Friday, January 11, 2008

Do Gene Patents Deny US Patients Access to the Best Available Genetic Diagnostic Testing Services?

Last week, while at the annual meeting of the American Association of Law Schools (AALS), I attended a talk by Professor Lori Andrews in which she described the supposed evils of gene patents and called for legislation to ban them. She alleged that US patients are dying as the result of gene patents, and asserted in particular that superior genetic diagnostic testing for mutations of the BRCA breast cancer gene is available in other countries because Myriad’s US gene patents block availability to the supposed superior test in the US. I’ve seen this assertion made a number of times by opponents of gene patents. But to what extent is it true? I personally lack the expertise to evaluate the relative merits of the competing genetic testing protocols, but it seems to me that if superior tests are available outside the US, then US patients and clinicians would seek to avail themselves to these tests rather than relying on the allegedly inferior Myriad test.

To investigate the question, I decided to ask someone with some actual practical expertise in the area, an M. D. who works at a breast cancer clinic and who has a great deal of experience ordering and using BRCA testing services. She informed me that the Myriad test is quite good and comprehensive, and is the test that she uses, but that it is possible that there might be tests in other countries that look for certain mutations not considered in the Myriad test. However, no test is perfect, and she did not think that any foreign test provided sufficient added value relative to the Myriad test that would warrant a US patient having their blood tested outside the US, and she knew of no instances where this had occurred.

If there were a significant difference in test quality, it would certainly be feasible for a US clinic to send a patient blood sample to a non-US laboratory for testing. Europeans regularly send their blood samples to other countries for testing, and there are predictions that in the future diagnostic testing will be increasingly off-shored to India and other Asian countries. To be sure, there are logistic hurdles that must be overcome by a US patient wishing to use the genetic testing services of a non-US laboratory. In particular, international shipments of blood are regulated and certain paperwork must be completed. This can be burdensome, but international shipments of blood happen all the time, so not a real obstacle for a determined patient or clinic. Perhaps more important is the issue of insurance reimbursement. Myriad has negotiated with major insurance companies and has procedures in place that facilitate patient reimbursement for tests conducted by Myriad. A patient using the services of a non-US laboratory might have more difficulty in receiving the necessary authorization for reimbursement from their insurance company.

Nevertheless, there are quite a few laboratories performing BRCA testing in other countries, and they can be identified at website such as (a site funded by NIH), which lists a number of laboratories throughout the world that perform BRCA testing. This website is set up as a service for US patients and clinicians, implying that US patients could avail themselves of the services of these non-US laboratories if there was reason to do so.

With this in mind, it seems to me doubtful that US patients are being denied substantially superior tests because of US gene patents, and if they are there is nothing to stop a determined US patient from having their test done overseas. Advocates seeking to make the best genetic diagnostic testing services available to US patients might do well to consider reforms aimed at facilitating transfer of blood samples outside the US and insurance reimbursement rather than seeking to ban the patenting of DNA.

Gene patents have played a critical role in securing investments in biotechnology that have resulted in life-saving products, including products benefiting women afflicted with cancer (Genentech’s Herceptin, for example). Even in the context of BRCA testing, patents have incentivized Myriad to make investments that have resulted in the continuing improvements in BRCA testing, so that today’s tests provide much more information than the tests that were first made commercially available. Moreover, Myriad has raised public awareness of the availability of BRCA testing, and facilitated insurance reimbursement for the testing, which has probably resulted in many more women being tested than would have occurred otherwise. On the other hand, the negative aspects of gene patents (to the extent they exist) could be circumvented by off-shoring genetic testing services. In my view, the fact that this option appears not to have been pursued with any vigor supports my position that gene patents are probably not such a grave threat to public health as some would have us believe.

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