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By recognizing the gravity of the public health problem in many developing and least-developed countries(75), Members, agreed that the WTO Agreement on TRIPS "does not and should not prevent Members from taking measures to protect public health," and "affirm that the agreement can 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."(76) The declaration also affirms "the right of WTO members to use, to the full, the provisions in the TRIPs Agreement, which provide flexibility for this purpose."(77) The flexibilities include "the right to grant compulsory licenses and the freedom to determine the grounds upon which such license are granted", "the right to determine what constitutes a national emergency" (including HIV/AIDS crisis as public health emergency), and the freedom to implement the exhaustion doctrine. The Doha declaration reaffirms use of the exhaustion doctrine under Article 6 of TRIPs by stating that the purpose is "to leave each Member free to establish its own regime for such exhaustion without challenge, subject to the MFN and national treatment provisions of Article 3 and 4."(78)

This statement from the Doha Declaration means that developing countries can issue compulsory licensing or/and allow parallel imports (by implementing the international exhaustion doctrine) for public health reason, without fear of invoking legal challenges from other WTO members, particularly the U.S.(79) Moreover, under Doha all least-developed countries have an additional ten years transition period, until 2016, to comply with pharmaceutical patents(80).

VI. The Unresolved or Remaining Problems after The Doha Conference

As the result of the Doha Conference, developing countries can issue a compulsory license or/and allow parallel imports (by implementing the international exhaustion doctrine) for public health reasons without fear of legal challenges from other WTO members. However, the U.S. still exerts pressure on developing countries to strengthen their patent protection on drugs because the volume of trade and profits from pharmaceutical sectors are large enough to get a close attention from both private and government agencies.

Although WTO Members recognized the issue of the limited pharmaceutical production capacities in developing countries, there has been no real resolution of this issue over whether developing countries, which cannot produce generic medicine by themselves, can issue a compulsory license to a company in another country to produce drugs for import into the developing countries. This situation is called a `third party compulsory licensing.(81) Indeed, in order to ultimately make compulsory licensing more effective, the Doha Declaration should specify that members are able to grant compulsory licensing to foreign manufactures to provide medicines in the domestic market. If Article 31(f) is interpreted to allow compulsory licensing only of domestic manufacturers serving the domestic market, the compulsory licensing would prove to be of limited use due to insufficient pharmaceutical production capacity in the developing nation. Therefore, developing and least-developed countries with low technology may be better off utilizing parallel imports instead of the compulsory licensing to increase access to essential drugs. Developing counties may be more secure from other countries' complaint against parallel imports because issues over international exhaustion doctrine cannot be brought to the WTO dispute settlement.

In comparison to compulsory licensing, parallel imports may be a better solution for developing countries, particular countries with low capacity to produce drugs. However, parallel importation still presents the problem of how to find a source of low-priced drugs. The low-priced drugs may be available in countries that provide a relaxed patent protection or use compulsory licensing. Currently, developing countries with production capacity such as India and Brazil have liberalized or relaxed their patent laws in order to produce the low cost drugs. Nevertheless, by the TRIPs deadline of 2005, these countries will have to raise their patent law standard to meet TRIPs obligation and may no longer be a source of parallel imports. In the case of compulsory licensing, developing countries with production capacity may issue compulsory licensing to produce essential drugs, but Article 31(f) of TRIPs Agreement only allows compulsory licensing of domestic manufactures serving the domestic market. So drugs made under compulsory licensing technically could not be imported for the need of a foreign country. The TRIPs council should allow parallel importation of compulsory licensed drugs. By relaxing on the interpretation of Article 31(f), the TRIPs Council should allow the strategy of the combination between compulsory licensing following by parallel imports (which is making drugs under compulsory licensing in one country and then import to another)(82). Also under Article 31(f) the countries with insufficient technology to manufacture drugs are not able to grant compulsory licensing to a foreign manufacture to produce and only provide medicines for the developing country's domestic market (known as a 'third party compulsory licensing'). WTO Members recognized this problem and instructed the TRIPs Council to find an expeditious solution before the end of 2002. Nevertheless, as of 2003, there has been no satisfying solution because of intense disagreement among members on this issue.

VII. Conclusion and Recommendation

The current TRIPs treatment on parallel imports is a good sign for developing countries. Countries are allowed to choose the exhaustion doctrine rule that will apply to parallel imports. This is beneficial to developing countries, as TRIPs Agreement does not require developing countries to apply a restrictive rule on parallel imports. However, it would be more beneficial to developing countries if the TRIPs Agreement specifically designated that the international exhaustion as applicable international legal standard, which allows parallel imports and supports the free trade. The current TRIPs Agreement incorporates strong patent protections and the rigorous restriction on compulsory licensing for pharmaceutical products. In relation to drug patents, liberalization on the parallel imports of pharmaceutical products enables developing countries to obtain medical drugs that are otherwise priced higher than poor patients can afford(83). In other words, allowing parallel imports in pharmaceutical products lessen the effect of strong patent protections and the rigorous restriction on compulsory licensing because the strong patent protection with limited utilization of compulsory licensing causes an adverse effect on developing countries in terms of high price and low availability of essential drugs. Comparing to compulsory licensing, parallel imports may be considered the better solution for developing countries to deal with the issue of inaccessible and unaffordable drugs.

In brief, arguments for liberalizing parallel imports of drugs focus on the consumers, social welfare and health policy concerns. Allowing parallel import not only lessens the problems of affordable access, but also reduces the volume of trade in counterfeit drug because consumers will trend to buy genuine parallel imported drugs over fake version. `Ib allow drug companies to stop parallel imports permits the companies to capture a double benefit at the expense of poor people. Regarding humanitarian concerns, drugs are not like other products since medicines are considered a necessary thing for all humans. Indeed, increasing access to essential medicines, such as the drugs for treatment of HIV/AIDS, benefits the entire global community. The more available affordable drug treatments are the less risk of infection world-wide.

As the result of Doha Conference, it obviously denotes that on the basis of public health, developing countries can issue compulsory license and allow parallel imports (by implementing the international exhaustion doctrine) without phobia of legal challenges from other WTO members particularly the U.S. They may expect that in area of public health, the U.S. would reduce the intimidate action. However, because of having dominant power to lobby the government and the high volume of trade and profits from pharmaceutical sectors, the U.S. pharmaceutical industries continually push the strong pressure to the government for impeding parallel imports and compulsory licensing.

In the long-run TRIPS Agreement should allow members to use a ‘third party compulsory licensing’ which grants compulsory licensing to a foreign manufacture to produce and provide drug for the need of domestic consumers. The third party compulsory licensing approach differs from the combination of compulsory, licensing and parallel imports since the former used no intermediary importers, thus avoiding price arbitrage. The later requires parallel importers and results in price arbitrage. The third party compulsory licensing approach is based on a straight pact between government and a foreign manufacturer and the goods produced under this licensing are directly exported from foreign country and import to the country issuing the compulsory licensing. This approach appears to be the best way to get a low-prices drug because, in the near future, it will be hard to find sources of low-priced drugs for parallel importation. Unfortunately, at present, ‘third party compulsory licensing’ is not allowed under the TRIPs Agreement. Therefore, parallel imports should help developing countries with insufficient technology to access to affordable essential drugs. In the short term, the combination of a relaxed patent law and liberalization of parallel imports under TRIPs may help to provide accessible low-priced drugs. Allowing parallel imports as a temporary solution may help to fill the need of developing countries in the intermediate term while the TRIPs Council works on providing a long-term solution to the issue.


(75) See Doha TRIPs and Public Health Declaration, supra note 70, at para 1.
(76) Id. at para 4.
(77) Id. at pare 4 and para 5.
(78) Id. at para 5 and 5 (d).
(79) See Alan 0. Sykes, Article, Public Health and International Law : TRIPS Pharmaceuticals, Developing Countries, and the Doha "Solution," 3 CHI. J. INT'L L. 47 (2002). (answering the question whether the declaration are bound in the dispute process by explaining that the Doha Declaration principally interprets vague obligations in the TRIPS Agreement, and does not seem to oppose any TRIPS provision. The Doha Declaration is likely to influence interpretation of the TRIPs Agreement.)
(80) See Doha TRIPs and Public Health. Declaration, supra note 70, at para. 7.
(81) Id.at para. 6. Paragraph 6 states "We recognize that WTO members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in marking effective use of compulsory licensing under the TRIPS Agreement. We instruct the Council for TRIPS to find an expeditious solution to this problem and to report to the General Council before the end of 2002."; This problem occurs because Article 31(f) of the TRIPs Agreement states that a product made under a compulsory license is supplied predominantly to the licensee's domestic market. Many developing countries lack or have an insufficient capacity to manufacture medicines on their own. This problem had been raised by developing countries. Developing countries argued "nothing in this TRIPS Agreement prevents Members from granting compulsory licenses for foreign suppliers to provide medicines in the domestic market... In this respect, the reading of Article 31 (f) should confirm that nothing in the TRIPS Agreement will prevent Members from granting compulsory licenses to supply foreign market." See The Developing Country Group's Paper, supra note 71, at para.34; In this matter, the EU supports developing countries by suggesting that it should allow developing countries that cannot produce drugs themselves to license a company in another country to manufacture a given drug for export to the Member granting the compulsory license. See The EU's Paper, supra note 71, at para.13.; and also see Correa, Implications of Doha Declaration on TRIPS and Public Health, supra note 55, at 19-22; and also see TRIPS, supra note 1, art.31(f). Article 31 (f) states "(f) any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use."
(82) This strategy can be work if the TRIPs Council agrees that the drugs made under compulsory licensing can be used not only for domestic market but also for potential foreign markets. The combination of compulsory licensing in one country and then parallel imports in another country would work in a way to get inexpensive drugs where they are needed.; see WATAL, supra note 12, at 325. (pointing out that Article 31(f) does not rule out exports. However, exports will be permissible only to countries where the product is not patented or where a compulsory license has been issued to a local entity to import the product. Moreover, in relation to parallel imports, it is dubious whether exports can be allowed to countries that allow parallel imports. This argument applies also to the use of compulsory license to import the patented product because the TRIPs Agreement does not prohibit this.); and also see Corlos M. Correa, Patent Rights, in INTELLECTUAL PROPERTY Arm INTERNATIONAL TRADE: THE TRIPS AGREEMENT 214-15 (Carlos M. Correa & Abdulqawi A. Yusuf, eds. 1998) (mentioning that the text of Article 31(f) does not completely ban exports of products covered under the compulsory licensing. In relation to the export market, the partial limitation may not be applied in connection with compulsory licenses on the grounds of anti-competitive practices under Article 31(k). This notion is consistent with the U.S. practices because exports by a compulsory licensee have been expressly permitted in the cases of license granted in the U.S. to remedy anti-competitive practices.)
(83) See Carlors M. Correa. Intellectual Property Rights, The WTO and Developing Countries: The TRIPS Agreement and Policy Option 36 (2000).; and also see MASKUS. supra note 3, at 211-12.( pointing out that in the perspective of developing and least-developed countries, the restrictions on parallel import amount to non-tariff barriers to goods that have legitimately been released from the control of IPRs owners. Actually parallel imports play an important role in countering "abusive price discrimination and collusive behavior based on private territorial restraints.")

 
Originally Published in The Intellectual Property and
International Trade Law Forum Journal, Seventh Anniversary, Current Issue 2004
 


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