Designing the Microbial Research Commons: Proceedings of an International Symposium (2011)

28. Access and Benefit Sharing under the CBD and Access to Materials for Research
– Stefan Jungcurt⁷⁶

International Institute for Sustainable Development, Canada

After having heard so much about the tsunami of information that researchers have to deal with, I am going to talk about the storm on the horizon, which might turn into a thunderstorm or it might turn into a hurricane. I work for the International Institute for Sustainable Development, which is a green policy think tank in Canada. We have a branch called reporting services, and the people in that branch monitor all multilateral environmental negotiations on the international level and write daily reports, called the Earth Negotiations Bulletin, of what is happening in these negotiations. I have been performing that function regarding the negotiations on an international regime on access and benefit sharing (ABS) under the Convention on Biological Diversity (CBD) for the past six years, and now I am like everybody else: I need to figure out how this works.

In essence, the access and benefit sharing regime will add another element of demands or conditions on the international level that will affect the management of microbial resources. In other words, it will add a layer of complexity to something that is already quite demanding to deal with.

When the Convention on Biological Diversity was adopted in 1992, it included a provision on access and benefit sharing in Article 15. The main principles are countries have national sovereignty over their genetic resources, but that there should be facilitated access and benefit sharing under mutually agreed terms and with prior informed consent.

In 2002, the first major effort was made to implement this provision, which was the Bonn Guidelines for access and benefit sharing. These were basically a collection of items that should be taken into consideration when a national access and benefit sharing law is implemented. The guidelines were voluntary.

At around the same time, at the World Summit for Sustainable Development, the G77 countries which act mostly as suppliers of genetic resources approved an initiative to negotiate, within the framework of the CBD, an international regime for benefit sharing. In essence, this conference more or less told the CBD Secretariat, “You have been too slow in implementing Article 15, so please take action and implement it soon.”

The CBD Secretariat reacted with a decision in 2004 to give a formal mandate to the ABS working group discussing the benefit-sharing regime. The user countries insisted on putting access back into the mandate, so the discussions focused on a regime for both access and benefit sharing and not just benefit sharing.

In 2006, the eighth conference of the parties (COP) established a deadline and asked that this regime be negotiated at the earliest possible time before the tenth COP. COP 10 will be held in October 2010, barely 12 months from now. The conference required that the negotiations be finished by then, but it is questionable whether this will actually happen, and even the delegates within the process have their doubts.

After the last meeting in Paris, one of the delegates who had been involved in this process from the beginning told me that this process now is where climate change was at in the 1970s. He said that the scientific basis for what we are trying to do here is so slow

_____________

⁷⁶ Presentation slides available at http://sites.nationalacademies.org/xpedio/idcplg?IdcService=GET_FILE&dDocName=PGA_053742&RevisionSelectionMethod=Latest.

in penetrating the process that it will take us many years of negotiation and learning to find out how we will realize this access and benefit sharing provision in the framework of the CBD.

That delegate was frustrated after a meeting that had not been very successful, so he may have been too pessimistic, but, nonetheless, the negotiations are certainly progressing slowly. We are now just a little more than 10 negotiation days away from the day when this should be adopted, and about half of the subject matter that should be covered by the regime has been consolidated into one text, but the text contains an enormous amount of the square brackets that indicate instances of disagreement. We have about 2,000 brackets or at least 1,000 cases where countries cannot agree on what the text should say concerning this regime.

At the same time, the pressure to adopt something in 2010 is very strong. For the CBD, 2010 will be the International Year of Biodiversity, and the CBD has an objective to significantly reduce the rate of biodiversity loss, so it might happen that a very broad declaration or framework agreement may be adopted, but there is sure to be an ongoing process afterwards. That means that there will be opportunities to continue engaging with this process after 2010, and the important thing will be to keep the door open at the tenth Conference of Parties in Japan in 2010.

Box 28–1 contains the first paragraph of the article on scope. Everything inside the brackets must still be negotiated. It demonstrates just how confused the question of what will be covered by the regime is right now.

The emphasized part of the text in the box is where a definition of the genetic material that is covered will eventually go. The only part of the definition that is not in brackets here is “genetic resources.” The reason is because this is covered in the convention, and it cannot be renegotiated the delegates have not yet started to renegotiate the convention. All the other terms in the text are highly diffused, overlapping, and sometimes conflicting. The one big source of frustration at the last meeting was that—for some reason that I do not understand—the European Union insisted on inserting a

reference to pathogens as a very specific subset of microorganisms. Everyone else’s reaction was, “Why do you do that?” Because the process is so politicized, there is a lot of suspicion about what it means.

It is possible that the background of that controversy can be found in some other recent discussions. Specifically, in the World Health Organization, Indonesia has been refusing to give access to virus strains for Avian influenza—not H1N1, but the one before that. The Indonesians were arguing that this should be regulated by the CBD first because they want access to the results of the vaccination and the medical treatments coming out of it.

The big question now is: Will all microbial materials be affected and how will they covered? It is not clear right now.

To offer some insight into the answers, I will start with a quick overview of the politics surrounding this process. When the CBD was negotiated, access and benefit sharing, or ABS, were the result of a “grand bargain.” As the negotiations drew to a close, there was a large fraction of developing countries that said, “Why should we join this regime? It is just going to increase costs for biodiversity conservation, and the question of how fairly this is going to be financed is not clear.” This led to the idea that access and benefit sharing could be a source of financing for biodiversity conversation. So, in essence, ABS was a promise that there would be, at some point down the road, markets that would generate revenue to cover the costs of implementing this convention. This promise was based on commoditization logic, which we have now discovered is not very adequate when working with genetic resources and information resources.

Thus, the ABS process faces the conundrum of coming to terms with this promise, which many developing countries are very adamant about. They say that this is a bill that you have not yet paid, so give us the access and benefit sharing or come up with something very big on financing. The latter option is almost impossible to expect from the developed countries right now, of course, so naturally the developing countries are expecting some sort of monetary benefits. For them, the idea has been that this resource will become part of our national income, and increasingly, as the intellectual property rights agenda has developed under the TRIPS agreement, the developing countries have seen it as a way to counterbalance what is sometimes called the “voracious appetites of intellectual property rights (IPRs)”—the trend to protect products of genetic resources through patents, which restricts access to those products, and sometimes even restricts traditional uses of genetic resources, for example as traditional medicines. Developing countries fear that IPRs will restrict them from benefiting from their own resources because of illegal or unauthorized access to genetic materials, or bio-piracy.

For a long time the rhetoric has been dominated by this idea that bio-piracy is a modern form of colonialism, that bio-prospecting is a criminal activity, and so on. It is getting better now. There is not such a strong divide in the process any more, but the mistrust still complicates the negotiations enormously.

On the other hand, user countries are increasingly offering other types of benefits. They have always been focused on making sure that access is not too restricted, so they have tried mostly not to get involved in IPRs. The user countries, however, have been coming forward with offers to share other types of benefits in areas such as technology transfer.

To summarize, we have a situation in which conflict about the distribution of potential benefits dominates the discussion of how we can safeguard the creation of those benefits. Unfortunately, this is a phenomenon that we see very often in international

negotiations. The issue of dealing with climate change faces a similar conflict, as the fight over the costs of dealing with it overshadows the considerations of how you can actually do it. It also resembles very clearly the blockbuster phenomenon—that the developing countries expect that they have something extremely valuable in their biological materials, and they do not want to miss out on benefiting from that. The potential value of such materials is overestimated.

It is worth noting that until the next-to-last meeting, of the sixth meeting, of the ABS working group, there was very little involvement of the scientific community. There have been a couple of position papers prepared. At some point, for instance, the WFCC submitted a position paper which is referred to quite a lot. There has been no active engagement of scientists on the delegations, however, and there has been little participation by nongovernmental organizations or other observers, although that has increased somewhat recently.

In general, there is some reason for optimism that at some point it will be possible to negotiate an agreement because there is an increasing recognition of the fact that no country is self-sufficient in genetic resources so that restricting access does not make much sense as a general principle. There is also greater recognition that any new ABS regime will have to address the link between access and use—that is, in order to have benefits to share; you must first be able to use the resource. Furthermore, there are several countries that are developing the capacity to use the resources themselves, and that affects their interests in the process. They are starting to explore on an informal level with the countries of the Organisation for Economic Co-operation and Development what the alternatives could be. What might be in there for them if they backed off of this extreme position that they have been taking so far?

The delegation of Brazil, which is obviously very large in these meetings, offers an interesting example. Their head negotiator was leading the group of like-minded mega-diverse countries - a coalition of biodiversity-hotspot countries. However, some people from the Brazilian delegation were talking to the European Union and asking questions like, “What do you mean when you talk about noncommercial research? What do you mean when you talk about collaborative projects?”

There is also an increasing recognition that the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA) actually seems to be a good model. It has been cited in the process.

There have been a number of recent activities intended to achieve a broader involvement of experts and user groups. For instance, there has been a total of four technical experts groups: one on certificates; one on concepts, terms and working definitions; one on compliance; and one on traditional knowledge. These groups were supposed to have expert participation—scientists and other users of biodiversity. Unfortunately, most of the time the countries just nominated their normal negotiators as their delegates to these groups. Nonetheless, the discussions at least have raised awareness of some of the kinds of problems that this process has to address, although you cannot yet see the effects in the negotiating text. The positions have not changed much so far.

There have been a couple of other, more informal initiatives. One was a workshop on noncommercial research, which was led by the Consortium for the Barcode of Life. Another was a workshop on sectoral linkages, led by the United Nations University. There was also a workshop on traditional knowledge. One of the big issues is always the traditional knowledge tree of genetic resources. If an organism or genetic resource that

has been used traditionally leads to the development of some treatment or product, the idea is that the community should also share in the benefits.

If we judge these activities intended to involve the experts and user groups on the basis of success in meeting the 2010 deadline, it has been too little involvement and far too late in the process. If you look at this as something that might continue in an ongoing fashion, however, it could be a good starting point.

It is possible to discern some emerging trends from the activities that have taken place so far. However, keep in mind the usual caveat that is quoted in international negotiations: Nothing is agreed until everything is agreed. Still, some things seem to be coming into focus.

First, there seems now to be a broad acceptance that the regime will be legally binding. For a long time that was a point of contention. There was some idea of making a hybrid with some elements binding and some elements nonbinding. That is mostly gone.

Second, the process has been proceeding on the assumption that the outcome will be a protocol to the CBD. So this will be similar to the Kyoto Protocol—a separate part that only members of the convention can sign. This would mean that the United States would not be able to ratify this protocol. It would have to ratify the CBD first.

This implies that there will probably be some kind of a minimum participation clause. For the ITPGRFA it was 40 countries, but it might be higher or lower for the ABS protocol. This implies that once the regime has been adopted, there will be a period before it enters into force after the minimum number of countries have ratified. This could take several years.

There also seems to be an assumption emerging that the objective of the regime will be to support implementation of national ABS legislation. There would be a series of international minimum standards, both for access and for benefit sharing. There might be model domestic legislation and model clauses for material transfer agreements. A very important part will be certificates that will be used as a tool to monitor compliance.

One interesting thing about terminology is that they talk about minimum standards for access, but they are wary of talking about anything that goes into harmonization of access law. That is a result of the mistrust I spoke of earlier, or perhaps it is just that most of the supplier countries want to keep control over how this works. Unfortunately, the implication of that is that there will be a multitude of regulations and procedures in domestic legislation and different conditions for access, so the transaction costs will remain high and the situation Michael Halewood described will mostly prevail even after the regime has been adopted. Some kind of agreement therefore is needed to address the clarity and transparency of these laws. There needs to be legal certainty, but it is not clear now just how to achieve it.

Concerning benefit sharing, there are a couple of interesting ideas currently in the text. These are not yet agreed to, but they are there. One is that there might be something like a research exemption, both in terms of sharing the results of research and in terms of access. It is clear that this will not just be about access to journal articles or that type of information, but there would also be a type of technology transfer if the results of research are other products that can be used as basis for further research.

There is a clause concerning participation in research activities and joint activities, which is fairly uncontested at the moment. The idea of minimum conditions and standards is in there. And at the last meeting delegates inserted two things inspired by the ITPGRFA Treaty. One would be the option for multilateral sharing of benefits when

the origin is unclear or when resources exist in several countries. The other idea is that there might be trust funds for realizing the benefit sharing in those cases.

Compliance is always a big issue, but it is probably the least certain at this moment because compliance is usually negotiated after everything else has been agreed. The wording now has hints that there might be codes of conduct for important user groups, and I think there are explicit references to the Food and Agriculture Organization codes of conduct as well.

Another idea is that research funding agencies should specify what ABS legislation must be followed when the projects are funded. A very big issue has always been the question of disclosure requirements, both in material transfer agreements and in patent applications on downstream innovations.

The take-home message is that some of the things being discussed are already done. A lot of the information being tracked—the idea for developing unit identifiers, for instance—are reasonable ideas that have made it into the text and will probably stay there.

As for possible implications, as I was saying, it looks like the regime will not solve the problems we have been talking about and it might actually aggravate them. An important point to note is that there has been no recognition of the diversity of user practice. This workshop has made it clear that microbial research is not one monolithic process, but that it includes many different and very specific practices. If the regime is not to have a very negative impact, this range of practices will have to be reflected somehow in the regime. There must be some flexibility built in.

A couple of things will probably be very hard to negotiate. One will be the disclosure requirements and how far they go. The basic idea is to achieve transparency so that you can trace back to the country of origin, which is, of course, impossible for all the materials already in collections for which this was not documented. Disclosure requirements might also be difficult to decide in the case of resources collected in multiple countries or when one does not know which country should be associated with a resource.

How can the scientific community engage more in the process? The experience of the ITPGRFA is very instructive in the sense that there should be a concrete proposal brought forward by a large group announcing what it sees as the best way of achieving the objectives. One way that this could be done would be to use existing institutions and networks to give clout to a proposal like that and to promote it at several points. These institutions should not just focus on the process itself, but should also go to national governments and tell them that if research capacity is not to be destroyed, then that needs to be considered in the negotiations.

I think it is important that the COP 10 decision does not close the door to these activities. Hoping for anything else is probably unrealistic, but the take-home message should be not to close the door.

Question and Answer Session

PARTICIPANT: Can you define bio-piracy precisely?

DR. JUNGCURT: There is no precise definition of bio-piracy, but it is on the list of things that the developing countries want to control. They want to have an “internationally agreed-upon understanding of misappropriation and misuse,” which is the politically accepted terminology for what bio-piracy would stand for. The word has been used by nongovernmental organizations (NGOs) basically for any kind of bioprospecting activity that did not comply with the CBD, either deliberately or inadvertently. Most of these activities have been called bio-piracy after the fact, and there have been some studies that have concluded that those companies who wanted to negotiate prior informed consent were the ones identified by the NGOs and called bio-pirates. These companies actually had the good will but did not know how to negotiate or fell into the trap that there was no national authority defined, or else they negotiated with the wrong party, and they were then called bio-pirates. The situation results in punishing the compliant, which, of course, has driven every other private-sector player away from even trying to comply.

PARTICIPANT: This may be naïve, or maybe inflammatory, but the whole discussion has been in terms of benefits, but you mentioned pathogens. At what point do lawsuits among countries begin for not controlling infections?

DR. JUNGCURT: It is part of the frustration that some felt during the process when this suggestion came up. Many delegates did not understand why this was specifically mentioned by the EU delegation. Most delegates seemed to agree that pathogens, as a type of resource, should be covered by a broader definition.

You can think of benefits in different ways. If a cure to a disease has been based on accessing a certain virus strain or a certain collection, there could be a way of doing that, but this is the first time this has actually been raised in the discussion.

This page intentionally left blank.