Deutsche Industrievereinigung Biotechnologie (DIB)

The UN Convention on Biodiversity (CBD) was concluded in 1992 at the UN Conference on Environment and Development. The three objectives of this Convention were the conservation of biological diversity, the sustainable use of genetic resources and the fair and equitable sharing of the benefits arising from utilization of genetic resources. Germany ratified the Convention in 1993. In the meantime, 190 states throughout the world have acceded to the CBD; of these, 167 states and the EU have already ratified it.

1.2 Binding national objectives

The CBD obliges the member states in Article 6 “to develop national strategies, plans or programmes for the conservation and sustainable use of biological diversity or adapt for this purpose existing strategies, plans or programmes”. Whereas about two thirds of the member states have already submitted their national strategies for biological diversity to the CBD Secretariat, Germany’s national strategy is still being awaited. For this reason, German Federal Government resolved in the coalition agreement for the 16th legislature period in 2005 to “improve nature conservation by introducing a national strategy and combine it with sustainable use.” In 2008, Germany will be hosting the 9th Conference of the Parties (COP 9) to the Convention on Biological Diversity. It is against this background in particular that the Federal Government will be drafting a relevant national strategy under the control of the Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, for ultimate submission to the Federal Cabinet for approval. In this connection it is important that Germany should be in a position to present a Cabinet resolution in good time for the COP 9 Conference in May 2008.

The national strategy must provide for the implementation of the CBD in Germany and define Germany’s contribution to the conservation of biological diversity throughout the world. It must be integrated into the European context and take account of international issues. This means that it is the concern not merely of the organizations and institutions at the Federal, State and local authority levels, but also of all social actors. The aim of the strategy is to mobilise all social forces and focus them in such a way that the hazard to biological diversity in Germany is perceptibly reduced and finally stopped altogether; and, as an ultimate aim, that biological diversity will be gradually restored again, in all its typical regional characteristics. A further objective is to ensure that Germany does more to fulfil its responsibilities on behalf of sustainable development worldwide: it is intended to establish quality and action goals with fields of activity for the envisaged period from now to 2050 and to implement them through the activities of state and non-state actors.

1.3How the industry is affected

All industries creating value by means of biotechnological processes or products are affected either actually or potentially by the implementing provisions of the CBD. There can be no single answer to the question as to how far individual sectors of the industry are affected. In detail, this will depend particularly on the definition of their operative range and their position within the industrial value creation chain. In principle, however, the relevant German industrial associations, including the DIB/VCI, have already repeatedly emphasized on behalf of their member companies that they support the aims of CBD for all categorized areas of activity in biotechnology – whether red, green, white or blue – and are willing to contribute to a significant reduction of the rate at which biological diversity is being lost in terrestrial and aquatic systems. To this end, they will back up the endeavours made by the German Federal Government in its preparation of a national strategy to arrive at a proposal for globally binding implementation rules at COP 9. The industry places special emphasis on practicable options for implementing the principle, laid down in Section 15 of the CBD, of regulated access to genetic resources and of sharing the benefits arising from their utilization in a fair and equitable way with the party providing such resources. For the industry, it is self-evident that those who have made the greatest contributions to discovery, research and development with a new product should have a fair and equitable share in the benefits from its products. Thus the industry’s support for the aims of the CBD expressly implies a fair sharing of the benefits between the countries of origin and the recipients. The companies are opposed to the use of genetic resources without the consent of the competent authorities.

With regard to furthergoing specifications, it should be accepted as a basic principle that issues connected with access to, and acquisition of, genetic resources should be kept separate from those connected with their use (including benefit sharing) along the entire industrial value creation chain. The “Bonn Guidelines” are seen in this context as the basis for furthergoing specifications of implementation obligations. It is of special importance for the DIB and its member companies that the CBD should be implemented with a minimum of bureaucracy and a maximum of legal security. The indispensable key points from the point of view of the affected industry will be dealt with below.

1.4 Purpose of the present Position Paper

The aspects described in this Position Paper reflect the key points of essential importance from the viewpoint of industrial practice, and we consider that they should also be taken into account by the competent authorities for the purposes of implementing the necessary biodiversity strategy at national and international level. At the same time, the Paper is intended as a practical guideline for the removal or acquisition of genetic resources for the use of the member companies organized within the DIB and as a basic framework for implementing benefit sharing at further stages along the value creation chain.

1.5 Terminology used

DIB (Deutsche Industrievereinigung Biotechnologie) is the German Association of Biotechnology Industries, forming part of the German Chemical Industry Association (VCI).

Ex situmeans genetic resources originally collected in situ but now cultivated under suitable conditions outside their natural in situ habitats.

Genetic resource means “any material of plant, animal, microbial or other origin containing functional units of heredity of actual or potential value” (based on Art. 2 of the CBD, combining the definition of “genetic resources” and “genetic material”).

Country of origin means the country from which the genetic resource was taken in situ.

In situ means the occurrence of a genetic resource in its natural habitat.

sMTA (Standard Material Transfer Agreement) means provisions in standard contracts which must be observed mandatorily by both the first user/taker and any subsequent users. These include in particular the obligation to share any benefits thus obtained with the country of origin.

Prior Informed Consent (PIC) means consent, based upon awareness of all relevant facts and given beforehand by the country of origin, to the legally binding mode of procedure with the desired genetic resource and to the use which will be made of it.

Benefit Sharing means the binding agreement between the first user, or any subsequent users, of a removed genetic resource and the organization authorized by the country of origin with regard to compensation in any form for permitting access to the desired genetic resource and its further use.

Access means the availability of actually existing organisms in situ and ex situ.

2. Scope of the CBD

2.1 Definitions

The term “genetic resource”, as already defined in 1.5, is to be understood here as “any material of plant, animal, microbial or other origin containing functional units of heredity of actual or potential value”. The following must be expressly excluded:

ügenetic material from human beings or of human origin;

ügenetic material acquired prior to national ratification of the CBD andsince then cultivated ex situ;

ügenetic material already made publicly available without any restrictions by the country of origin.

It may be asked at this point whether the term “genetic resource” also extends to derivatives, and what it actually means in detail. On this point the DIB/VCI adopts the view of Colombia and the Andes Community, which define derivatives as “a molecule, combination or mixture of natural molecules, including raw extracts of organisms of biological origin, whether alive or dead, derived from the metabolism of live organisms" (Decision 391 of the Andes Community, quoted in the UNEP/CBD/WG-ABS/3/4 document of the ad hoc open-ended Working Group on access and benefit sharing, dated 15 November 2004). The objective of the Convention, according to Article 1, is the fair and equitable sharing of the benefits arising out of the utilization of genetic resources. This means that the CBD can extend only to derivatives which themselves are to be considered as a genetic resource and of natural origin. If, as a result of human interventions along the value creation chain, these derivatives no longer contain functional units of heredity, they do not fall within the scope of the Convention. For this reason they are also not subject to its benefit sharing provisions. The DIB supports the proposal, put forward by Canada and included in the UNEP/CBD/WG-ABS/3/4 document, that derivatives, although frequently referred to in material transfer agreements and some national laws, are themselves outside the scope of the Convention.

2.2 Industrial sectors

Among the industrial sectors represented by the DIB and its member companies are pharmaceuticals, agriculture, cosmetics, food, cleaning agents and paper. The classical biotechnology fields – “red” (pharmaceutical uses), “white” (industrial uses) and “green” (agricultural uses) – are thus all represented. Moreover, the present Paper is concerned equally with genetic resources of terrestrial and aquatic origin. Also included, therefore, are industries which are at present already working on value creation of their own with genetic resources of aquatic origin, and which will do so even more in the future.

3. Procedural options within the industrial value creation chain

From the point of view of the DIB and its member companies, the essential key points to be incorporated in any implementation of the CBD and the relevant national strategies for the conservation of biological diversity can be derived from the considerations set out below. These key points are set out separately in each case for the processes of access to a genetic resource (including transfer) and for further development processes following integration in the industrial value creation chain, here presented in model form.

3.1 Access

3.1.1 Procedures in practice

At present, the DIB member companies obtain their genetic resources from databases, gene banks, from certified biological resource centers (e.g. German Collection of Mikroorganisms and Cell Cultures, Deutsche Sammlung von Mikroorganismen und Zellkulturen GmbH, DSMZ) or through cooperation, preferably with universities or national research facilities on the spot. This is described as indirect access, since in this way the desired material is acquired from ex situ collections at a research facility or trading/brokering organization domiciled in the country of origin, and not directly from ecosystems in the country of origin. Direct access occurs rarely in practice. It means that a company subsequently creating value with a genetic resource removes the desired material directly in situ from the ecosystem of the country of origin.

In either case, the DIB would suggest that, prior to access or transfer of the desired genetic material, the recipient should submit to the country of origin, or the competent authority authorized by the country of origin, an application to obtain “Prior Informed Consent” in the form of a Letter of Intent concerning the further use to be made of the resource. The DIB member companies would undertake not to include any of the resources acquired under the terms of the CBD in their R&D process without PIC or to make use of them in any other way for their own benefit. It is understood that the granting of PIC must always be in compliance with the national law of the country of origin.

For binding negotiations on individual aspects related to PIC, the industry is of the opinion that access to a resource should take place via a single national contact (“Focal Point”) within the framework of an internationally standardized administrative process. An authorized national Focal Point would also be in a good position to deal with issues concerned with the conclusion of the User Contract /sMTA in a binding way from the viewpoint of the country of origin and in accordance with internationally valid standards. Not all countries of origin have defined suitably authorized competence centres of this kind to increase the efficiency of the desired administrative process and provide a sufficient degree of legal security. In this connection, the industry would particularly emphasize that if access is regulated as simply as possible, with a minimum of administrative input, it would be of decisive advantage for the user, and even more so for the country of origin. If national hurdles are found by the user to be too high, they act simply as a knock-out criterion – the user will either decide altogether against removing the genetic resource (the commercial potential of which, if any at all, is still unknown at the time of removal), or obtain access in some other place where lower access hurdles appear to offer a more favourable cost-benefit relationship. In this regard, the countries of origin stand in close competition with one another. The simpler the national access regulations in force are felt to be, the greater the opportunity will be for the country to attract potential users and profit from subsequent commercialization of the national genetic pool within the framework of benefit sharing. At this point it is worth noting that the genetic diversity in the industrialized countries – particularly in the microbial context – is rated just as highly in scientific circles as that in the developing and threshold countries. This is a challenge particularly for less highly developed nations to regulate access with a view to securing competitive advantages.

A good way to lay the foundations for access rules would be for each of the countries subscribing to the CBD to build up a database listing the identified genetic resources of the country and, where applicable, the further uses made of them. In this way, it would be possible not only to organize and control direct access by the state in accordance with the country’s preferences, but also to simplify the usual indirect access for third parties and to regulate it exclusively in such a way as to provide legal security for the user.

A special case arises here when genetic material is isolated from legally acquired goods (e. g. construction timber, food commodities) and further developed. Despite the absence of a specific geographical target, a removal of this kind would definitely fall within the scope of the CBD if the isolated genetic trace had been listed beforehand as national property by a country of origin. However, the DIB takes the view that the genetic material would not fall within the scope of the CBD for the first user if it had not yet been listed at the time when it was removed from the legally acquired goods. As soon as the material had been notified by the first user, the resource would be listed in the country of origin and fall within the scope of the CBD for all subsequent uses. In general, the DIB and its members recommend that the access system should be taken to apply only to genetic resources which are already listed in national databases. If a genetic resource has not been entered there, the company will be under obligation to notify the finding to the country of origin but is otherwise not obliged to make a subsequent application for a PIC. This will also generate additional benefit for the user (lower administrative burden, resulting in the earliest possible access together with high legal security, and a head start on the competition) and at the same time for the country of origin (database permanently updated by the companies, offer for competitors widened by notified resource, fortuitous discoveries also included in database).

It can be generally be taken for granted that access to genetic resources in situ and ex situ without the authorization of the country of origin is more of a theoretical exception. This would constitute a violation of the CBD (misappropriation, misuse) and is equally to be condemned as access without obtaining a PIC. The industry draws attention to the fact that binding regulations should be exemplified by normal cases, and not by theoretical exceptions, since anything else would be a serious threat to any efficient and practicable procedure. In the event that a country of origin furnishes evidence for a case of misuse in which the geographical place of discovery of the genetic materials is decisive for determining the country of origin, the DIB and its member companies are in favour of penalizing the user with a fine twice as high as the monetary value of benefit sharing.

As soon the administrative conditions for access and transfer under the PIC system have been fulfilled, a bilateral licence agreement should be concluded between the user and the country of origin (or its authorised agency, e.g. the “Focal Point”), particularly with a view to agreeing on the subsequent benefit sharing. In this connection, attention should be drawn to the application of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) and its supplementary Standard Material Transfer Agreement (sMTA). The DIB and its member companies recommend that any kind of commercialization of the acquired genetic resource in all parts of value creation chain should take place exclusively within the framework of a bilateral licence agreement.

With a view to the necessary legal security both for the providing and the receiving party, the contents of the bilateral licence agreement should cover the conditions agreed on for the use of the genetic resource, provisions for patents, commercial rights and transfer of the genetic resource to third parties, also the procedure to be observed in the event of a dispute between the country of origin and the receiving party in the form of arbitration procedures such as the International Chamber of Commerce’s (ICC) International Court of Arbitration (www.iccarbitration.org)or other internationally accepted legal procedures. In addition, provision should be made for specifying the benefit sharing. For this purpose, a wide range of monetary (royalties, etc.) and non-monetary options (capacity building, etc.) will be found in the “Bonn Guidelines”, which are recognized internationally in connection with agreements on bilateral benefit sharing. Physical transfer of the genetic material should not take place until this bilateral licence agreement has been concluded.

3.1.2 Problem areas and position

Focal points: The industry concerned has always maintained that the best solution would be for the individual states to start by promulgating suitable national regulations. However, reality has shown that national regulations vary greatly from one another and make access more difficult rather than easier – which is not the intention of the CBD. From the point of view of the industry concerned, properly functioning national competence centres (“focal points”) are also indispensable if an international framework is to function at all. For this reason the DIB expressly recommends the establishment of national focal points on an internationally uniform basis.

3.2 Development, production and marketing

3.2.1 Procedures in practice

For the acquiring company, the transfer of the genetic resource to the company’s material stock marks the beginning of the industrial value creation process, which is carried out solely for commercial purposes with a suitable degree of internal confidentiality. The first step is usually to screen the genetic material to identify the main sought characteristics. The sought characteristics, as also the development and screening targets established for them, may differ completely in both content and procedure, depending on the particular sector of the industry doing the screening. Whereas the pharmaceutical sector, for example, looks for new therapeutic active substances, the main focus of interest in the crop protection industry may be a morphological or metabolism-specific characteristic for transfer into crop plants, or, in plastics research, a more efficient production process for particular substances. Moreover, the same industrial sector can have a great variety of different targets when screening new genetic resources for possible commercial advantages. For instance, the following development targets are conceivable in the pharmaceutical industry alone: as starting point for the development of a new active substance, as component of a vaccine, as inactive component of an end product, as “enabler” in an R&D process, or as a means of increasing production efficiency. This makes it abundantly clear that a single company is not necessarily in a position to discover and exploit all value creation potentials on its own. It must therefore be assumed that any multiple value creation for a genetic resource will take place inside and outside the acquiring company, and although this may not always be evident to outsiders, it has a significant influence on the implementation regulations for the practical handling of genetic resources under the provisions of the CBD. To round off the picture, it should be pointed out that only the very fewest development attempts based on collections of naturally occurring genetic resources ever reach the stage of commercial value creation. As an example of this, the European Federation of Pharmaceutical Industries has set the success quota at a mere 1:10 million.

As mentioned above, the processes leading to the commercialization of a new genetic resource are specific for each separate sector. In general though, it can be said that the first step towards identifying the essential characteristics is made by the research function, which gives an idea of the possible range of uses and leaves further work on the materials to the appropriate development department. If the company which originally acquired the resource is merely a technology provider, or if the discovered spectrum of effect or one of the main characteristics does not fit in with the company’s value creation model, then it is here, at this interface between the research and development functions, that the resource can be transferred for the first time to a legally autonomous company active in a different area – and thus bring in a commercial profit. For the original acquiring company, this profit is the end of its own value creation with the genetic resource, and thus at the same time the basis for benefit sharing with the country of origin in accordance with the CBD. But it also evident that, with every development step, the succeeding companies will get closer to a further value creation, which in turn will be subject to the benefit sharing rules envisaged by the CBD. It is irrelevant in this context whether the development target now being followed was already covered by the PIC obtained by the acquiring company. To secure the benefit sharing for the country of origin in the spirit of the CBD, measures must be taken to ensure that, when a genetic resource is transferred, the original obligation of the acquiring company should be passed on by contract (using the sMTA) to the next user, who will then enter with complete responsibility into the modalities of the CBD – thus assuming the obligation to notify the new intended use, which had not been recorded in written form in the PIC, to the country of origin, and to share all resulting material benefits with the country of origin. Genetic material can be transferred in this way to third parties at every step of the value creation chain. In addition to the research/development interface, the transfer could also be made at the end of product development, i.e. prior to large-scale production and marketing or at the end of production to various legally autonomous distribution channels.

3.2.2 International control mechanism

It is assumed that all users will meet their contractual obligations even without additional controls. However, the DIB acknowledges the need felt by the countries of origin for transparency and information concerning the further utilization of the removed genetic resources. From the point of view of the industry, transparency must be effected in as simple and unbureaucratic a fashion as possible. At the same time, measures must be taken to ensure that all forms of utilization generating a potential obligation to benefit sharing can be placed on record. And in any case, a high degree of legal safety is a basic precondition for all entrepreneurial activity in the field of genetic resources.

Starting out from these parameters, a control mechanism could take the following form:

1st Stage:

Access to, and removal of, genetic resources in the country of origin takes place on the basis of Prior Informed Consent (PIC) and the Mutually Agreed Terms (MAT) (Art. 15 CBD). The Mutually Agreed Terms encompass

a. the obligation to benefit sharing; if a flat-rate compensation or a one-off capacity building are agreed on, payments will be made directly to the country of origin. Otherwise, see 3rd Stage.

b. the obligation on the part of the remover of the genetic resource to transfer it only subject to the terms of a standard contract and to notify the recipient to the CBD Secretariat.

2nd Stage:

Where applicable, transfer (by licence, joint venture agreement, etc.) to the next user. This will take place exclusively on the basis of standard contracts (see above). Any benefits generated by third parties will be subsequently attributed to the transferring unit, if notification of transfer and recipient is not made (see 1.b).

3rd Stage:

If benefit sharing has not been agreed on in the form of a flat-rate compensation, the removing organization will notify the CBD Secretariat once yearly of the monetarily based benefits for each country of origin on the basis of an outside expert opinion.

4th Stage:

a. The CBD Secretariat passes the notified values on to the respective countries of origin.

b. At the wish of the countries of origin, the CBD Secretariat will carry out the collection procedure and pass the revenues on the countries.

The mutual obligations arise out of the standard contracts to be used at each utilization stage. Although there is no intention here of going any further into the exceptional case of a dispute, these standard contracts, as mentioned in 3.1.1 above, should contain indications of how to act in the event of a dispute, specifying, among other things, the seat of jurisdiction and the applicable law. Arbitration proceedings are today already common practice in the life sciences area, and for this reason it would be advisable to make provision in the standard contracts for the procedure to be adopted for arbitration proceedings, in the manner envisaged in Article 27 of the CBD itself for disputes between contracting parties. The ICC Rules of Arbitration, administered by the world-renowned ICC International Court of Arbitration, provide a secure yet flexible framework for the conduct of arbitral procedures. Such procedures involve less cost for the contracting parties and can be conducted more rapidly than normal civil proceedings before regular courts. Apart from this, civil proceedings are as a general rule always conducted publicly, whilst arbitration proceedings can take place confidentially.

3.2.3 Problem areas and position

National law: To ensure efficiency and legal safety with regard to access and to the contractual necessities for full compliance with the CBD, each country of origin is called on to make the corresponding national mechanisms and resources available in accordance with an international regime.

Pathogens: If human pathogens, plant pathogens and animal pathogens are successfully used for developing uses which find application for overriding humanitarian purposes, provision should be made in the internationally binding framework contracts for these to be exempted from the CBD benefit sharing.

Contract-based compliance versus certificates: Certificates providing evidence of origin, source and legal compliance are being discussed as the method of preference for monitoring CBD compliance and putting a stop to misappropriation and misuse of genetic resources. The advocates of certificates are of the opinion that certificates will greatly impede any misuse, such as collection of samples in situ without consent, even at subsequent stages of the value creation chain, and that taken overall, they will bring about a higher degree of legal security. Since in any case the DIB and its member companies dissociate themselves very decidedly from all misuse, it follows that an infringement of this kind is more of a theoretical exception. It is therefore unacceptable that the implementation of the Convention on Biological Diversity should be geared to exceptional cases likely to occur only in theory. The DIB also sees a danger of legal insecurity in cases, such as fortuitous discoveries, where it is impossible for certificates to be issued at all. Moreover, it would not be possible for a small to medium-sized biotech company to cope administratively with a large number of different national access systems. Instead, it would be better to apply easily manageable and, preferably, already existing regulations which can be fulfilled in the many normal routine cases even by small or medium-sized biotech companies without any added administrative input. For these reasons the DIB is opposed to the introduction of certificates, whatever their content may be.

The alternative proposed by the DIB is to adopt elements of the FAO system. These include standardized principles of access as well as standardized principles for evaluations of benefit sharing mechanisms. In any case, the CBD member states have the option to make voluntary use of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) and its supplementary Standard Material Transfer Agreement (sMTA), which is also designed for use without certificates and is already routine practice for the use of plant genetic resources for breeding purposes. However, the Standard Material Transfer Agreement is very much geared to specific features in the field of plant breeding. All breeding of a new plant variety starts out from pre-existing plant varieties and develops them further. Functional units of heredity from the initial plant are invariably present in the new variety. In the field of biotechnology this is often not the case: for example, enzymes are used as tools in pharmaceutical research. Functional units of heredity of these enzymes are no longer present in the end product. As described above, these cases do not constitute a use within the meaning of Art. 15 (7) of the CBD. Moreover, the sMTA is based on the so-called multilateral system of the ITPGRFA, according to which access and benefit sharing take place under standardized conditions, not under the bilateral conditions of CBD. A further point is that certificates would not exclude the possibility of conflicts or even of changes in patent law. The patent system, with its carefully balanced conditions for the granting of short-term exclusive rights, is an important element of innovation funding by the state. It is not suitable for enforcing compliance with regulations under the law of obligation or public law. For this reason no changes in patent law should be made with a view to fulfilling the CBD implementation provisions. These would result in a large measure of legal insecurity and would not ensure that the goals of the CBD are achieved: for one thing, not every patent granted results automatically in benefits, and not every benefit eligible for sharing arises out of a patent; and for another, it should be borne in mind that material changes in patent law do not facilitate access to genetic resources, as advocated in Art. 15(2) of the Convention, but on the contrary discourage research on and with genetic resources and the development of new products from genetic resources.

For these reasons the DIB is definitely of the opinion that the CBD implementation provisions should be realized on the basis of contract law, without certificates of origin or compliance, and without any changes in patent law, and that access should be granted in principle under uniform conditions. This would be greatly preferable to the conceptional approach of certification.

3.3 Recommended procedure

The DIB suggests that its members observe the following procedure for the acquisition of genetic resources:

Identify the Focal Point of the country of origin and take up contact.

In consultation with the Focal Point, identify all necessary access requirements imposed by the country of origin.

Where relevant, check whether the providing organization is authorized to this effect by the country of origin.

For the purpose of obtaining a PIC, submit a statement from the recipient on the proposed utilization to the Focal Point authorized by the country of origin.

Reach an agreement with the Focal Point on the provisions of the licence agreement, including benefit sharing in accordance with the possibilities set out in the “Bonn Guidelines”.

Ratify the licence agreement.

Take physical possession of the genetic material.

Transfer the genetic material to the utilization resources defined in the contract.

Comply strictly with the contractual obligations.

Sell or relinquish the genetic resource to subsequent users only under the provisions of the sMTA.

4. Key points and concluding remarks

From the point of view of the industry, the situation outlined above yields the following key points, which should find expression in all guidelines for implementing the CBD:

The countries of origin must recognize that their national access practices are decisive for the potential utilization of their genetic diversity. National access practices, as perceived by access seekers, are competitive factors for or against a country of origin.

The countries of origin are called on to give active support for the utilization and processing of their genetic resources by third parties, in the form of low access hurdles (including provision for nationally authorized “Focal Points”) and the inclusion of all CBD-relevant national genetic resources in a national database/gene bank.

It is of advantage to create a uniform international framework for utilization with harmonized provisions for the processing, acquisition and use of genetic resources, resulting in orientation and legal security for globally operating companies.

A contract-based system is definitely preferable to a certification system since it is more practicable overall and involves less administrative input. Under no circumstances should changes be made to national patent laws. Contract-based control mechanisms are feasible and sufficient.

The transfer of a genetic resource to subsequent users under the terms of a sMTA will ensure that benefit sharing takes place at each separate stage of the value creation chain.

Benefit sharing should be evaluated on the basis of the internationally recognized Bonn Guidelines.

The need felt by the countries of origin for an additional control mechanism is acknowledged and respected. To avoid any necessity of additional administrative input for this purpose, it is suggested that a closer analysis should be made of the possibilities offered by the system for controlling procedures under contract law and to determine whether sufficiently reliable control can be obtained in connection with the construction of national databases (complete with documentation of uses).

Frankfurt/Main, December 17, 2007

______________________________________

Contact person:

German Association of Biotechnology Industries

Dr. Ricardo Gent

Executive Director

Dr. Tina Heine
Manager Biotechnology

Phone +49 69 2556 1504

Mainzer Landstrasse 55

60329 FRANKFURT

GERMANY

The German Association of Biotechnology Industries (DIB) is the biotechnology division of the Association of the German Chemical Industry (VCI), the VCI sector groups and the VCI sector associations. DIB represents the biotechnology sector operating in Germany (Health Care, Industrial Biotechnology, Agri-Food, Environment). Through its direct membership of 12 national industry associations and leading biotech and chemical companies, DIB’s members constitute all in all over 95 % of the market of biotech-related products in Germany. DIB's overall objective is to improve the competitiveness of the biotech sector by setting up a national, European and international regulatory and political environment, which above all stimulates R&D and rewards innovation in the market.

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