Intellectual Property in Investment Agreements: More “Teeth” for Foreign Investors’ IP Rights, Less for Access to Medicines

By Adriana Benedict

Last week, Public Citizen published a Health GAP analysis entitled “Leaked TPP Investment Chapter Presents a Grave Threat to Access to Medicines,” in which Professor Brook Baker explains four ways in which access to medicines is compromised by the USTR’s leaked investment chapter proposal for the Trans-Pacific Partnership Agreement.  The problematic provisions he identifies — inclusion of intellectual property (IP) in the definition of “investment”, ambiguous scope of minimum standards of treatment, inadequate exceptions and limitations for public interest measures, and performance requirement limitations preventing development of local and sustainable production—are not new, but have been included either implicitly or explicitly in countless bilateral investment treaties (BITs) (including the U.S. Model BIT) and the investment chapters of free trade agreements (FTAs) (including virtually all US FTAs and the proposed EU-India FTA).  Such inclusion gives more “teeth” to foreign investors’ IP rights, but what of access to medicines?

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Upcoming Event – Health Care Reform: A View from Both Sides, 9/25/12

Tuesday, September 25, 2012
Austin Hall, Classroom 111
Harvard Law School
12-1:30PM

If you’re going to be in Cambridge next week, please join us for a special off-the-record debate on American health care reform, moderated by the Petrie-Flom Center’s Founding Faculty Director, Einer Elhauge.  John McDonough, official surrogate of the Obama campaign and director of the Center for Public Health Leadership at the Harvard School of Public Health, and Oren Cass, domestic policy director for the Romney campaign, will discuss what each candidate would mean for the future of US health policy.

This event is free and open to the public.  No reporting will be permitted without the express permission of the speakers. Lunch and refreshments will be served.

Co-sponsored by the Petrie-Flom Center, HLS Democrats, HLS Republicans, and HLS American Constitution Society.

Evidence for Policy: Nice If You Can Get It

By Scott Burris

Sometimes researchers can tell policy makers pretty confidently what public health law interventions really make a difference. The PHLR website has more than 50 Evidence Briefs that summarize the results of systematic reviews of the evidence on interventional public health laws conducted by the Cochrane and Campbell Collaboratives, and the Community Guide to Preventive Services.. We know, for example, that  there is significant evidence to support water fluoridation as an effective public health intervention aimed at reducing tooth decay (Portland, are you listening?). We know that workplace smoking bans prevent heart attacks. For laws like these, we have numerous high quality studies, sometimes even experiments, that show whether or not the law is effective.

Unfortunately, problems don’t wait for evidence, and usually by the time there is a substantial body of evidence in place to review, most states have already made their policy decisions. What do we do when there is a problem that demands action, but there is no clearly effective legal action to take?

One of these days we’ll blog about what we think should happen. But for now, we can look at what often does happen. Usually, it resembles the fads we see in fashion: One state tries something, and other states follow, until a lot of states are doing something that might, or might not be working.

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Written on The Body: Reflections on Reactions to Funding Sex Re-Assignment for Prisoners

By Glenn Cohen

Last week, as I mentioned before, Judge Wolf (D. Mass) ruled that Michelle Kosilek, who was born as a man but has received hormone treatments and lives as a woman in an all-male prison, was entitled to the sex re-assignment surgery that the Department of Corrections’ doctor ordered as the treatment necessary for Kosilek’s Gender Identity Disorder.  The court found this result compelled by the 8th Amendment of the U.S. Constitution after accepting a finding that Kosilek was at risk of serious self-injury. Kosilek is serving a life sentence for murdering his/her wife.

The ruling has been very controversial. The question is why? On one level this might be thought of as a general reflection of antipathy towards murderers, or towards the transgendered.  But I think if we cut deeper there are three more interesting things that might be going on. I say “might” very explicitly, treat these as hypotheses, and certainly don’t mean them to be exhaustive.

Here they are:

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MA Health Reform and Medical Debt – Getting the Facts Straight

by Rebecca Haffajee 

Earlier this week, the Boston Globe reported that medical debt is still a problem in Massachusetts, with scant change since the implementation of health reform legislation in 2006. Specifically, the article reports that of approximately 3,000 adults surveyed in 2010, 17.5% had trouble paying medical bills in the past year and 20% were carrying medical debt and paying it over time, statistically insignificant changes since 2006. The source of this finding is the Massachusetts Health Reform Survey (MHRS) funded by Blue Cross Blue Shield of MA Foundation, whose latest results published in January 2012 track annual trends from 2006 – 2010. The Globe story seems to suggest that in the absence of reductions in medical debt, health reform is failing to achieve one of its goals. The survey findings, however, don’t present a story of causal inference; they (at best) identify a loose association.

Just to recap some basics of MA health reform: the law required most residents to obtain insurance. It established Commonwealth Care through the Health Connector – an exchange of sorts – so that low income residents not eligible for Medicaid could qualify for a subsidized plan.  The Connector also offers Commonwealth Choice non-subsidized plans for individuals and employers.  Since passage of the law, insurance coverage among MA residents has increased from 94% to 98%.

The MHRS study design consists of 1 “pre” measurement, or the survey fielded in 2006 just before reform implementation, and 4 “post” measurements (2007-2010).  This design fails to provide a reliable counterfactual that reveals what would have happened in the absence of the health reform “treatment”.  A slightly better design would have administered survey questions for many years before health reform implementation. But even this design would be considered somewhat weak for causal inference given the presence of other factors that could have happened concurrently with the policy change that could explain outcomes. For instance, the recession could dramatically impact how much medical debt is incurred or not paid off, even with health insurance — especially with the proliferation of high deductible health plans in recent years.

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Tobacco Labeling and the Ethics of Persuasion

by Nadia N. Sawicki

The D.C. Circuit’s recent decision vacating the FDA’s graphic labeling requirements has prompted a flood of valuable commentary about compelled speech doctrine, including Richard Epstein’s, below.  While analysis of the First Amendment issues is important, I view the R.J. Reynolds case instead as an example of how emphasis on formal legal arguments may detract attention from the underlying source of public opposition.

My current research focuses on the state’s use of emotionally-gripping graphic imagery in medical and public health contexts. I focus on two examples – the “fear appeal,” exemplified by the FDA’s graphic tobacco labeling requirements; and appeals to positive emotions, such as maternal bonding, exemplified by state laws requiring that women view ultrasound images and hear the heartbeat of their own fetus before consenting to an abortion.

Both types of appeals to emotion have faced constitutional challenges – as violations of First Amendment compelled speech doctrine, or imposition of undue burdens on reproductive liberty interests.   But these formalistic constitutional tests do not, in my opinion, get at the heart of the public’s concern about government persuasion using emotional imagery.  Few contemporary commentators are willing to challenge requirements for scientifically valid textual warnings. Rather, it is the use of images – diseased lungs, cadavers, fetal heartbeats – that strikes a chord of concern among many critics.  Whether designed to inspire fear, love, or disgust, the government’s use of these images to persuade seems to run counter to the principles of democratic discourse.

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Jurimetrics Call for Papers – Special Issue: Intersection of Law, Science, and Policy to Protect the Public’s Health

Jurimetrics: The Journal of Law, Science, and Technology (ASU/ABA) is seeking submissions for a special symposium issue edited by James Hodge on the Intersection of Law, Science, and Policy to Protect the Public’s Health, to be published in Spring 2013.  Potential manuscripts may include:

  1. Examinations of how and why law, policy, and science either advance (or fail to advance) the public’s health;
  2. Assessments of the role of science in furthering legal and policy objectives to protect communal health;
  3. Strategies to advance public health initiatives through law or policy despite a lack of strong, scientific support or evidence;
  4. Strategies to make better use of existing legal or policy tools to achieve public health objectives.

Unlike some symposia, this issue is not focused solely on a specific public health topic.  Rather, manuscripts may explore one or more core public health law topics like obesity prevention, chronic and infectious disease control, emergency preparedness, public health system reform, or tobacco prevention, among others, at the national or global level.

Original articles may range in length from 3,500 – 5,000 words (not including footnotes).  Contributors may include scholars or practitioners in law, public health, science, or policy.  Co-authored, cross-disciplinary manuscripts are also encouraged.

Contact James Hodge (james dot hodge dot 1 at asu dot edu) for more information, but initial brief abstracts are due to him by Friday, Sept. 28 (manuscripts will be due Nov. 15).  He’s also seeking peer reviewers.

The Body Snatchers: Human Recycling in The Global Age

By Michele Goodwin

For all the attention by legal scholars, doctors, and politicians to the global organ shortage—and particularly the crisis in the United States, relatively little is said about tissue demand and that supply industry.  Well known are the horrific stories involving black markets specializing in organs like kidneys and livers.  The troubling stories of Indian women, Pakistani men, and Brazilian boys pillaged for parts and left suffering with grotesque scars, owing debts, and in medical need are chronicled by a growing chorus of scholars (see here, here, and here).  Even those of us who support incentives to encourage organ donation strongly oppose human rights abuses paraded as free markets.  What scholars continually overlook, however, are the surreptitious, global tissue trades that effect more people and have the potential to cause greater harm, such as diseased tissues, bones, and other body parts entering the stream of US commerce and transplantation.

Several years ago, I presaged some of these problems and wrote about these issues; one of the articles can be found here.  More recently, an international consortium of journalist have come on board with an eye-opening special report, revealing black markets in Europe for human tissues and bones.  Their story begins in the Ukraine, where earlier this year security guards discovered body parts and skin stuffed into coolers, and envelopes filled with cash–transported on a “grimy white minibus.”  Authorities stumbled onto this body part heist thinking that a mass-murder had been uncovered. To their surprise, the bus and its contents were headed off to Germany before shipment of the parcels to Korea, the US and other countries.

On its own, tissue transplantation makes as much sense as organ transplantation, because they help to improve patients’ quality of life and in some instances may be vital to saving lives, such as heart valve transplants.  The problem is that the dark-side of this industry operates nefariously.  Sometimes this includes pillaging parts from cadavers dead from communicable diseases such as HIV and hepatitis or acquiring tissues through illegal means, or mislabeling parts—claiming that body parts are from Germany, when in fact they are from developing countries.  Often companies that trade on stock exchanges are linked to the darker side.  For example, investigators discovered that a US business, RTI, located in Florida is linked to the Ukraine discovery.  As Dr. Martin Zizi remarked to reporters, “once a [body part] is in the European Union, it can be shipped to the U.S. with few questions asked…They assume you’ve done the quality check, [but] we are more careful with fruit and vegetables than with body parts.”

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Conference Announcement: Institutional Financial Conflicts of Interest in Research Universities

On November 2 at Harvard Law School, the Petrie-Flom Center and the Edmond J. Safra Center for Ethics will be co-sponsoring a day-long symposium organized by Dr. David Korn on institutional financial conflicts of interest in research universities. The speaker line-up is incredible, including Francis Collins, Derek Bok, and Zeke Emanuel, among other experts from academia and government.

For more information, and to register (attendance is free), check out the symposium webpage.  We hope to see you there!

 

New Product Liability Regime for Stem Cell Products?

By Hyeongsu Park

In May 2012, Health Canada granted market authorization for Prochymal. This decision is the world’s first regulatory approval of a stem cell drug (as well as the first therapy for acute graft-vs-host disease, a serious complication of bone marrow transplantation that kills up to 80% of children affected). Like Prochymal, many stem cell products have exciting therapeutic potential, such as bone regeneration and cartilage formation. And the global stem cell product market is estimated to reach $6.6 billion by 2016. However, side-effects remain unknown, and the regulations for such products are largely non-existent. So what should happen if a patient gets hurt?

Stephen R. Munzer (UCLA School of Law) discusses this question in his latest article in the Boston University Journal of Science and Technology Law, and recommends that qualified strict liability should govern product liability for stem cell products. Read More