Washington D.C., Letter to be delivered week of August 31, 2015
Dear President Daniels,
As organizations and concerned individuals caring for patients with tuberculosis, we are requesting a global public health approach in the licensing of sutezolid, a potentially important drug for the treatment of drug resistant tuberculosis (DR-TB), including open information sharing. Johns Hopkins University (JHU) is currently in discussions with a company called Sequella
about exclusively licensing JHU’s secondary patents for this potentially life-saving drug.
There is a longstanding and increasingly urgent need to improve DR-TB treatment. Sutezolid could represent a treatment turning point if developed appropriately and made available and affordable to patients. This molecule has shown superior activity against DR-TB as compared to the next best treatment in early studies. Current DR-TB treatment is particularly difficult for patients and providers: it is a two-year treatment including eight months of daily injections and a total of more than 14,600 pills to swallow. The cure rate is unacceptably low, with fewer than half of patients receiving treatment being cured. Moreover, many of the medicines have toxic side effects.
Any JHU licensing agreement for sutezolid will have significant impacts on the lives of DR-TB patients globally, many of whom are still waiting for treatment. A licensing agreement that does not enable all appropriate research entities to develop sutezolid and that lacks iron-clad commitments to ensure the timely development of sutezolid and to promote access will risk further delaying innovative developments of DR-TB regimens, inhibiting affordable and appropriate access to treatment for patients and hampering treatment providers like Médecins Sans Frontières.
JHU is a leader and pioneer in global health among US universities. Under your leadership in 2013, JHU adopted a Global Access Licensing Framework. This year, Universities Allied for Essential Medicines’ University Report Card: Global Equity & Biomedical Research
ranked JHU as the top university in the US for global health impact via its biomedical research. Despite this public commitment and profile, we have been dismayed with the lack of transparency so far in the sutezolid licensing process. There have only been limited possibilities for constructive engagement with the different actors working on ensuring access to medicines.
Given the global health importance of sutezolid, we are seeking your public commitment that:
1) the licensing agreement for sutezolid will offer a non-exclusive license to develop the product as part of a novel, appropriate and affordable regime for DR-TB patients. This includes allowing other public health entities, including product development partnerships and public-interest licensing entities, to have the opportunity to accelerate the development of the technology, as well as include appropriate provisions to ensure coherence with the global access licensing commitments made by JHU’s university policy;
2) the terms and conditions of the sutezolid licensing agreement will be made available for public health and expert input before it is concluded. We note that the closed-door consultation hosted by the JHU technology transfer office did not adequately take into account such public health and scientific expertise;
3) any final license agreement signed with Sequella, or any other company, will be made publicly available, as has become best practice in global health licensing since the creation of the UNITAID Medicines Patent Pool. We would suggest publishing the licensing agreement via the JHU website.
We are committed to ensuring the responsible and rapid development of sutezolid, as well as the future access by patients in need. We count on JHU to continue its leadership role by being accountable to its global access licensing commitments and putting its academic social mission to the service of the world’s most vulnerable populations.
We look forward to hearing from you at your earliest convenience.
MSF Access Campaign
Treatment Action Group
The Global TB Community Advisory Board (TB CAB)
JHU faculty and students/alumni