The Right to Health, the Affordable Care Act, and Non-Treaty Treaties (Part II)

Special guest post by Nicholas J. Diamond

In Part I, I argued that the Affordable Care Act (ACA), while a monumental step toward improving health care in the U.S., does not fully advance the right to health in a few key respects. Responding to shortcomings in the ability of the ACA to fully advance the right is, in my view, a matter of coalescing domestic health policymaking around the right to health.

Full advancement of the right to health in the U.S. requires a normative commitment to the content of the right as articulated in General Comment 14 and related instruments. This commitment requires internalization of human rights-based norms in domestic health policymaking. Such a commitment would not only encourage the consensus required to design appropriate domestic health policies, but also provide valuable guiding principles to shepherd implementation.

Given the current political climate around the ACA, coupled with an ongoing Presidential election, statutory amendment of the ACA in order to more fully advance the right to health is highly unlikely. What is more, reliance on the rulemaking process to advance the right to health, absent an appropriate statutory foundation, would be misplaced because agency rulemaking authority is itself a statutory construct.

In the alternative, ratification of the International Covenant on Economic, Social and Cultural Rights (ICESCR) could provide just such a commitment. The U.S. is, however, very unlikely to ratify the ICESCR as an Article II treaty. Historically, the U.S. has been reluctant to commit to international human rights instruments and the current Administration has expressed its intention not to pursue ratification (at least as an Article II treaty). Absent ratification, through which international norms are internalized in national policies, it remains unlikely that the right to health becomes a guiding norm in U.S. health policymaking. Continue reading

The Right to Health, the Affordable Care Act, and Non-Treaty Treaties (Part I)

Special guest post by Nicholas J. Diamond

The right to health has played a significant role in global health fora since the World Health Organization first identified the “enjoyment of the highest attainable standard of health” as a “fundamental right of every human being without distinction of race, religion, political belief, economic or social condition” in 1946. Twenty years later, the International Covenant on Economic, Social and Cultural Rights (ICESCR) would set out the right to health in a binding international instrument. Subsequent guidance in 2000 from the United Nations Committee on Economic, Social and Cultural Rights, referred to as General Comment 14, clarified the content of the right to health, as well as articulated four elements—availability, accessibility, acceptability, and quality—that constitute the right.

Despite widespread support in the international community, the U.S. has not ratified the ICESCR. Many have argued that the Affordable Care Act (ACA) is doubtless a significant step toward realization of the right to health in the U.S. Indeed, its design speaks directly, to varying degrees, to each of the four elements of the right to health. While I acknowledge the significance of the ACA in advancing the right to health in the U.S., there are at least three reasons to doubt its ability to fully advance the right. Continue reading

Senator Cruz’s RESULT Act Contains a Particular View of the FDA’s Role – But What About CMS?

Last week, I blogged here about the introduction of the Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act (text) by Senators Ted Cruz and Mike Lee. As I noted, the Act would require the FDA to speed review of drugs, devices, and biologics that are already approved for marketing in a particular list of countries, including EU member countries, Japan, and Canada. If the FDA declines to grant reciprocal marketing approval, the Act would permit Congress to override the FDA’s decision through a majority vote via a joint resolution.

My post, and additional commentary from numerous other outlets (including RAPS, Vox, and Marginal Revolution) largely focused on the Act itself – on the merits of the various provisions, and on whether those provisions would be effective at accomplishing the Act’s stated goals. But each commentator’s view of the situation depends in large part on their priors about what the purpose of the FDA is, and relatedly, how it should behave to achieve those purposes. In this post, I want to first briefly explain these different views about the purpose of the FDA before explaining the ways in which our views about pharmaceutical regulators are often tied to our views about public health insurers – a point which has largely gone unmentioned in the debate about the RESULT Act.

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New Developments in the Guatemala STD Experiments Case

In the late 1940s, US government scientists, in collaboration with Guatemalan counterparts, were involved in a horrible array of experiments on human subjects in which a variety of vulnerable groups in Guatemala were intentionally infected with syphilis, gonorrhea, and chancroid and left without treatment. [For more on how they ended up in Guatemala and the ethics of intentional infection studies, see my work here and here.] The experiments were done without consent and without scientific rigor, violating both contemporaneous and modern ethical standards.  They were not uncovered, however, until a few years ago when a historian discovered the files in the midst of doing archival research on one of the scientists, who had also been involved in the Tuskegee syphilis study in the US.

Since her discovery, the US and Guatemalan governments have both issued apologies and reports condemning the studies (here and here), and the US pledged a relatively small amount of money to support the Guatemalan government’s efforts to improve surveillance and control of H.I.V. and other sexually transmitted diseases in that country. However, individual compensation to the victims of the experiments and their families has not been forthcoming; the victims calls for a voluntary compensation program to be established have gone unheeded, and they have also been unable to prevail in court, for a variety of jurisdictional and technical reasons.

As Glenn Cohen and I argued following the victims’ first court loss in 2012, compensation is a moral imperative.  We expressed support for a voluntary compensation program, but in its absence, alternative mechanisms of justice are essential.  Therefore, we were heartened to hear that a petition for the victims was just filed in the Inter-American Commission on Human Rights in Washington, D.C., by the Office of Human Rights for the Archdiocese of Guatemala, represented by the UC Irvine School of Law International Human Rights Clinic and The City Project of Los Angeles.  The petition claims violations of the rights to life, health, freedom from torture, and crimes against humanity under both the American Declaration of the Rights and Duties of Man, and the American Convention on Human Rights, as well as the denial of a right to a remedy for human rights violations.

There are still a number of hurdles ahead, not the least of which is determining which individuals would actually be entitled to compensation, as the record keeping in the initial experiments was so poor and so much time has passed.  But we are heartened that advocates are still pressing forward for these victims and hope that justice, though certainly delayed, will not continue to be denied.

More information on the petition is available here.

Senator Cruz’s RESULT Act Unlikely to Achieve Results

On Thursday, Senators Ted Cruz and Mike Lee introduced the Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act (text), which would require the FDA to speed review of drugs, devices, and biologics that are already approved for marketing in a particular list of countries, including EU member countries, Japan, and Canada. The Act would require the FDA to grant such “reciprocal marketing approval” within 30 days, unless the FDA makes affirmative determinations about the drug or device’s lack of safety and efficacy. If the FDA declines to grant reciprocal marketing approval, the Act would also permit Congress to override the FDA’s decision through a majority vote via a joint resolution.

Zachary Brennan at RAPS has already provided a helpful explanation of the problems with this proposal, and in particular the problems created if Congress were permitted to override FDA denials of approval. In this post, I want to focus primarily on the Act’s premise. Senators Cruz and Lee argue that this bill would speed approval of drugs and devices “which are currently saving lives in other developed countries, but have not been approved in the U.S. because of FDA red tape.” The implication is two-fold: 1) that drugs are often left languishing at the FDA while they enjoy approval in other countries, and 2) that the FDA has no grounds for failing to approve these drugs. The first argument, about the speed of FDA approval, is made quite frequently by legislators who seek to weaken the FDA’s gatekeeping authority over new drugs and devices in the United States. Unfortunately, it hasn’t really been true for decades. The second argument ignores the historical context of the FDA’s decision-making authority.

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Why aren’t we talking about the Syrian refugees’ health?

Special guest post by Nicholas J. Diamond

The Hill is abuzz with talk over the Syrian refugee crisis and whether refugees should be allowed to resettle in the U.S. A group of former national security experts from both Republican and Democrat administrations recently urged Congress to allow refugee resettlement in the U.S. In contrast, Texas recently filed a lawsuit against the Federal government in an effort to prevent the arrival of a family of Syrian refugees scheduled to arrive in Dallas.

But the political buzz has been ignoring a significant fact. The refugee crisis is not just a political matter. It also poses serious health risks for the refugees themselves.

Let’s start with physical health. While migration in general introduces various health risks, forced migrations like the Syrian refugee crisis create particularly acute concerns. A forced migration tends to impact large numbers of people—an estimated 9 million Syrians have fled their homes since 2011. The rapid movement of this many people causes massive disruptions in all aspects of life, including the availability of food and potable water, basic health services, shelter, and proper sanitation, to name just a few. Continue reading

A Conversation about… Tax Rates?: The Pfizer and Allergan Deal

By Dalia Deak

Last week, Pfizer and Allergan announced a $155B merger that has the health care and policy world talking. The contours of the deal—in particular, where the new company will be based and the implications it has for the company’s tax rate— have raised important questions.

Pfizer is a company with a long history in the United States that dates back to the mid-1800s when it sold antiparisitics and then painkillers during the Civil War. In the modern era, Pfizer is perhaps best known for blockbusters drugs like Viagra and Lipitor. Yet, expiring exclusivities and patent protections have threatened to knock the drugmaker from its No.1 spot. In January of this year, revenues were higher than expected but still down 3% year-over-year, with a forecasted decline in sales from $49.6B in 2014 to between $44.5B and $46.5B expected in 2015. Without blockbusters to replace Lipitor and Celebrex in particular (which fell 6% and 31% respectively), the company has been looking for a deal, even trying to push through a $118B acquisition of UK-based Astrazeneca in 2013, though that deal ultimately failed.

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Lecture Tomorrow, 11/10! Euthanasia in Belgium: The most recent legal developments and policy challenges

Euthanasia in Belgium: The most recent legal developments and policy challenges
November 10, 2015 11:00 AM – 12:15 PM

Conference Room, 1st floor
Center for Bioethics at Harvard Medical School
641 Huntington Ave., Boston, MA [Map]

A lecture by Sigrid Sterckx, Professor of Ethics and Political and Social Philosophy, Ghent University, Belgium; End-of-Life Care Research Group, Vrije Universiteit Brussel & Ghent University, Belgium; Bioethics Institute Ghent, Ghent University, Belgium.

In 2002, euthanasia by a physician (the intentional termination of a patient’s life at his or her request) was depenalized in Belgium for adults and emancipated minors. In 2014, the law was extended to competent minors, without an age limit. The frequency of performance of euthanasia is rising very rapidly, having more than doubled in the last five years (accounting for one death in twenty, about 8 per day in Flanders, the Dutch-speaking region). Moreover, although the prevalence of euthanasia remains highest in patients with cancer, a clear shift is visible in the characteristics of patients who request euthanasia and whose requests are granted. The largest increases are among women, and those aged 80 or older, with lower education levels, and those dying in nursing homes. Continue reading

The Right to Health and Free Speech: Supreme Court of Argentina Rules Against Tobacco Advertising

by Martín Hevia (Universidad Torcuato Di Tella)

In 2006, Nobleza Piccardo, a main tobacco company in Argentina, had filed a claimed against the government of the Province of Santa Fe because a law sanctioned by the Provintial Congress completely banned the advertising and promotion of tobacco products in the Province (Santa Fe is one of the main Provinces of Argentina). Nobleza Piccardo argued that those restrictions infringed upon free speech and upon commercial freedom. It also claimed that, under the Argentine National Constitution, the Province is not allowed to pass legislation of that kind because the National Congress had already passed law 23.344, which regulated tobacco advertising (but did not ban it); once National Congress did so, Provintial Congresses cannot further legislate on the issue.

In its October 27 ruling, the Supreme Court held that nothing in the National Constitution provides National Congress with an exclusive power to legislate on health matters. Furthermore, Provintial legislation may complement federal legislation on the matter.

On the free speech and commercial freedom argument, the Court held that there is a tendency in other jurisdictions to restrict or even completely ban tobacco advertising. According to the Court, the restrictions established by the law are justified because they are proportionate to the public health concerns it wants to address; in addition, they follow internationallly accepted standards on the matter.

In his vote, Judge Lorenzetti, President of the Supreme Court, wrote that restricting tobacco advertising does not infringe upon free speech because tobacco advertising is not related to the working of republican and democratic institutions. Thus, Lorenzetti says, it would be wrong to analyze the restrictions established by the provintial law with the strict scrutiny test used in free speech cases. This claim, of course, is very important and will deserve much more discussion by the Supreme Court in future decisions. But the main teaching of the case is that, for the first time, the Supreme Court clearly states that tobacco control measures are a matter of human rights. This is, no doubt, a very important step.

China to Reform Review and Approval Process for Drugs and Medical Devices

China’s Standing Committee of the National People’s Congress (NPC), the country’s legislature, will hold a meeting from October 30 to November 4 to review the authorization of the State Council, the central government, to carry out a pilot program that will introduce market authorization holder of drug (MAH) system and reform the drug registration system. On August 9, the State Council issued the Opinions on Reforming Review and Approval Process for Drugs and Medical Devices (RAP Opinions). Since several key reform measures initiated by the RAP Opinions involve amendments to China’s Drug Administration Law, the State Council must receive the authorization of the NPC. If the authorization is approved by the NPC, the reform of China’s RAP will be accelerated.

The direct pressure for reform comes from the very serious backlog for RAP in China. As of August, there was a backlog of 21,000 applications, and large backlogs have appeared repeatedly in the past decade. For example, there was a backlog of 17,000 in 2005 and a backlog of 27,000 in 2008. These backlogs attract more and more criticism, both from companies and patients. Patients, unable to benefit from a new drug, especially those made by foreign companies and that have proven successful and effective in other territories, have suffered. Some patients have to either rely on  smuggled drugs or conduct expensive medical tourism. Now, the State Council seems determined to reform the broken RAP system completely, with the following key reforms:

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Research Ethics Extravaganza: New Draft CIOMS Guidelines

As if the proposed revisions to the Common Rule weren’t enough to process, the Council for International Organizations of Medical Sciences (CIOMS) just released its proposed changes to the current CIOMS Ethical Guidelines for Biomedical Research (last revised in 2002).  CIOMS invites public comments until March 1, 2016, at which point the CIOMS Working Group will process and review them and submit the final document to the CIOMS Executive Committee for approval.

According to CIOMS, most guidelines have been substantially revised in this draft, several have been merged, and new guidelines have been added.  The proposal also merges the guidelines for biomedical research with those for epidemiological research, and the scope has been broadened from biomedical research to health-related research with humans.

A busy and exciting time in research ethics!

Bioethicist Arthur Caplan: Euthanasia in Belgium and the Netherlands: On a Slippery Slope?

Bill of Health Contributor Art Caplan and Barron Lerner have a new piece up in JAMA Internal Medicine:

The slippery slope is an argument frequently invoked in the world of bioethics. It connotes the notion that a particular course of action will lead inevitably to undesirable and unintended consequences. Saying no to the original action, even if that act is moral in itself, may, in light of the slope that looms, be the ethical thing to do.

Slippery slope arguments have been especially pervasive in discussions of euthanasia, in which physicians actively end patients’ lives, and physician-assisted dying (or physician-assisted suicide), in which physicians supply medications to patients that enable them to end their own lives. The concern, fueled by the German experience with racially motivated euthanasia in the last century, has been that approving either of these procedures for a few individuals will inevitably lead to overuse and abuse. […]

Read the full article here.

The Right to Die and Informed Consent: New Ruling by the Supreme Court of Argentina

By Martín Hevia

In “D.M.A. s/ declaración de incapacidad” decided early this month, the Supreme Court of Argentina upheld the right to decide about one´s own death (“muerte digna”). As I had explained in a previous comment written when the ruling of the case was pending, the case involved a patient, M.A.D., that had been in a permanent, irreversible, vegetative state for 20 years due to a car accident. His sisters requested the discontinuation of the vital supportive measures which maintained M.A.D alive in an artificial way. Although this was not the first time that the Court discussed the right to die, it was a different case in that there was not a patient’s written statement on whether it was appropriate for him to continue or not certain medical treatment to keep him alive.

The Argentine National Congress had already passed legislation stating that, whenever a patient is unable to give informed consent, her relatives can do so in her name. On that basis, following the opinion of the sisters of M.A.D., the Supreme Court ordered the discontinuation of the vital supportive measures which maintained M.D alive in an artificial way. Continue reading

Human Rights Tribunal Upholds France’s Policies on Ending Life Support for Permanently Unaware Patients

By Norman L. Cantor

France recently confronted its version of America’s 2005 Schiavo case (in which the Florida Supreme Court upheld a spouse’s determination to end life support to a permanently unconscious patient despite the patient’s parents’ objections). In 2014, France’s Conseil d’Etat ruled that artificial nutrition and hydration (ANH) could be withdrawn from a permanently vegetative patient based on oral statements that the patient had made, while competent, indicating unwillingness to be medically sustained in such a condition. The patient’s objecting parents then sought a declaration from the European Court of Human Rights (ECHR) that such termination of life support would violate the European Convention on Human Rights. On June 5, 2015, the ECHR rejected the objecting parents’ contention, finding that France’s approach met human rights standards both in the process and the criteria followed by medical personnel in deciding to end life support.   Lambert v. France, #46043/14 (ECHR 2015).

Vincent Lambert, then 32 years old, was grievously injured in a 2008 traffic accident. He suffered massive brain trauma and was hospitalized for the next 7 years at Reims University Hospital. His precise medical status was initially uncertain. In July 2011, a medical evaluation found him to be “minimally conscious plus.” Over the next year and a half, he underwent 87 speech therapy sessions which failed to establish any code of communication between Mr. Lambert and his surroundings. In early 2013, the attending physician, Dr. Kariger, initiated a process to review Mr. Lambert’s condition and to determine whether the ANH sustaining Mr. Lambert should be withdrawn.

The process that followed was extensive. During 2013, Dr. Kariger consulted with 6 physicians concerning the patient’s mental status and held 2 family meetings at which Mr. Lambert’s wife, Rachel, his parents, and 8 siblings were present. In January 2014, Dr. Kariger announced his determination to end artificial nutrition and reduce hydration. Dr. Kariger’s written report explained that Mr. Lambert had become permanently unaware of his environment and, according to accounts of Mr. Lambert’s prior oral expressions, he would not wish to be medically sustained in such a debilitated condition. Five of the six medical consultants agreed, as did the patient’s wife and 6 of his 8 siblings.

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FDA’s Non-Response Response to My New York Times Op-Ed on Gay Blood Ban

On May 21, along with my frequent co-author Eli Adashi, I published an op-ed in the New York Times raising some questions about FDA’s proposed guidance recommending a ban on taking the blood on any man who has had sex with another man in the past year, or in other words imposing a one year celibacy requirement on gay men if they want to donate blood. This built on our critique last July in JAMA, wherein we argued that FDA’s then-lifetime ban on gay men and MSM donating blood was out of step with science and the practice of our peer countries, as well as potentially unconstitutional.

Thanks to our work, and a concerted effort by public health, medical, and gay rights groups, FDA has finally moved off of that prior policy and recognized that it was unjustified, and discriminatory.

Just to put this in context It took more than 30 years to convince FDA that it was problematic to ban blood donation for a lifetime any man who ever had sex with another man, even if both have repeatedly tested negative for HIV, while it imposed only a one year ban on people who had sex with individuals known to be HIV positive or a sex worker. FDA is appropriately a conservative agency, but on this issue of the lifetime ban its willingness to listen and reconsider has gone beyond conservatism to the point of lunacy. [By the way to be clear, I *love* FDA. I represented them while at the DOJ and have a new book coming out about FDA in the fall. You can think highly of an agency but think they have a bad track record on an issue. This is critique not hater-aide].

Well with that background, one should be not so quick to assume that a move to a one year ban — a de facto lifetime ban for any gay man who is sexually active, even one who is monogamously married with children — is the best policy. To put it bluntly, refusing to change a lifetime ban for such a long period makes me skeptical we should accept a “just trust us” line on their new restrictive policy.

The question we raised in our op-ed was whether FDA had adequately justified retaining a one year ban in light of the evidence from places like South Africa (with a much shorter time period ban), Italy (which does individualized risk assessment instead of stigmatizing all gay men as high risk for disease), etc.

Well FDA responded…sort of … through a NY TImes Letter To the Editor.

Here is what FDA said with my analysis in bold:

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Surrogacy, Israel, and the Nepal Earthquake

The Nepal earthquake has shocked with the devastation and suffering inflicted on a long suffering people.  Foreigners in Nepal were also affected, but most of them will be able to leave and carry on their lives without the poverty, housing, and health care deficits the Nepalese will be dealing with for years.  One sub-group of foreigners were Israelis awaiting the birth of children carried by Nepalese surrogates or the legal papers needed to bring home those infants who had already been born.  They have, of course, no moral priority over others hit by the earthquake, but their situation shines yet another light on the complexities of national surrogacy policy and surrogacy tourism.

Nepal has become a major surrogacy destination for Israelis who because they are unmarried or gay cannot obtain surrogacy in Israel.  India and Thailand had been the prime choice for surrogates, but those countries two years ago restricted surrogacy to married couples.  Indian women already pregnant with children commissioned by unmarried persons then went to Nepal to give birth.   With surrogacy available in Nepal for $30,000-$50,000, rather than $150,000 in the United States, Israeli surrogacy agencies started arranging surrogacy births there, even while Indian rather than Nepalese women are usually the carriers. Continue reading

China stops using executed prisoners as a source of organs for transplants

By Lydia Stewart Ferreira

According to the Lancet, China will stop using executed prisoners as a source of organs for transplants as of January 1, 2015. After January 1, 2015, “only voluntary donated organs from civilians can be used in transplants.” This decision was officially announced December 3, 2014 by Jiefu Huang, the former vice-Minister of Health at a seminar of China’s Organ Procurement Organization. While China needs to be commended for this government initiative, I find the fact that this initiative takes effect in 2015 quite shocking.

China has one of the largest organ transplant systems in the world, yet it has one of the lowest levels of organ donation – with a rate of 0.6 per 1 million people. In a 2011 Lancet article, Huang and colleagues reported that 65% of transplants in China used organs from deceased donors, more than 90% of whom were executed prisoners. The Lancet also reports that since 1984, it has been legal in China to harvest the organs of executed prisoners with the consent of the prisoner or their family. It was not until 2007 that China implemented its first legal regulatory framework for the oversight of their organ transplant system. In 2013, China went on to establish a national electronic organ allocation system.

Clearly, China has had a government endorsed organ procurement system. However, this procurement system has been internationally condemned by medical, scientific and human rights organizations. There were concerns about coercion, exploitation, undue inducement, non-existent consent, unjustified paternalism and the corruption of organ allocation. This organ procurement system used by China was legal under Chinese law. It is not clear to what extent illegal organ procurement – through transplant tourism and the black market sale of organs – was and is also taking place in China.

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Highlights from the Consortium of Universities for Global Health Conference: Part III

By Guest Blogger Dan Traficonte 

In this third blog post covering my visit to the Consortium of Universities for Global Health Conference, I highlight some research from the conference focused on the importance of considering local social practices and belief systems into health policies and interventions.

Faduma Gure, a Master’s student in Interdisciplinary Health Sciences at the University of Ottowa, conducted fieldwork in Somalia to explore awareness of and attitudes to emergency contraception and their implications for health interventions. Somalia’s high fertility rate, high maternal mortality ratio, and low contraceptive prevalence rate coupled with restrictive abortion laws make addressing the lack of family planning services an extreme challenge. In conflict or post-conflict settings like Somalia, emergency contraception can be critical for pregnancy prevention, yet Somalia remains one of the few countries in the world without a registered progestin-only emergency contraceptive pill.

Ms. Gure conducted a qualitative, multi-methods study comprised of structured interviews with key informants, including physicians, non-governmental officials, government officials, local Somali pharmacists, and married and unmarried Somali women. Most participants showed little knowledge of existing family planning methods or emergency contraception, however, once contraception was described, all participants expressed tremendous enthusiasm for expanding access to post-coital contraceptive methods in Somalia. All participants expressed that an available emergency contraceptive would fill a major gap in reproductive health service delivery, and all government officials interviewed indicated that emergency contraception could easily be incorporated into the existing health system.

It is a common belief—and often a misconception—that people in conflict-torn and impoverished countries like Somalia reject modern medical technologies due to conflicting local practices and beliefs. Ms. Gure’s preliminary research indicates that the lack of emergency contraception in Somalia does not result from local beliefs, but from lack of knowledge and access to the technology.

Dan Traficonte is a 1L at Harvard Law School interested in the intersection of global health and international development.

Transatlantic Lessons in Regulation of Mitochondrial Replacement Therapy: Prospect of Disease-Free Children for Women Carriers through MRT

Cambridge, Mass., April 9, 2015 – A paper forthcoming on Friday in Science discusses the regulation of a new technology that gives hope to women who carry genetic disease. Mutant mitochondrial DNA gives rise to a broad range of heritable clinical syndromes. Cure of those affected remains out of reach. However, recently developed Mitrochondrial Replacement Therapy (MRT) – sometimes known as “three-parent IVF” — has raised the prospect of disease-free progeny for women carriers.

In the UK, legislation regulating the clinical application of MRT has recently been approved by the House of Commons and the House of Lords, after a 10-year process.

In the United States, the vetting of MRT, underway for a year, remains a work in progress. A new paper in Science released Friday, April 10, compares and contrasts the regulatory history of MRT in the UK and the United States, discusses the relevant ethical overlay, examines potential lessons learned, and charts the likely path forward in the United States. It is written by I. Glenn Cohen, Harvard Law Professor and Faculty Director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School; Eli Adashi, Professor of Medical Science at Brown University; and Julian Savulescu, Uehiro Chair in Practical Ethics at Oxford University and Director of The Oxford Centre for Neuroethics.

“There is much FDA and the U.S. can learn from the way in which the U.K. has evaluated and regulated MRT,” said Professor Cohen. “These lessons are particularly important because MRT is just one of a series of new reproductive and genetic technologies, including gene editing and In Vitro Gametogenesis, that FDA and regulators across the world will soon be confronting.”

Read the full paper now on the Science website.

2015 Broad Institute Innovation & Intellectual Property Symposium

2015 Broad Institute Innovation & Intellectual Property Symposium

Monday, April 13, 2015 – Wednesday, April 15, 2015

Broad Institute, 415 Main St., Cambridge, MA

This ​symposium ​will ​bring ​together ​Broad ​scientists, ​delegates ​from ​the ​European ​and ​U.S. ​Patent ​Offices, ​and ​global ​business ​and ​legal ​thought ​leaders ​for ​discussion ​and ​information ​exchange ​on ​topics ​related ​to ​innovation ​and ​intellectual ​property ​law ​of ​interest ​to ​the ​Cambridge ​and ​Boston ​scientific, ​business ​and ​legal ​communities. ​