New Research Study Describes DNDi As “Commons” For Public Health

Since 2003, Drugs for Neglected Diseases Initiative (DNDi) has worked to meet the public health needs of neglected populations by filling gaps in drug development left by the for-profit pharmaceutical industry. A new research study by the French Development Agency analysed DNDi’s unique product development partnership (PDP) model, and found that it “illustrate[s] what can be presented as a ‘commons’ within the area of public health.”

The research study, “DNDi, a Distinctive Illustration of Commons in the Area of Public Health,” was published earlier this month by the Agence Française de Développement (AFD), the French public development bank that “works in many sectors — energy, healthcare, biodiversity, water, digital technology, professional training, among others — to assist with transitions towards a safer, more equitable, and more sustainable world: a world in common,” according to its website.

The study was researched and authored by Philippe Abecassis, Benjamin Coriat, and Nathalie Coutinet of CEPN/Université Paris 13, Jean-François Alesandrini of DNDi and Stéphanie Leyrona of AFD.

It explains that while DNDi was initially established as a simple PDP, its “practice evolved over the years to include features typical of commons,” and as such, it came to constitute “a unique and distinctive institutional model in the area of public health.”

The study highlights three features of DNDi that the researchers found to be indicative of commons:

  1. “its promotion of collaborative platforms and open innovation
  2. its innovative intellectual property policy
  3. its governance, partnership and funding mechanisms”

“The capability of commons to create institutions and business models that satisfy essential needs while guaranteeing universal access, especially for the neediest,” the study asserts, “is without doubt a major stake for the future of our societies.”

DNDi: PDP with “Unique Characteristics”

Product development partnerships (PDPs), the study explains, are “not-for-profit organisations dedicated to promoting the development of R&D [research and development] in the field of neglected diseases.” They “fill R&D gaps by creating public/private partnerships to conduct projects,” while “ensuring that the resulting goods will be made available at affordable prices to the most vulnerable populations.”

DNDi aims, like other PDPs, to address the neglected public health needs of developing countries in a context in which the large majority of R&D for innovative drugs is conducted for the benefit of the minority of “wealthy and creditworthy patients,” the study says.

The neglected diseases these PDPs aim to address include HIV/AIDS, malaria and tuberculosis, along with a range of other tropical diseases, which generally “prevail in the global South and are associated with very high morbidity and mortality rates.”

The study explains that “PDPs’ costs of research and development risks, are borne primarily by public funding or donations from charitable foundations, yet overall they are largely dominated by private actors both in terms of funding, partnership and governance.”

Also, most PDPs, it says, “operate within existing IP [intellectual property] legal frameworks without questioning them.”

DNDi, however, exhibits “unique characteristics” in comparison to other PDPs. “While DNDi unquestionably belongs to the wide PDP family,” the study says, “the characteristics of its institutional model and the arrangements it promotes clearly set it apart from conventional PDPs.”

Due to these “unique characteristics,” the study suggests that it is appropriate and particularly insightful to analyse DNDi “through the lens of commons – rather than that of PDPs.”

Global Public Goods vs. Commons Approach

The study says that public health has often been described as a global public good (GPG), which is archetypically represented by such shared global resources as air, atmosphere, or water, having “attributes of non-rivalry in use and non-exclusion in access.”

However, it states that GPGs presuppose “that a worldwide governance exists and is capable of applying regulatory and economic tools to all actors,” when in actuality, “no such governance has been put in place.”

Further, the GPG approach “focuses almost exclusively on regulations in a world seen as governed by agents in pursuit of private interests.”

The study says that the commons approach, on the other hand, offers a more appropriate framing for how public health can be provided as a common, public good.

While the commons approach “does not exclude at all the need for appropriate regulations,” it “attaches at least equal importance to the establishment of local, decentralised, often largely self-organised entities.”

It also establishes an institutional framework and rules that “target the reproduction or joint enrichment of the resource and the community around it,” while ensuring equity and promoting “universal access.”

DNDi as a Public Health Commons

The features of DNDi that make it indicative of a public health commons, according to the study, include its “methods based on collaborative clinical research platforms and open innovation approaches, its IP policy as well as its methods of governance,” which “secure the participation and representation of actors and partners while safeguarding their rights and needs.”

DNDi has initiated and funded a range of collaborative platforms that “do not belong to DNDi but to the medical and scientific community that works within them.” The purpose of these platforms, the study explains, is not just to develop drugs, but “to consolidate new skills and introduce them into national and local programmes, thereby strengthening local infrastructures.”

DNDi has also established an open innovation environment for R&D in partnership with pharmaceutical companies. As a “virtual R&D organisation without its own compound libraries, DNDi has initiated original mechanisms with companies based on the open innovation concept and practices.”

These mechanisms provide “access to the chemical libraries of pharmaceutical companies,” and attribute progress on the development of new treatments “to the collective effort of all partners, who agree to waive all intellectual property positions on resulting treatments.”

DNDi’s IP policy “relies first and foremost on the primacy of access to treatment,” and its “vision is that IP can and must be conceived as a set of shared rights.” The study explains that this “is innovative because it offers a way to escape from the all-or-nothing dichotomy which has dominated all IP issues: private and exclusive IP law versus a total absence of rights.”

“When IP rights are fully waived, combined with a distribution of medication free-of-charge or at drastically reduced price, with collaborative clinical research,” the study says, “public health becomes a common resource.”

Finally, DNDi’s governance resembles that of a public commons. It “is the first and the only PDP whose founding partners include medical research institutes from the public sector of developing countries,” and its Board of Directors “is constituted predominantly of public health experts from the public sector.”

At least 50 percent of DNDi’s budget must be publicly funded, the study explains, with no single donor contributing over 25 percent of all donations.

Further, the Board of Directors does “not include any active member of the pharmaceutical industry,” and the organisation “refuses direct grants from the pharmaceutical industry, not only to preserve its independence, but also to give priority to in-kind contributions from pharmaceutical companies such as access to chemical libraries or product registration.”

“DNDi’s public-sector led governance, partnerships and funding mechanisms all contribute to safeguarding its independence and the ability to conclude agreements guaranteeing the access to and availability of affordable products,” the study finds.

Combined with its innovative collaborative platforms and its IP policy, “they constitute key features of DNDi’s promotion of commons.”

Expanding the Commons by Addressing Funding Limitations

The study notes that two of the features of DNDi highlighted in the analysis of the organisation through the commons approach “constitute both its strength and limitation.” These include reliance on grant-based funding and delinkage.

Delinkage is “the principle of delinking the costs of research from the final price of drugs to make them affordable for those most in need,” and “is based on the premise that costs and risks associated with R&D should be rewarded, and incentives for R&D provided, by means other than the price of the end-products or sales volume,” the study explains.

Both of these features enable DNDi to guarantee “the drugs’ quality and safety, equitable access and availability at reasonable prices.” However, the study notes that they also pose a limitation on the expansion of DNDi, in particular due to the competition for funding between diseases in a climate with shifting priorities.

As of 2015, DNDi evolved its mission “from ‘neglected diseases’ to encompass ‘neglected patients,’” and the study notes that this “broadening of DNDi’s focus calls for potential additional revenue and raises the question of whether the organisation could generate such revenue through its own activity.”

The study then explores several ways that DNDi could indeed generate increased revenue through its ongoing activities. These include sharing data eligible for priority review vouchers (PRVs); differentiating pricing based on license policy; and funding for dual destination of drugs to developing as well as developed countries.

All of these options are based upon the offering of potential cost-savings that such ongoing and expanded DNDi activities could provide to a range of actors, including pharmaceutical companies, countries and consumers. The study suggests that leveraging these cost-saving opportunities could result in new institutional arrangements for DNDi to generate new funding and income.

The study contends that such a revenue-generating business model for DNDi would require an “extremely rigorous accountability,” which it says would simply be “another distinctive feature of not-for-profit and needs-driven commons, radically different from the opaque world of private for-profit pharmaceutical companies.”

 

Image Credits: DNDi.

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