Washington Update: Higher Education Associations Issue Statement on UN High Level Panel on Access to Medicines Report; HHS and NIH Announce Initiatives to Improve Access to Clinical Trials Information; and More

Higher Education Associations’ Statement on UN High Level Panel on Access to Medicines Report
APLU, along with the Association of American Medical Colleges (AAMC), Association of American Universities (AAU), Association of University Technology Managers (AUTM), and Council on Governmental Relations (COGR), issued a statement last week expressing concern regarding the September 14 Report of the United Nations Secretary General’s High-Level Panel on Access to Medicines, which singles out intellectual property rights, particularly patents, as responsible for limiting access to life-saving medicines and health technologies. The associations’ statement reiterates their commitment to improving global health through the technology transfer process and the importance of a strong patent system to ensuring university research can be translated into new medicines and treatments.

HHS and NIH Announce Initiatives to Improve Access to Clinical Trials Information
Last week, both the Department of Health and Human Services (HHS) and the National Institutes of Health (NIH) took steps to improve public access to information about clinical trials. HHS issued a final rule requiring certain clinical trials to register at ClinicalTrails.gov, a publically accessible database, no later than 21 days after enrolling the first participant. Further, the final rule requires the sponsor or principal investigator to submit summary data from the clinical trial to ClinicalTrails.gov, one year after the trial’s completion, regardless of whether the products under study have been approved, licensed or cleared for marketing by the Food and Drug Administration.

The NIH issued a complementary policy that applies to all clinical trials funded fully or in part by NIH, whether or not they are covered by the final rule.

A summary of the final rule and NIH policy can be found here. ClinicalTrails.gov will also offer three live webinars on the final rule. More information on the webinars can be found here.

USAID Title XII Report Released
Last week, the U.S. Agency for International Development (USAID) released its Title XII Report to Congress for FY2015. Title XII of the Foreign Assistance Act recognizes the role of U.S. land-grant institutions as critical partners in USAID development programs. The FY2015 report details USAID’s activities in partnership with institutions of higher education, including the work of the Feed the Future Innovation Labs and the Board for International Food & Agricultural Development (BIFAD). BIFAD’s response to the report is also included.