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New PRC Human Gene IPR Rules



>"http://www.usembassy-china.gov/english 	/sandt/geneipr.htm"
>Content-Location: "http://www.usembassy-china.gov/english
>	/sandt/geneipr.htm"       New PRC Human Gene IPR Rules
>
>  A September 1998 report from U.S. Embassy Beijing   New Human Gene Rules
>Reflect Chinese IPR Concerns
>
>  China banned some human genetic material exports last year while it
>drafted human gene IPR rules to regulate international cooperation. An
>internal distribution only State Council order of June 10, 1998 put the new
>Chinese human genome IPR protection rules into effect. An exclusive
>interview with a Ministry of Science and Technology (MOST) drafter of the
>new rules published in the August 11 issue of Beijing Youth Weekly
>describes a July 1997 letter from Chinese Academy of Sciences Academician
>Tan Jiazhen warning of great losses to China’s emerging biotechnology
>industry. According to the article, the letter moved President Jiang Zemin
>to call for new regulations to protect China’s genetic intellectual
>property rights. [Note: The regulations are now available in Chinese on the
>web site of the Science and Technology Daily [Keji Ribao] at
>http://www.stdaily.com/980926/0926b02.html]   Ongoing Gene Cooperation
>Projects Not Grandfathered
>
>  The new rules do not “grandfather” existing cooperation projects. The
>Chinese partner in existing projects must apply for approval of an ongoing
>project before a cooperation contract may be signed. The new rules, already
>in effect, may be announced to foreigners later this Fall. The highlights
>of the new rules on Chinese gene resources and international cooperation
>and the interview with a MOST drafter of the regulations which appeared in
>Beijing Youth Weekly article are translated below. The Beijing Youth
>article, entitled, “Holding Onto the Roots of the Chinese People”, is full
>of historically loaded terms like “unequal treaties” and “exploitation by
>western countries”. Many articles similar in tone appeared in the Chinese
>press during Spring 1997 are reported in “Alarm at U.S. Companies Draining
>China’s Gene Pool” on the Embassy Beijing web page at
>http://www.usembassy-china.gov/english/sandt/index.html   Comment: Chinese
>Genes and IPR Law
>
>  The human gene export ban affected the collaboration of some U.S.
>researchers and Chinese partners who are studying the genes related to
>diabetes and other genetically transmitted diseases. Some U.S. researchers
>found that they could not take samples out of China to confirm work done in
>China by their Chinese partners. The new rules, by allaying Chinese fears
>of a “gene drain” by foreigners may now make collaboration easier. Only
>experience of the implementation of the new rules will tell if that will be
>the case.   Concerns about gene IPR and unfair exploitation of suppliers of
>genetic source materials are not limited to China. The pages of journals
>such as Science carry an increasing number of gene IPR stories including
>one involving the heat-loving bacteria in Yellowstone Park Geysers, the
>U.S. National Park Service (“the exploited”) and a U.K. pharmaceutical
>company (“the exploiter”).   U.S. NIH rules require that all international
>cooperation be conducted in accordance with local government regulations.
>Discussions among Chinese and U.S. scientists and officials on this matter
>might well help resolve some of these issues. The Chinese practice of
>issuing confidential regulations and their historical sensitivities about
>exploitation by foreigners will however complicate efforts to arrange such
>discussions.      Highlights of New Rules on Human Gene IPR and
>International Cooperation
>
>  Temporary Regulations on Human Genetic Resources Management
>
>  Chapter One. General Regulations   Section One. These regulations have
>been established in order to effectively protect and utilize China’s human
>genetic resources, to strengthen human gene research, and to promote
>equitable and mutually beneficial foreign cooperation.   Section Two. The
>human genetic resources referred to in these regulations include the human
>genome, genes as well as organs, tissues, blood, and preparations made from
>the foregoing, as well as genetic materials such as DNA.   Section Three.
>All activities involving sampling, collection, study, development, buying
>and selling, export or transport beyond China’s frontiers of human genetic
>resources must conform to these regulations.   Section Four. A reporting
>and registration system shall be implemented with regard to family
>lineage’s which are important genetically as well as genetic resources
>specific to certain localities. Any person or unit which discovers a family
>lineage of genetic importance or genetic resources specific to a certain
>locality should report them immediately to the appropriate authorities. No
>work unit or individual, without proper authority, shall on the behalf of
>foreigners, sample, collect, buy and sell, export or transport beyond
>China’s frontiers or in some other fashion provide Chinese genetic
>materials to foreigners.   Chapter Two. Management Organization   Section
>Six. The State is implementing a system which manages human genetic
>resources at the varying levels of government but at the same time has a
>unified examination and approval system.   Section Seven. The science and
>technology management departments of the State Council and the Ministry of
>Health share joint responsibility for managing human genetic resources
>throughout China, and for the establishment of the Chinese Human Genetics
>Management Office to manage this work.   Chapter Three. Reporting,
>Examination and Approval   Section Eleven. Every international cooperation
>project related to Chinese human genetic material must be reported by and
>approvals obtained by the Chinese partner. Work units under the State
>Council shall make a report along the appropriate line of authority to the
>concerned departments within the State Council. Work units under the
>authority of local governments, management departments not under a higher
>level supervisory department or units under such a management department
>shall make a report to the managing department in their locality. After
>examination and approval of the application, an application is made to the
>Chinese Human Genetic Resources Management Office. Once the report has been
>examined and approved by the Office, the contract can be signed.   When the
>State Council departments or local management departments are examining an
>application for international cooperation, they should ask for the opinion
>of the managing departments in the area where the human genetic resources
>collection is to take place.   International cooperation projects begun
>before these regulations went into effect, but not yet completed, must go
>through the examination process described in these regulations. A
>supplementary report and application must made in these cases.      Holding
>Onto the Roots of the Chinese Nation: China’s “Temporary Regulations for
>the Management of Human Genetic Resources”
>
>  Beijing Youth Weekly   August 11, 1998 pp. 32 - 33   New regulations
>concerning the bodies of the Chinese people of the Twenty-First Century,
>long awaited by the Chinese medical community -- the “Temporary Regulations
>for the Management of Human Genetic Resources” have finally come out.
>Officials at the Science and Technology Ministry told journalists “This
>means that the incorporation of the management of Chinese human genome
>resources into laws and regulations is underway. These laws and regulations
>will help us more effectively protect and make use of Chinese genetic
>resources. They will also promote the development of equitable and mutually
>advantageous international cooperation so that the unique genetic resources
>of China will make greater contributions to the protection of human
>health”.   On August 3, Beijing Youth Weekly had an exclusive interview
>with one of the drafters of the new regulations.   A “Moon Landing Scale
>Project” for Human Physiology   Experts tell us that the human race only
>has one genome which is comprised of 100,000 genes. The human genome
>includes all the inherited information that determines the birth, aging,
>illness and death of the human spirit and behavior.   American scientists
>were the first to propose the human genome project. Since 1990, American
>scientists have been making a map of the entire human genome. This map has
>been called a periodic table of life by analogy to the periodic table of
>elements in chemistry. The periodic table of life is just as important. The
>goal of the human genome project is to decode all human genetic information
>by the year 2005. This will give humankind an understanding of itself at
>the molecular level. At the core of the genome mapping project is research
>aimed at determining which genes are associated with genetic diseases.  
>Chen Zhu [STC: 7115 4555], the director of the Shanghai Human Genome
>Research Center and academician of the Chinese Academy of Sciences,
>predicted that the human genome research project will greatly influence the
>development of life science and medical research, promote the development
>of life science as well as the cross-fertilization of the fields of
>information science, materials science, and high tech industries. Also
>affected will be agriculture, animal husbandry, environmental protection
>and many other fields. The effects will go even further than that, ethics
>and morals, law, economics (medical care, life insurance etc.) and other
>areas of the social sciences will also be affected. The human genome
>project will transform human social production, lifestyles, and
>environment. Just for this reason, the human genome project is called a
>“moon landing-scale project” in human physiology.   The War to Seize Genes
>Rages On   The Human Genome Project has already attracted more investment
>and more research than any other biomedical project. This 15 year, USD 3
>billion U.S. government-funded project, still just half-complete, is
>already facing a challenge from the private sector.   According to the June
>1st issue of Business Week, a private U.S. company plans to decode the
>entire human genome in three years at a cost of USD 200 million.   Seeing
>this challenge on the horizon, the largest charitable foundation in the
>biomedical industry, the Burroughs Welcome [translation note: Baowei in
>Chinese] of London, made a big investment in the U.S.-government funded
>project to prevent the results of the gene mapping project from falling
>into the hands of a private company.   The most important factor driving
>this effort, both government and private, is the prospect of the great
>benefits to be gained through this project. These prospects can only be
>realized if the genes are patented.   Gene resources are non-renewable.
>Some academics say that genes cannot be patented. Nonetheless, the
>patenting of genes is already a simple fact. Over one thousand human genes
>have been patented. Discovering a useful gene before other researchers
>means that you have gained intellectual property rights over that gene. An
>industry based on applications of that gene could provide the researcher
>with very large royalties, perhaps running into the tens of millions or
>hundreds of millions of U.S. dollars.   On July 18, 1977, Chinese
>geneticist Tan Jiazhen [STC: 6151 1367 2823] wrote a letter to Chinese
>leaders. Tan wrote that “Research on the genes which cause disease is very
>important. It has been calculated that there are about 5000 genes which
>play a role in disease. About 1500 of the genes involved in disease have
>already been found. Patents have been applied for these genes. Perhaps
>two-thirds of the disease-related genes which remain will be found within
>the next three years. A gene is a kind of wealth. Once the genetic code for
>a gene has been solved and that gene finds applications in the
>pharmaceutical industry the scientific and economic returns are enormous.
>Therefore, the “War to Seize the Genes” has already begun. If China does
>not gets its own gene patents, then in the next century China’s
>biotechnology industry and especially the pharmaceutical industry will be
>like “The Admiral of the Northern Fleet who saw all his ships capsize and
>sink beneath the waves.” Unless we were to spend a large sum of money to
>buy patents from other people, we will have no right to manufacture these
>living organisms and pharmaceuticals.”   China: A Major Gene Nation Losing
>Genes to “Unequal Treaties”   China is widely considered to be a gene-rich
>nation. Chen Zhu pointed out, “Our country has 22 percent of the world’s
>population, 56 different nationalities, and a number of genetically
>isolated groups. Many genetically isolated groups arose because of
>differences in customs that reduced or forbade intergroup marriage.”  
>“Chinese resources of populations with genetic diseases (includes
>individuals, families and groups) are the largest in the world. China has a
>wide variety of genetic diseases. China has both contagious diseases and
>some genetic diseases which appear most frequently in developing countries,
>as well as wealthy people’s diseases which appear as a result of the
>lifestyle changes brought on by development. Therefore the genomes of human
>populations of China provide a very diverse sample of human genetic
>material that is not found in many other places. Chinese populations are an
>important resource for the study of disease-related genes.   Some people
>involved in this issue say, “The rich genetic resources of China, India and
>Africa have become the target of western countries. Many work units
>visiting China or individuals, under the banner of cooperation indeed do
>plunder China’s human genetic resources. A few Chinese work units and
>individuals ignore the big picture and, in search of short-term profit,
>sign “unequal treaties” with foreign work units. Missing from these
>agreements is not only any provision for protection of intellectual
>property and production rights but any kind of actual cooperative research.
>These are just agreements to collect and provide samples for foreign
>organizations. Chinese genes are being drained away to foreign countries.” 
> Academician Tan Jiazhen wrote, “The developed countries always use the
>word “cooperation” for their activities but they do not allow Chinese to
>share in patent rights. They come to our country to collect over one
>hundred million genome samples (blood samples). China already has a serious
>gene drain problem. If China does not take action, all of China’s gene
>resources will be drained away and become simply patented genes owned by
>foreign companies”.   President Jiang Zemin wrote this comment on
>Academician Tan’s letter: “If we are not concerned about a danger when it
>is far away, we will certainly have great worries when it is near. We
>should treasure our genetic resources.”   Gene Management Rules Respond to
>the Problem at Hand   In 1996, the China Biotechnology Development Center
>made “disease-related genes” part of the 863 science and technology
>development plan.   In February 1997, the leaders involved called for
>stronger management of human genetic resources.   Later, the departments
>concerned reached agreement and drafted regulations. The draft regulations
>were revised many times are a result of advice from experts and
>departments. The draft was submitted to the State Council office. The
>regulations were issued on June 10, 1998 as State Council Office Order
>(1998) No. 36.   According to the temporary regulations, the Ministry of
>Science and Technology (MOST) and the Ministry of Health have joint
>responsibility for managing Chinese human genetic resources. The two
>ministries established the Chinese Human Heredity Resources Management
>Office [Zhongguo renlei yichuan ziyuan bangonshi] which is responsible for
>the day to day management of Chinese genetic resources. The two ministries
>also asked for experts to join expert groups to participate in the
>development of plans, the examination of projects, and technology
>evaluation. Everyone participating in activities concerned with the
>sampling, collecting, studying, developing, buying and selling, exporting,
>or transportation beyond China’s frontiers must comply with these
>regulations.   The Chinese partners in any international cooperation
>project involving Chinese human genetic resources must apply for permission
>to participate. Only after application is examined and approved can a
>contact be formally signed. Human genetic resources materials can be
>exported only if an application is made according to the temporary
>regulations. Moreover, the regulations make clear rules governing the
>reporting and registration of human genetic resources, the process involved
>in approval of export and the principles of intellectual property rights of
>human genetic resources developed in an international project.   Drafters
>of the regulations say that the purpose of “Regulations” is to protect the
>legitimate rights of the Chinese and foreign partner in cooperative
>projects. The regulations also aim to promote international cooperation and
>the reform and opening up of China. The regulations address questions
>involving the allocation and sharing of intellectual property rights. The
>regulations are a legal basis for managing human genetic resources in a
>manner consonant with China’s specific characteristics.   The “regulations”
>can be expected to, at least from a legal standpoint, intimidate those who
>would sell out China’s genetic resources. A person involved in these
>matters said that after the “temporary regulations” came into being, the
>director of a foreign gene collection project who asked about gene
>collection was told “the gene management rules” must be rigorously
>enforced.