Staff from the Federal Trade Commission, Canada’s Competition Bureau, the European Commission Directorate General for Competition, the U.K.’s Competition and Markets Authority, the U.S. Department of Justice’s Antitrust Division, and Offices of State Attorneys General has issued a notice seeking public comment to inform their review of how to best update their approaches to analyzing the effects of pharmaceutical mergers.
The agencies announced in March that they have launched a working group, now called the Multilateral Pharmaceutical Merger Task Force, to identify concrete and actionable steps to review and update the analysis of pharmaceutical mergers. This project will ensure that FTC investigations include fresh approaches that fully analyze and address the varied competitive concerns that these mergers and acquisitions raise. It taps expertise from competition authorities with whom the FTC cooperates frequently, as well as others with relevant experience.
“Public input is critical to the process of refreshing our approach pharmaceutical mergers,” said Acting Chairwoman Slaughter. “In the face of skyrocketing drug prices and ongoing concerns about anticompetitive conduct by pharmaceutical companies, we need to ensure that our investigations fully capture the potential impact on prices, quality, access, drug supply chain resilience, capital market investment, and innovation for new drugs.”
Task Force members encourage the public, including health policy experts, economists, attorneys, scientists, health care practitioners, academics, and consumers, to share ideas that will lead to the development of future enforcement and policy efforts. Accordingly, the Task Force poses these general questions, and encourages the public to submit comments on other issues concerning the effect of pharmaceutical mergers:
- What theories of harm should enforcement agencies consider when evaluating pharmaceutical mergers, including theories of harm beyond those currently considered?
- What is the full range of a pharmaceutical merger’s effects on innovation? What challenges arise when mergers involve proprietary drug discovery and manufacturing platforms?
- In pharmaceutical merger review, how should we consider the risks or effects of conduct such as price setting practices, reverse payments, and other ways in which pharmaceutical companies respond to or rely on regulatory processes?
- How should we approach market definition in pharmaceutical mergers, and how is that implicated by new or evolving theories of harm?
- What evidence may be relevant or necessary to assess, and if applicable, challenge a pharmaceutical merger based on any new or expanded theories of harm?
- What types of remedies would work in the cases to which those theories are applied?
- What factors, such as the scope of assets and characteristics of divestiture buyers, influence the likelihood and success of pharmaceutical divestitures to resolve competitive concerns?
For instructions on filing public comments, please see the notice requesting public comment. Comments will be posed to regulations.gov.