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Research resources Small scale business Multinational not-for-profit Small and medium Western firms, developing country firms, academics/public 45% Within PPPs 25% Alone 25% TDR* *Unable to verify details for three TDR projects Figure 1: The drug R&D landscape for neglected diseases (Dec 2004): 63 active drug development projects studied most closely.) The organizations themselves are private groups not publicprivate partnerings and are majority funded from private philanthropy Although they are entirely focused on forwarding the public interest in promoting developing country health, as opposed to a private interest in generating profit, and though they include extensive public health expertise on their Boards, Steering Committees and staff, these PPPs are nevertheless not public entities but are independent private not-for-profit groups with a public health focus. By accident, rather than design, they are also predominantly funded from private philanthropic sources (see Figure 2). The failure of government donors to step up to the table means that private groups such as The Bill & Melinda Gates Foundation and Médecins Sans Frontières continue to provide the bulk of funding for these PPPs and their activities, and to be the main auditors of their performance and outputs. The unintended outcome of this situation – and we note * Excludes TDR 3% Philanthropic organizations 2% Private sector 16% Public sector 79% UN agencies Figure 2: Total cumulative PPP funding by type of funder (as of April 2005, including forward funding committed by that date)* that most of these PPPs had hoped for, and sometimes planned on, having far more substantial government funding – is that, in practice, they are more “private” than “public” in both their funding, auditing and accountability. This situation has led to oft-voiced concerns that “Bill Gates is running world health”, however both private donors and PPPs themselves would strongly prefer a healthier public-private funding mix, and the greater public responsibility this would bring. Nevertheless, until this happens, these PPPs will continue to be predominantly privately-funded private organizations – they do not stand-in for public participation in the neglected disease field. PPPs fund academic and developing country R&D activity as well as private industry R&D These PPPs do not primarily channel public funds to private industry activity (often multinational companies), as the broad brush classical model would suggest. It is not only that PPP funds largely come from private philanthropic groups, as seen above, but that these funds are distributed to optimal R&D partners in both the public and private sectors and in both the developed and the developing world. In practice, around one third of PPP R&D grants go to public sector groups (academic drug development); around one third to private or not-forprofit companies, including companies in the developing world and small- to medium-sized drug firms; and one third to multinational drug companies (see Figure 3). This funding distribution reflects the fact that these PPPs not only develop promising industry leads but also work to actively generate new leads, many of these from the public academic sector. The role this plays in translating basic academic research into applied research that results in new neglected disease compounds is often overlooked. PPPs are not simply funders. They play a central management role in the R&D process, closely akin to the role played by Venture Capital (VC) firms or multinational drug companies in commercial areas. PPPs do not operate as a passive channel of funds to either their academic or industry partners, i.e. they do not provide grants in the more “hands off” way Global Forum Update on Research for Health Volume 4 ✜ 141
Research resources that many public donors may be used to. This is a very important point to understand. As discussed below, in practice effective PPPs operate more like a cross between social-VC funders and multinational drug company (MNC) divisions. Just as VC firms do when looking for optimal new products to take forward from a commercial perspective, the PPP also assesses the field to hone it down to a shortlist of the most promising R&D projects from a public health perspective. The PPP raises the funds, bears the risks, finances the chosen groups, provides support to get their products across the line, and finally reaps the (social) dividend. Likewise, the PPP plays a VC-like role in setting milestones, monitoring progress against these and making go/no-go decisions based on how well each project performs. PPPs are assisted in this task by their Scientific Advisory committees, composed of experts (often world-leaders) in industry pharmaceutical development and developing world health needs. Watching one of these committees grill R&D groups on their projects is a fascinating exercise in how public health and industry expertise can work together to ensure that the target products are not only possible from an industrial perspective, but also optimal in terms of affordability, suitability, efficacy and safety for the target developing country populations. This VC-like role is often unacknowledged, which is a great pity since it is an area where government funders of R&D projects (for example, via grant programmes) are often most exposed to the risk of poor investments and failed decisions. Shifting these decisions to PPPs with industry and public health expertise represents a clear bonus for government funders. If allied to additional government funding of PPPs, it could also help provide the magical formula of increased public involvement and accountability, but decreased public risk. An important proviso is that the PPP must, of course, have sufficient industry and public health expertise – some groups are stronger on this than others, an issue that is addressed through proposals set out elsewhere . PPPs also play a role that we have loosely categorized as “MNC-like”. In other words, they provide smaller or less experienced drug development partners with technical and scientific skills that they may lack and, importantly, provide overall management of the lengthy and complex drug development process. MNCs often play a similar role when working with small biotech companies. For instance, PPPs can supplement their partner’s skill gaps by arranging (and often funding) outsourcing to Contract Research Organisations (CROs), by finding industry partners for further development, or by putting together manufacturing deals with other firms. These activities closely mimic the modular approach that MNCs increasingly take to drug development, keeping core activities in-house but outsourcing other jobs to contracted groups who can do them more cheaply. PPP assistance of this nature can be invaluable for academic groups, developing country firms with limited experience of registering novel drug products (as opposed to generics) or biotech firms who are strong in drug discovery but have limited, if any, experience of regulatory approval or large-scale manufacturing and distribution. In each of these instances, the PPP can contract in the necessary skills to fill the gap (e.g. a CRO skilled in toxicology or regulatory approvals; a developing country company with experience in large-scale manufacture) and provide overall management of PPPs Cumulative direct R&D spend US $76m* 34.8 Academics 30.2 SMEs/CROs/ DC firms 35% Big pharma One third translation of research into drug leads Two thirds to industry * – Covers period 2000-2004 – PPP R&D spend only (total PPP spend was Us$112 million) – TDR figures are excluded SMEs: Small- and Medium-sized Enterprises, CROs: Contact Research Organisations DC: Developing Countries Figure 3: Resource allocation by PPPs 2000-2004 142 ✜ Global Forum Update on Research for Health Volume 4
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Global Forum Update on Research for
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Editorial Advisory Board: Luis Gabr
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Contents 096 Child immunization: ac
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Introduction Research contributions
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Introduction Type I Type II Type II
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Introduction making), takes account
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Access to health Strengthening heal
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Access to health raising public awa
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Access to health Recent trends in r
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Access to health districts with a p
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Access to health Understanding heal
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Access to health This study investi
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Access to health References continu
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Access to health combining particip
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Access to health 2002 2005 Diff. SU
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Access to health References continu
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Access to health Americans think th
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Access to health threatening and se
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Access to health References 1. Worl
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Access to health Open access to res
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Access to health References 1. Rose
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Access to health national and globa
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Access to health Senior Research Fe
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Access to health ✜ Rights alone a
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Access to health meaningful communi
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Access to health Inequality, margin
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Access to health questions, develop
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Access to health reasonable in abou
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Access to health References 1. Kohn
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Access to health The diverse pathwa
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Access to health 2001, WTO ruled th
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Access to health knowledge and educ
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Access to health References 1. Lee
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Innovation 076 Towards the developm
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Innovation ✜ Creating a viable va
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Innovation Natural sciences and env
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Page 87 and 88: Innovation Being healthy: the role
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Page 131 and 132: Decision-making Delivering evidence
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