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1.Data Access Policy
- Aim of Data Access Policy
- The aim of our Data Access Policy is to articulate the principles that promote the transparency of and accessibility to data related to the safety and efficacy of healthcare technologies.
- Scope of Data Access Policy
- This policy and its principles apply to data generated through activities primarily invested by the GHIT Fund, including but not limited to, those related to the discovery, development, and/or delivery of healthcare technologies.
- Principle of Data Access Policy
- Transparency & DisclosureAll 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 will be disclosed in a broad and prompt manner in order to optimize prospects for the translation of findings in the global advancement of new healthcare technologies. 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 & ConfidentialityRespect 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 as they pertain to 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 DataAny and 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 or intellectual property, will remain that of the original holder. The original holder may share, assign, or license their rights to a third party.
- New DataOwnership of any and all data and findings that is obtained or created through activities invested by the GHIT Fund and that can be applied for any intellectual property rights will be discussed and negotiated between participants and/or product development partners of a project. All final agreements shall be in alignment with the licensing and pricing principles outlined below.
- Patent Applications Any existing data owned by a product development partner and/or any new data obtained through activities invested by the GHIT Fund may be disclosed by the GHIT Fund to a third party if such data is used in a patent application for a product which was derived from the activities invested by the GHIT Fund; provided, however: (1) that the disclosure of such data shall be limited to the proposed title of the invention, a draft of the abstract, the international non-proprietary name (INN) where applicable, and an outline of the specifications of such patent application; and (2) such third party shall take reasonable measures to keep confidential any such data received from the GHIT Fund.
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 the GHIT Fund.
- Scope of Product Access Policy
- This policy applies to products primarily funded by the GHIT Fund, where such products refer to healthcare technologies approved for market by a national regulatory authority.
- Principle of Product Access Policy
- LicensesWhen product development partners and/or participants are successfully granted a patent deriving from projects invested by the GHIT Fund, product development partners and/or participants will grant royalty-free licenses to users operating in Least Developed Countries (LDCs) as categorized by the United Nations classification and Low-Income Countries (LICs) categorized by the World Bank classification. License-related matters concerning middle income countries will be reviewed on an individual basis with the goal of ensuring reasonable royalty licenses.
- PricingIn LDCs, LICs and middle income countries, product development partners and/or participants will set prices for products on the basis of a no gains/no loss policy that can improve access to the product for patients and citizens of LDCs, LICs and middle income countries.