Thailand Law Journal 2009 Spring Issue 1 Volume 12

III. The Dawn of Product Development Public-Private Partnerships

Leaving neglected disease research and development to the markets has typically resulted in the exacerbated marginalization of the poor. [FN82] Concomitantly, the public sector has itself neglected to devote resources to neglected disease product development sufficient to serve the public interest meaningfully. [FN83] Accordingly, a new breed of public-private partnership has emerged which seeks to synergize the resources and capabilities of public and private organizations within an overarching not-for-profit virtual project management scheme. [FN84]

The disengagement of most pharmaceutical companies from tropical disease research and development in the 1970s left a gap in the development of new and affordable drugs. [FN85] Over time, existing drugs deemed potent in the mid-twentieth century have outlived their efficacy due to the emergence of resistance, compliance and safety concerns, or financial and/or infrastructural inaccessibility. [FN86] At the same time, the coincidence of industry disengagement with the evolution of biotechnology in the 1970s yielded an unfortunate disparity in the technological advancement of neglected disease drugs as compared with first-world drugs. [FN87]

In 1975, the United Nations Development Programme/World Bank/World Health Organization Special Programme for Research and Training in Tropical Diseases (TDR) was established to enable a partnership-oriented approach to drug discovery and development between public-sector organizations and private companies. [FN88] TDR's mandate has ambitiously spread to explicitly cover multi-factor solutions to ten neglected diseases, including malaria and tuberculosis. [FN89] However, its inefficacy in fostering the development of drugs has led to a shift in strategy away from research and development. Coupled with chronic under-funding, the failure of TDR has led to the emergence of novel disease-specific public-private partnerships over the last few years.

The late 1990s and 2000 spawned disease-specific partnerships devoted to the three most common neglected diseases-AIDS, tuberculosis, and malaria. In 1994, the Rockefeller Foundation convened a meeting where virologists, immunologists, and vaccinologists discussed the incorporation of an AIDS vaccine research agenda into a not-for-profit initiative to be based in the United States. [FN90] After discussion regarding public-private dissonance, intellectual property issues, and financing constraints, the International AIDS Vaccine Initiative (IAVI) was launched in 1996 “to ensure the development of safe, effective, accessible, preventive HIV vaccines for use throughout the world.” [FN91]

After this pioneering initiative, Rockefeller discussed a more deliberate public-private collaboration with Glaxo Wellcome in order to combat malaria. [FN92] Incubated within WHO/TDR, the Medicines for Malaria Venture (MMV) was established as a public-private partnership to develop antimalarial drugs in a not-for-profit corporate format allocating venture capital funding on a competitive basis. [FN93] In 2000, the Cape Town Declaration of the Working Alliance for Tuberculosis Drug Development saw the establishment of a drug development partnership as an independent facet of the comprehensive Stop TB Partnership, aimed at controlling and ultimately eradicating tuberculosis. [FN94] With the endorsement of the WHO, TDR, the World Bank, Gates Foundation, and Stop TB, the Global Alliance for TB Drug Development (TB Alliance) was conceived to lay out scientific and economic blueprints for TB drug development and manage projects consistent with a WHO TB wish list. [FN95]

The establishment of these decentralized but popularized PPPs caused funds for neglected diseases to be funneled to one of the big three diseases. However, many other diseases-most notably, the other eight targeted by WHO/TDR (African trypanosomiasis, Dengue fever, leishmaniasis, schistosomiasis, Chagas disease, leprosy, lymphatic filariasis, and onchocerciasis)-still suffered from empty drug development pipelines. For these more obscure and less fatal diseases, procuring financial capital and attracting industry, or even first-world public sector, investment would prove a great challenge.

This decade has seen the establishment of many initiatives, two of which promise innovative models to contribute to the neglected disease arena: the Drugs for Neglected Diseases Initiative (DNDi) and BIO Ventures for Global Health (BVGH). DNDi was conceived in 2003 as a backward integration of the non-governmental organization, Medicins sans Frontieres, to provide affordable drugs for distribution through MSF's humanitarian distribution channels. [FN96] To best facilitate disproportionate public health impact for trypanosomiasis, Chagas disease, and leishmaniasis (all kinetoplastid diseases), the Drugs for Neglected Diseases Working Group sought the establishment of a PPP which “identifies the needs of neglected diseases, works for the development of the proper tools to fill the needs, and then takes these to those who are in need.” [FN97]

On the other end of the spectrum lies BVGH, an offshoot of the Biotechnology Industry Organization (BIO), a trade association encompassing over 1000 biotechnology companies. [FN98] BVGH is seeking to essentially “make a market” for neglected diseases by facilitating the flow of information and social capital funds to, from, and among member companies and the underserved markets. [FN99] BVGH's rationale is that only if biotechnology companies can learn to evaluate developing country projects within their strict venture capital finance models will they make the disproportionate impacts they are capable of for the world's poor. [FN100]

Though very few initiatives are highlighted in this paper, it is of note that there exist a multitude of product development initiatives. The now-defunct Initiative on Public-Private Partnerships for Health (IPPPH) maintains a database categorizing partnerships by approach. To date, one hundred PPPs for health have been identified, thirty-four of which are targeted at the discovery and/or development of new drugs, vaccines, or other health products addressing neglected diseases and conditions in low-and middle-income countries. [FN101] Whereas only sixteen drugs were developed for neglected diseases between 1975 and 1999, a recent study has identified 63 drugs in the pipeline today, 47 of which are under the auspices of PPPs. [FN102] Moreover, nine of these drugs are at Phase III or beyond. Therefore, the early inference on the efficacy of PPPs is optimistic.

This section was merely meant to identify trends in the emergence of PPPs for drug development. The next section will illustrate some of the early successes of existing partnerships in the context of the Section I framework and identify challenges which lay ahead before the first PPP-managed drug is brought to market.

IV. Using Partnership to Systematically Overcome Public and Private Failures

Before the management team of a PPP can determine its optimal strategy, it must have a strong understanding of its enabling environment. Once it has been established, however, attention must turn to the mobilization of resources *411 and capabilities of optimally-selected partners to explicitly overcome public and private failures. The nature of the PPP's aspirations will influence its partnering strategy and the strategic value propositions which it is able to offer to partners. These strategies, in turn, reflect organizational decisions regarding which failures-public, private, or both-are worth attempting to surmount. This section will elucidate how alternative strategies suit different health challenges through the use of examples of partnerships which have experienced intermediate success (as no drug developed by a PPP has yet been approved). However, by understanding how failures operate to stymie drug development, I will also reveal the challenges inherent in the strategic decisions made by organizations wishing to be successful in virtual drug development pursuits.

[FN82]. M. Reich, “The Global Drug Gap” (2000) 287:5460 Science 1979, 1979.

[FN83]. Trouiller et al., supra note 7, at 2191-92.

[FN84]. Nwaka & Ridley, supra note 15, at 919.

[FN85]. Kettler & Towse, supra note 77.

[FN86]. Though, any one disease or product has its own story. For examples, see A. Bryceson, “Current issues in the treatment of visceral leishmaniasis” (2001) 190 Med. Microbiol. Immunol. (Berl.) 81-84; D. Legros. et al. “Treatment of Human African Trypanosomiasis: Present Situation and Needs for Research and Development” (2002) Lancet 2, 437, 437; B.J. Seawort, “Multidrug-resistant Tuberculosis” (2002) 16 Infect. Dis. Clin. North Am. 73-105; P.J. Rosenthal, Antimalarial Chemotherapy: Mechanisms of Action, Resistance, and new Directions in Drug Discovery (Humana, Totowa, 2001).

[FN87]. Nwaka & Ridley, supra note 15.

[FN88]. C.M. Morel, “Reaching Maturity: 25 Years of the TDR” (2000) 16 Parasitology Today 503-551.

[FN89]. Special Programme for Research and Training in Tropical Diseases, TDR Strategy: 2000-2005 (2000) TDR/GEN/SP/00/1/Rev.1 available online: http:// www.who.int/tdr/publications/publications/pdf/strategy.pdf.

[FN90]. International AIDS Vaccine Initiative, “Historical Documents,” available online: http://www.iavi.org/about/history.asp.

[FN91]. International AIDS Vaccine Initiative, IAVI 2003 Annual Progress Report (New York: IAVI, 2003).

[FN92]. Robert G. Ridley, Winston E. Gutteridge & Louis J. Currat, “A Case Study of the Establishment of a Public Sector/Private Sector Partnership” (Adapted from a presentation made to the 3rd Global Forum for Health Research, Geneva, June 8, 1999).

[FN93]. Ibid.

[FN94]. Global Alliance for TB Drug Development, “The Cape Town Declaration of the Working Alliance for TB Drug Development”, Cape Town, South Africa (February 8, 2000).

[FN95]. Ibid.

[FN96]. Mychaylo Prystupa, “Orbinski to Launch Drug Initiative in Geneva” News@UofT (30 June 2003), available online: http:// www.newsandevents.utoronto.ca/bin5/030630e.asp.

[FN97]. Shyam Sundar in Drugs for Neglected Diseases Initiative, “Drugs for Neglected Diseases Initiative Newsletter No. 8,” Jan-March 2004 (Geneva: DNDI, 2004).

[FN98]. Biotechnology Industry Organization, “About BIO: Partner to a Dynamic Industry Coming of Age,” available online: http:// www.bio.org/aboutbio/history.asp.

[FN99]. Interview of Wendy Taylor, Executive Director of BVGH (6 August 2004).

[FN100]. Ibid.

[FN101]. Initiative on Public-Private Partnerships for Health, “Partnership Database: Browse by approach,” available online: http:// www.ippph.org/index.cfm?page=/ippph/partnerships/approach.

[FN102]. Mary Moran et al., “The New Landscape of Neglected Disease Drug Development,” London School of Economics and Wellcome Trust (2005), available online: http://www.wellcome.ac.uk/assets/wtx026592.pdf.

This article is published with the kind permission of Nathaniel Lipkus. The article originally appeared in Michigan State University Journal of Medicine & Law, Spring 2006 issue.