Category: Conference
Save the Date – May 17th “Issues and Case Studies in Clinical Trial Data Sharing – What Have We Learned?”
Please save the date for this upcoming conference at Harvard Law School on May 17, 2013:
Issues and Case Studies in Clinical Trial Data Sharing:
What Have We Learned?
Co-sponsored by the Multi-Regional Clinical Trial Center at Harvard University, and the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School
LOCATION: Wasserstein Hall, Milstein West A, Harvard Law School
1585 Massachusetts Avenue, Cambridge, MA
Speakers and registration information to be announced shortly
May 17, 2013 (8AM – 6PM)
Objectives:
-
To discuss opportunities for and implications of emerging clinical trial data disclosure standards
-
To review evidence from recent case studies in clinical trial data disclosure, especially related to disclosure of participant-level data
-
To review the rationale behind disclosure requirements of patient-level data and discuss whether the case studies demonstrate the goals have been met
-
To identify potential areas of collaboration among stakeholder groups, such as the formation of working groups to provide recommendations or standards in this area
-
To review variance in regulatory approaches and areas for possible harmonization
-
To identify other key areas of learning that may inform policy in this important area moving forward
-
To use conference findings as basis of a publication in a peer-reviewed journal that captures the case studies, provides insights into these issues and offers recommendations for moving forward
Conference Announcement: Governance of Tobacco in the 21st Century
Governance of Tobacco in the 21st Century:
Strengthening National and International Policy for Global Health and Development
February 26-27, 2013
Harvard University, Cambridge, MA, USA
| Keynote Speakers: | |
| Dr. Nkosazana Dlamini-Zuma Chairperson, African Union Commission |
Dr. Margaret Chan Director-General, World Health Organization |
How do international laws and institutions regarding tobacco, trade, investment, agriculture and economic development intersect? What are the implications for global tobacco control efforts? How should public health concerns be taken into account in international economic policymaking? What is the proper balance between a government’s obligations to protect the health of its citizens and other international agreements to which it has subscribed? What are the broader implications for global governance and for global health?
This conference will bring together representatives from governments, intergovernmental organizations, civil society, business, and academia to explore these questions with the objective of:
- Enhancing knowledge, information-sharing, network-building and learning across countries, contexts and policymaking arenas
- Identifying strategies to strengthen the governance of tobacco at national and international levels;
- Fostering greater policy coherence among actors working in health, trade and investment to ensure the protection of global health
The conference is being hosted by the Harvard School of Public Health’s Center for Global Tobacco Control and the Harvard Global Health Institute’s Forum on Global Governance for Health, with advice and support from the World Health Organization’s Tobacco-Free Initiative.
Additional support is provided by: American Legacy Foundation; American Cancer Society; the International Development Research Centre Canada; Campaign for Tobacco-free Kids; Harvard Law School; Framework Convention Alliance; O’Neill Institute for National and Global Health Law, Georgetown University; Institute for Global Tobacco Control, Johns Hopkins University; International Tobacco Control Policy Evaluation Project, University of Waterloo, Canada; Southeast Asia Tobacco Control Alliance (SEATCA).
Additional information is available here. Registration is required.
BU Law Conference on New Legal Challenges to Global Tobacco Control, Jan. 25, 2013
Boston is a great city for health policy. On Jan. 25, BU Law hosts a conference on New Legal Challenges to Global Tobacco Control. Just a month later, Harvard hosts its own conference on the Global Governance of Tobacco (details here).
The BU Law conference (announcement here; detailed schedule here) will focus on challenges rooted in constitutional law (First Amendment litigation in the US attacking FDA-required graphic images on tobacco packs); trade mark law (plain packaging in Australia); and global trade and investment treaties such as the Hong Kong-Australia Bilateral Investment Treaty and the WTO Agreements. Speakers include some of the world’s leading public health experts on this topic:
- Matthew Allen, Allen + Clarke Policy and Regulatory Specialists
- Micah Berman, New England School of Law
- Scott Burris, Temple University Beasley School of Law
- Julien Chaisse, The Chinese University of Hong Kong
- Richard Daynard, Northeastern University School of Law
- Samantha Graff, NPLAN
- Jane Kelsey, University of Auckland Faculty of Law
- Lara Khoury, McGill University Faculty of Law
- Mark Levin, University of Hawai’i at Manoa William S. Richardson School of Law
- Jonathan Liberman, Cancer Council Victoria
- Benn McGrady, Georgetown University Law Center
- Ted Mermin, Public Good Law Center
- Kevin Outterson, BU School of Law
- Robert Stumberg, Georgetown University Law Center
- Allyn Taylor, Georgetown University
- Tania Voon, University of Melbourne Law School
- George Annas, BU School of Law and BU School of Public Health
- Leonard Glantz, BU School of Law and BU School of Public Health
- Wendy Mariner, BU School of Law and BU School of Public Health
- Alexandra Roberts, BU School of Law
- Keynote Speaker: Dr. Michael Siegel, BU School of Public Health
The conference is open to everyone; see the schedule for details. The conference papers will be published in the American Journal of Law & Medicine.
Conference: The Governance of Tobacco in the 21st Century, February 26-27
The Harvard Global Health Institute will be co-hosting a conference on The Governance of Tobacco in the 21st Century: Strengthening National and International Policy for Global Health and Development at Harvard on February 26-27, 2013. The conference program is available here, and additional information can be found here. Space is limited. Please register by January 10.
For further information, contact Monique Bertic mbertic@hsph.harvard.edu
2012 Global Congress on Intellectual Property and the Public Interest
By Adriana Benedict
The 2012 Global Congress on Intellectual Property and the Public Interest has just come to a close in Rio de Janeiro, Brazil. The conference brought together global leaders in intellectual property-related fields like access to medicines, access to knowledge, internet freedom, innovation and development, and open educational resources. I was invited to participate in the various sessions concerning access to medicines, which focused on two sides of this global health challenge.
The first part of the access discussions focused on best practices and threats in the use of TRIPS flexibilities in developing countries. Participants emphasized the need to look beyond the usual focus on compulsory licenses to set new priorities for understanding and leveraging less-developed flexibilities such as patentability criteria, patent opposition mechanisms and parallel importation. An important overarching theme in these discussions was reframing flexibilities as rights, as they carry the same legal status as the intellectual property rights which make them necessary.
The other side of the discussions focused on innovation and research and development (R&D) for the developing world, primarily through recent advances by the WHO CEWG report in promoting a binding convention in this realm. At the forefront of these proposals is the notion that incentives for innovation should be de-linked from product prices in order to address the needs of the developing world. Participants emphasized that, moving forward, advocates should be careful to ensure that public and institutional debates on alternative R&D models do not narrow their focus from neglected populations to neglected diseases.
Drug Law Factoids for Your Consideration
By Scott Burris
This is a succinct paragraph from the weekly newsletter of U. Maryland’s Center for Substance Abuse Research. Seems relevant both to the conference on law enforcement and public health I reported on earlier this week, and the election results on marijuana:
There were an estimated 12,408,899 arrests in the United States in 2011, according to data from the national Uniform Crime Reporting (UCR) Program. The highest number of arrests were for drug abuse violations—selling, manufacturing, or possessing drugs, followed by larceny-theft and driving under the influence. The majority (82%) of these arrests were for possession and one-half of these drug abuse violations involved marijuana. A poll conducted in 2011 found that one-half of U.S. residents think that marijuana should be legalized (see CESAR FAX, Volume 21, Issue 19).
Dispatches from APHA 2012
By Scott Burris
Two thoughts for the Friday following the 2012 APHA Annual Meeting:
(1) This is a public service message for public health lawyers and their extra-disciplinary significant others.
The American Public Health Association now has a Health Law Section. This is a big step up, in organizational terms. Until this year, health lawyers and those interested in public health law were just a special primary interest group (really, that’s what they called them at APHA – a SPIG.) As a section, we have more opportunities to recruit members and fill presentation slots, and a greater voice in association governance.
That’s not the best part. The best part is that the officers behind the section and its elevation are all dynamic and mostly young. They’ve got energy and vision, which is going to make this section an exciting one to belong to. They are making the case within the association and beyond for the importance of law to health, and they are taking a multi-disciplinary view. The section is bringing together legal practitioners in public health, normative legal scholars, and empirical public health law researchers.
Twitter Round-Up: What Our Bloggers Are Tweeting About (10/28-11/3)
By Casey Thomson
[Ed. Note: Several of our bloggers are active on Twitter. In a new feature, we’ll be posting some highlights of their tweets each week so you can stay in the know – or think about following them directly!]
- Dan Vorhaus (@genomicslawyer) linked to Bloomberg’s article on the current underutilization of genetic tests for Lynch Syndrome, responsible for potentially 3% of all cases of colon cancer. Authors Langreth and Lauerman note that the lack of testing is but one example of the tendency to avoid such tests due to “doctors’ ignorance and financial disincentives.” (10/29)
- Daniel Goldberg (@prof_goldberg) shared Iona Heath’s article on the problematic nature of current breast cancer screening awareness programs, discussing how women are not given enough information to decide if the potential treatments that follow are indeed worth the psychological devastation often invoked. (10/30)
- Michelle Meyer (@MichelleNMeyer) retweeted an editorial on medical genetic paternalism. The post by Razib Khan discussed how physicians deciding whether to tell parents about unforeseen genetic test results of their children can be considered not only an act of malpractice, but also morally wrong. (10/30)
- Einer Elhauge (@elhauge) linked to a new review of his acclaimed book, Obamacare On Trial by the National Law Review. (10/31)
- Daniel Goldberg also tweeted a review by Boddice of Javier Moscoso’s new book, Pain: A Cultural History. (10/31)
- Arthur Caplan (@ArthurCaplan) linked to news about China’s promised initiative to reduce the dependence on death row inmates for organs. A new national organ donation system, based on a system previously piloted by the Red Cross Society of China, could take effect as soon as early 2013. (11/2)
- Arthur Caplan also posted on the Vatican’s announcement to hold its second “International Adult Stem Cell Conference,” revisiting this complicated issue. (11/2)
- Arthur Caplan additionally linked to a report on the debate and complications regarding feeding tube use, as published by Krieger of Mercury News. (11/2)
Is a Move Towards Freezing Oocytes a Move Towards Less Legal Liability for IVF Clinics? — Reflections from ASRM Annual Meeting Round 1
It was an exciting time to attend the annual meeting of the American Society for Reproductive Medicine in San Diego this week. Just before the meeting, ASRM reclassified cryopreservation of oocytes for future use, removing the procedure’s “experimental” label. The possibility of increased uptake of this procedure raises many ethical issues (some of which I hope to discuss in a later post), but it also presents the potential to sidestep a number of legal liabilities and ethical issues associated with frozen embryos which are not implicated by frozen gametes. This begs the question: Is a move towards egg freezing in lieu of freezing embyos a safeguard against some types of liability for IVF clinics? I think this may be the case.
Perhaps most importantly, frozen oocytes will not implicate personhood laws. Advocates of personhood laws, such as vice presidential candidate Paul Ryan, have come under fire by pro-choice and feminist groups for their attempts to ascribe legal rights to embryos and fetuses. However, IVF clinics and clinicians should also be concerned. It is an unanswered legal question if an IVF clinician or embryologist could be found guilty of manslaughter if there was an accidental thaw of a cryotank full of embryos. There have been no such criminal proceedings brought against an IVF clinic — yet. Freezing eggs would guard IVF clinics in states with personhood laws from this kind of criminal liability. Another question implicated by personhood laws is whether there is a doctor-patient relationship between a newly-created or frozen embryo. If one exists, then negligence claims regarding proper storage of embryos could become medical malpractice claims; if frozen gametes are mishandled it is unlikely such a relationship could exist. Litigation against the Oschner Fertility Clinic (which has now closed) brings some of these issues to life.
You must be logged in to post a comment.