First look: Full Text of America First Global Health Strategy Specimen Sharing Agreement

Access? Not really. Reciprocity? Not a chance.

A specimen sharing agreement that is a condition for US State Department-administered foreign aid for health makes no firm commitment to providing countries that sign with access to tests, treatments or vaccines based on information they may share. The specimen sharing agreement, reproduced in full below, is an annex to the Memorandum of Understanding text that is being used to structure two or five year agreements for health funding between the US government and a range of countries around the world.¹ It has no provisions for reciprocity: signatories required to share specimens (for example tissue or blood samples, genetic information from a virus) cannot expect comparable information in return.

The agreement, reproduced in full below, does not appear to preclude countries from participating in the WHO Pandemic Agreement, which sets out principles, approaches and tools for coordinating global pandemic prevention, preparedness and response, including through “the equitable and timely access to vaccines, therapeutics and diagnostics.”²

As I explain later in the piece, a Pathogen Access and Benefits Sharing (PABS) annex to the Agreement that is a close analog to this bilateral is in the drafting phase, with work resuming next week.

By any name, these agreements are at the crux of global health security and equity, as high-quality specimens are often needed to design effective vaccines, tests and treatments which are, in turn, essential for preserving health and saving lives.

Under the terms of the US sharing agreement, America does not have any obligations to share data or specimens with co-signatories, nor do countries have access to or co-authorship on research based on materials they provide. Instead, the copy of the model agreement that I reviewed states:

In the event that a medical countermeasure is developed primarily from specimen and related data shared under this Agreement by [INSERT COUNTRY NAME], the U.S. Government, subject to the availability of funds and applicable law, shall prioritize any request by [INSERT COUNTRY NAME] for the medical countermeasure immediately behind the U.S. Government’s domestic need for such medical countermeasure and make best efforts to make such medical countermeasure available to [INSERT COUNTRY NAME] at prices equal to or below those paid by the U.S. Government.

This text is so rich with loopholes favoring the US that, to this addled mind, it conjures a “find the hidden object” game from Highlights, an American children’s magazine. (I’ve put one at the end in case you prefer that kind of game.)

Let’s start with “developed primarily from specimen and related data.” Effective counter measures have many components. With no definition of “primarily” the US could advance any number of arguments that a product which used genetic sequences from several countries, or included a range of other components, or a product repurposed from other usages is not one a country is entitled to—even if it shared information useful to development or identification of the product. The COVID vaccines, for example, were developed from samples from a number of countries; vaccine updates or boosters developed against variant strains of COVID-19, influenza or other viruses use an array of sequences to create a final product designed to provide the broadest possible protection.

In this agreement, the US will “prioritize any request” after its own needs have been met. There’s no clarity about how the request should be made, or how multiple countries might be prioritized. At the risk of stating the obvious, prioritizing a request is not committing to take action.

“Make best efforts” is another phrase empty of commitment or obligation. In this text, it’s applied to the act of making the commodity available at or below the cost that the US pays for it, subject to available funding. The US government pays the top of the market price for just about everything. (Witness the huge price differential on the injectable PrEP drug Lenacapavir, which is USD$28,000 in the US per person per year and $55 in low-income countries).³ There are no provisions for transfer of technology or intellectual property sharing to support local or regional manufacturing.

The sharing and access provisions are also entirely uni-directional. Countries will give their specimens and samples to the US. They receive nothing in return. As I wrote in my post on the data sharing agreement, this is not how sharing works.⁴

Like the data sharing agreement, the USG specimen sharing agreement is in place for 25 years after signing. But unlike the data sharing terms, this agreement can be cancelled with one year’s notice by either party—and does not then remain in force. Data sharing terms remain in place for another decade after cancellation.

Signed versions of these agreements will be included in the Memoranda of Understanding that the US government is racing to sign in high-priority sub-Saharan African countries—perhaps as early as December 1, World AIDS Day, and certainly by December 12.

December 1 is also the day that formal negotiations for the Pandemic Agreement annex on Pathogen Access and Benefit Sharing (PABS) resume, with informal sessions planned for November 23 and 24⁵ The US will not be present, as it withdrew from the World Health Organization and Pandemic Agreement negotiations on President Trump’s first day in office.⁶

While the US document allows signatories to participate in arrangements governed by the Pandemic Agreement, or other compacts, the US itself will not. If the US were to originate a product based on samples shared under this bilateral agreements, then the terms of the PABS will have little impact. But in a world where samples and specimens are freely shared, other countries can (and will) generate their own countermeasures. Knowledge of the terms of the US bilateral agreement raises the stakes of the PABS annex discussions even more.

The Pandemic Agreement was signed without the PABS annex in part this topic is at the crux of contentious, competing concerns. Low-income countries and the people who live in them need transparent, enforceable terms that ensure they will have access to life-saving measures when they are needed, at an affordable cost, for all who need them; high-income countries and private sector stakeholders do not disagree with this but continue to seek to preserve pathways to profit.

Many low-income country governments have received the specimen sharing agreement text as part of the US Memorandum of Agreement negotiation process. I do not know if the Africa Centers for Disease Control and Prevention or other regional groupings have, formally or informally, discussed what signing the agreements as is might mean. It’s also unclear how these specimen sharing agreements will impact in the context of existing, functional US covering comparable arrangements, such as the Materials Transfer Arrangements (MTAs) used by the Department of Health and Human Services.

But I do know that on November 21, as I finished this update, the Elders released a statement on this very topic. It is always wise to let this bold, esteemed group have the last word:

“[B]ilateral agreements giving access to pathogen data could fragment multilateral arrangements for pandemic preparedness and response, which are needed to keep all people safe from future threats.”⁷

MODEL SPECIMEN SHARING AGREEMENT BETWEEN ΤΗΕ GOVERNMENT OF THE UNITED STATES OF AMERICA ΑΝD THE GOVERNMENT OF [INSERT COUNTRY NAME]

PREAMBLE

The United States of America (U.S. Government) and [INSERT COUNTRY NAME] (together the “Parties”) seek to engage in a bilateral Specimen Sharing Agreement (“Agreement”).

Article 1. Purpose and Scope

a. The purpose of this Agreement is to promote global health security through the facilitation of the rapid sharing of specimens, samples, sequencing data, and any other associated data related to novel and emerging infectious diseases with epidemic or pandemic potential (”specimen and related data”) between the U.S. Government and [INSERT COUNTRY NAME] for legitimate public health purposes, including responding to outbreaks and the development of diagnostics and medical countermeasures.

Article 2. Specimen Sharing with the U.S. Government

a. Upon a request by the U.S. Government, [INSERT COUNTRY NAME] agrees to initiate sharing specimen(s) and related data with the U.S. Government within [five (5)] days of [INSERT COUNTRY NAME] receiving such a request from the U.S. Government or on an alternative timeline as mutually agreed to between the U.S. Government and [INSERT COUNTRY NAME] on a case-by-case basis. If requested by the U.S. Government, [INSERT COUNTRY NAME] may provide sequencing data via sharing on a public database instead of or in addition to directly sharing specimens and related data with the U.S. Government.

b. [INSERT COUNTRY NAME] consents to the U.S. Government sharing the specimen and related data for the purpose of developing diagnostics and medical countermeasures with up to [ten (10)] non-U.S. Government U.S. entities (“U.S. Recipients”), each of whom must have the capability to assist in developing diagnostics and/or medical countermeasures.

Article 3. Benefits to [INSERT COUNTRY NAME]

a. In the event that a medical countermeasure is developed primarily from specimen and related data shared under this Agreement by [INSERT COUNTRY NAME], the U.S. Government, subject to the availability of funds and applicable law, shall prioritize any request by [INSERT COUNTRY NAME] for the medical countermeasure immediately behind the U.S. Government’s domestic need for such medical countermeasure and make best efforts to make such medical countermeasure available to [INSERT COUNTRY NAME] at prices equal to or below those paid by the U.S. Government.

Article 4. Representations

a. Each Party affirms that its participation in any multilateral agreement or arrangement, including surveillance and laboratory networks, governing access and benefit sharing of human and zoonotic specimens and related data shall not prejudice its compliance with this Agreement.

b. [INSERT COUNTRY NAME] acknowledges that, pursuant to Section 4.7 of the Memorandum of Understanding between [INSERT COUNTRY NAME] and the U.S. Government, of [date] (MOU), so long as the U.S. Government is providing any funding under the MOU, the U.S. Government has a significant and material interest in ensuring that [INSERT COUNTRY NAME] fulfills the commitments for specimen and related data sharing set out in this Agreement and that failure by [INSERT COUNTRY NAME] to fulfill these commitments could result in changes in U.S. Government planned assistance contemplated under the MOU, the discontinuation of the MOU, or the termination of this Agreement by the U.S. Government.

Article 5. Additional Terms

a. Duration: This Agreement shall enter into force thirty (30) days after signature by both Parties and shall remain in force for [twenty-five (25)] years.

b. Termination: In the event the MOU is discontinued prior to December 31, [2030], either Party may terminate this Agreement upon giving one year’s written notice to the other Party. If the MOU is no longer in effect, either Party may terminate this Agreement with one year’s written notice to the other Party. In the event [INSERT COUNTRY NAME] terminates this agreement, termination shall not affect the use by the U.S. Government of any specimens and related data previously shared under this Agreement.

c. Amendments: This Agreement may be amended by mutual written consent of the Parties.

d. Notices: Any notice required under this Agreement is expected to be provided to:

For the U.S. Government For [INSERT COUNTRY NAME] Government

[INSERT NAME] [INSERT NAME]

[INSERT ADDRESS] [INSERT ADDRESS]

Either Party may, by notice in writing to the other Party, designate additional representatives or substitute other representatives for those designated in this Section. The Parties intend any notice, request or other communication under this Agreement to be in writing and delivered to the address specified in this Agreement or such other address as either Party may provide to the other Party.

e. Procedures for Sharing: The Parties agree that the transfer, use, management and control of specimens and related data shared under this Agreement will be carried out consistent with applicable laws of the United States, including protection of human subjects, and internationally recognized standards of specimen handling. A document specifying characteristics of specimens and related data may be completed at the time of specimen transfer between the sending entity in [INSERT COUNTRY NAME] and the U.S. Government receiving entity.

f. Other Sharing Permitted: This Agreement neither precludes new agreements nor negates or replaces existing agreements for sharing specimen and related data between the U.S. Government and [INSERT COUNTRY NAME].

g. Privileges and Immunities of the Parties: Nothing in or related to this Agreement shall be construed as a waiver, express or implied, of privileges and immunities accorded to either of the Parties, including the sovereign immunity of either of the Parties, under any applicable law or agreement.

h. Resolution of Differences: The Parties agree to resolve any differences between them arising from or in connection with the interpretation or performance of this Agreement through consultations between themselves.

DONE at [INSERT CITY NAME], on [DATE], in duplicate, in the English language.

FOR THE GOVERNMENT OF THE FOR THE GOVERNMENT OF

UNITED STATES OF AMERICA: [INSERT COUNTRY NAME]:

__________________________________ __________________________________

AMBASSADOR TO [INSERT COUNTRY NAME] [HEAD OF GOVERNMENT OR HIS OR HER

DESIGNEE]

Alt text: A black and white line drawing of two octopi playing table football, while a dog pokes its head out of a ball pit, a pig goes down a slide into the pit and a giraffe pokes its head out at the top of the slide. There are a lot of other things in the picture including a squirrel drinking a milkshake with a puppy straw and a kangaroo plus a kid in the pouch playing what might be “Dance dance revolution.” The title at the top is “At the Animal Arcade” and all around the margin there are pictures of things to find in the drawing like: a t-shirt, a crown, a shoe, a hockey stick. These things are actually pretty easy to find, as are the loopholes in the US government specimen sharing agreement text regarding country’s ability to access benefits like tests, treatments and vaccines. One of the octopi is losing and has kind of upset face. There’s a wheel with random numbers on the wall and an attraction no one is playing right next to it that says: Game Over.

1. https://emilysbass.substack.com/p/breaking-first-look-at-the-usg-draft

2. https://www.who.int/news/item/20-05-2025-world-health-assembly-adopts-historic-pandemic-agreement-to-make-the-world-more-equitable-and-safer-from-future-pandemics

3. https://www.idsociety.org/news--publications-new/articles/2025/hiv-preventive-treatment-could-be-sold-for-one-thousandth-of-current-list-price/

4. https://emilysbass.substack.com/p/exclusive-us-demands-log-in-credentials

5. https://www.who.int/about/governance/world-health-assembly/intergovernmental-working-group-on-the-who-pandemic-agreement

6. https://www.whitehouse.gov/presidential-actions/2025/01/withdrawing-the-united-states-from-the-worldhealth-organization/

7. https://theelders.org/news/elders-warn-against-bilateral-pandemic-deals-could-impact-multilateral-cooperation