Abstract

In the event of the current COVID-19 pandemic and in preparation for future pandemics, open science can support mission-oriented research and development, as well as commercialization. Open science shares skills and resources across sectors; avoids duplication and provides the basis for rapid and effective validation due to full transparency. It is a strategy that can adjust quickly to reflect changing incentives and priorities, because it does not rely on any one actor or sector. While eschewing patents, it can ensure high-quality drugs, low pricing, and access through existing regulatory mechanisms. Open science practices and partnerships decrease transaction costs, increase diversity of actors, reduce overall costs, open new, higher-risk/higher-impact approaches to research, and provide entrepreneurs freedom to operate and freedom to innovate. We argue that it is time to re-open science, not only in its now restricted arena of fundamental research, but throughout clinical translation. Our model and attendant recommendations map onto a strategy to accelerate discovery of novel broad-spectrum anti-viral drugs and clinical trials of those drugs, from first-in-human safety-focused trials to late stage trials for efficacy. The goal is to ensure low-cost and rapid access, globally, and to ensure that Canadians do not pay a premium for drugs developed from Canadian science.

Highlights

  • The mission of DNDi is to develop safe, effective and affordable new treatments for patients suffering from neglected diseases, and to ensure equitable access to these

  • The DNDi intellectual property (IP) policy will be guided by the following principles as laid down in the business plan:

  • The DNDi IP approach will be pragmatic, and decisions regarding the possible acquisition of patents, ownership and licensing terms will be made on a case by case basis

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Summary

Intellectual Property and DNDi’s Work

In implementing the IP strategy, DNDi will adhere to the following basic principles:. DNDi does not seek to finance its research and operations through IP rent revenues They will constitute an exception rather than the rule, patents might be sought to strengthen DNDi’s ability to ensure control of the development process and to negotiate with partners. When IP is generated through DNDi-sponsored research projects, it should be used to achieve DNDi’s mission To this end, DNDi will pursue creative and innovative strategies to make the fruits of research projects readily available to patients affected by neglected diseases. DNDi will pursue creative and innovative strategies to make the fruits of research projects readily available to patients affected by neglected diseases This will require avoiding prohibitively costly approaches, restrictive IP strategies, or other issues that may inhibit or delay the rapid adoption of the invention to the benefit of developing countries

Rationale for Acquiring or Otherwise Dealing with Intellectual Property
Transfer and Licensing of Intellectual Property
VIII. Amendments and Changes to the Policy
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