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A study of laws in Latin America: is access to affordable medicine threatened?

1. Introduction

During the 1994 Uruguay round of the General Agreement on Tariffs and Trade (GATT), the member states negotiated the Trade Related Aspects of Intellectual Property Agreement (TRIPS). (1) TRIPS, which is administered by the World Trade Organization (WTO), guides and elaborates the minimum standards for worldwide intellectual property regulation. However, over the past several years, countries with the most extensive intellectual property right protection schemes have pursued an increasing number of bilateral free trade agreements (FTAs) in different parts of the world. The FTAs that have been (and are currently being) negotiated are accused of including provisions that go beyond the common requirements of the TRIPS Agreement, and that trespass into a domain commonly known as "TRIPS-plus", where it is thought the provisions might be unjust or too onerous for some countries. The debate is especially topical when it comes to the field of pharmaceutical technology, and whether TRIPS-plus provisions are likely to prejudice public health by making access to medicines substantially more difficult. (2)

However, few studies have attempted to catalogue and empirically analyze countries' laws to discover how intellectual property rights have evolved--and advanced--since the TRIPS Agreement was signed. The present study attempts to do exactly this, while focusing on the particular case of data exclusivity laws for pharmaceuticals to determine if in this field of technology, "TRIPS-plus" protection of intellectual property is coalescing and developing into any sort of global or regional norms.

II. Background

(i) Data Exclusivity Explained

'Data exclusivity' (or 'data protection') refers to the practice whereby for a period of time, national drug regulatory authorities cannot permit the pharmaceutical test data furnished by an originator company and relating to a drug's quality, safety, clinical efficacy, and physical and chemical characteristics to be used by a competing generic drug company for the purpose of registering a therapeutically equivalent, generic version of the drug. (3) Since no drug can be marketed without having test data supporting it, controlling access to the data is nearly tantamount to controlling access to the market, and that is why originator companies care about it so deeply. That said, nothing about data exclusivity prevents a generic drug company, rather than relying on data generated by the originator company, setting out to repeat all the tests and to generate data of its own. Therefore, data exclusivity rules are never an absolute barrier to the entry of generic medicines to a market, but only a qualified barrier, which a thoroughly determined generic company can lawfully circumvent, although likely at a high cost to itself.

Developing a new drug is very expensive. Estimates differ widely and are heatedly debated, but range from about $100 million to $2 billion, depending on the methodology used and the particular drug in question. (4) Importantly, the expense of drug development is only trending up, and dramatically so since TRIPS came into force, which calls into question whether the intellectual property provisions of TRIPS are not already obsolete. (5) A large share of the product development expense arises from research costs incurred in the laboratory, pre-clinical, and clinical phases of drug development. (6) The research data that an originator company amasses at each phase is used to assess and justify the development of the drug to the next phase, and this "dossier" (as it is called in the industry) grows more valuable as the project advances and the would-be drug moves nearer to regulatory approval. Needless to say much of the data in the dossier is proprietary and very carefully guarded, but to gain regulatory approval, ultimately the dossier has to be shared with the national drug regulatory authority. Hence the need for data exclusivity laws--to protect the dossier.

The increasing pressure for strict data exclusivity laws amongst those countries with strong pharmaceutical industries arises from three main factors: (7) (i) the length and cost of clinical trials; (ii) the recent drought of research pipeline productivity by some pharmaceutical companies (which in turn threatens future revenues) (8) and; (iii) the rise of legal disputes between generic and brand name pharmaceutical companies (which includes money spent on litigation). These factors have increasingly become the central issues for those countries with strong pharmaceutical interests to pursue highly regulated systems of data exclusivity.

Those countries with strong pharmaceutical lobbies include the United States (U.S.), and certain countries within the European Union (E.U.) and the European Free Trade Area (E.F.T.A.). In the U.S., the 1984 Hatch-Waxman Act (9) established the process by which generic drug companies can file abbreviated new drug applications (ANDAs) to seek approval of generics without having to perform the various stages of data collection. (10) The ANDA process allows generic drug companies who do not have the same funds as pharmaceutical companies to rely on the data in the original company's dossier to market drugs, but only after a period of data exclusivity has expired. Since 1984, the Act has established a 5-year data exclusivity period from the date of marketing approval for products containing new chemical entities. (11) In addition, there is a 3-year period of marketing exclusivity from the date of FDA approval for supplementary applications in relation to a chemical entity that was previously approved, where a later application contains reports of new clinical investigations (12) (this includes changes in its active ingredient(s), strength, dosage form, route of administration, or a new use/indication is discovered).

In the European Union (E.U), Directive 2004/27/EC (13) amended Directive 2001/83/EC (14) and Regulation (EC) No. 72612004, lengthening the period for the protection of test data. (15) According to Article 10(1) of Directive 2001/83/EC, "the applicant shall not be required to provide the results of pre-clinical tests and of clinical trials if he can demonstrate that the medicinal product is a generic of a reference medicinal product which is or has been authorised under Article 6 for not less than eight years in a Member State or in the Community" [emphasis added]. (16) In addition to the 8-year data exclusivity provision there is an additional 2-year market exclusivity provision, which in turn can be extended by an additional year if the originator obtains an authorization stating that new therapeutic indications were discovered during the scientific evaluation. (17) Experts have suggested that the E.U's rationale behind this new harmonized 8+2+1 Formula for new drugs is to encourage innovation and competitiveness within the pharmaceutical industry. (18)

On the other hand, there is also a movement encouraging countries to maintain relaxed data exclusivity laws. Opponents of stringent data exclusivity legislation argue that if there is no patent on a product (19), or a former patent period has expired, or a current patent is near to expire--basically any scenario in which data exclusivity expires at a date later than a patent--then data exclusivity would act independently of the patent status to delay generic manufacturers wishing to enter the market. (20) As a result, as long as the data exclusivity lasts, generic companies would be placed in the position of having to repeat clinical trials to prove safety and efficacy--in essence, rebuilding the dossier from scratch. Doing so would not be extremely costly, but raises issues about proper research ethics: i.e. is it ethical to repeat clinical trials on humans to demonstrate what has already been demonstrated by others to be effective? (21) Further, few generic companies have the capacity to repeat all the necessary tests and clinical trials to build a dossier from scratch: the skills, technology and financing belong not to their business model, but to that of the companies that invent medicines.

A second argument against strict data exclusivity laws is that they can impede the effective use of compulsory licenses, for these only override patents and not other barriers to market entry. A generic company cannot make use of a compulsory license, practically speaking, if it has to wait for the expiry of the data exclusivity before it can get its generic version approved by the drug regulatory authority and put on the market. (22) Opponents argue that data exclusivity is a much stronger right than a patent, because having no exceptions; even in times of national emergency it does not allow the governments to curtail intellectual property rights. (23) Further, data exclusivity is conferred automatically when a drug gains regulatory approval, unlike a patent which must be applied for. Thus the ability of countries to utilize compulsory licenses and respond to public health needs in times of greatest crisis will be lost if stringent TRIP-plus provisions are included and accepted in bilateral FTAs.

In summary the oppositional argument stands like this: by pressuring countries (through negotiations of bilateral FTAs) to accept data exclusivity provisions that

"limit generic competition and the ability of countries to make use of safeguards in their patent laws to protect public health and ensure access to medicines ... [countries with strong pharmaceutical lobbying] are creating a new 'TRIPS-plus' norm that will undermine the right of countries to protect public health." (24)

To that, the propositional argument answers: the proprietary data that the originator of a new drug must acquire to gain market approval is 'intellectual property' of a kind, and because it is generally acquired painstakingly and at a cost of hundreds of millions of dollars, by all rights it deserves to be protected, whether or not TRIPS--which is obsolete anyway, given the soaring cost of drug development--requires it to be so.

Framed this way, the issue really does come down to the importance of TRIPS: either as an inviolable ceiling for intellectual property protection in the eyes of the opponents, or as subterranean margin from which future trade agreements are needed to rise. We look at TRIPS in the next section.

(ii) History

Data exclusivity first arose as an international issue during the negotiations for the TRIPS Agreement. Those negotiations resulted in Article 39.3, which envisages the protection of proprietary test data in the field of pharmaceutical technology. It reads: (25)

39.3. Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use [emphasis added].

In the main, Article 39.3 imposes only indefinite obligations to protect data against "unfair commercial use" and precisely what the obligations are, or what sort of use is unfair, is left to the imagination.

In the drafting of Article 39.3, earlier versions were proposed and discussed. Unlike the present version that does not include a defined length of time for data protection, the Brussels Draft of the TRIPS Agreement of 1990 (26) included a specific time period. It stated:
   PARTIES, when requiring, as a condition of approving the marketing
   of new pharmaceutical products or of a new agricultural chemical
   product, the submission of undisclosed test or other data, the
   origination of which involves a considerable effort, shall [protect
   such data against unfair commercial use. Unless the person
   submitting the information agrees, the data may not be relied upon
   for the approval of competing products for a reasonable time,
   generally no less than five years, commensurate with the efforts
   involved in the origination of the data, their nature, and the
   expenditure involved in their preparation. In addition, PARTIES
   shall] protect such data against disclosure, except where necessary
   to protect the public (27) [emphasis added].

The two main differences between the current version of TRIPS and the Brussels Draft are, firstly, that there is no mention of "new chemical entities" in the latter, but rather "new pharmaceutical products" and secondly, that a reasonable time to protect data is declared to be "generally no less than five years" in the earlier Brussels Draft. The clear implication is that a defined period of data exclusivity protection for pharmaceuticals was considered--and along the way, rejected--because it does not appear in the text that ultimately was agreed upon. (28) If indeed there had been a consensus of negotiators to define a reasonable time of at least five years, these terms would have been carried over to the Final Act of 1994, containing Article 39.3 of the TRIPS Agreement as it is today.

That the text of the earlier Brussels Draft ultimately did not achieve consensus is conclusive that a precise definition of data exclusivity does not exist as a norm in multilateral trade law. According to Article 32 of the 1969 Vienna Convention on the Law of Treaties (29) where a treaty is ambiguous under the usual rules of interpretation, one can look to the negotiating history (the travaux preparatoires) for supplementary guidance. Applying that rule, if there can be said to be any norm arising from Article 39.3, it is that WTO member states are free to act within the reasonable exercise of discretion to define the period, however short or long, for which the stipulated classes of data will be protected from unfair commercial use.

A strict interpretation of Article 39.3 has also been unsuccessfully sought in WTO jurisprudence. Soon after TRIPS came into force, the United States brought a complaint before the dispute resolution body of the WTO against Argentina, on the grounds that Argentina passed legislation allowing for no period of exclusive use of test data. (30) After almost 2 years of ongoing discussions the dispute was settled at the consultation stage, without a hearing, and with a face-saving gesture. On May 2002, the Governments of the U.S and Argentina agreed "should Argentinean law be inconsistent with Article 39.3 ... Argentina agrees to submit to the National Congress within one year an amendment to Argentinean law, as necessary, to put its legislation in conformity with its obligations under Article 39.3." (31) Unsurprisingly, in the end "Argentina did not accept the U.S. claim that exclusive rights should be granted for test data and maintained its law unchanged," and as other scholars note, "No further action in the framework of the WTO has been taken by the U.S. against Argentina, nor any other country that does not recognize data exclusivity." (32) The case achieved nothing, except possibly to reinforce a damaging, counterproductive reputation (borne out in other WTO disputes too) that the U.S. takes overly-aggressive interpretations of TRIPS, and litigates non-meritorious cases essentially for reasons of intimidation. (33) Perhaps some of today's opposition to data exclusivity is a backlash to U.S. tactics of a few years ago.

In conclusion: an attempt was made when TRIPS was negotiated to introduce a multilateral norm of five years or longer of data exclusivity. This norm cannot be said to exist for two main reasons. First, when comparing the current language of Article 39.3 of TRIPS to its antecedents, there was a clear agreement by WTO member states to omit a defined minimum period of time for protection of test data. Second, the only attempt to litigate a period of protection of test data into TRIPS was abandoned without achieving that result, and on terms that all but concede it cannot be done.

That leaves bilateral trade agreements, for the time being, as the only practicable vehicles through which international norms for data exclusivity can be made concrete. The following section discussed the methodology of our study of these agreements, as well as the tables documenting the results.

III. Methods

We gathered the data by researching each jurisdiction's trade website and extracting the needed information in order to form comparative tables. (34) We chose to compare bilateral FTAs for two reasons: (1) TRIPS-plus standards have now permanently become integral to international trade and to many bilateral FTAs; (2) differences between the various bilateral agreements indicate regional and global trends in data exclusivity law. The recent surge in U.S and, to a lesser degree, European FTAs indicates these processes are well underway.

We gathered the domestic legislative data by searching through the The Collection of Laws for Electronic Access (CLEA) in the World Intellectual Properaty Organization (WIPO) website (35) and the Global Legal Information Network (GLIN) (in March 2009). (36) We acknowledge that it is possible that the data gathered is not up-to-date. However, countries that are part of WIPO have an obligation to notify WIPO if there are any legislative changes. We focused on evaluating domestic laws in Latin American countries because they are at the vanguard of legal evolution currently: 10 of the 17 countries involved in bilateral FTAs with the U.S are countries or regional trade communities in Latin America. The interest of the U.S. to pursue bilateral agreements with the smaller Latin American countries is not at first easy to understand, because they account for a minor share of U.S exports (37) Instead, the U.S. interest to institute data exclusivity laws in Latin America is likely explained by the fact that "until recently [many] did not provide patent protection for pharmaceuticals and/or chemical products for agriculture" (38), such that data exclusivity assumes importance as another technique of maintaining a market position. Analysis of the data exclusivity laws of the Latin American countries sheds light on the extent to which FTAs have influenced domestic laws, and actually rather than theoretically introduced TRIPS-plus standards. (Translation of Spanish language laws was performed by one of the authors, R.G.C., a native Spanish speaker.)

Finally we summarized data acquired in the above steps to compare domestic laws in Latin America with the language of the international agreement that offers the greatest data exclusivity. The juxtaposition matters, because as countries enter into bilateral arrangements, they engage their Most Favored Nation (MFN) obligations of Article 4 of TRIPS vis-a-vis all other WTO member states. This means, for example, that a country that signed a bilateral FTA with the U.S. that includes data exclusivity terms would be required to give identical terms to all other WTO member countries, thus spreading TRIPS-plus standards throughout the WTO with little fanfare and inching de facto toward a multilateral system by the device of de jure bilateral agreements.

In the following section, we compare and contrast the data exclusivity terms in FTAs to which the U.S., E.U, or EFTA are parties, and compare that set of obligations to current domestic legislation in Latin America (beginning with the most recent FTA), to study the actual effect that FTAs have had in that part of the world.

IV. Results

(i) Comparing U.S, and E.U FTAs with the Countries that have negotiated the FTAs

(a) United States

In comparing the legislation of countries that have bilateral FTAs with the U.S. we discovered regional differences with respect to data exclusivity of new pharmaceutical chemical entities. In the first U.S. FTA with Jordan in 200139, a defined time period for data exclusivity of was not included. By the second U.S.-FTA with Singapore in 2004 (40), a defined time period of "at least 5 years" (41) for the dossier was included. This trend continued with the U.S.-Chile FTA in 2005 (42); the U.S.-Australia FTA in 2005 (43); the U.S.-Morocco FTA in 2006 (44); the U.S.-Bahrain FTA in 2006 (45); the U.S.-CAFTA-DR (46) (Costa Rica, the Dominican Republic, El Salvador, Guatemala, Honduras, and Nicaragua) in 2009--until the U.S.-Peru FTA in 2009 (47).

In the FTA with Peru the language changed to, "a reasonable period shall normally mean five years from the date on which the Party granted approval to the person that produced the data for approval to market its product" (48) [emphasis added]. The scope to vary data exclusivity to be less or more than 5 years is unlimited, and the bases to depart from 5 years are undefined, except that the term of exclusivity should be decided "taking account of the nature of the data and person's efforts and expenditures in producing them". (49) The same phrase is also included in the pending U.S.-Colombia and U.S.-Panama FTAs. (50) Thus in Latin America, bilateral agreements with the U.S. stipulate a basic 5 years of data exclusivity--although countries with the most recent FTAs have some flexibility to adjust the period upward or downward.

The Middle Eastern countries of Morocco, Bahrain, and Oman have the most stringent data exclusivity terms in their FTAs (excepting the earlier U.S.-Jordan FTA that was signed in 2001). The U.S.-Oman FTA (2009) and U.S.-Bahrain FTA (2006) are virtually identical, whereas the U.S.-Morocco FTA varies slightly. All these agreements contain the standard 5 years of data exclusivity as in Latin America, but the Middle Eastern FTAs add a new clause that introduces 3 years of data exclusivity when "new clinical information" is submitted for marketing approval (not including information related to bioequivalency), or when the country bases its marketing approval on new clinical information that was submitted in another country. (51) The intent of the "new clinical information" clause is probably to cover the nationalistic occasions, known to one of the authors (A.A.) from experience in the pharmaceutical industry, where a country demands that before granting marketing approval a company submit new clinical data proving its drug is safe and effective in the contry's own nationals, since the dossier generally concerns only Homo sapiens at large. Even so, it is hard to imagine how the "new clinical information" clause adds anything in practice, since the 3 years of data exclusivity it offers runs concurrently with the standard 5 years of data exclusivity for the regular dossier, and it seems very unlikely that a country would grant marketing approval based solely on "new clinical information" without also relying on the "old" clinical information in the dossier. Thus the purpose of the "new clinical information" clause remains mysterious, even as it appears as a new term in the Middle Eastern FTAs and the pending U.S.-Korea FTA.

Another notable difference between the Latin American and Middle Eastern FTAs is that while the latter agreements trigger data protection only when "undisclosed" data are submitted to a regulatory authority, that word is missing from the former agreements. (52) In theory, this means that submitting even public data--such as that which is published regularly in medical journals--could trigger 5 years of data protection in the Middle East. Although plausible, such an interpretation of the Middle East FTAs suffers in credibility, since the whole raison d'etre of data exclusivity is that it protects data which the inventor amassed at considerable expense and effort and therefore chose to keep private. Further, since such public data would never be sufficient for marketing approval without the normally proprietary (i.e. undisclosed) dossier as well, in practice, this difference in wording probably makes no difference.

Thus while there are certain textual differences in FTAs drawn from different regions, in some cases they amount to distinctions without a practical difference. But there are some interesting distinctions to note that certainly do impart differences, and which suggest that recently the U.S. is getting less deference and more pushback from the countries with which it negotiates FTAs. For instance, even though the U.S.-Chile FTA was signed after the U.S.-Singapore FTA, it does not contain a provision extending data exclusivity over data that is submitted to regulators in another country. (53) Another meaningful difference is that unlike some earlier FTAs, the U.S.-Peru, U.S.-Colombia, and U.S.-Panama FTAs all contain provisions to protect public health in accordance with the Declaration on the TRIPS Agreement and Public Health, (54) which arguably suggests that derogations to data exclusivity might be permitted where compulsory licenses issued consistent with that Declaration are issued. This interpretation gains much credibility because these FTAs are the only ones to contain a provision stating that data exclusivity laws apply "except where disclosure is necessary to protect the public or unless steps are taken to ensure that the data are protected against unfair commercial use." (55) Such a phrase, if it were to take hold in future FTAs, would go a long way toward answering the fear of some critics that data exclusivity threatens to make compulsory licensing all but impossible. (56)

(b) Europe

European FTAs can be divided into essentially 2 blocs: (i) the European Union (E.U.) as one bloc; and (ii) the European Free Trade Association (E.F.T.A.) as another bloc (this includes Iceland, Liechtenstein, Norway and Switzerland, who are not E.U. members). Interestingly, the E.U. has not yet included a defined period of data exclusivity protection in their FTAs, despite those FTAs including other provisions on intellectual property.

The E.U.'s omission to seek data exclusivity terms in trade agreements is puzzling, and certainly out of character. At this writing, internally the E.U. appears to have the longest period of protection for pharmaceutical data in the world. (57) Further, other scholars have noted that the E.U., during the discussions at the TRIPS Council that ultimately led to the Doha Declaration on the TRIPS Agreement and Public Health, "took a fairly hard line [and pharmaceutical] industry perspective" on data protection. (58) It would therefore appear that the E.U. distinguishes its positions on data exclusivity in the multilateral and bilateral realms, and is a less demanding negotiating partner in the latter. Perhaps this is because, to date, all the E.U.'s bilateral FTAs are with middle-income or smaller countries, and in this context the E.U. may be willing to accept more lenient terms than it would when dealing with richer or larger countries. Consistent with that theory, others report that in the current negotiation text of the E.U. FTA with the ASEAN countries, who are hardly the world's poorest, there is an explicit data exclusivity provision included, and in the E.U. negotiation there is an apparent provision on data exclusivity. (59)

In regards to the data exclusivity provisions in the EFTA countries, not all the FTAs include express terms to protect pharmaceutical data, but where they do, the applicable provisions are many and varied. At the low end of the spectrum, the FTAs of Croatia, (60) Israel, (61) Jordan, (62) Macedonia (63) and Morocco (64) stipulate only that data protection should be "adequate and effective"--a phrase that the Mexico FTA somewhat ineffectively expands on by also referencing "the TRIPS Agreement, in particular Article 39". (65) The Republic of Korea is seemingly more precise in referring to data protection for "an adequate number of years", but on closer examination, the number of years is unspecified apart from nebulous wording that stipulates "the number of years shall be determined by the relevant laws and regulations of the Parties". (66) In contrast, the FTAs with Chile, (67) Egypt, (68) and Tunisia (69) include a precise and exact requirement to protect data for period of "at least five years" (alternatively worded as "not exceeding five years"). In the Lebanon FTA (70), the period is somewhat longer--"at least six years." The latest development is the FTA signed with Colombia (71) in late 2008, and which similarly to Colombia's FTA with the U.S. (already discussed above) includes a provision stating that data protection shall be for "normally five years"--but unlike the agreement signed with the U.S., this document defines "normally" to mean "that the protection shall extend to five years, unless there is an exceptional case, where the public health interests would need to take precedence." (72) The Doha Declaration on the TRIPS Agreement and Public Health is also cited in this regard. (73)

It is not easy to distil a trend among the many approaches that EFTA has taken to data protection. Overall, the later FTAs tend to converge on a 5 year requirement, similar to the U.S. Since 2004 all the EFTA FTAs have included an absolute or qualified term of at least 5 years for data exclusivity (with the exception of the Republic of Korea, as already described).

(ii) Data exclusivity laws in Latin American Countries

To determine how the expansion of data exclusivity laws has affected Latin American countries, we compared the U.S bilateral FTAs of Peru, Colombia, Chile and the CAFTA-DR countries (Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, and Nicaragua), with their respective domestic legislation on data exclusivity. We did not include the Dominican Republic or Panama, as we could not find any domestic data exclusivity legislation. (74)

The most recent Peruvian domestic legislation (75) has similar provisions when compared with the U.S.-Peru FTA, including the important public health sections contained in the bilateral agreement. The Peruvian national legislation with respect to data exclusivity is entitled, "Decreto Legislativo de proteccion de datos de prueba no divulgados de productos farmaceuticos"--Decreto Legislativo No. 1072. It was approved on June 28, 2008, or about a year before the U.S.-Peru FTA came into force. The main body of the Decreto Legislativo includes the definition for a new chemical entity; (76) the period of protection for undisclosed data (normally 5 years); (77) and a section on the public health implications (78) which mirrors almost exactly the provisions contained in the U.S.-Peru FTA. The Decreto Legislativo also maintains the important--and unique--public health flexibility of Peru's FTA, and states that "the Health Registry could divulge the test data, if it were necessary to protect the health of the public, always taking appropriate measures to avoid unfair commercial use." (79) Therefore as a matter of Peruvian domestic legislation, it is clear that if a public health emergency occurred, data exclusivity requirements would not prevent flexibilities such as compulsory licensing.

The Colombian domestic legislation (80) Decreto 2085, is quite unlike the recent FTA signed with the U.S. or EFTA. This may be due to the fact that the version of the law being promulgated on the WIPO website in 2009 appears not to have been amended since 2002, or 7 years before the current pending U.S.-Colombia FTA. Article 3 of the Decreto contains transitional provisions which phase in pharmaceutical data protection: from a period of 3 years from the date of marketing approval for early applicants under the Decreto, incrementally up to 5 years for those applying in the third or later years of the Decreto. (81) Also, similar to Peru, Article 4 contains a provision for public health flexibilities, and it mandates that data exclusivity "will not apply" when in the determination of the Minister of Health that "would be necessary to protect the public". (82) How the Minister shall exercise discretion in this regard is not specified--an issue to bear in mind when the Decreto in its 2002 version is in the future updated to reflect the obligations of both the U.S. and EFTA FTAs.

The Chilean Domestic Legislation (Texto refundido Ley de Propiedad Industrial) (83) is an example of a domestic law that takes a simpler approach than set out in the U.S. and the EFTA FTAs. Whereas both those agreements require Chile to protect data for a period of "at least 5 years", this legislation omits the words "at least" and rather commits Chile to just the minimum of data exclusivity "period of 5 years starting from the date of registration with the Health registry." (84) The legislation also maintains a section on access to medicines and states that the data protection term can be abrogated "for reasons of public health, national security, non-commercial use, national emergencies or other circumstances of extreme urgency." (85) There is no wording in the legislation that requires such a step to be "necessary", but it is clearly implied in the context that some circumstance of extreme urgency should exist.

The CAFTA-DR countries are quite varied. At present, Costa Rica's domestic legislation, (86) is unusual in far surpassing the requirements of the U.S.-CAFTA-DR FTA. In other words, the legislation is much more stringent. It contains a striking provision assuring exclusivity for data collected on new pharmaceutical chemical, but without an end date. Could it be the data is meant to be protected eternally? There is, however, a generous clause which can be used to ease access to medicines, and it reads that "protection for data will be against all unfair commercial use, except when the use of the data is required to protect the public," such as may arise "to protect life, health or the security of humans ... or to prevent against abuses in intellectual property." (87) There is an obvious need for Costa Rica to amend this inadequate legislation, and at least to provide an end date on its data exclusivity obligations.

In contrast, the recently enacted Decreto Legislativo in El Salvador (88) does a better job reflecting the obligations that that country undertook in the U.S.-CAFTA-DR FTA. Unusually, the Decreto Legislativo goes to lengths to define a new chemical entity that qualifies for data exdusivity. (89) Similar to the Chilean legislation, it does the minimum that is required to implement the requirement of U.S.-CAFTA-DR FTA that pharmaceutical data protection be for a period of "at least 5 years", by dropping the words "at least." As written, El Salvadorean law states that protection will be for "a period of 5 years starting from the marketing approval date in El Salvador." (90) A possible concern is that the Decreto Legislativo is fairly terse on flexibilities for access to medicines: the clause permitting derogations from data protection "when necessary to protect the public" is not precise about the conditions in which necessity exists. (91) Since the Decreto Legislativo was enacted in 2005 before the U.S.-CAFTA-DR FTA (but during the negotiations) it may be possible that certain provisions are in need of updating.

The domestic legislation of Guatemala (92) deviates markedly from the U.S.-CAFTA-DR FTA, and similar to the Costa Rican law; it actually is far more stringent on data exclusivity than the FTA. To begin with the legislation's data exclusivity rights are unprecedentedly expansive and apply not only to pharmaceutical products containing new chemical entities but also to those containing new active ingredients. (93) This language means that a reformulation of an existing medicine, containing no new chemical entity, would trigger data protection afresh--a circumstance neither required by the U.S.-CAFTA-DR FTA, nor normal in other countries' laws. Further, the legislation fails to place any end date on the protection of data; as with Costa Rica's law, the protection therefore appears eternal. Nor does this legislation contain any provision for derogating from this endless data protection in the name of access to medicines, public health crises, human health protection or any other weighty concern. (94) Possibly these deficiencies of legislation are explained by the fact it predates the U.S.-CAFTA-DR FTA by 7 years. An updating is obviously necessary, given these many failings.

The domestic regulation of Honduras, (95) which came into force in 2000, was at one time also more stringent on data exclusivity than required by the U.S.-CAFTA-DR FTA. While not quite as ill-conceived as Guatemala's law, Honduras's law also failed to place any end date on the protection of data on new chemical entities; the protection is eternal. (96) However, on 21 March 2006, the "Ley de Propiedad Industrial" was amended to conform with the FTA. (97) Articles 19-24 contain provisions about patents and undisclosed information, and in particular, article 19 contains a provision stating that protection for the data of pharmaceutical products will be for a period of 5 years. (98)

Nicaragua recently enacted a new law (99) which introduced amendments to its patent law to ensure that it abides by the U.S.-CAFTA-DR FTA. Although the law states that protection for the data of pharmaceutical products "should be granted for a period of five years" (100)--and not "for at least 5 years" like in the FTA--it qualifies this difference by including the phrase, "in conformity with ... Article 15.10 of the CAFTA-DR FTA." (101) The legislation also makes reference to ensuring that data exclusivity laws in Nicaragua are in conformity with the U.S.-CAFTA-DR FTA--the only country whose laws make that mention. (102)

In summary, only Peru's domestic legislation includes reference to the Declaration on the TRIPS Agreement and Public Health. Although, Chile maintains a section on public health emergencies no other country has a strong provision allowing access to medicines in times of emergency. Several countries, such as Guatemala and Costa Rica, oddly protect data exclusivity in excess of what the U.S.-CAFTA-DR FTA requires of them, with no end date, but this is probably owing less to any considered decision than their failure to bring in amendments as Honduras did to impose an end date. No Latin American country that has recently amended its laws has done anything but the minimum to implement the wording of the U.S.-CAFTA-DR FTA requiring data exclusivity for "at least" five years, although certainly the U.S. must have hoped five years was a floor and not a ceiling, as it seems to have become.

V. Discussion & Analysis

There is no question that data exclusivity provisions in international law have gradually become more demanding over time. Overall, the data demonstrates that FTAs, particularly U.S.-FTAs and EFTA-FTAs, have become an effective means of introducing standards for the guarding of confidential data that do not exist at the multilateral level. In fact, the language in these bilateral FTAs is much closer to the rejected Brussels Draft of the TRIPS Agreement of 1990 than the actual TRIPS Agreement of today. The E.U., which has not to date insisted on data exclusivity terms in bilateral trade agreements, is also said to be negotiating agreements that trend in this direction.

Recall that the Brussels Draft included an explicit phrase extending the data exclusivity period for "a reasonable time, generally no less than five years." (103) A clause resembling this one is standard in U.S.-FTAs (although it may be qualified with exceptions, as in the cases of Colombia and Peru) and is increasingly common in EFTA-FTAs. In the case of the EFTA-Lebanon FTA, the requirements are more stringent than the Brussels Draft, and oblige 6 years of data exclusivity. Similarly, the U.S. has introduced a clause in its various Middle Eastern FTAs that provides 3 years of data exclusivity not for data in the original dossier, but for "new clinical information" that may be submitted to drug regulatory authorities--a term that has no forerunner at all in the Brussels Draft or other negotiating instruments.

These examples plainly show that by engaging in bilateral FTAs, the E.F.T.A. and to a lesser degree the U.S. has managed to circumvent--and even exceed--the high-water mark of what was possible to discuss in the TRIPS Agreement negotiations. In other words, TRIPS-plus standards are a reality, and FTAs are the method of choice in international law for effecting them.

As already discussed, public health advocates are often opposed to FTAs for just this reason, fearing that TRIPS-plus standards on data exclusivity could prejudice affordable access to medicines. That data exclusivity can prevent generic drug manufacturers entering the market is obvious and beyond question; indeed that is their raison d' etre. The correct question these opponents must ask is whether FTAs can be altogether blamed for spreading TRIPS-plus standards. Our data suggest that such blame is at least partially misguided.

The problem with the hypothesis that FTAs are uniquely responsible for advancing TRIPS-plus data exclusivity in countries that can ill afford it is that, in a number of cases, the countries in question already possessed domestic data exclusivity laws far in excess of anything stipulated in FTAs. For example, years before they signed any FTAs with data exclusivity clauses, Costa Rica, Guatemala and Honduras already possessed domestic laws providing for never-ending, eternal data protection. No FTA goes as far as that. The standard term in U.S. FTAs is only 5 years, and indeed, not even the domestic law of the U.S. or E.U. goes as far as that. The same is true of, for example, Guatemala's domestic law which protects the data of pharmaceutical products not containing new chemical entities, but merely new active ingredients. Again no FTA requires such stringent or extensive data protection. To blame the FTAs as being the vector for TRIPS-plus levels of data protection in such circumstances is illogical. In fact, if these countries implemented the U.S.-CAFTA-DR FTA that they signed into domestic law, paradoxically it would result in them lowering the standard of data exclusivity that now exists.

That said it also is not logical to argue that FTAs have no impact on public health flexibilities. Very few FTAs include the wording found in the Colombia-EFTA FTA, which refers to the Doha Declaration on the TRIPS Agreement and Public Health and the flexibilities it contains regarding compulsory licensing of medicines. As such, the concern that FTAs create data exclusivity requirements that could impede lawfully-engaged compulsory remains a legitimate one. Wording of this kind should be introduced into future FTAs, simply to remove the concern (and it should be noted that this is very unlikely to increase resort to compulsory licensing, which in this past decade have been very infrequent even in countries having no additional data exclusivity requirements prescribed by FTA).

Data exclusivity opponents have a further concern, not so much about the substantive terms of FTAs, but the legal climate that they produce in which data exclusivity increasingly appears to be an international norm. It has been argued that each time a bilateral FTA is signed and a country newly accepts strict data exclusivity laws, the road is paved toward a larger, cumulative effect. (104) It is not out of the question that after accruing enough bilateral agreements that support strict data exclusivity, the U.S. or EFTA countries will strive in international forums such as the WIPO or the WTO to negotiate similar multilateral standards.

Perhaps the strongest evidence for this argument is the one that marries the FTAs with the Most Favoured Nation (MFN) obligation in TRIPS, as alluded to earlier. Article 4 of TRIPS states in part:

"With regard to the protection of intellectual property, any advantage, favour, privilege or immunity granted by a Member to the nationals of any other country shall be accorded immediately and unconditionally to the nationals of all other Members."

This clause is important when discussing bilateral FTAs, because as mentioned earlier, if one WTO member country gives preferential treatment to another country (whether a WTO member or not), then any other WTO member country may claim the reciprocal preference as of right. Thus, those Latin American countries that have signed bilateral FTAs with the U.S. or EFTA are obliged to extend any preferences therein to all other WTO members. The gradual globalization of TRIPS-plus standards for medicines could be the result, and at least in theory, this could do harm to public health.

But is the effect of the MFN obligation problematic? Not likely. Once a country agrees to sign a single bilateral FTA containing data exclusivity obligations--a decision that it takes with knowledge, and after reflecting on the countless pluses and minues of the FTA on matters having nothing to do with data exclusivity and pharmaceuticals--it will normally amend its domestic laws of general application, so as to be in keeping with the FTA. This is how all countries whose laws were examined in this study brought the FTA's data exclusivity terms into effect: all amended laws of general application, and none enacted laws of special application only for the FTA partner country. It is therefore true that the empirical effect of the MFN obligations appears less than the theoretical effect, and for the countries in this study, MFN obligations add nothing when all comers are entitled to rely on laws of general application anyway.

In fact, probably the most worrying thing about FTAs and TRIPS-plus standards is how they will be interpreted in the context of a trade dispute. Many of the terms found in FTAs are so vague or execrably drafted as to invite questionable litigation, such as occurred when the U.S. proceeded at the WTO against Argentina. Even in the most recent U.S. FTAs implemented with Peru, or pending with Colombia and Panama, fundamental terms of the agreement are ambiguous and unrefined. What is actually meant by the clause that "a reasonable period [for data exclusivity] shall normally mean five years ... taking account of the nature of the data and person's efforts and expenditures in producing them"? (105) The second half of the sentence can equally well be interpreted to lengthen the time period for data exclusivity, as it could be to shorten it. One perceives in the wording not thoughtful legal drafting, but rather a diplomatic fudge in which both sides can see what they want to see.

The problem with such wording is that even if one wanted to make the period of data protection commensurate with a "person's efforts and expenditures" there seems no normative way to do it. (106) While pharmaceutical companies certainly expend a significant amount of resources--hundreds of millions of dollars--in developing drugs, it is not clear how those efforts are to be quantified and then translated. Companies' research and development expenditures are typically secret and not disclosed, even as part of the drug's dossier, making this phrase all but unenforceable. (107) All it seems to contribute is an opportunity for meritless litigation.

An interesting finding of this study is the varying levels of data protection in FTAs for Latin American countries versus those countries of the Middle East. It is clear that the U.S. applies different data exclusivity standards to these different geographical regions. This difference is perhaps related to the fact that negotiations in the Latin American dynamic are more complex, and marked by rancorous political divisions that sometimes assert themselves within regional negotiating blocs. In South America, the Andean Community is composed of Bolivia, Colombia, Ecuador, and Peru, while the Mercusur countries are composed of Argentina, Brazil, Paraguay, and Uruguay. At present none of the Mercusor countries have begun negotiations with the U.S for bilateral FTAs, and Argentina has expressed a lack of receptiveness to standards on data exclusivity. (108) The Andean Community has bifurcated: Peru and Colombia have negotiated FTAs, while Bolivia and Ecuador have not, and that has generated significant tensions. When Colombia adopted an exclusivity period for test data in 2002 (Decree 2085), this protection was challenged before the Andean Court of Justice in Quito as violating Decision 486, which contains a provision (Article 266) that is essentially the same as Article 39.3 of TRIPS. (109) In 2005, the Court of Justice decided that the Republic of Colombia had breached Andean norms. (110) However at the time, because Peru and Colombia were negotiating the FTA, the Commission of the Andean Community adopted Decision 632 clarifying the relevant part of Article 266, thereby clearing the way for member countries to include an exclusivity period for test data. (111) A rupture followed, in which Venezuela quit the Andean Community after over three decades of membership, and Ecuador declared that it was considering doing likewise. (112) FTA negotiations cannot be easy in such a volatile political climate.

Access to medicines is increasingly viewed as a vital necessity of human life. The developing country governments that have signed FTAs with data exclusivity clauses do so in a complex negotiation, in which access to medicines is but one consideration among many that have implications for the well-being of their populations. There is no doubt that FTAs are promulgating TRIPS-plus standards which could be potentially prejudicial to access to medicines, but equally, there is no doubt that flexibilities can be and have been implemented in FTAs and domestic legislation to mitigate that adverse outcome. As such, the challenge to developing countries is not to sideline their ambitions to conclude bilateral trade agreements, but to do so in a manner that leaves their flexibilities intact, while assuming a burden for the protection of pharmaceutical data that is reconcilable with their level of development.

(1) Agreement on Trade-Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex IC, Legal Instruments--Results of the Uruguay Round, art.23, 33. I.L.M. 81 (entered into force 1 January 1995). As of 23 July 2008 there were 153 WTO Members and thereby signatories to TRIPS.

(2) Carlos Maria Correa, "Implications of bilateral free trade agreements on access to medicines" (2006) 84 Bulletin of the World Health Organization 337; Jean-Frederic Morin, "Tripping up TRIPS debates IP and health in bilateral agreements" (2006) 1 International Journal of Intellectual Property Management 37; Francisco Rossi, "Free trade agreements and TRIPS-plus measures" (2006) 1 International Journal of Intellectual Property Management 150.

(3) Medicines Sans Frontieres (MSF), Data Exclusivity & Access to Medicines in Guatemala, online: MSF <>.

(4) Michael Dickson and Jean Paul Gagnon, "The Cost of New Drug Discovery and Development" (2004) 4 Discovery Medicine 172; Christopher P. Adams and Van v. Brantner, "Estimating The Cost Of New Drug Development: Is It Really $802 Million?" (2006) 25 Health Affairs 420.

(5) Dickson and Gagnon, Ibid.

(6) Carlos Maria Correa, Protection of Data Submitted for the Registration of Pharmaceuticals: implementing the standards of the TRIPS Agreement (Geneva: South Center, 2002), online: WHO <>.

(7) Meir Perez, "Intellectual property and pharmaceutical data exclusivity in the context of innovation and market access" (ICTSD-UNCTAD Dialogue on Ensuring Policy Opinions for Affordable Access to Essential Medicines Bellagio, University of Haifa, 12-16 October 2004). Online: IPRsonline < Pugatch_Bellagio3.pdf>.

(8) Experts have suggested that since the mid 1990's the pharmaceutical industry has had a difficult time introducing drugs that are truly innovative. See Ibid.

(9) Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (codified at 21 U.S.C. [section][section] 355, 360cc (2003); 35 U.S.C. [section][section] 156 (2002), 271 (2003), 282 (2000) (collectively, the "Hatch-Waxman Act").

(10) Steven R. Ludwig, "The Medicine Chest: Data Exclusivity--A Necessary Form of Intellectual Property" Intellectual Property Today (August 2007) online: <>.

(11) Supra note 9.

(12) Judith Ruis Sanjuan, "U.S. and E.U. Protection of Pharmaceutical Test Data" CPTech Discussion Paper--No. 1, online: CPtech <>.

(13) EC, Directive 2004/27/ec of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, [20041 O.J. L 136/34.

(14) Directives EC, Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, [2004] O.J L. 311.

(15) European Commission, Notice to Applicants: Volume 2A, Procedures for marketing authorization, Chapter 1, Marketing Authorisation (Brussels: European Commission, 2005), online: European Commission < pharmaceuticals/eudralex/vol-2/a/vol2a_chap1_2005-11.pdf>.

(16) Ibid. at 29 (emphasis added).

(17) European Commission, "Guidance on elements required to support the significant clinical benefit in comparison with existing therapies of a new therapeutic indication in order to benefit from an extended (11-year) marketing protection period" (Brussels: EC, 2007) online: European Commission <http://ec.europa. eu/enterprise/pharmaceuticals/eudralex/vol-2/c/guideline_14-11-2007.pdf>.

(18) David W. Childs, "The World Health Organization's Prequalification Program and Its Potential Effect on Data Exclusivity Laws" (2005) 60 Food & Drug L.J at 79.

(19) MSF, Data exclusivity in international trade agreements: what consequences for access to medicines?, online: MSF <>.

(20) WHO Commission on Intellectual Property Rights, Innovation and Public Health, Public Health Innovation and Intellectual Property Rights, online: WHO <>.

(21) Ibid.

(22) Supra note 19.

(23) Charles Clift, "Data Protection and Data Exclusivity in Pharmaceuticals and Agrochemicals" in A. Krattiger et al., eds., Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices (Oxford: MIHR, 2007) 431.

(24) Supra note 3.

(25) Supra note 1 at Article 39.3.

(26) GATT, Brussels Draft TRIPS Agreement Draft Final Act Embodying the Results of the Uruguay Round of Multilateral Trade Negotiations, GATT Doc. MTN.TNC/W/35/ Rev. 1 (3 December 1990) [Brussels Draft TRIPS Agreement].

(27) Ibid. at Art. 4A.

(28) Nuno Pires de Carvalho, The TRIPS regime of patent rights (2d ed.) (Manchester: Kluwer Law International, 2005).

(29) 23 May 1969, 1155 U.N.T.S. 331 at art. 32.

(30) Carlos M. Correa, "TRIPS and TRIPS-plus Protection and Impacts in Latin America" in Daniel Gervais, The TRIPS Agreement: Drafting History and Analysis, 2d ed. (London: Sweet & Maxwell, 2006) 221.

(31) See Notification of Mutually Agreed Solution According to the Conditions Set Forth in the Agreement, 20 June 2002, (IP/D/18/Add. 1, IP/D/22/Add. 1), online: World Trade Organization <>.

(32) Supra note 30. He also states that although no formal action has been taken, the U.S. does continually list those countries that do not have exclusive protection for test data in the special section 301 of the U.S. Trade Act.

(33) Paul Champ and Amir Attaran, "Patent Rights and Local Working under the WTO TRIPS Agreement: An Analysis of the U.S.-Brazil patent dispute" (2002) 27 Yale J. Int'l L. 365.

(34) See: Office of the United States Trade Representative Website, "Free Trade Agreements", online: U.S.T.R. < Bilateral/Section_Index.html>; European Trade Federation Website, "EFTA Free Trade Agreements" online: E.F.T.A. < fta-countries>; European Union Website, "Bilateral Relations", online: <>.

(35) See Coalition of Laws for Electronic Access (CLEA), online: World Intellectual Property Organization, <>.

(36) See Global Legal Information Network, online: <>.

(37) For instance, see Carlos M. Correa, "Bilateralism in Intellectual Property Defeating the WTO System for Access to Medicines" (2004) 36 Case W. Res. J. Int'l L. 79, at Note 15 where he observes that "all Central American countries account for 1.44 % of U.S. exports." See Richard E. Feinberg, "The Political Economy of United States' Free Trade Arrangements" (2003) 26 The World Economy 1019.

(38) Correa, Ibid. at 83.

(39) Agreement Between the United States of America and the Hashemite Kingdom of Jordan on the Establishment of a Free Trade Area, 17 December 2001, online: Office of the United States Trade Representative <

(40) United States-Singapore Free Trade Agreement, 1 January 2004, online: Office of the United States Trade Representative <>.

(41) Ibid. at Art.16.8(2)

(42) United States-Chile Free Trade Agreement, 1 January 2004, online: Office of the United States Trade Representative <>.

(43) United States-Australia Free Trade Agreement, 1 January 2005, online: Office of the United States Trade Representative <>.

(44) United States-Morocco Free Trade Agreement, 1 January 2006, online: Office of the United States Trade Representative < free-trade-agreements>.

(45) United States-Bahrain Free Trade Agreement, 1 August 2006, online: Office of the United States Trade Representative <>.

(46) The Dominican Republic--Central America-United States Free Trade Agreement, 5 August 2005, online: Office of the United States Trade Representative <>.

(47) The United States-Peru Free Trade Agreement, 1 February 2009, online: Office of the United States Trade Representative <>.

(48) Ibid., Art.16.10(2)(b).

(49) Ibid., s. 2(b)

(50) See United States-Colombia Free Trade Agreement, 5 August 2005, online: Office of the United States Trade Representative < trade-agreements/free-trade-agreements>, Art.16.10(2)(b) and United States-Panama Trade Promotion Agreement, 28 June 2007, online: Office of the United States Trade Representative < free-trade-agreements>, Art. 15.10 (2) (b).

(51) See U.S.-Morocco FTA, supra note 44, s.15.10(2); U.S.-Bahrain FTA, supra note 45, Art. 14.9(2)(a)(b); United States-Oman Free Trade Agreement, 1 January 2009, online: Office of the United States Trade Representative < trade-agreements/free-trade-agreements>, Art. 15.9 (2) (a) (b).

(52) Compare for example U.S.-Bahrain FTA, supra note 45, Art. 14.9(1), to U.S.-CAFTA-DR, supra note 46, Art. 15.10(1).

(53) See art. 16.8.2 in United States-Singapore Free Trade Agreement, 1 January 2004, online: Office of the United States Trade Representative <http://www.ustr. gov/trade-agreements/free-trade-agreements>: "If a Party provides a means of granting approval to market a product specified in paragraph 1 on the basis of the grant of an approval for marketing of the same or similar product in another country, the Party shall defer the date of any such approval to third parties not having the consent of the party providing the information in the other country for at least five years from the date of approval for a pharmaceutical product and ten years from the date of approval for an agricultural chemical product in the territory of the Party or in the other country, whichever is later."

(54) See Peru-FTA, supra note 47, art. 16.10.2(e); Colombia-FTA, supra note 50, art. 16.10.2(e); and Panama-FTA, supra note 50, art. 15.10.2(e)

(55) Ibid.

(56) Supra note 23.

(57) The E.U has an 8 year period of data exclusivity (supra note 18).

(58) Frederick M. Abbott, "The Doha Declaration on the TRIPS Agreement and Public Health: Lighting a Dark Corner at the WTO" (2002) 5 Journal of International Economic Law 469 at 482.

(59) Alexandra Heumber, "TRIPS plus provisions & Access to medicines in the current E.U. FTAs" (Paper presented to the European Parliament, Brussels, 17 February 2009), online: < +data+exclusivity+in+E.U.+FTA%27s&cd=1&hl=en&ct=clnk&lr=lang_ en|lang_es>.

(60) Free Trade Agreement Between the EFTA States and The Republic of Coratia, 21 June 2001, online: EFTA <>, Annex VII, Art. 3.

(61) Agreement Between the EFTA States and Israel, 17 September 1992, online: EFTA <>, Annex V, Art. 3.

(62) Agreement Between the EFTA States and the Hashemite Kingdom of Jordan, 21 June 2001, online: EFTA <>, Annex VI, Art. 3.

(63) Free Trade Agreement Between the EFTA States and the Republic of Macedonia, 19 June 2000, online: EFTA <>, Annex V, Art. 3.

(64) Agreement Between the EFTA States and the Kingdom of Morocco, 19 June 1997, online: EFTA <>, Annex V, Art. 3.

(65) Free Trade Agreement Between the EFTA States and the United Mexican States, 27 November 2000 online: EFTA <>, Annex XXI, Art. 3.

(66) Free Trade Agreement Between the EFTA States and the Republic of Korea, 15 December 2005, online: EFTA <>, Annex XXIII, Art. 3.

(67) Free Trade Agreement Between the EFTA States and The Republic of Chile, 26 June 2003, online: <>, Annex XII, Art. 3.

(68) Free Trade Agreement Between the Arab Republic of Egypt and the EFTA States, 27 January 2007, online: <>, Annex V, Art. 3.

(69) Agreement Between the States of the European Free Trade Association and the Republic of Tunisia, 17 December 2004, online: <>, Annex V, Art. 4.

(70) Free Trade Agreement Between the EFTA States and the Republic of Lebanon, 24 June 2004, online: EFTA <>, Annex V, Art. 4.

(71) Free Trade Agreement Between the Republic of Colombia and the EFTA States, 25 November 2008, online: EFTA <>, Art. 6.11 (2).

(72) Ibid.

(73) Ibid., Art. 6.11(4).

(74) The most recent available legislative document found (by using GLIN and CLEA) for the Dominican Republic was: Ley No. 20-00 sobre Propiedad Industrial, 18 April 2000, online: <>. There were no provisions included regarding 'data protection' or 'data exclusivity'. Similarly the most recent legislative instrument for Panama was, Ley 10/05/1996, No.35, online: World Intellectual Property Organization <>--provisions on data exclusivity were also absent. It is possible that the documents were missing because the countries' have not yet submitted updates to GLIN or CLEA.

(75) Decreto Legislativo de proteccion de datos de prueba no divulgados de productos farmaceuticos, D ecreto Legislativo No. 1072, 28 June 2008.

(76) Ibid., Art. 2.

(77) Ibid., Art. 3.

(78) Ibid., Art. 4.

(79) Ibid., Art. 4(4).

(80) Decreto 2085 DE 2002, Por el cual se reglamentan aspectos relacionados con la informacidn suministrada para obtener registro sanitario respecto a nuevas entidades quimicas en el area de medicamentos, 19 September 2002.

(81) Ibid., Art. 3.

(82) Ibid., Art. 4.

(83) Texto refundido Ley de Propiedad Industrial, Ley No.19.039, 2410111991. Note: We are aware that Ley No. 20.160 de 17 January 2007, que modifica la ley No 19.039 de propiedad industrial amends ley 19.039, de Propiedad Industrial. However based on our research from the GLIN website, it seems that amendments concern: standing to appear before the Department of Industrial Property, notifications in proceedings before that unit, submission of evidence, including expert witness testimony, the contents of the final decision, and other administrative consequences stemming from the granting or denial of petitions within the aforementioned procedures concerning trademarks or other protected intellectual property rights. No full texts were available for additional research.

(84) Ibid., Art. 89.

(85) Ibid., Art. 91(b)

(86) Ley de Informacion no Divulgada, No. 7975, online: <>.

(87) Ibid., at Art. 8.

(88) Reformas a la Ley de Fomento y Protection de la Propiedad Intelectual, Decreto Legislativo No.912 of the 14 December 2005, 9 January 2006.

(89) Ibid., Art. 181-C.

(90) Ibid., Art.181A.

(91) Ibid., Art.181D.

(92) Reglamento de la Ley de Propiedad Industrial, Acuerdo Gubernitvo No. 89-2002. Note: We are aware that Governmental Accord 242-2006 of 10 May 2006 issued by the Vice President of the Republic acting in the Presidency issues amendments to the Regulation of the Law of Industrial Property and its amendments. However based on our research using the GLIN website, the amendments refer only to title holder of a collective trademark, application for registry and the administration organ, in articles 29, 48 and 58.

(93) Ibid., Art 87(b).

(94) Ibid.

(95) Ley de Propiedad Industrial, Decreto Ley 12-99-E.

(96) Ibid. at Art.77

(97) Ley de Propiedad Industrial, Decreto No. 16-2006 signed by the President of the Republic on 21 March 2006, containing the Law on Application of the Free Trade Treaty Dominican Republic, Central America, United States of America (Ley de Implementacion del Tratado de Libre Comercio Republica Dominicana, Centroamerica, Estados Unidos).

(98) Ibid., Art. 19

(99) Reforma al Decreto No.88-2001, Reglamento de la Ley de Patentes de Invencion, Modelo de Utilidad Y Disenos Industriales, Decreto No. 16-2006, 9 March 2006).

(100) Reforma al Decreto No.88-2001, Reglamento de la Ley de Patentes de Invencion, Modelo de Utilidad Y Disenos Industriales, at Art 55.

(101) Ibid., Art. 1 (amending Art 55 of the predecessor law).

(102) Ibid, Art 2.

(103) Supra note 27.

(104) Gaelle P. Krikorian, "Intellectual property rights in the making: the evolution of intellectual property provisions in U.S. Free Trade Agreements and Access to Medicine" (2007) 10 The Journal of World Intellectual Property 388.

(105) Supra note 50, Art.16.10(2)(b)

(106) Ibid.

(107) See the studies cited at footnote 4, concerning research and development expenditures.

(108) Supra note 31.

(109) Supra note 30 at 247.

(110) Ibid.

(111) Supra note 30.

(112) "Venezuela quits Andean Trade Bloc" BBC News (20 April 2006), online: BCC News <>.

Rosario G. Cartagena * & Amir Attaran **

* Rosario G. Cartagena, was a third year law student at the University of Ottawa at the time this paper was written. She is currently a Student-at- Law in Ottawa and Toronto.

** Amir Attaran, Associate Professor in the Faculties of Law and Medicine and Canada Research Chair in Law, Population Health and Global Development Policy, University of Ottawa, Ottawa.
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