WEDNESDAY, 4/23: Reforming Brazilian Pharmaceutical Patent Policy

Reforming Brazilian Pharmaceutical Patent Policy: Lessons from the Past and the Road for the Future

April 23, 12:00pm 

Wasserstein Hall 1010, Harvard Law School, 1585 Massachusetts Ave.

In this lecture by Pedro Paranaguá, he will discuss the report issued by the Brazilian House of Representatives in 2013 as part of an effort to revamp the country’s patent law. Brazil does not want to be a mere exporter of commodities, neither does it want to be a simple consumer of knowledge goods. Brazil wants to be at the cutting edge of innovation; it wants to innovate to compete. Paranaguá’s presentation will introduce the current state of affairs of the Brazilian patent system, with a focus on pharmaceuticals. He will present the main findings and recommendations of the 2013 report, including the tabling of a bill to fix the mistakes of the 1990s.  The talk will be followed by discussion with a panel of experts. Panelists include:

  • Brook K. Baker, Professor of Law, Northeastern University School of Law; Policy Analyst for Health GAP (Global Access Project)
  • Benjamin N. Roin, Hieken Assistant Professor in Patent Law, Harvard Law School; Co-Director, Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics; Associate Member, Broad Institute

Pedro Paranaguá has been a Lecturer in Law at the LL.M. in Business Law at Fundação Getulio Vargas (FGV), Brazil, since 2007. Mr. Paranaguá is also the lead Advisor to the ruling Workers Party at the Brazilian House of Representatives for Internet, copyright, patent, data privacy, cybercrime, and related matters. He is responsible for drafting the Brazilian Internet Framework Bill (“Marco Civil”) for the rapporteur, including provisions on net neutrality, ISP liability, and privacy. He coordinated the 350-page report, “Brazil’s Patent Reform,” for the Brazilian House of Representatives. He has been an invited instructor at Duke University School of Law (2011), lecturer in law at FGV Rio, and has held numerous other lectureships in Brazil and abroad (Lecturer in Brazil and abroad (Brazil’s Supreme Court and Senate, Yale, UCLA, UNESCO, UNCTAD, WIPO). He was Director of the A2K Brazil Program at the Center for Technology and Society (CTS-FGV), and co-representative of Creative Commons in Brazil (2005-2010). He produced commissioned studies on copyright and technology for the country’s Culture Ministry, and served as FGV-delegate at the World Intellectual Property Organization (WIPO) in Geneva (2005-2009). He has also served as a member of the Brazilian Free Software Project. From 2001 to 2003, he was an IP lawyer at Gusmão & Labrunie, where he was Project Manager on patents and access to medicines. He is the author of the books Copyright Law (Portuguese) (with Sergio Branco) andPatent Law (Portuguese) (with Renata Reis). Mr. Paranaguá holds a LL.M. (cum laude) in Intellectual Property, Internet and Policy (London) and is a Doctoral candidate (S.J.D.) at Duke University School of Law, where he is finalizing his thesis, “Brazil’s Copyright Law Reform: Tropicália 3.0?”, under the supervision of Professor Jerome Reichman.

Sponsored by the HLS Brazilian Studies Association, with support from the Petrie-Flom Center.

Announcing 2014-2016 Petrie-Flom Academic Fellow Rachel Sachs

We are pleased to announce that Rachel Sachs will be joining the Petrie-Flom Center later this summer as an Academic Fellow for the 2014-2016 fellowship term. In 2013, Rachel earned her J.D. magna cum laude from Harvard Law School, where she was the Articles Chair of the Harvard Law Review and a student fellow with both the Petrie-Flom Center and the John M. Olin Center for Law, Economics, and Business. Rachel has also earned a Masters in Public Health from the Harvard School of Public Health, during which she interned at the United States Department of Health and Human Services. She also holds an A.B. in Bioethics from Princeton University. After law school Rachel clerked for the Honorable Richard A. Posner of the United States Court of Appeals for the Seventh Circuit. Rachel’s primary research interests lie at the intersection of patent law and public health, with a particular focus on problems of innovation and access and the ways in which law helps or hinders these problems. Her past scholarship has examined the interactions between patent law and FDA regulation in the area of diagnostic tests, and explored the mechanisms behind the passage of patent-related legislation. Her current scholarship applies this focus on innovation and access to the intersection of patent law and drug reimbursement policies.
You can learn more about Rachel on our website.
Welcome Rachel!

5/2-3: Petrie-Flom Center Annual Conference, “Behavioral Economics, Law, and Health Policy”

Petrie-Flom Center 2014 Annual Conference: Behavioral Economics, Law, and Health Policy

May 2-3, 2014

Wasserstein Hall, Milstein East ABC, Harvard Law School, 1585 Massachusetts Ave.

Richard H. Thaler and Cass R. Sunstein’s book  Nudge: Improving Decisions About Health, Wealth, and Happiness brought behavioral economics to the masses, beginning a discussion of libertarian paternalism and the many ways that “choice architects” can help nudge people to make better choices for themselves without forcing certain outcomes on anyone. Some of their examples fall in the realm of health policy, as is also the case of Daniel Kahneman’s recent book, Thinking, Fast and Slow, which examines various cognitive errors people make in their judgments, choices, and conclusions, as well as how we might correct them.  But the conversation has only just begun.

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New Joint Project on Law and Applied Neuroscience

The MGH Center for Law, Brain and Behavior and Harvard Law School’s Petrie-Flom Center announce joint “Project on Law and Applied Neuroscience” for 2014-2016

The MGH Center for Law, Brain and Behavior and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School will collaborate on a joint venture – the Project on Law and Applied Neuroscience – beginning in Fall 2014. The collaboration will include a Senior Fellow in residence, public symposia, and an HLS Law and Neuroscience Seminar.

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Sex Selection or Gender Selection? Queering the Ratio Question

I am at a fantastic event at Yale I co-organized on Intersections in Reproduction: Perspectives on Abortion, Assisted Reproductive Technologies, and Judicial Review with some amazing scholars present and excellent papers being presented. Like many people who have thought about sex selection, I would have imagined I have thought through most of the issues from most perspectives. What I love about these gatherings is that they always prove me wrong.

Today two very interesting questions were raised about a common argument raised about sex selection, the risk that it will result in unbalanced sex ratios. Our discussion, I would say, “queered” the typical claim in two interesting ways, and I am curious what others think (to be clear these were my thoughts on questions raised, not putting words in their mouths).

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New Profile of Petrie-Flom Annual Conf. Keynote Speaker Cass Sunstein

From the article. (Nadav Kander/Trunk Archive)

The Atlantic has just published a new piece profiling Harvard Law School Professor Cass Sunstein, “Our Nudge in Chief,” exploring “How, and why, Cass Sunstein believes laws and public policies should help save us from our irrational impulses.”

Sunstein, the Robert Walmsley University Professor at Harvard Law School, will deliver the keynote lecture at the Petrie-Flom Center’s upcoming annual conference, “Behavioral Economics, Law, and Health Policy,” on Friday, May 2. His talk is entitled “Choosing Not to Choose.” You can find out more about the conference here.

Read the full profile.

Art Caplan on “Pediatric Euthanasia in Belgium: Disturbing Developments”

Art Caplan has coauthored a new piece in JAMA on problems with Belgium’s new law allowing terminally-ill children and their families to choose euthanasia. From the article:

The Belgian pediatric euthanasia law seeks to respect the moral status of children as agents who possess the nascent capacity for self-determination. Specifically, the law requires the medical team to demonstrate a patient has the “capacity for discernment,” indicating that he or she understands the consequences of a choice for euthanasia.

What the law does not consider, however, is that adults choose euthanasia for reasons that go beyond pain. For adults, the decision to end their life can be based upon the fear of a loss of control, not wanting to burden others, or the desire not to spend their final days of life fully sedated. These desires might be supported by the experience they have had witnessing a loved one express a loss of dignity or because they understand what terminal sedation is and wish to refuse it. Children, however, lack the intellectual capacity to develop a sophisticated preference against palliative interventions of last resort. Instead, in the case of the new Belgian law, children seem to be asked to choose between unbearable suffering on the one hand and death on the other.

This possibility causes the Belgian euthanasia law to fall short of the standard required for valid assent. The criterion related to the “capacity for discernment” runs the risk of ignoring the fact that children and adolescents lack the experiential knowledge and sense of self that adults often invoke—rightly or wrongly—at the end of their lives.

Read the full article.

FOR HARVARD STUDENTS: TOMORROW: Dallas Buyers Club: Free Film Screening and Discussion

Image by christian razukas from Wikimedia Commons.

Dallas Buyers Club: Free Film Screening and Panel Discussion

April 16, 2014 6:00 PM
Wasserstein Hall 1010, 1585 Massachusetts Ave.

Students from across Harvard are invited to view a free screening of the Academy-award winning film Dallas Buyers Club and participate in a panel discussion about issues addressed in the film related to access to health care for the HIV community.  The panel discussion will address the following issues: the history of access to care and treatment for HIV; ongoing issues with fair pricing of HIV medications; the role of the FDA in access to experimental medicines; and the portrayal of HIV and LGBTQI individuals in the media as it impacts access to individual and public health resources. Panelists include:

  • Robert Greenwald, Director, Center for Health Law & Policy Innovation; Clinical Professor of Law, Harvard Law School
  • Christopher T. Robertson, Visiting Professor of Law, Harvard Law School; Faculty Affiliate, Petrie-Flom Center
  • Grace Sterling Stowell, Executive Director, BAGLY: Boston Alliance of Gay, Lesbian, Bisexual and Transgender Youth

This event is open to students from all Harvard schools.  No pre-registration is required.

This event is co-sponsored by the Center for Health Law & Policy Innovation; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics; and Lambda at Harvard Law School.

5/20 conference: “Biostatistics & FDA Regulation: The Convergence of Science & Law”

Biostatistics and FDA Regulation: The Convergence of Science and Law

Tuesday, May 20, 2014, 8:00am – 5:00pm

Wasserstein Hall, Milstein West AB, Harvard Law School, 1585 Massachusetts Ave.

Symposium Presented by the Drug Information Association (DIA), the Food and Drug Law Institute (FDLI), and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, in collaboration with the Harvard School of Public Health Department of Biostatistics and Harvard Catalyst | The Harvard Clinical and Translational Science Center.

Biostatistics is the application of statistics — the study of the collection, organization, analysis, interpretation and presentation of data — to a wide range of topics in life sciences.  Biostatistics informs the Food and Drug Administration’s regulatory decision-making processes for premarket review of investigational drugs and devices and post-market surveillance of medical products, including decisions to require safety labeling changes and withdraw approval.   Recent developments, such as Congress’s creation of a new federal infrastructure for the dissemination of comparative effectiveness information, point to the need for a fresh look at the way in which biostatistical principles inform federal health care policy, particularly at the FDA.  This one-day symposium will give attendees the foundational knowledge they need to understand how biostatistics applies in FDA regulation, and will also address closely related issues residing at the intersection of statistical analysis and life sciences litigation. The full conference agenda is available on the website.

Registration is required in order to attend this event. Please register here.

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Research Round-Up: New Publications from the PHLR SciVal Experts Community

In honor of last week’s National Public Health Week, we have a lot of fresh, new PHLR. The latest crop of papers from public health law researchers touch on a number of important points and issues including transportation safety, implementation, tobacco control, and media presentation of public health law. Check out Scott Burris’s brief summaries after the jump!

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Petrie-Flom Intern’s Weekly Round-Up, 4/4-4/11

By Chloe Reichel

Following the release of information on Medicare billing practices, it was revealed that approximately 4,000 physicians each billed over $1 million in 2012. This data may shed light on medical billing procedures.

Despite a proposed 1.9 percent cut to the Medicare Advantage program, these cuts will not be implemented. On Monday the Centers for Medicare and Medicaid Services announced that funding to Medicare Advantage will increase by an average of .4 percent in 2015.

Though genetic testing is becoming cheaper and more accessible, many Americans refrain from getting tested. This is because the Genetic Information Nondiscrimination Act does not protect consumers from discrimination for life, disability, and long-term care insurance plans.

On Friday, Kathleen Sebelius, current Secretary of Health and Human Services, will resign from her role. Sebelius oversaw the oft-criticized implementation of the Affordable Care Act. Sylvia Mathews Burwell, director of the White House Office of Management and Budget, has been selected by President Obama to fill the role. Burwell served in the Clinton administration, and was president of the Walmart Foundation, prior to her work with the Obama administration.

This Thursday the European Parliament debated a petition that would prevent the allocation of EU funds for research, aid, and public health programs that involve the destruction of human embryos. The petition had 1.8 million signatures, and is seen as a sign of popular support for social conservatism.

Hawaii’s extensive health system has led to excellent health outcomes for the state’s residents and the state’s budget, since the state has some of the lowest healthcare costs in the nation. Hawaii has near-universal health insurance coverage, and starting forty years ago, has required employers to provide health benefits to their employees.

On Saturday, Maryland legislators voted to decriminalize possession of small amounts of marijuana. Those found in possession of less than 10 grams of marijuana will now be charged with civil fines, as opposed to criminal penalties.

FOR HARVARD STUDENTS: 4/16: Dallas Buyers Club: Free Film Screening and Discussion

Image by christian razukas from Wikimedia Commons.

Dallas Buyers Club: Free Film Screening and Panel Discussion

April 16, 2014 6:00 PM
Wasserstein Hall 1010, 1585 Massachusetts Ave.

Students from across Harvard are invited to view a free screening of the Academy-award winning film Dallas Buyers Club and participate in a panel discussion about issues addressed in the film related to access to health care for the HIV community.  The panel discussion will address the following issues: the history of access to care and treatment for HIV; ongoing issues with fair pricing of HIV medications; the role of the FDA in access to experimental medicines; and the portrayal of HIV and LGBTQI individuals in the media as it impacts access to individual and public health resources. Panelists include:

  • Robert Greenwald, Director, Center for Health Law & Policy Innovation; Clinical Professor of Law, Harvard Law School
  • Christopher T. Robertson, Visiting Professor of Law, Harvard Law School; Faculty Affiliate, Petrie-Flom Center
  • Grace Sterling Stowell, Executive Director, BAGLY: Boston Alliance of Gay, Lesbian, Bisexual and Transgender Youth

This event is open to students from all Harvard schools.  No pre-registration is required.

This event is co-sponsored by the Center for Health Law & Policy Innovation; the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics; and Lambda at Harvard Law School.

TOMORROW: Hot Topics at Presidential Commission on Bioethics

Hot Topics at the Presidential Commission for the Study of Bioethical Issues: Plus Q&A on Careers in Law and Bioethics!

Friday, April 11, 2014, 12:00pm

Pound Hall 100, Harvard Law School, 1563 Massachusetts Ave.

Please join us for an update from the Presidential Commission for the Study of Bioethical Issues, delivered by Michelle Groman (HLS ’05), Associate Director at the Bioethics Commission.  Since its inception in 2009, President Obama’s Commission has issued reports on synthetic biology, human subjects research, whole genome sequencing, pediatric medical countermeasure research, and incidental findings. Currently, the Commission is examining the ethical implications of neuroscience research and the application of neuroscience research findings as part of the federal government’s BRAIN Initiative.  The Commission also has developed educational materials to support teaching of bioethics ideas, principles, and theories in traditional and non-traditional settings.

This final half-hour of this event will feature a discussion of career opportunities in law and bioethics, led by Ms. Groman and Holly Fernandez Lynch, Petrie-Flom Center Executive Director.  Bring your questions!

This event is free and open to the public. Lunch will be served.

For questions, contact petrie-flom@law.harvard.edu, or 617-496-4662.

Cosponsored by the Office of Career Services at Harvard Law School. This event is supported by the Oswald DeN. Cammann Fund.

4/10 Book Launch: The Witch-Hunt Narrative: Politics, Psychology, and the Sexual Abuse of Children

Thursday, April 10, 2014, 12:00pm

Wasserstein Hall 2019A, Harvard Law School, 1585 Massachusetts Ave.

Please join us for the launch of Professor Ross E. Cheit‘s new book The Witch-Hunt Narrative: Politics, Psychology, and the Sexual Abuse of Children (Oxford University Press, April 2014). It has become widely accepted that a series of high-profile child sexual abuse cases from the 1980s and early 1990s were “witch hunts.” That view first took hold in the media, then spread to the courts and academia. But purveyors of the witch-hunt narrative never did the hard work of examining court records in the many cases that reached the courts throughout the nation. Drawing on fifteen years of original trial research into these child sex abuse cases, Cheit challenges the accuracy of the narrative. The launch event will feature panel discussion including:

  • Ross E. Cheit, Professor of Political Science and Public Policy, Brown University
  • Jeannie Suk, Professor of Law, Harvard Law School
  • Alan A. Stone, MD, Touroff-Glueck Professor of Law and Psychiatry, Harvard Law School

This event is free and open to the public.

For questions, contact petrie-flom@law.harvard.edu or 617-496-4662.

Twitter Round Up

This week’s twitter round up features a variety of topics from our contributors, from discussions about health care spending and the Affordable Care Act to articles about environmental poisoning of soldiers in Iraq.

  • Amitabh Chandra tweeted that “Healthcare spending growth hits a 10yr high… so much for ‘ACA is bending the cost curve’” and shared an article from USA Today.
  • Frank Pasquale shared a blog entry by Larry Backer about Pennsylvania State University students’ worries about the rise of health care costs.
  • I. Glenn Cohen shared a link to an article in The New York Times entitled “‘Environmental Poisoning’ of Iraq Is Claimed” and states that many veterans suffer from environmental poisoning while the “IOM [is] not sure.”
  • Kate Greenwood retweeted Austin Frakt and an article from The Incidental Economist about the negative impact of the insurance market before the implementation of the Affordable Care Act on entrepreneurship.
  • Stephen Latham tweeted a link to his blog reporting on the recent announcement of the Public Health Committee of the Connecticut Legislature that it does not plan to vote on a bill addressing “Aid-In-Dying” or physician-assisted suicide despite “61% public support for the bill.”

Expedited FDA Approval for Breakthrough Therapies: Promises and Pitfalls

By Michael Young

In 2012, the FDA introduced a novel pathway for expedited review of breakthrough therapies. The ‘breakthrough-drug’ designation was carved out by the Food and Drug Administration Safety and Innovation Act (FDASIA), which provided for expedited development and review of any drug “intended, alone or in combination with 1 or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development.”  This pathway added to a variety of other accelerated FDA approval programs aimed at improving access to innovative, safer, or more effective therapies for serious medical conditions.

In a recent New England Journal of Medicine article, Jonathan Darrow, Jerry Avorn and Aaron Kesselheim examine the clinical consequences and ethical dimensions of the breakthrough-drug category, and raise a variety of vital questions about its implications for patients.

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Smoke and Mirrors and Women, Oh My

[Guest post by Katherine L. Record, JD, MPH, MA]

Last week the Supreme Court attracted lots of attention when it heard arguments about whether a corporation can exclude mandatory preventive benefits from its employee health plan, based on a religious objection to certain types of healthcare.  This is a tale as old as time; religion has long been the basis for opposition to reproductive (i.e., women’s) health – including the preventive healthcare now in question, contraception.

Yet this argument has nothing to do with government infringement on the practice of religion.

In fact, the corporation, Hobby Lobby, covered two of the four contraceptive devices in dispute until its lawyers were actually arguing the issue in court, apparently to little detriment to the company’s faith in God.  What’s more, Hobby Lobby’s 401(k) includes more than $73 million invested in the companies that produce these objectionable contraceptives (e.g., intrauterine devices, emergency contraception).

This has not stopped Hobby Lobby from arguing that the Affordable Care Act (ACA) is threatening its freedom, as a corporation, to practice religion.

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