Recent Developments in Health Law

BRIC is an acronym used to refer to the “fast-growing developing economies” of Brazil, Russia, India, and China originally popularized by Goldman Sachs

See O'Neill J. , “Why it would be wrong to write of the BRICS,” Financial Times, January 5, 2009.

Doctor M. , “Country Focus: Brazil,” Political Insight 2, no. 1 (2011): 7–9.

See Prada P. , “For Brazil, It's Finally Tomorrow: How the Country of the Future has at Last Made It – and What Remains to be Done,” Wall Street Journal, March 29, 2010.

Victora C. G. , “Maternal and Child Health in Brazil: Progress and Challenges,” Lancet 377, no. 9780 (2011): 1863–1876 at 1863.

Id., at 1866.

Committee on the Elimination of Discrimination Against Women (CEDAW Committee), Views Communication 17/2008, U.N. Doc. CEDAW/C/49/D/17/2008 (2011) [hereinafter cited as Alyne v. Brazil].

Presidência da República, Casa Civil, Subchefia para Assuntos Jurídicos, “Medida Provisória,” available at <http://www.planalto.gov.br/ccivil_03/_Ato2011–2014/2011/Mpv/557.htm>(last visited July 14, 2012).

MP 557, Art. 1.

Kane G. Slate , “Brazil's Insidious New Pregnancy Registration Law Violates the Privacy of Women,” available at <http://www.slate.com/blogs/xx_factor/2012/01/06/brazilian_pm_557_how_the_pregnancy_registration_law_violates_the_privacy_of_women.html>(last visited July 14, 2012).

See Harris M. Haines A. , “Brazil's Family Health Program: A Cost Effective Success That Higher Income Countries Could Learn From,” BMJ 341, no. 4945 (2010): 1171–1172.

Brazilian Constitution, Chapter 2, Section II, Article 196.

See Victora , supra note 4, at 1872.

See Macinko J. , “Major Expansion of Primary Care in Brazil Linked to Decline in Unnecessary Hospitalization,” Health Affairs 29, no. 12 (2010): 2149–2160.

See also Guanais F. C. Macinko J. , “The Health Effects of Decentralizing Primary Care in Brazil,” Health Affairs 28, no. 4 (2009) 1127–1135.

See Harris and Haines, supra note 10, at 1171.

Id.

Barros F. C. , “Recent Trends in Maternal, Newborn, and Child Health in Brazil: Progress Toward Millennium Development Goals 4 and 5,” American Journal of Public Health 100, no. 10 (2010): 1877–1889, at 1878.

See Victora , supra note 4 at 1866.

Maternal Mortality in 2005, Estimates Developed by WHO, UNICEF, UNFPA and the World Bank, available at <http://www.who.int/whosis/mme_2005.pdf>(last visited July, 15, 2012) [hereinafter cited as Maternal Mortality in 2005].

See Victora , supra note 4 at 1866.

See Barros , supra note 16 at 1886.

See Maternal Mortality in 2005, supra note 18.

Center for Reproductive Rights, Supplementary Information on Brazil, scheduled for review by the U.N. Committee on the Elimination of Discrimination against Women during its 51st Session (February 2012) (January 30, 2012), at 5 [hereinafter cited as Center for Reproductive Rights Letter].

See Alyne v. Brazil, supra note 6.

Id., at 2–8.

Id.

See Center for Reproductive Rights Letter, supra note 22, at 5.

See Alyne v. Brazil, supra note 6 at 21.

Id., at 21–22.

Id.

See Center for Reproductive Rights Letter, supra note 22, at 15–16.

Id.

See MP 557, Art 2, supra note 7.

See MP 557, Art. 10, supra note 7.

See Alyne v. Brazil, at 21–22.

See MP 557, Art. 1, supra note 7.

Galli B. Reality Check, “Using Special Powers, Brazil's President Passes Law Requiring Compulsory Registration of All Pregnant women,” available at <http://www.rhrealitycheck.org/article/2012/01/06/using-special-powers-brazilian-president-passes-law-requiring-registration-with-n>(last visited July 15, 2012).

A Paper Bird: Sex, Rights and the World,” The State and Your Sex Life II,” available at <http://paper-bird.net/2012/01/05/the-state-and-your-sex-life-ii/>(July 15, 2012).

Id.

Id.

See also Kane , supra note 9.

See Center for Reproductive Rights Letter, supra note 22, at 16–19.

See Center for Reproductive Rights Letter, supra note 22, at 18–19.

Id., at 19.

See Kane, supra note 9.

See also Garcia K. K. , O'Neill Institute for National and Global Health Law, “Brazil's Compulsory Pregnancy Registration Violates Women's Privacy,” available at <http://www.oneillinstituteblog.org/brazils-compulsory-pregnancy-registration-violates-womens-privacy/>(last visited July 15, 2012).

See Center for Reproductive Rights Letter, supra note 22, at 16.

Mariner W. K. , “Medicine And Public Health: Crossing Legal Boundaries,” Journal of Health Care Law & Policy 10, no. 1 (2007): 121–151, at 133.

See MP 557, Art. 10, supra note 7.

See Kane , supra note 9.

See Garcia , supra note 43.

See Galli , supra note 36.

See Kane , supra note 9.

See Center for Reproductive Rights Letter, supra note 22, at 17.

United Nations Treaty Collection Database, “Chapter IV Human Rights,” available at <http://treaties.un.org/Pages/ViewDetails.aspx?src=TREATY&mtdsg_no=IV-8&chapter=4&lang=en#8>(July 15, 2012).

Id.

Convention on the Elimination of All Forms of Discrimination against Women (CEDAW), adopted December 18, 1979, G.A. Res. 34/180, U.N. GAOR, 34th Sess., Supp. No. 46. U.N. Doc. A/34/46 (1979), 1249 U.N.T.S. 13 (entered into force September 3, 1981).

CEDAW Committee, General Recommendation No. 24 (Article 12: Women and Health), ¶ 31(c), U.N. Doc. A/54/38/Rev.1 (1999).

See Center for Reproductive Rights Letter, supra note 22 at 17.

See generally Simmons B. , Mobilizing for Human Rights: International Law in Domestic Politics (Cambridge University Press, 2009): at 202–255.

For brevity, the terms “pharmaceutical industry” and “industry” describe the manufacturers of pharmaceuticals, bio-logics, and devices.

42 U.S.C.A. § 1320a-7h (2010).

Center for Medicare & Medicaid Services, HHS, “Proposed Rule, Medicare, Medicaid, Children's Health Insurance Programs; Transparency Reports and Reporting of Physician Ownership or Investment Interests,” 76 Federal Register 78742 (December 19, 2011) [hereinafter cited as Proposed Rule].

US Senate Finance Committee, Use of Educational Grants by Pharmaceutical Manufacturers, Committee Staff Report to the Chairman and Ranking Member (April 2007) [hereinafter Senate Report].

105 C.M.R. §§ 970.000, et seq (2009).

Minn. Stat. Ann. § 151.47 (2011).

18 V.S.A § 4632 (2011).

Va W. Code § 16–29H-8 (2009).

Mun D. C. Regs. tit. 22-B, §§ 1800.1, et seq (2010).

Maine's disclosure law was repealed in 2011: 10–144–275 Me. Code R. §§ 2.01 et seq. With the exception of Minnesota, which passed its law in 1994, the laws were all passed in the early 2000s amid growing criticism of pharmaceutical promotion practices. Vermont led the charge in 2002, and maintains the strictest demands for disclosure and gift limits.

On the eve of the PPSA's implementation, nine major pharmaceutical manufacturers had begun publishing some of their data on marketing to physicians. The companies are Allergan, AstraZeneca, Cephalon, Eli Lilly, EMD Serono, Johnson & Johnson, Novartis, Pfizer, and Valeant. Three pharmaceutical manufacturers have begun publishing the data voluntarily: GlaxoSmithKline, Merck, and ViiV. For an analysis of the available reports see ProPublica's Dollars for Docs database, available at <http://projects.propublica.org/docdollars/>(last visited July 14, 2012).

For an example of industry support, see Silverman E. , “Drugmakers Back Watered-Down Disclosure Bill, Pharmalot,” May 22, 2008, available at <http://www.pharmalot.com/2008/05/drugmakers-back-watered-down-disclosure-bill/>(last visited August 1, 2012).

For criticism on the quality of self-reported data, see Wilson D. , “Data on Fees to Doctors Is Called Hard to Parse,” New York Times, April 12, 2010.

For criticism on the quality of data available in Vermont and Minnesota, see Ross J. S. Lackner J. E. Lurie P. Gross C. P. Wolfe S. Krumholz H. M. , “Pharmaceutical Company Payments to Physicians: Early Experiences with Disclosure Laws in Vermont and Minnesota,” JAMA 297, no. 11 (2007): 1216–1223.

See Pharmaceutical Marketing Disclosures: Report of Vermont Attorney General Sorrell William H. , available at <http://www.atg.state.vt.us/issues/pharmaceutical-manufacturer-payment-disclosure/pharmaceutical-marketing-disclosures-reports.php>(last visited July 14, 2012).

Vermont passed its disclosure law in 2002 (18 V.S.A § 4632 (2011) and its statutory prohibition in 2009 (18 V.S.A. § 4631a (2011).

See Proposed Rule, supra note 3, at 78742, 78751. A similar awareness standard applies to fraud and abuse laws, including the False Claims Act.

Accreditation Council for Continuing Medical Education, ACCME annual report 2010, (2010). Although the 2010 report does not break down the commercial support by industry, earlier reports (e.g., 2003) show that over 95% of the “commercial support” is from companies that sell FDA-approved products.

See Accreditation Council for Continuing Medical Education, ACCME annual report 2006, (2006). See also e.g. GlaxoSmithKline, list of [CME] grants approved in 2010, available at <https://www.partnersinknowledge.com/GSKCenterforMedicalEducation/fundedIMEGrants/2010/index.html>(last visited July 14, 2012) (Listing several major AMCs as recipients). For an overview of the relationship between PMAs and the industry,

See Rothman D. J. McDonald W. J. Berkowitz C. D. , “Professional Medical Associations and Their Relationships with Industry: A Proposal for Controlling Conflict of Interest,” JAMA 301, no. 13 (2009): 1367–1372.

Walker L. , “ROI for Meetings Beats Detailing and DTC,” Medical Meetings website (2001), available at <http://meetingsnet.com/medicalmeetings/ar/meetings_roi_meetings_beats/index.html>(last visited July 14,2012).

Bowman M. A. Pearle D. L. , “Changes in Drug Prescribing Patterns Related to Commercial Company Funding of Continuing Medical Education,” Journal of Continuing Education of Health Professionals 8 (1988):13–20 (surveying prescription habits before and after attending a CME event);

Bowman M. A. , “The Impact of Drug Company Funding on the Content of Continuing Medical Education,” Mobius 6, no. 1 (1986): 66–69.

See Ross J. S. Lurie P. Wolfe S. M. , Medical Education Services Suppliers: A Threat to Physician Education, Public Citizen's Health Research Group, Washington, D.C., July 19, 2000.

Chren M. M. Landefeld C. S. , “Physicians' Behavior and Their Interactions with Drug Companies: A Controlled Study of Physicians Who Requested Additions to a Hospital Drug Formulary,” JAMA 271, no. 9 (1994): 684–689.

See Senate Report , supra note 4.

See Relman A. S. , “Separating Continuing Medical Education from Pharmaceutical Marketing,” JAMA 285, no. 15 (2001): 2009–2012.

For a full argument, see Brody H. , “Pharmaceutical Industry Financial Support for Medical Education: Benefit, or Undue Influence?” Journal of Medical Ethics 37, no. 3 (2009): 451–460.