Lead Author: Bernard Pecoul
Additional Authors: Rachel M. Cohen, Michelle Childs, and Jean-Francois Alesandrini
Organization: Drugs for Neglected Diseases initiative (DNDi)
Country: Switzerland; USA; Brazil
Over the past two decades there has been growing recognition that the current system for biomedical innovation fails to deliver adapted and affordable health technologies. The lack of innovation of and access to health tools that address public health needs is well-documented. This crisis was initially understood to affect ‘diseases of poverty’ in developing countries but today, despite important progress, the dominant model for financing and incentivizing R&D, which relies primarily on the intellectual property system, is increasingly problematic for all countries – regardless of disease area or income classification.
DNDi was created in 2003 as an experiment in ‘innovation for access’ by MSF and five public research institutions from India, Brazil, Kenya, Malaysia, France, and WHO/TDR, in response to the frustration of being faced with medicines that were ineffective, highly toxic, unavailable, or had never been developed.
This contribution provides concrete evidence of DNDi’s experience implementing needs-driven, open, collaborative R&D, which has resulted in the development of six adapted, affordable, and non-patented treatments and the most robust pipeline ever for some of the world’s most neglected diseases. DNDi’s model is a practical illustration of how R&D can be conducted in the public interest, if a de-linked approach is implemented, with R&D costs at a fraction of the traditional pharmaceutical business model.
It draws lessons that may be applicable to other disease areas and product types, to help inform the deliberations of the UN SG’s HLP.
Finally, it recommends a series of progressive policy steps to re-orient the global biomedical R&D system so that it responds to patient needs, particularly that the UN SG launch a political process to negotiate one or more binding global agreement(s) on the financing, prioritization, coordination, and norms required to enable the discovery, development, and delivery of and equitable access to innovations of public health importance.
I. DNDi: AN EXPERIMENT IN ‘INNOVATION FOR ACCESS’
The Drugs for Neglected Diseases initiative (DNDi) is an international not-for-profit research and development (R&D) organization created in 2003 by Médecins Sans Frontières (MSF) and five public research institutions from India, Brazil, Kenya, Malaysia, France, and WHO/TDR. DNDi was a response to the frustration of being faced with medicines that were ineffective, highly toxic, unavailable, or had never been developed.
In 2001, MSF and partners found that of the 1,393 new drugs brought to market globally between 1975-1999, only 1.1% were for tropical diseases although they represented 12% of the global disease burden. This situation was a result of both market failure, as investments in R&D were guided by market considerations leaving public health needs unaddressed, and public policy failure, as governments had not corrected this situation.
Despite important progress, today the ‘fatal imbalance’ persists. A 2012 study by DNDi and MSF showed that of the 756 new drugs approved between 2000-2011, 3.8% were for neglected diseases, despite a global disease burden of 10.5%. The 2014 Ebola epidemic and the global threat of antibiotic resistance are stark reminders of the need to steer R&D to respond to public health imperatives. Global attention has also focused on the high prices of hepatitis C (HCV) and cancer treatments, illustrating that the accessibility and affordability of new health technologies, even when they are developed, is a major concern, including in high-income countries.
DNDi was an experiment in innovation both in what it did – develop urgently needed treatments for neglected populations – and how it did it – testing an alternative R&D model based on patient needs, not profit maximization. DNDi’s 13-year experience can highlight lessons for other diseases and product types, which may inform deliberations of the United Nations Secretary General’s High-Level Panel on Access to Medicines (HLP).
II. DNDi’s MODEL
DNDi’s funding model does not require the organization to recoup R&D investments or finance its future research through the sales of products or revenues generated by intellectual property (IP). Public and private contributions pay for the cost of R&D upfront, allowing DNDi to independently identify needs, gaps, and priorities based on patient needs; promote sharing of research knowledge and data; and price products at the ‘lowest sustainable price.’ As such, the DNDi model is a practical illustration of how R&D can be conducted in the public interest, if a de-linked approach is implemented.
To date, with total expenditures of US$285 million, DNDi has delivered six new treatments for four diseases (malaria, sleeping sickness, visceral leishmaniasis, and Chagas disease) that are affordable, adapted, and non-patented. For example, 400 million treatments of the anti-malarial artesunate-amodiaquine (ASAQ) have been distributed. Developed in partnership with Sanofi and others in 2007, ASAQ is available for less than US$1 per treatment course for adults (less than 50 cents for children), was prequalified by WHO in 2008, and is registered in 35 African countries and elsewhere. The technology was transferred to a manufacturer in Tanzania for the African market. In addition, DNDi has created a robust pipeline with 30 R&D projects covering six disease areas, including 15 potential new chemical entities (NCEs).
Some key pillars of DNDi’s model include:
1) Patients’ needs at the center of the R&D process
Therapeutic impact is the most important driving force behind DNDi’s work. Exemplified in the following ways:
• Governance: DNDi’s founding partners, particularly from endemic countries, MSF, and two patient representatives on the Board ensure the organization remains rooted in the reality of patients’ needs.
• Target product profiles (TPPs): TPPs describe the ideal specifications needed for a treatment to be developed by DNDi, considering the needs of the patients and the characteristics of the related health system, and drive all R&D activities. Because they are tailored to patient needs from the start, products developed by DNDi are, by design, adapted to ‘field conditions’ and aim for maximum affordability.
• Commitment to research capacity-strengthening: Rather than ‘parachuting’ in expertise, DNDi helps increase sustainable endemic-country ownership in health R&D, for example by establishing three regional clinical research ‘platforms’.
• Continuous assessment of needs and landscape: In 2011, DNDi added filarial infections and pediatric HIV to its portfolio. In 2015, DNDi took on work on mycetoma, for which DNDi plans to test a promising treatment in Sudan; HCV, for which DNDi aims to develop an affordable (< US$300 per treatment course), pan-genotypic combination of existing direct-acting antivirals to enable dramatic treatment scale-up in low- and middle-income countries; and antimicrobial resistance, for which DNDi and WHO are collaborating to incubate a new product development partnership (PDP) to develop antibiotic treatments, promote responsible use, and ensure equitable and affordable access.
2) Scientific access to data and knowledge and patient access to medicines
IP rights can create roadblocks throughout the innovation cycle, limiting the possibility of collaboration, follow-on R&D, production, or equitable access to end-result products. To address these barriers, DNDi’s IP policy is based on two guiding principles that inform all contract negotiations: the need to ensure that drugs are affordable and accessible in an equitable manner to patients who need them; and the desire to develop drugs as global public goods.
DNDi negotiates research and licensing agreements to gain access to patented compound libraries and data, and secure the necessary freedom to operate. Such information jumpstarts the expensive and time-consuming discovery phase, avoids duplication, and reduces overall R&D costs.
Using its negotiating experience with pharmaceutical companies and others, DNDi has defined ‘gold standard’ licensing terms to ensure equitable and affordable access to treatments:
• Perpetual royalty-free, non-exclusive, sub-licensable licenses to DNDi in the contractually defined target disease(s);
• Worldwide research and manufacturing rights;
• Commitment to make the final product available at cost, plus a minimal margin, in all endemic countries, regardless of income level;
• Non-exclusivity, enabling technology transfer and local production to multiply sources of production and decrease price of product.
Licenses can be more difficult to negotiate in cases of pre-existing licenses, prospects of returns on investment from sales in certain markets, and/or significant investments of a private partner in early stages of development. A global normative framework to ensure equitable access to research knowledge and end products would speed negotiations, and enhance efficiency and affordability.
Where IP barriers exist (e.g. HCV), DNDi uses available IP flexibilities for research purposes (e.g. experimental use and/or research exemptions), and supports the use of TRIPS flexibilities to enable production/importation of products.
In an effort to encourage open access to research knowledge and follow-on R&D, data emanating from DNDi projects including clinical trials are made available primarily in open access journals and publicly accessible databases.
Open models of innovation may speed up research and reduce overall R&D costs, although they should be carefully monitored and evaluated. There are encouraging signs from industry in the field of AMR for a more open, collaborative approach. In addition, in 2015, DNDi launched the Neglected Tropical Diseases (NTD) Drug Discovery Booster, which aims to speed up the process and cut the cost of discovering new treatments for leishmaniasis and Chagas disease. By using a simultaneous search process across four pharmaceutical companies’ compound libraries, DNDi accesses millions of unique compounds to screen, significantly condensing the time it will take to find promising treatment leads. Any progress or successful new treatment resulting from the Booster will be attributed to the collective effort of all partners, which have agreed that no IP barriers for NTD indications will be imposed.
3) Decreasing R&D costs through partnerships and collaboration
DNDi does not have its own laboratories or manufacturing facilities, and consequently cannot function without the engagement of partners. Acting as a ‘conductor of a virtual orchestra,’ DNDi leverages partners’ assets, capacities, and expertise to implement projects at all stages of the R&D process, integrating capabilities from academia; public research institutions; NGOs and other PDPs; governments; and pharmaceutical and biotechnology companies (DNDi has partnered with more than 20 companies on early stage research, clinical development, and implementation).
Not all R&D efforts should function virtually, but the important lessons are that openness and collaboration are critical to reducing the time it takes to deliver new technologies and decreasing the overall cost of R&D. In 2014, DNDi published case studies to document the actual expenditures associated with several DNDi products. DNDi estimates its direct costs to range from US$6.5-22 million for an improved treatment, and US$33-44 million for a NCE. Applying the usual attrition rate in the field of infectious diseases, the cost to develop an improved treatment would be US$11-44 million and US$110-165 million for an NCE. Deeper analysis of R&D costs should be conducted, particularly to fairly quantify in-kind contributions of partners. Although it is difficult to compare R&D costs between different business models, DNDi’s experience indicates that innovative models can both deliver rapidly for patients and potentially be more efficient than the traditional pharmaceutical business model.
4) Strengthening and harmonizing regulatory mechanisms
A DNDi-commissioned report on the regulatory environment in Africa showed that new regulatory pathways are needed to expedite research, registration, and patient access to new health tools. DNDi has jointly involved regulators from endemic countries – who know patients’ needs best and are responsible for assessing the benefit/risks for their own populations – and regulators from developed countries – who have broader experience approving new drugs. For example, the dossier for ASAQ, which was first approved in endemic countries, was reviewed for a virtual approval by participants from African countries, with support from WHO’s Prequalification Programme and European Medicines Agency experts.
Ultimately, it is necessary to strengthen capacities of poorly-resourced regulatory bodies in endemic countries, and stimulate support for regional initiatives and harmonization aimed at maximizing patient access to quality medicines.
III. LESSONS LEARNED AND IMPLICATIONS FOR THE HLP
Over the past decade, there have been positive trends in the global health R&D field, including new resources from public and private donors; new incentives and financing mechanisms; increased interest in open innovation models; and new R&D initiatives from governments, academic consortia, and the pharmaceutical industry as well as PDPs.
But the patchwork of ‘solutions’ that have emerged to date is still ad hoc and highly fragmented. Scientific progress has been largely incremental and the situation for neglected patients has not fundamentally changed. Private sector engagement is still being driven primarily by public relations or corporate social responsibility concerns. Funding is insufficient and unsustainable, with unhealthy dependence on a handful of donors, often driven by national interests or a charity-based approach. Many new incentive mechanisms, such as the FDA Priority Review Voucher, though promising, need to be amended to prevent abuse, drive genuine innovation, and ensure access and affordability. There is no global body in place for identifying needs, gaps, and priorities, no effective monitoring and coordination of R&D efforts to maximize scientific collaboration and reduce wasteful duplication. And there is no overarching framework of globally agreed norms to ensure sharing of data and knowledge, and ensure the affordability of end products.
It is time to transform individual successes into a more systematic and sustainable approach for all diseases of public health importance. DNDi’s collaborative model has shown at a small scale that alternative approaches to R&D that address pressing public health needs are possible. However, individual initiatives cannot be the only solution to the problem. To fully address the scale of public health needs, public leadership is needed to redefine the ‘rules of the game.’
IV. PROPOSAL: GLOBAL BIOMEDICAL R&D AGREEMENT
DNDi recommends that the HLP launch a political process that will lead to the negotiation of one or more binding global agreement(s) on the financing, prioritization, coordination, and norms required to ensure the discovery, development, and delivery of appropriate and affordable innovations of public health importance. This should include initiatives that may be launched this year via the WHO as one of the remaining issues under the Consultative Expert Working Group: R&D Financing and Coordination (CEWG).
DNDi’s collaborative model has shown that R&D that addresses public health needs requires two policy moves that must occur simultaneously within a global framework:
• Increased financial and technical scientific resources, through new incentives and financing mechanisms;
• Reduced R&D costs, through open innovation mechanisms, public health-driven IP management, innovative regulatory strategies, and transparency of R&D costs.
Specifically, the following elements are critical to any global biomedical R&D agreement(s):
R&D that addresses priority public health needs must be the overarching objective. An independent body to identify R&D needs and gaps, establish clear priorities, and coordinate efforts to enhance collaboration and reduce duplication will be necessary. WHO is best placed to manage these functions. The WHO Global Health R&D Observatory could play this role, provided it is adequately financed by member states and its remit is expanded to cover all areas of public health importance for both developed and developing countries.
(2) Adequate, sustainable public financing based on the principle of delinkage
R&D requires adequate, sustainable funding from governments, which should be available at the national, regional, and international levels, as well as mechanisms to incentivize innovation and secure access, based on the principle of delinkage. Funding and incentive mechanisms should promote open, collaborative approaches that aim from the start to deliver affordable products efficiently. In order to best direct funding to agreed priorities, at least some portion of health R&D funding should be pooled. WHO is moving forward with a health product R&D fund for certain diseases, which is an important first step. However, it is essential to think beyond a narrow disease mandate so that all areas of public health importance are included.
(3) Global norms that ensure innovation and access, accelerating the R&D process and decreasing R&D costs
Public funding for R&D should be tied to the adoption of fundamental norms, which include:
• Delinkage, to ensure public health focus and access, which applies across the innovation cycle and can be implemented in a number of ways (e.g. grants, prizes);
• Accessibility, meaning universal and equitable availability and affordability of health technologies for individuals and the health systems that serve them;
• Openness, transparency, and access to knowledge, meaning the greatest possible sharing of research knowledge to ensure efficiency and collaboration, and transparency of R&D costs;
• Pro-public health IP management and equitable licensing – concerning the availability, scope, and use of research tools and affordability of end products – to enable research and the fruits of innovation to be global public goods;
• Scientific and technological cooperation to harness expertise in both developed and developing countries, encourage collaboration between research centers, and facilitate technology transfer;
• Essential regulatory standards to expedite access for patients, while ensuring that new treatments are safe, effective and of quality, reduce R&D costs linked to regulatory approvals, and strengthen regulatory capacity.
These norms should build on research ethics principles as well as the principles formulated in the CEWG report and summarized in WHA 66.22, namely ‘affordability, effectiveness, efficiency and equity, including delinking the costs of R&D from the price of end products.’
V. IMPACT ON REMEDYING POLICY COHERENCE, PUBLIC HEALTH AND HUMAN RIGHTS
Access to medicines is a core component of the right to the highest attainable standard of health. Realizing that right requires new innovation approaches so that needed medical technologies are developed and affordable.
Currently, the only global R&D agreement is TRIPS, which relies on one approach, IP, to incentivize R&D. Despite some success, there is still a major deficit in innovation and access to new tools in relation to public health needs.
WHO member states and the Special Rapporteur in the field of cultural rights have endorsed the need to look for alternative models for financing R&D, including those based on the principle of delinking R&D costs from product prices As has been noted by others, adoption of an approach that includes the ‘full implementation of delinkage to fund and incentivize biomedical innovation is the most straightforward way to bring policy coherence between the areas of law and policy that the HLP has been asked to resolve.’
By starting the process to create a new normative framework that underpins the biomedical R&D system and by elevating the decision-making process to the highest political level, the HLP can promote policy coherence between the different frameworks and initiatives being proposed at WHO and elsewhere and play a definitive role in ensuring that appropriate health tools are designed from the start to work in the places and for the people that need them, and are available and affordable in an equitable manner to all, consistent with public health and human rights principles, as well as Sustainable Development Goal 3.
The UN SG has the unprecedented opportunity to launch a political process that will support the progressive changes needed to re-orient the global biomedical R&D system so that it responds to patient needs. Practically, it may be valuable to adopt a progressive approach to the policy-making process. Thus, the HLP should:
• Support countries to implement and use TRIPS flexibilities to allow development of and access to medical technologies;
• Strongly encourage governments, industry, and academia to increase participation in and support for approaches to access medical technologies and data, e.g. disclosure of research data and R&D costs, pre-competitive research platforms, and patent pools that further develop licensing conditions to include all affected countries;
• Advocate for a declaration by key public and private R&D funders ensuring that R&D funding will be tied to implementation of the norms in section (IV)(3) above;
• Advocate for amending existing incentive mechanisms when they do not sufficiently induce innovation and guarantee access;
• Pilot innovative regulatory pathways that expedite research, ensure access, and strengthen regulatory capacity where needed;
• Expand the remit of the WHO Observatory to cover all areas of public health importance in all countries and request WHO to accelerate the elaboration of a process for R&D priority-setting;
• Expand the remit of existing pooled funds, or develop funds to cover all areas of need, tied to agreed priorities and norms (IV above);
• Launch a high-level political process aimed at creating a binding global agreement or agreements, based on the principle of delinkage to ensure the financing, coordination, and norms required for the discovery, development, and delivery of appropriate and affordable innovations of public health importance.
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 One of the most important ways in which DNDi secures financial independence is through diversification of funding to prevent unhealthy influence by or dependence upon any single donor. This is why DNDi’s funding policy, as established by its founding partners in 2003, also seeks to maintain a balance of public and private support, to minimize as much as possible earmarked donations, and to ensure that no one donor contributes more than 25% of the overall budget.
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 Including India, Ecuador, and Colombia.
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 A full report on the DNDi model was published in January 2014: An Innovative Approach to R&D for Neglected Patients: Ten Years of Experience and Lessons Learned by DNDi. Geneva: DNDi, 2014.
 DNDi has helped to establish three clinical research platforms: the Leishmaniasis East Africa Platform (LEAP) in Kenya, Ethiopia, Sudan, and Uganda; the Human African Trypanosomiasis (HAT) Platform in the Democratic Republic of the Congo, Angola, Central African Republic, Chad, Republic of the Congo, Sudan, South Sudan, and Uganda; and the Chagas Clinical Research Platform in Brazil, Bolivia, Argentina, Mexico, and many others.
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 A draft resolution to be debated at the 2016 World Health Assembly may add mycetoma to the WHO NTD list. See: WHO Executive Board draft resolution EB138.R1. Addressing the burden of mycetoma. Available at http://apps.who.int/gb/ebwha/pdf_files/EB138/B138_R1-en.pdf (accessed February, 26, 2016).
 For a summary of DNDi’s hepatitis C project, see: http://www.dndi.org/wp-content/uploads/2015/09/DNDi_HCV_Project_summary_2015.pdf (accessed February 25, 2016).
 For the WHO/DNDi concept note, notes from technical consultations, etc., see: http://www.who.int/phi/implementation/consultation_imnadp/en/ (accessed February 25, 2016).
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 See, for example, the ChEMBL Neglected Tropical Disease (NTD) archive, an open access repository for primary screening and medicinal chemistry data directed at neglected diseases; Medicines for Malaria Venture’s Pathogen Box; GlaxoSmithKline’s Open Lab; the Medicines Patent Pool; etc.
 See, for example: Universities Allied for Essential Medicines. RE: ROUTE: A map of the alternative biomedical R&D landscape. UAEM, 2016. Available at (http://altreroute.com/assets/download/UAEM_Reroute_Report.pdf (accessed February 25, 2016).
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 For further elaboration, see: Drugs for Neglected Diseases initiative. Transforming Individual Successes into Sustainable Change to Ensure Health Innovation for Neglected Patients: Why an Essential Health R&D Convention Is Needed. Geneva: DNDi, 2012. Available at http://www.dndi.org/images/stories/advocacy/DNDi_Policy_brief_CEWG_lowres.pdf (accessed February 26, 2016).
 For a more in-depth exploration of the benefits of pooled funding, see: Moon, S. Demonstration Financing: Considerations for the New International Fund for R&D. Geneva: DNDi, 2014. Available at: http://www.dndi.org/wp-content/uploads/2009/03/pilot-pooled-international-fund_web.pdf (accessed February 25, 2016).
 See http://www.who.int/tdr/capacity/gap_analysis/en/ (accessed February 25, 2016).
 See, for example, the Helsinki Declaration, available at http://www.wma.net/en/30publications/10policies/b3/ (accessed February 27, 2016) and more recent writings on Ebola and the importance of patient participation in setting research priorities, for example: Moon, S. et al. Will Ebola change the game? Ten essential reforms before the next pandemic. The report of the Harvard-LSHTM Independent Panel on the Global Response to Ebola. The Lancet, Volume 386, Issue 10009 , 2204 – 2221 (2015).
[37 For the full resolution text, see: http://www.who.int/phi/resolution_WHA-66.22.pdf (accessed February 26, 2016).
 ICESCR. art. 15(1)(b)-(c). See also: Human Rights Council. Access to medicines in the context of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health. A/HRC/23/L.10/Rev.1.http://www.ohchr.org/EN/HRBodies/HRC/RegularSessions/Session23/Pages/ResDecStat.aspx (2013). See also General Comment 14 of the Committee on Economic, Social, and Cultural Rights (CESCR), http://www.nesri.org/sites/default/files/Right_to_health_Comment_14.pdf (“providing access to essential drugs, as defined by the WHO Action Programme on Essential Drugs, is a core obligation” of states).
 The Special Rapporteur in the field of cultural rights. The right to enjoy the benefits of scientific progress and its application. A/HRC/20/26 http://www.ohchr.org/Documents/HRBodies/HRCouncil/RegularSession/Session20/A-HRC-20-26_en.pdf at 33. For a longer discussion on this point see submission by Yale Global Health Justice Partnership.
 A/HRC/20/26 at 34.
 World Health Organization. Resolution WHA63.28. 2010. Available at http://apps.who.int/gb/ebwha/pdf_files/WHA63/A63_R28-en.pdf?ua=1&ua=1 (accessed February 25, 2016).
 See submission to the HLP from MSF/Knowledge Ecology International (Rius, Love et al), February 2016.
 For the full text of SDG 3, see: http://www.un.org/sustainabledevelopment/health/ (accessed February 26, 2016).
 See contribution of the Global Health Law Committee of the International Law Association (‘t Hoen et al) to the HLP, February 2016.
 For example, the FDA PRV program. See, for example, http://www.msfaccess.org/content/open-letter-us-senate-help-committee-leadership-suggestions-fix-fda-prv-neglected-diseases (accessed February 26, 2016).