Acute Hospitals in England

By John Tingle

One thing that strikes the UK visitor to the USA is the vast array of  large public and private hospitals that exist with many having trauma and emergency rooms. Private hospitals don’t exist on this scale in the UK. Our major hospitals are public, state run NHS (National Health Service) hospitals. Independent, private acute hospitals are generally small in size, have no emergency rooms and maintain a bespoke health care provision. The focus is on patients with a single condition and routine elective surgery. The myriad number of complex multiple conditions, dementia etc that the NHS regularly face as a norm are not covered in the independent sector here with such cases being screened out. This limited focus on the type of care provided does mean that staff within independent acute hospitals have a sheltered and more controlled work remit and environment. This is a significant patient safety issue.

The Independent Health and Social Care Regulator of England, the Care Quality Commission (CQC) have recently published their findings of independent acute hospital inspections. They inspected and rated 206 independent acute hospitals and the majority were assessed as providing high quality care. At 2nd January 2018, 62% were rated as good,16 (8%) as outstanding. The report contains some very positive findings on health care provision in these hospitals but also some major governance and patient safety failings were found which are very concerning.

The Independent Newspaper reported back in 2015 reported that private hospitals ‘lack facilities to deal with emergencies’, and quoted a study that found that between 2010 and 2014, 800 patients, including those referred by the NHS, died unexpectedly in private hospitals. Continue reading