This issue refers to provisions aimed at ensuring access to products for the populations that need them the most. As demonstrated by the global inequities in access to vaccines, therapeutics and diagnostics during the COVID-19 pandemic it is important to include terms in agreements that require product developers and manufacturers to make timely supply commitments that extend beyond high income countries.

The “Territory” to which a product must be supplied can be defined in a number of ways. For example, in addition to listing specific countries, a Territory could make distinctions between public and private sector purchasers within a country.

An important detail to consider in order to ensure that a product can be made available in the intended territory is the regulatory pathway that must be followed to obtain approval for use of the product. Historically, medical products have often received approval for use in high income markets (e.g. from the FDA for the U.S. or EMA for the European Union) long before reaching lower income markets. Agreement terms that require timely engagement with local regulatory authorities can help to accelerate global access to the product.

Questions to consider when developing a territory access commitments provision

• How should ‘territory’ be defined under the agreement? Should the definition make a distinction between different types of purchaser (e.g. public sector vs. private sector)?
• Should the developer be required to apply for regulatory approval in priority access markets?
• Should the developer be required to commit a proportion of the product manufactured to a certain country or purchasing organization?
• Should the developer be required to identify a third party that could fulfill supply requirements for the access territories in the event that the developer does not?
• Should the agreement include any anti-diversion provisions?

Example approaches found in the MAPGuide

• How should ‘territory’ be defined under the agreement? Should the definition make a distinction between different types of purchaser (e.g. public sector vs. private sector)?
  • Some agreements in the MAPGuide allow the product developer to choose whether they will sell a product in a part of a territory (e.g. to certain developing countries). If the developer does not elect to sell in these markets, then the funder retains a license to make selects in those countries itself.
  • Some agreements in the MAPGuide make a distinction between sales to public and private sector purchasers in certain countries. The organizations included in the definition of “public sector” can vary between agreements, but they often include government ministries, intergovernmental organizations (e.g. WHO), and non-profit organizations.
  • In some cases, the definition of Territory is different depending on the field (i.e. disease) for which the product will be used.
  • Some agreements define “Developing” or “Access” countries as the regions to be supplied. These are identified using sources such as the World Bank list of low- and middle-income countries or the countries eligible for GAVI support.
  • Another approach used by some agreements in the MAPGuide is to define “Affected Territories” which are those where an Outbreak has occurred or is at risk of occurring. 

• Should the developer be required to apply for regulatory approval in priority access markets?
  • Some agreements state that the developer must make and maintain an Investigational New Drug (“IND”) application or Clinical Trial Application (“CTA”) with both a major regulatory authority (for example see the WHO’s list of Stringent Regulatory Authorities) and a local regulatory authority in territories to be supplied under the agreement.

• Should the developer be required to commit a proportion of the product manufactured to a certain country or purchasing organization?
  • Agreements in the MAPGuide that make a distinction between public and private sector purchasers require the developer to make reasonable efforts to fulfill public sector purchase orders within the required timeframe.
  • Reasonable efforts to make a product available can include adequate manufacturing capacity, adequate supply of product meeting specifications, registration of a product with applicable local and global health authorities, participation in local tenders and making available to local policy makers information regarding the product.
  • Some agreements place an obligation on the funder to provide a rolling forecast for provides to be supplied to access countries, which must be fulfilled by the developer. There may be restrictions on the proportion of manufacturing capacity that can be used by the funder.
  • Another approach taken in provisions found in the MAPGuide is that the developer must supply a certain percentage of the doses manufactured for a certain number of years after scale-up of manufacturing under the direction of the funder.
  • Some funding agreements require a developer to enter into a supply agreement with a global body responsible for the allocation and distribution of vaccines (e.g. GAVI or COVAX). These provisions may further specify that the developer cannot allocate doses to other parties in a way that would conflict with equitable access obligations under the agreement.
  • During the COVID-19 pandemic, some global health funders entered into material reservation agreements that secured a supply of vaccine manufacturing inputs for the product developers that they funded. The terms of these agreements allow the funder to direct the supply of the materials for use by developers manufacturing vaccines to be supplied to COVAX.
  • Some licensing agreements which are for the purpose only of supplying products to low- and middle-income countries, do not require specific manufacturing volumes but do have rights for termination if the licensee does not make sufficient efforts to promote access in the relevant countries. In making this assessment, the licensor may take into account factors such as the period within which the relevant authorities provide the necessary approvals and normal development lead time for the Products, and progress reported by Licensee in its quarterly reports and meetings.
  • Some licensing agreements go beyond a general requirement to ‘promote access’ and require certain minimum supply commitments to be met

• Should the developer be required to identify and transfer technology to a third party that could fulfill supply requirements for the access territories in the event that the developer does not?
  • Some funding agreements in the MAPGuide require the product developer to appoint a third party that would be willing and able to fulfill demand for the product (sometimes referred to as a “Trusted Collaborator” or “Trusted Manufacturer“). The product developer must provide intellectual property rights, conduct a technology transfer and provide other reasonable assistance to the third party.
  • Some funding agreements also specify that the third party will be from a low- or middle-income country or ‘geographically dispersed’.

• Should the agreement include any anti-diversion provisions?
  • Anti-diversion provisions are found in some MAPGuide agreements which involve funding or license rights for the development and commercialization of affordable products for specific markets. These provisions can be used as a way of ensuring that a product manufactured and priced for supply to a lower income market is not made available for sale in high income countries.