No One Is Sovereign Over Genetic Sequences

Most of the time the sanctity of national sovereignty is invoked in international law, it’s covering for something bad. The debates about the interpretation of the Nagoya Protocol, a 2010 supplement to the Convention on Biological Diversity, are no exception.

A number of states party to the Protocol, a cryptic document designed to ensure the “fair and equitable sharing of benefits arising from the utilization of genetic resources,” enshrines a principle of state sovereignty over the genetic sequences of all life—including those of pathogens—within state territory.

This interpretation is not obvious on the face of the treaty. But neither is it foreclosed. The resolution of this question has profound implications for global public health: if the states that espouse this position are right, global genetic research will be impeded, possibly dramatically, and epidemics will be harder to fight. Read More

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

Malaria Eradication: For Africa as America

There is a page in the history books waiting to be written for the eradication of malaria. In recent years, malaria has killed more people globally than war—it’s killed predominately children, and predominately in sub-Saharan Africa. Despite being curable, and eliminated from most developed countries, malaria is the fifth deadliest infectious disease in the world.

A team of scientists in Italy is looking to write that history. Read More

Abstract representation of DNA double helix

Gene Editing and Intellectual Property: A Useful Mix?

The Health Policy and Bioethics Consortia is a monthly series that convenes two international experts from different fields or vantage points to discuss how biomedical innovation and health care delivery are affected by various ethical norms, laws, and regulations.

They are organized by the Harvard Medical School Center for Bioethics and the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital, in collaboration with the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Support provided by the Oswald DeN. Cammann Fund at Harvard University.

A light lunch will be provided. This event is free and open to the public, but space is limited and registration is required. Please note that attendees will need to show ID in order to enter the venue. Register now!

 

One way of thinking about genome editing is through the lens of the legal and ethical obligations of ensuring the technology is deployed safely and accurately, for the betterment of human society.

Or, if that’s a mouthful for you, genome editing’s rights—and wrongs. Which brings me to a talk I’ll* be giving at Harvard Medical School on March 8: “Genome Editing: Rights and Wrongs” I feel obligated, however, to asterisk the personal pronoun (“I”) because, in truth, what I’ll be doing is sharing the stage with one the world’s most celebrated scientists, George Church, world-renowned bioethicist, Jeantine Lunshof, and moderated by health policy guru, Aaron Kesselheim. Read More

thumbprints on glass

Ethical Concerns of DNA Databases used for Crime Control

By Aziza Ahmed

Genetic databases for crime control have become a national topic for debate after the arrest of the Golden State Killer, also known by his real name, Joseph James DeAngelo.

At the time of his arrest, DeAngelo was 72 years old and had committed more than 50 rapes and 12 murders. While his arrest was celebrated as a law enforcement victory, a host of questions emerged because of the way law enforcement officials eventually found DeAngelo: through a combination of traditional detective work and utilization of data from a crowd-sourced genetic database. In this case, police searched GED-Match, a website created by the Mormon church where users can share genealogical information and find “familial” DNA matches

The Golden State Killer case reignited numerous debates on the issue of DNA searches and the use of DNA evidence, but with a twist. The big question is, should investigators utilize genetic databases, whether run by the government or by private agencies and individuals, to identify the families of suspects, if doing so will lead them to the culprit?

Though the opportunities for crime-solving by utilizing DNA database searches may be vast, new technologies and innovative uses of them do not occur in a vacuum. Instead, novel uses of technology demand consideration of a vast number of ethical issues, and mandate careful interrogation of the potential impact of DNA databases on crime control. Read More

3 Things You Should Know About the Petrie-Flom Center’s 2019 Annual Conference

Breakthroughs in genetics have often raised complex ethical and legal questions, which loom ever larger as genetic testing is becoming more commonplace, affordable, and comprehensive, and genetic editing becomes poised to be a consumer technology. As genetic technologies become more accessible to individuals, the ethical and legal questions around the consumer use of these technologies become more pressing.

We are excited, therefore, to have many major thought leaders in this space discuss these issues at the Petrie-Flom Annual Conference, “Consuming Genetics: Ethical and Legal Considerations of New Technologies,” which will take place at Harvard Law School in May. Read More

close up of human eye

The Luxturna Debate: Why Ethics Needs a Seat at the Drug Pricing Table

By Clio Sophia Koller

Jack Hogan can now ride his bike home at dusk after an afternoon of playing with his friends. Is that childhood rite-of-passage worth $850,000?

Recently, the Health Policy and Bioethics Consortium convened by Harvard Medical School’s Center for Bioethics and the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital met to discuss the implications of Spark Therapeutics’ new gene therapy treatment—along with its staggering price tag.

Luxturna, a novel therapy approved by the FDA last year, treats a rare form of inherited blindness known as retinitis pigmentosa. The therapeutic agent targets the RPE65 gene, associated with the disorder, and is shown to improve vision in a population with progressive vision-loss and an inability to see in dim light. Read More

Anya Prince on Gene Therapy and Exacerbating Health Care Inequalities

Anya Prince, a legal scholar and thought leader in the field of genetic discrimination, will present a new paper at Monday’s Health Law Workshop that interrogates whether gene therapies will exacerbate inequalities in health care, as more treatments enter the market. “Gene Therapy’s Field of Dreams: If You Build It, Will We Pay?” focuses on some of the many issues raised by the prices of gene therapies.
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hand with a pencil drawing on DNA results

Silver Spoons and Golden Genes: Designing Inequality?

A recent web series sparked controversy with the headline that “Designer babies aren’t futuristic. They’re already here.” The online articles make the case that disparate access to frozen embryo screening for debilitating diseases—sickle cell anemia, Tay-Sachs, or cystic fibrosis—is “designing inequality into our genes.”

The authors are right that reproductive technology isn’t open to everyone. A single cycle of in vitro fertilization (IVF)—the tool that combines sperm and egg in a lab—costs 57% of the average American’s annual income in 2018. The multiple cycles it usually takes to get a baby costs upwards of $100,000. Just fifteen states make insurers cover reproductive technology. Even these often limit coverage mandates to married couples unable to conceive, thereby denying equal benefits to non-traditional families.

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23 and me boxes

You Received Genetic Test Results from Direct to Consumer Companies or from Research – Will Your Doctor Be Happy to See You?

By Ellen W. Clayton

You recently responded to a TV advertisement by a direct to consumer (DTC) genetic testing company because you wanted to find more of your relatives. The company also offered to send you your genomic data.  Although not what you originally had in mind, you decided to send the data to another DTC company for interpretation to learn more about your health. Unfortunately, you were told that you are at risk for a condition you had never heard of.  Even though the company sent some educational information, you quickly decided to call your doctor for more information and to start prevention or treatment.

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Opportunities and challenges for user-generated licensing models in gene-editing

By Timo MinssenEsther van Zimmeren & Jakob Wested 

An earlier version of this contribution had been published in Life Science Intellectual Property Review (LSIPR).

A voluntary pool or clearinghouse model may give rise to a robust commercial ecosystem for CRISPR and could include special provisions for royalty-free research use by academics. Hence, there may be a path through the CRISPR patent jungle. But, there are many obstacles still in the way.

The revocation of Broad Institute’s patent EP2771468 reported and discussed here, marks the latest major development in a series of patent battles over the revolutionary and highly lucrative CRISPR-Cas9 technology (and other gene editing technologies) in the US and Europe.

While this is the first EPO decision in an opposition procedure concerning the Broad patent portfolio, the outcome may have implications for other related patents as the rationale for the revocation reflects a larger, systemic challenge based on the different rules regarding priority claims in different jurisdictions.

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