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General Scope of GHIT Access Policy*1
- The GHIT Access Policy provides guidance to GHIT grantees on the access expectations and requirements that ensure that GHIT's objectives of providing equitable and affordable access are met. Because GHIT grants cover multiple diseases and multiple technologies in different phases of development, the Access Policy is intentionally high level, with the understanding that the specific expectations and requirements for each product and contract will be addressed in further detail in each specific Investment Agreement (IA). For clarity, the Investment Agreement will be separately negotiated and entered into between GHIT and the applicable grantees, and such agreement may be amended from time to time by GHIT and such partners.
- The aim of the GHIT Access Policy is to:
- - Strengthen the link between R&D, access and delivery, and health system strengthening to create a seamless end-to-end R&D ecosystem.
- - Outline the GHIT approach to ensuring that GHIT-funded products are accessible to those who need them the most in line with public health access norms and principles.
- - Establish the GHIT Access and Delivery Strategy and align with global health stakeholders to facilitate access to and delivery of essential health technologies and increase the public health impact of GHIT's activities.
GHIT works closely with grantee product developers to ensure that access considerations (including
regulatory pathways, manufacturing considerations, financing strategies, market dynamics and pricing
strategies) are imbedded in their plans, particularly for late-stage products. GHIT requires
grantees to agree to specific access commitments, access targets and milestones that are appropriate
for the technology and intended beneficiaries, ensuring that any contractual obligations fairly
reward the grantee as well as optimize access and affordability for the beneficiaries.
The GHIT Access Policy focuses primarily on data access and product access and the linkage and interaction between the two. It reflects GHIT's maturing product development pipeline and is meant to ensure that GHIT-funded products reach and have an impact on the intended beneficiaries.
- ※1 Data Access Policy and Product Access Policy
1.Data Access Policy
- Aim of Data Access Policy
- The aim of the Data Access Policy is to articulate the principles that promote the transparency of and accessibility to data resulting from the research and development of healthcare technologies funded by GHIT.
- Scope of Data Access Policy
- This policy and its principles apply to data generated through activities primarily funded by GHIT, including but not limited to, those related to the discovery, development, and/or delivery of healthcare technologies.
- Principle of Data Access Policy
Transparency, Disclosure & Data Sharing
All data and its processes for access will be transparent and clearly defined with the aim to ensure
data quality, security, and equitable access. All data and findings generated through activities
[primarily] funded by GHIT will be disclosed, shared, or published to a reasonable extent in a broad
and prompt manner, using unrestricted, open access platforms, to optimize prospects for the
translation of findings in the global advancement of new healthcare technologies. All such data and
findings shared should be compliant with all applicable local laws, regulations, and codes of
practice, and consistent with the
Product development partners should utilize public-access repositories and, if unavailable, should use alternatives for access that can ensure the transmission of new scientific findings to the larger research and development community globally.
- Respect & Confidentiality RRespect must be given to individuals and communities from or about whom data are collected. Respect must also be given to all matters of confidentiality and attribution. In furtherance of the foregoing, any data shared or published should be anonymized and all efforts made to ensure that such data does not contain any identification characteristics as they pertain to patients, researchers, evaluators, and their collaborators. Confidentiality and respect for such should be fully recognized where necessary or required by law or regulation.
- Conditions of Data Access Policy
- Existing Data All existing data and findings owned by a product development partner at the initiation of a project, including but not limited to information, know-how, technology or background intellectual property (IP), will remain that of the original holder. Such pre-existing data and findings should be clearly identified and disclosed by such product development partner, at the time of signing of the Investment Agreement, to clearly distinguish such data and findings from the new data and findings generated with GHIT funding. The product development partner (as the original holder) may share, assign, or license their rights to any such pre-existing data and findings to a third party.
- New Data Ownership of all new data and findings that are obtained or created through activities [primarily] funded by GHIT and that can be applied for any intellectual property rights, including but not limited to information, know-how, technology or foreground intellectual property (IP), will be discussed and negotiated between GHIT and/or product development partners of a project. Such product development partners shall report strategies and/or plans on management of all such data and findings, including details about anticipated patent applications or applications to register for other IP right protections (including copyright registrations), and management of data sharing and material/technology transfers. This applies to data and findings obtained from both fully and partially funded GHIT investments. The strategies/plans shall be in alignment with the principles of this Data Access Policy.
- Intellectual Property (IP) Rights GHIT supports the use of IP rights as an incentive for innovation and advocates for the use of IP rights to promote equitable and affordable access as set forth in the GHIT founding principles. Any existing data and other data included in issued patents owned by a product development partner, and/or any new data obtained through activities [primarily] funded by GHIT, may be disclosed by GHIT to a third party if such data is used in a patent application for a product which was derived from the activities [primarily] funded by the GHIT [in agreement with the grantee].
2.Product Access Policy
- Aim of Product Access Policy
- The aim of the Product Access Policy is to articulate the principles that improve access to products developed with funding from GHIT.
- Scope of Product Access Policy
- This policy applies to the products funded (partially or fully) by GHIT, where such products refer to healthcare technologies approved for market by a Stringent Regulatory Authority (SRA), WHO-Listed Authority (WLA) or a national regulatory authority (NRA) and/or Pre-qualified (PQ) or endorsed by the WHO.
- Principle of Product Access Policy
When product development partners are successfully granted a patent deriving from projects funded
(in part or in full) by GHIT, such product development partners shall use the patents to facilitate
equitable access, including through voluntary licensing with a broad geographical scope,
royalty-free licenses and/or
, to users in Least Developed Countries (LDCs) as categorized by the United Nations classification
and Low-Income Countries (LICs) and Lower-Middle Income Countries (LMICs) categorized by the World
Bank classification. License-related matters concerning middle income countries will be reviewed and
discussed with GHIT on an individual basis with the goal of ensuring access, equity, and affordable
At the time of signing the Investment Agreement, grantees (including product development partners) shall disclose any pre-existing IP and plans to patent products using evidence generated from activities funded by GHIT. GHIT and such grantees shall agree on how such pre-existing IP will/can be used to facilitate access to GHIT-funded (partially or fully) products.
GHIT grantees shall be transparent in how prices for GHIT-funded products are set in relation to the
TPPs and the
WHO pricing policy guidelines
. In addition, GHT grantees shall take into consideration
the R&D and manufacturing costs of the technology and set prices that would not have a damaging
impact upon the viability and sustainability of their product in the market and would not damage the
prospect of the product being acquired, obtaining further investment, or entering into other forms
GHIT advocates for a fair pricing model which ensures that the innovator or product developer has no loss and allows a reasonable margin of gain, while also giving the end user the ability to pay. Product developers shall set affordable prices for products based on a “no gains/no loss” policy that allows for a reasonable margin of profit but also ensures affordability of the products for the intended communities, specifically in LICs and LMICs. As used herein, “affordable price” means the lowest sustainable, competitive price for the product which covers the cost of raw materials, manufacturing, distribution, and operational overhead, and includes a reasonable margin to help ensure the economic sustainability of the R&D, production and distribution of the product. “Reasonable profit margin” shall be determined through negotiations between the product developers and partners designated/recommended by GHIT to support price negotiations.
Grantees shall articulate how they will ensure that the prices for GHIT-funded products take into consideration the socio-economic status of and affordability to the intended beneficiaries and explore/consider any mitigation strategies to lower such pricing in LICs and LMICs. Such strategies include, for example: at-cost or at cost-plus pricing, out-licensing, technology transfer to third parties, differential pricing, discounts based on volume guarantees or advance purchase mechanisms, volume-based price reductions, etc.