Equitable Access Glossary
This glossary includes key terminology used for the development, negotiation, and implementation of policies and agreements that aim to support equitable access to medical products. It is designed to be used by, and facilitate common understandings between, a variety of stakeholders including legal practitioners, business development professionals, policymakers, funders, researchers, and access advocates across academic, industry, non-profit, and public sector organizations.
Scope and Limitations
The glossary includes terms that are commonly used in the policy documents and agreement provisions that are accessible through GHIAA’s MAPGuideⓇ platform. It focuses on terms that have specific relevance to facilitating equitable access to medical products and is not intended as a comprehensive list of all technical, legal, scientific, medical, and/or financial definitions that may be relevant to the development, manufacturing, and commercialization of a medical product.
The purpose of this resource is to provide explanations of frequently used terms to enable readers to understand how and when those terms might be used. Some explanations have been developed based on the GHIAA team’s knowledge and experience, while others have been quoted from relevant sources.
Some of the terms included in the glossary are frequently defined in equitable access-related agreements, and others are used in policy documents or in related discussions. In the case of terms that are often defined in agreements we have provided one or more examples from the MAPGuide® provision database. These examples are intended to illustrate the range of approaches that have been taken to defining a particular term, particularly where we noted variations in definitions during our review process. The examples are not exhaustive nor does the order in which they are listed indicate any order of preference or prevalence.
The explanations and definitions in this glossary are provided as they are commonly used in the context of supporting equitable access to medical products. These may be defined differently in different contexts or in standard dictionary or legal definitions.
The terms Access, Equitable Access and Global Access generally refer to the availability, acceptability, affordability, and accessibility of appropriate medical products. Global health funders and product development partnerships often have Equitable or Global Access policies; links to a number of these are available on GHIAA’s Equitable Access Policies page. Both organizational access policies and agreement provisions may use definitions of access that are specific to the organizational or agreement context. Some agreements also define Global Access Objectives.
Some examples of agreement definitions from the MAPGuideⓇ provision database are:
Alternative One: A Project Vaccine is available first to populations at risk when and where they are needed at affordable prices. (CEPI – Novavax, COVID-19 Vaccine Funding Agreement, §14.1).
Alternative Two: Equitable Access to epidemic vaccines in the context of an Outbreak means that appropriate vaccines are first available to populations when and where they are needed to end an Outbreak or curtail an epidemic, regardless of ability to pay. (CEPI CfP3i Vaccine Funding Agreement Template, §14.1).
Alternative One: (a) knowledge gained using the Foundation’s funding is promptly and broadly disseminated and (b) the products and technologies developed or supported with the Foundation’s funding will be made available and accessible at an affordable price to people most in need in Developing Countries. (Bill & Melinda Gates Foundation – Arsanis, S. Aureus Antibody Strategic Relationship Letter Agreement, §1).
Alternative Two: The principles according to which diagnostic products shall be available, affordable, and appropriate for use in the territory, as further set forth in FIND’s Global Access Policy available at http://www.finddx.org/policies, as amended from time to time. (FIND Sample Funding Terms and Conditions, §1).
Global Access Objectives
Alternative One: The objectives to provide funding to support the development of drugs and vaccines to address diseases that have a disproportionate impact on people within developing countries, and to ensure that such products can be made available and accessible at reasonable cost and with all due speed to people within developing countries. (Gates Foundation – Visterra, Strategic Relationship Letter Agreement, §1).
Alternative Two: The objectives (a) to improve the processes and technologies for the development, manufacture and delivery of Products for use in the Field, with the aim of making them more available and more accessible in terms of cost, quantity and quality to people most in need in the Developing Countries; and (b) to ensure that information and data resulting from activities under the Project are promptly and broadly disseminated – without jeopardizing intellectual property protection – to the relevant scientific and educational communities. (Academic Institution – Company, Research Collaboration Agreement, §1.13).
Advance Market Commitments aim to incentivize research and development for medical products where traditional market incentives fail, for example, due to lack of demand in commercial markets or other market uncertainties. Product developers receive an incentive in the form of purchase volume and/or price guarantees provided that a product receives marketing authorization. In return, the developers commit to making a product available at an affordable price in lower-income markets (World Bank, Financial Intermediary Funds, Advance Market Commitments, accessed April 25, 2023).
AMCs are usually made by procurement agencies or national governments. Examples include the pilot AMC for pneumococcal vaccines, and the COVAX AMC for COVID-19 vaccines. An AMC is an example of a pull incentive and of a market shaping strategy.
Advance Purchase Agreements aim to incentivize product developers to develop and scale up manufacturing for products which have yet to receive marketing authorization. The developer receives an upfront investment to support development and manufacturing scale-up, and the purchaser (usually a national government or a procurement agency), receives a guarantee that it will receive an agreed volume of doses of an approved product in exchange for its investment and potentially an agreed per unit price. These agreements were a common mechanism for the purchase of COVID-19 vaccines, particularly bilateral agreements between national governments and a vaccine developer.
Examples of COVID-19 advance purchase agreements are available in the MAPGuideⓇ provision database.
The concept of an Affordable Price can encompass a low price, but also one that is sustainable for the product manufacturer. The term is not always defined in agreements, even if there are affordable pricing provisions. Mechanisms for achieving an Affordable Price include a maximum or not-to-exceed price for certain geographies and/or purchasers, tiered pricing and tiered royalties.
Some example definitions from the MAPGuideⓇ provision database are:
Pricing a Product at the lowest sustainable level which may include only: a) full production costs, as optimised without compromising the quality of the Product; and b) direct distribution costs, and c) a reasonable margin, not to exceed [x] percent of the foregoing costs, for the selling Party. (DNDi Template Development Collaboration and License Agreement, §1.3).
The maximum price at which a Final Product may be offered for sale in the Territory, reflective of the lowest, sustainable, competitive price level for a Final Product, to be agreed upon between [the parties]. (University of Washington – MPP, Long-acting Injectable HIV Treatment License Agreement, §1.1).
The lowest sustainable, competitive price for the Product(s) which covers the cost of raw materials, manufacturing, distribution and operational overheads, and includes a reasonable margin to help ensure the economic sustainability of the production and distribution of the Product(s). (Pfizer – MPP, Sutezolid License Agreement, §3.3).
See Regulatory Authority.
The terms Background, Background Intellectual Property (“Background IP”), and Background Technology generally refer to data, know-how, technology, inventions, intellectual property rights and other similar information that has been created by an organization prior to entering into an agreement. Agreement definitions for these terms are usually restricted to information that is necessary for the performance of the agreement. In some cases, the agreement definitions also include information that is generated during the same period as, but independently from, the performance of the agreement (this is also known as sideground).
Some example definitions from the MAPGuideⓇ provision database are:
Alternative 1: information, including data and know-how which is held by participants prior to the accession to this agreement, as well as copyrights or other intellectual and industrial property rights pertaining to such information, and which is necessary for carrying out the project and identified in the project agreement. (IMI 1 JU Model Grant Agreement, §II.1).
Alternative 2: any data, know-how or information – whatever its form or nature (tangible or intangible), including any rights such as intellectual property rights – that: (a) is held by the beneficiaries before they acceded to the Agreement, and (b) is needed to implement the action or exploit the results. (IMI 2 Model Grant Agreement, §24.1).
Any Intellectual Property owned or controlled by a party at the Effective Date or which a party develops or acquires independently of the work under the Project, in each case, which is necessary or useful for undertaking any Work Phase, or the protection or exploitation of Foreground Intellectual Property. (Funder Development Partnering Agreement, §1.1.6).
Any and all products, services, processes, technologies, materials, software, data, or other innovations, and intellectual property created by [developer] or a third party prior to or outside of the Project used as part of the Project. (Gates Foundation Sample Grant Terms & Conditions, as well as a number of actual Foundation grant agreements).
Bayh-Dole Act is the term commonly used to refer to the U.S. federal Patents and Trademark Law Amendments Act, Pub. L. No. 96-517, 35 U.S.C. §§ 200-212. The legislation was designed to incentivize private sector development and commercialization of government funded inventions by allowing the funding recipients to retain title to, and file patents for, inventions developed with government support. The legislation also provides the government with a “nonexclusive, nontransferable, irrevocable, paid-up license” to federally funded inventions for the government’s own use, as well as “march-in rights“. (Thomas, J R, March-In Rights Under the Bayh-Dole Act, 2016).
See Best Efforts.
Best Efforts, and similar terms, are used to describe the level of effort that parties must make to fulfill certain obligations under an agreement. These terms are not always defined in agreements, but can be subject to different legal interpretations in different jurisdictions.
Examples of different usages are available in the MAPGuideⓇ provision database for: Best Efforts, Best Commercial Efforts/Commercial Best Efforts, Best Reasonable Efforts/Reasonable Best Efforts, Commercially Reasonable [Best] Efforts/Endeavors, Diligent Efforts, Good Faith Efforts, Reasonable Efforts/Endeavors, Reasonably Diligent Efforts. Definitions of these terms found in the MAPGuideⓇ provision database often include reference to the degree of effort that a similar organization in the same industry would employ in similar circumstances.
See Best Efforts.
A biosimilar medicine is “a biological medicine highly similar to another already approved biological medicine (the ‘reference medicine’)”. (EMA, Biosimilar medicines: Overview, accessed May 8, 2023). A biosimilar is not the same as a generic medicine because it is not an exact copy of the reference product.
The introduction of biosimilars can help to improve the affordability and availability of biological medicines, but they are more expensive and time-consuming to develop than generic medicines. Additionally, if a medicine is covered by a valid patent, a license agreement and technology transfer from the patent holder are likely to be needed to enable biosimilar manufacture and commercialization. (Morin S, Segafredo G, Piccolis M et al, Expanding access to biotherapeutics in low-income and middle-income countries through public health non-exclusive voluntary intellectual property licensing: considerations, requirements, and opportunities, Lancet Global Health, 2023).
Organizations that are legally structured as tax-exempt charitable foundations in some jurisdictions, such as the US and the UK, are required by national authorities to make investments in accordance with a “Charitable Purpose”. These organizations need to ensure that the recipients of their investments also use those funds in accordance with the defined Charitable Purpose, and may therefore include a Charitability Default provision in their investment agreements. The exact definition of Charitability Default can vary between agreements, but the term generally describes a breach of the agreement terms by the product developer.
An example definition of a Charitability Default from the MAPGuideⓇ provision database is:
Company: (i) fails to comply with the restrictions on the use of funds or the other related U.S. tax obligations set forth in the Grant Agreement or the requirements set forth in this GACA [Global Access Commitments Agreement]; (ii) commits a material breach of term of the Grant Agreement or this GACA; (iii) commits gross negligence, fraud or willful misconduct; or (iv) makes a strategic decision to discontinue the Product development and/or commercialization of the Product which meets the Minimum TPP; or (v) experiences a Change of Control or Transfer in violation of section [x] of this GACA; or (vi) experiences any Force Majeure Event, failure to cure or nonperformance exceeding 150 days, unless otherwise agreed to by the Parties in writing. (Gates Foundation – Novavax, RSV Vaccine Global Access Commitments Agreement, §6(a)).
The term Commercial Benefits refers to economic benefits that are obtained as a result of the commercialization of a product. These benefits could include revenue from licensing agreements, priority review vouchers, or revenue from sales of combination or derivative products.
The MAPGuideⓇ provision database includes examples of commercial benefit sharing provisions which are sometimes used by funders or PDPs to obtain a share of returns made by for-profit development partners. These returns can then be reinvested in activities to further the funder or PDP’s mission.
The Commercialization of medical products refers to activities related to the sale of the final product including marketing, distribution, import and potentially interactions with regulatory authorities. Specific activities included in, or excluded from, the definition of Commercialization can vary by agreement. These definitions may vary from more commonly understood meanings which may encompass additional activities or the concept of selling for commercial gain.
Some examples of agreement definitions from the MAPGuideⓇ provision database are:
Alternative 1: any and all activities directed to the preparation for sale of, offering for sale of, or sale of a Licensed Product, including activities related to marketing, promoting, distributing, and importing such Licensed Product. (MPP – AbbVie, HIV Antiretroviral License Agreement, §1.3).
Alternative 2: any and all activities directed to the marketing, promotion, distribution, pricing, reimbursement, offering for sale, and sale of a pharmaceutical, biologic, or vaccine product and interacting with Governmental Authority in the applicable country or region for such pharmaceutical, biologic, or vaccine product regarding the foregoing, but excluding activities directed to Manufacturing, Medical Affairs, or Development. (Novavax – Serum Institute of India, COVID-19 Vaccine Supply and License Agreement, Appendix A.15).
Alternative 3: any and all activities directed at obtaining pricing and reimbursement approvals, obtaining and maintaining regulatory approvals to commercialize, marketing, promoting, distributing, importing, or more generally commercializing or selling a Licensed Product, including any related scientific and medical affairs and pharmacovigilance activities. Commercialization shall also include the preparation and submission of regulatory filings and regulatory affairs activities with respect to the foregoing. For the avoidance of doubt, Commercialization and Commercialize do not include the Manufacture or Development of the Licensed Product (even if such activities are required to obtain or maintain regulatory approvals for the Commercialization or Manufacture of the Licensed Product). (Shionogi – GARDP, Cefiderocol License Agreement, §1.1).
See Best Efforts.
A compulsory license arises “when a government allows someone else to produce a patented product or process without the consent of the patent owner or plans to use the patent-protected invention itself” (WTO, Compulsory Licensing of Pharmaceuticals and TRIPS FAQs, accessed July 28, 2023).
Compulsory licenses have been used in certain circumstances to enable access to critical medical products, such as HIV/AIDS and hepatitis therapeutics, in the absence of voluntary licenses (WHO, Access to affordable medicines for HIV/AIDS and hepatitis: the intellectual property rights context, 2014).
Conditional Marketing Authorization is a term used by some regulatory authorities including the European Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to describe the “approval of a medicine that addresses unmet medical needs of patients on the basis of less comprehensive data than normally required.” Medical products are eligible for conditional approval if they are intended to address seriously debilitating or life-threatening diseases or public health emergencies (for example, this status was granted for COVID-19 countermeasures) (EMA, Conditional marketing authorisation, accessed May 2, 2023).
CMOs and CDMOs are organizations that specialize in performing outsourced product manufacturing (and in the case of a CDMO product development) services for organizations who do not have all of the resources needed to develop and manufacture their products in-house. CMO/CDMO agreements generally require the contracted party to perform specific services under a scope of work. Unlike a license agreement, the CMO/CDMO does not have the right to conduct its own R&D activities for the product, nor to direct the use of end products.
Examples of contract manufacturing agreements are available in the MAPGuideⓇ provision database.
The term Data can be used in global health agreements to encompass a broad range of information generated at different stages of the product development, manufacturing and commercialization process.
An example definition from the MAPGuideⓇ provision database is:
“Data” means any and all scientific, technical or test data including Know-How, research data, clinical pharmacology data, immunogenicity data, CMC data (including analytical and quality control data and stability data), pre-clinical data, clinical data, information concerning clinical trials, pharmacoeconomic data and data in publications, Regulatory Filings, submissions to Regulatory Authorities, Platform Confirmations, marketing approvals and Master Files related thereto. (CEPI – CureVac, Framework Partnering Agreement, §1.1.20).
Data exclusivity is a form of regulatory exclusivity that “prevents regulatory authorities from relying on the reference product test data [e.g., from preclinical and clinical trials] for approval of a generic medicine for a given period of time.” (WHO, WIPO, WTO, Promoting access to medical technologies and innovation: intersections between public health, intellectual property and trade, 2020). The period of data exclusivity can vary according to jurisdiction and a number of other variables. (Palmedo, M. Evaluating the Impact of Data Exclusivity on the Price per Kilogram of Pharmaceutical Imports, Boston University Global Policy Development Center, 2021).
Data exclusivity can delay access to affordable generic medicines. Therefore, agreements that aim to support equitable access to medical products may include an agreement by the parties to waive and/or not to seek data exclusivity. (Unitaid & WHO, Improving access to novel COVID-19 treatments, 2023).
The term Delinkage refers to “separating the price of medicines, vaccines and diagnostics from the R&D costs associated with those products.” (Unitaid, An Economic Perspective On Delinking The Cost Of R&D From The Price Of Medicines, 2016). Both Push and Pull Incentives can be used as Delinkage mechanisms to drive new product innovation whilst also ensuring the affordability and accessibility of the resulting products. In the context of antibiotics and antimicrobial resistance (“AMR”), Delinkage can also serve to incentivize good stewardship and product conservation. (Outterson, K et al, Delinking Investment in Antibiotic Research and Development from Sales Revenues: The Challenges of Transforming a Promising Idea into Reality, PLoS Medicine, 2016).
The terms “Developed” and “Developing” have been used to group countries into categories based on the human development index and other socioeconomic factors. The MAPGuideⓇ provision database includes examples of agreement provisions that use the term “Developing Countries”, defined using criteria including country income levels and Gavi-eligibility, to describe a territory to which terms such as license grants or affordable pricing and supply obligations apply. However, other terms, including Low-, Middle-, and High-Income Countries, which are based on World Bank analysis of per capita gross national income (GNI), are increasingly preferred for this purpose. (Hern, P., We asked, you answered: Inclusive language in global development, Devex, 2023; Oxfam, Inclusive Language Guide, 2023).
See Tiered Pricing.
See Best Efforts.
The Diversion of medical products occurs when a product approved for use and intended for sale in one market is intercepted and sold in another market. Diversion can occur between countries and also within the same country, where a product may have been sold at a discounted price for use by a certain customer but is sold elsewhere at a higher price. (OECD, Counterfeit Pharmaceuticals: Scope and Data, accessed November 10, 2023).
The MAPGuideⓇ provision database contains examples of non-diversion provisions under which the parties to an agreement agree to make efforts to ensure that funded or licensed products under the agreement are only sold in the intended markets.
Emergency Use Authorization is the term used by the U.S. Food and Drug Administration (FDA) to indicate authorization of unapproved medical products or unapproved uses of approved medical products. EUAs can be granted for products that can “diagnose, treat, or prevent serious or life-threatening diseases in an emergency, for serious or life-threatening diseases, or conditions caused by chemical, biological, radiological, and nuclear (CBRN) threats.” EUAs granted by the FDA include those for COVID-19 countermeasures (FDA, Emergency Use Authorization, accessed May 2, 2023).
Agreements related to the development, manufacturing and commercialization of medical countermeasures sometimes use the term EUA to refer to authorizations for emergency use in multiple jurisdictions, although different terms may exist (for example, the European Medicines Agency refers to Conditional Marketing Authorization). An example of agreement definition of an EUA that goes beyond an FDA authorization is:
A risk-based procedure developed by a Stringent Regulatory Authority to approve the use of a vaccine under development for use during a public health emergency. (Gavi Alliance – Novavax, COVID-19 Vaccine Advance Purchase Agreement, §1).
Emergency Use Listing refers to WHO’s “risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics with the ultimate aim of expediting the availability of these products to people affected by a public health emergency”. The EUL is intended to guide UN procurement agencies and WHO member states in their assessment of product acceptability (WHO, Emergency Use Listing, accessed May 2, 2023).
The MAPGuideⓇ provision database includes examples of agreement provisions that require product developers to apply for an EUL. This can support equitable access to a product by facilitating regulatory approval and product registration in countries that do not have a Stringent Regulatory Authority, as well as eligibility for purchase by UN procurement agencies.
Enabling Rights are the rights and information that an organization needs in order to be able to fully exploit intellectual property related to a product, project or agreement. For example, this term is used by CEPI in some of its funding agreements to describe rights that may be required in order to exercise a Public Health License and ensure CEPI’s freedom to operate. The exact definition may vary by agreement, but one example is:
“Rights to Background Intellectual Property, Project Intellectual Property and Project Results that could be asserted by Awardee or a Subawardee to block CEPI from exercising the Public Health Licence to make, have made, use, have used, import, sell or otherwise exploit the Project Vaccine. For purposes of this Agreement, Enabling Rights also includes the contractual rights that control the use of such items as, for example, rights to use biological materials covered in material transfer agreements entered into between Awardee and third parties.” (CEPI – VBI, COVID-19 Vaccine Development Funding Agreement, §1.16).
The U.S. CDC describes an Epidemic as “similar to an outbreak, but with a larger number of cases or occurring over a greater area or both.” (U.S. CDC, Science Ambassador Program Glossary, accessed May 9, 2023).
The start or end of an Epidemic can have an impact on the obligations of parties to an agreement, particularly where that agreement is intended to address health emergencies. Examples of provisions related to response to Epidemics, outbreaks, and pandemics can be found by searching the preparedness & response issue in the MAPGuideⓇ provision database.
The term Equitable Pricing is similar to tiered pricing, and is used by the Access to Medicines Foundation (ATMF) as part of its analytical framework for assessing actions by companies to support equitable access to their products. ATMF describes equitable pricing as:
“A targeted pricing strategy which aims at improving access to medicine for those in need by taking affordability for individuals and healthcare systems into account in a manner that is locally appropriate.” (ATMF, Generic Medicine Manufacturers Research Programme 2023 – Analytical Framework, 2023).
The term Essential Background Technology is used by the Bill & Melinda Gates Foundation in some of its funding agreements in connection with its Humanitarian License provision. Similar to enabling rights, a license to Essential Background Technology provides the Foundation with comfort over its freedom to operate if it chooses to exercise the Humanitarian License. It is defined as:
Background Technology that is (i) owned, controlled, or developed by [developer], or in-licensed with the right to sublicense; and (ii) either incorporated into a Funded Development or reasonably required to exercise the license to Funded Developments. (Gates Foundation Sample Grant Terms & Conditions, as well as a number of actual Foundation grant agreements).
See License Agreement.
The Field defined in an agreement usually refers to the therapeutic area(s) to which the rights and obligations in the agreement apply. The exact definition is therefore dependent on the context of the product and project specific to the agreement.
Foreground or Foreground Intellectual Property (IP) generally refers to data, patents, know-how, inventions and other intellectual property arising directly from the performance of an agreement. This may also be referred to as Collaboration, Program, or Project IP or Technology. Some examples of definitions from the MAPGuideⓇ provision database are:
Foreground Intellectual Property
Any Intellectual Property (including the Project Patents and Project Inventions) arising out of the undertaking and performance of any Work Phase of the Project. (Funder Development Partnering Agreement, §1.1.35).
Collaboration Technology shall mean any Technology that is made, developed, conceived and reduced to practice by either Party (or on its behalf) during the performance of the Development and Distribution Program. (DNDi Template Development Collaboration and License Agreement, §1.6).
Any Intellectual Property (a) conceived and/or reduced to practice by Program Participants under the Research Program during the Research Term or within [**] months of the end thereof, or (b) arising out of research conducted under the Research Program during the Research Term or within [**] months of the end thereof with funding provided by Alnylam under this Agreement. Program Technology does not include any Background Technology. (Alnylam Pharmaceuticals – University of British Columbia- AlCana Technology, Sponsored Research Agreement, §2.65).
Project Intellectual Property
Any and all inventions (whether patentable or not), proprietary information, know-how, technology, formulae, processes (including all SOPs), trade secrets, materials, technical data and any other information for or related to the formulations developed for Rotavirus Vaccine, or as invented, developed or acquired by, or come into the possession or control (by licensure or otherwise) of Aridis, all where arising out of performance by Aridis of the work under the Project Plan. (PATH – Aridis, Rotavirus Vaccine Development Agreement, §1.17).
Freedom to Operate (FTO) refers to an assessment as to whether “the making, using, selling or importing of a specified product is free from potential infringement of third-party IP or tangible property rights.” FTO assessments help organizations to manage and evaluate the risk of infringement, but do not provide a guarantee that no such risk exists. There are a number of strategies for obtaining FTO where potential infringements exist, including voluntary or compulsory licensing, or seeking a non-assert declaration. (WHO, WIPO, WTO, Promoting access to medical technologies and innovation: intersections between public health, intellectual property and trade, 2020).
Funded Development is a term used by the Bill & Melinda Gates Foundation to describe “the products, services, processes, technologies, materials, software, data, other innovations, and intellectual property” resulting from a Foundation-funded product. The definition includes “modifications, improvements, and further developments to Background Technology” (Gates Foundation Sample Grant Terms & Conditions, as well as a number of actual Foundation grant agreements). Funded Developments are included in the scope of a Humanitarian License.
A country is eligible for Gavi support if its Gross National Income (GNI) per capita is below an eligibility threshold that is set annually by Gavi ($1,730 in 2023). Eligible countries are listed on Gavi’s website. The term Gavi-Eligible Country may be used in an agreement to describe a territory to which terms such as license grants or affordable pricing and supply obligations apply, in which case the agreement may specify the date at which Gavi eligibility is established and whether the territory will include countries that subsequently graduate from eligibility.
A generic medicine is “a medicine that is developed to be the same as a medicine that has already been authorized”. (EMA, Generic medicine, accessed May 8, 2023). To prove that a Generic Medicine meets the same standards as an original (“innovator”) product, a manufacturer is likely to be required to conduct a bioequivalence study, requiring careful study design and selection of a suitable product against which the Generic Medicine will be assessed (a “comparator product”). (WHO, Prequalification of Medical Product – Bioequivalence, accessed November 10, 2023).
The manufacturing and commercialization of Generics can facilitate equitable access as they are usually less expensive than the branded product, and Generics manufacturers may be better positioned to supply markets that are underserved by the original product developer. If there is a valid patent on the branded product then a license is usually needed to permit Generic manufacture and commercialization. For example, licenses to the Medicines Patent Pool for HIV therapeutics enabled the entry of Generic competition in a number of underserved markets, resulting in increased accessibility. (Juneja S, Gupta A, Moon S, Resch S. Projected savings through public health voluntary licenses of HIV drugs negotiated by the Medicines Patent Pool (MPP). PLoS One. 2017;12(5)).
Global Access License and Global Health License are terms used in some product development funding agreements to describe a license granted to the funder which can be exercised in certain circumstances for the purpose of supporting equitable access to a funded product. GHIAA describes Global Access Licenses and other similar mechanisms (e.g., March-in Rights, Humanitarian Licenses, Public Health Licenses and Step-in Rights) as “access licenses”. The scope and implications of access licenses are discussed further in GHIAA’s Equitable Access Toolkit.
Example definitions from the MAPGuideⓇ provision database are:
Global Access License
A non-exclusive, irrevocable, perpetual, sublicenseable, royalty-free and fully-paid up, worldwide […] license to the [Funder] to all intellectual property, technology, know-how, and information owned, controlled or used (subject to reasonably sublicensability by third party licensor(s)) by the Company at the time of [a] Charitability Default that are necessary or useful to research, develop, make, have made, offer-for-sale, sell, import, export, distribute or use the Product, such license solely to research, develop, make, have made, offer-for-sale, sell, import, export, distribute or use Product for [Field] intended for the benefit of people in Developing Countries. (Gates Foundation – Novavax, RSV Vaccine Global Access Commitments Agreement, §6(c)(i)).
Global Health License
A nonexclusive, perpetual, irrevocable, non-terminable, fully-paid up, royalty free license in Target Countries for Global Health Purchasers and for the sole purpose of achieving the Global Access Commitments (with the right to sublicense to third parties reasonably acceptable to the Company) to the Program Products to use, reproduce, modify, make, have made, distribute, sell and otherwise dispose of such Products in the Target Countries (AXA Prime Impact Master Fund – Revelation Biosciences, Diagnostics & Therapeutics for Viral Infections, Global Health Agreement, §4(c)(i)).
See Best Efforts.
Good Manufacturing Practice, or Current Good Manufacturing Practice, refers to standards for ensuring that medical products are “consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification”. (WHO, Health products policy and standards – Good Manufacturing Practices, accessed November 10, 2023).
The term High Income Countries generally refers to a list of countries classified as high income economies by the World Bank on an annual basis. The World Bank classification is based on an assessment of Gross National Income (GNI) per capita.
The term Humanitarian License is used by the Bill & Melinda Gates Foundation to describe:
“a nonexclusive, perpetual, irrevocable, worldwide, royalty-free, fully paid up, sublicensable license to make, use, sell, offer to sell, import, distribute, copy, create derivative works, publicly perform and display Funded Developments and Essential Background Technology.” (Gates Foundation Sample Grant Terms & Conditions, as well as a number of actual Foundation grant agreements).
GHIAA describes Humanitarian Licenses and other similar mechanisms (e.g., March-in Rights, Global Access Licenses, Public Health License and Step-in Rights) used by other organizations as “access licenses”. The scope and implications of access licenses are discussed further in GHIAA’s Equitable Access Toolkit.
The term Humanitarian Purposes is used in some license agreements to describe situations when the licensed intellectual property can be used by a third party, even if the license grant is exclusive. The Universities Allied for Essential Medicines’ (UAEM) Global Access Licensing Toolkit encourages academic institutions to include a reservation of rights for Humanitarian Purposes in their license agreements.
Alternative 1: practice of Patent Rights in the prevention or treatment of disease in humans by or on behalf of any Qualified Humanitarian Organization (including, for clarity, practice of Patent Rights by contractors, manufacturers or distributors acting for or on behalf of such Qualified Humanitarian Organizations on a fee-for-service, fee-for-product or charitable basis) for the benefit of the developing world: (a) to use, manufacture, make, have made, produce, reproduce, distribute, copy, offer to sell and sell Licensed Products anywhere in the world for the sole and express purposes of distribution and use of such Licensed Products in one or more GAVI Countries, and (b) to sell or otherwise distribute Licensed Products for use solely in one or more GAVI Countries; provided, however, that sales and distribution of Licensed Products shall not be deemed made for Humanitarian Purposes unless products are distributed at locally-affordable prices. (Elkurt – Ocean Biomedical, Malaria Vaccine, Exclusive License Agreement, Exhibit E, §1.2).
Alternative 2: (a) the use of Licensed Products and Licensed Services for research and development purposes by any nonprofit organization or other third party, anywhere in the world that has the express purpose of developing the Licensed Products or Licensed Services for use solely for protection from, treatment of, or diagnosis of Neglected Diseases in a Low- or Middle-income country as that term is defined by the World Bank (hereinafter “LMI Country(ies)”); and (b) Sale of Licensed Products and Licensed Services in LMI Countries at or below the cost of manufacture and distribution. (UC Berkeley, Exclusive License Agreement Template, §2.2).
The term Improvements generally refers to enhancements, modifications or refinements related to the development or manufacturing of a product. The rights to Improvements can be particularly important in license or collaboration agreements, for example to allow one party to use an Improvement developed by the other. Improvements may also be included in the scope of access licenses.
Example definitions of Improvements found in the MAPGuideⓇ provision database are:
Alternative 1: All improvements, methods, modifications and other know-how developed by or on behalf of a Licensee and relating to a Product. (Medicines Patent Pool and Gilead Amended and Restated License Agreement, §11).
Alternative 2: All Know-How related to the Vaccine Components invented or developed solely by either Party or jointly by both Parties during the Term in the performance of this Agreement. (Novavax – Serum Institute of India, COVID-19 Vaccine Supply and License Agreement, Appendix A-54).
Alternative 3: all Technology conceived, discovered, invented, developed, created, made or reduced to practice in connection with this Agreement. (Moderna – Lonza, COVID-19 mRNA Vaccine & Therapies, Manufacturing & Process Development Agreement, §1).
Indemnification refers to compensation made in respect of losses, damages or expenses incurred as a result of an action (or lack of action) taken by an individual or organization. The MAPGuideⓇ provision database includes examples of Indemnification provisions related to the use of funds, intellectual property, confidential information or a final product
Indemnification requirements included in COVID-19 vaccine purchase agreements between procurement agencies and vaccine developers have drawn attention and criticism, particularly due to the demands made of LMICs and the resulting impact on equitable access (Gorodensky, A., Kohler, J.C., State capture through indemnification demands? Effects on equity in the global distribution of COVID-19 vaccines, Journal of Pharmaceutical Policy and Practice, 2022). Further analysis of these indemnification provisions is available in GHIAA’s MAPGuide commentary: Liability and Indemnification Provisions in COVID-19 Vaccine Supply Agreements.
Intellectual Property (IP) refers to “creations of the mind such as inventions; literary and artistic works; designs; and symbols, names and images used in commerce”. IP can be protected by IP Rights (IPRs) which enable the inventor to obtain financial or other benefits from their creation. The main types of IPRs are: patents, industrial design rights, trademarks, geographical indications, copyright, and trade secrets (About IP, WIPO, accessed April 4, 2023).
The management of IP Rights is an important consideration in facilitating equitable access to medical products, for example granting voluntary licenses for patents and sharing information and know-how that would otherwise be protected as trade secrets through technology transfer.
The definitions of IP found in global health agreements often include common elements, such as patents, trademarks and copyright, but can differ as to whether they include certain types of information, such as data, know-how, results and materials, that may be used or generated under the agreement. Some agreements also use a definition of technology in a similar way to IP.
Some example definitions of IP from the MAPGuideⓇ provision database are:
Alternative 1: any patentable inventions or any other proprietary rights that are conceived or reduced to practice by or on behalf of Recipient, in connection with or as a result of the Project (hereafter “Inventions”), and (ii) any data, results, know-how, and other intellectual property that are not Inventions and that are generated by or on behalf of Recipient, in connection with or as a result of the Project (hereafter “Know-How’). (WHO Template Material Transfer Agreement, §1).
Alternative 2: (a) inventions, patents, utility models, and rights in the foregoing; (b) trade marks, trade names, geographical indications and appellations of origin, rights under the law of passing off, unfair competition and equivalents; (c) copyright, rights in software, rights in performances and in recordings, moral rights, and database rights; (d) designs, design patents, registered and unregistered designs and design rights; (e) confidential information consisting of trade secrets and rights under the law of breach of confidence and equivalents; and all other intellectual property rights of any kind however designated that may subsist anywhere in the world whether arising by operation of law, treaty, contract, conduct or otherwise, together with all registrations, applications, rights to priority, renewals, extensions, continuations, divisions or reissues thereof and all rights to bring action for infringement past, present and future. (CEPI – VBI, COVID-19 Vaccine Development Funding Agreement, §1.25).
Alternative 3: the intangible property rights claiming or covering the discoveries, inventions and materials as well as the works of authorship made by Awardee under the Project, such as copyrights, patents and trademarks. (CEPI – Novavax, COVID-19 Vaccine Funding Agreement, §1.13).
An Investigational Product is “any pharmaceutical product (new product or reference product) or placebo being tested or used as a reference in a clinical trial” (WHO, Quality Assurance of Medicines Terminology Database – List of Terms and related guideline, 2022).
Some agreements in the MAPGuideⓇ provision database refer to Investigational Products in the context of the development of product stockpiles that can be used for clinical trials in the event of a disease outbreak.
Know-How generally refers to the undisclosed, proprietary information, including trade secrets, related to the development and manufacture of a product. Know-how is not disclosed in a patent application but can be critical to an organization’s ability to produce an approvable product. Access to know-how, and the rights to use it, are therefore important for manufacturers seeking to produce generic or biosimilar products with the goal of expanding affordable access. This can be achieved through voluntary license agreements and technology transfer. (Perehudoff K, ‘t Hoen E, Mara K, et al, A pandemic treaty for equitable global access to medical countermeasures: seven recommendations for sharing intellectual property, know-how and technology, BMJ Global Health 2022).
Some example definitions of Know-How from the MAPGuideⓇ provision database are:
Alternative 1: any technical and other information which is not in the public domain, including information comprising or relating to concepts, discoveries, data, designs, formulae, ideas, inventions, methods, models, assays, research plans, procedures, designs for experiments and tests and results of experimentation and testing (including results of research or development), processes (including manufacturing processes, specifications, and techniques), laboratory records, chemical, pharmacological, toxicological, clinical, analytical and quality control data, trial data, case report forms, data analyses, reports, manufacturing data or summaries and information contained in submissions to and information from ethical committees and Regulatory Authorities (including the Master File) and computer programs or algorithms including those relating to manufacturing and source code for manufacturing processes. Know-How includes Documents containing Know-How, including any rights such as trade secrets, copyright, database or design rights protecting such Know-How. The fact that an item is known to the public shall not be taken to preclude the possibility that a compilation including the item, or a development relating to the item, is not known to the public. (CEPI – CureVac, Framework Partnering Agreement, §1.1.35).
Alternative 2: (a) inventions, technical information, know-how, show-how, data (including physical data, chemical data, toxicology data, animal data, raw data, clinical data, analytical and quality control data), formulae, assays, sequences, discoveries, procedures, processes, practices, protocols, methods, techniques, results of experimentation, knowledge, trade secrets, designs, skill, experience; and/or (b) any information embodied in compounds, compositions, materials (including chemical or biological materials), formulations, dosage regimens, apparatus, devices, specifications, samples, works, regulatory documentation and submission pertaining to, or made in association with, filings with any Regulatory Authority. (Fiocruz – AstraZeneca, COVID-19 Vaccine Technology Transfer Agreement, §1.33).
Alternative 3: any and all confidential or proprietary information and materials, including discoveries, improvements, processes, methods, protocols, formulas, molecular constructs, reagents, assays, data, results, inventions, trade secrets, compositions of matter (including compounds), formulations, and findings, in each case, patentable or otherwise and including any copyrights therein. (Merck – MPP, Molnupiravir License Agreement, §1.8).
The United Nations defines Least-Developed Countries (LDCs) as countries that “have low levels of income and face severe structural impediments to sustainable development.” The LDC criteria are: (i) average per capita income of below USD$1,018; (ii) a low score on the Human Assets Index; and (iii) a high score on the Economic and Environmental Vulnerability Index. (United Nations, Least Developed Countries Category, accessed May 5, 2023). A current list of LDCs is available here.
The MAPGuideⓇ provision database includes examples of agreement provisions that refer to LDCs as a definition of a territory to which terms such as license grants or affordable pricing and supply obligations apply. Using LDCs as a definition of territory results in a narrower scope of countries than those included in a definition referring to Gavi-Eligible Countries or LMICs.
A License Agreement is “a contract in which the [IP] holder allows another party to use the IP, either in return for a payment of royalties (or some other consideration, such as marketing of the product or access to the other party’s assets) or free of charge, for a certain field of use, in a certain territory.” (WHO, WIPO, WTO, Promoting access to medical technologies and innovation: intersections between public health, intellectual property and trade, 2020). The IP holder is a Licensor and the other party is a Licensee.
Governments can grant Compulsory Licenses under certain circumstances, but License Agreements usually relate to a Voluntary License granted by the licensor (i.e., the licensor is not acting upon the order of a government authority). An Exclusive Voluntary License means that the licensee is granted sole rights to use the licensed intellectual property. Exclusivity can be limited to a certain territory or field, or include the option to grant rights to other parties in certain circumstances, for example for research or humanitarian purposes. A Non-Exclusive License refers to a license under which the licensee is not granted sole rights.
Non-Exclusive Voluntary Licenses (“NEVLs“) or “public health licensing” can be an effective tool in expanding equitable access to innovative medical products. (Gore C, Morin S, Røttingen J-A, et al. Negotiating public-health intellectual property licensing agreements to increase access to health technologies: an insider’s story. BMJ Glob Health 2023;8:e012964).
Important considerations related to the scope of a license grant are discussed in the license grants issue summary in the MAPGuideⓇ provision database.
The term Low- and Middle- Income Countries generally refers to a list of countries classified as low, lower-middle, or upper-middle income economies by the World Bank on an annual basis. The World Bank classification is based on an assessment of Gross National Income (GNI) per capita.
The MAPGuideⓇ provision database includes examples of agreement provisions that include LMICs in a definition of a territory to which terms such as license grants or affordable pricing and supply obligations apply.
The term Low Income Countries generally refers to a list of countries classified as low income economies by the World Bank on an annual basis. The World Bank classification is based on an assessment of Gross National Income (GNI) per capita.
The MAPGuideⓇ provision database includes examples of agreement provisions that include LICs in a definition of a territory to which terms such as license grants or affordable pricing and supply obligations apply.
The term March-In Rights is generally used to refer to the U.S. Government’s rights under the Bayh-Dole Act. The rights are part of the conditions of most federal R&D funding agreements; they allow the government to require an organization that owns an invention made using federal funds to grant a license to that invention to a third party. March-In Rights can only be exercised under certain circumstances, including to meet public health and safety needs or public use requirements. Complete details of the rights are set out in Title 35, §203 of the U.S. Code.
GHIAA describes March-in Rights and other similar mechanisms (e.g., Global Access Licenses, Humanitarian Licenses, Public Health Licenses and Step-in Rights) used by other organizations as “access licenses”. The scope and implications of access licenses are discussed further in GHIAA’s Equitable Access Toolkit.
Market Exclusivity is a form of regulatory exclusivity. It prevents a regulatory authority from granting marketing authorization for a competitor product (e.g., a generic) for a certain period of time. (WHO, WIPO, WTO, Promoting access to medical technologies and innovation: intersections between public health, intellectual property and trade, 2020).
Market Shaping refers to activities that are undertaken to close gaps in markets and reduce barriers to product introduction and adoption in lower income markets. Organizations including the Global Fund, Gavi, CHAI, MedAccess, UNICEF and Unitaid engage in Market Shaping activities such as providing demand forecasting to increase manufacturer confidence in market viability, entering into pricing agreements to support affordable pricing, regulatory systems strengthening to shorten country approval timelines, and incentivizing innovation to drive the development of appropriate and quality assured products.
In general, Marketing Authorization or Marketing Approval refers to an approval obtained from a regulatory authority for the sale and use of a medical product within a given jurisdiction. Marketing Authorization may also be referred to as Product Licensure or Product Registration. (WHO, WHO – Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control) Glossary, accessed April 6, 2023).
Global health agreements do not always refer to Marketing Authorization as a defined term, but where definitions are used, they may reflect the relevant jurisdiction(s) for the purpose of the agreement, as well as agreement specific requirements such as whether price approvals from the relevant national or regional bodies are included in the definition. Some example definitions of Marketing Authorization or Marketing Approval from the MAPGuideⓇ provision database include:
Alternative 1: a marketing authorisation granted by the European Commission in accordance with the procedure for the authorisation and supervision of medicinal products for human use set forth in Regulation (EC) No. 726/2004, or any Approved Regulatory Authority and any corresponding Regulatory Approval necessary to manufacture, use, sell or store a Product in any other country or jurisdiction, but not including pricing and reimbursement approvals. (Funder Development Partnering Agreement, §1.1.51).
Alternative 2: all approval(s), registration(s) and authorisation(s) necessary to be obtained from an applicable Drug Regulatory Authority to lawfully import, promote, distribute and sell the Product in the Field in a country of the [Territory] (Entasis – DNDi/GARDP, Gonorrhoea Medication, Collaboration Agreement, §1.51).
Alternative 3: the Regulatory Approval required under Applicable Laws in the Territory to place the Product on the market for human use outside of clinical trials, including any conditional use approval or any approval issued pursuant to Directive 2001/83/EC or Part 5 of the Human Medicines Regulations 2012 (or any replacement or superseding legislation), but excluding any pricing or reimbursement approvals. (UK Secretary of State – AstraZeneca, COVID-19 Vaccine Supply Agreement, §1.1).
The term Materials is often used to refer to tangible biological and chemical materials that are used for, or created during, the performance of the agreement. Some agreements use this term without a definition, but where a definition is included, it is often specific to the type of activity and product under the agreement. Examples of context-specific usage can be reviewed in the MAPGuideⓇ provision database.
Medical Countermeasures are “medicines and medical supplies that can be used to diagnose, prevent, or treat diseases related to chemical, biological, radiological, or nuclear (CBRN) threats.” (U.S. Centers for Disease Control and Prevention, Medical Countermeasures, access May 5, 2023). This term has particularly been used in relation to vaccines, drugs and diagnostics developed in response to the COVID-19 pandemic.
The term Middle-Income Countries generally refers to a list of countries classified as Lower-Middle, or Upper-Middle Income economies by the World Bank on an annual basis. The World Bank classification is based on an assessment of Gross National Income (GNI) per capita.
An MFC or MFN provision is one that requires the sales price charged by a product developer or manufacturer to a purchaser (often a national government agency) to be at a preferential price compared to the price charged to other purchasers for the same product. Examples of MFC and MFN provisions are available in the MAPGuideⓇ provision database.
National Regulatory Authorities or Agencies (NRAs) are “responsible for ensuring that products released for public distribution (normally pharmaceuticals and biological products, such as vaccines and medical devices including test kits) are evaluated properly and meet international standards of quality and safety and efficacy” (WHO, National Regulatory Agencies, accessed April 12, 2023). NRAs are sometimes incorporated into a broader definition of Regulatory Authority in agreements.
A Non-Assert Declaration is a commitment by a patent rights holder not to enforce certain patent rights, therefore allowing a third party to manufacture a generic version of a patented product (provided that all of the patent rights relevant to the product are included in the declaration). A Non-Assert Declaration may be subject to certain conditions, for example it may only apply for certain countries or organizations. The MAPGuideⓇ provision database includes some examples of non-assert commitments.
See License Agreement.
Open Access generally refers to the method for journal publication of scientific data and results. The Directory of Open Access Journals defines Open Access journals as those in which “the copyright holder of a scholarly work grants usage rights to others using an open license (Creative Commons or equivalent) allowing for immediate free access to the work”.
Open Access publication of data and results is often a requirement in agreements involving public or philanthropic funders, or product development partnerships. A number of these organizations are also signatories of Plan S which sets out 10 principles for the publication of results associated with public or philanthropic grants. Examples of open access publication requirements can be found in the MAPGuideⓇ provision database.
A disease Outbreak is “the occurrence of disease cases in excess of normal expectancy” (WHO, Disease Outbreaks, accessed April 5, 2023). Some agreements that aim to ensure equitable access to outbreak response products or medical countermeasures may define the term differently, for example:
Alternative 1: A Public Health Emergency of International Concern declared by WHO or a public health emergency on a national or regional scale declared by one or more national governments and in each case for a material increase in the number of cases of people infected with [disease] including any regional outbreak, an epidemic or a pandemic. (CEPI CfP3i Vaccine Funding Agreement Template, Schedule A).
Alternative 2: (i) the occurrence in a community or region of cases of an illness with a frequency in excess of normal expectancy; (ii) a public health emergency of international concern declared by WHO; and/or (iii) a public health emergency on a national or regional scale declared by the relevant national or regional government (CEPI – CureVac, Framework Partnering Agreement, §1.1.41).
The start or end of an Outbreak can have an impact on the obligations of parties to an agreement, particularly when that agreement is intended to address health emergencies. Examples of provisions related to response to Outbreaks, epidemics and pandemics can be found by searching the preparedness & response issue in the MAPGuideⓇ provision database.
The U.S. CDC describes a Pandemic as “similar to [an] epidemic, but has spread over several countries or continents, usually affecting a large number of people. (U.S. CDC, Science Ambassador Program Glossary, accessed May 9, 2023).
The start or end of a Pandemic can have an impact on the obligations of parties to an agreement, particularly when that agreement is intended to address health emergencies. Examples of provisions related to response to Pandemics, outbreaks, and epidemics can be found by searching the preparedness & response issue in the MAPGuideⓇ provision database.
The term Patent Pool is generally used to describe “an agreement between at least two patent owners to group their patent rights relating to a specific technology and to license the rights to use these patents to each other and to third parties, subject to certain conditions, such as the payment of royalties” (WHO, WIPO, WTO, Promoting access to medical technologies and innovation: intersections between public health, intellectual property and trade, 2020).
Examples of patent pools working in the field of equitable access are:
- The Medicines Patent Pool (MPP): an organization that supports increased and equitable access to medical products using a model under which MPP negotiates license agreements with patent holders and then grants sublicenses to manufacturers who will produce generic versions of the product for use in LMIC markets.
Patent Rights are “an exclusive right granted for an invention, which is a product or a process that provides, in general, a new way of doing something, or offers a new technical solution to a problem”. Inventors can apply for these rights by filing a patent application which must include technical information about the invention and is available to the public. Patent Rights generally last for 20 years, although it is sometimes possible to obtain a patent extension, and they apply only in the country or region for which an application is filed and granted. (WIPO, Patents, accessed April 6, 2023).
The term Pooled Procurement refers to the combination of financial and other resources across different procurement agencies to create a single entity for procuring health products on behalf of the individual agencies. (WHO, Pooled procurement: WHO guideline on country pharmaceutical pricing policies. A plain language summary, 2021). Organizations such as The Global Fund, UNICEF, PAHO, and the Africa Medical Supplies Platform (AMSP) leverage Pooled Procurement mechanisms to facilitate affordable access to quality assured medical products for the countries that they support.
A Pricing Agreement is a form of market shaping activity which secures a ceiling price at which a product can be purchased by certain buyers – usually public sector purchases for low- and middle-income countries. The aim of these agreements is to expand product access by obtaining an affordable price, generally reduced from a commercial or private sector market price. Pricing agreements may be supported by a volume guarantee agreement which incentivizes a manufacturer to offer a lower price. An example of how these agreements work together is the partnership between MedAccess, CHAI, and SD Biosensor for dual rapid tests for syphilis and HIV.
The U.S. Food and Drug Administration (FDA) can issue Priority Review Vouchers (PRVs) to organizations that sponsor an application for approval of a new drug or biological product for the prevention or treatment of certain tropical diseases, rare pediatric diseases, or medical countermeasures. PRVs were introduced as a pull incentive to encourage new drug development for therapeutic areas with limited other incentives for innovation. PRVs create value because they can: (i) be used to obtain priority review for an approval application for any drug, therefore potentially shortening time to market for a product with high commercial returns; or (ii) be sold to a third party, potentially for substantial sale proceeds. (FDA, Tropical Disease Priority Review Vouchers Guidance for Industry, 2016; FDA, Rare Pediatric Disease Priority Review Vouchers: Draft Guidance for Industry, 2019; FDA, Material Threat Medical Countermeasure Priority Review Vouchers – Draft Guidance for Industry: Draft Guidance for Industry, 2018).
The MAPGuideⓇ provision database includes examples of commercial benefits sharing provisions which address the potential for deriving commercial value from a PRV and how it should be shared between the parties.
A Procurement Agency is an entity that purchases medical products for eventual distribution to patients or other end users. Procurement Agencies can be governmental entities or multilateral institutions.
PDPs are “non-profit organizations that develop new products for people who suffer from diseases and health threats underserved by traditional markets by building partnerships between the public, private, academic, and philanthropic sectors.” (Keeping the Promise [a coalition of 12 PDPs], Product Development Partnerships’ Role in the New Age of Health Research and Product Development, accessed November 12, 2023).
Some PDPs, such as the Drugs for Neglected Diseases Initiative (DNDi), PATH, the Foundation for Innovative New Diagnostics (FIND), and Medicines for Malaria Ventures (MMV), take a long-term approach, working across a range of projects and products to address the health care challenges falling within their mandate. Some other partnerships, such as the pediatric praziquantel consortium, are established with a narrower scope to address a certain project or product.
Registration is “any statutory system of approval required at national level as a precondition for introducing a pharmaceutical product on to the market” (WHO, WHO – Prequalification of Medical Products (IVDs, Medicines, Vaccines and Immunization Devices, Vector Control) Glossary, accessed April 6, 2023).
A strategy for timely Registration in relevant countries should be included in access plans in order to support equitable access to new medical products.
The International Health Regulations 2005 (IHR) define a PHEIC as “an extraordinary event which is determined to constitute a public health risk to other States through the international spread of disease and to potentially require a coordinated international response” (WHO, IHR, 2005).
Public Health License is a term used by CEPI in its vaccine development funding agreements. The exact definition may be different for different agreements, but it can be generally understood as:
“a non-exclusive, fully paid-up, sublicensable and worldwide license under the Project Results and Enabling Rights to develop, manufacture, market and/or supply the Product worldwide; in each case for use in preparation for or response to an Outbreak or Increased Outbreak Preparation Need”. (CEPI CfP3i Program Funding Agreement and Terms and Conditions, Schedule A).
GHIAA describes Public Health Licenses and other similar mechanisms (e.g., March-in Rights, Global Access Licenses, Humanitarian Licenses and Step-in Rights) used by other organizations as “access licenses”. The scope and implications of access licenses are discussed further in GHIAA’s Equitable Access Toolkit.
The term Public Sector often encompasses a range of entities including governments, multilateral organizations, and non-profit organizations, as well as for-profit organizations in certain circumstances. Some example definitions of this term from the MAPGuideⓇ provision database are:
Alternative 1: (i) a government or a department or agency thereof, including ministries of health; (ii) intergovernmental organizations, including the United Nations, its Specialized Agencies such as the World Health Organization and its Programmes or Funds such as the United Nations Children’s Fund (UNICEF); (iii) a non-profit organization or entity organized under the laws of a government or department or agency thereof, including non-governmental organizations such as Médecins sans Frontiéres and faith-based organizations; and (iv) entities (including entities in the private sector) that are funded by governments or non-profit organizations or foundations such as the UNICEF, the President’s Emergency Plan for AIDS Relief, or the Global Fund to Fight AIDS, Tuberculosis and Malaria. (Academic Institution – Company, Research Collaboration Agreement, §1.9).
Alternative 2: governmental health ministries and other governmental agencies of Developing Countries, the Global Fund for Children’s Vaccines, the WHO, World Bank, UNICEF and other governmental and non-profit charitable agencies or organizations, including PATH, and shall include without limitation United States and European governmental agencies (e.g. USAID, DANIDA, DFID and GTZ) that may purchase vaccines for delivery, distribution and/or sale to Developing Countries. (PATH – Aridis, Rotavirus Vaccine Development Agreement, §1.18).
(a) the following organizations to the extent that they are not for profit organizations:
(i) Governments including without limitation government ministries and agencies, together with government-funded institutions and programs, such as state-run hospitals and prison services in those countries;
(ii) NGOs including without limitation those recognized by the applicable local government ministry;
(iii) UN-related organizations working for or in those countries, including but not limited to UNDP and UNICEF;
(iv) Not-for-profit organizations including without limitation, Médecins Sans Frontières, Save-the-Children, OXFAM and the International Committee of the Red Cross (ICRC);
(v) Funding mechanisms and programs funded by such mechanisms, including without limitation, Unitaid, PEPFAR, USAID, Global Fund, etc.; and
(vi) agencies based outside of an applicable country to the extent that they are supplying Licensed Products in the Territory, and
(b) nominally for profit procurement organisations but only to the extent that such procurements are supporting not-for-profit treatment programmes as described in (a) above.
Pull Incentives aim to stimulate product R&D through direct or indirect financial rewards. Examples include Advance Market Commitments and Priority Review Vouchers, prizes, and extensions to market exclusivity periods. (Mueller-Langer F. Neglected infectious diseases: are push and pull incentive mechanisms suitable for promoting drug development research? Health Econ Policy Law, 2013; Cama, J et al. “To Push or To Pull? In a Post-COVID World, Supporting and Incentivizing Antimicrobial Drug Development Must Become a Governmental Priority.” ACS infectious diseases vol. 7,8 (2021): 2029-2042). These incentives can be particularly important for products for which there is otherwise limited commercial incentive to develop new products, for example antimicrobials, rare diseases, and neglected tropical diseases.
Push Incentives subsidize the initial costs of product research and development, for example publicly funded research programs, Product Development Partnerships, and R&D tax credits. (Mueller-Langer F. Neglected infectious diseases: are push and pull incentive mechanisms suitable for promoting drug development research? Health Econ Policy Law, 2013). Product development funding from organizations such as CARB-X, the Bill & Melinda Gates Foundation, and CEPI also act as a form of Push Incentive.
Push Incentives can be particularly important for products for which there is otherwise limited commercial incentive to develop new products, for example antimicrobials, rare diseases, and neglected tropical diseases.
Quality Assurance refers to the processes that should be undertaken throughout the product lifecycle to ensure that an end product is of the expected quality and to protect patients from the risks associated with falsified or substandard products. Quality Assurance requirements are a particularly important consideration for agreements related to the development, manufacturing and commercialization of medical products in lower-income markets which often have weak legal and regulatory oversight mechanisms. (Quality of medicines in resource-limited settings: need for ethical guidance, Ravinetto R, Pinten W, Rägo L, Glob Bioeth. 2018; 29(1): 81–94).
See Best Efforts.
External Reference Pricing refers to the comparison of medical product prices across different countries. It can be used as a mechanism to ensure that a country does not pay more for a product than other comparable countries. (WHO, External reference pricing: WHO guideline on country pharmaceutical pricing policies. A plain language summary, 2021).
Internal Reference Pricing refers to price comparisons between products that are therapeutically similar and can be used as substitutes within a single country. It can be used as a mechanism to ensure that comparable products have similar prices, and can stimulate price competition among those products. (WHO, Internal reference pricing: WHO guideline on country pharmaceutical pricing policies. A plain language summary, 2021).
The term Regulatory Approval may be used in different ways in agreements, potentially dependent on the context of the agreement. In some cases, definitions of Regulatory Approval are similar to marketing approval, but in other cases it is used to define a broader set of regulatory approvals required throughout the product life cycle. For example:
Alternative 1: any technical, medical, scientific or other license, registration, authorization or approval of any Regulatory Authority necessary for the development, manufacture or commercialization of a pharmaceutical product in any regulatory jurisdiction. (Medicines Patent Pool and Pfizer Sutezolid License Agreement, §1.10).
Alternative 2: any approval (excluding price and reimbursement approvals), license, registration or authorisation (including a Marketing Authorisation) of any Regulatory Authority that is necessary for the development, manufacture, use, storage, import, transport, sale or distribution of a Product in such jurisdiction. (DNDi Template Development Collaboration and License Agreement, §1.40).
Alternative 3: “Regulatory Approval” means: (a) Marketing Authorisation Approval from a Stringent Regulatory Authority; or (b) WHO Prequalification. (Gavi Alliance – Novavax, COVID-19 Vaccine Advance Purchase Agreement, §1).
The term Regulatory Authority is generally used to describe a national or international body that is responsible for regulations and approvals related to the development, manufacture, and commercialization of medical products. Related terms include National Regulatory Authority (NRA), Stringent Regulatory Authority (SRA) and WHO Listed Authority.
Regulatory Exclusivity is “an umbrella term that encompasses data exclusivity […] and market exclusivity” (WHO, WIPO, WTO, Promoting access to medical technologies and innovation: intersections between public health, intellectual property and trade, 2020).
The MAPGuideⓇ provision database includes examples of commitments to waive and/or not seek Regulatory Exclusivity in order to facilitate equitable access to a product.
The terms Results and Project Results are generally used to refer to any outputs or outcomes resulting from the performance of an agreement or project. Agreement definitions of this term may vary in terms of the scope of information included, particularly whether the term encompasses intellectual property related to the agreement.
Some example definitions of Results from the MAPGuideⓇ provision database are:
Alternative 1: the outcomes and results of the Project, [which] may comprise biological samples, data, intellectual property, materials, any Product and Investigational Product, publications, reference standards, technology and other results and shall include all Project IP, Project Data and Project Materials. (CEPI – Valneva, Chikungunya Vaccine Funding Agreement, §10.1).
Alternative 2: all results, including information, knowledge, non-individually identifiable data, materials, analysis, reports, evaluations and other documents, generated by or on behalf of the [funding] Recipient as result of implementation of the Project, but not including any Recipient Background IP or Recipient Foreground IP. (UnitaidExplore Sample Funding Terms and Conditions, §21).
Any (tangible or intangible) output of the action such as data, knowledge or information — whatever its form or nature, whether it can be protected or not — that is generated in the action, as well as any rights attached to it, including intellectual property rights. (IMI 2 Model Grant Agreement, §26.1).
Rights of Reference allow one party to an agreement to reference data in a regulatory application that was originally included in a regulatory application filed by another agreement party. This term is often not defined in agreements, but the MAPGuideⓇ provision database includes examples of provisions requiring the grant of rights of reference in connection with license grants, technology transfer obligations, and the development of regulatory strategies.
The term Sideground generally describes data, know-how, technology, inventions, intellectual property rights and other similar information created by an organization during the same period as, but independently from, the performance of an agreement.
The term Socially Responsible Licensing is often used in the context of the licensing of university innovations through university technology transfer offices (TTOs). It refers to granting licenses under terms that are in the public interest and support equitable access to a final product created using the licensed intellectual property. Examples of university Socially Responsible Licensing policies are available on GHIAA’s Equitable Access Policies page.
The term Step-In Rights refers to the right of a licensor or product development funder to take over the development and commercialization of a product if the original developer fails to act in accordance with the terms of a license or funding agreement. The MAPGuideⓇ provision database includes examples of agreement provisions that set out the triggers and conditions for Step-In Rights.
GHIAA describes Step-in Rights and other similar mechanisms (e.g., March-in Rights, Global Access Licenses, Humanitarian Licenses and Public Health License) used by other organizations as access licenses. The scope and implications of access licenses are discussed further in GHIAA’s Equitable Access Toolkit.
The term Stewardship is used in the context of antimicrobial resistance (AMR) to refer to a “coherent set of actions to promote the responsible use of antimicrobials.” These actions can be at individual, national, and global levels across human, animal, and environmental health. (WHO, Antimicrobial stewardship programmes in health-care facilities in low- and middle-income countries, 2019).
A Stringent Regulatory Authority (SRA) is a regulatory authority that is either:
a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) – meaning the European Commission, the United States Food and Drug Administration, and the Ministry of Health, Labour and Welfare of Japan;
b) an ICH observer – meaning being the European Free Trade Association, as represented by Swissmedic, and Health Canada; or
c) a regulatory authority associated with an ICH member through a legally-binding, mutual recognition agreement, including Australia, Iceland, Liechtenstein and Norway.
The MAPGuideⓇ provision database includes examples of agreement provisions referring to SRAs in relation to regulatory approval obligations under the agreement.
WHO has more recently developed a definition of WHO Listed Authority (WLA), which it will introduce as a replacement for SRA. (Macé C, Rägo L, Ravinetto R, How the concept of WHO-listed authorities will change international procurement policies for medicines, BMJ Global Health 2022;6:e008109).
A Target Product Profile (TPP) “outlines the desired ‘profile’ or characteristics of a target product that is aimed at a particular disease or diseases. TPPs state intended use, target populations and other desired attributes of products, including safety and efficacy-related characteristics”. TPPs can be used to guide product R&D and WHO develops TPPs that “recognize that access, equity and affordability are integral parts of the innovation process and need to be considered at all stages, not just after a product is developed”. (WHO, Target Product Profiles, accessed July 18, 2023).
Some agreements include obligations for a product developer to develop a product that conforms to an agreed-upon TPP which may be attached to the agreement for reference.
In the context of medical products, the term Technology is often generally understood to mean a particular product, type of product or an underlying platform used to produce products or support healthcare services. However, Technology may also be used differently as a defined term in global health agreements where it may be used to refer to intellectual property, know-how and/or other undisclosed information related to the development of a product. The aim of these definitions is to confer “maximum legal certainty” that all knowledge that is needed in the context of the agreement is included. . (Dominique Junod Moser et al, Striking fair deals for equitable access to medicines, Journal of Intellectual Property Law & Practice, April 2023).
Some example definitions of Technology from the MAPGuideⓇ provision database are:
Alternative 1: “Technology” means any Know-How together with all intellectual property rights and similar or equivalent rights anywhere in the world which currently exist or are recognized in the future (whether or not registered) covering such Know-How; and applications, extension and renewals in respect of the foregoing including patent applications, patents resulting from any such applications, utility certificates, improvement patents and models, certificates of addition and all foreign counterparts in all countries, including any divisional applications and divisional patents, refiling, renewals, continuations, continuations-in-part, patents of addition, extensions (including patent term extensions), reissues, substitutions, confirmations, registrations, re-validations, pipeline and administrative protections and additions, supplementary protection certificates and equivalent protection, designs, trademarks and trade names, copyright and related rights, and database rights. (CEPI – CureVac, Framework Partnering Agreement, §1.1.68).
Alternative 2: Collectively, data, results, technology, inventions, discoveries, improvements, trade secrets and proprietary methods, whether or not patentable and in any tangible or intangible form, including: (a) methods of manufacture or use of, and structural and functional information pertaining to, biologics;(b) compositions of matter, data, formulations, processes, techniques, know-how and results; and (c) unregistered design rights, copyright, database rights, rights in respect of confidential information, rights under data exclusivity laws, rights under orphan drug laws, rights under unfair competition laws, property rights in biological or chemical materials, extension of the terms of any such rights, applications for and the right to apply any of the foregoing registered property and rights, and similar or analogous rights. For clarity, Technology excludes Patent Rights. (Ocugen-BBIL, COVID-19 Vaccine (Covaxin), Co-development, Supply & Commercialization Agreement, §1.70).
Alternative 3: Technology shall mean Patent Rights, Know How, proprietary reagents, rights in designs, database rights, copyright and related rights, moral rights, any improvements, enhancements or modifications to any of the foregoing, and any rights or property similar to any of the foregoing in any part of the world, whether registered or not. (DNDi Template Development Collaboration and License Agreement, §1.47).
A general definition of technology transfer is “a series of processes for sharing ideas, knowledge, technology and skills with another individual or institution (e.g., a company, a university or a governmental body) and of acquisition by the other of such ideas, knowledge, technologies and skills.” (WIPO, Standing Committee on the Law of Patents, SCP/14/4 Rev.2, 2011).
In the context of global health agreements, technology transfer usually refers more specifically to the provision of all of the information and support necessary for an agreement party to successfully manufacture a licensed product or otherwise conduct the activities anticipated under an agreement. The inclusion of Technology Transfer, in addition to patent rights, in a license agreement can be an important factor in the successful production of generic or biosimilar products with the goal of expanding affordable access. (Perehudoff K, ‘t Hoen E, Mara K, et al, A pandemic treaty for equitable global access to medical countermeasures: seven recommendations for sharing intellectual property, know-how and technology, BMJ Global Health 2022).
The MAPGuideⓇ contains examples of Technology Transfer provisions which include varying levels of detail as to the components of Technology Transfer. Specific technology transfer obligations can also be set out in separate work plans or Technology Transfer agreements.
Broadly speaking, an agreement Territory defines the country(ies) to which the rights and obligations under an agreement are intended to apply. For example, the countries in which a licensed product can be manufactured and sold, the countries to which a particular pricing requirement applies, or the countries in which a product may be administered.
Tiered Pricing structures are sometimes included in product development or purchase agreements as a mechanism to support equitable access to a medical product. Typically these structures set out different sales prices depending on whether the product is sold for use in a low-income, middle-income or high-income country, with sales to high-income countries bearing a higher price. Alternatively, the Tiered Pricing structure may be based on sales volume, as it is generally understood that there are increasing cost efficiencies with higher production volumes.
The MAPGuideⓇ provision database includes examples of Tiered Pricing provisions.
Tiered Royalty structures are sometimes included in license agreements as a mechanism to support equitable access to a medical product. Typically, these structures adjust the royalty rate payable to a licensor by a licensee depending on whether the product is sold for use in a low-income, middle-income or high-income country, with sales to high-income countries bearing a higher royalty.
The MAPGuideⓇ provision database includes includes examples of Tiered Royalty provisions.
The TRIPS Agreement is a multilateral agreement on intellectual property that applies to all WTO members, although Least Developed Countries have a transitional period for implementing the TRIPS provisions, which runs until 2034. The agreement sets minimum standards in relation to the protection of intellectual property rights. (Frequently asked questions about TRIPS in the WTO, WTO, accessed July 20, 2023).
The inequities in access to medical countermeasures during the COVID-19 pandemic gave rise to discussions around “TRIPS Flexibilities” which, in the context of medical products, refer to the options available to governments to address urgent public health needs, including grants of compulsory licenses. Under article 31(f) of the TRIPS Agreement, use of patent subject matter without the patent holder’s consent should be primarily for supply to the domestic market. However, the COVID-19 pandemic led to a “TRIPS Waiver” which, amongst other items, waives the domestic market requirement and allows export of COVID-19 vaccines to any developing country member of the WTO. (An Integrated Health, Trade and IP Approach to Respond to the COVID‑19 Pandemic, Second Update, WHO, WIPO, WTO, May 2023).
Trade secrets are intellectual property rights on confidential information. To qualify as a Trade Secret, information must derive commercial value from being secret, be known only to a limited group of people, and have been subject to reasonable confidentiality precautions to keep it a secret. (WIPO, About IP, Trade Secrets, accessed September 13, 2023).
Access to Trade Secrets and other forms of know-how are important for manufacturers seeking to produce generic or biosimilar products with the goal of expanding affordable access. This can be achieved through voluntary license agreements and technology transfer. (Perehudoff K, ‘t Hoen E, Mara K, et al, A pandemic treaty for equitable global access to medical countermeasures: seven recommendations for sharing intellectual property, know-how and technology, BMJ Global Health, 2022).
The term UMICs refers to a list of countries classified as high income economies by the World Bank on an annual basis. The World Bank classification is based on an assessment of Gross National Income (GNI) per capita.
The MAPGuideⓇ provision database includes examples of agreement provisions that include UMICs in a definition of a territory to which terms such as license grants or affordable pricing and supply obligations apply.
A Vector Expedited Review Voucher (VERV) is an incentive for the development of new vector control tools. It is modeled on a PRV and rewards the manufacturer of a new public health insectiside with an expedited registration review by the U.S. Environmental Protection Authority (EPA) for a second, more profitable product. The manufacturer can choose to use the voucher itself, or sell it to another party. (Vector Expedited Review Voucher, IVCC, accessed May 9, 2023).
A Volume Guarantee Agreement is a form of market shaping activity through which a public or philanthropic organization guarantees the purchase of a certain volume of a product over a certain period of time. This provides market certainty for a product manufacturer, enabling them to supply new markets or continue production of a product for which there is a limited or uncertain market. In exchange for the Volume Guarantee, the manufacturer must commit to launching the product in certain markets. A Volume Guarantee can also support negotiation of a pricing agreement which secures an affordable price for the product. An example of how these agreements work together is the partnership between MedAccess, CHAI, and SD Biosensor for dual rapid tests for syphilis and HIV.
See License Agreement.
A WHO Listed Authority is ”a regulatory authority or a regional regulatory system (RRS) which has been documented to comply with all the relevant indicators and requirements specified by WHO for the requested scope of listing based on an established benchmarking and performance evaluation process.” (WHO, Evaluating and publicly designating regulatory authorities as WHO listed authorities, 2021).
WHO is introducing this term as a replacement for Stringent Regulatory Authority (SRA). (Macé C, Rägo L, Ravinetto R, How the concept of WHO-listed authorities will change international procurement policies for medicines, BMJ Global Health 2022;6:e008109).
WHO Prequalification (WHO PQ) of medicines is a service provided by WHO to assess the quality, safety and efficacy of immunization devices, in vitro diagnostics, medicines, vaccines and vaccine control products (WHO, Prequalification of medicines by WHO, accessed April 21, 2023; WHO, World Health Organization Prequalification, accessed April 21, 2023).
Obtaining and maintaining WHO PQ can facilitate access to a product as it is used as a quality assurance mechanism for UN and other public procurement agencies. (Årdal C, Røttingen JA, An Open Source Business Model for Malaria, PLOS ONE, 2015). The MAPGuideⓇ provision database includes examples of provisions that require application for WHO PQ as part of the access plan and equitable access commitments for a product.