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Economic Regulation of Next-Generation Sequencing

Published online by Cambridge University Press:  01 January 2021

Barbara J. Evans
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Extract

The genetic testing industry is in a period of potentially major structural change driven by several factors. These include weaker patent protections after Association for Molecular Pathology v. Myriad Genetics (the “Myriad decision”) and Mayo Collaborative Services v. Prometheus Laboratories, Inc.; a continuing shift from single-gene tests to genome-scale sequencing; and a set of February 2014 amendments to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. This article explores the nature of these changes and why they strain existing regulatory frameworks for protecting patients, research subjects, and other consumers who receive genetic testing.

Oversight of genetic testing has, at least to date, had two major thrusts: (1) privacy and ethical protections and (2) traditional consumer health and safety regulations. Examples of the first are the Genetic Information Nondiscrimination Act and the HIPAA Privacy Rule, which after 2013 amendments expressly protects genetic privacy as well as other medical privacy.

Type
JLME Supplement
Information
Journal of Law, Medicine & Ethics , Volume 42 , Issue S1 , Fall 2014 , pp. 51 - 66
Copyright
Copyright © American Society of Law, Medicine and Ethics 2014

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References

133 S. Ct. 2107 (2013).Google Scholar
132 S. Ct. 1289 (2012).Google Scholar
U.S. Department of Health and Human Services, CLIA Program and HIPAA Privacy Rule; Patients' Access to Test Reports, Federal Register 79 (February 6, 2014): 7290–7316 (to be codified at 42 C.F.R. pt. 493 and 45 C.F.R. pt. 164).Google Scholar
Pub. L. No. 100-578, 102 Stat. 2903 (1988) (codified as amended at 42 U.S.C. § 263a).Google Scholar
42 C.F.R. pt. 493 (2013).Google Scholar
Pub. L. No. 104-191, 110 Stat. 1936 (1996) (codified as amended in scattered sections of 18, 26, 29, 42 U.S.C.)Google Scholar
45 C.F.R. pts. 160, 164 (2013).CrossRefGoogle Scholar
Pub. L. 110–233, 122 Stat. 881 (2008) (codified as amended at 42 U.S.C. §§ 2000ff – 2000ff-11).Google Scholar
U.S. Department of Health and Human Services, “Modifications to the HIPAA Privacy, Security, Enforcement, and Breach Notification Rules Under the Health Information Technology for Economic and Clinical Health Act and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules,” Federal Register 78 (January 25, 2013): 5566–5702 (to be codified at 45 C.F.R. pts. 160 & 164); see 45 C.F.R. § 160.103 (2013).Google Scholar
Javitt, G. H. and Carner, K. S., “Regulation of Next Generation Sequencing,” Journal of Law, Medicine & Ethics 42, no. 3, Supp. (2014): 9–21.CrossRefGoogle Scholar
Topol, E., The Creative Destruction of Medicine (New York: Basic Books, 2012): at 79 and 94.Google Scholar
Secretary's Advisory Committee on Genetics, Health, and Society, U.S. Department of Health and Human Services, U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of Health and Human Services (April 2008): at 17, available at <http://osp.od.nih.gov/sites/default/files/SAC-GHS_oversight_report.pdf> (last visited June 27, 2014). (last visited June 27, 2014).' href=https://scholar.google.com/scholar?q=Secretary's+Advisory+Committee+on+Genetics,+Health,+and+Society,+U.S.+Department+of+Health+and+Human+Services,+U.S.+System+of+Oversight+of+Genetic+Testing:+A+Response+to+the+Charge+of+the+Secretary+of+Health+and+Human+Services+(April+2008):+at+17,+available+at++(last+visited+June+27,+2014).>Google Scholar
Evans, J. P., “When Is a Medical Finding ‘Incidental'?” Genetics in Medicine 15, no. 7 (2013): 515–516, at 515.CrossRefGoogle Scholar
Miles, J. J., Health Care and Antitrust Law (Eagan, MN: Thompson-Reuters, 2014): at § 5.02.Google Scholar
Id.Google Scholar
See Evans, , supra note 13, at 515.Google Scholar
Id.Google Scholar
Conley, J. M., Cook-Deegan, R., and Lazaro-Munoz, G., “Myriad After Myriad: The Proprietary Data Dilemma,” North Carolina Journal of Law and Technology 15, no. 4 (2014): 597–637.Google Scholar
Cook-Deegan, R., “Myriad Continues to Fight as Judge Denies Injunction,” The Cancer Letter 40, no. 1 (March 14, 2014): 10–14, at 10, 12; Evans, B. J., “Mining the Human Genome after Association for Molecular Pathology v. Myriad Genetics,” Genetics in Medicine 16, no. 7 (2013): 504–509.Google Scholar
Evans, B. J., “Preventing Harms to Patients Who Know Too Much about Their Own Genomes,” paper presented at Behavioral Economics, Law, and Health Policy, 2014 Annual Conference, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, Cambridge, MA, May 3, 2014.Google Scholar
See Topol, , supra note 11, at 93–94.Google Scholar
Personal communication from Robert Cook-Deegan to author (April 27, 2014).Google Scholar
Green, R. C., Berg, J. S., Grody, W. W., Kalia, S. S., and Korf, B. R. et al., “ACMG Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing,” Genetics in Medicine 15, no. 7 (2013): 565–574, at 570–571.CrossRefGoogle Scholar
Lunshof, J. E., Church, G. W., and Prainsack, B., “Raw Personal Data: Providing Access,” Science 343, no. 6169 (January 2014): 373–74.CrossRefGoogle Scholar
See U.S. Department of Health and Human Services, supra note 3.Google Scholar
See Evans, , supra note 20.Google Scholar
Vorhaus, D., “DNA DTC: The Return of Direct to Consumer Whole Genome Sequencing,” Genomics Law Report (Nov. 29, 2012), available at <http://www.genomicslawreport.com/index.php/2012/11/29/dna-dtc-the-return-of-direct-to-consumer-whole-genome-sequencing/> (last visited June 27, 2014).+(last+visited+June+27,+2014).>Google Scholar
Vorhaus, D., “DTC Testing and the FDA: Is There an End in Sight to the Regulatory Uncertainty?” Genomics Law Report (June 16, 2011), available at <http://www.genomicslawreport.com/index.php/2011/06/16/dtc-genetic-testing-and-the-fda-is-there-an-end-in-sight-to-the-regulatory-uncertainty/> (last visited June 27, 2014).+(last+visited+June+27,+2014).>Google Scholar
Cook-Deegan, R., Conley, J. M., Evans, J. P., and Vorhaus, D., “The Next Controversy in Genetic Testing: Clinical Data as Trade Secrets?” European Journal of Human Genetics 21, no. 6 (2013): 585–588, at 585; Eggington, J. M., Bowles, K. R., Moyes, K., Manley, S., and Esterling, L. et al., “A Comprehensive Laboratory-Based Program for Classification of Variants of Uncertain Significance in Hereditary Cancer Genes,” Clinical Genetics 86, no. 3 (2014): 229–237.CrossRefGoogle Scholar
Cook-Deegan, et al., supra note 29, at 585–586.Google Scholar
Shirts, B. A., Jacobson, A., Jarvik, G. P., and Browning, B. L., “Large Numbers of Individuals Are Required to Classify and Define Risk for Rare Variants in Known Cancer Risk Genes,” Genetics in Medicine 16, no. 7 (2013): 529–534.CrossRefGoogle Scholar
See Eggington, et al., supra note 29.Google Scholar
See Cook-Deegan, et al., supra note 29, at 585.Google Scholar
Id.Google Scholar
Evans, B. J., “Much Ado about Data Ownership,” Harvard Journal of Law and Technology 25, no. 1 (2011): 69–130, at 82–86.Google Scholar
See Cook-Deegan, et al., supra note 29, at 587.Google Scholar
Id.Google Scholar
See Evans, , supra note 19, at 507.Google Scholar
See Conley, et al., supra note 18.Google Scholar
See Evans, , supra note 20.Google Scholar
Id.Google Scholar
See Conley, et al., supra note 18.Google Scholar
See Cook-Deegan, , supra note 29, at 586.Google Scholar
Waller, S. W., “The Past, Present, and Future of Monopolization Remedies,” Antitrust Law Journal 76, no. 1 (2009): 11–29, at 11 and 15–16.Google Scholar
See e.g., Associated Gas Distribs. v. FERC, 824 F.2d 981 (D.C. Cir. 1987), cert. denied, 485 U.S. 1006 (1988).Google Scholar
Pub. L. 95–617, 92 Stat. 3117 (1978) (codified as amended in scattered sections of 7, 15, 16, 42, 43 U.S.C.)Google Scholar
Spence, D. B. and Prentice, R., “The Transformation of American Energy Markets and the Problem of Market Power,” Boston College Law Review 53, no. 1 (2012): 131–202, at 146–147.Google Scholar
Id., at 147.Google Scholar
Pub. L. 102–486, 106 Stat. 2776 (1992) (codified as amended in scattered sections of 2, 11, 12, 15, 16, 25, 26, 30, 42, 48 U.S.C.)Google Scholar
See Spence, and Prentice, , supra note 47, at 147–148.Google Scholar
Farrell, J. and Weiser, P. J., “Modularity, Vertical Integration, and Open Access Policies: Towards and Convergence of Antitrust and Regulation in the Internet Age,” Harvard Journal of Law and Technology 17, no. 1 (2003): 85–134, at 95.Google Scholar
Associated Gas Distribs. v. FERC, 824 F.2d 981, 998 (D.C. Cir. 1987), cert. denied, 485 U.S. 1006 (1988).Google Scholar
Federal Energy Regulatory Commission, U.S. Department of Energy, “Promoting Wholesale Competition through Open Access Non-Discriminatory Transmission Services by Public Utilities; Recovery of Stranded Costs by Public Utilities and Transmitting Utilities,” Federal Register 61 (May 10, 1996): 21,540-21,716, at 21,560-61; see Spence, & Prentiss, , supra note 47, at 147–148.Google Scholar
Pub. L. 104–104,110 Stat. 56 (1996) (codified as amended in scattered sections of 15, 18, 47 U.S.C.)Google Scholar
Verizon Commc'ns Inc. v. Law Offices of Curtis V. Trinko, LLP, 540 U.S. 398, 402–03 (2004) [hereinafter Trinko]; Robinson, G. O., “On Refusing to Deal with Rivals,” Cornell Law Review 87, no. 5 (2002): 1177–1232, at 1217–1223.Google Scholar
45 C.F.R. § 164.524 (2013).Google Scholar
See U.S. Department of Health and Human Services, supra note 3.Google Scholar
Ekstrom, L., Flaherty, D., Henry, J., Kulkarni, S., Pattabiraman, K., and Rudolf, T., “Capturing Value for Dx in Personalized Medicine – Is There a Path?” in Personalized Medicine: The Path Forward (Palo Alto, CA: McKinsey and Company, 2013): at 34.Google Scholar
See U.S. Department of Health and Human Services, supra note 9.Google Scholar
Pub. L. 111–5, Div. A, Title XIII, Div. B, Title IV, 123 Stat. 226, 467 (2009) (codified as amended in scattered sections of 42 U.S.C.)Google Scholar
42 U.S.C. § 17935(d)(1) (Supp. V 2012).Google Scholar
Id. § 17935(d)(2).Google Scholar
45 C.F.R. § 164.512(i) (2013).Google Scholar
See Shirts, et al., supra note 31.Google Scholar
Evans, B. J., “Sustainable Access to Data for Postmarketing Medical Product Safety Surveillance under the Amended HIPAA Privacy Rule,” Health Matrix 24 (2014): 11–47, at 20–24.Google Scholar
Dogan, S. L. and Lemley, M. A., “Antitrust Law and Regulatory Gaming,” Texas Law Review 87, no. 4 (2009): 685–729, at 690.Google Scholar
Interstate Commerce Act, ch. 104, 24 Stat. 379 (1887) (codified as amended in scattered sections of 49 U.S.C.)Google Scholar
Communications Act of 1934, ch. 652, 48 Stat. 1064 (codified as amended at 47 U.S.C. §§ 151–620).Google Scholar
Public Utility Act of 1935, ch. 687, 49 Stat. 803 (codified as amended in scattered sections of 16 U.S.C.)Google Scholar
Natural Gas Act of 1938, ch. 556, 52 Stat. 821 (codified as amended at 15 U.S.C. §§ 717–717w).Google Scholar
Frischmann, B. and Waller, S. W., “Revitalizing Essential Facilities,” Antitrust Law Journal 75 (2008): 1–65, at 4.Google Scholar
See Evans, , supra note 35, at 92.Google Scholar
See Cook-Deegan, , supra note 29, at 586.Google Scholar
See Evans, , supra note 19, at 508; Evans, supra note 65, at 26–27.Google Scholar
132 S. Ct. 1289 (2012).Google Scholar
Zacks Equity Research, “Myriad Genetics Jumps on Medicare Decision,” April 3, 2014, available at <http://www.zacks.com/commentary_print.php?article_id=128671type=BLOcollab> (last visited July 1, 2014).+(last+visited+July+1,+2014).>Google Scholar
See Evans, , supra note 19, at 5.Google Scholar
Office for Civil Rights, U.S. Department of Health and Human Services, “Health Information Privacy, Frequently Asked Questions: available at <http://www.hhs.gov/ocr/privacy/hipaa/faq/right_to_request_a_restriction/512.html> (last visited August 22, 2013).+(last+visited+August+22,+2013).>Google Scholar
45 C.F.R. § 164.501 (2013).CrossRefGoogle Scholar
15 U.S.C. §§ 1–7 (2012).Google Scholar
Id. § 1.Google Scholar
Id. § 2; Miles, supra note 14, at § 5:1.Google Scholar
15 U.S.C. §§ 12–27 (2012); 29 U.S.C. § 52 (2012).CrossRefGoogle Scholar
15 U.S.C. §§ 13–13b, 21a (2012).Google Scholar
15 U.S.C. § 18 (2012).Google Scholar
Id. § 14.Google Scholar
Id. §§ 41–58.Google Scholar
Id. § 45.Google Scholar
See Miles, , supra note 14, at § 1:1.Google Scholar
See e.g., United States v. Columbia Steel Co., 334 U.S. 495, 525 (1948) (noting that vertical integration is not itself unlawful); Byars v. Bluff City News Co., 609 F.2d 843, 861 (6th Cir. 1979) (observing that firms, in theory, will only pursue vertical integration when the firm is at least as efficient as other firms in the segment into which it integrates).Google Scholar
See e.g., Eastman Kodak Co. v. Image Technical Servs., Inc., 504 U.S. 451, 480 (1992) (noting that monopoly power under § 2 of the Sherman Act demands something greater than the market power required for purposes of § 1); Safeway Inc. v. Abbott Labs., 761 F. Supp. 2d 874, 886 (N.D. Cal. 2011) (stating “monopoly power is best understood to be the substantial degree of market power”).Google Scholar
United States v. Grinnell Corp., 384 U.S. 563, 571(1966); Pac. Bell Tel. Co. v. Linkline Commc'ns, Inc., 555 U.S. 438, 447–48 (2009) (Simply possessing monopoly power and charging monopoly prices does not violate § 2); Trinko, 540 U.S. at 407 (“The mere possession of monopoly power … is not … unlawful”).Google Scholar
United States. v. Grinnell Corp., 384 U.S. at 570–71.Google Scholar
Trinko, 540 U.S. at 407; Aspen Skiing Co. v. Aspen Highlands Skiing Corp., 472 U.S. 585 (1985).Google Scholar
See Miles, , supra note 14, at § 5:7.Google Scholar
Pac. Bell Tel. Co. v. Linkline Commc'ns, Inc., 555 U.S. at 448.Google Scholar
Trinko, 540 U.S. at 414 (citing United States v. Microsoft Corp., 253 F.3d. 34, 58 (D.C. Cir. 2001)).Google Scholar
See Evans, , supra note 65, at 30–32.Google Scholar
Colorado Interstate Gas Co. v. Federal Power Comm'n, 324 U.S. 581, 589 (1945).Google Scholar
See Evans, , supra note 19, at 508.Google Scholar
Spulber, D. F. and Yoo, C. S., “Mandating Access to Telecom and the Internet: The Hidden Side of Trinko,” Columbia Law Review 107, no. 8 (2007): 1822–1907, at 1841–42; Joskow, P. L. and Noll, R. G., “The Bell Doctrine: Applications in Telecommunications, Electricity, and Other Network Industries,” Stanford Law Review 51, no. 5 (1999): 1249–1315, at 1250–1251.Google Scholar
See Joskow, and Noll, , supra note 101, at 1262–1263.Google Scholar
Margiotta, P., “Communications Law: The Local Exchange Carrier Price Cap Order,” George Washington University Law Review 63, no. 5 (1995): 723–758, at 724–725.Google Scholar
See Farrell, & Weiser, , supra note 51, at 94.Google Scholar
See Eastman Kodak Co. v. Image Technical Servs., Inc., 504 U.S. 451, 480 (1992) (quoting Times–Picayune Publ'g Co. v. United States, 345 U.S. 594, 611 (1953).Google Scholar
Ill. ex rel. Hartigan v. Panhandle E. Pipe Line Co., 730 F. Supp. 826, 883 (C.D. Ill. 1990), aff'd, 935 F.2d 1469 (7th Cir. 1991).Google Scholar
Trinko, 540 U.S. at 408 (quoting Aspen Skiing Co. v. Aspen Highlands Skiing Corp, 472 U.S. 585, 601 (1985)).Google Scholar
Id., at 408, 414.Google Scholar
410 U.S. 366 (1973).Google Scholar
Id., at 377.Google Scholar
Id., at 368–69.Google Scholar
Id., at 377 (citing Lorain Journal v. United States, 342 U.S. 143, 154 (1951).Google Scholar
Id., at 381–82.Google Scholar
472 U.S. 585 (1985).Google Scholar
540 U.S. 398 (2004).Google Scholar
Id., at 409.Google Scholar
Id., at 409–10.Google Scholar
Id., at 402–404.Google Scholar
Id., at 404.Google Scholar
Pub. L. 104–104, 110 Stat. 56 (1996) (codified as amended in scattered sections of 15, 18, 47 U.S.C.)Google Scholar
Trinko, 540 U.S.at 401.Google Scholar
Id., at 409.Google Scholar
Scalia, A. and Garner, B. A., Reading Law: The Interpretation of Legal Texts (St. Paul, MN: ThomsonWest, 2012): at 174 (citing United States v. Butler, 297 U.S. 1, 65 (1936)).Google Scholar
See Evans, , supra note 19, at 506–506.Google Scholar
Id.Google Scholar
Id.Google Scholar
Trinko, 540 U.S at 409.Google Scholar
Otter Tail Power Co. v. United States, 410 U.S. 366, 381–82 (1973).Google Scholar
Trinko, 540 U.S at 411.Google Scholar
Id., at 412.Google Scholar
Id. (internal quotation and citation omitted).Google Scholar
See Mills, , supra note 14, at § 5:8, n. 10 (noting that it is an unanswered question whether a reasonable price may need to include some measure of monopoly rent in situations where the facility in question is truly irreproducible and unique).Google Scholar
708 F.2d 1081, 1132–33 (7th Cir. 1983).Google Scholar
See e.g., Loren Data Corp. v. GXS, Inc., 501 F. App'x 275, 284 (4th Cir. 2012), cert. denied, 133 S. Ct. 2835 (2013).Google Scholar
MCI Commc'ns Corp. v. AT&T, 708 F.2d at 1132–33.Google Scholar
Waller, S. W. and Tasch, W., “Harmonizing Essential Facilities,” Antitrust Law Journal 76 (2010): 741–767, at 741; Cotter, T. L., The Essential Facilities Doctrine (University of Minnesota Law School Legal Studies Research Paper No. 08-18, 2008): 6–11, available at <http://ssrn.com/abstract=1125368> (last visited April 29, 2014).Google Scholar
See e.g., Areeda, P., “Essential Facilities: An Epithet in Need of Limiting Principles,” Antitrust Law Journal 58, no. 4 (1989): 841– 853; Cotter, supra note 136, at 11.Google Scholar
Trinko, 540 U.S. at 411.Google Scholar
Pitofsky, R., Patterson, D., and Hooks, J., “The Essential Facilities Doctrine under U.S. Antitrust Law,” Antitrust Law Journal 70, no. 2 (2002): 443–462, at 443–444.Google Scholar
United States v. Terminal R.R. Ass'n of St. Louis, 224 U.S. 383 (1912); Associated Press v. United States, 326 U.S. 1 (1945); Otter Tail Power Co. v. United States, 410 U.S. 366 (1973); Aspen Skiing Co. v. Aspen Highlands Skiing Corp., 472 U.S. 585 (1985).Google Scholar
See Cotter, , supra note 136, at 11.Google Scholar
Id.Google Scholar
See Cotter, , supra note 136, at 14–15.Google Scholar
Id.Google Scholar
See Miles, , supra note 14, at § 5:7.Google Scholar
Id. at § 5:8.Google Scholar
See Evans, , supra note 19, at 508.Google Scholar
Associated Gas Distribs. v. FERC, 824 F.2d 981, 998 (D.C. Cir. 1987), cert. denied, 485 U.S. 1006 (1988)Google Scholar
See Federal Energy Regulatory Commission, supra note 53, at 21560–61.Google Scholar
Trinko, 540 U.S. at 402–03; Robinson, supra note 55, at 1217–23.Google Scholar
See Associated Gas Distribs. v. FERC, 824 F.2d at 998.Google Scholar
See Waller, and Tasch, , supra note 136, at 741.Google Scholar