Part 7
Conclusions and recommendations

Chapter 1
Prospects for harmonization of biosafety regulations

The picture of the situation in biosafety in the Mercosur countries as described indicates the need to proceed with harmonizing the internal regulations of those countries. It is important to work on a scientific basis where plant science criteria will prevail over ideological approaches. The process should be based on a permanent dynamic, able to adapt to changes resulting from the rapid advancement of scientific and technological knowledge in the field of biotechnology.

The process should win over public opinion in relation to the products and processes of modern technology. It is also necessary to have mechanisms for social participation, education policies and strategies to implement innovations in biotechnology, in the context of preservation of biosafety and protection of human health and the environment.

The harmonization of biotechnology regulations in Mercosur should be based on knowledge which reinforces the scientific basis of the regulatory process and encourages it to be continuously updated. The agenda of issues should include significant joint projects for biosafety, addressing the following topics: the escape of pollen, the introduction of genes in an extreme environment and the catalog of beneficial insects.

Article 14 of the Cartagena Protocol on Biosafety of Biotechnology suggests the development of bilateral, regional and multilateral agreements and arrangements relating to the intentional transboundary movement of living modified organisms, provided that such agreements and arrangements are consistent with the objective of the Protocol and do not reduce the level of protection established by it. The Protocol will not affect intentional transboundary movement which occurs in the presence of an agreement between the parties.

Chapter 2
Harmonization of intellectual property regulations

International and regional contexts of negotiations

Within the process of integration of the Mercosur countries, instruments have been negotiated which establish minimum standards relating to trademarks and geographical indications, industrial designs, and rights of creators and related parties, but there have been no improvements on other issues, such as patents. The new patent laws adopted by the four countries are based on standards established by the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). However, there are significant differences between them, for example, with regard to patents in biotechnology and the obligation to locally exploit inventions.

The TRIPS Agreement signed in 1994 imposed international standards of intellectual property protection on member countries of the World Trade Organization (WTO), especially in regard to patents. The TRIPS Agreement established a “transition period” for developing countries to conform their laws to the new standards. Mercosur member countries, however, established their new patent laws using processes developed within each country, without regard to any regional coordination. Because of this, it was not possible for Mercosur’s system of intellectual property protection to match the standards set by TRIPS.

In many academic fields and in international organizations and forums, such as the United Nations Development Programme (UNDP) and the World Health Organization (WHO), concerns have been raised about the impact of TRIPS on health conditions in developing countries. These concerns have also been raised at the WTO, whose Fourth Ministerial Conference held in Doha, Qatar on November 9-24 2001, endorsed an interpretation of TRIPS which allows countries to produce generic drugs. The issue of legalizing free importation of generic drugs from countries that have no economic or technological conditions for producing them, as a valid practice within the framework of the WTO, remained pending.

At the Summit of the Americas held in December 1994, the American countries decided to negotiate the establishment of the Free Trade Area of the Americas (FTAA). Among the topics of negotiation was intellectual property, for which a special working group was created.

During the FTAA’s 6th Business Forum of the Americas, held in Buenos Aires, various business entities from the Mercosur countries, such as the Brazilian Association of Industries of Fine Chemistry, Biotechnology and their Specialties (ABIFINA) [Associação Brasileira das Indústrias de Química Fina, Biotecnologia e suas Especialidades], the Argentine Industrial Union (UIA) [Unión Industrial Argentina], the Brazilian National Confederation of Industry (CNI) [Confederação Nacional da Indústria do Brasil] and the Chamber of Industry of Uruguay (CIU) [Cámara de Industrias del Uruguay], presented proposals on the subject. A joint proposal on behalf of the Mercosur Industrial Council was also presented, composed of the UIA, the CNI, the CIU and the Industrial Union of Paraguay (UIP) [Unión Industrial Paraguaya]. These positions could help to identify the basis for a convergence of procedures at the regional level, using the opportunity that the FTAA offers for harmonization of intellectual property regulations in Mercosur.

Main areas of disagreement in the FTAA negotiation process106

In the process of negotiation of the FTAA, the main areas of disagreement between the countries involve the scope of the eventual agreement to be signed within the framework of the FTAA, in relation to TRIPS, and basic questions about the development of biotechnology, in particular about patenting of plants and animals. The main points of debate involve the following issues:

Scope of the agreement on intellectual property rights

Patentability

Principle of exhaustion of rights

Compulsory licenses

Second uses

Duration of patent

Exceptions for experimentation

Undisclosed information

Relations between government agencies

Other divergent positions

Positions of Mercosur business organizations

ABIFINA107

The proposal from the Brazilian Association of Industries of Fine Chemistry, Biotechnology and their Specialties (ABIFINA) recalls that Article 4 of TRIPS prohibits the favoring of any nation, which greatly reduces the chances of negotiating such matters within the FTAA. It also emphasizes that any preferential treatment accorded to countries in the Americas will be extended automatically to other WTO countries, possibly without consideration of reciprocity on the part of WTO countries not in the Americas.

The proposal emphasizes that the rules relating to intellectual property cannot be transformed into a market control mechanism. Rather, they should serve as an instrument of the technological and social development process, as recognized in Articles 7 and 8 of TRIPS. These rules have not yet been introduced as mandates in the FTAA negotiating process, which implies serious harm to developing countries and the industrial and commercial activities of such countries. The FTAA negotiations should be conducted based on the following principles:

Argentine Industrial Union108

The Argentine Industrial Union (UIA) proposes to focus negotiations on establishing a common understanding regarding the enforcement and interpretation of certain provisions of existing multilateral agreements on intellectual property and on the promotion of technology transfer. The implementation of the TRIPS Agreement represents a program of major scope and depth, not only because it requires modifications in existing laws, but also because it introduces entirely new laws, such as those dealing with integrated circuits and plant varieties. The recommendations are to ratify the following propositions:

The UIA, meanwhile, suggests that the negotiations on intellectual property should focus on finding a common agreement that meets the goals set out in TRIPS to reduce trade distortions in the Southern Hemisphere, and ensure adequate and effective protection of rights. These actions include the following:

Mercosur Industrial Council109

This organization has adopted a common position, which consists of:

Agreements reached at the 6th Business Forum of the Americas110

The above-mentioned issue was discussed during the development of the 6th Business Forum of the Americas,111 held in Buenos Aires on April 5-6, 2001. Regarding intellectual property, businesspeople agreed with the following recommendations: