— On March 24, 2020 the Antitrust Division of the United States Department of Justice (“Antitrust Division”) and the Federal Trade Commission (“FTC”) (together, “the Agencies”) released a joint statement regarding the COVID-19 pandemic (“Joint Statement”).Footnote 1 In their statement, the Agencies recognized the pandemic as a “national emergency” that has created a need for possible cooperation and coordination between organizations of any and all economic sectors,Footnote 2 and that those joint efforts required swift guidance to adequately address a quickly changing crisis.Footnote 3 Accordingly, the Antitrust Division and the FTC announced expedited timelines of their respective review procedures to organizations that requested for such review in matters related to COVID-19.Footnote 4
I. DEPARTMENT OF JUSTICE ANTITRUST BUSINESS REVIEW PROCESS
The Antitrust Division’s business review process provides a way for organizations to determine how the Antitrust Division may respond to a proposed joint venture or other types of cooperative business conduct.Footnote 5 Specifically, the purpose of this process is to provide an opportunity for parties who are concerned about the legality of their proposed business conduct to obtain guidance from the Antitrust Division regarding scope, interpretation, and application of federal antitrust laws (and only federal antitrust laws)Footnote 6 to the proposed conduct.Footnote 7 Ultimately, this review process aids parties in avoiding future complex legal issues and litigation.Footnote 8
While the Antitrust Division historically has had some type of business review procedure,Footnote 9 the modern process was first announced in 1992.Footnote 10 To request a business review, a party submits a request in writing to the Assistant Attorney General.Footnote 11 The Antitrust Division must then decide whether or not to consider the request.Footnote 12 Refusals usually occur when the request relates to ongoing, instead of proposed, business conduct.Footnote 13 Additionally, the Antitrust Division may refuse to review if the proposed conduct must be approved by a regulatory agency.Footnote 14 The number of granted Antitrust Division review requests (i.e., Antitrust Division issues a business review letter) varies each year. If the Antitrust Division does agree to consider a request, the Antitrust Division’s Office of Operations refers the request to the section or field office having jurisdiction over the product or service involved.Footnote 15 The requesting parties must also provide the Antitrust Division with all necessary information and documents related to the conduct and review process.Footnote 16
Generally, the amount of time it takes for the Antitrust Division to respond to business review requests depends on the complexity of the proposed conduct and the time required for the requesting parties to compile all the information the Antitrust Division seeks.Footnote 17 Regardless, after the Antitrust Division reviews, it will reply to the requesting parties via a business review letter that is signed by the Assistant Attorney General.Footnote 18 The business review letter includes the procedural history of the request, a description of the representations that the requesting parties made, a statement of the Antitrust Division’s enforcement intentions, and a description of how the Antitrust Division makes public the information in the business review file.Footnote 19 Most importantly to the requesting parties is the Antitrust Division’s enforcement intentions. Those intentions will generally be one of the following: 1.) the Antitrust Division does not presently intend to bring an enforcement action against the proposed conduct; 2.) the Antitrust Division declines to state its enforcement intentions and may or may not file suit if the proposed conduct happens; or 3.) the Antitrust Division will sue if the proposed conduct happens.Footnote 20 Notably, while the Antitrust Division remains free to bring a subsequent action,Footnote 21 the Antitrust Division has thus far never subsequently brought a criminal action (if there was full disclosure in the request) when it has stated in a business review letter that it did not intend to bring suit against the proposed conduct.Footnote 22
II. THE AGENCIES REVIEW PROCEDURES IN RESPONSE TO COVID-19
On January 31, 2020, the Department of Health and Human Services (“HHS”) declared COVID-19 to be a public health emergency;Footnote 23 on March 11, 2020, the World Health Organization declared COVID-19 to be a pandemic;Footnote 24 and on March 13, 2020, a national emergency was declared in the United States.Footnote 25 Two weeks later on March 24, 2020, with COVID-19 growing exponentially in the United StatesFootnote 26 (and in the world),Footnote 27 the Antitrust Division and FTC released the Joint Statement.Footnote 28
Most importantly, the Joint Statement indicated that the Agencies would commit to responding to review requests within seven calendar days of receiving all necessary information from the requesting parties in order to address the “rapidly evolving crisis.”Footnote 29 Seven calendar days is a substantial acceleration of the usual months-long time period between a review request and a response.Footnote 30
Also, crucially, the Agencies stated that they would account for the “exigent circumstances” COVID-19 had created in their evaluations of any proposed joint conduct requests.Footnote 31 Specifically, the Joint Statement expressly stated that certain “joint efforts, limited in duration and necessary to assist patients, consumers, and communities affected by COVID-19 and its aftermath, may be a necessary response to exigent circumstances that provide Americans with products or services that might not be available otherwise.”Footnote 32
Additionally, the Agencies detailed that where the government enlists help from private businesses in addressing COVID-19, the Agencies would assist such efforts to effectuate the Defense Production Act and Pandemic and All-Hazards Preparedness Act and to work with other government agencies.Footnote 33
The final part of the Joint Statement outlined specific procedures regarding how parties can request this expedited review with each respective agency.Footnote 34 Significantly, the Antitrust Division declared that its enforcement intentions provided in an expedited business review would only be in effect for one year from the date of the response. After one year, the requesting parties could subsequently again request the Antitrust Division for review under the expedited COVID-19 procedures to allow the Antitrust Division to reiterate its intention not to challenge the ongoing conduct.Footnote 35 Implicitly, this note creates an exception to the Antitrust Division’s usual rule of refusing to review requests that contain ongoing business conduct.Footnote 36
III. ANTITRUST DIVISION COVID-19 EXPEDITED REVIEW PROCESS IN PRACTICE: PERSONAL-PROTECTIVE EQUIPMENT DISTRIBUTORS
As of March 9, 2021, the Antitrust Division has granted review and responded to six requests for such expedited review under the COVID-19 policy announced in the Joint Statement.Footnote 37 The first of these granted expedited review requests was from McKesson Corporation (“McKesson”), Cardinal Health, Inc. (“Cardinal”), Owens & Minor (“OMI”), Medline Industries, Inc. (“Medline”), and Henry Schein, Inc. (“Henry Schein”) (together, “Requesting Parties”).Footnote 38
A. Expedited Review Request Letter
The Requesting Parties are all healthcare distributors of personal-protective equipment (“PPE”) and medications.Footnote 39 PPE includes masks, gowns, gloves, and other equipment designed to protect against infection. In their request letter to the Antitrust Division sent on March 30, 2020, the Requesting Parties asked for expedited treatment to confirm the legality of their “immediate efforts to expedite and increase manufacturing, sourcing and distribution of personal-protective equipment…intended to help protect first responders and other members of the medical community against Coronavirus-related infection.”Footnote 40 They noted that federal government agencies, including HHS and Federal Emergency Management Agency (“FEMA”), asked the Requesting Parties to use their industry expertise and contacts to address PPE supply chain shortages and apply their expertise to evaluate potential laboratory and medication supply issues.Footnote 41 The request letter specifically states ways the Requesting Parties planned on collaborating with each other, including identifying suppliers, distributing supplies to FEMA-designated COVID-19 hotspots, helping FEMA and HHS understand competitive prices for PPE supplies, and providing government agencies with data. The request letter also highlighted the need for the Requesting Parties to communicate with each other, even when government agencies were not on the call or email chain.Footnote 42
B. Review Granted: Expedited Business Review Letter
As promised in the Joint Statement, the Antitrust Division responded on April 4, 2020, five calendar days after the request was sent,Footnote 43 approving the proposed conduct.Footnote 44 In its approval, the business review letter specifically addresses both how the circumstances are “exceptionally pressing and unlikely to recur frequently” and how dangerous COVID-19 is to human life.Footnote 45 It found in its review that addressing the potential disruptions to the global PPE supply was central to the federal government’s efforts to save American lives and livelihoods.Footnote 46 In addition to the expedited nature of the response, the Antitrust Division again showed its willingness to make an exceptionFootnote 47 to its usual rule of refusing to review requests that contain on-going business conduct.Footnote 48 This exception was expressly allowed due to the “President’s declaration of a national emergency and the current exigencies” related to COVID-19.Footnote 49
In its finding, the Antitrust Division relied on three legal underpinnings to supports its intention to not challenge the Requesting Parties’ efforts to collaborate.Footnote 50 First, the Antitrust Division noted that conduct by federal agencies is not subject to antitrust scrutiny, and that courts have extended that immunity to conduct by private parties when (i) the collaboration is compelled by an agreement with a federal agency or a clearly defined federal government policy, and (ii) a federal agency supervises the conduct;Footnote 51 alternatively, if the conduct does not meet that standard, it would still not be violative of antitrust laws if the collaboration offered “unique benefits.”Footnote 52 The Antitrust Division then explicitly stated that it would assess the efforts to address COVID-19 and its aftermath as consideration for such “unique benefits.”Footnote 53 In its evaluation of the Requesting Parties’ request, the Antitrust Division noted many of the proposed and on-going collaborative activities were under the direction and supervision off FEMA and HHS.Footnote 54 Additionally, the Antitrust Division explained such collaboration efforts were directly related to COVID-19 and limited in duration and scope.Footnote 55 Finally, the Antitrust Division found the proposed and ongoing conduct to offer “unique procompetitive benefits under the exigent circumstances presented by COVID-19 that outweigh any hypothetical anticompetitive harm.”Footnote 56
Second, the Antitrust Division concluded the conduct likely did not raise competitive issues, even if such conduct did not directly involve a government agency’s presence.Footnote 57 It noted that
[A]s time is of the essence given the current circumstances…it may not be possible for FEMA representatives to be included in all discussions…Therefore, activities that occur outside of FEMA’s presence are treated as encompassed within the scope of this business review letter to the extent that they are necessary to facilitate FEMA’s directions… [emphasis added].Footnote 58
Next, the Antitrust Division wrote that the collaboration would be evaluated under the rule of reason because none of the proposed conduct falls under price-fixing or market allocation,Footnote 59 and that the collaboration efforts proposed were limited in scope and duration, necessary to specifically address COVID-19-related scarcity.Footnote 60 The letter noted that consumers may benefit from this proposed collaboration, as it enables the Requesting Parties to bring “life-saving goods faster to market than would be possible absent coordination,”Footnote 61 and that “these benefits have the potential to save lives and limit the tremendous damage physically and economically the pandemic is causing.”Footnote 62 Accordingly, the Antitrust Division found the proposed conduct to be necessary and in support of governmental agencies’ responses to the pandemic.Footnote 63 Thus, the “procompetitive aspects of this arrangement far outweigh any potential harm [emphasis added].”Footnote 64
Finally, the Antitrust Division found that other antitrust exemptions and immunities may apply to the proposed conduct.Footnote 65 First, the Antitrust Division found that Noerr-Pennington immunity likely applies.Footnote 66 Put simply, Noerr-Pennington immunity doctrine is a limited exemption from antitrust liability for conduct done in an attempt to influence government activity. The Antitrust Division found the proposed conduct described efforts to influence governmental agencies’ decisions regarding policy of expediting health and medical resources in response to COVID-19.Footnote 67 Second, the Antitrust Division found that the Requesting Parties’ proposed conduct may have implied immunity.Footnote 68 Courts can hold certain conduct immune from antitrust liability when application of antitrust laws would disrupt or be repugnant to a regulatory scheme.Footnote 69 The Antitrust Division found that the proposed conduct in this request met several factors that the Supreme Court requires in finding conduct immune to antitrust laws, such as FEMA’s and HHS’s regulatory authority and direction under that authority.Footnote 70 “If particular activities ‘would produce conflicting guidance, requirements, duties, privileges, or standards of conduct,’ and the possible conflict is within an area that the pandemic laws seek to regulate, then implied immunity may cover those activities.”Footnote 71
IV. IMPLICATIONS
The expedited review process is a novel solution created in the face of a novel public health crisis. This unique expedited process at the Antitrust Division is likely to remain in place as the battle against COVID-19 continues. After an almost full year of this policy being in place, a few trends have started to appear, refining this antitrust legal development.
A. Use of the Antitrust Division’s Business Review Process Has Increased
One notable trend that has occurred is that the usage of the Antitrust Division’s business review process has increased. Prior to March 24, 2020, when the Joint Statement was issued, there were very few granted Antitrust Division review requests.Footnote 72 The 1990s produced 20 or more business review letters annually, but that number has steadily declined.Footnote 73 2000 was the last year there were at least ten business review letters.Footnote 74 In 2015, 2016, 2017, and 2019, there was only one issued business review letter,Footnote 75 and there were none in 2018.Footnote 76 In 2020, prior to the Joint Statement, there was one business review letter issued for a request made in 2019.Footnote 77 This decline cannot be attributed to a single particular reason.Footnote 78
However, after the Joint Statement, in 2020, there were eight business review letters issued in response to eight different request letters, including the McKesson-Cardinal-OMI-Medline-Henry Schein request.Footnote 79 Of these eight reviews, five were COVID-19 expedited reviews.Footnote 80 This increased usage of the Antitrust Division’s business review process remains a trend. As of March 9, 2021, there have been three business review letters issued in 2021,Footnote 81 with only one of those three being a COVID-19-related expedited request.Footnote 82 Furthermore, as each expedited business review letter approval is only good for one year,Footnote 83 and with the COVID-19 crisis still ongoing,Footnote 84 parties will soon need to resubmit a request letter for new review under the expedited process if their conduct is still ongoing.Footnote 85
B. The Antitrust Division Is Willing to Review Ongoing-Conduct
This expedited process announced in response to COVID-19 also demonstrates the Antitrust Division’s flexibility with its business review process in order to adequately address the special needs that the pandemic has created. Specifically, in response to the pandemic, the Antitrust Division has shown a willingness to make an exception for its general rule of refusing to review any ongoing conduct.Footnote 86 As seen in the McKesson-Cardinal-OMI-Medline-Henry Schein request, the Antitrust Division still granted review and issued a business review letter despite the fact that some of the proposed conduct was already ongoing. Furthermore, by its own proclamation, the Antitrust Division’s intention to not challenge proposed COVID-19 related conduct only lasts for one calendar year,Footnote 87 and that it expressly invites parties to resubmit a request for new review, impliedly demonstrating that the Antitrust Division will review ongoing conduct if it relates to COVID-19.Footnote 88
C. Proposed Conduct Due to COVID-19 Will Likely Be Approved
The McKesson-Cardinal-OMI-Medline-Henry Schein request was the firstFootnote 89 of six granted requests (as of March 9, 2021) for expedited review under the COVID-19 policies announced in the Joint Statement.Footnote 90 More significantly, all six requests have been approved (i.e., the Antitrust Division stated it does not intend to challenge the proposed conduct).Footnote 91 Four of these six requests directly addressed COVID-19:
1). McKesson-Cardinal-OMI-Medline-Henry Schein request;Footnote 92
2). AmerisourceBergen, an American distributor of medications and other healthcare products, submitted a substantially similar request as the McKesson-Cardinal-OMI-Medline-Henry Schein request;Footnote 93
3). Pharmaceutical companies (Eli Lilly, AbCellera Biologics, Amgen, AstraZeneca, Genentech, and GSK) developing antibodies for COVID-19 treatment submitted a request letter proposing to exchange information regarding manufacturing facilities and raw materials to expand production;Footnote 94 and
4). Biopharmaceutical companies (Baxalta, Emergent BioSolutions, Grifols Therapeutics, and CSL Plasma) developing plasma therapies targeting COVID-19 submitted a request letter to work together to help the government develop Quality Assurance parameters for such COVID-19 treatments;Footnote 95
The other two requests were more tangentially related to COVID-19 yet still were approved:
1). The National Pork Producers Council submitted a request outlining proposed conduct of its members working together to assist the USDA in depopulating excess hogs (due to COVID-19 forced closures of pork packing facilities) and sharing information amongst its members regarding best practices for depopulating those unmarketable hogs;Footnote 96 and
2). ecoHair Braiders Association, a voluntary membership association that provides training and support to individual hair braiders, hair braiding schools, and hair braiding salons, submitted a request letter to allow its members to work together to create COVID-19 policies and trainings.Footnote 97
These approvals demonstrate the Antitrust Division’s commitment to its original statement that it is “committed to providing individuals and businesses in any sector of the economy that are responding to this national emergency…[emphasis added].”Footnote 98 It is not just organizations directly associated with combating COVID-19, such as PPE and pharmaceutical companies, that are receiving the benefits of expedited business reviews. The approval of the two more tangentially COVID-19 related issues also demonstrates the Antitrust Divisions’ recognition of the impact that the pandemic has had outside of traditional health concerns.
The Antitrust Division may also be more comfortable approving such conduct because of the various safeguards in place for COVID-19 related collaborations. Most of these requests involve a government agency that both requested the conduct and was prepared to oversee the coordination efforts.Footnote 99 Furthermore, the Antitrust Division seems to be committed to aiding any and all government agencies in an effort to address COVID-19.Footnote 100 The limited duration and scope of the proposed conduct combined with the requisite need to submit a new review after a calendar year is yet another safeguard that offers the Antitrust Division more comfort and flexibility in stating its intentions not to challenge proposed conduct under this process.Footnote 101
D. How Other Antitrust Doctrines May Be Applied to a Public Health Crisis
Traditionally, business review letters are fact and industry-specific and generally not overwhelmingly confirmatory; thus, they do not often provide detailed guidance for organizations at large.Footnote 102 However, the legal analyses found in the expedited business review letters provide a glimpse of how antitrust law may more broadly be applied to various types of collaborative arrangements in the face of a national public health emergency.
First, the Antitrust Division has demonstrated its willingness to assist private organizations in their work with other government agencies and to account for such relationships when reviewing any proposed conduct. In the Joint Statement, the Agencies stated “where the government enlists help from private businesses in addressing COVID-19, the Agencies stand ready to assist, such as by working with the Department of Health and Human Services…along with other agencies working to address COVID-19.”Footnote 103 The Antitrust Division appears to confirm this appeasement in many of its expedited business review letters.Footnote 104
Second, as COVID-19 should limit any proposed conduct outlined in a request letter in both duration and scope, unless the conduct obviously falls under per se antitrust violations of price-fixing or market allocation, activities will likely be evaluated under rule of reason.Footnote 105
Finally, the Agencies made clear in its Joint Statement that certain exemptions or immunities may apply to collaborative conduct in response to COVID-19. The Joint Statement specifically mentioned that antitrust laws permit private lobbying to solicit governmental action in passing and enforcing laws and policies in response to COVID-19.Footnote 106 The McKesson-Cardinal-OMI-Medline-Henry Schein Expedited Review Letter further expanded on the various types immunities availed to the parties during this public health crisis, including Noerr-Pennington and implied immunity.Footnote 107
V. CONCLUSION
The Antitrust Division expedited business review process is a continuing and developing legal solution that has and continues to provide necessary guidance to organizations and brings necessary help to the greater public during this public health emergency.