Approved: April 2010

access to medicines in the developing world, to the extent consistent with a company's own
business model and all applicable laws and regulations.2
When entering into license agreements, explore creative strategies that help to expand access to
medicines in the developing world.
Many biotechnology companies in-license inventions from universities, non-profit entities, orcommercial partners. Others serve as the licensor in such transactions. When negotiating suchlicensing agreements, BIO's members should explore with their partners opportunities to expand
access to resulting medicines in the developing world. For example, companies may seek out
licensees or licensors in the developing world, or from other non-traditional sources. Also,
companies might consider geographic limitations, sublicensing arrangements, and alternativeroyalty payments and incentives designed to facilitate greater access in the developing world.
While researching and developing products, work to identify compounds or technologies that
can have useful applications in the developing world.
There are times when products made for the developed world for the treatment of a particularcondition can have other useful applications for diseases that afflict the developing world. Othertimes, research and development efforts yield compounds or technologies that have no market in
the developed world, but have promise for addressing unmet needs in the developing world. Insuch situations, BIO's members should consider approaches to help further R&D and ultimately
the availability of these technologies in the developing world. For example, companies may
consider pooling their intellectual property so that their inventions would be made available tointerested parties in ways specifically designed to facilitate, and reduce cost and transaction
barriers, to research and development of useful products or particular applications for thedeveloping world.3 Alternatively, they could seek out licensees in the commercial or non­governmental organization (NGO) global arenas to further such R&D efforts aimed at thedeveloping world.
Where practicable, participate in partnerships that develop medicines and medical technologies
for the developing world.
Biotechnology companies may have medical inventions that, for one reason or another, are notcommercially viable or useful on their own. These inventions may, however, be useful for thedeveloping world when utilized in combination with other available technologies or products. Insuch situations, BIO's members should consider partnering with other commercial entities orparticipating in public-private partnerships (PPP) with governmental or non-governmentalorganizations to further such efforts. Information about PPPs is available on the NIH's website(http://ppp.od.nih.gov) and the BIO Ventures for Global Health website (http://www.bvgh.org).
Many of BIO's members and other stakeholders also participate in the recurring Partnering for
Global Health meeting, which is co-hosted by BIO and BIO Ventures for Global Health and2 Note that the links cited in this document are only for the purpose of providing examples.
3One example of such patent pool Information is available at http://www.bvgh.org/News/Global-Health-R-D­News.aspx

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Approved: April 2010serves as a vital forum for the development of such pa rtnerships. For more information, visit theevent website at http://pgh.bio.org/opencms/pgh/2010.
When doing clinical trials, take into consideration the needs of people living in developing
countries.
BIO's members support including populations that have previously been underrepresented inclinical research whenever possible and appropriate. This approach provides increased access toexperimental treatments, including those that may provide benefit, and also helps ensure thecollection of comprehensive clinical information. BIO's members adhere to universal ethicalstandards regarding the conduct of clinical trials and to their specific provisions regarding
potentially vulnerable populations living in developing countries.
When commercializing medical products, explore individualized strategies that will help
improve the affordability of medicines in the developing world.
BIO's members recognize that the financial resources of most people living in the developingworld are extremely limited, and that governmental budgets in these nations are similarlylimited. As a result, many of BIO's members already have company-specificprograms in place
to provide free or low-cost access to their medical products in such countries. BIO's members
should also explore various individualized strategies that are consistent with their particularbusiness model and could help improve the affordability of medicines in the developing world.
Consistent with applicable laws and regulations, companies might consider, for example,
donating supplies to certain governmental or non-governmental organizations, exploring tiered­pricing approaches that include special humanitarian pricing (at-cost/low-cost), engage incapacity-building with local partners, or licensing to generic companies or other non-traditional
partners for production or distribution in certain countries.
Where practical, explore ways to overcome non-price barriers that hinder access to
medicines and medical technologies in the developing world.
While there is much focus on the issue of price of medicines and medical technologies in thedeveloping world, often there are other - larger - barriers that hinder access, as described above.
BIO's member companies should explore ways to overcome these barriers to facilitate access tomedicines and related technologies for people living in the developing world.
Share individual experiences and approaches broadly to advance the goals of enhanced
access in the developing world.
There are many individual efforts that are being, or have been, taken by BIO's members to help
improve access to medicines in the developing world. Consistent with applicable laws andregulations, BIO's members should broadly share their individual experiences in this area, inorder to foster greater industry involvement in similar efforts and to spread knowledge about
successes and challenges with varying approaches.
4

See footnote 1, supra.

3