The paper provides an overview of laws and regulations for the protection of data submitted by pharmaceutical companies for the purposes of obtaining marketing approval for a drug in Member States of the World Trade Organization, which must comply with intellectual property provisions set in the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Article 39.3 of the agreement requires countries to protect undisclosed test or other data against unfair commercial use but not the adoption of exclusivity periods to protect such data. In general terms, today all developed countries have implemented an array of data exclusivity provisions with specific periods of protection, whereas most developing and least developed countries have often adopted language similar to that of Article 39.3. There are exceptions to this, mainly those countries that have negotiated free trade agreements with the United States such as Chile, Morocco and Jordan, and others that have agreed to adopt periods of exclusivity under pressure from other governments and industry groups. Furthermore, trade agreements have gradually broadened the scope of the protection thus undermining generic competition and therefore consumers' access to more affordable drugs.
In its 2007 submission to the Special 301 annual review of the Office of the United States Trade Representative (USTR) which identifies countries that deny adequate and effective protection of intellectual property rights, the Association of Pharmaceutical Research and Manufacturers of America (PhRMA) detailed its concerns regarding IP protection in 48 countries. PhRMA criticises 37 of them which, in its opinion, are failing to adequately protect pharmaceutical test data. See: Pharmaceutical Research and Manufacturers of America (PhRMA), ‘Special 301 Submission 2007’, February 2007.
2.
Multilateral Trade Negotiations — The Uruguay Round, ‘Draft Final Act Embodying the Results of the Uruguay Round of Multilateral Trade Negotiations’, MTN.TNC/W/35/Rev.1, 3rd December, 1990. Special distribution. Page 215.
3.
Multilateral Trade Negotiations — The Uruguay Round, ‘Draft Agreement on Trade Related Aspects of Intellectual property Rights’, Negotiating Group on Trade Related Aspects of Intellectual Property Rights, including Trade in Counterfeit Goods, Restricted, MTN.GNG/NG11/W/68, 29th March, 1990. Special Distribution. Page 13.
4.
Countries on the United Nations list of least developed countries were given a transitional period of 11 years to meet their obligations under the TRIPS Agreement. The Doha Declaration on the TRIPS Agreement and Public Health extended the period until 2016.
5.
The WTO currently has 150 members. The table does not include St. Kitts and Nevis, St. Vincent and the Grenadines, and the EU as a regional organisation (individual members were included).
6.
Directive 2004/27/EC of the European Parliament and of the Council of 31st March, 2004, amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. Article 1,8.
7.
Source: Beata Stepniewska, ‘Key Provisions Related to Generic Medicines’, Presentation made before the Drug Information Association, 19th Annual EuroMeeting, Vienna, March 2007.
8.
Spain, ‘Ley 29/2006, de 26 de julio, de garantías y uso racional de los medicamentos y productos sanitarios’.
9.
Poland, Hungary and Latvia are in the process of implementing their EU exclusivity obligations.
10.
Switzerland, ‘Loi federale sur les medicaments et les dispositifs medicaux’ (Loi sur les produits therapeutiques), 15 Decembre 2000 (Etat le 27 decembre 2006). Article 12 ((RS 812.21). The Swiss Act as well as others are applicable in Liechtenstein according to the Customs Union Treaty and a special bilateral agreement relating to the application of the Swiss legislation on therapeutic goods in Liechtenstein.
11.
The European Commission has stated that ‘The provisions on data exclusivity, although a significant improvement compared to the previous regime which did not envisage data exclusivity, still cause concerns as on a number of aspects they fall short of full compliance by Turkey with its commitments under the WTO rules and the EC-Turkey Customs Union Agreement. These include essentially the issue of the so-called pending generic applications tabled with the Turkish Ministry of Health until 31 December 2004 and the conditional data exclusivity afforded to original products approved in the Customs Union Area between 1 January 2001 and 31 December 2004.[…] The Commission continues to monitor developments and has urged Turkey to fully comply with the relevant EC acquis on the matter. The matter was again discussed on 30 June 2006 at an expert's meeting held in Brussels between Commission services and representatives of the Turkish Ministry of Health and the Turkish Delegation to the EU in Brussels’ (Source: http://ec.europa.eu/trade/issues/respectrules/tbr/cases/tur_pha.htm).
12.
U.S. Code, Title 21, Chapter 9, Subchapter V, Part A, § 355(c) (3) (E). New Drugs. U.S. Code Title 21. Chapter 9. Subchapter V. Part A § 355a. Pediatric studies of drugs. U.S. Code-Title 21-Chapter 9-Subchapter V-Part B-Sec. § 360bb. Designation of drugs for rare diseases or conditions.
13.
See: ElizabethH. D. (1999). FDA's role in making exclusivity determinations. Food and Drug Law Journal54; Valerie, J. (2004). Drug marketing exclusivity under United States and European union law’. Food Drug Law J., 59.
14.
NAFTA, Article 1711, paragraphs 5, 6 & 7.
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PhRMA, ‘Special 301 Submission 2007’, February 2007, pages 221–223. The Special 301 Report of 2007 released at the end of April retained Canada in the Watch List and stated the following: ‘The United States commends Canada for issuing regulations correcting deficiencies in its system for protecting against unfair commercial use pharmaceutical data generated to obtain marketing approval’. The report can be found at http://www.ustr.gov/assets/Document_Library/Reports_Publications/2007/2007_Special_301_Review/asset_upload_file230_11122.pdf.
16.
Office of the USTR, ‘2007 Special 301 Report’, Page 30.
Similar language was included in a decree issued by the Health Secretariat on 19th September, 2003: ‘Decreto por el que se reforma el Reglamento de Insumos para la Salud y el Reglamento de la Ley de Propiedad Industrial’, Diario Oficial, Viernes 19 de septiembre de 2003, pages 106–107.
19.
The approval of the FTA in Costa Rica is still pending (a national referendum will be held on the FTA in October 2007). The Peruvian Congress has approved the FTA but the approval by the US Congress is still pending. The agreements with Panama, Colombia and South Korea still have to be approved by their respective congresses as well as by the US.
20.
Andean Community of Nations (CAN), Decision 486, Article 266.
21.
Ruling of the Andean Court, 15th December, 2005. See also Resolution 817 of the General Secretariat of the Andean Community, 14th April, 2004.
For Argentina, see Law 24.766 of December 1996 (Ley de Confidencialidad sobre informacion y productos que estén legitimamente bajo control de§ una persona y se divulgue indebidamente de manera contraria a los usos comerciales honestos).
24.
Brazil's Law 10.603 of 2002 provides ten years of exclusivity for products that utilise new chemical or biological entities from the data of approval or from the first registration in any country, or whichever it first, guaranteeing a minimum of one year of protection; five years if the entities are not new, also with a minimum of one year, and if new data is required after the approval, such data is protected for the remaining period or one year from the submission of the new data, whichever is later.
25.
World Trade Organization, ‘Argentina- Patent Protection for Pharmaceuticals and Test Data Protection for Agricultural Chemicals (WT/DS171); Argentina-Certain Measures on the Protection of Patents and Test Data’ (WT/DS196); Notification of Mutually Agreed Solution According to the Conditions Set Forth in the Agreement. WT/DS196/4 IP/D/18/Add.1 IP/D/22/Add.1 20th June, 2002 (02-3427).
26.
Barbados, ‘Protection against Unfair Competition Act 1998-20’, Article 4; Trinidad and Tobago, ‘Protection Against Unfair Competition Act 1996’ (No. 27 of 1996, as amended by Act No. 18 of 2000), Article 9.
27.
Antigua and Barbuda, ‘Protection Against Unfair Competition Act 2001’, Article 8.
28.
These 16 member states are Benin, Burkina Faso, Cameroon, Central Africa, Congo, Ivory Coast, Equatorial Guinea, Gabon, Guinea, Guinea Bissau, Mali, Mauritania, Niger, Senegal, Chad and Togo. See Agreement Revising the Bangui Agreement of 2nd March, 1977, on the Creation of an African Intellectual Property Organization (Bangui (Central African Republic), 24th February, 1999), Annex VIII, Article 6.4.
29.
Under Article 55 of Law 82, undisclosed information shall be protected when it meets the following criteria: (1) Information which is confidential, in the sense that it is not, as a body or in the precise configuration or assembly of its components, generally known or common among those skilled in the art within the scope of which the information falls; (2) Information that has commercial value because it is confidential; 3) Information that depends on the effective measures taken by the person lawfully in control of it, to keep it confidential.
30.
RéhabE.-B. (2005). Jagged little pills. Zawya, Business Monthly, April.
31.
World Trade Organization, ‘Trade Policy Review Body — Trade Policy Review — Report by the Secretariat. Israel. Revision’, WT/TPR/S/157/Rev.1, 24th March, 2006. The recognised countries (as defined in the Pharmacists Regulations) are Australia, Canada, the EU member States, Iceland, Japan, New Zealand, Norway, Switzerland and the United States.
32.
Australia, ‘Therapeutic Goods Act 1989, Act No. 21 of 1990 as amended’, Section 25A. Although Australia accepted at least three years for new clinical investigations, a footnote recognises that Australia's existing data protection system meets its obligations under this provision. A ‘new active component’ under Section 25A.3 ‘is a substance that is, or one of the substances that together are, primarily responsible for the biological or other effect identifying the goods as therapeutic goods’.
33.
Vietnam, ‘Law on Intellectual Property’, November 2005; and ‘Decision No. 30/2006/QD-BYT-Ministry of Health; Singapore: Medicines Act (Amended June 2003)’.
US–South Korea Free Trade Agreement, Chapter 18, Article 18.9.
36.
World Trade Organization, Council for Trade-Related Aspects of Intellectual Property Rights, ‘Review of Legislation, China’, WTO, P/Q/CHN/1, IP/Q2/CHN/1, IP/Q3/CHN/1, IP/Q4/CHN/1, 10th December, 2002.
‘The U.S. Oman Free Trade Agreement(FTAA). The Intellectual Property Provisions’, Report of the Industry Trade Advisory Committee on Intellectual Property Rights (ITAC-15), 15th November, 2005. Pages 5–6.
39.
Most other trade agreements include IP sections that are very broad. There are some exceptions, for example the one signed between Chile and the European Free Trade Association (EFTA). Annex XII, Article 4.2 of the agreement requires parties to protect the information submitted for a product with a new chemical entity for at least five years. Annex XIII of the EFTA with the Republic of Korea of 2005 states that data must be protected for an ‘adequate number of years from the date of approval’ which shall be determined by the laws and regulations of the parties. The EFTA signed with Egypt in January has language similar to Article 56 of Egypt's Law 82 (Annex V), but those negotiated with Mexico (2000-Annex XXI), Croatia (2001-Annex VII) and Jordan (2001-Annex VI) only require countries to provide ‘adequate and effective protection of undisclosed information’.
40.
Letter to Ambassador Susan Schwab, United States Representative, signed by Representatives Henry A, Waxman, Tom Allen, Jim McDermott, Lloyd Doggett, Janice D. Schakowsky, Pete Stark, Diana DeGette, Chris Van Hollen, Barbara Lee, Earl Blumenauer, Barbara Lee, John Lewis and Rahm Emanuel. 12th March, 2007.
41.
Chile, ‘Texto de la ley de propiedad industrial (Ley 19.996 que “Modifica la Ley N° 19.039 sobre Propiedad Industrial”)’, Article 91. A similar limit of six months was adopted in Israel. Also, the implementing laws of the Dominican Republic, Honduras, Guatemala and El Salvador included a five-year limit while in Nicaragua the law states that the authorities may require that it be registered within five years of the first registration in the other territory (Nicaragua, Ministerio de Salud, ‘Resolución Ministerial 115-2006’, 22nd March, 2006).
Office of the USTR, Results of Bilateral Negotiations on Russia's Accession to the World Trade Organization (WTO), Action on Critical IPR Issues, 19th November, 2006.
