Sponsored by the American Civil Liberties Union Women’s Rights Project, the American Civil Liberties Union of Connecticut, the Information Society Project at Yale Law School, and the YLS Law and Health Initiative.

www.inthefamilyfilm.com

At 31, filmmaker Joanna Rudnick faces an impossible decision: remove her breasts and ovaries or risk incredible odds of developing cancer.

Armed with a positive genetic test result that leaves her essentially ‘a ticking time bomb’, she balances dreams of having her own children with the unnerving reality that she is risking her life by holding on to her fertility. In The Family follows Joanna as she takes us on a journey through the unpredictable world of predictive genetic testing.

Turning the camera on herself, Joanna bares her conflicting emotions about preventative surgery and the potential consequences. Turning the camera on her new relationship, she and her partner capture a young couple falling in love in the shadow of the mutation. Turning the camera on the company that owns the patents to the BRCA genes, she questions their control over access to the test. Along the way, she looks to other women and families dealing with the same unbelievable information.

Intensely personal and timely, In The Family is a groundbreaking investigation that attempts to answer the question: How much do you sacrifice to survive?

EVENT DESCRIPTION

The screening will be followed by a panel discussion addressing the implications of gene patents for access to health care. Refreshments will be served. Panelists include:

Christopher Mason, Weill Cornell Medical College of Cornell University

Ellen Matloff, Genetic counselor and plaintiff in the breast cancer gene patent challenge

Sandra Park, ACLU Women’s Rights Project Attorney

Ady Barkan, Yale Law School

This event is a collaboration with P.O.V., PBS’ award-winning nonfiction film series; more information available at http://www.pbs.org/pov/.

COMMENTS ON FILM

Interlaced with the personal stories of women with the genetic predisposition for breast and ovarian cancer are interviews with the scientists who discovered the link between BRCA1 and BRCA2 and cancer.

At one point, filmmaker Joanna Rudnick interviews the founder Founder and Chief Scientific Officer of Myriad, Dr. Mark Skolnick. Myriad Genetics is the biopharmaceutical company that owns the patent to BRCA1 and BRCA2, two genes that help determine a patient’s risk of developing breast cancer and ovarian cancer.

One of Dr. Skolnick comments elicited a particularly strong reaction from the viewing audience here at Yale. In response to Joanna’s suggestion that the BRCA1 patent was Myriad’s most controversial, Dr. Skolnick  stated, “There is no controversial patent. It is all very easy to understand if you take the time.”

Later, after Joanna questioned her further about whether genes that exist in nature should be patented, Dr. Skolnick asserted, “I guarantee you [women] would not be being tested if it weren’t for Myriad … We’ve taken every problem that comes up and solved it because we have a commercial interest.” He did acknowledge, however, that the $3,000 dollars that costs to have the tests should perhaps be decreased.

A short video of just the scene with Dr. Skolnick can be found here: http://www.huffingtonpost.com/joanna-rudnick/aclu-files-case-challengi_b_203593.html

DISCUSSION WITH PANELISTS

Sandra Park, ACLU Women’s Rights Project Attorney, opened the discussion on gene patenting following the showing of the film. She is involved in the lawsuit against Myriad, Association For Molecular Pathology et al v. United States Patent and Trademark Office et al, filed in 2009 in the district court of the Southern District of New York.

This case, initiated by the ACLU, is the first case in the United States about whether genes should be patentable subject matter. Sandra Park described the various claims, including both statutory and Constitutional claims, featured in the lawsuit. She argued that these patents on human genes do not further the progress of science.

Ellen Matloff, genetic counselor and plaintiff in the breast cancer gene patent challenge, described how the cost of the test has increasingly gone up during the last decade despite the underlying genomic technologies becoming cheaper and cheaper. She also described the problems with interpreting genetic tests. For example, some women whose tests results were misinterpreted had their breasts removed despite not having the mutation. Other women ended up dying from breast cancer despite thinking that their tests had come up negative. Ellen Matloff refuted Dr. Skolnick’s claim in the film that tests are available because of Myriad. She claimed that many genetic counselors were administering the tests for BRCA1 and BRCA2 before Myriad began to enforce its patents.

Christopher Mason, from Cornell University, described his involvement in the gene patenting case. He also suggested that the ability of university researchers to study patented genes in the course of academic research is unclear. He suggested that in a few years it will be possible to sequence each person’s genome for a few hundred dollars. If the gene patenting issue is not solved, it is possible that we will get our sequences with large sections (those that include patented genes) redacted.

Ady Barkan, a 3L at Yale Law School, then described the relation of gene patenting to the issues that face a YLS student group, Universities Allied for Essential Medicines (UAEM), in which he is involved. He raised the issue of monopoly pricing for pharmaceutical companies. The goal of UAEM is to induce governments to sell drugs cheaply in the third world, while charging monopoly prices in the United States. This contrasts with the goals of the ACLU in the Myriad case, which is to eliminate patents for genes. Sandra Park responded to Ady’s comments, stating that studies show that the financial incentives associated with patents do not further the discover of genes or the availability of genetic testing. For pharmaceuticals, which are so expensive to produce and push through the government’s approval process, patents are more appropriate than for for human genes.

Sandra Park suggested that the 1980 case of Chakrabarty supports the opinion of the ACLU. There have been many cases that concern the purification of natural products. Some of these seem to support that ACLU, some do not. This issue, whether isolated DNA is patentable, will likely be the key to the Myriad case. The process of isolating DNA was well known at the time that Myriad isolated BRCA1 and BRCA2. The only thing new in Myriad’s patent claim is the sequence itself, which should perhaps be considered a natural product or law of nature, and therefore unpatentable.

The public awareness raised by the Myriad case could lead to legislation on gene patenting even if the lawsuit is unsuccessful. The issue of whether a correlation could be patented, that is, whether it is a law of nature, was granted certiorari and then dismissed as improvidently granted in a previous case. But Justices Breyer’s dissent from the dismissal suggests that at least some on the Supreme Court are resistant to the idea that correlations can be patented.

]]> http://yaleisp.org/2010/02/a2k4screening/feed/ 2 http://yaleisp.org/2010/02/a2k4health/ http://yaleisp.org/2010/02/a2k4health/#comments Wed, 10 Feb 2010 15:08:28 +0000 Jake Lucchi http://yaleisp.org/?p=857 International human rights treaties, as well as domestic constitutions in many countries, recognize a universal right to the highest attainable standard of health, which includes a claim to effective and equitable access to health care. Realization of this right guarantee, however, has been complicated by the high costs of health care, in the context of limited available resources. These questions of access, affordability, and quality in health care are in turn intricately tied to issues of efficiency and equity in health care innovation, among other factors.

Recent expansions of patent coverage have dramatically raised the cost of medicines in many parts of the world, and also introduced new questions of upstream innovation controls through gene patents. Technological innovations in eHealth hold great promise for improving access to healthcare and health information for the poor and underprivileged.  Unfortunately, obstacles to effective eHealth include lack of open and interoperable standards, closed digital repositories and inaccessible scholarship, and technical infrastructure barriers. How will these developments impact access to health care in the years to come?

Panelists include:

Christopher Mason, Weill Cornell Medical College of Cornell University

Thana Cristina de Campos, Fundação Getúlio Vargas Law School – Sao Paulo

Amy Kapczynski, UC Berkeley School of Law

Talha Syed, UC Berkeley School of Law

Moderator: Lisa Larrimore Ouellette, Yale Information Society Project

Some of the questions to be pursued by this panel include:

In light of the increasing trend toward personalized medicine, what are the implications of genetic patenting for the right to health care?

How has TRIPS implementation impacted access to medicines in developing countries? What implications does this have for constitutional treatment of the right to health in those countries affected?

What solutions are promising for easing the tradeoffs currently experienced between innovation systems and access to health care? How can the tensions be resolved between conceptions of health and knowledge as public goods, and efforts to create markets for the supply of health innovations?

What other ingredients of access to effective and equitable health care should an A2K framework be concerned with; for example, eHealth innovation, access to health information, technical infrastructures, training of personnel, etc.?

Thana Cristina de Campos begins by discussing the way in which transnational corporations must collaborate with states to further human rights.  Her goal here is to raise public awareness on a shared global responsibility for access to medicines.  Pharmaceutical companies are at the center of this issue.

-What is Access to Medicines?  Human right to health under Art. 25, of Universal Declaration of Human Rights (UDHR)

-What is Access to Knowledge? also a human right, right to enjoy the benefits of scientific progress and its applications: Art. 27, UDHR

These two are intrinsically linked.  She argues that a rights approach is important in addressing health policy.

Drugs are goods embedded with information and knowledge.  The most suitable policies for addressing neglected diseases is a public/private partnership.  This partnership should ensure meaningful participation, empowerment, etc.; it’s not just about the drugs themselves.  How should we define responsibilities of parties?

She argues corporate responsibility must extend beyond merely respecting human rights but should also protect and fulfill rights to access to medicines.  Access to medicines should be clearly stated as a priority in corporate policies.  This leaves me with some questions.  Should this be a state regulatory issue, or is it just a normative argument aimed at corporations?

Amy Kapczynski is up next.  She asks what do we mean by human rights in this context?  It might be an analytic structure, a philosophical conception.  Alternatively, she says, rights might be a political claim to justice.  Third, it could be a set of legal priorities.  What is the difference among these, and how are they related?   She asserts that the legalistic lens is all we should use.

Where do we need more conceptual work?  We need to get more rigorous about our arguments about what countries need to do to pursue the right to health.  The recent Grover report gets very concrete about the proper policy measures.  She argues that the Grover list is good, but we might want to extend it–e.g., limiting remedies in patent suits.

But, on the other hand, she says there are conceptual issues.  How can right to health require one patent framework?  There are other ways to pursue right to health outside of patent policy.  Why is it that developing countries need these patent policies rather than price controls, insurance reforms, etc?  Even though these things are important, she argues that the effectiveness of these alternative reforms often depends to some degree on patent policy as well.

Are flexibilities with TRIPS enough?  She thinks that forcing countries to go through TRIPS flexibilities might already be a violation of the right to health.  She thinks that sometimes it narrows our arguments too much to work only through this constrained legal framework.  She thinks it’s hard to talk about obligations of one state to the people of another, and it’s hard to talk about corporate obligations to the global population.  Question: Does she mean it’s difficult to make these arguments philosophically or pragmatically?

Talha Syed is up next.  He will consider three approaches and their implications.  We can do much more with economic analysis than is often done in this field, but he ultimately thinks economic analysis has positive and normative failings.

He thinks economic analysis supplemented by distributive justice is better than a  human rights approach.  He thinks the economic analysis of patent protection is often weak; pharma may be the exception, but only in a narrow case-by-case basis.  It also has normative failings, however.  Rights are often associated with absolutist claims of inviolability.  They often don’t tell us how to make trade-offs.

As a result, he finds distributive justice frameworks more helpful.  Each person has a legitimate claim to have his or her life go as well as possible.  He also holds that there is a priority principle: it’s more important to raise the welfare of those who are worse off.  He is open to hearing how rights could be helpful, but he wants to know how they can do any work beyond the justice framework?

He thinks the fundamental economic tradeoff is access for poorer people today and better off people tomorrow.  Even if you think that access does harm innovation incentives, which he doesn’t, under the priority principle we still should do it.  What do rights add to this?

Christopher Mason is the final panelist.  What are genomic rights?  Many people think we have rights to our genetic code in the same way we have rights to bodily integrity.  Within a year and a half to two years, it will be cheap and quick to trace or genomes to facilitate very personalized medicine. But it won’t be economical to give complete pictures if companies own exclusive rights to many of the genes. In fact, more than 20% of the human genome is already patented.

Presentation: Mason_Talk_A2K4.ppt

Questions and Answers:

To Professor Syed, isn’t his framing of the trade-off between helping someone worse off today and better off tomorrow too simplistic?  People down the line who get access to drugs after patents expire might be better off because more drugs have been produced under the current regime.  Amy Kapczynski wonders about whether the people who need drugs the most will ever get the drugs they need considering that incentives are skewed to produce drugs for diseases in wealthy countries but not so much in poorer countries.

Question 2: do you think there’s a right to healthcare? if so, what does it entail?   Talha Syed says that there isn’t much of a difference between saying there’s a right and saying societies should do certain things for people.  He doesn’t think rights add a lot.  Amy Kapczynski says there are lots of ways to think about rights.  There isn’t a problem if you think about a right as a bundle of certain policy tools.  Thana de Campos says it doesn’t matter whether we call it a right but rather whether it furthers human dignity.

Question 3: In biotechnology and gene patents, do you think the market will roll back patents without requiring state intervention? Christopher Mason says you don’t need patents with genes.  You can do genetic work better without patents; you only need it for selling things.

Question 4: Does a rights framework help us to encourage sharing knowledge and technology transfer from private actors when states might lack other tools for achieving this?  Amy Kapczynski says the language might be useful at the pragmatic level but not necessarily rights institutions.

Question 5: Other legal systems have different domestic normative tools for analyzing these problems; how do we navigate all these differences in the international sphere? They do have different tools, but often when these issues are actually treated the dispositive outcome factors end up being the same.

Question 6: In my view, rights actually do add something to this.  If we start with a distributive justice framework, many people are going to think about distributive justice through a resourcist paradigm, about what people have.  If you can move the discourse to focus on a broader paradigm of justice, such as the capabilities approach, you need to have an account of which capabilities are the relevant ones.  It seems to me that the most effective way to frame this debate is through the language of rights.  It is implausible to think of rights as absolute inviolabilities; instead we could think of them as “optimization requirements” (Robert Alexy) or “excluded reasons” (Richard Pildes, arguably Ronald Dworkin).  This, I think, is a more effective way to frame these health issues than merely a distributive justice paradigm, because it allows us to establish more concrete constraints on both the substantive limitations to health and also on the process through which these limitations are formulated.  Talha Syed says that rights can be useful in the abstract, but as they are employed often aren’t.

For twitter commentary on this panel from the audience, check out http://twapperkeeper.com/a2k4/ entries for Friday, February 12 at 19:00h to 20:30h.

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