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Data Exclusivity and Public Health under the TRIPS Agreement
Olasupo A Owoeye [*]
The Agreement on Trade Related Aspects of Intellectual Property Rights (the ‘TRIPS Agreement’) is the first international agreement to set certain minimum standards for the protection of test data submitted to national drug regulatory authorities in order to obtain marketing approval for pharmaceuticals.[1] This protection has created a sui generis proprietary right in undisclosed information, akin to a patent right. The TRIPS regime for test data protection is also popularly known as data exclusivity, although there is some controversy as to whether the TRIPS data protection provisions actually establish a data exclusivity regime or not. There has been much concern as to the effect that the TRIPS framework for test data protection may have on access to medicines, even though this issue has not yet attracted the same level of academic commentary or analysis in comparison to the impact of the TRIPS patents regime. The standard of test data protection required by the TRIPS Agreement and the implications for access to medicines in developing countries are issues that are yet to be fully examined and understood.
This article examines the legal framework for test data protection under the TRIPS Agreement and the obligations it creates for Member States in relation to data exclusivity. It investigates the extent to which the TRIPS test data protection requirements impose fetters on compulsory licensing and the question of whether the right to keep undisclosed information confidential can be dispensed with through the compulsory licensing mechanism. The article considers the connection between test data protection and the need to safeguard public health, with particular focus on the implications for access to medicines in developing countries. It is posited that developing countries are not likely to derive any real benefit from data exclusivity, other than as a possible boost to investment in the local pharmaceutical industry. However, developing countries are still obliged to comply with their obligations under the TRIPS Agreement, including introducing data protection legislation, which could delay the availability of generic medicines. The article argues that data exclusivity should not be a barrier to the use of compulsory licences and that it may be possible to rely on the grounds for compulsory licensing under the TRIPS Agreement to satisfy the exceptions to TRIPS data exclusivity requirements. It takes the view that the promotion of free trade and development of pharmaceutical manufacturing capacity will go a long way in alleviating some of the challenges relating to access to medicines that may be caused by data exclusivity and intellectual property (IP) protection.
The Agreement on Trade Related Aspects of Intellectual Property Rights (the ‘TRIPS Agreement’) is the first international agreement to set certain minimum standards for the protection of test data submitted to national drug regulatory authorities in order to obtain marketing approval for pharmaceuticals.[2] This protection has created a sui generis proprietary right in undisclosed information, akin to a patent right. The TRIPS regime for test data protection is also popularly known as data exclusivity, although there is some controversy as to whether the TRIPS data protection provisions actually establish a data exclusivity regime or not. There has been much concern as to the effect that the TRIPS framework for test data protection may have on access to medicines, even though this issue has not yet attracted the same level of academic commentary or analysis in comparison to the impact of the TRIPS patents regime. The standard of test data protection required by the TRIPS Agreement and the implications for access to medicines in developing countries are issues that are yet to be fully examined and understood.
This article examines the legal framework for test data protection under the TRIPS Agreement and the obligations it creates for Member States in relation to data exclusivity. It investigates the extent to which the TRIPS test data protection requirements impose fetters on compulsory licensing and the question of whether the right to keep undisclosed information confidential can be dispensed with through the compulsory licensing mechanism. The article considers the connection between test data protection and the need to safeguard public health, with particular focus on the implications for access to medicines in developing countries. It is posited that developing countries are not likely to derive any real benefit from data exclusivity, other than as a possible boost to investment in the local pharmaceutical industry. However, developing countries are still obliged to comply with their obligations under the TRIPS Agreement, including introducing data protection legislation, which could delay the availability of generic medicines. The article argues that data exclusivity should not be a barrier to the use of compulsory licences and that it may be possible to rely on the grounds for compulsory licensing under the TRIPS Agreement to satisfy the exceptions to TRIPS data exclusivity requirements. It takes the view that the promotion of free trade and development of pharmaceutical manufacturing capacity will go a long way in alleviating some of the challenges relating to access to medicines that may be caused by data exclusivity and intellectual property (IP) protection.
Data exclusivity has been defined as the ‘protection of clinical test data required to be submitted to a regulatory agency to prove safety and efficacy of a new drug, and prevention of generic drug manufacturers from relying on this data in their own applications.’[3]
Data exclusivity has also been described as:
a time-bound form of intellectual property protection that seeks to allow companies to recoup the cost of investment in producing data required by the regulatory authority. The effect of data exclusivity is to prevent the entry of generic competitors, independent of the patent status of the product in question.[4]
A data exclusivity regime is therefore concerned with the extent to which a national drug regulatory body may be prohibited from relying on the originator’s data in approving the products of prospective generic competitors. Test data normally contains information that enables the government to assess the risks and efficacy of a drug before granting it market authorization.[5] Such information may include drug composition, factoring method and potential health risks to people, which makes the data of significant commercial value.[6]
Generally, before marketing approval is granted for pharmaceuticals in any country, the relevant national drug regulatory authority must have been satisfied as to the safety, efficacy and quality of the drug. This is normally satisfied through reliance on the information that can be gleaned from the test data submitted by the manufacturing company, which would, amongst other things, include the chemical composition of the drugs and pre-clinical and clinical drug trials, as well as tests conducted in the manufacturing process. Such test data may subsequently be relied on to register generic substitutes on the ground of bioequivalence. The implication of this is that generic manufacturers are able to rely on proprietary information generated at considerable cost by the originator once the period of protection provided by the data exclusivity regime has expired. This allows generic manufacturers to enter the market without the financial burden of generating their own test data. There are also ethical issues involved in allowing generic manufacturers to rely on the originator’s test data. Clinical trials generally involve the use of both human and animal research subjects[7] and requiring generic manufacturers to duplicate clinical results will entail onerous consequences for the research subjects. Paragraph 12 of the World Medical Association’s Declaration of Helsinki is particularly instructive in relation to the ethical issues involved in clinical trials. It provides:
Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation. The welfare of animals used for research must be respected.[8]
Paragraph 18 of the Helsinki Declaration further provides that any medical research involving the use of human subjects must be preceded by a careful assessment of the foreseeable risks and burdens to human subjects and communities affected by the investigation. The implication of these provisions is that where there is already sufficient knowledge in the field from previous clinical trials, there can hardly be a justified basis for repeating the same process.
Precluding generic manufacturers from using previously submitted test data in order to gain access to a given market can pose a real barrier to access to medicines in developing countries.[9] It has thus been argued that the ‘regulatory miasma’ occasioned by the data exclusivity regime is a significant part of the global system that embargoes access to medicines in developing countries.[10] The reason the data exclusivity regime is problematic in terms of access to medicines is that, where test data is protected, generic manufacturers will not be able to rely on it for the purpose of seeking marketing approval until the expiration of the protection offered. The implication is therefore that the rigorous, time consuming and expensive process of generating test data will serve as a substantial disincentive to market entry by the generic industry and, as a consequence, access to cheaper medicines will be delayed.
Where a product is under patent, data exclusivity is unlikely to be of material effect as the patent has the same effect in preventing entry onto the market of generic versions of the product. However, where the product is not patentable or off patent, data exclusivity can act independently to prevent any generic companies wishing to enter the market from doing so until the data exclusivity regime ends.[11] Data exclusivity may confer a stronger right than a patent as governments have a limited ability to interfere with it. A government may interfere with the exclusive rights of a patent holder through compulsory licensing but a data exclusivity regime cannot be so easily truncated.[12]
Trade secrets have been recognised and protected under common law rules and unfair competition legislation in a number of countries for many years, long before the advent of TRIPS.[13] The TRIPS Agreement is, however, the first international convention to introduce an international regime for test data protection and this is generally considered one of its most significant features.[14] Prior to TRIPS, Article 10bis of the Paris Convention for the Protection of Industrial Property provided for protection against unfair competition.[15] A broad interpretation of Article 10bis of the Paris Convention may have the effect of protecting test data against unfair competition but does not offer anything akin to data exclusivity. However, as will be seen below, the TRIPS test data protection framework transcends the requirement of protecting products against unfair competition by establishing a data exclusivity framework that accords the status of an independent proprietary right on the party entitled to such protection.
The TRIPS Agreement imposes an obligation on all Member States to offer adequate protection for confidential information submitted as a prerequisite for gaining market approval for a new drug. Article 39 of the TRIPS Agreement addresses this issue in the following terms:
1. In the course of ensuring effective protection against unfair competition as provided in Article 10bis of the Paris Convention (1967), Members shall protect undisclosed information in accordance with paragraph 2 and data submitted to governments or governmental agencies in accordance with paragraph 3.
2. Natural and legal persons shall have the possibility of preventing information lawfully within their control from being disclosed to, acquired by, or used by others without their consent in a manner contrary to honest commercial practices so long as such information:
a. is secret in the sense that it is not, as a body or in the precise configuration and assembly of its components, generally known among or readily accessible to persons within the circles that normally deal with the kind of information in question;
b. has commercial value because it is secret; and
c. has been subject to reasonable steps under the circumstances, by the person lawfully in control of the information, to keep it secret.
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.
An argument has been made that the initial wording of Article 39(1), ‘ensuring effective protection against unfair competition’, suggests that the protection afforded under Article 39 is founded on the rules relating to unfair competition as outlined in Article 10bis of the Paris Convention.[16] Such protection would therefore offer a safeguard against unfair commercial practices without giving rise to exclusive rights.[17] On this basis, Article 39 does not create proprietary rights but only gives de facto control to the owner of the undisclosed information.[18] Daniel Gervais has taken the view that the protection against unfair commercial use is enough to satisfy the protection against non-disclosure.[19] Carlos Correa also maintains the position that the text of Article 39 is ‘unusually clear’ in showing that the obligation under the provision does not go beyond the requirement of protection against unfair commercial practice recognised in the Paris Convention.[20] He further argues that not only does the language of Article 39 fall short of what could be recognised as data exclusivity or the creation of an independent proprietary right, but also that any interpretation requiring the establishment of exclusive rights,as constantly stated by the United States (‘US’) and the pharmaceutical industry, is fundamentally at variance with the language of TRIPS.[21]
While the argument that Article 39 does not go beyond the requirement to protect against unfair commercial use (as provided for in the Paris Convention) does sound attractive, it is not necessarily convincing. It is important to note that obligations under the Paris Convention are already incorporated in the TRIPS Agreement by virtue of Article 2, which provides:
1. In respect of Parts II, III and IV of this Agreement, Members shall comply with Articles 1 through 12, and Article 19, of the Paris Convention (1967).
2. Nothing in Parts I to IV of this Agreement shall derogate from existing obligations that Members may have to each other under the Paris Convention, the Berne Convention, the Rome Convention and the Treaty on Intellectual Property in Respect of Integrated Circuits.
Given the fact that obligations under the Paris Convention are already binding on parties, it would be superfluous to reproduce Article 10bis of the Paris Convention in the text of the TRIPS Agreement. In addition, it is clear that Article 39 of TRIPS contains specific provisions that substantially differ from Article 10bis. Indeed, the opening wording of Article 39 says that Members, in the course of ensuring adequate protection against unfair competition, must protect undisclosed information in line with the further standards imposed by the provision. It is therefore submitted that the protection required under Article 39 is not just confined to the protection against unfair commercial use, as a number of eminent scholars in the field have argued, but also requires standards significantly higher than those available under the Paris Convention. Writing in a similar vein, Nuno Pires de Carvalho argues:
...the purpose of Article 39 is not to oblige WTO Members to provide for effective protection against unfair competition, but rather to clarify two issues relating to the protection of trade secrets that the legislation of many countries had failed to address appropriately...[22]
The drafting history of TRIPS shows that the US attempt to introduce a ten-year data exclusivity standard was wholly rejected by the negotiators.[23] Correa has particularly argued that the language of TRIPS does not suggest that the mandated test data protection should be accorded through the grant of exclusive rights.[24] A literal interpretation of TRIPS Article 39 does not explicitly disclose a data exclusivity regime.[25] However, when interpreted against the backdrop of the fact that Article 39(3) is meant to restrain countries from acting in a way inconsistent with the trade secret status of test data, it would seem that the reasonable inference to be drawn is that Article 39(3) is meant to operate as a data exclusivity standard.[26] Indeed, Lorna Dwyer has expressed the view that test data is fast becoming a new IP right:
It shifted from a mere trade secret to a separate right akin to a patent with a minimum protection of five years. It also shifted from a protection of undisclosed test information to a protection for even publicly available information. The impact has been to prevent generic pharmaceutical manufacturers from entering the market, thus preventing people in developing countries from receiving lifesaving medicines. No credible justification for such protection has been offered. The research and development costs have already been recovered by the patent holders, having been included in the price of the medications for over twenty years.[27]
Aaron Fellmeth has argued that the public protection exception in Article 39(3) can only be justified in cases of real public emergency and that allowing a competitor to use the test data can hardly be justifiable even in an emergency except when it can be proven that the competitor had the only available facilities for testing the drug.[28] On the other hand, in dubiis benigniora praeferenda sunt is a principle of statutory interpretation that says the imposition of onerous obligations should be discouraged where the language of a treaty is capable of different interpretations or contains certain ambiguities.[29] Having regard to the fact that Article 39 allows the use of test data where such use is necessary to protect the public, a literal interpretation of Article 39(3) does not support the view that such use can only be available where there is an emergency. It is submitted that all that is required to use test data under Article 39 is evidence that this use is clearly in the public interest and not for commercial considerations. Requiring a public health emergency before allowing the use of test data would unnecessarily fetter the flexibility of the TRIPS Agreement.
Data exclusivity has been the subject of much criticism for a number of reasons. It is viewed as conferring patent-like protection on test data through the creation of financial disincentives against generic manufacturers who may want to enter the market by requiring them either to wait for the data exclusivity to expire or to invest significantly in the production of a new set of test data. It also extends patent protection which, it is believed, would have provided adequate compensation for the originator brand company.[30] Data exclusivity is therefore another factor that may have very serious implications for health care systems and access to affordable medicines in developing countries.
Whilst data protection limits the ability of countries to derogate from the exclusive rights of originators by enhancing generic production, pharmaceutical companies continue to pursue greater protection for patents and test data and the reduction of price controls.[31] In the words of Fellmeth:
economically developed countries have consistently pushed for an interpretation of the TRIPS Agreement that would confer on large pharmaceutical companies price-inflating monopolies over drugs that are neither patented nor patentable, through guarantees of exclusive rights to clinical testing data necessary to obtain marketing approval.[32]
Another significant consideration here is the effect of test data protection on patented products that are compulsorily licensed. Given that the data exclusivity regime confers a right independent of the patent, the grant of a compulsory licence in relation to a pharmaceutical product is arguably without prejudice to the test data protection. Therefore, the ability of the compulsory licensee to rely on the originator’s clinical trial results for gaining marketing approval on the basis of the compulsory licence alone may be debatable. This point is examined further below.
As already noted above, Article 39(3) provides for test data protection and encapsulates the TRIPS test data protection regime. This regime can be broken down into the following elements:
a. the product must utilize new chemical entities (newness requirement);
b. the origination of the undisclosed test data must involve considerable effort (origination requirement)
c. the test data must be protected against unfair commercial use (protection against unfair competition requirement); and
d. the test data must be undisclosed except where necessary to protect the public or where steps are taken against unfair commercial use (non-disclosure obligation and the exceptions).
Article 39(3) provides that the pharmaceutical or agricultural chemical product for which protection is sought must utilise new chemical entities. It could be argued that the requirement that the chemical entity is ‘new’ is akin to the requirement for novelty in patent law. If this is the case, then the next question is what is the standard required to satisfy this newness requirement? Since this term is not defined by the TRIPS Agreement, it is submitted that countries are at liberty to decide the standard of newness for test data protection that suits their local circumstances. This position is fully in consonance with Article 1(1) of the TRIPS Agreement which provides that Members are under no obligation to provide more extensive protection than that required under the Agreement and that they shall be free to determine the suitable method of enforcing the provisions of the Agreement within their legal system and practice.
In the alternative, it has been argued that the concept of ‘newness’ in respect of chemical entities does not relate to the novelty or undisclosed nature of the data but the administrative act of registration.[33] In other words, the concept of ‘new’ under Article 39(3) has nothing to do with the patent standard of novelty but registration and the effects of registration of a chemical entity for purposes of its novelty are basically territorial.[34] Gervais has described this as the practical approach to defining ‘new’ under Article 39(3).[35] He opines that provided that a chemical entity has not been previously submitted for regulatory approval in a given country, it should be considered new and the data generated from it should be eligible for protection.[36] To date, there has been no official guidance as to which of these differing views should be adopted by Members as fulfilling the ‘newness’ requirement in Article 39(3). Section 201 of the US Food Drugs and Cosmetic Act, for instance, defines a new drug as:
Any drug (except a new animal drug or an animal feed bearing or containing a new animal drug) the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.
Although using the act of registration as a benchmark for newness is defensible under Article 39, it is nonetheless submitted that the newness requirement in Article 39 should not be based on the act of registration. Chemical entities should only be considered new where the chemical composition has not been formerly recognised by people, qualified by scientific training and experience, as safe and effective for the treatment it has been found to offer. There is also support for the view that Article 39(3) will not cover cases where approval is required for ‘new dosage forms, combinations, new forms of administration, crystalline forms, isomers, etc of existing product’,[37] as they would not fall within the definition of a new chemical entity. In summary, it is submitted that since TRIPS does not provide a clear definition of the newness requirement, Members may rely on Article 1(1) of the TRIPS Agreement to interpret this requirement in a way conducive to their socio-economic welfare.
Article 39(3) provides that the origination of test data to be protected must involve considerable efforts. It is generally assumed that for pharmaceuticals, the generation of test data in most cases involves considerable effort especially in conducting clinical trials.[38] It would appear that a reasonable inference to draw from this provision is that the ‘effort’ involved should not only be substantial economically but also in technical and scientific terms.[39] On the other hand, this part of the test data protection regime has been criticised as extending IP beyond its boundaries of rewarding the creators of original ideas and new inventions to the protection of investment and not intellectual contribution.[40] The protection of investment, according to Correa, should be within the purview of competition law and not IP.[41] It is, however, doubtful if it can be rightly argued that the development of a new invention can be fully separated from the investment that inevitably goes with it. There is also no gainsaying the fact that test data generation involves substantial economic resources and scientific knowledge. It is thus submitted that the ‘considerable effort’ requirement will be easily met in virtually all cases of pharmaceutical test data generation.
2.1.3 Protection Against Unfair Competition Requirement
Article 39(3) requires national drug regulatory authorities to protect information submitted to them against unfair commercial use to the extent that such information remains undisclosed. It should be noted that the test data regime under Article 39(3) is essentially for regulatory approval for marketing pharmaceutical or agricultural products. It does not entail selling or offering data for sale.[42] To that extent, the point has been made that ‘commercial use can only mean granting marketing approval to competing goods without the consent of the first registrant’.[43] As Pires de Carvalho argues:
The whole idea of Article 39.3 is to prohibit parasitic behaviour or free riding. Any measures, such as relying on bioequivalence tests or other abridged procedures that alleviate the second registrant from obligations that have been imposed to the first registrant should be deemed as such.
On the other hand, Correa has argued that the concept of ‘unfair’ is relative to the values of a particular community and varies among Members.[44] He posits that even though the use by government may have commercial implications, it still does not amount to a commercial activity but a defensible State practice.[45] He thus highlights the following as actions a country may undertake without violating Article 39(3):
a. Require the second-entrant to produce its own testing data or to obtain an authorization of use from the ‘originator’ of the data;
b. Allow the second-entrant to rely on the ‘originator’s’ data against payment of compensation;
c. Use the ‘originator’s’ data in order to technically examine second-entry applications. In this case, the authority directly relies on the originator’s data;
d. Require the second-entrant to prove that his product is similar to an already registered product, without having to examine and rely upon the ‘originator’s’ data.[46]
Hiroko Yamane also takes a similar view, positing that Article 39(3) only requires Members to prevent the disclosure of data submitted to regulatory bodies to competitors and does not entail more than the protection against unfair commercial use by competitors.[47] In Ruckelshaus v Mosanto,[48] it was argued before the US Supreme Court that the use by a subsequent applicant of Mosanto’s protected agrochemical product data was unconstitutional, even though Mosanto was entitled to compensation for the use. The US Supreme Court rejected Mosanto’s complaint and noted the common practice of relying on originator’s data in the US. This case was decided a decade before the entry into force of the TRIPS Agreement. The Court in the Mosanto’s case did not recognise the originator’s right to exclusive use but there was an obligation to compensate the original owner of the data. The Canadian Federal Court of Appeal’s decision in Bayer Inc. v Canada (Attorney General)[49] is also very instructive. The decision was based on North American Free Trade Agreement (NAFTA)[50] provisions concerning test data protection that are similar to the provisions of TRIPS Article 39. The Court held in Bayer Inc. v Canada (Attorney General) that if the generic manufacturer exercises the option of having the Minister examine the confidential information filed by the innovator, it will be relying on the test data. The Court however noted that this would not be the case if the generic manufacturer is able to establish the safety and effectiveness of its product on the basis of bioequivalence or bioavailability studies without the Minister having to rely on the innovator’s data.
Although the Canadian courts have recognised use on the basis of bioequivalence as not amounting to unfair commercial use, it is wrong to contend that there is a general consensus on this point. Daniel Gervais noted that such use could come under scrutiny and that the interpretation of the Canadian Court is at odds with the view supported by a number of WTO Members including the European Union and the United States.[51] In a similar vein, Nuno Pires de Carvalho describes any reliance by government on the innovator’s data as ‘an unauthorised free riding’ that should be discouraged.[52] Jerome Reichman on the other hand contends that Article 39 of TRIPS does not prohibit governments from relying on innovator’s data on the basis of bioequivalence.[53]
Whilst the Canadian courts and some experts seem to favour the view that use on the basis of bioequivalence does not amount to an unfair commercial practice, it is still doubtful if this view can be seen as fully consistent with obligations under the TRIPS Agreement. A literal interpretation of Article 39, it is submitted, clearly suggests that any use of protected test data without the owner’s consent will be inconsistent with the TRIPS Agreement except where it is used to protect public health or if it does not amount to unfair commercial use. The use of such data for the purposes of ascertaining the safety and efficacy of drugs will not be unfair commercial use.[54]
As mentioned earlier, one unsavoury effect of restraining drug regulatory authorities from granting marketing approval on the basis of bioequivalence is the problem of having to substantially repeat toxicological and clinical trials, which will not only be profligate but also ethically problematic.[55] Nonetheless, it would appear that reliance on the originator’s test data for the purposes of granting marketing approval to a generic company, whether state owned or not, would run afoul of the tenor of the provision except where there are public health considerations.
Where generic companies rely on data that is publicly available, Article 39 will not apply, as the information must be undisclosed to qualify for protection. This provision is, however, subject to the public protection exception in Article 39(3).[56] The implication of this exception is that Members may disclose such information where necessary to protect public health or interest or where certain steps have been taken to adequately protect the disclosed data against unfair commercial use or competition. The TRIPS Agreement does not provide guidance on when it will be ‘necessary to protect the public’. Correa has opined that this provision is subject to a necessity test.[57] Deference may be given to Members in determining when such necessity arises but a Member invoking the provision may have to bear a very onerous burden of proof, should the measure taken be challenged.[58]
There is some support for the view that disclosure may be allowed to enable a compulsory licensee to acquire marketing approval, especially where the licence is issued to correct anti-competitive practices or to meet the demands of public health.[59] This is examined further below in the section on data exclusivity and compulsory licensing.[60] It is important to note that Article 39 does not provide for a set duration of test data protection and it would seem that such protection may continue indefinitely until the data can no longer be considered ‘undisclosed’. The generally accepted term of protection, from the current practice amongst Members, is five to ten years.[61] It has been suggested that terms of protection should be decided on a case-by-case basis, taking into account the resources committed to the generation of the test data and its novelty, but subject to a maximum protection period to avoid abuses.[62]
A pertinent point to consider here is the likely implication of test data protection on the use of compulsory licensing. Article 31 of the TRIPS Agreement, which deals with ‘use without authorisation’, provides for compulsory licensing of patented products. In 2001, the WTO Ministers adopted the Doha Declaration on the TRIPS Agreement and Public Health (Doha Declaration). Paragraph 4 of the Doha Declaration provides thus:
We agree that the TRIPS Agreement does not and should not prevent members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO members' right to protect public health and, in particular, to promote access to medicines for all.[63]
The problem was that under Article 31(f) of TRIPS, goods made pursuant to a compulsory licence in any given country should be predominantly for the supply of the domestic market. Paragraph 6 of the Doha Declaration mandates the Council for TRIPS to find a solution to the problems that countries without a manufacturing capacity in the pharmaceutical sector may encounter in using the compulsory licensing system. The solution came in the form of the Doha Paragraph-6 Implementation Decision[64] which has now become TRIPS Article 31bis through the Protocol Amending the TRIPS Agreement of 6 December 2005. The amendment is to take effect upon acceptance by two thirds of Member States but the number of acceptances that have so far been recorded is still below this requirement. WTO Members presently have until December 2015 to accept the amendment.[65] The Doha Paragraph-6 Implementation Decision is, however, in force in the meantime.[66]
A potential problem that may arise is that even where a compulsory licence is issued, the generic manufacturer may still have to seek the approval of the patent holder to make use of the test data to obtain marketing approval.[67] It has been argued that where a compulsory licence is issued in respect of a drug, data exclusivity may still present a significant hurdle by making marketing authorisation for the drug more difficult.[68] This is because Article 39(3) establishes a quasi-proprietary, quasi-patent system that confers rights that are separate and distinct from a patent right.[69] In the words of Nuno Pires de Carvalho:
Test data, actually may support marketing approval of patented products, but they are invariably developed after the invention is submitted to the patent office. For these reasons, the terms of protection of test data have no connection with patents.
It therefore follows that the grant of a compulsory licence to produce generics does not, generally, affect the protection available under Article 39(3).
The question that follows from this is whether a compulsory licensee may avoid gaining the data owner’s authorisation for marketing approval. A case could be made for arguing that use by government, pursuant to the grant of a compulsory licence, is not unfair and should not be treated as such. This is because the compulsory licensing regime under Article 31 of the TRIPS Agreement requires the payment of adequate remuneration where a compulsory licence is to be issued. It is therefore presumed that the compensation paid to a patent holder for the compulsory licence would have taken the data exclusivity right into account and such use of the information should, therefore, no longer be considered unfair. Besides, such use can also conveniently fall under the public health exception available under Article 39(3).
In a similar vein, use by a third party pursuant to a compulsory licence granted for public health reasons will not, it is submitted, be inconsistent with Article 39(3) provided that the third party is required to pay adequate compensation to the patent holder who will also be the owner of the test data. Article 31(h) of the TRIPS Agreement provides that ‘the right holder shall be paid adequate compensation in the circumstances of each case, taking into account the economic value of the authorization’. It is thus submitted that it will be an onerous burden indeed to expect a compulsory licensee to pay a separate remuneration for the patent right and another for data exclusivity. Since Article 31(h) already requires the compensation paid to the right holder to take cognisance of the economic value of the authorisation, this will be enough to compensate for the use of test data as well. In the light of the foregoing arguments and the provisions of the Doha Declaration, it is submitted that once a compulsory licence is issued under Article 31 of TRIPS the data exclusivity regime should pose no further barrier to the use of the compulsorily licensed product.
Another issue that is necessary to consider is whether the government can grant a compulsory licence in relation to a test data right, especially in cases where there is no need to get a compulsory patent licence. A brief examination of the negotiation history of the TRIPS Agreement may be pertinent here. The Anell draft (Chairman’s draft) of 23 July 1990 provided as follows on this point:
2A(a). Parties shall not discourage or impede voluntary licensing of undisclosed information by imposing excessive or discriminatory conditions on such licences or conditions which dilute the value of such information.
2A(b). There shall be no compulsory licensing of proprietary information.[70]
The Brussels Draft of December 1990 did not have the equivalent of Article 2A(b) in the Anell draft but nonetheless provided thus:
3A. Parties shall not discourage or impede voluntary licensing of undisclosed information by imposing excessive or discriminatory conditions on such licences or conditions which dilute the value of such information.[71]
These provisions prohibiting or discouraging the compulsory licensing of proprietary information were not included in the final text of the TRIPS Agreement. Does this mean the TRIPS Agreement can now be interpreted as allowing the compulsory licensing of proprietary information? Pires de Carvalho argues that the fact that Article 39(3) does not mention compulsory licensing does not support the inference that it forbids it, as the Agreement does explicitly forbid compulsory licensing where such is deemed necessary. This is the case in respect of trademarks under Article 23, which provides thus:
Parties may determine conditions on the licensing and assignment of trademarks, it being understood that the compulsory licensing of trademarks shall not be permitted and that the owner of a registered trademark shall have the right to assign his trademark with or without the transfer of the business to which the trademark belongs.
The argument, therefore, is that TRIPS has clearly and unequivocally made it known where compulsory licensing is not available, as in the case for trademarks, and in the absence of such express prohibition, it should be presumed that compulsory licensing will be available. While this argument is very compelling in principle, it is unlikely that compulsory licensing can be effectively pursued in practice under the provisions of Article 39(3) except where the grounds for the compulsory licence fall within the exceptions recognised under Article 39(3). Thus, no compulsory licence can be granted under Article 39(3) save to the extent necessary to protect the public interest or unless adequate steps are taken to prevent unfair competition. It would therefore appear that compulsory licensing may be available under Article 39(3) where it is used as a measure for taking advantage of the exceptions recognised under that provision. Any steps taken in excess of the exceptions will be afoul of the TRIPS Agreement.
Many countries have already legislated to provide for data exclusivity protection. In the US, the Food and Drug Administration (the national drug regulatory authority) is forbidden from accepting an application for marketing approval from a competitor for the first five years of registration without the consent of the initial registrant.[72] The same practice has been adopted by Health Canada.[73] In the European Community (‘EC’), Members are now required to grant six to ten years of data exclusivity to drugs that have been given marketing approval.[74] The EC has taken the position that the best way to protect test data against unfair commercial use is data exclusivity irrespective of whether the product is patented or not.[75] In Australia, test data registration is performed by the Therapeutic Goods Administration and protection is available for a period of five years from the date of registration.[76]
The justification for limiting the extent of the data exclusivity period, as already noted, is to avoid a situation where every generic manufacturer will have to undertake their own clinical trials, which will not only entail a significant waste of resources as well as ethical issues, but also make it substantially difficult for people in developing countries to gain access to much needed drugs at affordable prices. The contrary argument, put forward by the IP exporting countries, is that there will be little incentive to market drugs in developing countries without a robust data exclusivity regime.[77] Test data protection offers another layer of protection to products that are not patented or where the patent term has expired or is close to expiration at the time of registration.
Since the emergence of the TRIPS Agreement, the US has developed the practice of including a five year data exclusivity regime in its bilateral trade agreements.[78] The US has also been using more coercive measures under its 301 Watch List to enforce this interpretation of the TRIPS obligations. For instance, in 1996 a special 301 procedure was launched against Australia for failing to provide adequate protection to test data submitted for marketing approval.[79] This probably influenced Australia’s adoption of its own five-year data exclusivity regime in 1998.[80] Other countries that have come under US trade sanctions or pressure for non-compliance with data exclusivity requirements include Argentina, Taiwan and Thailand.[81]
The various free trade agreements and bilateral trade agreements negotiated by the US contain provisions that impose a level of test data protection that goes beyond the requirements contained in TRIPS. For instance, the Peruvian Trade Promotion Agreement and the Colombia Trade Promotion Agreement both include provisions that prohibit the use of test data on safety and drug efficacy to obtain governmental approval of generic drugs.
In a similar vein, the Dominican Republic-Central American Free Trade Agreement (CAFTA) requires signatories to provide test data protection for five years from the moment the product is granted market approval in their country.[82] This has been described as ‘an effective five-year bar on compulsory licensing from the time of marketing approval’.[83] NAFTA also provides for test data protection for a minimum of five years from the date on which market approval is granted.[84] It is arguable that the standard of protection required by TRIPS is that the test data must not be used for an unfair commercial purpose, and must not unduly restrict generic manufacturers seeking to use it for marketing approval. Data protection under TRIPS is only applicable to data relating to new chemical entities. However, under CAFTA, it applies to new products with a chemical entity not formerly approved in the country irrespective of whether the chemical entity is new or not.[85]
There is an emerging discourse on the need to recognise access to information from clinical trials as a basic component of the right to health.[86] It is important to note that the expiration of data exclusivity does not make the test data available to the public, as such information still remains confidential even after the period of data exclusivity has expired. However, arguably there is considerable public interest in making clinical trial results available to the public to safeguard public health. Access to early clinical trials, including phase 1 exploratory trials, could provide helpful information about the health and safety issues that may attend the marketing of pharmaceutical products.[87] It is arguable, therefore, that there exists the need to develop appropriate knowledge systems and reliable regulatory structure around medical knowledge.[88] Hence, it is submitted that following the expiration of the data exclusivity period, such information should be readily available, at least for the purposes of medical research and the advancement of knowledge.
The controversy regarding research reporting and marketing practices of GlaxoSmithKline and the use of its drug Praxil for the treatment of depression in children illustrates the point that access to clinical trial information is in the public interest.[89] The company was prosecuted by the Attorney General of New York for failing to disclose negative data and lopsided publications to promote off-label prescriptions.[90] Another example is the controversy surrounding Merck and its pain relief medication Vioxx, which is estimated to have caused hundreds of thousands of severe myocardial infarctions and cardiac deaths.[91] These incidents provide a sound basis for the proposition that clinical trial data should be accessible where necessary to ascertain the safety and efficacy of pharmaceuticals.
The argument that access to test data is a fundamental part of the right to health is founded on the premise that test data is a ‘public good’[92] and the ability to access test data information is seen as a major element of the right to the highest attainable standard of health.[93] As noted earlier, the TRIPS Agreement does recognise the public interest in test data and thus provides an exception to the rule against disclosure where it is necessary to protect the public.[94] The right to health entails the actualisation of public goals such as availability, accessibility and quality,[95] particularly in the field of pharmaceuticals. Such goals can hardly be realised without fair access to medical care that is substantially shown to be scientifically dependable and publicly accepted as effective. The European Court of Human Rights (‘ECtHR’) decision in Sunday Times v United Kingdom is somewhat pertinent to the topic.[96] An article in The Sunday Times, examining the history of the manufacturing and regulatory approval of thalidomide, had been banned by an injunction because its publication would amount to contempt of court. The ECtHR found that the injunction would amount to an unjustifiable infringement of Article 10 of the European Convention on Human Rights, which guarantees the freedom of expression. The ECtHR particularly noted that in issues pertaining to public health, the public has a right to be ‘properly informed’.[97]
The human rights dimension to the data protection provision of the TRIPS Agreement may therefore be a powerful weapon in addressing the public health implications of the TRIPS data protection regime. There is definitely the possibility of public health issues arising from data protection and this is equally recognised in Article 39(3) of the TRIPS Agreement. Member States, therefore, reserve the right to use such information or allow an independent third party to use it where necessary to protect public health to the extent that the protection against unfair commercial use is not compromised. States, in either using or allowing the use of such information, can justify the use by relying on the right to health.
The originator test data can be used for granting marketing approval to generic manufacturers, either pursuant to a compulsory licence or following the expiration of the data exclusivity period. Use or disclosure of such information can also be justified both under TRIPS and international human rights law for the purposes of ascertaining the efficacy or safety of the product, provided adequate steps are taken to ensure the disclosure does not result in unfair commercial use of the data.
In 2004, the Global Forum and Ministerial Summit on Health Research issued the Statement on Health Research which emphasised the need to promote access to reliable ‘and up-to-date evidence on the effects of interventions’ and called on the WHO to create a platform connecting ‘a network of international clinical trials registers to ensure a single point of access and the unambiguous identification of trials’. This was further reinforced by the fifty-eighth World Health Assembly in Resolution WHA58.34. As a result, the International Clinical Trial Registry Platform (‘ICTRP’) was established by the WHO in 2005, with the aim of enhancing the WHO Trial Registration Data Set on all clinical trials and promoting public access to the information.[98] The ICTRP search portal provides a one-stop point of access on information relating to current or completed clinical trials by using records submitted by data providers all over the world. The ICTRP is largely dependent on both national and regional regimes for implementation and enforcement.[99] Whilst the creation of the ICTRP is undoubtedly a significant step towards ensuring the accessibility of clinical trial data, a number of experts have taken the view that the ICTRP minimal data set is somewhat inadequate and more information would be required for any meaningful analysis of clinical trials to be possible.[100]
One major concern of the pharmaceutical industry is that clinical trial registration may offer competitors access to information that is substantially proprietary. Representatives of the industry have particularly expressed the objections of its members to the disclosure of five data items in the ICTRP system for being commercially sensitive, these being: official scientific title; intervention name; target sample size; primary outcome; and key secondary outcomes. The industry has argued that the disclosure of such information would deprive the originator company of the benefits of being the first to enter the market with a novel product.[101] It is, however, pertinent to note as stated earlier, that the obligation to protect test data under TRIPS is not unqualified. Disclosure is allowed where necessitated by overriding public interest and the implementation of registration and results reporting systems fall within this exception.[102]
In general, the TRIPS Agreement seems to have imposed uniform standards that are likely to benefit major IP holders, largely resident in developed countries, at the expense of emerging and least developed economies, which will have to pay heavier rents for the use of modern technology. This is also the case with regard to the specific provisions relating to data exclusivity. Indeed, for the vast majority of African countries and other developing countries without any significant manufacturing capacity in the pharmaceutical industry, data exclusivity offers no real benefits. Its contribution to boosting the investment climate in such countries is at best equivocal, given the fact that political stability, social security and economic viability are also important factors that inform investment decisions. Nonetheless, as succinctly noted by Michael Morgan, the TRIPS Agreement has become ‘a reality that must be taken into account in any strategy to remedy the gaps in access and innovation in developing world pharmaceutical markets’.[103]
The extent to which the TRIPS data protection requirements can be said to preclude the grant of marketing approval on the basis of bioequivalence may continue to elicit significant commentaries. It is nonetheless clear that the TRIPS negotiators directly rejected proposals to include provisions that might absolutely prohibit the use of originator test data in granting marketing approval to generic manufacturers.[104] However, as the preceding section demonstrates, the flexibilities allowed under TRIPS are further circumscribed by the TRIPS-plus obligations contained in many free trade agreements pursued by the US and the European Union. This point was noted by the African Union in the 2005 Cairo Declaration where the Ministers posited as follows:
We note that the African Group initiated the discussion on the clarification of flexibilities in TRIPS, particularly in relation to patents and public health as well as biodiversity. We call on African countries to take appropriate measures at the national level to make full use of these flexibilities in line with the outcome of the AU Commission Workshop held in March 2005 in Addis Ababa. We call on the EU not to introduce in the EPA [Economic Partnership Agreement] negotiations any TRIPS plus proposals (which go beyond existing TRIPS obligations) which would compromise these flexibilities. If such proposals are advanced, they should be rejected.[105]
For Africa, it seems the need to build innovative capacity is not in any way enhanced by a data exclusivity regime, but the TRIPS Agreement contains certain safeguards to ensure IP protection does not become an impediment to free trade and development. It is unlikely that Africa and most developing countries stand to benefit significantly from the global move towards a universal standard for data exclusivity and IP protection.
It is contended that it is critical for developing countries to form a common front in resisting bilateral or free trade agreements that take away or circumscribe the flexibilities allowed in TRIPS. The TRIPS standard for data protection is that it must be protected against unfair commercial use. However, the obligation against disclosure does not preclude countries from acting in the national interest in the event of a public health emergency. It is submitted that developing countries need to ensure that these distinctions are captured in their national frameworks for data protection.
The TRIPS Agreement has a number of provisions to protect public interest and the interest of developing countries. These provisions are collectively known as the TRIPS flexibilities. Articles 7 and 8 of the TRIPS Agreement provides that the Agreement should be implemented in a way conducive to the socio-economic interests of parties and that Members are allowed to take measures to protect public health and interest.[106] Compulsory licensing is another major flexibility that may be used to whittle down any barrier that may be constituted by the TRIPS data exclusivity regime, especially where such licences are issued to protect public health. This position is further reinforced by the fact that Article 39(3) of the TRIPS Agreement explicitly allows a public interest exception where public health is involved. In addition, the least developed countries are given until 1 July 2021 to comply with the standards imposed by the TRIPS Agreement.[107] WTO Members may therefore rely on the available TRIPS flexibilities to address any significant public health problem affecting them and this will not run afoul of their obligations under WTO law. It is, however, important to note that developing countries can deprive their populations of these flexibilities if they do not put a guard against inordinately high standards or TRIPS-plus provisions that may be imposed by bilateral or plurilateral trade agreements.
The impact of the TRIPS data exclusivity requirements on access to medicines is not without its controversies. It is incontrovertible that patents, and obligations arising from their protection, are not the only reason for the problems associated with access to medicines. A myriad of socio-economic factors are responsible for the access to medicines conundrum. That is why trade rules and IP protection should not be fashioned in a way that will exacerbate the problem.
It is beyond doubt that the regulatory purpose for drug marketing approval is more connected with efficacy and safety of drugs than lowering their prices. Data exclusivity also offers another layer of protection to patent holders in the pharmaceutical industry and that protection is not dependent on the patent term. It therefore appears that data exclusivity will only be of real benefit to developing countries that have some substantial pharmaceutical manufacturing capacity.
Article 39 of TRIPS should, however, not be construed as making the use of compulsory patent licensing more onerous as the valid issuance of a compulsory licence under the TRIPS regime should adequately satisfy the requirements of Article 39(3). Developing countries are bound by their international obligations in relation to the protection of IP rights. Nonetheless, the operation of the TRIPS Agreement is likely to make access to goods significantly difficult in regions that are yet to fully embrace the global move towards the promotion of free trade. The TRIPS Agreement was introduced to ensure that the free flow of goods and services in international trade does not infringe on IP rights. Having a strong international IP framework without a corresponding removal of barriers to market entry is likely to make access to goods more difficult and expensive. An important way of addressing the access to medicines problem in developing countries is through the stratagem of free trade. The removal of barriers to trans-border movement of goods will further facilitate access to cheaper goods and even encourage manufacturers to invest more in the regions that are likely to be more commercially viable due to the absence of market barriers.
It is submitted that access to test data for the purposes of ensuring drug safety and efficacy is an integral part of the right to health and relevant to consumers’ welfare and protection. The same argument applies to access to such products by market competitors especially where necessary to address a public health situation, even if it is not a real and immediate emergency. Data exclusivity, it is submitted, should not be a barrier to the use of compulsory licences under TRIPS, but neither data exclusivity nor compulsory licensing is of real significance where there is a minimal pharmaceutical manufacturing capacity. It is thus further submitted that there is a need for developing countries to use the stratagem of economic collaboration and regional market integration to develop strong local manufacturing capacity in the pharmaceutical sector and promote the free movement of goods within regional markets.
* Olasupo A Owoeye LL.B (Ibadan), GradCertRes, PhD (Tasmania), Lecturer in Law, RMIT University, Vietnam. The author acknowledges with thanks the research grants from the University of Tasmania Law School and the Institute for the Study of Social Change, University of Tasmania. Special thanks also to my PhD supervisors, Prof Dianne Nicol and Dr Jane Nielsen as well as the anonymous peer reviewers for their comments on the manuscript of the article.
1 Marrakesh Agreement Establishing the World Trade Organization, opened for signature 15 April 1994, 1867 UNTS 3 (entered into force 1 January 1995) annex 1C,The Agreement on Trade Related Aspects of Intellectual Property Rights (‘TRIPS Agreement’).
[2] Marrakesh Agreement Establishing the World Trade Organization, opened for signature 15 April 1994, 1867 UNTS 3 (entered into force 1 January 1995) annex 1C, The Agreement on Trade Related Aspects of Intellectual Property Rights (‘TRIPS Agreement’).
[3] G E Evans, ‘Strategic Patent Licensing for Public Research Organizations: Deploying Restriction and Reservation Clauses to Promote Medical R&D in Developing Countries’ (2008) 34 American Journal of Law and Medicine 175, 184.
[4] C Clift, ‘Data Protection and Data Exclusivity in Pharmaceuticals and Agrochemicals’, in A Krattiger, R T Mahoney, L Nelsen, et al. (eds) Intellectual Property Management in Health and Agricultural Innovation: A Handbook of Best Practices (MIHR and PIPRA, 2007) 435 <http://www.iphandbook.org/handbook/chPDFs/ch04/ipHandbook-Ch%2004%2009%20Clift%20Data%20Protection%20and%20Exclusivity.pdf> .
[5] L Dwyer, ‘Patent Protection and Access to Medicine: The Colombia and Peruvian Trade Promotion Agreements’ (2007) 13 Law & Business Review of the Americas 825, 840.
[6] Ibid.
[7] PhRMA, Clinical Trials: The Phases of Drug Testing and Approval (2006) <http://www.phrma.org/innovation/clinical-trials> .
[8] World Medical Association, Declaration of Helsinki, adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964.
[9] M R Morgan, ‘Medicines for the Developing World: Promoting Access and Innovation in the Post – TRIPS Environment’ (2006) 64 University of Toronto Faculty of Law Review 45, 68.
[10] B K Baker, ‘Ending Drug Registration Apartheid: Taming Data Exclusivity and Patent/Registration Linkage’ (2008) 34 American Journal of Law and Medicine 303, 344.
[11] Clift, above n 3, 433.
[12] Ibid.
[13] UNCTAD-ICTSD, Resource Book on TRIPS and Development (Cambridge University Press, 2005) 522.
[14] C M Correa, Trade Related Aspects of Intellectual Property Rights: A Commentary on the TRIPS Agreement (Oxford University Press, 2007) 367.
[15] Paris Convention for the Protection of Industrial Property. adopted 20 March 1883, 828 UNTS 305 (entered into force 7 July 1884).
[16] UNCTAD-ICTSD, above n 12, 527.
[17] Ibid.
[18] Ibid.
[19] D Gervais, The TRIPS Agreement: Drafting History and Analysis (Sweet & Maxwell, Thomson Reuters, 4th ed, 2012) 545.
[20] Correa, above n 13, 367.
[21] Ibid.
[22] N Pires de Carvalho, The TRIPS Regime of Patent Rights (Kluwer Law International, 2nded, 2004) 388.
[23] Gervais, above n 18.
[24] Correa, above n 13.
[25] A X Fellmeth, ‘Secrecy, Monopoly, and Access to Pharmaceuticals in International Trade Law: Protection of Marketing Approval Data under the TRIPS Agreement’ (2004) 45 Harvard International Law Journal 443, 459.
[26] Ibid 463.
[27] L Dwyer, ‘Patent Protection and Access to Medicine: The Colombia and Peruvian Trade Promotion Agreements’ (2007) 13 Law & Business Review of the Americas 825.
[28] Fellmeth, above n 24, 464.
[29] B A Garner (ed), Black’s Law Dictionary (Thomson Reuters, 9th ed, 2009) 1836.
[30] T Lemmens and C Telfer, ‘Access to Information and the Right to Health: The Human Rights Case for Clinical Trials Transparency’ (2012) 38 American Journal of Law & Medicine 63, 85.
[31] F M Abbott, ‘The WTO Medicines Decision: World Pharmaceutical Trade and the Protection of Public Health’ (2005) 99 American Journal of International Law 317, 357.
[32] Fellmeth, above n 24, 445
[33] Pires de Carvalho, above n 21, 397.
[34] Ibid 397-8.
[35] Gervais, above n 18, 544-5.
[36] Ibid.
[37] Correa, above n 13, 379.
[38] Gervais, above n 18, 545.
[39] UNCTAD-ICTSD, above n 12, 531.
[40] Correa, above n 13, 380.
[41] Ibid.
[42] TRIPS Agreement art 39.
[43] Pires de Carvalho, above n 21, 393.
[44] Correa, above n13, 381.
[45] Ibid 383.
[46] Ibid 384.
[47] H Yamane, Interpreting TRIPS (Hart Publishing, 2011) 470-1.
[48] Ruckelshaus v Mosanto, [1984] USSC 152; 467 US 986 (1984).
[49] Bayer Inc. v Canada (A-G) [1999] 3 F.C. D-25.
[50] North American Free Trade Agreement, signed 17 December 1992, [1994] CTS 2 (entered into force 1 January 1994) (‘NAFTA’).
[51] Gervais, above n 18, 545-6.
[52] Pires de Carvalho, above n 21, 395.
[53] J H Reichman, ‘Rethinking the Role of Clinical Trial Data in International Intellectual Property Law: The Case for a Public Goods Approach’ (2009) 13 Marquette Intellectual Property Law Review 1, 22.
[54] This point is examined further in 4.2 below.
[55] UNCTAD-ICTSD, above n 12, 531.
[56] TRIPS Agreement, art 39(3).
[57] Correa, above n 13, 380.
[58] Ibid.
[59] UNCTAD-ICSTD, above n 12, 532.
[60] See section 3 below.
[61] IFPMA, A Review of Existing Data Exclusivity Legislation in Selected Countries (International Association of Pharmaceutical Manufacturers Association, 2002).
[62] Pires de Carvalho, above n 21, 399.
[63] Doha Ministerial Declaration on the TRIPS Agreement and Public Health, WTO Doc WT/MIN(01)/Dec/2 (20 November 2001, adopted 14 November 2001) para 4.
[64] Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, WTO Doc WT/L/540 (2 September 2003) (Decision of 30 August 2003).
[65] Amendment of the TRIPS Agreement – fourth extension of the period for the acceptance by Members of the Protocol Amending the TRIPS Agreement, WTO Doc WT/L/899, (27 November 2013) (Decision of 26 November 2013).
[66] References to compulsory licensing or art 31 of TRIPS in this article should be understood in the context of the provisions of 31 and 31bis (Doha Paragraph-6 Implementation Decision) of the TRIPS Agreement. For more discussion on compulsory licensing, see D Nicol and O Owoeye, ‘Using TRIPS Flexibilities to Facilitate Access to Medicines’ (2013) 91(7) Bulletin of the World Health Organisation 533-539; O A Owoeye, ‘Compulsory Patent Licensing and Local Pharmaceutical Manufacturing Capacity in Africa’ (2014) 92(3) Bulletin of the World Health Organisation 214 – 219.
[67] Dwyer, above n 26, 843.
[68] Clift, above n 3, 433.
[69] Pires de Carvalho, above n 21, 390.
[70] Chairman’s Report to the GNG, Status of Work in the Negotiating Group, Negotiating Group on Trade-Related Aspects of Intellectual Property Rights, including Trade in Counterfeit Goods, WTO Doc MTN.GNG/NG11/W/76, (23 July 1990).
[71] Draft Final Act Embodying the Results of the Uruguay Round of Multilateral Trade Negotiations – Revision, GATT Doc MTN.TNC/W/35/Rev.1 (3 December 1990).
[72] Food, Drugs and Cosmetic Act, 21 USC § 355(c)(3)(E)(ii) (2001).
[73] Food & Drugs Act, CRC. c. 870 (1985), amended by § C.08.004.1, 129 C. Gaz. 2494 (1995) (Can.).
[74] Council Directive 2001/83 [2001] OJ L 311/75, art. 10; I Dodds-Smith, ‘Data Protection and Abridged Applications for Marketing Authorisations in the Pharmaceutical Industry’ in Richard Goldberg and Julian Lonbay (eds), Pharmaceutical Medicine, Biotechnology and European Law (Cambridge University Press, 2001) 93, 113.
[75] Communication from the European Communities and Their Member States to the Council on Trade-Related Aspects of Intellectual Property Rights, WTO Doc 15 IP/C/W/280 (June 12, 2001) 6.
[76] See Section 25A(2)(e) Therapeutic Goods Act 1989 (Cth).
[77] See C M Correa, Protection Of Data Submitted For The Registration Of Pharmaceuticals: Implementing The Standards Of The TRIPS Agreement (South Centre, 2002) 6-7.
[78] See, eg, Pharmaceutical Patent Issues: Interpreting GATT: Hearings before the Senate Comm. on the Judiciary, 104th Cong. 35 (1997).
[79] United States Trade Representative, Fact Sheet: "Special 301" On Intellectual Property Rights (1996) <http://www.cptech.org/ip/health/ustr/301-96.htm> .
[80] Therapeutic Goods Legislation Amendment Act (No 34) 1998 (Cth).
[81] United States Trade Representative, above n 78. In 2012, countries on the US 301 Priority watch list for non-compliance with test data obligations included: Algeria, Argentina, Chile, China, India, Indonesia, Israel, Pakistan, Thailand and Venezuela. Others on the watch list for inadequate test data protection were: Brazil, Dominican Republic, Ecuador, Egypt, Lebanon, Mexico, Philippines, Tajikistan, Turkey and Vietnam.
[82] Dominican Republic-Central American Free Trade Agreement, signed 5 August 2004 (entered into force 1 March 2006) art 15.10.1(b) (‘Dominican Republic-Central American Free Trade Agreement’).
[83] E Cowley, ‘The Right to Health: Guatemala’s Conflicting Obligations under the Central American Free Trade Agreement and the International Covenant on Economic, Social and Cultural Rights’ (2007) 11 Michigan State University Journal of Medicine & Law 227, 242.
[84] NAFTA art.1711 (6).
[85] Dominican Republic-Central American Free Trade Agreement art 15.10.1(c).
[86] See generally Lemmens and Telfer, above n 29, 65.
[87] Ibid.
[88] Ibid.
[89] D Rennie, ‘Trial Registration. A Great Idea Switches from Ignored to Irresistible’ (2004) 292(11) Journal of the American Medical Association 1359, 1359; J N Jureidini, L B McHenry and P R Mansfield, ‘Clinical Trials and Drug Promotion: Selective Reporting of Study 329’ (2008) 20 International Journal of Risk and Safety in Medicine 73.
[90] See New York v GlaxoSmithKline, No. 04-CV-5304 MGC (S.D.N.Y. 26 August 2004).
[91] R Horton, ‘Vioxx, the Implosion of Merck and Aftershocks at the FDA’ (2004) 364 The Lancet 1595; E J Topol, ‘Failing the Public Health -- Rofecoxib, Merck, and the FDA’ (2004) 351 New England Journal of Medicine 1707.
[92] J H Reichman, ‘Rethinking the Role of Clinical Trial Data in International Intellectual Property Law: The Case for a Public Goods Approach’ (2009) 13 Marquette Intellectual Property Law Review 1.
[93] Lemmens and Telfer above n 29, 99.
[94] TRIPS Agreement art 39(3); See also 3.1. above.
[95] Paul Hunt, Special Rapporteur on the Right to Health, The Right of Everyone to the Enjoyment of the Highest Attainable Standard of Physical and Mental Health, UN Doc. E/CN.4/2004/49/Add.l (1 March 2004) 33-38.
[96] The Sunday Times v The United Kingdom (1979) 30 Eur Court HR (ser A) 245.
[97] Ibid 66.
[98] WHO, International Clinical Trials Registry: About the WHO ICTRP (2013) <http://www.who.int/ictrp/about/en/> .
[99] Lemmens and Telfer, above n 29, 72.
[100] C Haug, P Gatzsche and T Schoeder, ‘Registries and Registration of Clinical Trials’ (2005) 353 New England Journal of Medicine 2811, 2812.
[101] Letter from Alan Goldhammer, Associate Vice President United States Regulatory Affairs, to ICTRP, RE: PhRMA's Second Round Comments on International Clinical Trials Registry Platform (ICTRP): Disclosure Timing (World Health Organisation, 2006) <http://www.who.int/ictrp/002-PhRMA_29March06.pdf)> .
[102] Lemmens and Telfer, above n 29, 82.
[103] M R Morgan, ‘Medicines for the Developing World: Promoting Access and Innovation in the Post – TRIPS Environment’ (2006) 64 University of Toronto Faculty of Law Review 45, 59.
[104] See 3.1.
[105] African Union Conference Of Ministers Of Trade, AU's Ministerial Declaration on EPA Negotiations, 3rd Ordinary Sess, AU/TI/MIN/DECL. (III) (09 June 2005) <http://www.issafrica.org/uploads/EPADECLJUN05.PDF> .
[106] TRIPS Agreement, arts 8 and 7. See also O Owoeye, ‘Patents and the Obligation to Protect Health: Examining the Significance of Human Rights Considerations in the Protection of Pharmaceutical Patents’ (2014) 21 Journal of Law and Medicine 900, 915-6.
[107] See Extension of the Transition Period under Article 66(1) for Least Developed Country Members, WTO Doc IP/C/64 (Decision of 11 June 2013) <http://www.wto.org/english/news_e/news13_e/trip_11jun13_e.htm#decision.> .
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