On May 3 and 4, 2018, the O’Neill Institute for National and Global Health Law hosted experts from academia, government, the World Health Organization and the private sector to discuss the changing relevance of Material Transfer Agreements (MTAs) for infectious disease research.
Material Transfer Agreements tend to elicit little excitement from practicing lawyers but the mere mention of MTAs has the power to induce an instant and profuse cold sweat in scientists!
Material Transfer Agreements are usually standard form contracts that accompany the transfer of research materials from one set of researchers (who may be affiliated with either public or private laboratories) to others. They outline how the materials can and cannot be used by the recipient: whether they are allowed to pass those materials on to third parties, whether they can claim intellectual property rights over anything created using those materials and how the recipient is to store or dispose of the materials after their use.
The use of an MTA is common for proprietary materials like cell lines, engineered plasmids or enzymes. But these contracts are starting to accompany the transfer of infectious disease agents, like bacteria and viruses, that have not undergone any innovative or transformative steps to make them any different to the form in which they existed in the environment or host organism. Pathogens were once openly shared between scientific networks of colleagues and friends, but they are starting to attract claims of ownership and national sovereignty. Thus, the MTA is becoming ever more pervasive and scientists must now participate in the negotiation process to access infectious disease samples on which to conduct their research!
This issue is particularly salient during epidemics and pandemics. During the course of a health emergency, pathogens will undergo genetic changes: mutating and evolving as they traverse their hosts. Understanding these changes, for example, allowed researchers to determine early on that in 2014, the Ebola outbreak originated in Guinea and traveled to Sierra Leone through human hosts, not vice versa or through another host species like bats. Scientists must secure access to up-to-date samples of pathogens to generate the data necessary to inform the public health response. Delays in obtaining samples can have disastrous consequences.
The Conference, convened by Professors Sam Halabi and Rebecca Katz, and supported by the National Institute of Allergy and Infectious Disease (NIAID) of the National Institutes of Health (NIH), addressed various facets of obtaining and transferring infectious disease materials for infectious disease and public health research, including:
The commodification of genetic resources, including pathogens;
The international regime on access and benefit-sharing (ABS) under the UN’s Convention on Biological Diversity and its Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization;
The physical, biosafety and regulatory obstacles to accessing pathogens and negotiating MTAs;
Special considerations for collecting pathogen samples from human subjects;
Ethical considerations when conducting infectious disease research in developing countries; and
How MTAs are shaping research practices in the biological sciences.
The Conference succeeded in creating a forum where researchers, lawyers, and ethicists could discuss material transfer issues outside of the specific siloes where they are normally determined (always with imperfect information). World Health Organization representatives discussed the particular perspective of MTAs within the international agreements it oversees with researchers affiliated with governments, development agencies, industry, and scientific societies. Similarly, researchers from different arms of the U.S. government (and the perspectives imposed by their specific mandates) could explore with non-governmental researchers what issues they encountered in trying to develop diagnostic tests, therapeutics, and vaccines.
The outcome of the meeting will be a more comprehensive and better informed survey instrument to appreciate in a broader and more generalizable way what scientists and policymakers must understand about materials, their transfer, and each other in order to facilitate the research process in light of new norms about access and benefit-sharing. The presentations will also be published as an edited volume and future meetings planned with an even wider range of stakeholders.
The views reflected in this expert column are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.