Anita Kleinsmidt

Carolina Lasén Lasén Diáz

Dafna Feinholz

Doris Schroeder

Fatima Alvarez-Castillo,

Miltos Ladikas

Udo Schuklenk

English

Crossref

Sharing the benefits of genetic research

Schroeder, Doris

CLoK

ArticleSharing the benefits of genetic researchSchroeder, DorisAvailable at http://clok.uclan.ac.uk/9703/Schroeder, Doris (2005) Sharing the benefits of genetic research. BMJ, 331 (7529). pp.  1351-1352. ISSN 0959-8138  It is advisable to refer to the publisher’s version if you intend to cite from the work.http://dx.doi.org/10.1136/bmj.331.7529.1351For more information about UCLan’s research in this area go to http://www.uclan.ac.uk/researchgroups/ and search for <name of research Group>.For information about Research generally at UCLan please go to http://www.uclan.ac.uk/research/ All outputs in CLoK are protected by Intellectual Property Rights law, includingCopyright law.  Copyright, IPR and Moral Rights for the works on this site are retained by the individual authors and/or other copyright owners. Terms and conditions for use of this material are defined in the http://clok.uclan.ac.uk/policies/CLoKCentral Lancashire online Knowledgewww.clok.uclan.ac.ukdoi:10.1136/bmj.331.7529.1351  2005;331;1351-1352 BMJ  Anita Kleinsmidt, Fatima Alvarez-Castillo and Dafna Feinholz Doris Schroeder, Miltos Ladikas, Udo Schuklenk, Carolina Lasén Lasén Diáz,   Sharing the benefits of genetic research http://bmj.com/cgi/content/full/331/7529/1351Updated information and services can be found at:  These include: References http://bmj.com/cgi/content/full/331/7529/1351#otherarticles1 online articles that cite this article can be accessed at:    http://bmj.com/cgi/content/full/331/7529/1351#BIBLThis article cites 3 articles, 1 of which can be accessed free at: Rapid responses http://bmj.com/cgi/eletter-submit/331/7529/1351You can respond to this article at:  serviceEmail alertingbox at the top left of the article Receive free email alerts when new articles cite this article - sign up in theTopic collections (2985 articles) Sociology  (1698 articles) Legal and forensic medicine  (1428 articles) Research and publication ethics  (638 articles) Informed consent   Articles on similar topics can be found in the following collections  Notes    http://group.bmj.com/group/rights-licensing/permissionsTo Request Permissions go to: http://journals.bmj.com/cgi/reprintformTo order reprints go to:  http://resources.bmj.com/bmj/subscribers go to: BMJTo subscribe to  on 25 February 2009 bmj.comDownloaded from should be the same for all submissions regardless ofcountry of origin or type of institution.Kenneth J Rothman vice president, epidemiology researchRTI Health Solutions, RTI International, 200 Park Offices Drive,Research Triangle Park, NC 27709, USAStephen Evans professor of pharmacoepidemiology(stephen.evans@lshtm.ac.uk)Medical Statistics Unit, London School of Hygiene and TropicalMedicine, London WC1 7HTCompeting interests: KJR is an employee of RTI HealthSolutions, an independent non-profit research organisation thatdoes work for government agencies and pharmaceuticalcompanies. SE has no conflicts of interest to declare.1 Instructions for authors. JAMA 2005;294:119-25.2 Fontanarosa PB, Flanagin A, DeAngelis CD. Reporting conflicts of inter-est, financial aspects of research, and role of sponsors in funded studies.JAMA 2005;294;110-1.3 Rothman KJ. Conflict of interest: the new McCarthyism in science. JAMA1993;269:2782-4.4 Smith R. Medical journals are an extension of the marketing arm ofpharmaceutical companies. PLoS Med 2005;2:e138.Sharing the benefits of genetic researchWill the World Trade Organization act to stop the exploitation of biodiversity?Campaigners are calling on policy makers atnext week’s sixth World Trade Organizationministerial conference in Hong Kong to maketrade fairer for and improve the lives and health of theworld’s poorest people. This broad and important aimmay dominate the headlines, but ministers will also bediscussing technical issues surrounding internationalpatenting laws. One issue with implications for thedevelopment of medical products is the tensionbetween international patenting laws and benefit shar-ing requirements, which may threaten agreements onprotecting biodiversity. If the biodiversity door shutsbecause of protests in developing countries, pharma-ceutical research will be seriously hampered.In Hong Kong the World Trade Organization canstop the exploitation of non-human genetic materialand traditional knowledge by aligning the trade relatedintellectual property rights (TRIPS) agreement withthe Convention on Biological Diversity. Over the pastdecade benefit sharing has become a recurrent themein international debates on human and non-humangenetics. The term arose from the Convention on Bio-logical Diversity adopted at the 1992 earth summit inRio de Janeiro, Brazil.1 The convention has threeobjectives: the conservation of biological diversity, thesustainable use of its components, and the fair andequitable sharing of benefits from the use of geneticresources (“benefit sharing”). Although benefit sharingis compulsory when the biosciences industry orresearch centres use biodiversity and associated localor indigenous knowledge to develop new products andservices, it is not covered by legally bindinginternational trade agreements, such as TRIPS,2 nordoes it cover human genetic resources.Benefit sharing is particularly important in threecontexts in genetics: access to non-human geneticresources and associated traditional knowledge, humangenetic banking, and research on rare genotypes.3 Thefew benefit sharing agreements that have been signedto date have been widely criticised (see box onbmj.com).4–7Concerns regarding benefit sharing for non-humangenetic resources and traditional knowledge haveincluded practical problems such as: how can priorinformed consent be obtained from large communitieswithout adequate means of representation; how can thesocioeducational gap between negotiating partners bebridged; how can lack of trust between negotiatingpartners be overcome; and which benefits should bemade available when and to whom? Principledobjections have included concerns about incompatibilitybetween the concept of communally owned traditionalknowledge and the intellectual property rights system;views that sacred knowledge ought never be patented;and the fear that benefiting individual communitiesaccording to ethnic distinctions is divisive.These concerns should not detract from the factthat 187 countries and the European Union haveagreed in the Convention on Biological Diversity thatbenefit sharing for non-human genetic resources andtraditional knowledge is legally binding.1 It is in thiscontext that an earlier ministerial conference of WorldTrade Organization members agreed the DohaMandate in Qatar in November 2001.8 This mandateidentified the need for further negotiation on the clashbetween TRIPS and the Convention on BiologicalDiversity. This was reinforced by a series of submissionsto theWorld Trade Organization from a group of LatinAmerican and Asian countries which suggested how tobridge the gap between the two agreements.9 Thesesubmissions urged that patent applicants shouldprovide disclosure of the source and country of originof the biological resource and of the traditional knowl-edge used in the invention; evidence of prior informedconsent through approval of authorities under the rel-evant national regime; and evidence of fair and equita-ble benefit sharing under the relevant national regime.Without the proposed revision of TRIPS, the Con-vention on Biological Diversity is legally binding butlacks “teeth” because it does not include the strongmechanism for dispute settlement that is provided byWorld Trade Organization treaties. Ministers willconsider the revision in Hong Kong and are in anexcellent position to stop the exploitation of non-human genetic resources and traditional knowledge.Aside from the discussions in Hong Kong, benefitsharing for human genetic resources is an even greaterchallenge, as none of the relevant international guide-lines are legally binding (HUGO Ethics Committeestatement on benefit sharing,10 UNESCO InternationalDeclaration on Human Genetic Data11). It has thereforebeen suggested that the Convention on BiologicalDiversity should be extended to include human geneticBox showing benefit sharing agreements is on bmj.comEditorialsBMJ 2005;331:1351–21351BMJ VOLUME 331 10 DECEMBER 2005 bmj.com on 25 February 2009 bmj.comDownloaded from resources.12 However, benefit sharing agreementsunder the Convention are negotiated locally, betweencontracting individuals (“I want your plant, what do youwant in return?”). This market model does not sit com-fortably with human health needs. Merely expandingthe convention to cover human genetic resources mightserve as “window dressing” for national governmentsand detract from efforts to make them regard healthand health research as a state priority and the best eco-nomic investment they could make.13–15 Instead theresearch community should make a concerted effort incooperation with national governments to devise alegally binding framework for sharing the benefits ofhuman genetics research that is based on equity, justice,and the spirit of the convention.Doris Schroeder reader in ethics and acting head of centre(dschroeder@uclan.ac.uk)Miltos Ladikas international development officerCentre for Professional Ethics, University of Central Lancashire,Preston PR1 2HEUdo Schuklenk professor and head of centreCentre for Ethics, Public Policy and Corporate Governance, GlasgowCaledonian University, Glasgow G4 0BACarolina Lasén Diáz environmental lawyer9 rue des Veaux, 67000 Strasbourg, FranceAnita Kleinsmidt acting headUniversity of Witwatersrand, Faculty of Health Sciences, BioethicsDivision, Johannesburg, South AfricaFatima Alvarez-Castillo professor in social sciencesUniversity of the Philippines, Department of Social Sciences, Diliman,Quezon City 1101, PhilippinesDafna Feinholz chair, Latin American Federation ofEthical Review CommitteesNational Commission of Bioethics, 01900 Mexico DF, MexicoWe thank Véronique Delpire for providing writing and editorialassistance and Michael Parker, Leonardo de Castro, andEugenijus Gefenas for comments on an earlier draft. This edito-rial is based on research undertaken with a European Commis-sion grant, Science and Society programme, Framework VI(contract SAS6-CT-2003-3583): “Genomics and Benefit Sharingwith Developing Countries” (January-December 2004).Competing interests: None declared.1 Convention on Biological Diversity. 5 June1992. www.biodiv.org/doc/legal/cbd-en.pdf (accessed 2 Dec 2005).2 World Trade Organisation. IP/C/W/442 of 18 March 2005 andIP/C/W438 of 10 December 2004. www.wto.org/english/tratop_e/trips_e/art27_3b_e.htm (accessed 2 Dec 2005).3 Williams G, Schroeder D. Human genetic banking and the limits ofinformed consent. New Genet Society 2004;23:89-103.4 Wynberg R. Rhetoric, realism and benefit sharing: use of traditionalknowledge of Hoodia species in the development of an appetite suppres-sant. J World Intellectual Property 2004;7:851-76.5 Andersen B, Arnason E. Iceland’s database is ethically questionable. BMJ1999;318:1565.6 Arnason V. Coding and consent:moral challenges of the database projectin Iceland. Bioethics 2004;18:27-48.7 Special issue on benefit sharing. Developing World Bioethics (in press).8 World Trade Organization. The Doha Declaration explained. 2002. www.wto.org/english/tratop_e/dda_e/dohaexplained_e.htm[trips (accessed2 Dec 2005).9 Submissions to the WTO TRIPS Council from Bolivia, Brazil, Colombia,Cuba, Dominican Republic, Ecuador, India, Peru, Thailand andVenezuela: IP/C/W/420, March 2004; IP/C/W/429/Rev.1, September2004; IP/C/W/438, December 2004; IP/C/442, March 2005. http://docsonline.wto.org/ (accessed 2 Dec 2005).10 HUGO Ethics Committee. Statement on benefit sharing. 9 April 2000.www.gene.ucl.ac.uk/hugo/benefit.html (accessed 3 Dec 2005).11 UNESCO. International declaration on human genetic data. 16 October 2003http://portal.unesco.org/en/ev.php-URL_ID = 17720&URL_DO=DO_TOPIC&URL_SECTION= 201.html (accessed 2 Dec 2005).12 Miles SH. Human genomic research ethics: changing the rules. HumanSciences Research Council of South Africa: Africa Genome Initiative,Genomics and African Society: The Future Health of Africa. Cairo, 26-29March 2004.13 Schroeder D, Lásen Diaz C. Sharing the benefits of genetic resources:from biodiversity to human genomics. Devel World Bioethics (in press).14 World Health Organisation, Commission on Macroeconomics andHealth. Macroeconomics and health: investing in health for economicdevelopment. 2001. www3.who.int/whosis/cmh/cmh_report/report.cfm?path =whosis,cmh,cmh_report&language = english (accessed 2 Dec 2005).15 Andanda P. International Legal Frameworks for Benefit Sharing. CapeTown Workshop on Benefit Sharing with Developing Countries.(European Commission funded workshop within the Genomics andBenefit Sharing with Developing Countries project.) Cape Town, 5-6 May2004.Is methadone too dangerous for opiate addiction?The case for using a safer alternative, buprenorphine, is strongMethadone is an effective treatment for heroinaddiction, and it remains the mainstay ofdrug treatment for opiate dependence in theUnited Kingdom.1 The lethal dose of methadone isestimated at 50 mg for an opiate-naive adult.2Nevertheless, many authorities recommend thatmethadone doses should be gradually increased tomaintenance doses of 80-120 mg1—that is, twice thelethal dose for non-users. The greatly increased risk tousers from methadone, particularly black marketmethadone, thus remains a major concern. Buprenor-phine is a partial agonist that has a lower potential forcausing respiratory depression than many other opio-ids, including methadone and heroin.3 It is increasinglyused in the United Kingdom to treat opiatedependence, with guidelines for clinical managementin primary and secondary care summarised by Ford etal4 and Taikato et al.5 It is time it replaced methadone asthe mainstay of drug treatment for opiate dependence.A long running debate continues between propo-nents of long term maintenance treatment with metha-done and the proponents of detoxification (in which thedose of a substitute drug is reduced over time to achieveabstinence from all agents). An expert US panelconcluded, “although the drug free state represents anoptimal treatment goal, research has demonstrated thatthe state cannot be achieved or sustained by the major-ity of persons dependent on opiates.”6 Withoutdigressing further into this debate, we point out that thatbuprenorphine is at least as effective as methadone inboth maintenance and detoxification.7–9One mechanism to reduce the diversion ofmethadone on to the black market is to insist that thesedrugs are taken in the presence of a pharmacist ratherthan being given “to take away.” Repeated advice to thiseffect is provided by the UK Department of Health andthe Home Office.1 10 We have recently contacted 120 ofthe 140 community drug teams in England andWales toask what proportion of new patients on methadoneundergo supervised consumption.We found that at least25% of people who start prescriptions for methadoneare still prescribed methadone to take away. ThisEditorialsBMJ 2005;331:1352–31352 BMJ VOLUME 331 10 DECEMBER 2005 bmj.com on 25 February 2009 bmj.comDownloaded from 

Sharing the benefits of genetic research

Abstract

Similar works

Full text

Available Versions

Crossref

CLoK