Home > Topics > Specific Strategies and Mechanisms for Facilitating Access to Innovation > Ensuring Global Access through Effective IP Management: Strategies of Product-Development Partnerships > Editor's Summary, Implications and Best Practices

The world’s major killers—HIV, tuberculosis, and malaria—kill mostly the poor. This is because the poor have no access to affordable treatments and because funds for research and development are overwhelmingly focused on treatments for diseases in developed countries: just 10% of the world’s healthcare R&D dollars are allotted for 90% of the world’s disease burden. Major initiatives are underway to provide more funding for research on these and other neglected diseases in developing countries, but it is now recognized that research is never enough. Accordingly, the last decade has seen the rise of product development partnerships (PDPs), hybrid approaches that build on the respective strengths of both the public and private sectors, to move research discoveries from the lab to poor communities in developing countries. This chapter examines how PDPs work and identifies six dynamically-linked components necessary for their success:

1. Development and expansion of national health delivery systems, including an attractive, private-sector domestic market for health products
2. Development of manufacturing capability for health products
3. Development of a drug and vaccine regulatory system
4. Development of an IP regulatory system
5. Development of R&D capability by the public and private sectors
6. Development of international trade systems for health products, including global procurement funds

Failure to address each of these components greatly increases the risk of overall failure. The chapter considers the approach of six different PDPs, noting the range of their approaches and their ability to identify and seize upon public and private sector strengths. These include the Drugs for Neglected Diseases initiative (DNDi), the Institute for OneWorld Health (iOWH), the International AIDS Vaccine Initiative (IAVI), the Aeras Global TB Vaccine Foundation, the Medicines for Malaria Venture (MMV), the International Partnership for Microbicides (IPM), the TB Alliance, the Foundation for Innovative New Diagnostics (FIND), BIO Ventures for Global Health (BVGH), and the Public Intellectual Property Resource for Agriculture (PIPRA). The innovative ways that these PDPs are leveraging existing infrastructure and research in developed and developing countries make for essential reading.

Because PDPs are partnerships, IP management issues are unavoidable. That’s good news, however, because these issues present promising avenues for enhancing the effectiveness of PDPs. Although they are all very different, PDPs nonetheless share some common strategies for maximizing IP management for global health. These include:

• Defining a discrete territorial market
• Establishing different structural incentives in public sector and private sector markets
• Extending field of use to make the product applicable to diseases in developed countries
• Using royalties to benefit the party that needs the most incentive
• Providing access to the developed technology, should the private sector not follow through on the project

These issues can be complex and should be addressed as early as possible in order to avoid potential delays or even the project’s derailment.

In addition to these IP concerns, this core chapter addresses important issues for anyone interested in the potential of PDPs, especially when it comes to ensuring access to new products in developing countries. Public-sector pricing, market segmentation and sizing, production and capacity issues, and—surprisingly—the inflexibility of universities when it comes to licensing, all receive thoughtful and careful analysis. Overall, however, an approach that takes into account the six components above will have a much better chance of success than those efforts—no matter how promising initially—that take a piecemeal approach to product development and distribution. Such a comprehensive effort should not be considered a daunting prospect, but rather an opportunity for creativity. With so many variables, there are many ways forward. We should first simply imagine them.

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

• Access to essential innovations in health and agriculture, fundamental for raising the standard of living and improving the well being of all, will require an integrated strategy. Several factors, including R&D capabilities, ability to manufacture, safe and effective regulatory systems, access to markets, and sound trade policies, should simultaneously be present in the innovation framework promulgated by governments. IP management and capability is interwoven into this innovation framework.

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

• Instituting policies and implementing programs that foster and facilitate best practices in IP management will be essential in order for an institution to effectively participate in the broader area of dynamic innovation.
• Partnerships are an important way to fill in the capacities that are required to make an institution innovative. Few institutions have the entire range of capacities to bring ideas to market.

For Scientists

• Your work with industry partners will be a valued contribution to your institution’s broader participation in innovative initiative, for example product development partnerships (PDPs).

For Technology Transfer Officers

• Institute licensing practices, for example humanitarian use reservation provisions, that make health and agricultural technologies available for product development that will serve the needs of the poor.
• Through partnerships with developed countries and private sector organizations, institute training programs build a broad range of competencies (for example R&D and IP capacities), that are essential to active participation in and contribution to the overall innovation system.