Executive Order 13944

WTO Government Procurement — proposed action by the United States to modify obligations of the central government on medicines and medical goods contained in Annex 1

On November 27, 2020, the United States filed two documents with the WTO’s Committee on Government Procurement. Each proposed modifications to Annex 1 of the U.S. schedule of commitments under the GPA dealing with central government agency/entity procurements. Proposed modification to Appendix 1 of the United States under the 1994 Agreement on Government Procurement, GPA/MOD/USA/17; Proposed modification to Appendix 1 of the United States under the Revised Agreement on Government Procurement, GPA/MOD/USA/18. As the title of the submission indicates, the U.S. proposed modifications pertain to Annex 1 commitments of the U.S. which are central government commitments only. Thus, for the 1994 Agreement, Annexes 2-5 are not in play with Annex 2 dealing with sub-central government entities being the relevant other major Annex (Annex 1: central government entities; Annex 2: sub-central government entities;
Annex 3: other entities; Annex 4: services; Annex 5: construction services). On the revised Agreement there are seven Annexes, of which only Annex 1 on center government entities is covered by the U.S. proposed modification (Annex 1: central government entities; Annex 2: sub-central government entities; Annex 3: other entities; Annex 4: goods; Annex 5: services; Annex 6: construction services; Annex 7: general notes).

While both U.S. proposed modification documents are presently restricted (and hence not available to the public), the notices constitute USTR following the requirements of Executive Order 13944 of August 6, 2020 to take steps within 30 days after the Food and Drug Administration had published its list of drugs and active pharmaceutical ingredients that are essential. See Executive Order 13944 of August 6, 2020, Combating Public Health Emergencies and Strengthening National Security by Ensuring Essential Medicines, Medical Counter- measures, and Critical Inputs Are Made in the United States, 85 Fed. Reg. 49,929 – 49-934 (August 14, 2020). USTR’s obligations extend beyond the WTO and include any trade agreements with government procurement commitments. But for purposes of this post, I am focusing just on the WTO Agreement on Government Procurement (1994 and Revised). The Executive Order is embedded below but is an effort to address perceived supply chain problems and “over reliance” on imported product including active pharmaceutical ingredients (“APIs”).

FR-of-EO-13944

While the United States is a major pharmaceutical research and development country, U.S. pharmaceutical companies have moved much API production offshore as well as finished product production. China and India are the largest suppliers of APIs to the United States. With the challenges of the COVID-19 pandemic, the Trump Administration has pursued efforts to onshore manufacturing of essential medical products including through the Executive Order 13944. See, e.g., Datex, Onshoring U.S. Pharmaceutical Manufacturing:COVID-19, Congress and Puerto Rico Pharma Hub, Ideas for returning pharmaceutical manufacturing to the U.S., https://www.datexcorp.com/onshoring-u-s-pharmaceutical-manufacturing-covid-19-congress-and-puerto-rico-pharma-hub/; Fierce Pharma, June 3, 2020, U.S. seeks to onshore drug production in response to COVID-19. Is pharma even interested?, https://www.fiercepharma.com/manufacturing/pharma-pushes-back-u-s-legislation-to-bring-drug-manufacturing-stateside; Policy & Medicine, August 26, 2020, Trump Signs Executive Order Regarding Medical Supply Chain,https://www.policymed.com/2020/09/trump-signs-executive-order-regarding-medical-supply-chain.html.

While onshoring is not supported by pharmaceutical companies and has been cited as not likely cost-effective or necessary to address the current or future pandemics, to date both the Trump Administration and President-elect Biden have expressed support for at least some onshoring to ensure greater availability of medicines and materials. See, e.g., S&P Global Market Intelligence, October 15, 2020, US drug onshoring is more complex than Trump, Biden political pitches – experts, https://www.spglobal.com/marketintelligence/en/news-insights/latest-news-headlines/us-drug-onshoring-is-more-complex-than-trump-biden-political-pitches-8211-experts-60714320.

Deputy Director-General Alan Wolff in a statement to the World Economic Forum on November 12, 2020 reviewed some of the reasons for WTO Members not to put excessive reliance on onshoring and to use supply chains and strengthen them. See WTO, 12 November 2020, DDG Wolff calls for new initiatives to cut tariffs on medical supplies and equipment, https://www.wto.org/english/news_e/news20_e/ddgaw_12nov20_e.htm.

On the feasibility of localization

“Trade this year has proved to be essential to meet the world’s needs for medical supplies. National stockpiles proved inadequate. Investment was only part of the answer.

“Trade played a critical role in meeting the vastly increased demand for medical goods and medicines. WTO data show that trade in personal protective equipment (PPE) more than doubled from May 2019 to May 2020. It was a key factor in creating supply resilience, even though some shortages persist even in advanced economies.

“Purely domestic supply chains would have been unable to meet a surge in demand of the suddenness and magnitude experienced. Export controls may have exacerbated the problems, even though many have been subsequently rolled back.

“It appears that the shock persisted in policymakers’ minds in many countries, following initial calls for re-shoring manufacturing production for key products.

“Supporters of localization tend to portray it as risk-free. This is wrong. Concentrating industry at home might insulate it from turbulence elsewhere, but the domestic sources of supplies are more vulnerable to localized disruptions, such as from a hurricane or an outbreak of disease. In addition, the economics dictate that complete self-sufficiency is unworkable for any country, rich or poor.

“Deep and diversified international markets offer the most promising and cost-effective path to supply resilience. But its viability will hinge on whether countries and their citizens feel that international markets can be trusted in a crisis

On reliance on global supply chains

“Economics will be the key determinant of the resilience of international supply chain.

“If countries can be confident that they will be able to rely on international markets for imports when they need them, they will have less reason to restrict exports.

“The preliminary evidence suggests that moves to diversify supply chains have primarily seen production shift from one low-cost country to another.

“Increasingly sophisticated machines have already been diminishing the importance of labor cost arbitrage in the choice of manufacturing location.

“Productivity will be a key determinant of which firms are able to go compete internationally.

“A few years ago, the Brookings Institution looked at five key determinants of the manufacturing environment: 1) overall policies and regulations; 2) tax policy; 3) energy, transportation, and health costs; 4) workforce quality; and 5) infrastructure and innovation. It is instructive that when the study made recommendations for how to improve the manufacturing environment, at the top of their list was political and economic predictability, including open trade policies.

“On shoring and near-shoring have to obey these economic rules if they are going to play an increasing role in national choices.”

U.S. commitments in Annex 1 of the 1994 GPA and the Revised GPA

The U.S. commitments under the GPA include purchases by the Departments of Health and Human Services and of Defense. The two sets of Annex 1 obligations (1994 GPA; revised GPA) are embedded below.

GPA-1994-usa1

rev_usa1e

The Food and Drug Administration list of essential pharmaceutical and other medical products is embedded below and constitutes what is presumably being proposed for withdrawal from coverage of the GPA 1994 and revised GPA in the U.S. Annex coverage. It is a long list of products, if, as assumed, it is the FDA list that has been put forward.

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Modification of Annexes under the WTO 1994 GPA and under the WTO revised GPA

While the WTO’s Agreement on Government Procurement envisions expanded coverage over time by signatories, both the original agreement and the revised agreement provide for possible modifications of the Agreement with rebalancing of benefits for other countries or retaliation where action is taken without rebalancing. The 1994 Agreement in Article XXIV:6 provides for rectifications and modifications of commitments:

Article XXIV: Final Provisions

* * *

“6.     Rectifications or Modifications

“(a)    Rectifications, transfers of an entity from one Annex to another or, in exceptional cases, other modifications relating to Appendices I through IV shall be notified to the Committee, along with information as to the likely consequences of the change for the mutually agreed coverage provided in this Agreement. If the rectifications, transfers or other modifications are of a purely formal or minor nature, they shall become effective provided there is no objection within 30 days. In other cases, the Chairman of the Committee shall promptly convene a meeting of the Committee. The Committee shall consider the proposal and any claim for compensatory adjustments, with a view to maintaining a balance of rights and obligations and a comparable level of mutually agreed coverage provided in this Agreement prior to such notification. In the event of agreement not being reached, the matter may be pursued in accordance with the provisions contained in Article XXII.
 

“(b)    Where a Party wishes, in exercise of its rights, to withdraw an entity from Appendix I on the grounds that government control or influence over it has been effectively eliminated, that Party shall notify the Committee. Such modification shall become effective the day after the end of the following meeting of the Committee, provided that the meeting is no sooner than 30 days from the date of notification and no objection has been made. In the event of an objection, the matter may be pursued in accordance with the procedures on consultations and dispute settlement contained in Article XXII. In considering the proposed modification to Appendix I and any consequential compensatory adjustment, allowance shall be made for the market-opening effects of the removal of government control or influence.”

The revised Agreement has more detailed provisions for modifications and rectifications contained in Article XIX:

Article XIX — Modifications and Rectifications to Coverage Notification of Proposed Modification

“1. A Party shall notify the Committee of any proposed rectification, transfer of an entity from one annex to another, withdrawal of an entity or other modification of its annexes to Appendix I (any of which is hereinafter referred to as ‘modification’). The Party proposing the modification (hereinafter referred to as ‘modifying Party’) shall include in the notification:

“a. for any proposed withdrawal of an entity from its annexes to Appendix I in exercise of its rights on the grounds that government control or influence over the entity’s covered procurement has been effectively eliminated, evidence of such elimination; or

“b. for any other proposed modification, information as to the likely consequences of the change for the mutually agreed coverage provided for in this Agreement.

“Objection to Notification

“2. Any Party whose rights under this Agreement may be affected by a proposed modification notified under paragraph 1 may notify the Committee of any objection to the proposed modification. Such objections shall be made within 45 days from the date of the circulation to the Parties of the notification, and shall set out reasons for the objection.

“Consultations

“3. The modifying Party and any Party making an objection (hereinafter referred to as “objecting Party”) shall make every attempt to resolve the objection through consultations. In such consultations, the modifying and objecting Parties shall consider the proposed modification:

“a. in the case of a notification under paragraph 1(a), in accordance with any indicative criteria adopted pursuant to paragraph 8(b), indicating the effective elimination of government control or influence over an entity’s covered procurement; and

“b. in the case of a notification under paragraph 1(b), in accordance with any criteria adopted pursuant to paragraph 8(c), relating to the level of compensatory adjustments to be offered for modifications, with a view to maintaining a balance of rights and obligations and a comparable level of mutually agreed coverage provided in this Agreement.

“Revised Modification

“4. Where the modifying Party and any objecting Party resolve the objection through consultations, and the modifying Party revises its proposed modification as a result of those consultations, the modifying Party shall notify the Committee in accordance with paragraph 1,and any such revised modification shall only be effective after fulfilling the requirements of this Article.

“Implementation of Modifications

“5. A proposed modification shall become effective only where:

“a. no Party submits to the Committee a written objection to the proposed modification within 45 days from the date of circulation of the notification of the proposed modification under paragraph 1;

“b. all objecting Parties have notified the Committee that they withdraw their objections to the proposed modification; or

“c. 150 days from the date of circulation of the notification of the proposed modification under paragraph 1 have elapsed, and the modifying Party has informed the Committee in writing of its intention to implement the modification.

“Withdrawal of Substantially Equivalent Coverage

“6. Where a modification becomes effective pursuant to paragraph 5(c), any objecting Party may withdraw substantially equivalent coverage. Notwithstanding Article IV:1(b), a withdrawal pursuant to this paragraph may be implemented solely with respect to the modifying Party. Any objecting Party shall inform the Committee in writing of any such withdrawal at least 30 days before the withdrawal becomes effective. A withdrawal pursuant to this paragraph shall be consistent with any criteria relating to the level of compensatory adjustment adopted by the Committee pursuant to paragraph 8(c).

“Arbitration Procedures to Facilitate Resolution of Objections

“7. Where the Committee has adopted arbitration procedures to facilitate the resolution of objections pursuant to paragraph 8, a modifying or any objecting Party may invoke the arbitration procedures within 120 days of circulation of the notification of the proposed modification:

“a. Where no Party has invoked the arbitration procedures within the time-period:

“i. notwithstanding paragraph 5(c), the proposed modification shall become effective where 130 days from the date of circulation of the notification of the proposed modification under paragraph 1 have elapsed, and the modifying Party has informed the Committee in writing of its intention to implement the modification; and

“ii. no objecting Party may withdraw coverage pursuant to paragraph 6.

“b. Where a modifying Party or objecting Party has invoked the arbitration procedures:

“i. notwithstanding paragraph 5(c), the proposed modification shall not become effective before the completion of the arbitration procedures;

“ii. any objecting Party that intends to enforce a right to compensation, or to withdraw substantially equivalent coverage pursuant to paragraph 6, shall participate in the arbitration proceedings;

“iii. a modifying Party should comply with the results of the arbitration procedures in making any modification effective pursuant to paragraph 5(c); and

“iv. where a modifying Party does not comply with the results of the arbitration procedures in making any modification effective pursuant to paragraph 5(c), any objecting Party may withdraw substantially equivalent coverage pursuant to paragraph 6, provided that any such withdrawal is consistent with the result of the arbitration procedures.

“Committee Responsibilities

“8. The Committee shall adopt:

“a. arbitration procedures to facilitate resolution of objections under paragraph 2;

“b. indicative criteria that demonstrate the effective elimination of government control or influence over an entity’s covered procurement; and

“c. criteria for determining the level of compensatory adjustment to be offered for modifications made pursuant to paragraph 1(b) and of substantially equivalent coverage under paragraph 6.”

Likely consultations with trading partners will extend into Biden Administration

Considering the list of other GPA signatories, it is certain that a number of signatories will seek compensation from the United States or will pursue retaliation if the U.S. proposed modifications take effect. Assuming a desire by one or more signatories to seek rebalancing and/or to pursue retaliation, the timing of implementation of the modifications appear to vary based on the relevant Agreement but will almost certain extend into the Biden Administration after January 20.

Thus, while the incoming Biden Administration intends to have its focus on domestic challenges in the early part of its first term, the modification of U.S. WTO GPA commitments is another example of an important trade issue that will require focus in the early days of the new Administration.

Conclusion

During the COVID-19 pandemic there has been concern both within the Trump Administration and in the U.S. Congress about the shortages of personal protective equipment and the high reliance on offshore production of APIs and essential medicines for the treatment of patients with COVID-19 in the United States. The concern on domestic capabilities is held by both Republicans and Democrats and has been identified as an issue of importance to the incoming Biden Administration. While there is opposition from the pharmaceutical companies and certainly concerns from economists and some policy professionals about over reliance on onshoring, the United States has been taking some actions to encourage onshoring. The Executive Order 13944 addresses U.S. government procurement of essential medicines and other medical goods.

Action last week by USTR in submitting proposed modifications to its Annex 1 commitments under the 1994 GPA and the revised GPA is a necessary step to comply with WTO obligations if a change in coverage is to occur. Because of the likely actions of trading partners in the coming weeks and months, the Biden Administration, if it chooses to move forward with the Trump Administration initiative, will face an important WTO task in the early months of the new Administration to negotiate a rebalancing of commitments or face retaliation by WTO GPA partners. Similar obligations and needs will be present in FTAs that include government procurement commitments as well. This increases the importance for the Biden Administration to fill the USTR posts early as well.