Friday, August 26, 2011
Cynthia Ho, Global Access to Medicine: The Influence of Competing Patent Perspectives, SSRN/Fordham Int'l L.J.
Jeffrey Kahn, The Operation of the Individual Mandate, SSRN/Tax Notes
Paul Schwartz and Daniel Solove, The PII Problem: Privacy and a New Concept of Personally Identifiable Information, SSRN/NYU L.Rev.
Thursday, August 25, 2011
I found this article by David Brown a good introduction to new directions in CER. Some excerpts:
The federal Agency for Healthcare Research and Quality, which this year is spending about $21 million on comparative effectiveness studies. . . . Only 1.5 percent of money spent on medical research goes to “outcomes research,” of which comparative effectiveness is a sub-category. About 13,000 new clinical studies start up each year; about 112,000 are running now. A meticulous search in 2008 revealed only 689 studies that fit the general description of “comparative effectiveness.” Many experts believe that’s not enough.
The Obama administration created a permanent stream of funding for comparative effectiveness research by establishing, as part of the Patient Protection and Affordable Care Act, an independent entity called the Patient-Centered Outcomes Research Institute, or PCORI. . . .
The institute’s duties are to establish national priorities for this type of research, with input from patients, doctors, scientists, public-health officials and representatives of the health-care industry. It will eventually have about $550 million a year, provided by the federal government, to pay for studies and disseminate results. PCORI opened its office in Washington last month.
But not everyone is happy with this activity. Some critics see comparative effectiveness research as a Trojan horse that will eventually bring government control and rationing to every hospital and clinic in the land. Even if that doesn’t happen, they’re worried that “cost effectiveness” — a different concept, one that puts a price tag on patient outcomes such as illnesses averted or years of life saved — will make its way into medical decision-making.
I'm torn on the issue. On the one hand, I am all for eliminating costly and ineffective procedures. On the other hand, I am extremely doubtful that health care cost savings are going to reach workers who are privately insured. In an employment market as bad as ours, employers are far more likely to simply pocket the savings, and transfer it to top managers (and perhaps shareholders--again, not that egalitarian an option, as the bottom 80% of households only hold about 9% of stocks). There is a better case for saving taxpayers money, especially given how much of Medicare is financed via payroll taxes and premiums. However, if the past decade is any guide, the savings may just be channeled to wars and tax cuts tilted to the wealthy. I don't know if these goals are any more meritorious than providing expensive placebos. [FP]
Wednesday, August 24, 2011
It has been a while since the topic of imported inexpensive Canadian drugs was hot, see here. However, one side effect of that trade came back to bite Google today as it was forced to forfeit the AdWords revenue it received related to Google searches for illegally imported prescription drugs. The DoJ press release is here and notes:
[A]s early as 2003, Google was on notice that online Canadian pharmacies were advertising prescription drugs to Google users in the United States through Google’s AdWords advertising program. Although Google took steps to block pharmacies in countries other than Canada from advertising in the U.S. through AdWords, they continued to allow Canadian pharmacy advertisers to target consumers in the United States. Google was aware that U.S. consumers were making online purchases of prescription drugs from these Canadian online pharmacies, and that many of the pharmacies distributed prescription drugs, including controlled prescription drugs, based on an online consultation rather than a valid prescription from a treating medical practitioner. Google was also on notice that many pharmacies accepting an online consultation rather than a prescription charged a premium for doing so because individuals seeking to obtain prescription drugs without a valid prescription were willing to pay higher prices for the drugs.
The cost to Google? $500 million, representing "the gross revenue received by Google as a result of Canadian pharmacies advertising through Google’s AdWords program, plus gross revenue made by Canadian pharmacies from their sales to U.S. consumers." [NPT]
Tuesday, August 23, 2011
Although, incidence of malaria has decreased over the past century, a recent article points out the rising concern about new malaria risks worldwide brought about by global climate change. The article quotes a scientist with the Sudanese National Academy of Sciences explaining that because malaria is transmitted by mosquitoes, its distribution patterns can be altered by changes in weather conditions, including changes in temperature, humidity, rainfall and the general availability of fresh water.
The shifting distribution of water is certainly something that adaptation planners need to consider – the malaria risk and droughts in the Horn of Africa both examples of climate change effects with influences on the spread of illness. According to a recent article in Science Daily, there is also evidence that climate change is playing a role in disease outbreaks of diseases such as chytridiomycosis, and of Lyme disease, as the tick vector Ixodes scapularis expands its range. The same article suggests that climate change will render conditions more favorable for human bubonic plague, caused by the bacterium Yersinia pestiswhich, and is still reported regularly in Central Asia.
This and other evidence make the development of adaptation approaches a global health policy priority. And to work, it is generally agreed that top down approaches are rarely effective: the people who must implement the strategies – which are often rural, poor communities most vulnerable to these diseases - must be involved in the design and implementation. Nonprofit stakeholder groups like the Prolinnova network (whose brief is available here)emphasize the need to empower local communities and facilitate grassroots innovation to address adaptation strategies.
Sunday, August 21, 2011
The World Health Organization (“WHO”) acknowledges traditional medicine and the role it plays in many societies. According to WHO, a majority of the population in some Asian and Africa countries rely on traditional medicine for their health care. In many industrialized countries, a majority of the population has used some form of traditional medicine in addition, or as an alternative, to traditional western medicine. Thus, one of the objectives of the WHO traditional medicine strategy is to help Member States facilitate the integration of traditional medicine into their national health systems. While WHO is focused primarily on the health-related aspects of traditional medicinal knowledge, the World Intellectual Property Organization (“WIPO”), thorough its Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge, and Folklore (WIPO IGC), is working towards creating some form of international legal protection for this kind of knowledge. In 2009, the WIPO IGC was mandated to submit a text that will ensure effective protection of traditional knowledge, genetic resources, and traditional cultural expressions to the WIPO General Assembly when it meets this fall.
Legal protection for traditional medicinal knowledge has become a somewhat controversial issue in global discussions about intangible property rights. Traditional medicinal knowledge is typically knowledge that is held by certain communities and that has been passed down from one generation to another. It is often based on genetic resources (usually from plants) that are located in a specific community, and whose valuable properties are known to those within the community. This medicinal knowledge may be highly valued locally, nationally, or even globally. Hence, the need to respect traditional knowledge and genetic resources has been addressed in international instruments like the Convention on Biological Diversity.
The intellectual property aspect arises when university researchers, multinational corporations, or others external to the traditional knowledge holding community seek to rely on the knowledge of these “local” or “indigenous” peoples to develop a new product, and subsequently obtain intellectual property protection. This has resulted in allegations of “biopiracy” and “misappropriation” of genetic resources. A well-known example of alleged biopiracy is that of the hoodia cactus plant. Several generations of the San people of southern Africa used this plant to stave off hunger. An extract from the plant was patented for its hunger-fighting properties, and licensed to the pharmaceutical giant, Pfizer. Yet, the traditional knowledge held by the San people of southern Africa about the use of the hoodia cactus as an appetite suppressant is not protectable under the current intellectual property system.
The question is whether, given the value of this medicinal knowledge, it should be protected by some kind of intangible property right. Pharmaceutical companies are able to obtain patent protection and a corresponding period of market exclusivity for the drugs they develop. Should traditional medicinal knowledge also be entitled to some form of protection, even if it is not novel in the patent law sense? It may not be novel, but traditional medicinal knowledge has been described as innovative because it is constantly evolving. Another common argument against any legal protection for such knowledge is that it is in the public domain, and part of the “common heritage of mankind.” However, this argument been criticized on many levels. For example, some commentators have characterized traditional knowledge as “developing country intellectual property” and classic intellectual property as “western” and therefore non-inclusive.
There are many complex legal and policy issues that arise in the discussions about legal protection for traditional knowledge. For instance, given the intergenerational nature of the knowledge, should the protection be perpetual? How does one define and identify the community that has rights to the traditional knowledge or genetic resources? Is this a North-South issue, and will a legal right for traditional medicinal knowledge ultimately benefit developing countries and indigenous peoples? How will it impact access to traditional medicine? For a more comprehensive discussion of these issues, please see my 2011 article, A Sui Generis Regime for Traditional Knowledge: the Cultural Divide in Intellectual Property Law.
 The Beijing Declaration, adopted by the WHO Congress 8 November 2008, refers to a global plan of action on public health, innovation and intellectual property.