Bold New Policies for The Brave New Biologies: IPRs and Innovation in Synthetic Biology and Gene editing

Research Seminar at the University of Copenhagen debating intellectual property and innovation in synthetic biology, systems biology & gene editing.

New technologies in biology offer a brave new world of possibilities. Promising solutions to some of the most urgent challenges faced by humanity: climate change, environmental protection, growing population, renewable energy and improved health care. Scientific and technological progress has been remarkable. Simultaneously, emerging life science technologies raise outstanding ethical, legal and social questions.

In this research seminar, Prof. Esther Van Zimmeren from the University of Antwerp joins Prof. Timo Minssen, Postdoc Ana Nordberg and Ph.D. Student Jakob Wested from the Centre for Information and Innovation Law, debating bold new policies for intellectual property law and incentive to life science innovation.

Programme

15:00 – 15:10 Welcome
Prof. Timo Minssen, CIIR, Faculty of Law, University of Copenhagen.
15:10 – 15:30 Waiting for the Rumble in the Jungle: – An overview of current CRISPR/CAs9 patent disputes, central legal issues and some thoughts on conditioning the innovation system.
PhD Student Jakob Wested, CIIR, Faculty of Law, University of Copenhagen.
15:30 – 15:50 From FRAND to FAIR for Synthetic and Systems Biology? The Implications of Openness, IP Strategies, Standardization and the Huawei-case.
Prof. Esther van Zimmeren, Faculty of Law, University of Antwerp.
15:50 – 16:10 Keeping up with the technologies: IP Law and Regulation in the age of gene editing.
Postdoc Ana Nordberg, CIIR, Faculty of Law, University of Copenhagen.
16.10 – 17.00 Questions and panel debate

Time: 13 March 2017, 15:00 – 17:00

Venue: Meeting Room 7A-2-04 , Faculty of Law, Njalsgade 76, DK-2300 Copenhagen S

Registration:
The event is free to attend. Registration is mandatory. Please use this registration form no later than Monday, 13 March 2017, 11:00 at the latest.

Organizer: Copenhagen Biotech & Pharma Forum, at CIIR, Faculty of Law, University of Copenhagen

Fantastic New Resource on Regulation

Peter Drahos and a roster of the minds that have made RegNet at the Australian National University the hub of regulatory research and theory have put (it seems) all they know into a new, FREE ebook, Regulatory Theory: Foundations and Applications.  It is a comprehensive account of the field, written to serve both as a reference for the essentials and a text book for classes in regulation and governance.  It even has a chapter on regulatory research methods in public health by this correspondent.

I am hoping to conduct a serial book review over the next couple of weeks. Here goes:

The first chapter is an introduction to the field by Drahos and Martin Krygier. It usefully orients the reader to the breadth of the field, a breadth that reflects the spread of regulatory activity beyond the state and across networks. Attention to those two phenomena, indeed, is properly presented as the foundation of the field.  There is a bit of intellectual history, highlighting the sigificance of Ayres and Braithwaite’s Responsive Regulation, and the emergence of RegNet as an intellectual gathering place. (I saw that first hand, and had a little experience of RegNet collegiality, when I spent a semester there and ended up writing an article on Nodal Governance with Drahos and Clifford Shearing — still my most downloaded paper.) Read More

CMS Publishes Final Rule Revising and Expanding Conditions for HHA Participation in Medicare and Medicaid

By Wendy S. Salkin

The Centers for Medicare and Medicaid Services (CMS) finalized a rule concerning home health agencies on January 9th, “Medicare and Medicaid Program: Conditions of Participation for Home Health Agencies.” The rule has been a long time coming, since the proposed rules were set forth on October 9, 2014. This is the first time that CMS has successfully updated the home health agency (HHA) conditions of participation (CoPs) since 1989.

The aim of the final rule, according to CMS, is to “improve the quality of health care services for Medicare and Medicaid patients and strengthen patients’ rights.” The final rule

revises the conditions of participation (CoPs) that home health agencies (HHAs) must meet in order to participate in the Medicare and Medicaid programs. The requirements focus on the care delivered to patients by HHAs, reflect an interdisciplinary view of patient care, allow HHAs greater flexibility in meeting quality care standards, and eliminate unnecessary procedural requirements.

According to CMS,

[t]hese changes are an integral part of [the Agency’s] overall effort to achieve broad-based, measurable improvements in the quality of care furnished through the Medicare and Medicaid programs, while at the same time eliminating unnecessary procedural burdens on providers.

As is likely well known to readers, the use of home health services in the United States is widespread. According to the National Center for Health Statistics, as of 2014, there were 12,400 home health agencies in the United States and, during 2013, 4.9 million patients in the United States received and ended care from home healthcare workers. These numbers have since risen, and today in the United States there are nearly 12,600 Medicare and Medicaid-participating home health agencies and more than 5 million patients. Home health care serves a wide range of purposes. The Medicare website touts it as “usually less expensive, more convenient, and just as effective as care you get in a hospital or skilled nursing facility (SNF).” In addition to serving the aims of treating illness or injury, according to Medicare home health care “helps [patients] get better, regain [their] independence, and become as self-sufficient as possible.” Some examples of what home health care providers do with and for patients, upon doctor’s orders, include: wound care, patient and caregiver education, intravenous or nutrition therapy, injections, monitoring patient health condition, monitoring patient drug and treatment use, teaching patients how to care for themselves, and coordinating care between the patient, their doctor, and any other caregivers. Read More

Well-rested versus well-trained doctors: New twist in debate over resident duty hours (Part II)

By Brad Segal

When people fall acutely ill, they deserve a non-sleep deprived doctor—but they also deserve an adequately-trained doctor. There are only so many hours to the day, and so in medical education a resident’s need for self-care must be balanced against the need for maximum clinical exposure. Since 2003, when restrictions to resident duty hours were first enacted, there has been disagreement about how to best navigate the tension. Recently, the debate resurfaced when the Accreditation Council for Graduate Medical Education (ACGME) proposed a change to the policy governing resident duty hour limits. Perhaps the most surprising part of the announcement was that their proposal increased the time limit that interns (first year residents) can care for patients without sleep. The policy ACGME enacted in 2011 had capped interns at 16 hours on-call, and the proposal increases the limit to 28 hours.

In my prior post I raised arguments for and against the proposed changes to duty hour limits. Here I will unpack the conclusions and limitations of the best empirical evidence available to ACGME: the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial. Published in the New England Journal of Medicine (NEJM) in 2016, the FIRST Trial randomized 117 surgical residency programs nationwide to have either “standard” duty hour policies, which included the current 16-hour cap on interns, or “flexible” policies, which reflect the recent ACGME proposal. Data were collected from July 2014 to June 2105. The sister-study involving medical residencies nationwide has regrettably not yet published.

The FIRST Trial warrant close attention because, like a Rorschach test, different people see different things in the data. For instance, take the finding that neither group caused significantly more or less harm to patients, though shorter duty hours were associated with more handoffs of patient responsibility. Taken at face value, these results neither clearly bolster nor contradict the proposed duty hour changes; yet they are used to both support and undermine the tentative changes to ACGME policy. The study’s first author told NPR that, “We believe the trial results say it’s safe to provide some flexibility in duty hours.” On the other hand, an editorial published in NEJM alongside the study argues that, “The FIRST Trial effectively debunks concerns that patients will suffer as a result of increased handoffs and breaks in the continuity of care.” Is there a right conclusion to draw from the study? Read More

REGISTER NOW (1/23/17)! PFC’s 5th Annual Health Law Year in P/Review

The Fifth Annual Health Law Year in P/Review symposium will feature leading experts discussing major developments during 2016 and what to watch out for in 2017. The discussion at this day-long event will cover hot topics in such areas as health policy under the new administration, regulatory issues in clinical research, law at the end-of-life, patient rights and advocacy, pharmaceutical policy, reproductive health, and public health law.

This year’s Health Law Year in P/Review is sponsored by the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, Harvard Health Publications at Harvard Medical School, Health Affairs, the Hastings Center, the Program On Regulation, Therapeutics, And Law (PORTAL) in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, and the Center for Bioethics at Harvard Medical School, with support from the Oswald DeN. Cammann Fund. 

Agenda Read More

New twist in debate over resident duty hours (Part I)

By Brad Segal

Amidst a roller-coaster presidential campaign, on November 4th the Accreditation Council for Graduate Medical Education (ACGME) presented a plan to change resident duty hour limits. That the specifics have largely flown under the radar is perhaps unsurprising given the current news cycle. But the understated revision to, “Resident Duty Hours in The Learning and Working Environment” is the latest twist in a relatively contentious issue within medical education (see 2016 NEJM op-ed vs. responses). The proposal is currently undergoing requisite comment period until December 19. This week I’ll briefly lay out the history of duty hours to help explain the significance of ACGME’s proposal, and I will then go through general empirical arguments for and against such a change. My next post will examine how well these argument hold in light of the most recent data available.

Today the physicians’ training experience immediately following medical school is no longer the whir of dangerous sleep deprivation lampooned in the House of God. Amid mounting evidence that resident sleep deprivation caused medical errors, and under threat of federal legislation, in 2003 the ACGME first introduced national guidelines restricting resident work hours to 80 hours per week (averaged over 4 weeks), and capped residents to 30 hours of continuous in-house call. Then in 2009 the Institute of Medicine (IOM) released a 427-page report reviewing scientific evidence on resident work hours, sleep deprivation, and fatigue-related errors. The evidence overwhelmingly suggests that sleep deprivation significantly impairs most aspects of cognition. Hence the IOM ultimately recommended that residents not exceed 16 hours of continuous work before dedicated rest.

The ACGME subsequently modified duty hour guidelines in 2011 and limited first-year residents (‘interns’) to working 16-hour stretches. The reason ACGME’s most recent proposal is curious, though, is that it back-tracks on the 2011 intern duty-hour limits, raising their in-house cap to 28 hours. In response to this proposal a national advocacy group, Public Citizen, claimed it, “would expose residents, their patients and the general public to the risk of serious injury and death.” Read More

NEW REPORT: Protecting and Promoting the Health of NFL Players – Legal and Ethical Analysis and Recommendations

fphs_lawethics_coverThe Football Players Health Study at Harvard University today released a set of legal and ethical recommendations to address a series of structural factors that affect NFL player health. The Football Players Health Study is a research initiative composed of several ongoing studies examining the health and wellbeing of NFL players.

The newly released report, nearly 500 pages long, is based on analysis performed over two years by researchers from the Petrie-Flom Center at Harvard Law School, and is unprecedented both in scope and focus. (Read the executive summary).

This is the first comprehensive analysis of the legal and ethical obligations of various stakeholders that influence the health of NFL players. While clinical interventions are essential, players’ health is also affected by the environment in which players work.

The report reviews and evaluates the roles of 20 relevant stakeholders, including the NFL, NFL Players Association (NFLPA), players, and Club (team) doctors.  In total, the report makes 76 recommendations.

Highlights of the key proposals are summarized below: Read More

Medical Errors – The Third Leading Cause of Death in the US

Source: https://i0.wp.com/www.lawbbg.com/images/top-banner/medical-malpractice.jpg?resize=353%2C195By Matthew Young

John James, PhD, became involved in the movement to bring greater attention to patient safety and rampant medical errors by way of tragedy. In 2002, Dr. James lost his 19-year-old son as a result of problematic care provided by cardiologists at a hospital in central Texas. A toxicologist by training, Dr. James taught himself cardiology in order to piece together the events that led to the death of his son despite an extensive evaluation by a team of cardiologists. His journey is chronicled in his book, “A Sea of Broken Hearts: Patient Rights in a Dangerous, Profit-Driven Health Care System.” From there, Dr. James became an advocate for patient safety and a crusader against medical errors. His website is called Patient Safety America.

Major media outlets around the globe extensively covered the recent British Medical Journal article showing that medical errors are the third leading cause of death in the US.  In 2013, Dr. James published a related paper in the Journal of Patient Safety that showed how nearly 440,000 lives per year are lost to medical errors in the American healthcare system.

I wanted to provide Bill of Health readers with a summary of how Dr. James’s paper in many ways pre-saged and perhaps even exceeds the recent BMJ article. A KevinMD article provides further context in this debate.

Read More

Social Media Use in Research Recruitment: A New Guidance Document from Petrie-Flom and Harvard Catalyst

stethoscope_computerImagine this scenario: you are a researcher conducting a clinical trial on a promising treatment for a rare but serious heart condition. Unfortunately, you are struggling to locate and enroll enough eligible participants and your study is at risk of not completing. Then you discover a Facebook support group for precisely the condition you are studying. The group is open: you do not need to be invited or to suffer from the condition to become a member—anyone can join. Here are the eligible participants you have been looking for!

But what are your obligations in approaching members of this group for recruitment? Would such recruitment be ethically advisable? Under what conditions? And what ethical norms apply when approaching sick and potentially vulnerable people for recruitment over social media? How should you (and the IRB) evaluate this type of activity from an ethical perspective?

Read More

Confidentiality or Public Disclosure: Trump’s Gastroenterologist and an Ethical Dilemma

By Brad Segal

“If elected, Mr. Trump, I can state unequivocally, will be the healthiest individual ever elected to the presidency,” proclaimed Dr. Harold Bornstein. The gastroenterologist’s letter, released on the candidate’s website nine months ago, stumbles from the outset with a typo (“To Whom My Concern,”), then steamrolls over the most basic descriptions of health (medical school teaches us that vital signs are, well, vital), omits information pertinent to the public discourse (why does it fail to mention the medical reason exempting Trump from the Vietnam draft?), and strangely emphases non-medicalized traits (“His physical strength and stamina are extraordinary”). Most experts agree that this medical record, if we can even call it that, is at best hyperbole. It draws grandiose conclusions without medical justification. Even Dr. Bornstein conceded, “In the rush, I think some of those words didn’t come out exactly the way they were meant.”

Just this morning the Trump campaign released a second letter from Dr. Bornstein. But this time the doctor rather humbly concludes, “In summary, Mr. Trump is in excellent physical health.”  These letters from Dr. Bornstein’s letter demonstrate a modern-day moral dilemma in providing care for a party nominee. At conflict is the physician’s professional duty to respect patient confidentiality, and his or her obligations to care for society more broadly.

First, patient-doctor confidentiality is not merely a byproduct of the law—it is a moral obligation grounded in the core tenants of the medical profession. To put it simply, if a patient comes to expect that his doctor will tell the entire community about the patient’s most embarrassing bodily defects, the patient may understandably deny his worsening symptoms of poor health at the next office visit. In the long run, erosion of trust in the medical system could endanger the public’s health–everyone is thus better off when doctors uniformly respect patient privacy. It is important to point out, however, that an informed and competent person can voluntarily waive one’s right to patient-doctor confidentiality, such as when a patient gives a physician the permission to provide updates to family members. Or when then-candidate John McCain instructed his physicians all 1,100 pages in his medical records.

Read More