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To the editor:The feature by Lori Knowles in the Februaryissue (Nat. Biotechnol. 22, 157163, 2004)outlined embryonic stem (ES) cell regulationsaround the world and in the United States.Different political bodies are pursuing a widevariety of ES cell policies, ranging from ban-ning the controversial research to nurturing it.This surfeit of policies is not promoting thedevelopment of scientifically progressive,economically effective or socially responsiblestem cell research. There are sound scientific,economic and ethical reasons for trying toachieve uniform international and nationalpolicies on stem cell research.
First, research on ES cells is not limited toany particular nation or state. A lack of uni-form policies can inhibit national and interna-tional collaboration in stem cell research,which is vital to the development of this newfield. In one recent episode, a German prof-essor faced a possible jail sentence for con-ducting in another country stem cell researchthat was forbidden in Germany1.
Geographically diverse policies can alsoencourage stem cell scientists and researchsponsors to migrate to nations or states withES-cell friendly laws and policies. Already,countries that allow ES cell research, such asthe United Kingdom and Singapore, haveshown that they are capable of siphoningscientific resources from countries that shunthe research, such as Germany and France.The potential for an ES cell brain drain couldaffect scientific collaboration and straininternational relations.
Second, diverse policies can interfere withinternational and national commerce relatedto ES cell research because different politicalbodies might not honor tangible or intellec-tual property rights in ES cells. As ES cellresearch and companies develop productswith economic clout and an ES cell industrybegins to emerge, controversies concerningcommerce in ES cells could affect negotiationsover trade agreements and intellectual pro-perty treaties. For example, countries that donot allow the derivation of stem cells will haveto decide how they will respond to the impor-tation of ES cell lines, and countries that do
not grant patents on ES cells will have todecide whether they will undermine anothercountrys ES cell patents.
Third, and most important, variations instem cell policies can have a detrimental im-pact on the health, safety and rights of patientsand research subjects. There are many ethicalissues concerning stem cell research and itspotential in therapy that need to be resolved,including informed consent for embryo orgamete donors and stem cell recipients, pri-vacy, the use of ES cells for reproduction, thecreation of ES cells for research and qualitycontrol of stem cells and their products2.Patients (or research subjects) who will receivetherapy (or take part in experiments) in coun-tries that do not uphold ethical standards forstem cell therapy (or research) may suffer direconsequences from poorly designed therapyor research. To protect patients, researchsubjects and others, nations (and states)should adopt uniform scientific and ethicalstandards for stem cell therapy and research3.
Nations should work separately andtogether to develop sound and workablenational and international policies on ES cellresearch and its potential therapeutic use.Although different countries disagree onimportant bioethical issues related to ES cellresearch, such as cloning for reproduction andabortion, it should be possible to reach agree-ment on some common ground, such as the
need for an international moratorium onreproductive cloning and the importance ofinformed consent, safety and privacy in bio-medical therapy and research.
For many years, the United Nations (UN,New York) has served as a forum for addres-sing bioethics issues related to human healthand human rights. In 2003, the GeneralAssembly of the UN decided to take no actionproposals to ban human cloning until the2005 session4. In its next session, the GeneralAssembly should revisit the topic of humancloning with a firm eye toward the need todevelop international standards to regulate EScell research. Individual countries, such as theUnited States, should also develop nationalpolicies designed to harmonize regional andlocal laws.
This letter does not represent the views ofthe NIEHS or the NIH.1. Vogel, G. Science 301, 577 (2003).2. The Presidents Council on Bioethics. Human Cloning
and Human Dignity: an Ethical Inquiry (PresidentsCouncil on Bioethics, Washington, DC, 2002).http://www.bioethics.gov/
3. Brivanlou, A. et al. Science 300, 913915 (2003).4. http://www.un.org/law/cloning/
David B Resnik
National Institutes of Health, National Instituteof Environmental Health Science, PO Box 12233,Mail Drop NH-06, Research Triangle Park,North Carolina 27709, USA.e-mail: email@example.com
The need for international stem cell agreements
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To the editor:We read with interest the piece by Willy deGreef in the July issue (Nat. Biotechnol. 22,811812, 2004) describing the impact of theCartagena protocol on genetically modified(GM) crops. This protocol initially wasdrafted with an emphasis on protectingbiological diversity against the potential riskof deliberate release of living modifiedorganisms (LMOs) into the environment(with human health and socioeconomicaspects of GM supposedly a secondary
issue). Yet most of the concerns of devel-oping countries at the First Meeting ofthe Parties (MOP1) in Kuala Lumpur onFebruary 2327, 2004and at recentregional meetings organized by suchagencies as the Asia Pacific EconomicCooperation, Association of South EastAsian Nations and the Organization ofIslamic Conference Standing Committee onScientific and Technological Cooperation(OIC-COMSTECH)focused on trade andagricultural issues surrounding GM crops.
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As of August 17, 2004, 106 countries andthe European Commission had ratified theprotocol. Implementation of the protocolmeans that any LMO transported acrossnational borders will require precisedocumentation complying with Article 18,Handling, Transport, Packaging andIdentification of the LMOs. Those whocontravene these rules could be subject topenalties, such as import rejection, suspen-sion of research or business, fines and/orimprisonment, depending on the particularnational regulation.
Only 12 Asian countries have become aparty to the protocol, as of August 17, 2004:Bangladesh, Bhutan, Cambodia, the Demo-cratic Peoples Republic of Korea, India,Japan, Lao Peoples Republic, Maldives,Malaysia, Mongolia, Sri Lanka and Vietnam.And even among these, several, includingBhutan, Cambodia, Laos and Mongolia, stilldo not have a national legal framework forimplementing the protocol. Indeed, manydeveloping countries, particularly the least-developed countries and small-island devel-oping states have inadequate national legalprovisions to put the protocol into practice.
We have carried out a survey of the publicsector (e.g., Ministries of Agriculture,Science & Technology, Industry andEnvironment), the private sector, the UnitedNations (UN)/international organizationsand nongovernmental organizations opera-ting in sixty-seven nations regarded asdeveloping countries1. On the basis of thissurvey, and information compiled fromregional meetings under the Convention onBiological Diversity and UN EnvironmentProgram, we have identified several factorsresponsible for slow ratification and imple-mentation of the protocol in developingcountries.
1. Lack of a definition and understanding of the sense of risk in general or ofestablished standard risk managementprocedures in other sectors, such asindustrial safety matters. For example,many countries still do not have regula-tions on workers safety, chemical safety,pesticide use, hazard safety, wastedisposal, among other areas. Suchregulations need to be addressed beforeconsidering specific rules for biosafetyrisk management.
2. Insufficient knowledge and shortage ofindigenous expertise. For example, incountries like North Korea and Myanmar,UN sanctions and the isolationist stanceof the present governments limit the flow
of information from abroad. InBangladesh, certain communities aredeprived of information because of ethnicdiscrimination and for the rest, officialexpertise in the science and technology is insufficient to comprehend the issues.Lack of expertise is also a significantproblem in Bhutan, Cambodia, Laos and Mongolia.
3. Need for national government to form astrategic policy for LMOs. In Pakistan, forexample, national pride to compete withIndias Bacillus thuringiensis (Bt) cottonprogram provides strong incentive for thenational government to draw up newpolicy and regulations2.
4. Lack of harmonization between differentstakeholders during the setup of the legal framework. This has meant thatdifferences in regulations among, forexample, Indonesia, the Philippines,China and Thailand confoundcoordination and import/export of LMOs.
5. Political turmoil (e.g., in Afghanistan andNepal) and its impact on drafting relevantlegislation.
6. Suspicion and distrust of foreign assist-ance in developing national regulations.Some countries prefer to halt the processuntil they have developed their ownnational capacity to deal with LMO issues(which may prove difficult because offactors 1, 2 and 3 above).
7. Inconsistent and often conflicting inter-national expert guidance. For example,African Biotechnology Model Law3 andOIC-COMSTECH discussions4 conflictwith the common understanding made at the protocol.
One means of addressing these problemswould be for help and guidance to be pro-vided by international agricultural researchorganizations, such as the ConsultativeGroup on International AgriculturalResearch (CGIAR)5. CGIAR expertise in
the Asian region and elsewhere in thedeveloping countries, for example, couldhelp local countries decide whether theywish to import and/or use GM crops forfood, feed and processing to alleviate foodsecurity issues.
Other international organizations, such as the World Trade Organization (WTO,Geneva), Joint Food and AgricultureOrganization/WHO Food StandardsProgram Codex Alimentarius Commission(Rome), Organization for EconomicCooperation and Development (Paris) andInternational Organization for Standardiza-tion (Geneva), have extensive experience in various aspects of LMO regulationsassociated with trade. From the perspectiveof developing countries, such organizationscould provide pilot-case implementationprojects on biosafety risk assessment thatwould provide guidance to national gov-ernments about the science & technologyassociated with LMOs and familiarize themwith the evaluation and approval process of GM products.
Thus far, when support has been providedby international bodies and nongovern-mental organizations, it has mainly beenrelated to developing and redevelopingpolicy and enhancing the legal andadministrative framework, rather than on implementation of such framework.Support, such as gene-ecology programs6,which help developing countries put inplace the infrastructure to implement riskassessment practices, may correct theimbalance, but a shift of focus away frompurely theoretical and preparatory legalframeworkbuilding to practical pilot-caseimplementation studies is a timely andurgent requirement.
1. Watanabe, K.N. in Agriculture for Peace (eds. Taeb,M. & Zakri, A.H.) in press (United Nations UniversityPress, New York, 2004).
2. Jayaraman, K. S. Nat. Biotechnol. 22, 255256(2004).
5. http://www.cgiar.org6. Cyranoski, D. Nature 428, 6 (2004).
Kazuo N Watanabe1,2, Mohammad Taeb2 &Haruko Okusu2,3
1Gene Research Center, University of Tsukuba,Tsukuba, 305-8572, Japan. 2Institute ofAdvanced Studies, United Nations University,1-1-1 Minatomirai, Yokohama, 220-0012,Japan. 3Sheffield Institute of BiotechnologicalLaw and Ethics, University of Sheffield, Sheffield,S10 1FL, UK.e-mail: firstname.lastname@example.org
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A shift of focus away from purelytheoretical and preparatory legalframeworkbuilding to practicalpilot-case implementationstudies is a timely and urgentrequirement.
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