Categories and Definitions Incentives
At launch the aim of the presented information in the Dynamic Dashboard's Incentive Gallery is on capturing, displaying and tracking incentives, worldwide, with the potential to improve the functioning of markets – and the broader R&D ecosystem – responsible for the development and distribution of therapeutics for the treatment of priority, human, bacterial infections.
The exclusion criteria are to ensure – in the absence of output or impact data – the focus of our incentive capture remains on those activities with the potential to have more than a narrow, local or transient impact. We will work towards fostering a long-term, sustainable, R&D ecosystem.
The scope and definitions provided below represent this initial focus.
Categories have been developed, that represent targets for incentives or incentive strategies, along the value-chain from discovery to consumption.
TABLE OF CONTENTS
1. Incentives in Scope
Any currently implemented or trialed activity with the potential to improve the functioning (efficiency, productivity) of the R&D ecosystem responsible for the development and distribution of therapeutics for the treatment of priority, human, bacterial infections.
The activities could include but are not limited to:
- Direct financial support, through a dedicated or majority-focused financing tool/stream
- Dedicated initiatives, organizations, networks or activities with an AMR product R&D relevant mandate (in part or full)
- Legislative or regulatory actions that have been ratified into law
2. Supporting Definitions
Push incentive (covers categories 01-04):
Input-based; push mechanisms target current work and reduce a developers cost & risk of researching and developing new drugs either by lowering the costs, decreasing the barriers to participation or by sharing the costs/risks across multiple parties.
Pull incentive (covers categories 05-09):
Output-based; rewarding the successful development of a drug by increasing or ensuring future revenue. Can be achieved through market-making (financial) tools or market-shaping (lego-regulatory policies) rewards.
Public and private product developers including the R&D context or facilitatory environment in which they conduct their work. Includes actors, collaborations, infrastructures, lego-regulatory frameworks, institutions and competencies.
Human bacterial infections considered a current or emerging public health priority as defined by the WHO´s priority pathogen list.
3. Exclusion Criteria
Information will not be collected for incentives on:
- Policy proposals, discussions, draft legislation or legislation in development/revision
- Single or ad hoc financial awards that do not present the possibility for a sustained impact
- Activities that are very-narrow in their focus such as those targeting a specific/single indication, syndrome, product or trial
- Non-dedicated or majority-earmarked activities (for investments these are captured by our investment gallery)
- One-off or time-limited interventions (less than 5 years)
- Tax-based incentives
- Interventions specifically targeting the tuberculosis (TB) market
- Interventions targeting non-human or non-therapeutic product markets
- Sub-national (state-level) interventions
Our launch categories have been created to represent targets, or strategies, for incentives along the value-chain. As much as possible, these try to be mutually exclusive and encompass all incentives that may conceivably be implemented now and in the future. As with all taxonomies categorization can sometimes be an artificial exercise that will fit some incentives better than others.
1. Support for early-stage R&D
Supporting research, development and translation relating to discovery, preclinical research and Phase I clinical trials.
2. Enhancing clinical trial conduct
Improving clinical trial conduct and infrastructure, across products, to enhance efficiency, exploit synergies, reduce duplication and more readily generate better data.
3. Support for late-stage R&D
Financing and otherwise supporting the conduct of advanced registration trials (Phase II and III) through to product filing.
4. Streamlining regulatory requirements
The clarification and convergence of requirements across indications and medicine regulators which acknowledge the specific challenges of generating data for licensure and decrease the time and expense for products to reach patients.
5. Earlier & broader uptake
Maximizing the use of all available data about a product, support for new data-generation & optimizing data utilization so patients may benefit from newer agents more rapidly. Includes mechanisms to cushion smaller developers through this period.
6. Improving continuity of supply
Captures system, regulatory & market-making measures with the objective of fostering a sustainable & predictable market for older efficacious antibiotics particularly for those products where there are few or no alternatives.
7. Enhancing relative market attractiveness
Regulatory, system & financial levers, implemented nationally, trans-nationally or globally (a nod to the global nature of markets) – which improve the attractiveness of the market relative to other therapeutic areas & within the class.
8. Expediting sustainable global patient access
Measures to improve the speed of physical access & affordability to patients globally while ensuring that stewardship principles are adhered to.
9. Governance & priority signaling
Steps taken to orient the R&D ecosystem towards the development & preservation of antibiotics – a global public good. Including, but not limited to, the signaling of priority societal needs to developers & meaningful oversight of the system.