ReRouting biomedical innovation: observations from a mapping of the alternative research and development (R&D) landscape

Abstract

In recent years, the world has witnessed the tragic outcomes of multiple global health crises. From Ebola to high prices to antibiotic resistance, these events highlight the fundamental constraints of the current biomedical research and development (R&D) system in responding to patient needs globally.To mitigate this lack of responsiveness, over 100 self-identified “alternative” R&D initiatives, have emerged in the past 15 years. To begin to make sense of this panoply of initiatives working to overcome the constraints of the current system, UAEM began an extensive, though not comprehensive, mapping of the alternative biomedical R&D landscape. We developed a two phase approach: (1) an investigation, via the RE:Route Mapping, of both existing and proposed initiatives that claim to offer an alternative approach to R&D, and (2) evaluation of those initiatives to determine which are in fact achieving increased access to and innovation in medicines. Through phase 1, the RE:Route Mapping, we examined 81 initiatives that claim to redress the inequity perpetuated by the current system via one of five commonly recognized mechanisms necessary for truly alternative R&D.Preliminary analysis of phase 1 provides the following conclusions:No initiative presents a completely alternative model of biomedical R&D.The majority of initiatives focus on developing incentives for drug discovery.The majority of initiatives focus on rare diseases or diseases of the poor and marginalized.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.There is a trend towards public funding and launching of initiatives by the Global South.Given the RE:Route Mapping’s inevitable limitations and the assumptions made in its methodology, it is not intended to be the final word on a constantly evolving and complex field; however, its findings are significant. The Mapping’s value lies in its timely and unique insight into the importance of ongoing efforts to develop a new global framework for biomedical R&D. As we progress to phase 2, an evaluation tool for initiatives focused on identifying which approaches have truly achieved increased innovation and access for patients, we aim to demonstrate that there are a handful of initiatives which represent some, but not all, of the building blocks for a new approach to R&D.Through this mapping and our forthcoming evaluation, UAEM aims to initiate an evidence-based conversation around a truly alternative biomedical R&D model that serves people rather than profits.

Crossroad of intellectual property rights of technology innovators and human rights: a systematic literature review

“…It is the HR obligation of developed countries to ensure smooth access to medicines in developing economies (Khachigian, 2020). The more prosperous countries are urged to adopt a rights-based approach in carrying out biomedical research (Greenberg and Kiddell-Monroe, 2016) and develop a “sending culture” of technologies, resources and competencies to less prosperous countries (Bozorgmehr et al , 2014; Thompson, 2010). However, this approach will deliver expected outcomes only when the productive sector is ready for high knowledge absorption and capabilities generation to turn the knowledge into innovation (da Veiga and Martins, 2015).…”

Pragmatic Progress and the Improvement of Medical Knowledge for Global Health

“…In sum, strategies to restructure medical research in order to prioritize public health problems instead of prioritizing commercial interests exist and have been implemented in different ways (for a survey of alternatives to biomedical R&D, see Kiddell-Monroe et al, 2016;Greenberg and Kiddell-Monroe 2016). Some strategies, such as DNDi, reject the commercial development of medical treatments and instead support a non-for-profit patient-centered framework.…”

“…More recently, a number of alternative approaches to pharmaceutical research and development (R&D) have emerged, especially in areas of market failure, such as research on neglected tropical diseases (NTDs), establishing public-private partnerships and new communities of collaboration (Lezaun and Montgomery, 2015). Many have argued for a 'delinkage' of the price of medicines, and thus market profitability, from the financial investment in R&D; and different financing mechanisms (such as the so called 'pushing' and 'pulling' strategies) have been proposed and implemented with this goal in mind (Greenberg and Kiddell-Monroe, 2016;Suleman et al, 2020). But are these 'delinking' mechanisms good enough to solve the crisis in medical knowledge today?…”

Antimicrobial Resistance: Identifying the Major Conflicts of Interest and Way Forward

“…Innovation, access and empowerment have become the three pillars for Universities Allied for Essential Medicines 91 responsible for several positive changes in the area of access to essential medicines, [92][93][94] including antibiotics. 95 Young professionals are driving this process, while gathering evidence and increasing their outreach in the form of publications [96][97][98][99] as well, to coordinate focussed activities on essential medicines. While literature surrounding adult leadership focusses on "issues of authority (voice, influence and decision-making power)", youth leadership tends to focus on "issues of ability (skills, knowledge and talents)".…”