MAPGuideⓇ: Key Issues

Key Issues for Global Health Agreements: an Introduction

Our analysis in the MAPGuideⓇ Provision Database is organized into “issues” which are key areas of consideration for rapidly developing and negotiating global health agreements with the aim of enabling increased global access to healthcare products.

Business Model

This issue refers to provisions that address the right of funders and partners to require allocation of revenues or other commercial benefits arising from development of a funded product. Read more

This issue identifies provisions that describe the responsibilities and decision-making authorities of parties to an agreement, as well as dispute resolution procedures. Read more.

This issue refers to provisions setting out the payment structure for an agreement. Read more

This issue refers to provisions that address supply volume and timeline commitments, as well as remedies available if those commitments are not met. Read more

This issue focuses on provisions that define who is responsible for making applications for regulatory approvals, as well as how the agreement parties will share information and provide assistance related to the regulatory process. Read more.

Equitable Access

This issue is used to identify provisions that acknowledge the equitable access objectives of a project. Read more

This issue refers to provisions requiring product developers to ensure affordable pricing for certain markets. Read more

This issue is used to identify provisions that address the right of a purchaser of a global health product, particularly in pandemic times, to make donations of that product to other countries or regions. Read more

This issue refers to provisions that enable funders to assume or reassign the development and/or commercialization of funded products in the event of actual or anticipated failure by a developer to perform in a manner consistent with the agreement. Read more

This issue refers to provisions that establish actions to be taken by the agreement parties in order to respond, or be ready to respond, in the event of a disease outbreak or pandemic. Read more

This issue refers to provisions that require product developers to apply for regulatory approval and make the approved product available in certain markets. Read more

Protecting & Sharing Information

This issue is used to identify examples of provisions setting out the scope and protection of confidential information, as well as rights to disclose information related to an agreement in public announcements. Read more

This issue is used to identify requirements for the reporting of project-related data and information between the parties to an agreement. Read more

This issue identifies agreement provisions that set out the rights and obligations of agreement parties to make project data and results publicly available. Read more

This issue is used for provisions related to the transfer of technology and/or materials between organizations. Materials can include a number of tangible items whereas technology transfer generally refers to the provision of a broader set of data, materials, documentation, know-how and other assistance needed to manufacture a product. Read more

Term & Termination

This issue identifies provisions setting out actions to be taken upon termination of an agreement. Read more

This issue is used to identify the different ways in which the term of an agreement may be determined or extended.  Read more

This issue identifies provisions that illustrate the range of conditions that may trigger termination of, or withdrawal from, an agreement. Read more

Intellectual Property

This issue identifies how agreement provisions address the ownership of intellectual property related to the activities under an agreement. Read more

This issue refers to rights granted from one party to another to their intellectual property (IP) in connection with the development, manufacture or sale of a product. Read more

This issue refers to the rights and obligations of parties to an agreement to file for and maintain patents for the background and foreground IP related to a project. Read more

Liability

This issue is used to identify provisions related to the acceptance of, and protection from, liabilities arising in relation to an agreement. Read more

This issue is used to identify provisions that require organizations to obtain insurance against losses or damages related to an agreement. Read more

This issue is used to identify provisions in which parties to an agreement make assurances or guarantees that certain statements of fact are true. Read more