Authors

How global regulations are written

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By Kevin Outterson

In secret, during “trade” negotiations. Just one example: the 12 years of data exclusivity for biologics is currently US law, but that may get carved into stone in the new Trans-Atlantic Trade and Investment Partnership (TIIP). Once enshrined in a trade agreement, this rule and thousands more will be immune to change by any national democratic process.

Who participates in this process? Generally, only “cleared advisors” from the Fortune 500.

A partial (leaked) list of the initial bargaining positions for the EU are downloadable here. In the Initial Positions Papers, the EU notes that they have approved 16 biosimilars which have not yet been recognized as such in the US. Other topics include generic approvals, GMP inspections, and regulatory science for drug approvals.

All of decisions have immense potential impact for consumer welfare. My concern is the undemocratic lack of transparency for the entire process.

(cross-posted from TIE)
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Politics after a SCOTUS decision

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Some SCOTUS opinions stir up politics and legislation (think: Roe v Wade). Others tend to end the process. When the Court is interpreting a federal statute, if they get it “wrong” it is of course possible for the elected branches to reverse them. But for some of these issues, political stalemate in Congress gives the Justices the last word, perhaps for decades.

Which makes the Roberts Court both activist and powerful.

For more, see “Political gridlock empowers US justices” in today’s Financial Times, quoting me.

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Maintenance of Effort in Maine

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After the NFIB decision in June, Maine tried to expand Justice Roberts’ remedy to also make the “maintenance of effort” provision optional for states. Maine was unsuccessful in the First Circuit with the argument, for procedural reasons.  Prior coverage here.

The Obama Administration is sticking to the letter of the law, and announced Tuesday that it is refusing to allow cuts for Medicaid beneficiaries at or below 133% (138% after the 5% income disregard) of FPL in Maine.

Maine has not yet announced whether it will take the case back to the First Circuit. With Huberfeld & Leonard, we’ve argued at length (see esp. pp. 75-83) that Maine does not have the winning argument, in an article to be published in the BU Law Review later this month. SSRN version here. The short version is that MOE is a common tool to lock-in states during transition to a new program, was discussed in the briefing, but was not part of the coercion analysis in Justice Roberts’ plurality. The key provision was 42 USC 1396c, the Secretary’s authority to reduce some or all of the funding to non-compliant states. But we will see if Maine wants to argue the substance of this point at the First Circuit.

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BU Law Conference on New Legal Challenges to Global Tobacco Control, Jan. 25, 2013

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Boston is a great city for health policy. On Jan. 25, BU Law hosts a conference on New Legal Challenges to Global Tobacco Control. Just a month later, Harvard hosts its own conference on the Global Governance of Tobacco (details here).

The BU Law conference  (announcement here; detailed schedule here) will focus on challenges rooted in constitutional law (First Amendment litigation in the US attacking FDA-required graphic images on tobacco packs); trade mark law (plain packaging in Australia); and global trade and investment treaties such as the Hong Kong-Australia Bilateral Investment Treaty and the WTO Agreements.  Speakers include some of the world’s leading public health experts on this topic:

  • Matthew Allen, Allen + Clarke Policy and Regulatory Specialists
  • Micah Berman, New England School of Law
  • Scott Burris, Temple University Beasley School of Law
  • Julien Chaisse, The Chinese University of Hong Kong
  • Richard Daynard, Northeastern University School of Law
  • Samantha Graff, NPLAN
  • Jane Kelsey, University of Auckland Faculty of Law
  • Lara Khoury, McGill University Faculty of Law
  • Mark Levin, University of Hawai’i at Manoa William S. Richardson School of Law
  • Jonathan Liberman, Cancer Council Victoria
  • Benn McGrady, Georgetown University Law Center
  • Ted Mermin, Public Good Law Center
  • Kevin Outterson, BU School of Law
  • Robert Stumberg, Georgetown University Law Center
  • Allyn Taylor, Georgetown University
  • Tania Voon, University of Melbourne Law School
  • George Annas, BU School of Law and BU School of Public Health
  • Leonard Glantz, BU School of Law and BU School of Public Health
  • Wendy Mariner, BU School of Law and BU School of Public Health
  • Alexandra Roberts, BU School of Law
  • Keynote Speaker: Dr. Michael Siegel, BU School of Public Health

The conference is open to everyone; see the schedule for details. The conference papers will be published in the American Journal of Law & Medicine.

More religious objections to contraception coverage

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I wrote last week (at TIE) that corporations might have First Amendment or RFRA religious rights to object to contraception coverage. Now we have a second federal judge agreeing, this time on behalf of Tyndale Bible Publishers (complaint here; preliminary injunction here). The short answer:

The plaintiffs have therefore shown that the contraceptive coverage mandate substantially burdens their religious exercise.

The Tyndale opinion again focuses on the rights of the owners of the company (here, a family foundation) rather than the company itself:

This Court, like others before it, declines to address the unresolved question of whether for-profit corporations can exercise religion within the meaning of the RFRA and the Free Exercise Clause. See, e.g., First Nat’l Bank v. Bellotti, 435 U.S. 765, 777–78 n.14 (1978) (recognizing that corporations have First Amendment speech rights, but declining to “address the abstract question whether corporations have the full measure of rights that individuals enjoy under the First Amendment”); Stormans, Inc. v. Selecky, 586 F.3d 1109, 1119 (9th Cir.2009) (“We decline to decide whether a for-profit corporation can assert its own rights under the Free Exercise Clause …”); Church of Scientology of Cal. v. Cazares, 638 F.2d 1272, 1280 n.7 (5th Cir.1981) (same). Instead, the Court will assess whether Tyndale has standing to assert the free exercise rights of its owners…

Viewing the rights of Tyndale’s owners (in particular, those of the Foundation) as the basis for its RFRA claim, the Court finds that Tyndale has made a satisfactory showing of Article III standing.

The court also found “third party standing”

It bears emphasizing that if the Court accepted the defendants’ position, no Tyndale entity would have standing to challenge the contraceptive coverage mandate—not even the Foundation. This is because, in the defendants’ view, Tyndale—though directly injured by the regulation—cannot exercise religion, and the Foundation—though capable of exercising religion—is not directly injured by the regulation. The third-party standing doctrine serves to avoid such conundrums.

These cases are serious, but the threat is to mandatory contraception coverage, not the entire ACA.

Cross-posted from TIE

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