Addressing global health needs requires different approaches and stakeholders in the biotechnology sector to make meaningful contributions in more than one way. Consider endemic diseases like malaria or Chagas’ disease. If the goal is to provide an underserved population with a low-cost therapy that does not require temperature-controlled distribution and can be administered by medical personnel with minimal skills, the most effective strategy to assist might be driven by a charity or foundation with funding sourced from donors, NGOs, intergovernmental organizations (WHO, for example) or governments rather than from companies or investors. Conversely, some biotechnology products are unlikely to be developed without the involvement of the for-profit sector and stakeholders in small, medium or large companies as well as sophisticated investors. Neither model is wrong, as both have a place in improving global health care.
Sometimes, but not always, the models can cooperate or overlap, so it is critical for all parties in the biotechnology innovation ecosystem to acknowledge which route – charity or for-profit entity – they are choosing. Expecting a foundation or NGO to invest millions in clinical trials or produce a highly complex vaccine may be unrealistic. Conversely, assuming that a biotechnology company will be willing to operate with low or no profit margin is equally mistaken. Finding a creative way to cooperate and utilize both approaches is difficult but possible. As an example, the Gates Foundation allows grantees that make a therapeutic discovery that can serve different populations depending on the indication, to set up two licensed fields, one which will address underserved populations in, for example, Africa, and another to incentivize investment and corporate efforts in development, clinical trials, manufacturing and distribution.
The COVID-19 pandemic raised questions about academic licensing of patents and technology that can address diagnosis or treatment of COVID-19. These can be dealt with by first determining whether the license will be used for charitable purposes or for revenue generation, and then by utilizing the following common licensing tools:
field of use limitations
geographic limitations
time limitations.
The licensor may consider granting a royalty-free or low-cost license for the duration of the pandemic, for use only for vaccines targeting COVID-19 antigens but not antigens associated with other infectious diseases, and for sale or distribution in underdeveloped and developing countries. This approach addresses immediate humanitarian needs but leaves open other uses and initiatives which will depend on traditional, profit-based investment and effort.