Access and Benefit Sharing Agreement

Mandatory benefit-sharing was the dominant option for industrial users. One respondent felt that industry would prefer mandatory benefit-sharing to ensure legal certainty. Another respondent argued that the ideal option would be to make benefit-sharing mandatory while allowing users to choose between monetary and non-monetary. ● Transfer of technology: Referring to Articles 15, 16, 18 and 19 of the Convention on Biological Diversity, Article 23 of the Nagoya Protocol requires Parties to “undertake to promote and promote access to technology by developing country Parties and the transfer of technology, in particular the least developed countries and small island developing States among them, as well as Parties with Countries with economies in transition. to enable the development and strengthening of a sound and sustainable technological and scientific basis for the achievement of the objectives of the Convention and this Protocol. Some countries, such as Costa Rica (1998), take an approach whereby technology transfer is a state obligation under absconding, which means that when negotiating benefits, the state is obliged to seek technology transfer options. However, most countries view technology transfer as a kind of non-monetary benefit-sharing (e.g. B Ethiopia, Kenya and Vietnam). Some countries, such as the Philippines (2005), include the conditions for technology transfer in their standard access and benefit-sharing contracts. Ecuador`s ABS framework requires parties to discuss technology transfer options during benefit-sharing negotiations. The methodology of this article consists of two phases. The first step follows a descriptive approach to examine and explain common regulatory mechanisms for ABS. During this phase, a legal analysis of primary sources (laws, regulations, national guidelines and guidelines, if any) in selected countries and regions is conducted to examine the similarities and differences of supplier countries in regulating ABS issues. Once identified, these regulatory mechanisms are briefly described and explained.

The explanation is then followed by a comparative analysis of the associated regulatory mechanisms of the selected countries and regions in terms of access, benefit-sharing and compliance. The vast majority of industrial users were in favour of this benefit-sharing option. One of them stressed that this would be the best approach for his sector, as services would be returned directly to the people who need them. However, the majority agreed that this is a heavy burden, as ensuring that research accurately helps the supplier country would require a significant amount of resources. ● In situ, ex situ and access to digital sequence information (DSI): Physical access, access via biobanks (i.e. collections) and access to DSI are covered. DSI is not defined in the field of international law. It was presented to the Parties to the CBD and Nagoya Protocols at UNEP COP 13 (2016a, 2016b). Parties to the Convention are currently discussing the possible inclusion of access to or use of other CIDs in the scope of the CBD and the Nagoya Protocol (Laird and Wynberg, 2018). For example, the Andean Community (1996) includes the ISD in its scope. The vast majority of academic users stated that this benefit-sharing option was within their field of activity and would therefore be able to maximize the positive impact of such research.

It is also possible to see that users and supplier countries are always looking for solutions to reduce transaction costs. The majority believe that the multiplicity of competent authorities in a country leads to a lack of clarity and increases transaction costs, while most advocates facilitate access to basic research. However, some participants argued that the separation between basic and applied research is becoming increasingly complex. During interviews, users generally repeatedly stated that compliance with certain ABS laws has proven to be particularly difficult for non-commercial research and SMEs, as the system is quite expensive for them. ● Sharing search results: There is no indication of what the search results mean. However, based on the day-to-day practice of research institutions, we could conclude that it is the reports that describe the results of research based on its methodology (Anderson, 2003). The user would then have to submit a report as part of the non-monetary benefit-sharing obligation. Some countries, such as Australia (2012b) and India, explain in more detail which research findings might be of interest to them. I. That document shall grant the accessing Party access to the biological resources in the access area in conjunction with an access authorisation granted in accordance with Part 8A of the epbc Rules.

UNEP. (2002). UNEP/CBD/COP/DEC/6/24 Bonn Guidelines on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization. First, it should be noted that neither the CBD nor the Nagoya Protocol defines access to genetic resources. In addition, the countries that are the subject of this study do not define access or correspond to their understanding of access. Therefore, this study refrains from defining access and claiming one of the two approaches, as the objective of this study is to identify common elements in national regulatory options for ABS. ● Search: Access only for research activities. Access is only allowed for activities that do not involve product/process development. ● Case-by-case negotiations: Benefit-sharing is subject to negotiations between suppliers and users.

The majority of countries participating in this study (e.g. B, Kenya, South Africa, Thailand, France, Spain and Costa Rica) have ABS frameworks that lead to negotiations on access permissions. 5.3.3. An agreement under clause 5.3.2.c shall ensure that the Commonwealth continues to receive a fair share of the benefits arising from the further use of the samples or products, or from the rights in such samples or products by the third party and all subsequent parties. G. Taking into account the Party`s entry into access in this document, the Commonwealth shall grant the Party access to the living resources of the Commonwealth territory or territories listed in Annex 2. Dominican Republic. (2018). Regulation of Access to Genetic Resources and Distribution of Services (ABS). Reactions from industrial users and collections have varied in terms of choosing the cheapest option.

One speakers from the collections opted for “in situ access only” because it would be easier for collections to provide genetic resources. One of the industrial users who chose “in situ and ex situ access” as the cheapest option stated that in the sector that the stakeholder is familiar with (plant breeding), ex situ access would be much cheaper, as this sector would be ex situ rather than in situ access. Responses from industrial users from different sectors (e.g. B, pharmaceuticals) as well as academic collections and users have also shown different trends towards in situ access compared to ex situ access. Brazil. (2015). Law 13,123 of 20 May 2015 regulating Article 225( 1) (II) and Paragraph 4 of the Federal Constitution; Article 1, Article 8(j), Article 10(c), Article 15 and Article 16(3) and (4) of the Convention on Biological Diversity, adopted by Decree No 2.519 of 16. March 1998; ensuring access to genetic heritage, protection and access to associated traditional knowledge, and benefit-sharing for the conservation and sustainable use of biodiversity; Provisional Law No. 2,186-16 of 23 August 2001; and for other purposes. Question 21 asked stakeholders for their views on sanctions. The majority of stakeholders preferred fines for minor offences, criminal sanctions for serious violations, while the least preferred option was criminal sanctions for all types of violations.

Industrial users stated that they would prefer not to have access to the genetic resources of countries that have criminal sanctions, especially for all types of violations. The same was true for scientific users and collections with regard to research activities. The majority of supplier countries stressed the need to create proportionate sanctions. The development of compounds of a particular tree species in the Malaysian rainforest can lead to the treatment of certain types of cancer. But to whom do the trees belong? And who has the right to benefit from their genetic traits? For reasons similar to the sample access charge, the majority of industrial users felt that this option had a negative impact and a high burden on their sector. They argued that benefit-sharing at the beginning of the activity would be a major disadvantage as it discouraged R&D. Industrial users found sharing search results to be a better option than sharing raw data. However, they found that there is some burden in inserting search results into a usable, user-friendly and easy-to-distribute format. In addition, the comparative analysis shows that, apart from some (such as Brazil, India, South Africa and the Philippines), the laws of supplier countries often do not explicitly mention the trigger for benefit-sharing, meaning that users could not directly understand when they should share the benefits.

If this information is analysed with the data collected by the representatives of the supplier countries during the interviews, we might think that this may be due to the fact that the majority of supplier countries opt for benefit-sharing at the access point and assume that benefit-sharing will take place in some way immediately after the granting of the CIP and the negotiation of the mutually agreed terms (MAT). However, this perception needs to be tested more closely. Similarly, the majority of academic users supported this option in terms of the potential to simplify access for researchers. .