a) Report of the CGIAR Panel on Proprietary Science and Technology
b) Report of the CGIAR Panel on General Issues in Biotechnology
TAC Commentary on the Report of the CGIAR Panel on Proprietary Science and Technology
131. The TAC Chair introduced the report of the CGIAR Panel on Proprietary Science and Technology. He echoed the importance of this issue for the System in the current setting of accelerating knowledge in science, biology and information technology. He noted that the task of the Panel was not an easy one; also, it had a varied composition which led to divergent views on the CGIAR mission, and on the role and legitimacy of International Property Rights (IPR) in the System. The Chair then requested Mr. Timothy Roberts to present the report.
132. Mr. Roberts began by stressing the rapidly changing scientific environment in which new science was contributing at a geometric pace to the existing stock of scientific knowledge. In this context, it was important to distinguish between the proprietary science of the Centres and of other actors, recognizing that both must be respected. Corollary questions were how and where technologies were protected; which technologies the Centres wished to use; and the legal status of Centres' products.
133. The Panel commissioned three studies to answer these questions. A survey on North-South trade of CGIAR commodities and implications for biotechnology was conducted by Drs. Binenbaum and Wright, University of California, Berkeley, but the results were not very conclusive for the purpose of the review. The second, an inquiry by Dr. Joel Cohen, ISNAR, on the present use of biotechnology and proprietary science in seven CGIAR Centres was highly informative. A third survey was carried out by Dr. June Blalock, USDA, on current involvement of private firms with CGIAR Centres on biotechnological applications. Finally, the Panel report included, inter alia, a study on the mechanisms of market segmentation; it focused on licensing technology and selling products in different markets which could benefit poor producers but, by the same token, protect companies in profitable markets, thus enabling them to remain involved in the business of innovation.
134. The main findings of the Panel were that the mission of the CGIAR should determine whether intellectual protection of its research outputs was desirable or not. If necessary, the mission statement of the CGIAR should be changed to firmly embed the IPR issue in the System. The Panel urged the CGIAR to review its present policy on IPR with a view to revising and subsequently applying new IPR guidelines. The Panel also saw an urgent need for the CGIAR to analyze its capacities in intellectual property management.
135. In the ensuing discussion, it was observed that: CGIAR Centres, as trustees of germplasm collected prior to the coming into force of the Convention on Biological Diversity, could not claim rights on materials held in their collections; CGIAR policies on IPRs were not clear; local laws might not protect the IPRs of CGIAR Centres. It was also queried whether it would be possible to achieve the mission of the CGIAR with or without "alternative rights regimes".
136. In reply, Mr. Roberts, in his capacity as a lawyer, recognized the difficulties of the Panel in providing compelling guidance to the CGIAR. He stressed, however, the following points:
(i) The CGIAR had to make available the best products to its clients and through the right channels. From the surveys commissioned by the Panel it appeared that the Centres were already doing so.(ii) An institutional, central steering mechanism on issues regarding intellectual property protection in the CGIAR would require corresponding mechanisms at Centre level.
(iii) For the current germplasm collections, a central question remained the assessment of the germplasm held in trust by the CGIAR versus its role as trustee of the germplasm in the current collections.
(iv) Cooperation between the CGIAR and its partners would increase, but objectives might diverge; therefore, the CGIAR needed to ensure recognition of the IPR policies of other actors.
137. Mr. Roberts closed by stating that the plain recognition of IPR by the System would in itself be significant and an important step in the right direction.
138. The TAC Chair drew the discussion to a close by thanking all those who participated, Mr. Roberts, and the members of the Panel for their report. After further consideration backed by views from external expert assessors and discussion in the working group, TAC offered the following commentary.
139. TAC is grateful to Timothy Roberts, Panel Chair, and to members of the Panel that prepared the report on the future role of the CGIAR in proprietary science and technology. The Committee particularly appreciates the wealth of synthesized information on the protection of intellectual property (IP) as it relates to the CGIAR and the broad spectrum of opinions reflected in the report. The report significantly advances our understanding of the issues confronting the CGIAR with respect to intellectual property rights (IPR).
140. TAC recognizes that the Panel's Terms of Reference were difficult to satisfy, given the diversity of views on the issues and the uncertainty of the legal environment. Against that background, TAC supports the recommendations made, but wishes that the Panel had reviewed more fully the advantages and disadvantages of various policy options.
141. In what follows, TAC first reaffirms specific areas of agreement, expands on some points made by the Panel, and then supplements aspects of the Panel's recommendations with inputs from the CGIAR Secretariat.
Reaffirming Panel Observations
142. The Panel made several observations aimed at setting a context for their recommendations:
· IPR will have an ever-stronger influence on the CGIAR's access to the IP of others (see below: Expanding on Panel Observations).· IPR can be significant in managing the IP developed by the Centres (both improved germplasm and enabling technologies) and in supporting Centre commitments for genetic resources held in trust (see Expanding...).
· The CGIAR must attend closely the evolution of international agreements on genetic resources, e.g., the obligations under the Convention on Biological Diversity (CBD) and the International Undertaking for Plant Genetic Resources.
· In the future, other rights, which the Panel has called alternative rights regimes (e.g., farmers' rights and national sovereignty) may become dominant considerations for some classes of genetic resources.
· To manage effectively the three broad groups of material of concern to the CGIAR (that in trust; IP belonging to others, and IP developed by the Centres) access to relevant legal and negotiating counsel is essential. (see below: Supplementing the Recommendations).
· CGIAR Centres are now using biotechnology-based IP belonging to others (see Supplementing...).
· The CGIAR has an interim working document "Guiding Principles for CGIAR Centres on Intellectual Property and Genetic Resources" which orients current work (see Supplementing...).
Expanding on Panel Observations
143. The Panel was charged to deal with proprietary science; it concentrated its attention on patents and plant variety protection. TAC accepts the idea that the CGIAR must be concerned with genetic resources held in trust, the IP developed by others, and the IP developed by the Centres; and that some situations will favour the application of legal rights to IP developed by Centres. The Panel set out criteria which could guide the CGIAR in deciding about protecting intellectual property emerging from its work. These suggest several situations in which such protection might be conducive to attaining CGIAR goals:
· to assure ready access to the IP by others,
· to support public and private partnerships,
· to facilitate commercialization, utilization and technology transfer,
· to assure that centre-developed IP might be traded for the protected IP of others, and
· to generate revenue
144. With respect to IP emerging from the work of the CGIAR, and where publishing is not thought to offer adequate protection, TAC joins the Panel in favouring the arguments for acquiring protection in three situations: access, partnerships, and technology transfer. TAC notes that establishing protection through patents is costly and that protecting rights claimed can entail heavy costs. TAC went on to consider arguments against claiming IPR for tradeables and for revenues. Three concerns were prominent. One was that encouragement in those areas might lead to the diversion of effort from the System's primary goals with relatively low probabilities of success (to judge by the success rates of others). The second was that such pursuits might threaten working relationships with primary partners in the south. The third was that the economic surpluses on which revenues would be based might better be transferred to producers and consumers than to the CGIAR.
145. TAC's conclusion, like that of the Panel, is that Centre research and development should not be undertaken explicitly for the purpose of generating IP for trade or for revenue. Even so, and recognizing that such circumstances will be exceptional. Centre research aimed explicitly at CGIAR goals might lead to IP that could be traded or could generate income, were it protected. In such cases, and where publishing does not offer adequate protection, TAC believes CGIAR policy should permit an assessment of patenting while assuring that advantages and disadvantages (e.g., see above) are accounted for.
146. Like the Panel, TAC did not discuss in detail the arguments some make about ethical issues, following the Group's MTM97 suggestion to look to the findings of the Genetic Resources Policy Committee (GRPC). TAC did, however, note that, for the CGIAR, the ethics of the case for IPR are rooted in the CGIAR's people-centered strategies for poverty alleviation. TAC notes that biosafety, another theme of abiding concern in the biotechnology arena, is treated in its commentary on the findings of the General Biotechnology Panel.
Supplementing Panel Recommendations
147. TAC supports much of the first recommendation, especially the need to base policy on the goals of the CGIAR. TAC believes that the recommendation should be expanded to include:
i. more emphasis on the need to take into account commitments made by the CGIAR to duties that will emerge from the implementation of international agreements, e.g., CBD, dealing with genetic resources;ii. more emphasis on the need for all decisions about protection for CGIAR-developed IP to be made on a case-by-case basis;
iii. the possibility to decide about protection for IP developed in direct pursuit of CGIAR goals but seen to further CGIAR goals if used to trade for the protected IP of others or for revenue.
148. In the case where revenues ensue from CGIAR IP, TAC's view is that such revenues (net of the costs Centres incur in obtaining protection) should be assigned to a freestanding agency, e.g., a foundation, whose objective would be to ensure that obligations emerging from international agreements are met and to support research consistent with CGIAR goals.
149. In deciding about protection for Centre-developed IP:
i. Decisions should be decentralized to Centres.ii. Centre decision-making should be strongly supported by expert legal and negotiating counsel, especially that provided by a centralized service (see below), in addition to whatever expertise Centres access directly.
iii. For all such decisions, the underlying logic should be made transparent.
150. TAC supports the Panel's second recommendation, notes the urgency of the matter, and notes that the experience gained from reviewing and normalizing present CGIAR use of the IP of others will help the CGIAR to assess its future options and policies. TAC favours more emphasis on the management of legal and negotiating expertise for dealing with others whose IP is of interest to the CGIAR, for the IP emerging from the CGIAR efforts, and/or for materials in trust.
151. With respect to the third recommendation. TAC agrees with the points made there. Moreover, TAC notes the tentative tone of the present "Guiding Principles..." and wonders if events during the years since its first drafting do not favour a more positive view about the role of IP and a more neutral view about IPR as the CGIAR pursues its goals. The CGIAR will carry out its mandate in a world in which proprietary claims are evolving rapidly; to perform effectively for the poor will require great sensitivity to the issues and opportunities emerging from intellectual property.
152. Beyond this, given its understanding about the concerns of others, TAC recommends a review of circumstances under which the use of material transfer agreements (as required by the agreements with FAO about genetic resources held in trust) will ensure that access to the original genetic resources (as distinct from products derived from those materials, e.g., improved varieties or isolated and assayed genes) held in trust can be maintained in the public domain and readily available to all. TAC recognizes that cross-cutting concerns will emerge as international treaties incorporating national sovereignty and farmers ' rights are implemented (e.g., CBD), and that CGIAR policy must be reviewed in the light of such concerns.
TAC Commentary on the Report of the CGIAR Panel on General Issues in Biotechnology
153. The TAC Chair then turned to Mr. Sam Dryden, Member of the CGIAR Panel on General Issues in Biotechnology, who presented the report on behalf of the Panel Chair, Dr. Richard Flavell. The Panel examined carefully the implications of biotechnology applications on the CGIAR highlighting two perspectives: the clients, i.e., the farmers as well as the NARS; and the eventual impact on the genetic improvement of crop varieties in the CGIAR. The Panel met with the Heads of the Biotechnology Units of three CGIAR Centres, namely CIAT, IRRI and CIMMYT. In conducting its work, the Panel initially identified ten general, important questions regarding the application of biotechnology in the CGIAR and contacted about 100 scientists. Broadly speaking, the replies received were the basis for the Panel's recommendations.
154. For the CGIAR, germplasm improvement was of great importance. Thus, developments in biology were of crucial significance for the work of the CGIAR and oriented the conclusions of the Panel. The Panel discerned two levels of advances in biological science: transgenics, which inherently bore more controversy; and genomics, which were eventually even more important for the CGIAR. The Panel's view was that developments in information technology were important as these had a direct stance on developments in biotechnology. The increase in knowledge in the biological sciences, information technology and economic sciences calls for Duty of Care Committees which would bring together the relevant actors to advise the CGIAR and partners on biotechnology.
155. Mr. Dryden added that the CGIAR had an important role to play as it operated at a global level, but farmers were the ultimate clients of the institution. The utilization of germplasm was thus responding and interacting with the site-specific conditions of the users.
156. Mr. Dry den reported that the Panel focused on biotechnology related to genome improvement. The CGIAR was in a unique position to explore the information contained in the germplasm it was holding. However, other actors were trying to determine the genomic information and this imposed constraints on the CGIAR, a public body, due to the protection of intellectual property by other research institutes and firms.
157. The Panel noted that genomic information was increasing geometrically. It was in this context that the CGIAR needed its own policy on the protection of its discoveries. The Panel recommended that a Genome Summit be held at which all involved with generating information on this aspect of biotechnology needed to participate.
158. Regarding the conduct of biotechnological research in the CGIAR, the Panel argued that for the System one possible approach would be to set up a central coordinating unit with a corresponding appropriate capacity at Centre level. The Panel stressed that, at the CGIAR level, the search for technology needed to be consistent with the needs of the clients which, in turn, would drive the objectives of the Centres.
159. As well, the Panel recommended the creation of networks on biotechnology. As scientific breakthroughs were occurring all over the world there was an urgency for linking all actors to networks to share information which could not be captured by common means. The Panel stressed the notion that all developments in biology were important, not just transgenics, and that Boards and Management of the Centres had to back the dedicated work done by most competent researchers.
160. In the ensuing discussion, one aspect raised was whether the CGIAR could play a role in biosafety standards as the issue of transgenics was most controversial. The Panel recommended that the CGIAR establish a biosafety committee and a protocol on biotechnological research. The Panel representative added that the proposal to establish duty of care committees was intended to take care of biosafety issues as the use of transgenics in the USA may be different from issues tackled in other countries. Mr. Dryden noted that at OECD level a biosafety protocol already existed, and the CGIAR would not have to start from the outset. However, harmonization is still necessary as, for instance, the description of Genetically Modified Organisms (GMO) was appallingly different from country to country.
161. Mr. Dryden stressed the Panel's belief that the information the CGIAR produced would be competitive for exchanges on the genomics' markets which would be established in the future. As a trustee of germplasm, the CGIAR had a particular place in the global market for genetic information. He added that biotechnology was furthering germplasm improvement, but the full potential would be exploited only when all productivity parameters had reached optimal levels.
162. The Panel's view was that more initial investments may be required in biotechnology. However, over time increased efficiencies implied considerably reduced expenditures, thus indicating the great long-term profitability of these investments.
163. A central biotechnology unit was recommended by both CGIAR Panels. The Panel on general issues considered that one structure would be able to address the aspects of biotechnology on which the two Panels focused; initially, the necessary structure could be small and increase in time according to the needs of the System.
164. The discussion on general issues in biotechnology in the CGIAR centred also on the need to tailor the technology to the requirements of the users. It was also suggested that the CGIAR be cautious in assuming that research of CGIAR concern would necessarily be taken up by the private sector; less overlaps and synergies might be a more realistic picture for the setting.
165. Responding to the discussion, Mr. Dryden mentioned that staff for research in biotechnology was no longer a limiting factor. The human resources in this area of science were developing fast and keeping pace with the needs of the institutions employing biotechnologists.
166. In closing the discussion, the TAC Chair stressed that the protection of public goods could well function under a public trust. He reiterated the CGIAR mission of helping poor people in developing countries with its research products. After extended discussion in the working group, and consideration of views generated from external sources, TAC offered the following commentary with inputs from the CGIAR Secretariat.
167. TAC is grateful to Dr. Richard Flavell, Panel Chair, and to the Members of the Panel on General Issues in Biotechnology for a concise and thought-provoking report that brings out the clear perception of biotechnology as a key instrument for genetic improvement. TAC concurs with the Panel that were the term "biotechnology" further defined, more useful discussion of the topic would result. TAC noted that the Panel gave strong emphasis to genomics and bio-informatics while recognizing the CGIAR strength in germplasm collections, knowledge of the mandate crops, collaborative arrangements, testing sites, and partnership with NARS. The Panel highlighted the potential role that the CGIAR Centres can play in serving the poor as foci on genomic information pertaining to crops, livestock, trees, fish, insect pests and pathogens.
168. TAC reiterates that the CGIAR's use of molecular genetics and other biotechnological techniques should be strategically grounded in its responsibility as trustee for the genetic materials being held. The fulfillment of these trust responsibilities should be clearly linked to its mission and to the entire range of stakeholders that the System serves. Tins establishes the moral, ethical and rational foundation for a mandate to fully utilize all appropriate scientific tools in serving CGIAR's ultimate beneficiaries.
169. The Committee endorses in general the views set out by the Panel and urges the CGIAR Members to carefully consider the report as a whole as it contains many useful recommendations and perceptions. TAC endorses in general the recommendations of the Panel and offers the following comments to supplement the Panel's work.
170. The Panel, for a variety of reasons, decided to concentrate its study on the applications of biotechnology for germplasm improvement. TAC recognizes that the Centres currently, and increasingly, will use molecular genetic tools for a broad range of purposes. So, while TAC recognizes the current advantage of the Panel's concentration on germplasm improvement, the ultimate scope of the System's work will be in terms of its mission and the opportunities through molecular science. Any policy and network activity should therefore be able to accommodate a more comprehensive use of molecular genetics. Like the Panel, TAC also considers it expedient that the CGIAR Centres have sufficient capabilities to interact effectively with others engaged in biotechnology in order to be able to incorporate and make the best use of molecular genetics and emerging technologies.
171. The Committee notes that the Panel has recommended that the CGIAR be instrumental in bringing about the "Genome Summit". TAC interprets this to be a Summit at a policy and administrative level rather than at a scientific level. If so, then TAC wonders whether there are other sponsors who could play a facilitating role, with the CGIAR participating where it can best serve.
172. TAC endorses the recommendation on biotechnology networks as a practical mechanism to strengthen information flows. If the Group endorses the recommendation, it is TAC's view that the Centres should be requested to propose models for organization (the Panel describes one model), Centre roles, and mechanisms for implementation, e.g., for coordination.
173. TAC recognizes that biotechnology is becoming increasingly important as a tool for genetic improvement and that the CGIAR Centres need to have in-house capabilities to make best use of these new genetic tools. The Committee would like to stress, however, that the Centres must ensure that germplasm conservation and improvement programmes continue to receive adequate attention, and that, as the Panel recommends, biotechnology and molecular genetics should be integrated with these programmes both in terms of planning and funding.
174. Finally TAC notes that while the Panel did not focus on biosafety issues but referred to the Report of the World Bank Panel on transgenic crops, " Bio-engineering of Crops", by Kendall et al., the Panel has strongly advocated the implementation of "Duty of Care" Committees whose task would include the assurance that appropriate safeguards are being met. TAC is impressed with the role that such Committees could play.
