Alexandra Greenberg and Rachel Kiddell Monroe, UNIVERSITIES ALLIED FOR ESSENTIAL MEDICINES

Lead Author: Alexandra Greenberg and Rachel Kiddell Monroe
Organization: Universities Allied for Essential Medicines
Country: Canada; USA

Contributors:  Mark Chee, University of Chicago; Sam Mehr, Central Michigan University; Manuel Martin, Vienna International School; Kathi Hawlik, Vrije Universiteit; Jessica Farber, McGill University; and Merith Basey, Executive Director, UAEM North America

Abstract

Recent global health crises have highlighted the ongoing failure of the current biomedical research and development (R&D) system to address the needs of patients globally. Various self-proclaimed alternative R&D initiatives have emerged in the past fifteen years to address those failings.

To understand the myriad efforts undertaken to counteract the dysfunction of the current R&D model, UAEM began an extensive, though not comprehensive, mapping of the alternative biomedical R&D landscape. Phase 1 is a mapping of the initiatives that exist, or are proposed, and claim to be an alternative to the current system. The Re:Route Report mapped 81 such initiatives. Preliminary analysis shows that:
1. None of the initiatives included present a completely alternative model of biomedical R&D or a new system.
2. The majority focus on developing incentives for drug discovery.
3. Most are focused on rare diseases or diseases of the poor and marginalized.
4. There is an increasing emphasis on the use of push, pull, pool, collaboration and open mechanisms alongside the concept of delinkage.
5. There is a trend towards public funding and initiatives from the Global South.

Though apparently impressive in range, UAEM believes the fragmented alternative landscape needs to be evaluated to identify which initiatives not only aim to but actually do support a new approach to R&D. Phase 2, an evaluation tool, will assess if in fact included initiatives are achieving increased access to and innovation in medicines and for those that are, which practices contribute to their success. These should then be considered as building blocks to effective R&D and can inform the development of a global R&D agreement. Through this mapping and our upcoming evaluation, UAEM aims to initiate an evidence-based conversation around a truly alternative approach to biomedical R&D that serves people rather than profits.

Submission

Background: A system chronically failing patients

Today the world is witness to the tragic outcomes of the West African Ebola outbreak, the soaring price of medicines in both rich and poor countries, and the lack of major new antibiotics to address the spread of microbial disease. Together these events have further highlighted the ongoing failure of the current biomedical research and development (R&D) system to address the needs of patients globally and treat health as a human right.

For over two decades, concerns have been raised about the current biomedical R&D system. Since the passage of international patent protection laws in the mid 1990s [1], evidence of the multiplicity of ways that people in lower income settings are deprived of access to affordable and appropriate medications has grown. The WHO has maintained its estimate made in 2000 that at least one third of people worldwide lack access to essential medicines and 10 million people per year die as a result [2]. In 2009, total global investments in health R&D amounted to US$240 billion. Yet in 2010, only about one percent of all health R&D investments were dedicated to neglected diseases [3]. Furthermore, under the current system, therapeutic advances are a rarity with the majority of new drugs showing little to no added value compared to previously available treatments [4].

This crisis of high prices spans the entire disease spectrum and affects populations in all countries. From 2014 to 2015 alone, drug prices increased almost 14% in the United States [5]. A bipartisan report from the US Senate Finance Committee showed that Gilead’s “pricing strategy was focused on maximising revenue” [6]. The result is a price tag of US$84,000 for a 12-week course of their Hepatitis C treatment Sofosbuvir, brand-named Sovaldi ®. A recent study showed that manufacturing costs for similar drugs are as low as US$21 to US$63 per 12-week treatment course [7]. A study on the pricing of four oral cancer drugs found that mass generic production of the evaluated drugs could result in treatment prices ranging from US$128 to $4,020 while current US prices range from $75,161 to $139,138 [8]. Insufficient pharmaceutical innovation exacerbates this crisis. “Historically, evidence suggests that patents were not a necessary condition for innovation, that the large majority of innovations occurred outside of the patent system, and that policies that limit the scope of patents act to encourage innovation” [9].

We need a people-centered framework for R&D

On its surface, the Re:Route Report shows an impressive range of alternative biomedical R&D initiatives challenging the current system by tackling issues that have long contributed to lack of access to and innovation in medicines. Yet, initial observations from the Mapping point to a lack of fundamental systemic change. While some initiatives have undoubtedly made important advances on specific diseases and systemic issues, others are simply promoting a “business as usual” approach. And despite these manifold initiatives claiming to fix the system, shockingly little has changed for the majority of people trying to access essential medicines. The Ebola outbreak epitomizes the pitfalls of the current piece-by-piece approach. GAVI’s recent commitment to further develop, license and stockpile an Ebola vaccine previously owned by Merck & Co Inc. is laudable [10]. However, it comes too late for many. The West African Ebola outbreak has claimed over 11,000 lives [11] while GlaxosmithKline and the National Institutes for Health left the vaccine sit on the shelf for years due to lack of potential profits from its further development [12]. If a system that worked to meet the needs of all populations had been in place, a vaccine for Ebola, and now for Zika virus, would already exist and be on the market before these diseases became a global threat [13].

Various actors and policy processes have acknowledged the need for a new approach to medical innovation over the past decade, including those that recommend a new global agreement for medical R&D. We believe that the Mapping supports those ongoing calls for a new global framework. The fragmented and haphazard landscape revealed by the Mapping will not lead to a truly new approach to biomedical R&D. One reason is that many initiatives are based on the notion that the current biomedical R&D system needs to be fixed and some of its side effects remedied. Yet, the current system is not broken. It was designed to treat health as a commodity and it is successfully maintaining that approach. Many of the myriad of short and long-term fixes currently being debated will not change the fundamental nature of that profit-driven system [14]. In our view, while incremental steps are important and necessary, it is time to do more to address the underlying issues inherent in the current system.

Mapping alternatives: Methodology & Preliminary Observations

Methodology

Myriad self-proclaimed alternative R&D initiatives have emerged in the past fifteen years [15]. In light of the 2005 WHO Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) Report, the WHO Consultative Expert Working Group on Research and Development: Coordination and Financing (CEWG) actively called for projects to demonstrate alternative ways of approaching biomedical R&D [16]. Universities Allied for Essential Medicines (UAEM) wanted to understand the range of efforts undertaken to counteract the dysfunction of the current R&D model. We therefore began an extensive, though not comprehensive, mapping of the alternative biomedical R&D landscape with two phases: (1) investigating what initiatives exist, or have been proposed, that claim to be an alternative approach to R&D and (2) evaluating which of those existing and proposed initiatives are already achieving increased access to and innovations in medicines.

The Re:Route Mapping represents phase one of this effort. We reviewed more than 130 “alternative” initiatives using a simple methodology based on a specific set of defined inclusion and exclusion criteria. These were developed from accepted alternative mechanisms such as delinkage of prices from costs of R&D, openness, collaboration and use of push, pull, and/or pooling (See Inclusion Criteria). We retained 81 initiatives that claim to redress the inequity caused by the current biomedical R&D system and that fulfilled at least one of the criteria. We then separated the initiatives into existing initiatives (49), which are currently underway, and proposed initiatives (32), which are not yet in place but show signs of ongoing development.

Inclusion Criteria: Mapping Alternative Mechanisms for Biomedical R&D [17]

- Push Mechanism: Direct funding for R&D, often in the form of a grant, as well as indirect incentives, such as tax breaks and in-kind contributions, that help finance R&D upfront and thus, mitigate the R&D investment required.
- Pull Mechanism: Mechanisms to incentivize R&D activities through the promise of financial rewards once specified objectives or milestones have been met, creating viable market demand.
- Pooling Mechanism: Pooling of funds that are aggregated and managed jointly by an established entity to be allocated based on priority setting in order to distribute risk and finance biomedical R&D. Additionally, pooling of intellectual property (IP), typically via a patent pool, an agreement between two or more patent owners to pool their patent rights and license the rights to use these patents together to one another as well as third parties. These two distinct types of pooling can occur independently or jointly.
- Collaborative Initiative: Involves a network, consortium, or partnership between two or more of any academic or research institutions, non-profit organizations, NGOs, governments, government entities, or members of the private sector including biotech and pharmaceutical companies.
- Open Initiative: Applies open source, open access, open data, or open knowledge principles. Interested parties are able to contribute knowledge or know-how, data, technology, etc. to be shared in the public domain and, in the case of open source, in coordination with patent-free research.

Preliminary observations

Firstly, none of the initiatives included in the Mapping present a completely alternative model of biomedical R&D or a new system. Having classified the initiatives according to elements of the biomedical R&D process, we see the majority of the initiatives address just one aspect of the biomedical R&D chain, a few try to address multiple parts of the pipeline and very few seek to apply a revolutionary or novel approach to biomedical R&D.

Among the 49 existing R&D-related initiatives, we did not find an initiative that both addressed four or more of the five key innovative R&D mechanisms we identified (push, pull, pool, collaborative and open) and utilized the concept of delinkage. Of the 32 proposed initiatives however, we found six (19%) that covered four or more key mechanisms and embraced the concept of delinkage. Disappointingly, these six initiatives remain un(der)funded and without active projects.

Second, the initiatives are largely focused on rare diseases or diseases of the poor and marginalized. Nearly 9 in 10 of the existing initiatives focus on neglected tropical diseases (NTDs), rare diseases or malaria, TB and/or HIV, while 40% (19) of the proposed initiatives focus on NTDs and rare diseases. While NTDs represent real needs, the fact that only 3 existing initiatives and 1 proposed initiative focus on chronic and noncommunicable diseases (NCDs) highlights a lack of attention to an important portion of global health needs [18]. New antibiotic development is a key focus of only 2% of existing but 16% of proposed initiatives, all of which are based in the North and publicly funded. It is also striking to note that only 4% (2) of the existing initiatives and 32% (7) of the proposed initiatives focus on diagnostics, a critical stage of medical treatment.

Third, there is an increasing emphasis on the use of push, pull, pool, collaboration and open mechanisms alongside the concept of delinkage in alternative R&D. The number of initiatives implementing push mechanisms has increased from 14% existing (7) to 50% proposed (16), the number of initiatives with pooling has risen from 2% of existing (1) to 47% proposed (15) and openness is an overt strategy in 10% existing (5) compared to 32% (10) of proposed initiatives. Pull mechanisms have become slightly more prevalent, present in 16% of existing (8) and 25% of proposed (8) initiatives, whereas collaboration has remained fairly constant, present in 24% (12) of existing and 28% (9) of proposed initiatives. Additionally, implementation of more than two mechanisms is prevalent in both existing (32.5%) and proposed initiatives (56%). While only one existing initiative applies three mechanisms together, 8 proposed initiatives apply three or more mechanisms, indicating an increase in joint application of alternative mechanisms.

Finally, we observed that there is a trend towards public funding and launching of initiatives by the Global South. Only 20% of existing initiatives (10) rely solely on public funding sources, compared to 50% of proposed initiatives (16). As demand for public funding has grown, reliance solely on private funding sources has fallen from 29% of existing to 12% of proposed. Reliance on public and private funding sources together has also declined from 51% existing to 38% proposed. While, 78% of existing and 69% of proposed initiatives originated in the North, there seems to be a trend towards more initiatives being developed in the South.

Next steps

UAEM is now preparing to launch phase two of the mapping process. While the Mapping is an important first step, alone it does not allow us to separate what enables and supports equitable biomedical access and innovation and what does not. Only by conducting collaborative, accurate and in-depth analysis of the mapped initiatives can we identify key gaps in the alternative biomedical R&D landscape. We can then also begin to understand methodologically the approaches and mechanisms that are in fact effective and appropriate for an alternative R&D approach that prioritizes the needs of patients.

The evaluation will publicly share critical information about these initiatives through an evaluation tool, available online, that scores all 81 initiatives in key metrics relating to access, innovation, and collaboration. It will enable initiatives to be compared, fostering renewed and ongoing dialogue concerning the criteria and principles to be laid out for a framework for biomedical R&D that puts people before profits. It will also show opportunities for improvement for individual initiatives. An overall score will be allotted for each initiative as well as specific scores for each metric and section. This evaluation tool can push us to bridge both smaller and larger gaps, working from the current fragmented and incomplete landscape towards the revolutionary R&D system that currently has yet to be clearly defined. Through this evaluation, promising initiatives can serve as building blocks for an overarching framework to govern and guide R&D.

This tool will be modeled after UAEM’s Report Card project, with three overarching principles that will guide the analysis. The tool will be built around evidence-informed, expert-approved metrics, criteria and indicators that measure each initiative’s ability to and success in promoting access to and innovation in medicines and health technologies as well as whether the initiative is working towards access and innovation openly and collaboratively (See Annex for detailed draft structure of tool). These metrics, criteria and indicators are being developed to clearly and accurately measure impact. They will be weighted based on their relative importance to achieving open access and innovation and are based on both public and private data and information. The list of criteria in the Annex (included in the References section) will need to be expanded to more appropriately evaluate proposed initiatives. With the support and advice of a group of access and innovation specialists, UAEM will create a student-led team to conduct data collection and analysis. This team will publish a manuscript to share findings, based on the results of the evaluation.

Using UAEM’s Report Card as a model, we furthermore have a basis for how to develop this new tool and understand the resources that it will require for implementation. UAEM will need approximately 25,000 dollars for web design and development and PR services. This project has already garnered support from key allies in the access to medicines field including the MSF Access Campaign, Salud Por Derecho, and Open Science Foundations and we will be able to build from the momentum and interest around the mapping when seeking funding, since it has already garnered attention since UAEM publicly launched Re:Route via release of our microsite.

Conclusion

While we are morally bound to do what we can today to improve patient access to medicines, we must also be bold enough to collectively aim for and work towards a novel, ethical and rights-based way of carrying out biomedical R&D that can benefit all those who need access to lifesaving medicines. Through this mapping and through the evaluation of existing and proposed alternative R&D initiatives, UAEM aims to initiate an evidence-based conversation around a truly alternative biomedical R&D model that serves people rather than profits in order to encourage change at a global level, both in policy and practice.

To view UAEM’s Re:Route Mapping, please visit http://altreroute.com

Annex, Bibliography and References

Annex

Proposed List of Criteria for an Alternative R&D Initiative Report card for Global Equity and Biomedical Research: Structure for Existing Initiatives

1.     ACCESS: Promotes Global Access to Medicines

Metric: Minimizes barriers to access and promotes socially responsible licensing

-        Criteria 1: Socially responsible licensing strategy

-        Indicator 1a: Has a licensing policy, guidelines, or practices in place with Global Access Licensing Framework language

-        0: No such statement

-        1: Statement exists but with no clear commitment

-        2: Regularly includes GALF language in licenses

-        3: Regularly includes GALF language and has a statement promoting use of GALF+

-        4: All licenses include GALF language

-        5: All licenses include GALF language and has a statement committing to always use GALF in licenses

-        Indicator 1b: Licensing policy or list of practices/guidelines is publicly shared

-        0: Not public

-        1: Public

-        Criteria 2: Commitment to ensuring that research products are in the public domain

-        Indicator 2a: Has a licensing policy, guidelines, or practices in place to put any products of research in the public domain

-        0: No such statement

-        1: Statement exists but with no clear commitment

-        2: Regularly puts research in public domain

-        3: Regularly puts research in public domain and has a statement promoting open publication and data-sharing

-        4: All research is put in the public domain

-        5: All research is put in the public domain has a statement committing to do so

-        Indicator 2b: Licensing policy or list of practices/guidelines is publicly shared

-        0: No statement

-        1: Statement

-        Criteria 3: Action towards placing products on Essential Medicines List(s) (EML)

-        Indicator 3a: Has or is working towards getting products onto the World Health Organization EML

-        0: Never

-        1: Working on it for some products

-        2: Working on it for all products

-        3: Has some products on WHO EML

-        4: Has all products on WHO EML

-        Indicator 3b: Has or is working towards getting products onto national EML(s)

-        0: Never

-        1: Working on it for some products in some countries

-        2: Working on it for some products in all countries

-        3: Working on it for all products in some countries

-        4: Working on it for all products in all countries

-        5: Has some products on EML in some countries

-        6: Has some products on EML in all countries

-        7: Has all products on EMLin some countries

-        8: Has all products on EML in all countries

-        9: Has some products on WHO and national EMLs

-        10: Has all products on WHO and national EMLs

-        Indicator 3c: Has a policy pertaining to EML(s)

-        0: No policy

-        1: Policy endorsing placement of products on EML(s)

-        2: Policy committing to get all products onto EML(s)

Metric: Pricing strategy that ensures affordability

-        Criteria 3: Publicly available and detailed pricing strategy

-        Indicator 3a: Detailed pricing strategy

-        0: No detailed strategy

-        1: No mention of value-based pricing

-        2: Tiered pricing excluding MICs

-        3: Tiered pricing including MICs

-        4: Inclusion of delinkage as a principle

-        5: All of the above

-        Indicator 3b: Pricing strategy is publicly shared

-        0: Not public

-        1: Public

-        Criteria 4: Affordability

-        Indicator 4a: Percentage of end products that are affordable

-        0: No public strategy to ensure affordability

-        1: Affordability strategy exists but relies on tiered pricing/ government subsidies

-        2: The initiatives affordability strategy ensures the availability of >1 generic producer

-        3: The initiative’s affordability strategy ensures at cost (+) pricing of medicines

-        Criteria 5: Translational research

-        5a: Initiative participates in or takes steps to ensure that translational research occurs

2.     INNOVATION: Research purpose is driven by global health needs

Metric: Research focuses on areas of unmet global health needs

-        Criteria 1: Research focuses on Type I diseases, as defined by the WHO.

-        Criteria 2: Research focuses on Type II diseases, as defined by the WHO.

-        Criteria 3: Research focuses on type III diseases, as defined by the WHO.

Metric: Initiative’s potential for global health impact

-        Criteria 4: Product(s) treat disease more effectively than existing treatments and/or at a lower cost

-        Criteria 5: Product(s) are appropriate for low resource settings

-        Criteria 6: Product(s) are developed to best meet health needs based on North-South collaboration

-        Indicator 6a: The organization is a north-south collaboration

-        Indicator 6b: Where does the organization have offices?

-        Indicator 6c: % of work that is done with involvement of/partners from global south

Metric: Scope of initiative includes more than one alternative financing mechanism

-        Criteria 7: Initiative includes mechanisms that finance research (push)

-        Criteria 8: Initiative includes mechanisms that provide appropriate incentives for the development of new drugs (pull)

-        Criteria 9: Initiative includes mechanisms to pool funds for biomedical R&D (pooling)

Metric: The initiative’s scale, replicability and sustainability

-        Criteria 10: Initiative has been / is applied across therapeutic categories

-        10a: Initiative develops multiple types of health technologies

-        10b: Initiative works across multiple diseases

-        10c: Initiative has incorporated new technologies/diseases since its inception

-        Criteria 11: Is the funding for the initiative sustainable and can it be expanded?

-        11a: Does the initiative depend on external funding to function (or is it self sustaining)

-        11b: What are the administration costs associated with the initiative?

-        11c: Can the initiative be upscaled/can the scale be adjusted? (perhaps indicated by past expansion of initiative)?

-        11d: Has funding remained constant, decreased or increased over the past three years?

-        Criteria 12: Initiative has a business plan that works to ensure access and innovation and sustainability

-        12a: Does the initiative publicly share its business plan and/or strategy?

-        12b: Is the initiative’s business plan forward looking?

-        Clear goals for next five years and funding plans (Ex: DNDi’s goal to develop X technologies by X year)

-        12c: Has the initiative achieved its plans in the past three years, or those set out in its last plan, whichever was most recent?

3.     OPEN: Promotes open collaboration and data sharing between researchers

Metric: Access to research outputs

-        Criteria 1: Open access publication

-        Indicator 1a: % of publication output that is open access

-        Indicator 1b: Participation in data pooling

Metric: Publicly available data

-        Criteria 2: Access to clinical trial data

-        Indicator 2a: % of clinical trials that have publicly available data

Metric: Collaboration

-        Criteria 3: Initiative incorporates collaboration with other academic, government, civil society, or private organizations and institutions

-        Indicator 3a: The initiative is collaborative

-        0: No

-        1: Yes

-        Indicator 3b: % of research that is a joint effort with others

-        From alternative R&D

-        From pharma

-        From universities

-        From government

Metric: Transparency

-        Criteria 4: Research inputs and outputs

-        Indicator 4a: Full disclosure of both public and private funding of R&D

-        Indicator 4b: Full disclosure of R&D investments and other financials

Metric: Conflicts of Interest

-        Criteria 5: Is the initiative free from conflicts of interest/has the initiative incorporated some form of policy on undue influence on decision making?

References

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