Patient Safety and Communication Breakdown

Good communication is an essential prerequisite for good and safe patient care. To effectively communicate is an everyday life skill and it’s one of the most basic that we all must master in some way.

From a patient safety context, poor health carer communication practices are a worldwide problem which continues to cause global patient harm. The WHO states that communication failures are the leading cause of inadvertent patient harm.

Successive Health Service Ombudsman in England have maintained that communication failures are a leading cause of patient complaints. In 2014-2015 poor communication, including quality and accuracy of information, was a factor in one third of all health care complaints.

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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. Read More

Simulated Side Effects: FDA Uses Novel Computer Model to Guide Kratom Policy

By Mason Marks

FDA Commissioner Scott Gottlieb issued a statement on Tuesday about the controversial plant Mitragyna speciosa, which is also known as kratom. According to Gottlieb, kratom poses deadly health risks. His conclusion is partly based on a computer model that was announced in his recent statement. The use of simulations to inform drug policy is a new development with implications that extend beyond the regulation of kratom. We currently live in the Digital Age, a period in which most information is in digital form. However, the Digital Age is rapidly evolving into an Age of Algorithms in which computer software increasingly assumes the roles of human decision makers. The FDA’s use of computer simulations to evaluate drugs is a bold first step into this new era. This essay discusses the potential risks of basing federal drug policies on computer models that have not been thoroughly explained or validated (using the kratom debate as a case study).

Kratom grows naturally in Southeast Asian countries such as Thailand and Malaysia where it has been used for centuries as a stimulant and pain reliever. In recent years, the plant has gained popularity in the United States as an alternative to illicit and prescription narcotics. Kratom advocates claim it is harmless and useful for treating pain and easing symptoms of opioid withdrawal. However, the FDA contends it has no medical use and causes serious or fatal complications. As a result, the US Drug Enforcement Agency (DEA) may categorize kratom in Schedule I, its most heavily restricted category.

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The Opioid Crisis Requires Evidence-Based Solutions, Part II: How the President’s Commission on Combating Drug Addiction Ignored Promising Medical Treatments

By Mason Marks

Last year more than 64,000 Americans died of drug overdose, which is “now the leading cause of death” in people under 50. Opioids kill an estimated 91 Americans each day and are responsible for most drug-related deaths in the US. This public health crisis requires solutions that are supported by science and reason instead of emotion and political ideology. In Part I of this three-part series, I discuss how the President’s Commission on Combating Drug Addiction and the Opioid Crisis misinterpreted scientific studies and used data to support unfounded conclusions. In this second part of the series, I explore how the Opioid Commission ignored medical interventions that are used successfully in the U.S. and abroad. In Part III, I will discuss non-medical interventions such as drug checking and safe injection sites. The Commission’s failure to consider these options is likely driven by emotions such as fear and disgust rather than a careful review of scientific evidence.

Medical marijuana is currently accepted in 29 U.S. states and the District of Columbia. It is also permitted in at least 10 countries. However, the Opioid Commission outright rejected calls to consider the use of medical marijuana as an alternative to opioids for managing pain. Prior to the Commission’s first meeting, it solicited input from industry and members of the public on how to address the opioid crisis. In response, it received over 8,000 public comments. According to VICE News, which obtained the documents by submitting a Freedom of Information Act (FOIA) request, most comments were submitted by individuals urging the Commission to “consider medical marijuana as a solution to the opioid epidemic.” A spokesman for the Office of National Drug Control Policy, a body of the Executive Branch that provides administrative support to the Opioid Commission, reports receiving “more than 7,800 public comments relating to marijuana.” Despite these comments, in its final report, the Commission dismissed the notion that marijuana should play a role in treating chronic pain and opioid addiction. Its report cited a recent study from the American Journal of Psychiatry, which concluded that marijuana use was associated with an increased risk of opioid abuse. However, this study relied on data that was collected over twelve years ago. One of its authors, Columbia Medical School Professor Mark Olfson, told CNN that if the data were collected today, they could yield different results.

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The Opioid Crisis Requires Evidence-Based Solutions, Part I: How the President’s Commission on Combating Drug Addiction Misinterpreted Scientific Studies

By Mason Marks

The opioid crisis kills at least 91 Americans each day and has far-reaching social and economic consequences for us all. As lawmakers explore solutions to the problem, they should ensure that new regulations are based on scientific evidence and reason rather than emotion or political ideology. Though emotions should motivate the creation of policies and legislation, solutions to the opioid epidemic should be grounded in empirical observation rather than feelings of anger, fear, or disgust. Legislators must be unafraid to explore bold solutions to the crisis, and some measured risks should be taken. In this three-part series on evidence-backed solutions to the opioid crisis, I discuss proposals under consideration by the Trump Administration including recent recommendations of the President’s Commission on Combating Drug Addiction and the Opioid Crisis. Though the Commission made some justifiable proposals, it misinterpreted the conclusions of scientific studies and failed to consider evidence-based solutions used in other countries. This first part of the series focuses on the misinterpretation of scientific data.

Last year more than 64,000 Americans died of drug overdose, which is “now the leading cause of death” in people under 50. Opioids are responsible for most of these deaths. By comparison, the National Safety Council estimates about 40,000 Americans died in auto crashes last year, and the Centers for Disease Control reports that 38,000 people were killed by firearms. Unlike deaths due to cars and firearms, which have remained relatively stable over the past few years, opioid deaths have spiked abruptly. Between 2002 and 2015, U.S. opioid-related deaths nearly tripled (from about 12,000 deaths in 2002 to over 33,000 in 2015). Last year, synthetic opioids such as fentanyl contributed to over 20,000 deaths and accounted for the sharpest increase in opioid fatalities (See blue line in Fig. 1 below). Read More

Patenting Bioprinting Technologies in the US and Europe – The Fifth Element in the Third Dimension

By Timo Minssen

I am happy to announce the publication of our new working paper on  “Patenting Bioprinting Technologies in the US and Europe – The 5th element in the 3rd dimension.” The paper, which has  been co-authored by Marc Mimler, starts out by describing the state of the art and by examining what sorts of bioprinting inventions are currently being patented. Based on our findings we then discuss what types of future innovations we can expect from the technological development and how far these would and/or should be protectable under European and US patent laws.

The paper is forthcoming in: RM Ballardini, M Norrgård & J Partanen (red), 3D printing, Intellectual Property and Innovation – Insights from Law and Technology. Wolters Kluwer, but the working paper is already available on SSRN. Read More

Innovation and Intellectual Property Policies in European Research Infrastructure Consortia

By Timo Minssen

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.

Abstract:

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.

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

The National Health Service (NHS) in England is standing on a burning platform?

By John Tingle

In the introduction to a new report on the state of acute hospitals in the NHS in England, the Chief Inspector of Hospitals, Professor Sir Mike Richards of the Care Quality Commission (CQC) controversially states:

“The NHS stands on a burning platform — the model of acute care that worked well when the NHS was established is no longer capable of delivering the care that today’s population needs. The need for change is clear, but finding the resources and energy to deliver change while simultaneously providing safe patient care can seem near impossible.” (p.4)

This statement raises the fundamental question of whether the current model of the NHS is,’ fit for purpose’? The NHS since its formation has always had both a good and bad press. Since its inception it always been short of resources. Changing times bring with them new demands which can make established health care delivery structures obsolete and no longer capable of delivering optimal performance. One important NHS developing health care trend is the need to keep pace with a growing elderly population with more complex health needs along with other trends. Read More

Making a Moral Case for Regulation

Valerie Braithwaite’s chapter in the ANU’s Press’s new Regulatory Theory: Foundations and Applications provides a general introduction to looking at regulation through a social lens.  If regulation is so great, she asks, why do so many people approach it with fear and loathing?

I won’t rehearse her argument here, but instead skip to some key points about how we who appreciate the social good provided by regulation can best make that case. One of ten suggestions she concludes with was particularly resonant to me: “Engage with dissent on moral grounds. Is it right morally to steer the flow of events in the way proposed?”

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