In the previous post of this series, we took a look at how comprehensively certain proposed revisions to human subject research regulations would apply and whether they would, if effective, really fulfill a broad goal of enabling the consent of everyone to researchers’ use of their clinical data. The answer is a big “No,” based on their scope. If public trust in science depends, as the government claims, on individuals’ consent reliably and consistently governing research use of their data, then science is in trouble; all the government has proposed is a restriction on the institutions a supermajority of the people trust already to protect their privacy: healthcare providers, researchers funded by the NIH, and a handful of other federal agencies. Everyone else, from Google to spymaster, drug company to next-door neighbor, is unaffected except to the extent that those entities, or reviewing IRBs, require contracts that say something more, which in this case is left to chance.
The proposed regulations call for government to draft a general blanket consent to govern tissue banking and banked data. “Blanket” means that it covers everything, in undifferentiated language, with no opt outs – all or nothing. Such an approach will eliminate most or any choice about what one is consenting to. It will require consent to any research by anybody using any technique, with any goal in mind. The options will be to consent to that or not consent at all. Continue reading →
Abstract: This brief comment complements Dan Burk’s excellent paper ( Dolly and Alice, J Law and the Biosciences (2015), 1–21, doi:10.1093/jlb/lsv042 ) by providing a very brief summary of the European approach regarding patents on medical diagnostic methods. This serves as the basis for a comparative discussion of the current US approach and its’ impact on biomedical innovation. We are concerned that unless the Supreme Court clarifies its two-part test and adopts a more holistic interpretation of the eligibility-test, global standards for medical diagnostic patents will diverge to the detriment of advanced therapies and ultimately patients worldwide. In case that the current US eligibility doctrine prevails without further Supreme Court clarification, we highlight the need for developing a more flexible, well-calibrated system for alternative and complementary forms of drug development incentives. In addition to a better-funded and well-administered prize system (an interesting option for some areas of diagnostics that we did not elaborate upon), our paper highlights the need for an improved and more flexible system for regulatory exclusivities in this sector.
Citation:Separating sheep from goats: a European view on the patent eligibility of biomedical diagnostic methods Timo Minssen; Robert M. Schwartz Journal of Law and the Biosciences 2016; doi: 10.1093/jlb/lsw019