Home > IP Topics Index > Specific Strategies and Mechanisms for Facilitating Access to Innovation > Facilitating Humanitarian Access to Pharmaceutical and Agricultural Innovation > Editor's Summary, Implications and Best Practices

Universities and public sector research institutions have an express mission to contribute to the wellbeing of humankind through their patenting and licensing activities. Federal agencies also seek to promote public benefit. The mission of the U.S. National Institutes of Health (NIH), for example, is to support biomedical research to promote health by reducing illness worldwide, especially in developing countries. NIH therefore engages in a variety of forms of humanitarian licensing and humanitarian use agreements.

Systematically discussing the global importance of humanitarian licensing, this chapter offers some pragmatic answers about the why, who, and how of the process:

1. Why there is such a great need for humanitarian licensing strategies?
2. Who is involved in humanitarian licensing initiatives?
3. How can humanitarian use licensing provisions actually be structured and successfully implemented?

It encourages IP managers, in both the private and public sectors, to understand and employ strategies that will advance humanitarian licensing. As private-sector licensees understand the rationale and potential benefits of such strategies—in particular, that they are not necessarily incompatible with their business models—their role in humanitarian licensing can increase.

The rationale (the “why”) for humanitarian use licensing is directly connected to the vast unmet medical and agricultural needs of developing countries. Low and middle-income countries account for less than 10% of worldwide research and development expenditures. Furthermore, despite increasing levels of investment in pharmaceutical R&D during the past 30 years, only 1% of new compounds marketed have been for developing world diseases. Innovative research related to diseases specific to poor countries has increased some, though this remains extremely low relative to pharmaceutical research overall, and has resulted, in large part, from increased public R&D funding for global health. Similarly, private-sector agricultural research is more likely to focus on commodity crops of developed countries than on the staple crops of importance to resource-poor farmers in developing countries.

Significantly, some types of humanitarian IP strategies have little or no impact on licensing revenues for public-sector technology creators, so there is no financial conflict of interest. Moreover, many types of humanitarian licensing have no effect on the financial interests of commercial licensees. And there are certainly other benefits for commercial interests: a corporation may advance its reputation for social responsibility and win greater esteem from the public through humanitarian licensing.

Who is doing this? An increasing number of organizations have been using IP management practices to promote the health and food-security of underserved populations throughout the developing world. In terms of heath-related innovations, organizations include the Program for Appropriate Technologies in Health (PATH), the International AIDS Vaccine Initiative, the Global Alliance for TB Drug Development, and several others. International entities (for example, the World Health Organization) have also undertaken humanitarian licensing. And several governmental organizations in developing countries have begun to adopt humanitarian licensing, for example, the Council for Scientific and Industrial Research in India. Agricultural organizations with relevant experience in handling humanitarian licensing include the African Agricultural Technology Foundation (AATF), the International Service for the Acquisition of Agri-biotech Applications (ISAAA), and the Consultative Group on International Agricultural Research (CGIAR).

In addition, many nonprofit public-private partnerships (PPPs or perhaps more accurately product-development partnerships or PDPs) have been formed recently to develop health and agricultural products for markets that are neglected by traditional for-profit R&D companies. These PDPs can guide the licensing or donation of a patented invention as well as contributions of know-how or scientific expertise. PDPs can also segment the market into developed and developing country sectors, with appropriate pricing regimes for each. PDPs are typically funded by foundations or public sources and may receive in-kind support, or in some cases, direct funding from private companies. There are many kinds of PDPs at work in the world today (see the chapter for more information).

University technology managers can facilitate nonprofit product development efforts by offering PDPs ownership of patents that the university no longer wishes to maintain. But if a university has already licensed intellectual property to a company, renegotiating to provide access for a PDP can be costly and difficult—even if the PDP seeks to develop the invention into a non-competing product. It is very important, therefore, for universities to establish policies and guidelines to manage university-generated intellectual property for humanitarian use and applications, preferably in advance of other licensing commitments.

Examples of how humanitarian licensing can proceed are increasing. Among the earliest and most noteworthy is that of golden rice, which clearly illustrated that it is quite possible to make intellectual property available for research and commercialization in developing countries. This chapter presents a number of strategies for fostering success in implementing humanitarian licensing. These include traditional and also new, non-traditional, IP management techniques to promote the development of products for neglected markets. These approaches are too numerous and nuanced to list in detail here, so consult the Handbook chapter to learn the latest about these approaches and strategies.

It is worth briefly noting, however, that the chapter suggests shorter lengths of license exclusivity. Instead of granting exclusive licenses that match the term of the patent, the licensor can grant licenses for shorter periods, allowing access by multiple licensors over the patent’s lifetime. Next, equitable access licensing is suggested to enable competition in low- and middle-income countries. An equitable access license ensures freedom to operate for any party that manufactures and distributes the licensed technology and any derivative products in low- and middle-income countries. It minimizes administrative overhead and political contingency by initiating a self-enforcing open licensing regime.

The importance of managing public sector intellectual property to facilitate humanitarian use and applications cannot be overstressed. But just structuring licensing agreements is not enough. Development partners who can utilize the protected technologies should be found, and it will be important to establish simple, efficient ways for such potential partners to identify technologies that public-sector institutions are willing to share. As these efforts advance, the number and variety of technologies being managed with humanitarian goals in mind will definitely increase. Certainly, intellectual property can inhibit access to agricultural and pharmaceutical innovations, if managed strictly to exclude. But creative IP management strategies can actually promote access to needed technologies in developing countries.

Key Implications and Best Practices

Given that IP management is heavily context specific, these Key Implications and Best Practices are intended as starting points to be adapted to specific needs and circumstances.

For Government Policymakers

• By promoting IP rights legislation and enforcement, policies that foster licensing can be increased. This will demonstrate to key owners of intellectual property, whether in the public or private sectors, that their intellectual property will be protected pursuant to licensing provisions.
• Foreign owners of intellectual property will look for institutionalized and implemented best practices in IP management. When they are convinced that these are actually in place, they will be have the confidence and motivation to proceed with more licensing agreements and technology transfer arrangements.
• Although licensing provisions are pursuant to a mission of humanitarian licensing, these are still business deals, unwaveringly followed according to stringent provisions in any agreement.
• It is critical to support capacity building in IP management, licensing, and technology transfer. These essential activities require ongoing, sustained support from policy makers in the government. These strong, concerted, voices of advocacy and support can, and will, make this happen.

For Senior Management (university president, R&D manager, etc)

• Humanitarian licensing can benefit both the research and public service missions of the university, so it should be pursued as a top priority endorsed—and more importantly—promulgated by senior management.
• Humanitarian licensing of essential advances in agricultural and health-care technologies requires three essential ingredients: mission, capacity, and networks.
• The mission of an institute should be clearly stated in a prominent policy statement that lays out the fundamental goals for technology transfer, research partnerships, and IP management. However, a policy document is not enough.
• Public sector institutions need to plan and implement focused capacity building in technology transfer, licensing, and IP management. All licensing activity, whether for humanitarian purposes or not, is built on this educational foundation.
• Networks with individuals and organizations, such as foreign universities, corporations, product development partnerships (PDPs), and government agencies, need to be built and cultivated. An appropriate knowledge base is important but insufficient. It should be linked into appropriate networks. Critical innovations in agricultural and health care can then be licensed and, from there, begin to flow to those most in need in your country.

For Scientists

• Awareness of and compliance with IP policies, guidelines, and regulations will further your research programs.
• By following IP guidelines, your program can assist the poor in developing countries and you can gain the opportunity to interact more with colleagues and organizations that own intellectual property attached to technologies of critical scientific and humanitarian value.
• Your activities can raise the international profile of your research program and your institution. Goodwill has its own karma, catalyzing more scientific and development success.

For Technology Transfer Officers

• Your office will implement access to agricultural and health care innovations via humanitarian licensing. Hence, the practical details of putting mission and policy into motion are your responsibility.
• Capacity building in IP management is essential. It raises awareness for all involved, whether it’s your office, researchers and their staffs, or university administrators. Capacity building should be an ongoing and mandated, pursuant to university policy.
• Potential licensors of intellectual property connected to critical agricultural and health care technologies will be motivated by your institution’s demonstrated IP capacity, and will be more likely to enter into more licensing agreements.
• You and your office should conduct ground level networking and negotiating with organizations who own intellectual property connected to needed technologies. Although these may be humanitarian licensing agreements, they are still licenses, and compliance will build confidence, and confidence will build long-term relationships, which mutually benefit all parties.
• Your office should be the central clearing area for all licensing activity in your institution, whether humanitarian or not.