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
- Treating the FTAA intellectual property using the standards provided for in TRIPS, without attempting to increase or introduce of new protected areas.
- Introducing other patterns of intellectual property protection, in addition to those under TRIPS.
Patentability
- Eliminating the exclusion of patents on plants and animals.
- Maximally restricting the scope of patenting in biotechnology.
Principle of exhaustion of rights
- Applying the principle of winning national rights to prevent parallel imports.
- Applying the principle of winning international rights to intellectual property.
Compulsory licenses
- Implementing the non-restrictive nature of compulsory licenses.
- Adopting the restrictive nature of compulsory licenses.
Second uses
- Specifically excluding protection of second use of the products already patented.
- Allowing patentability for second use.
Duration of patent
- Establishing an additional protection that extends the duration of the term of the rights granted by a patent, when delays in obtaining marketing authorizations, on the part of administrative entities handling health issues, do not allow the owner the full exercise of these rights.
- Not accepting the extension of duration of the term of a patent.
Exceptions for experimentation
- Excluding experimentation for commercial purposes, but allowing analysis and use of information and of the patented product in order to obtain approval for health products before the patent expires, and allowing them to be commercialized after they are produced.
- Restricting the experimental uses of a patented invention in order to avoid, for the duration of the patent, its commercially relevant use.
Undisclosed information
- Protecting undisclosed information and simultaneously rejecting any coordination which would give that information an exclusive nature, and allowing marketing of similar products already in the public domain.
- Protecting undisclosed information while the trade secret lasts. This information would not be allowed to be used for the purpose of obtaining a second authorization permit by a person other than the owner, for at least 5 years.
Relations between government agencies
- Maintaining the independence of functions between patent offices and drug approval agencies.
- Establishing the link between patent offices and offices involved in approving registration for marketing a pharmaceutical product.
Other divergent positions
- Resolving disputes.
- Protecting plant varieties.
- Explicitly anticipating the requirement of local production for the granting of patents.
- Requiring local manufacturing of the patent.
- Providing mechanisms that facilitate the granting of patents and trademark registrations in various countries.
- Passing legislation on unfair competition.
- Handling trade secrets.
- Involving government agencies and non-governmental organizations in cases of suspicion of piracy.
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:
- In terms of intellectual property, no provision will be negotiated which can constitute or establish an advantage, favor, privilege or immunity, including procedures for acquisition or maintenance of rights, for the originating countries of the FTAA, allowing its extension, without reciprocity, to a country which is not a member of the FTAA.
- During the process of creating the FTAA and for the interpretation of any agreements which are signed, all countries have recognized that the objectives of national intellectual property include providing technological and social development; that protection and enforcement of intellectual property rights should encourage technological innovation and technology transfer and dissemination, striking a balance between rights and obligations in order to promote social and economic welfare.
- Countries may adopt the measures necessary in order to: protect public health and nutrition, promote the public interest or social sectors of vital importance to their socioeconomic and technological development; and prevent or eliminate rights abuses or practices on the part of owners of intellectual property rights which unreasonably restrict trade, including not fully satisfying the internal market of the country, or hindering the transfer of technology.
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:
- That the TRIPS Agreement should provide an appropriate standard, with the consensus of the entire international community, regardless of the degree of development of the signatory countries, ensuring the promotion of technological innovation and adequate transfer and dissemination of technology for the benefit of producers and users.
- That it should take into account the differences in technological capability and productivity of the Southern countries, and restrictions on their ability to innovate.
- That it the less developed countries should emphasize. in developing their intellectual property systems, the aspects of technology transfer, the regulation of abusive practices and the protection of minor innovations.
- That the harmonization provided for in TRIPS should establish a reasonable limit in terms of alignment of intellectual property in the Americas.
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:
- Approving, as soon as possible, national laws consistent with TRIPS, while respecting the right to use transition periods.
- Adopting mechanisms for rapidly incorporating international treaties into national legal and regulatory systems.
- Adopting and implementing formal measures to ensure effective enforcement of laws by government authorities.
- Being aware of differences in technological capability and productivity among the countries in the region.
- Encouraging countries in the Southern Hemisphere to use the multilateral dispute settlement system to resolve conflicts of intellectual property protection.
Mercosur Industrial Council109
This organization has adopted a common position, which consists of:
- Negotiations on Intellectual Property in the FTAA should focus on effective implementation of the provisions in the various international agreements in force, in particular the TRIPS Agreement, aimed at reducing trade barriers and eliminating distortions affecting trade relations between member countries. The chapter on Intellectual Property in the FTAA should not introduce additional protection or levels above the minimum standards set forth in TRIPS, nor should protection levels incompatible with the standards established in the agreement be interpreted as constituting a reduction in protection.
- Considering the importance of intellectual property as a tool for technological development, mechanisms should be created to promote the effective transfer of technology to developing countries – one of the objectives of TRIPS – through the elimination of restrictions that currently exist.
- Lines of credit should be created, within the framework of multilateral financial institutions such as the Inter-American Development Bank (IDB), to promote innovation, technology transfer and diffusion of technology in the Southern Hemisphere. These lines of credit would help bring about, in the FTAA, the commitment undertaken by developed countries under Article 7 of the TRIPS Agreement.
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:
- Promoting studies of domain names in relation to trademarks and trade names, and that such topics should be considered jointly by groups involved in intellectual property and electronic commerce.
- Adopting, within the FTAA, measures to ensure intellectual property rights and service marks and provide protection for software.
- Recommending studies on biodiversity and traditional knowledge in relation to intellectual property.
- Studying and proposing measures of technological protection to encourage rights holders and users to establish rules that prevent internet piracy.
- Recommending that government agencies in FTAA countries adopt domestic measures to ensure the use of legal computer programs.
- Studying and proposing measures to facilitate technology transfer to developing countries, in order to reduce disparities in the economies of their respective continents.
- Creating lines of credit within the multilateral financial institutions to promote innovation, technology transfer and dissemination of technology on the continent, accepting that private companies can act as a local counterpart.
- Recommending that the FTAA chapter on Intellectual Property Rights should include a sub-section on geographical appellations and indications of provenance, including alcoholic beverages.