North-South America Conference on Biotechnology
Peter Commandeur
Keywords:  Policies/Programmes; Intellectual property rights; Biosafety/Foodsafety; Latin America/Carribean.
Correct citation: Commandeur, P. (1996), "North-South America Conference on Biotechnology." Biotechnology and Development Monitor, No. 26, p. 20-22.

The North-South America Conference on Biotechnology, held in November 1995 in Mexico, brought together a varied group of people involved in biotechnology development on the American continent. Since most experiences with existing biotechnology are found in the USA, developments in this country have received most attention. This article, however, concentrates on the few Conference contributions that critically addressed the specific difficulties of biotechnology development in Latin America.

The question for what purpose Latin American countries would need their own domestic biotechnology sector was not addressed as such at the Conference. Nevertheless, the contributors would have had their implicit view on this issue. Should a lively biotechnology sector just be understood as a new industrial sector which could generate economic growth, employment and export gains? According to one of the speakers, the US biotechnology sector currently employs 100,000 people and the top 10 biotechnology drugs alone have reached gross sales of approximately US$ 5 million. Or are other objectives at stake as well? According to José Luis Solleiro (Technology Innovation Center, UNAM, Mexico), the potential advantage of developing countries of having their own biotechnology sector goes beyond direct economic benefits. A national biotechnology industry could be beneficial to address the country’s particular needs. This is in contrast to the international biotechnology industry, which will not be worried about the problems of a developing country as such, unless their solutions were to provide an attractive market.
These two perspectives on the main purpose of a domestic biotechnology industry were not equally represented at the conference. Most attention was given to the experiences and opportunities of the, in economic terms, successful US biotechnology development as the example for Latin America. The questions which Latin American needs could be addressed by the application of biotechnology, how this should be done, and what could be learned from US experiences in this respect, was only addressed by some participants.

Government role
In the workshop on legal and regulatory aspects, Walter Jaffé (Venezuelan Science and Technology Council) addressed the role of governments in fostering biotechnology in developing countries. Based on the experiences with existing institutional models of agrobiotechnology development in Latin American countries, he presented his optimal model for biotechnology development in late-coming countries, provided that these countries already have a significant scientific and industrial base. In the first stage, the academic institutions of the late-coming country should attract biotechnology from leading countries, develop research capabilities in academic institutions and train scientists. In the second stage, the focus is on application: biotechnology should be transferred to applied research, and diffused to industry. Capabilities to use biotechnology in industry and research organizations need to be developed. Ideally, in the third and last stage of the development model, the emphasis should be put on the development of innovation capabilities. Industry carries out its own basic research on which it can base its competitiveness.
It is clear that the governmental role in the different stages should vary. In the first stage, government should invest in academic infrastructure and training. It the second stage, it should concentrate on the facilitation of the diffusion of biotechnology to the productive and service sector by providing a suitable legal and regulatory framework, favourable economic climate and access to risk capital. It also could provide direct support to certain sectors of particular economic and social importance. Finally in the third stage, a strong government role is no longer needed except for an optional direct support to specific biotechnology industries.

IPP for late-coming countries
Regulation on intellectual property protection (IPP) is an issue of current interest in most Latin American countries due to changes in the General Agreement on Tariffs and Trade (GATT) and, in the case of Mexico, the establishment of the North American Free Trade Agreement (NAFTA) of which Mexico is member. At the Conference, many speakers from the USA, based on their own US experiences, emphasized the need for strong IPP regulation as being critical for the development of a biotechnology industry. Most of them, unfortunately, failed to address what the differences between the US and Latin American economic context would mean for the design of an optimal IPP regulation that would enable the creation, diffusion and use of biotechnology in Latin American countries. An exception was the Mexican José Luis Solleiro. He subscribed to the importance of IPP regulation for the development of a domestic biotechnology industry, although he mentioned that this development depends on lots of other aspects, such as general economic growth, social and political stability and relative costs, as well. Solleiro criticized the many Mexican researchers who, according to him, are not aware of the changes in IPP which have been taking place, and are even less interested in establishing an appropriate IPP strategy for their own research institute. In this respect the US biotechnology sector, both private and public, is far ahead. But this does not imply that Mexico should just copy the US IPP regulation. In the opinion of Solleiro, Mexico and other Latin America countries should develop IPP regulation adapted to their position as followers (not leaders) in biotechnology development. Being a ‘good follower’ is based on the development and diffusion of new products derived from existing (foreign) biotechnologies. This strategy also includes the development of a certain level of basic research capabilities to train scientists and to choose, adapt and assimilate (rather than create) biotechnology developed elsewhere. In this respect, his view seems to fit very well in the ideal development model formulated by Jaffé, where in the first two phases biotechnology has to be attracted and transferred to applied research and industry. Solleiro further specified Jaffé’s requirement for a suitable regulatory framework in these phases.
IPP in follower countries should not function as a tool for large foreign firms to protect an export monopoly without being interested in manufacturing their biotechnology products in these countries. Instead, IPP legislation should enforce the country’s weak innovation system by emphasizing diffusion of technology. In this respect, Solleiro warned against the recognition of broad patents which mainly prevent diffusion of new technology (see also Monitor No 25). Mexico should nourish its requirement for patentability that inventions should be ‘industrially applicable.’ In US patent law, the requirement is ‘usefulness’ which leads to applications that speculate on the use of the invention. A proper implementation of the requirement ‘industrial applicable’ would include that the patent office test the actual applications of the inventions, and thus would prevent speculative and broad patents. In Brazil, it is proposed in the current draft of its new patent law, that a micro-organism cannot be patented per se, but only in conjunction with an actual application in an industrial process. Additionally, Mexico should defend the current research exemption in its patent law which is relatively strong compared to that of the USA. Finally, he questioned the exceptional position of patent holders under the Mexican Economic Competition Law. In most industrial countries, unfair and anti-competitive market practices based on patent protection represent a violation of economic competition legislation. In Mexico, however, several restrictions in the Law do not apply once a patent has been granted. Thus, anti-competitive practices are not illegitimate, which could negatively affect economic development.

Biosafety regulation
In several Latin American countries biosafety regulation and national committees to evaluate field test requests are evolving. These countries have to deal with the introduction of several transgenic plants from abroad, while also the first transgenic plants from Latin American laboratories are being field-tested now. Latin American countries can draw from Northern experiences, but, as Rodolfo Quintero (Institute of Biotechnology, UNAM, Mexico) expressed, they also have to face specific practical difficulties. For example, many countries only have to deal with a rather small number of field tests which makes a national committee a relatively heavy burden, especially since it often consists of the countries’ best scientists. But also more fundamental differences are at stake, for example, the concerns about field tests of transgenic plants in their centres of biological origin.
According to Terry L. Medley (Animal and Plant Health Inspection Service, APHIS, USA) biosafety regulation should facilitate instead of prohibit biotechnology development. Considerations of risk versus safety are of paramount importance, but biosafety regulations should also consider their impact on safe technology transfer, economic competitiveness, international harmonization and global needs and acceptance. Biosafety regulation should be developed and applied in a strategic manner. Ideally, ‘strategic regulation’ is based on identifiable science-based triggers that are consistent, easily understood and transparent; strategic regulation is flexible and dynamic (the USA has adapted its regulation 4 times and now includes field tests on notification and a non-regulated status for ten transgenic plants, see also Monitor No. 24); and meets domestic and international needs. APHIS is working on several fronts to bring about international harmonization of biosafety regulations in order to ensure that the new agricultural biotechnology products developed in the USA "can enter existing export markets without the imposition of undue regulatory burdens." Since biosafety regulation in the USA is very liberal, biosafety regulation requirements in other countries might easily be considered ‘undue’ by APHIS standards. The Service is in contact with the Commission of the European Union to come to mutually acceptable criteria to be used in safety assessments. Under the joint auspices of the Organisation for Economic Co-operation and Development (OECD), the USA has taken the lead in a project on the Commercialization of Agricultural Products Derived Through Modern Biotechnology, which stimulates the transparency of regulations in the Member countries to facilitate trade. Harmonization and mutual acceptance of data and assessment procedures are major goals. Among the USA, Canada and Mexico, all members of NAFTA, a discussion continues on streamlining regulatory aspects regarding biotechnology derived products that are under regulatory review or already approved in one of the three countries. APHIS is also active on biosafety regulation and harmonization in the Conference of Parties to the Convention of Biological Diversity. The USA signed the Biodiversity Convention in October 1993. However, unlike 128 other countries, the USA has not ratified the Convention.

International programmes
Several contributors paid attention to international programmes that support biotechnology, among them the Latin American network of the International Centre for Genetic Engineering and Biotechnology (ICGEB) and the biotechnology programme of the Organization of American States (OAS). The relatively new programme CamBioTec was presented by William Edwardson (International Development Research Centre, IDRC, Canada). CamBioTec, launched in January 1995 by IDRC, promotes biotechnology-based applications and products in the agrifood and environmental management fields in Latin America.
Underpinning CamBioTec is the belief that biotechnology could contribute significantly to more sustainable agricultural practices and better environment management. Latin American R&D capabilities are mostly found at universities, while product development and technology diffusion is often a problem. The Canadian Institute of Biotechnology (CIB), one of CamBioTec’s supporters, on the other hand, has a scientific capacity and business experience in transgenetics and biological alternatives for chemical agricultural inputs. Besides, the CIB concentrates on soil and water remediations and clean process technologies which could be helpful for the existing Latin American agrifood industry.
The programme aims at identifying opportunities for biotechnology research and applications; strengthening public biotechnology policies through advisory services and impact monitoring; improving innovation management within firms through training and information exchange; and fostering partnerships between Canadian and Latin American entrepreneurs and researchers. Apart from the Canadian CIB, the network has been built around key institutions involved in biotechnology development in Mexico, Argentina, Colombia and Cuba, apparently countries with a significant lead in biotechnology in Latin America. In Mexico a methodological training in priority-setting has been held so far. Priority-setting workshops are planned for Argentina, Colombia and Brazil in 1996. Especially in Mexico after the start of NAFTA, new opportunities are welcomed to collaborate with Canada and also European countries to avoid a unilateral dependence on the USA in biotechnology and in other sectors.
Peter Commandeur (editor)

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