A trade agreement's impact on access to generic drugs

Health Affairs

Volumn 28, Issue 5, 2009, Pages

  Shaffer, Ellen R ^a   Brenner, Joseph E ^a  

^a Center for Policy Analysis on Trade and Health   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADEFOVIR DIPIVOXIL; AMLODIPINE PLUS VALSARTAN; AMPHOTERICIN B; CANDIPIUS; CARBIDOPA PLUS ENTACAPONE PLUS LEVODOPA; CASPOFUNGIN; CEFDINIR; CILASTATIN; CLOPIDOGREL; DOXYCYCLINE; ETIRACETAM; ETORICOXIB; EXINEF; FLUCONAZOLE; GENERIC DRUG; IMATINIB; IMINEM; INSULIN GLARGINE; ITRACONAZOLE; IVABRADINE; LOPINAVIR PLUS RITONAVIR; MEROPENEM; NAPROXEN PLUS SUMATRIPTAN; NYSTATIN; OXIPEN; PERINDOPRIL; PIPERACILLIN; PREGABALIN; RIFAXIMIN; ROSUVASTATIN; TADALAFIL; TAZOBACTAM; TAZZI W; TETRAHYDROLIPSTATIN; UNCLASSIFIED DRUG; UNINDEXED DRUG; VALACICLOVIR; VORICONAZOLE;

ARTICLE; DRUG COST; DRUG INDUSTRY; DRUG LEGISLATION; GUATEMALA; HEALTH CARE ACCESS; PATENT; TRADE UNION; UNITED STATES;

CENTRAL AMERICA; DRUG INDUSTRY; DRUGS, GENERIC; ECONOMIC COMPETITION; GUATEMALA; HEALTH SERVICES ACCESSIBILITY; HUMANS; INTELLECTUAL PROPERTY; LEGISLATION, DRUG; UNITED STATES;

EID: 70349202404     PISSN: 02782715     EISSN: 15445208     Source Type: Journal    
DOI: 10.1377/hlthaff.28.5.w957     Document Type: Article

References (48)

1. United States Trade Representative, "CAFTA Final Text," 16 June 2009, http://www.ustr.gov/tradeagreements/free-trade-agreements/cafta-dr- dominican-republic-central-america-fta/final-text (accessed 10 August 2009). These countries signed CAFTA in August 2004. The agreement entered into force in Guatemala on 1 July 2006. Guatemala is still drafting and implementing related legislation.
2. 21 US Code 355(c)(E)(ii) limits data exclusivity in the United States to five years or less. TRIPS 39.3 allows data exclusivity only to protect against unfair commercial use and to protect new chemical entities. CAFTA 15.10 gives applicants (for example, pharmaceutical companies) the right to five years or more of data exclusivity, at the discretion of the applicant, and for conditions other than to protect against unfair commercial use or for the presentation of a new chemical entity. (Footnote 15 in CAFTA Article 15 preserves the right of the United States to maintain a shorter termfor data exclusivity but does not offer this right to any other signatory country that did not already have a shorter termcodified in law.)
3. World Health Organization, Public Health, Innovation, and Intellectual Property Rights: Report of the Commission on Intellectual Property Rights, Innovation, and Public Health (Geneva: WHO, April 2006).
4. A.M. Solares, Drugs and Pharmaceuticals: Vitamins/Nutritional Supplements, Industry Sector Analysis: Guatemala, 17 March 2003, http://strategis.ic.gc.ca/eic/site/imr-ri.nsf/eng/gr112076.html (accessed 18 August 2009).
5. CAFTA 15.101(a) states, "If a Party requires, as a condition of approving the marketing of a new pharmaceutical or agricultural chemical product, the submission of undisclosed data concerning safety or efficacy, the Party shall not permit third persons, without the consent of the person who provided the information, tomarket a product on the basis of (1) the information, or (2) the approval granted to the person who submitted the information for at least five years for pharmaceutical products." This gives companies ("the person who provided the information") the right to five years or more of exclusive use of their clinical trial data, during which time other companies ("third persons") cannot use or refer to those data to support their applications for marketing. CAFTA 15.10.1(b) confers these same rights in the case of products already marketed in another country. TRIPS 39.3 allows data exclusivity only to protect against unfair commercial use and to protect new chemical entities. CAFTA leaves the use of these data to the discretion of the originator company and does not limit the grounds for data protection to protecting against unfair commercial use or for the presentation of a new chemical entity.
6. Office of the United States Trade Representative, "Trade Facts, Bipartisan Agreement on Trade Policy: Intellectual Property Provisions," May 2007, http://www.ustr.gov/sites/default/files/uploads/factsheets/2007/asset- upload-file945-11283.pdf (accessed 10 August 2009).
7. Data exclusivity is included in existing U.S. trade agreements with Chile, Singapore, Jordan, Morocco, Bahrain, and Australia, and in the agreement with South Korea that is pending congressional action.
8. These sources are available in an appendix, online at http://content.healthaffairs.org/cgi/content/full/hlthaff.28.5.w957/DC2.
9. This paper summarizes key findings from a more extensive report and document library to be posted online at http://www.cpath.org. In Guatemala we interviewed a deputy minister of health, the regional representative of the Pan American Health Organization who formerly directed the Guatemalan Department for the Regulation and Control of Pharmaceuticals, the director of the generic pharmaceutical association (ASINFARGUA), a representative of a generic drug company (Biocross), a professor in the pharmacy department of the national university, and the director of the government program on AIDS medicines.
10. Implementation can be delayed for some low-income countries.
11. Departamento de Regulación y Control de Productos Farmacéuticos y Afines, Leyes y Reglamentos, Accord 712.99, Guatemala (Guatemala City: Dirección General de Regulación, Vigilancia y Control de la Salud, Ministerio de Salud Pública y Asistencia Social, 28 November 2008).
12. DRCPFA, Patentes Farmacéuticas (Guatemala City: DGRVCS, MSPAS).
13. Claudia Herrate, on behalf of ASINFARGUA, personal communication, 26 November 2007.
14. For a discussion of the role of TRIPS-Plus measures, see V.B. Kelly and K. Lee, "TRIPS, the Doha Declaration and Paragraph 6 Decision: What Are the Remaining Steps for Protecting Access to Medicines?" Globalization and Health 3, no.3 (2007). In higher-income countries like the United States, where drugs are commonly patented, data-exclusivity rules may also apply. They usually run simultaneously with patents, for a shorter term, and they have a different effect on price and access.
15. The term of data exclusivity depends on whether the drug was listed during the years when the law offered a fifteen-year term, or in later years when the law offered five years.
16. A summary of the changes follows. In 2000, Decree 57-2000 authorized brand-name companies to register their products for data exclusivity for fifteen years. Alist of twenty-two data-protected drugs was created. In 2002, Decree 76-2002 eliminated data exclusivity for any time period. In 2003, Decree 9-2003 repealed Decree 76-2002 and implemented five years of data exclusivity. The U.S. Department of Commerce's Special 301 Watchlist is a prelude to possible trade sanctions. In 2003 the Special 301 Watchlist noted unfavorably Decree 76-2002 and encouraged the ongoing implementation of Decree 9-2003. Office of the U.S. Trade Representative, 2003 Special 301 Report (Washington: Executive Office of the President, 2003), 22. Decree 9-2003 also stated that the protected data "must require considerable effort to produce," an attempt to limit the frivolous listing of medicines. In 2004, Decree 34-04 repealed Decree 9-2003, again eliminating data exclusivity. As CAFTA was being negotiated in 2005, Decree 30-2005 repealed Decree 34-04 and reinstated a five-year period for data exclusivity. It states that trade agreements will prevail over this law in the event of conflicts.
17. Embassy of the United States, Guatemala, "CAFTA, Data Protection, and Generic Drugs, Fact Sheet Generics," 10 January 2005, http://guatemala.usembassy.gov/factsheetcaftagenerics.html (accessed 10 August 2009). The document states: "This law [34-2004] gives the U.S. Congress the impression that Guatemala is not serious about complying with commitments it made in the CAFTA.
18. This could result in CAFTA not being ratified by the U.S. Congress, where a close vote is expected." See also H.L. Solis, H.A. Waxman, and C.B. Rangel, Letter to the Honorable Robert B. Zoellick, U.S. Congress, 26 January 2005, http://www.cpath.org/sitebuildercontent/sitebuilderfiles/ congressguatemalatest-data-secrecy-letter1-05.pdf (accessed 18 August 2009).
19. Trade Compliance Center, U.S. Department of Commerce, Press release, 18 January 2002, http://tcc.export.gov/Country-Market-Research/All-Research- Reports/exp-005742.asp (accessed 10 August 2009).
20. The implementing legislation mitigated the problem somewhat by requiring that an originator company must apply for approval in Guatemala within five years of a drug's initial approval in another country. This means, for example, that if the brand-name company introduces its drug in Guatemala six years after its launch in the United States, data exclusivity rules would not apply.
21. ASINFARGUA, personal communication, 21 November 2007.
22. DRCPFA, Listado de Moléculas Protegidas por Datos de Prueba al 25/01/2008 (Guatemala City: DGRVCS, MSPAS, 25 January 2008).
23. DRCFPA, Listado de Moléculas Nuevas Registradas del Año 2000 al 2003(Protegidas por Datos de Prueba) (Guatemala City: DGRVCS, MSPAS).
24. Comisión para el Mejoramiento de las Estadísticas y Análisis de Genero en Salud, Perfil de Salud de Mujeres y Hombres en Guatemala (Guatemala City: Ministerio de Salud Pública, 2005).
25. Perfil de Salud de Mujeres y Hombres en Guatemala, 2005. Ibid.
26. Pan American Health Organization, Health Systems Profile Guatemala, 3d. ed., February 2007, p. 41, http://www.lachealthsys.org/index.php?option=com- docman&task=doc-download&gid=169&Itemid= (accessed 18 August 2009);
27. and Programa de Accesibilidad de Medicamentos, "Listados Básicos," http://www.proam.gob.gt/listados.html (accessed 18 August 2009).
28. Food and Drug Administration, Electronic Orange Book, Approved Drug Products with Therapeutic Equivalence Evaluations, 10 June 2009, http://www.fda.gov/cder/ob (accessed 10 August 2009);
29. DRCPFA, Listado de Moléculas Protegidas;
30. and DRCPFA, Listado de Moléculas Nuevas Registradas del Año 2000 al 2003.
31. Plavix is certainly patented in Guatemala. Its data-exclusivity status is less clear. In 2007 the Department of Regulation reported that Plavix was supposed to be listed as one of the twenty-two drugs protected for fifteen years while the original decree was in effect. The department reversed this determination at some point. Its present status is unclear.
32. Reported by key informant in Guatemala based on interviews with Drug Regulatory Agency. There is at least one other company that has registered clopidogrel (Laboratorias Stein in Costa Rica), but it is not known whether its registration was revoked.
33. MSPAS, Dirección General de Regulación, Vigilancia y Control de la Salud, Departamento de Regulación y Control de Productos Farmaceùticos y Afines, Productos Farmaceúticos con Registro Sanitario Autorizado Vigente al 28/09/2007 (Guatemala City: MSPAS, 2007). Currently, registration for drugs in Guatemala is for a five-year period.
34. The date listed on the Ministry of Health document is for the date that registration expires. The registration datewas extrapolated based on the date of expiry. See DRCPFA, Listado de Moléculas Nuevas Registradas del Año 2000 al 2003.
35. Ministerio de Salud Pública y Asistencia Social, Dirección Normativa de Contrataciones y Adquisiciones del Estado Prorroga 2007, Oferta Nacional de Precios DNCAE no. 10-2005, Area: Productos Medicinales y Farmaceuticos Paquete 1 (Guatemala City: Ministerio de Salud Pública, 2007).
36. Aschedule provided by PAHO lists forty-five medicines that either are not available through the open contract at the prices accepted from bidders or are less expensive through PAHO than the Open Contract price.
37. USTR, Pharmaceutical Research and Manufacturers of America (PhRMA) Special 301 Submission 2008 (Washington: USTR, 2008), 247-248.
38. CAFTA applies both to the United States and to Guatemala. As described in Note 2, CAFTA allows the United States to maintain its pre-existing law that permits data-exclusivity terms for less than five years. The term may also expire sooner in the United States if it runs simultaneously with a patent term, which is longer.
39. FDA, Electronic Orange Book;
40. and DRCPFA, Listado de Moléculas Protegidas.
41. Listado de Moléculas Protegidas, Ibid.
42. and DRCPFA, Listado de Moléculas Nuevas Registradas del Año 2000 al 2003.
43. USTR, "Trade Facts."
44. R. Weissman,. "Public Health-Friendly Options for Protecting Pharmaceutical Registration Data," International Journal of Intellectual Property Management 1, nos. 1/2 (2006): 113-130.
45. World Health Assembly, "Global Strategy and Plan of Action on Public Health, Innovation, and Intellectual Property," WHA61.21 Agenda item 11.6 (Geneva: WHA, 24May 2008).
46. In the Annex, Elements 2 and 3 discuss improving research and development capacity and incentive schemes for health-related innovation. Element 4 addresses technology transfer. See also WHO, Public Health, Innovation, and Intellectual Property Rights.
47. WHA, "Global Strategy and Plan of Action."
48. S. Dentzer, "Eliminating Neglected Diseases in Poor Countries: A Conversation with Andrew Witty," Health Affairs 28, no.3 (2009): w411-w416 (published online 19 March 2009; 10.1377/hlthaff.28.3.w411).