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FTAA.soc/civ/109/Add.1
October 24, 2003

Original: Spanish
Translation: FTAA Secretariat
 

FTAA - COMMITTEE OF GOVERNMENT REPRESENTATIVES ON THE PARTICIPATION OF CIVIL SOCIETY

CONTRIBUTION IN RESPONSE TO THE OPEN AND ONGOING INVITATION – EXECUTIVE SUMMARY


Name(s) José Manuel Álvarez Zarate
Organization(s) Association of Pharmaceutical Industries of Colombia ASINFAR
Country Colombia

INTELLECTUAL PROPERTY IN THE FRAMEWORK OF THE NEGOTIATIONS FOR A FREE TRADE AREA OF THE AMERICAS (FTAA): WHAT SHOULD THE SCOPE BE FOR DEVELOPING COUNTRIES?

Executive Summary

At present, Colombia is holding discussions in three fora that are vital to its development and proper insertion into the international economy: the Doha Round of Negotiations in the WTO, the FTAA, and the FTA with the United States. These processes involve greater trade liberalization, as well as a more comprehensive treatment of third- and fourth-generation trade issues, including: investment, services, competition, intellectual property, and government procurement.

In the case of intellectual property, multilateral rules in the WTO, the FTAA or at the bilateral level could have significant repercussions on the production sector and society as a whole. Because factors such as trade balance, production, employment, and the protection or promotion of public health are closely linked to the advances made and treatment given to intellectual property in these fora, an in-depth study of this issue is increasingly important for these negotiations.

A consolidated position is needed to face these challenges; a position that objectively protects the national interests at stake. A Colombian and Andean position cannot be based solely on theoretical principles to protect individual rights, which have proven to be of little use to developing countries, or on legal discussions, which is what multinational industry would like.

Patents and public health

Undoubtedly, the FTAA, which is characterized by asymmetrical and unbalanced negotiations in the realm of intellectual property, will have an impact on the production sectors that work with national capital. The Ministry of Trade, Industry, and Tourism (Mincomercio), therefore, should be sufficiently clear in this regard so as to formulate, orient, and defend a trade negotiation policy that reflects the nation’s interest in this process, while taking into account these two highly sensitive social and business-related factors.

The type of patent system chosen will have a direct bearing on the accessibility of know-how and technology; consequently, a country's economic and social development will depend largely on this factor. A patent system that tends towards greater monopolistic advantages where drugs are concerned will certainly have an impact on the price of and access to the latter, as well as on the budgetary allocation made to purchase these drugs.

Mandatory licensing

Developing countries should not agree to international standards that limit access to these resources. On the contrary, an attempt to maintain access should be made by signatories to the DOHA Declaration.

Parallel imports

Pursuant to TRIPS, Article 28, the Member Country is fully empowered to decide whether or not to apply the principle of exhaustion of rights of the patent holder.

This broad and discretional framework granted to Member Countries allows them to improve access to products, including drugs, by establishing that the exclusive rights of the patent holder cannot be claimed in the case of imported products that are legally marketed in any other country.

In this regard, Colombia and the other countries of the Hemisphere should keep the possibility open of allowing the importation of patented products when these products are legitimately placed on the export market by the patent holder or with the authorization of the patent holder. Because this issue is entirely contractual, contractual regulations should be established between the patent holder and licensees and not through international public law.

The limitation on parallel imports will affect the price of products and, at the same time, markets may be divided at the convenience of multinational corporations, which will be able to freely set and manage prices according to the market.

Second use patents

Developing countries and the countries of the Andean Community in particular need to maintain the possibility of prohibiting the patenting of second uses. The reason for this is that a second use does not comply with the innovation requirement, which is imperative in determining that an invention merits protection. In addition, it has been observed that most second uses have arisen by chance, that is, they have been discovered. Given that discoveries are not patentable, neither can second use be so.

The elimination of the provision would give rise to many conflicts in the private and public sectors, in view of the fact that multinationals, faced with the possibility of losing their protection, will be prompted to request new patents for second uses.

Protection for test data

Pursuant to the country's customs, it is hoped that the negotiators will adopt a stance of defending and maintaining the position set forth in Decision 486, Article 266. As with second use patents, where a conflict had to be settled before the Andean Community, we hope that Colombia does not support any type of temporary protection for test data which is submitted with requests for the marketing of agrochemical and pharmaceutical products.

 
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