Access & benefit sharing in population based research: Indirect benefit sharing as a model of regulation

- Prof. Dr. Juergen Simon and Cristina Blohm-Seewald, M.A.
Institut fur Rechtswissenshaften,
Universitat Luneburg, D-21332 Luneburg, GERMANY
Email: simon@euroacademy.com

Eubios Journal of Asian and International Bioethics 14 (2004), 199-203.


 

This paper concerns a regulatory model, which regards populations as market participants with adequately shared property rights. This model is generally considered as a fairly basic one within a globalized world and might thus serve as a starting point from which further forms of participation and cooperation as market-immanent structures develop. We are starting out from the very broad division into two different worlds: An industrialised one on the one hand and the so-called developing countries on the other. The following assumptions underlie this model:

 

1st Thesis:

The conflict about the regulation of access to genetic resources as well as access and benefit sharing within industrialised nations differs significantly from the conflict existing between industrialised nations and the developing countries.

The latter moreover being a historical conflict whose roots date back to the colonisation era having been carried over into current times. Especially through a continuation of exploitation and forced ownership practices by industrialised nations regarding indigenous genetic and intellectual resources and the run on human genetic resources of indigenous population[3], without any adequate consideration and compensation of the interests of indigenous communities concerned, this conflict has become more intense[4]. The escalation of any conflict may lead to a hardening of positions that make a turn-around of the processes concerned very difficult. In the most extreme this escalation reaches a ăpoint of no return". In conjunction with the setting up of bigger national biobanks over the last couple of years a sometimes fairly fierce debate around the legal and ethical problems of access to these has ensued within the industrialised nations themselves. This discussion enters upon the various forms of access to humane genetic resources from within the population and the subsequent socially fair way of compensation; however, without reaching the degree of escalation concerning the other conflict described earlier.

Conflicts as social phenomena are inherent to any social structure and as such exhibit both negative as well as positive characteristics. Generally speaking a positive aspect of conflicts is the widespread discussion around them, arising mostly from the grievances and misunderstandings, which caused the conflict. Considering the corresponding populations the chance meant before could be the opportunity to develop creative possibilities of conflict solution. For the parties involved, conflicts are therefore a challenge to introduce the necessary social changes in a carefully directed and guided form. The solution of the conflict about the regulation of the access to genetic resources and benefit sharing between industrial and developing nations is a global challenge, which can only be coped with through a collective effort of the community of states. To fulfil the difficulty about access and benefit sharing an approach that considers the specific culture values is essential. Neither the conceptions about access nor those about benefit sharing are valid all over the world and therefore not comparable.[5] Especially benefit sharing is marked by the properties, subjectivity and immeasurableness what means that there are no "objective standards ... to measure benefit and to compare the benefit which is reached by different people". The lack of such scales makes it very difficult to find a universal solution for this problem.[6]

Concerning the conflicts in the periphery of access and benefit sharing mentioned it would be a challenge to reconsider and deform the existing rights of disposal.

 

2nd Thesis

Actors and actions are dominated in the "industrialised world" by an economic orientation. The economic calculation in terms of aspiration for individual profit dominates the reasons for acting. Economically oriented acting does not preclude the maintenance of ethic, social and ecological principles which are immanently given.

 

Biobanks are a typical example for immanent social and ethic principles in terms of the discussion about informed consent and therefore for indirect benefit sharing. The focus here lies on legal and ethic forms of organisation in agreement to the collection, storage and utilisation of data as well as the allocation of texture and cells from the donors. These are of course individually assigned to the donors before separation in into property rights. Traditionally these rights lose their function as property rights for the donor with the integration into a biodatabank because of being involved in the database by default. Normally, the donors pass on their rights for the benefit of the bank, the industry or the researcher. After a "normal" declaration of consent certain rights still remain with the donor such as rights over control and destruction of data. If somebody gives a blank acceptance these rights are mostly lapsed. The different forms of consent are realised in practice as emptied-out rites during which both sides of the conflict are lead to their aimed conclusions: One part dispenses and another is allowed to work for his own and the benefit of others if research is successful. That is why it has come to a conventional direct reallocation of disposal rights in favour of the pharmaceutical industry and indirectly – concerning the future possibility of medical results – in aid of a benefit for the donors as well. In case of successful drug development the community of patients will profit from the donation even if the donor himself has no direct earning at all (this problem comes up again if less-developed-countries or purely indigenous communities are affected). From this point of view however the focus lies on the industrialised countries.

If continuing to think along this way informed consent, despite its apparently emptied-out non-significance, through its latent structure quasi-automatically transports benefit sharing with it. In other words: Every time genetic data is allocated to researchers for another use there is the chance to share positive results with the whole community on one hand. On the other hand this positive abnegation of individuals is washed out and apparently limited through the expansion of property rights of the business. "Apparently limited" should mean that the knowledge about the results is now demarcated alongside monetary equivalents. The donor gives up his property rights for the benefit of the industrial side of the transaction. From the view of the business they fulfil a process of collecting the given material and data because of research and because of taking the risk of capital investment. This is why generally an adequate return of invest can be realised and thus also should be debated under ethical aspects.

There is a common consensus about the necessity of the conservation of the genetic diversity because of its existential importance for humankind and for the following generations. The loss of genetic diversity is irreversible. That means that a living space once damaged or the breed, which is destroyed, is "lost forever" – hand in hand with the destruction of diversity there will be a demolition of the connected economic potential.[7] It is for this reason protection and preservation of genetic diversity should be the prior principle leading the actions. This principle is also valid for the use of human genetic diversity. Preservation and diversity of life are to elevate to the most important principle for academic work and the connected economic activities. If research is done within the own population, then this "humanitarian" principle is not only immanent existent, but explicit destination of population orientated biobanks.

Things look differently if research is done by industrial nations in communities abroad for example in indigenous communities. In the face of the now discharged Human Genome Diversity Project (HGDP) the indignation of the indigenous facing the HGDP is comprehensible.[8] The research had no pertinence for the people chosen by this project; it was of no importance for the conservation of endangered populations. The research objectives did not include their social cultural reality but corresponded – from their perspective – with the ethnocentrically behaviour of the dominant population. The official denouncing of the project by indigenous representatives and organisations was focused mainly on one goal of the HPGD which was called "immortalization of cell lines", which means, to collect and store the genetic material of populations before they disappear. Even if the problem here is mainly a linguistic one because: "English terms such as 'immortalization' of cell lines can be badly misunderstood" [RAFI 1993, p. 2]. It is not difficult to imagine that members of a small group being told that samples are needed because they are endangered would be deeply offended, and it is unlikely that they would take much comfort from being told that they are making an important contribution to the advancement of scientific knowledge about the human body" (IDRC 2003: 7).

The cultural and ethical insensitive modus operandi of the project leaders and the ethnocentric direction of the research goals (the history of the developing of Homo sapiens, the genetic diversity of humankind, the aetiology of diseases mainly found in the western world) of the project have aroused great resistance, scepticism and displeasure among indigenous organisations. The afresh subjugation in the form of degradation of the indigenous to objects of research, the reduction of indigenous to extra precious data material to a resource of research and the bizarre expectation that the marginalized indigenous – formerly being suppressed and exploited by colonisation – would consider altruistic motifs for the welfare of the western world and to take therefore part in the project, harmed and disgusted the indigenous populations. Primarily the danger of increasing the economic exploitation of the people through commercialisation and the possibility of patent on their indigenous genomes on the part of the dominant countries without adequate consideration and respect of indigenous ethic-religious mental attitude towards life and the human body (forbiddance of a patent of life) and without a cultural adequate and equitable participation of indigenous, led to an almost complete refusal of the 722 populations and to an official condemnation by the World Council of lndigenous Peoples. In reference of the benefits of biobanks for the population of industrial nations we have to consider that many in indigenous communities do not perceive a benefit.

The indirect benefit for the western donors exists - as described above - in the possibility of being available to have and to make use of the potential positive results from the biobank research in the case of diseases. But these possibilities are irrelevant for the indigenous. The research objective of biobanks is mainly focused on the so-called "Volkskrankheiten"[9] or in the industrialised nations common diseases from the cardiovascular system (e.g. high blood pressure), metabolism failure, hormone diseases (diabetes, osteoporosis) cancer, illnesses of the nervous system, infectious- and immune diseases[10], diseases which have different frequencies among (marginalized) indigenous communities.

The reality in the developing countries, especially in the indigenous communities is, following the opinion of the WHO, completely different: "In many developing countries, health systems are in disarray because of long-standing underinvestment, and cannot provide even basic coverage, in particular at the periphery and for the most disadvantaged in terms of human development. Marginalized ethnic populations, often distanced both physically and culturally from mainstream society, face additional difficulties in accessing effective and culturally appropriate health care. In developing countries, marginalized ethnic groups are among those particularly susceptible to such conditions associated with poverty as malaria, tuberculosis, HIV/AIDS, diarrhoeal and respiratory diseases, malnutrition, high infant and maternal mortality rates, and low life expectancy at birth".[11] Apart from not having any advantages from eventually existing research output, indigenous communities could not bring up the capital for the purchase of such medicaments or therapies.

The immanent existent indirect benefit of having the potential chance to heal or to better examine diseases is thus of no significance for indigenous donors. But immanent for indigenous people is the danger of being infected by an introduced and spread pathogenic western germ against which they have no power of resistance.[12]  "It is a.... generally accepted fact that without the preparation of a constant medical care one third or even more of the original inhabitants die in the first five years after first contact.[13] This potential thread - in the context of access to isolated living indigenous communities - should be reconsidered in the discussion about regulation of access.

Out of these thoughts we would like to correct the second thesis to that effect that it says: Actors and actions in the "industrialised world" are dominated by an economic orientation. The economic calculation in terms of aspiration for individual profit dominates the reasons for acting. Economically oriented acting does not preclude the maintenance of ethic, social and ecological principles of the own culture and for the benefit of the own society, which are immanently given. In view of foreign communities, especially indigenous people we find imbalanced estimations.

An immanent existing indirect benefit at the level of scientific output is – as mentioned above – not relevant for the indigenous population. But considering the dimension of the conflict process then it crystallizes some kind of indirect benefit for the indigenous people. This indirect benefit refers to an aspect of the positive consequences of conflicts we mentioned in the first thesis of this paper.  We refer to the positive effects of the discussion about property rights, access and benefit sharing in relation to genetic resources, which was enforced, aroused through the Convention on Biological Diversity from 1992. These discussions induced a process in the developing countries and especially among the indigenous representatives, which was highly beneficial for the assertion of the indigenous peoples from today's point of view. This process started with the dispute about the regulation of the ănational sovereignty" over genetic resources (CBD Art. 15)[14]:

"In the CBD, access to and transfer of genetic resources and technologies (including indigenous and traditional technologies) are assumed to be basic rights of states. But Indigenous peoples consider this a problematic issue that must be negotiated with local communities, whose rights are enumerated by international agreements and laws to which these same states are parties".[15]

The dispute with the conflict about the property rights of the genetic resources of the indigenous populations provoke the indigenous to make public their own rights and interests on the local, national and international levels and to make the world listen to them. In the past twelve years processes of unionizing and organizing indigenous communities and ethnic groups and of active participation of indigenous actors on many levels up to UN-Organisations took place. At various opportunities the indigenous representatives expressed their demand to consider and respect their right to self-determination and full participation in international processes, as well as their status as right holders and not of mere stakeholders for example in the "Closing Declaration Sixth Conference of the Parties of the Convention on Biological Diversity, The Hague, 19 April 2002"[16], and in the year 2003 in Durban in "The Indigenous Peoples' Declaration to the World Parks Congress"[17] and additionally this year during the COP7 in Kuala Lumpur in the "Statement to the Conference of the Parties regarding the Ad Hoc Open-Ended Working Group on Access and Benefit Sharing (Agenda Item 19.11)[18].

The indigenous peoples are defending their property rights against external interests – and may it be in an extreme case through the complete exclusion of others in using their resources. Thus the indigenous populations are little by little becoming almost equal partners and therefore we consider this achievement in some way as an indirect benefit or positive effect of the conflict about access and benefit sharing.

 

3rd Thesis

Economic acting, which is ethically, socially and ecologically aligned, might lead to a significant gain in economic efficiency.[19]

 

The implementation of and the compliance to voluntary codes of conduct such as corporate governance not only leads to a significant increase of economic efficiency but contributes also to break down the existing asymmetry between the disputing antagonists and the proximate confrontations.

The redesign of disposal rights in terms of granting populations the status of right holders leads to a fortification of theses social actors (collective of patients, indigenous communities, minorities etc.) within the field of a free market economy.

An improvement of the economic positions of the aforementioned populations might basically lead to the breakdown of asymmetric positions of power and might open the port to a frank and emancipated communication between the different groups and thus to conflict solution.

 

Conclusions

A regulatory model which regards populations all over the world as equal market participants, that respects the right of self-determination and recognizes the right to full and effective participation and that guarantees the property rights of the different populations could be an important contribution to conflict solution in the context of access and benefit sharing for research in population based research.

 

Bibliography

Associated Press: Diseases threaten Brazilian tribe. Monday, February 5, 2001

BRECHT, Christine; Sybilla NOKOLOW: Displaying the Invisible: Volkskrankheiten             on Exhibition in Imperial Germany.  Stud. Hist. Phil. Biol. & Biomed. Sci., Vol. 31, No. 4, pp. 511–530, 2000

CEVALLOS, Diego: Abortan convenios de bioprospecci—n. TierramŽrica, 22. Octubre           2000 – www.tierramerica.net/2000/1022/articulo.html

Closing Declaration Sixth Conference of the Parties of the Convention on Biological Diversity, The Hague 19th April 2002 http://www.nciv.net/engels/IIFB/Closing%20Decl.Cop.htm

Convention on Biological Diversity, 5th June 1992http://www.biodiv.org/doc/legal/cbd-en.pdf

CUNNINGHAM, Hilary und Stephen SCHARPER: Proyecto Genoma Humano. Patentar lo 'primitivo'. In: Revista del Sur 55. Montevideo 4/1996www.revistadelsur.org.uy/revista.055/Biotecnologia.html

GETTKANT, Andreas: Umsetzung der BiodiversitŠtskonvention. Ein Projekt derdeutschen Entwicklungszusammenarbeit. Eschborn: GTZ 1999

IDRC: Appendix 1. The Human Genome Diversity Project. ID 30136, 2003: 7  http://web.idrc.ca/en/ev-30136-201-1-DO_TOPIC.htm

International Indian Treaty Council: Statement to the Conference of the Parties regarding the Ad Hoc Open-Ended Working Group on Access and Benefit Sharing (Agenda Item 19.11). The Indigenous Peoples' Declaration to the World Parks Congress in Durban 2003 www.treatycouncil.org/section_211812142.htm

Nationaler Ethikrat: Biobanken fŸr die Forschung. Stellungnahme. Berlin: NER 2004

NOVY, Andreas: Internationale Politische …konomie. Mit Beispielen aus Lateinamerika. WirtschaftsuniversitŠt Wien. Wien: LASON 2004http://www.lateinamerika-studien.at/content/wirtschaft/ipo/ipo-937

RAGHAVAN, Chakravarthi: Patentes. Trasnacionales al asalto de la biodiversidad.   In: Tercer Mundo Econ—mico.. No. 75, Montevideo: Red del Tercer Mundo 11/1995

Sekretariat des Runden Tisches Verhaltenskodizes c/o Deutsche Gesellschaft fŸr Technische Zusammenarbeit (GTZ) Hrsg.: Ratgeber Verhaltenskodizes zu Sozialstandards.  Eschborn: GTZ 2004

Statement to the Conference of the Parties regarding the Ad Hoc Open-Ended Working Group on Access and Benefit Sharing (Agenda Item 19.11, COP7 in Kuala Lumpur www.nciv.net/Frans/COP/Docop7/ABS%20Opening%20Statement%2012%20Feb%202004%20Final%20English.doc

TIERNEY, Patrick: Verrat am Paradies. Journalisten und Wissenschaftler zerstšren das Leben am Amazonas. MŸnchen, ZŸrich: Piper 2002

WHO: FIFTY-FIFTH WORLD HEALTH ASSEMBLY A55/35, Provisional agenda item 19: 2002 www.who.int/gb/EB_WHA/PDF/WHA55/ea5535.pdf

WZB (Wissenschaftszentrum Berlin fŸr Sozialforschung): Results presented by Working Group II at Montreux. 2002

 http://www.wz-berlin.de/ipr-dialogue/argumentations/tk/tk4.htm

 



[3] Which is called ăgenetic fever" in analogy to ăgold fever" by the indigenous and is decried as genetic colonisation by the indigenous peoples. The most famous example is the - now deposed – ăHuman Genetic Diversity Project (HGDP)" from 1991.

[4] For the affected population of the developing countries the human genetic research is a new danger, which might lead to control and depression by a dominant population.

[5] See: NOVY 2004

[6] These considerations are in contrast with the utilitarianism approach (NOVY 2004)

[7] see: GETTKANT 1999:1

[8] see: CEVALLOS 2000; CUNNINGHAM & SCHARPER 1996; RAGHAVAN 1995

[9] ăHowever, it is by no means coincidental that there is no counterpart to the term Volkskrankheiten in the English and French languages. Rather, the reason for this can be found in the divergent histories of political and social languages; in this respect, the linguistic difference is closely linked to the history of the formation of the nation-state. The search for the genesis and the meaning of the term Volkskrankheiten thus leads into the heart of the history of the key terms 'people/folk', 'nation', 'nationalism', 'mass' (Volk, Nation, Nationalismus, Masse), which correspond to terms in English and French but are by no means identical with them.

In contrast to the medical and scientific term 'infectious diseases', which super-seded (but did not abolish) the language of scourges and epidemics in the wake of the validation and establishment of the bacteriological conception of disease, the term Volkskrankheiten was a political and social term charged with meanings

that changed over time" (BRECHT & NIKOLOW 2000: 518)

[10]  Nationaler Ethikrat 2004: 12

[11] WHO 2002:3

[12] "Over the past 20 years, malaria and other diseases that arrived with prospectors and other invaders have killed at least 3,000 Indians on the reservation's Brazilian side. About a quarter of the nearly 13,000 Indians who live in Brazil came down with malaria last year alone, according to the National Health Foundation" (Associated Press: Monday, February 5, 2001).

[13] The journalist Patrick Tierney writes in his book ăDarkness in El Dorado" about ă...the dangers which contact with a foreigner, the gifts, pistols, cameras and future plans for academic research means for the Indians". (TIERNEY 2002: 417).

[14]"1. Recognizing the sovereign rights of States over their natural resources, the authority to determine access  to genetic resources rests with the national governments and is subject to national legislation" (CBD Art. 15. Access to Genetic Resources, 1992: 9).

 [14]  WZB 2002

 

 

[16] "International Indigenous Forum on Biodiversity" (Den Hague April 2002):

1. "Madame Chair, Indigenous Peoples have the right to self-determination. This right is the basis of our recognition as a Major Group in Agenda 21 and other instruments that emerged from the 1992 Rio Summit. Agenda 21 recognises the right to full and effective participation in international processes that affect us. That is why we are here. We believe that the provisions and programs approved by the Parties of this Conference affect the future of the Peoples of the Planet. For us, these discussions are a matter of life and death.

2. Indigenous Peoples are rights holders and not mere interested parties. We did not come here to negotiate our rights, but rather to guarantee the obligations of the Parties with respect to our Peoples".  

 

[17] "Preamble We, the Indigenous Peoples united here in Durban, South Africa, at the Indigenous Peoples' Preparatory Conference for the World Parks Congress, held 6 to 7 September 2003, would especially like to thank our Indigenous hosts, the Khoi and the San Peoples of South Africa for welcoming us to their territory..." Affirming that Indigenous Peoples are rights-holders, not merely stakeholders".

 

[18] "Indigenous peoples stand firmly upon our rights of self-determination.  Our rights of self-determination are fundamental to the freedom to carry out our responsibilities in accordance with our cultural values and customary laws. All decisions in the CBD process must recognize and protect the fundamental premise that Indigenous peoples are rights holders with proprietary, inherent, and inalienable rights to our Indigenous knowledge and biological resources. The rights of Indigenous peoples, as the owners of their territories, exist and stand independent of the discussions on any proposed international regime".

 

[19] For example in the form of:

á        Increased identification of the people concerned (dedication, power of   innovation etc.)

á        Improvement of image and confidence

á        Encouragement of current value

á        Advancement of product quality

á        Improvement of competitive advantage and market position.

 (see: GTZ 2004:  5 – 7)


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