Close up of a mosquito sucking blood on human skin. This mosquito is a carrier of Malaria, Encephalitis, Dengue and Zika virus.

Responsibly Developing Gene Drives: The GeneConvene Global Collaborative

By James Toomey

Researchers believe that gene drives could eliminate vector-borne diseases such as malaria, by modifying mosquito species or eradicating those that carry disease, kill off invasive species, and combat the growing problem of pesticide resistance.

A gene drive is a technique for genetically modifying entire species of wild organisms. Genetically modified individuals of the species are released into the wild, so as to raise the probability that a particular gene will be passed onto the species’ progeny via reproduction.

Over the course of many generations, the gene — even if detrimental — can spread to an entire population.

But as of now, this is all hypothetical. No gene drive has been tested in the wild, and many people are skeptical that they should ever be used.

The GeneConvene Global Collaborative, a project of the Foundation for the National Institutes of Health, was started this past July to promote the responsible development and regulation of gene drive technologies. It brings together researchers, regulators and stakeholders around the world to develop best practices for gene drive research and implementation.

Because of my prior writing on this topic, I participated in GeneConvene’s fall webinar series and spoke with scientists there about the project. Read More

doctor holding clipboard.

The Inherent Value of Patient Safety Reports as Key Educational Tools

By John Tingle

Many patient safety adverse events across the National Health Service (NHS) in England have common causes, which exist regardless of clinical specialty, such as failures in communication, poor record keeping, and poor staffing levels.

This commonality of cause means that patient reports emanating from various clinical areas can have general, health system-wide value, relevance, and application. From these reports, it is possible to extrapolate generally applicable patient safety themes that can apply in a wide range of health care settings.

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Empty hospital bed.

The Inevitability of Error in Health Care

By John Tingle

A recent publication by the World Health Organization (WHO), a first draft of a global patient safety action plan 2021-2030, seems to have rekindled conversations about the “inevitability of error” in the field of patient safety.

The “inevitability of error” argument indicates that mistakes in health care do inevitably happen; that they are the consequences of the complex nature of health care treatment. Nursing and medicine depend on people, and nobody is infallible — we all make mistakes.

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Map of United States made up of pills.

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

By Ameet SarpatwariBeatrice Brown, Neeraj PatelandAaron 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.

Below are the citations for papers identified from the month of September. The selections feature topics ranging from commentaries on political pressures and questions of integrity facing the FDA, to a critique of the financial incentive structure for antibiotic development, to an estimation of how much NHS England would spend if it paid U.S. Medicare Part D prices. A full posting of abstracts/summaries of these articles may be found on our website.

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NHS building

COVID-19 and the State of Health and Social Care in England

By John Tingle

The COVID-19 pandemic has exacerbated challenges facing the provision of health and social care in England, a recent report from the Care Quality Commission (CQC) finds.

The CQC is the independent regulator of health and social care in England. Every year they produce an assessment of the state of the country’s health and social care. The yearly lookbacks include information on trends, challenges, successes, failures and opportunities.

The most recent report analyzes service provision both pre- and post COVID-19, and draws key conclusions from this information. From a patient safety perspective, the report contains important lessons about issues the COVID-19 pandemic has brought into sharp focus. The report also highlights trailing patient safety problems that existed before the pandemic, and are still present as England grapples with the pandemic’s second wave.

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Supreme Court of Mexico.

How Does the Mexican Constitution Regulate Crisis?

By David García Sarubbi

When the Mexican Constitution was issued in 1917, one of its main concerns was to regulate how democracy must deal with crisis, that is, with exceptional situations that demand the exercise of powers outside the Constitution’s regular limits to suppress potential dangers.

There is not an “off switch” available for political powers to put the Constitution to rest while solving urgent issues. Instead, there are complex rules to govern decisions in extraordinary circumstances.

The Constitution’s Article 29 has a Suspension Clause, which contains a detailed regulation for such cases. Moreover, in Article 73, Section XVI, there is another regulation relating to pandemics like the one we are experiencing currently.

Thus, from the founding era, the Mexican constitution has upheld the value of the rule of law, even in extraordinary circumstances.

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Medicine doctor and stethoscope in hand touching icon medical network connection with modern virtual screen interface, medical technology network concept

Regulation of Access to Clinical Data in Chile’s New Constitution

By Gabriela Y. Novoa and Alexis M. Kalergis

As Chileans prepare to vote on whether or not to create a new Constitution, an issue worth considering relative to this reform concerns access to clinical data.

The Political Constitution of the Republic of Chile dates back to 1980, and, in the past decades, has undergone several amendments, including key reforms in August 1989, August 2005, and August 2019. As part of this last modification, it was agreed to organize a plebiscite to democratically decide whether or not to elaborate an entirely new constitutional text. If the alternative of generating a new constitution is adopted, it will consist of a constitution written from square one, rather than a modification to the existing text.

As part of the public discussion relative to the potential approval of the need for a new constitution, an open debate has taken place about which issues should or should not be incorporated into this new text.

Among several important themes, the need to regulate the access to clinical data of patients, also called “interoperability,” arises as a major one. Such an issue is linked to the rights to life, to health and privacy protection, individual honor and personal data and property, which are currently established as constitutional guarantees by Article 19 of the current Constitution. Further, the legal framework dealing with this issue is currently mainly found in Law No. 20,584, which regulates the Rights and Duties of individuals in connection with actions associated to their health care, and in Law No. 19,628 (on the protection of the privacy of individuals).

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WHO flag.

A Dose of Perspective on World Patient Safety Day

By John Tingle

The second World Health Organization (WHO) World Patient Safety Day was held on September 17th, 2020.

WHO made a call for global support, commitment, and collective action by all countries and international partners to improve patient safety. The theme for the year is “health worker safety: a priority for patient safety.”

The annual WHO World Patient Safety Day campaign is a welcome one, especially in the context of the COVID-19 pandemic.

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Santiago, Chile - Crosswalk in long-exposure.

Chile’s New Constitution, the Right to Health, and Health System Reforms

By Marco Antonio Nuñez

During these months of the COVID-19 pandemic in Chile, the need to align the constitutional process with long-postponed structural reforms to the health system has become evident among public health experts.

Capitalizing on this moment might avoid the possibility of a constitutional right to health becoming a dead letter or being reduced only to the prosecution of particular cases, postponing again the aspirations of the majority of Chileans.

Although the Chilean Constitution promulgated under the dictatorship in 1980 and subsequently reformed in several of its chapters recognizes “The right to the protection of health,” it has been tainted by authoritarianism from its origin, and promotes a subsidiary role of the state in health.

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