Category: Pharmaceuticals

#BELHP2014 Panel 3, Behavioral Economics and Health Care Costs

W. Nicholson Price Leave a comment

By Nicholson Price

[Ed. Note: On Friday, May 2 and Saturday, May 3, 2014, the Petrie-Flom Center hosted its 2014 annual conference: “Behavioral Economics, Law, and Health Policy.”  This is an installment in our series of live blog posts from the event; video will be available later in the summer on our website.]

Our third panel, moderated by PFC Academic Fellow Matthew Lawrence, addresses the use of behavioral economics techniques to control health care costs.  Speakers are Christopher T. Robertson, Brigitte Madrian, Ameet Sarpatwari, Anupam Jena, and Jim Hawkins.  (Many projects are co-authored, but I’m only listing the presenters here)

The first speaker is Professor Christopher T. Robertson, coming from Arizona Law but visiting Harvard and the PFC this year, speaking on Cost-Sharing as Choice Architecture.  He starts by talking about the cost side of cost sharing, which we know works in reducing consumption from empirical evidence; from the RAND study, it reduced use without reducing health.  More recent studies also confirm this.  But cost sharing presents four problems:

  1. Underinsurance relative to ability to pay
  2. Indiscriminate reductions in health care (more of an ax than a scalpel)
  3. An unfair tax on sickness (more tentative if we can solve the first two)
  4. The burden of deciding.

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Summer Course for Professionals in “Pharma Law & Policy” at the University of Copenhagen

Timo Minssen Leave a comment

Stay abreast with recent developments and trends determining the legal and regulatory framework of the European pharmaceutical industry.

What are the most significant current issues shaking and shaping the pharmaceutical industry today? The business environment and legal framework relevant to the pharmaceutical industry continues to change rapidly in the face of constant challenges posed by competition, politics and technological innovation. Considering the highly lucrative and competitive nature of the industry, it is more important than ever for professionals working with legal and regulatory aspects of drug development to stay abreast of the most recent developments.

This course provides a broad and practical understanding of the ‘hot topics’ and will present and analyse these topics from scientific, legal and policy perspectives.

Further information about the course is available here.

Course content

The course begins with a general overview of the current scientific and legal trends in pharmaceutical R&D, organisation and policy. This is followed by a review of the hot topics through a combination of lectures, discussions, group work and case studies. The course is designed to allow room for the issues and challenges crucial to the participants’ daily work and practice.

Participants

The course is designed for professionals working with legal issues and/or regulatory aspects of drug development, decision-makers, administrators and health care practitioners within both the public and private sectors, e.g.:

  • Legal departments in the pharmaceutical industry.
  • Law firms dealing with patent and competition law in the pharmaceutical industry.
  • Branch organizations in the pharmaceutical sector.
  • Health care professionals and decision makers.
  • Bank and finance consultants working with risk and investment in the pharmaceutical industry.

Credit – especially for lawyers and trainee solicitors

This course meets the Danish requirements for compulsory supplementary training for lawyers and trainee solicitors.

Course dates

5 days, 18 – 22 August 2014, 9:00 – 17:00 at the University of Copenhagen, Frederiksberg Campus.

Course director

Timo Minssen, Associate Professor, Dr., LL.M., M.I.C.L., Centre for Information and Innovation Law, Faculty of Law, University of Copenhagen

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A More Transparent System for Clinical Trials Data in Europe – Mind the Gaps!

Timo Minssen Leave a comment

By Timo Minssen

Following the approval of the European Parliament (EP) earlier last month, the Council of the European Union (the Council) adopted on 14 April 2014 a “Regulation on clinical trials on medicinal products for human use” repealing Directive 2001/20/EC.  As described in a press-release, the new law:

“aims to remedy the shortcomings of the existing Clinical Trials Directive by setting up a uniform framework for the authorization of clinical trials by all the member states concerned with a given single assessment outcome. Simplified reporting procedures, and the possibility for the Commission to do checks, are among the law’s key innovations.”

Moreover, and very importantly, the Regulation seeks to improve transparency by requiring pharmaceutical companies and academic researchers to publish the results of all their European clinical trials in a publicly-accessible EU database. In contrast to earlier stipulations which only obliged sponsor to publish the end-results of their clinical trials, the new law requires full clinical study reports to be published after a decision on – or withdrawal of – marketing authorization applications. Sponsors who do not comply with these requirements will face fines.

These groundbreaking changes will enter into force 20 days after publication in the Official Journal of the EU. However, it will first apply six months after a new EU portal for the submission of data on clinical trials and the above mentioned EU database have become fully functional. Since this is expected to take at least two years, the Regulation will apply in 2016 at the earliest (with an opt-out choice available until 2018).

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How should we label these “cognitive errors” that are particularly common among MDs?

jurrutia Leave a comment

Behavioral economists are really into giving the cognitive errors they study, and the corrective policy interventions they favor, labels. “Status quo bias,” “availability bias,” “recall bias,” etc., can all be fixed through “nudges” that involve “asymmetric paternalism” and the like.

Here’s an interesting “cognitive error” that I’m trying to crowd-source a label for: When America’s joint surgeons were challenged to come up with a list of unnecessary procedures in their field, their selections shared one thing: none significantly impacted their incomes.

And here’s another odd cognitive anomaly that seems to be especially limited to ophthalmologists: forgetting there’s a $50 dollar alternative that works just as well as the $2,000 injection they get 6% commission on. 

I’ve thought of my own labels (or rather, euphemisms) for the policy interventions I would suggest in response: “continuing medical education”  for the first of these neat little errors, and “resocialization” for the second.

WEDNESDAY, 4/23: Reforming Brazilian Pharmaceutical Patent Policy

The Petrie-Flom Center Staff Leave a comment

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

The Petrie-Flom Center Staff Leave a comment
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!

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

The Petrie-Flom Center Staff Leave a comment
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”

The Petrie-Flom Center Staff Leave a comment

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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You can’t put a price tag on Sovaldi (unless it’s over $84K)

jurrutia 2 Comments

Gilead Sciences has developed a new drug (Sovaldi) that cures hepatitis C.

This is a huge deal: about 150 million people world wide are chronically infected with the hepatitis C virus (HCV); according to the CDC 60-70% of people with chronic HCV will go on to develop chronic liver disease, 5-20% will develop cirrhosis over 20-30 years, and 1-5% will eventually die from the direct consequences of chronic infection (liver cancer or cirrhosis).

Sovaldi, which cures patients about 90% of the time with minimal side effects, could change all of this. John Castellani, President of Pharmaceutical Research and Manufacturers of America says that this breakthrough is so valuable, that “you just can’t put a price tag on it.”

But of course, a price tag has been put on it: $84,000 for the 12-week course of treatment (or $1,000) per day.

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

The Petrie-Flom Center Staff Leave a comment
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.