On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
Supreme Court Issues Long-Awaited Health Reform Decision: Upholds Entire Law, but Imposes Certain Restrictions on Medicaid Expansion
A brief description of the Court’s analysis with respect to each of the questions presented follows.
Constitutionality of Individual Mandate. Chief Justice Roberts concluded that requiring individuals to obtain “minimum essential coverage” or pay a penalty is a valid exercise of Congress’ Taxing power. Four of the five Justices—Ginsburg, Breyer, Sotomayor, and Kagan—would have upheld the individual mandate under the Commerce Clause as well.
Constitutionality of Medicaid Expansion. A majority of the Court also held that Congress is permitted to offer funds under the ACA to states to expand Medicaid eligibility to childless adults with incomes at or below 133 percent of the federal poverty level, and require that states that accept such funds comply with the conditions on their use. However, the majority also found that Congress is not permitted to penalize States that choose not to participate in the expansion by taking away their existing Medicaid funding. The opinion of Chief Justice Roberts explains: "Nothing in our opinion precludes Congress from offering funds under the Affordable Care Act to expand the availability of health care, and requiring that States accepting such funds comply with the conditions on their use. What Congress is not free to do is to penalize States that choose not to participate in that new program by taking away their existing Medicaid funding."
Severability. Because the Court upheld both the individual mandate and Medicaid provisions, it did not need to address the severability question.
Anti-Injunction Act. As expected, the Court found that the Anti-Injunction Act did not preclude the Court from addressing the merits of the case now, rather than in 2014 after the individual mandate takes effect, because the ACA denominated the “shared responsibility payment” a “penalty” rather than a “tax.” Chief Justice Roberts notes that this label governs the decision under the Anti-Injunction Act, but not for purposes of the Constitutionality.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017