text:
ARCHIVES HISTORIQUES
 DE LA COMMISSION
 COLLECTION RELIEE DES
 DOCUMENTS "COM"
 COM (88) 424
 Vol. 1988/0156
 ---pagebreak--- Disclaimer
 Conformément au règlement (CEE, Euratom) n° 354/83 du Conseil du 1er février 1983 concernant
 l'ouverture au public des archives historiques de la Communauté économique européenne et de
 la Communauté européenne de l'énergie atomique (JO L 43 du 15.2.1983, p. 1) modifié en dernier
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 In accordance with Council Regulation (EEC, Euratom) No 354/83 of 1 February 1983 concerning
 the opening to the public of the historical archives of the European Economic Community and the
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 In Übereinstimmung mit der Verordnung (EWG, Euratom) Nr. 354/83 des Rates vom 1. Februar
 1983 über die Freigabe der historischen Archive der Europäischen Wirtschaftsgemeinschaft und
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 Verordnung (EU) Nr. 2015/496 vom 17. März 2015 (ABI. L 79 vom 25.3.2015, S. 1), ist dieser Akt
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 ---pagebreak--- COMISSÃO DAS COMUNIDADES EUROPEIAS
 COM ( 88 ) 424 final - SYN 146
 Bruxelas , 21 de Outubro de 1988
 Proposta de
 DECISÃO DO CONSELHO
 que adopta um programa especifico de investigação
 no domínio da saúde : Medicina Predictiva - análise do genoma humano
 ( 1989-1991 )
 ( apresentada pela Comissão )
 ---pagebreak--- V
 PROPOSAL FOR A COUNCIL DECISION ADOPTING A SPECIFIC RESEARCH
 . PROGRAMME ,IN T*i& FIELD OF HEALTH i
 PREDICTIVE 'MEDICINE . V HUMAN GENOME ANALYSIS
 't . CONTENTS
 0. SUMMARY - ... 1
 1. REASONS FOR PROPOSAL t
 1 . What is Predictive Medicine ?
 1 . The scientific basis for Predictive Medicine
 1 . L The organization of genetic information :
 Mapping human genes
 1 . 22 The occurrence of genetic disease
 1 . 33 Technologies for mapping genes
 1 . 3.1
 3.1 Genetic linkage maps
 1 . 3.2
 3.2 Physical maps
 1 . 3.3
 3.3 Ordered clone libraries
 1 . 3.4
 3.4 Sequencing
 1 . 3.5
 3.5 Management of information and materials
 1 . 4i Applications of gene mapping in Predictive Medicine
 1 . 1.1
 4.1 Diagnostic applications
 1 . 1.2
 4.2 Identification of genes associated with disease
 1 . 1.3
 4.3 Gene therapy
 1. Social and ethical considérations
 2. THE PREDICTIVE MEDICINE PROGRAMME : HUMAN GENOME ANALYSIS 10
 3 . ' JUSTIFICATION OF THE CONFORMITY OF THE PROGRAMME WITH
 THE OBJECTIVES AND METHODS OF THE EUROPEAN COMMUNITY
 3.1 . Conformity with the objectives of the framework
 programme of research and technological development 12
 3.2 Justification of the scientific content of the programme :
 the international challenge and European scientific
 cohesion 13
 3.3 Relation to other Community research programmes 13
 3.4 Precompetitive nature of the research 14
 3.5 Management and évaluation 14
 4. IMPLEMENTATION AND FINANCIAL MEANS 15
 4.1 . Networks of facilities
 4.2 Research contracta 16
 4.3 Training 16
 4.4 Scientific Management 17
 4.5 Commission Staff 17
 4.6 Summary of Financial Means 17
 l/
 PROPOSAL FOR COUNCIL DECISION AND ANNEX 18
 FINANCIAL RECORD 26
 IMPACT ON SMALL AND MEDIUM-SIZED ENTERPRISES 30
 A
 ---pagebreak--- SUMMARY
 Infectious disease is no longer the major cause of illness or
 death in the Western world . Instead , much disease has a genetic
 component s it may be the result of inheritance of a single
 defective gene ( monofactorial ) or of the interaction of multiple
 ge.ie defects ( multifactorial ) with environmental factors . Many
 common and debilitating diseases such as coronary artery disease ,
 diabetes and the major psychoses*, fall into tha latter category ,
 i.e. the disease results from the exposure of genetically
 susceptible people to environmental factors . Predictive Medicine
 seeks to predict susceptibility to diseases with a view to their
 prevention and early diagnosis , as well as to improved prognosis
 and , eventually , treatment .
 The human genome is the complete set of genetic material
 ( deoxyribonucleic acid , or DNA ) which embodies the instructions
 describing each human being . It is now possible to analyse , or
 map , the genome in such a way that one can " read " these
 instructions and , in so doing , locate the genes which , when
 altered , give rise to particular diseases . Along the way it will
 be possible to make fundamental new discoveries in biology and
 acquire new technology for medicine .
 The Predictive Medicine Programme will contain the following
 strands :
 .1 improvement of the resolution of the human genetic map , i.e.
 crea tion of a map of the human genome , consisting of DNA
 7i' = i-Vers , which would enable researchers to locate genes easily
 and quickly ;
 the setting up of ordered clone libraries , i.e. of
 collections of ordered sets of DNA fragments which fully
 r-' - ^esent the DNA present in the entire genome , selected
 chromosomes or chromosomal fragments ;
 the improvement of advanced genetic technologies and , through
 a training programme , the spreading of these advanced
 technologies throughout the Member States .
 The programme is a European response to the international
 challenges presented by the large-scale biological research
 projects in the United States ( Mapping and Sequencing the Human
 Genome ) and Japan ( Human Frontier Science Programme ). Although
 it is a programme of basic precompetitive research , both new
 information and new materials of potential commercial value will
 result ? new technological processes will also be developed .
 These , will all contribute to the development of Europe 's
 biotechnology industry - often based in small and medium-sized
 enterprises .
 1 tà_n.
 ---pagebreak--- As the title implies , the content of the programme will have the
 ultimate aim of identifying genes involved in disease , with a
 view to their isolation and structural analysis .
 The enormous increase in genetic information - or rather the uses
 to which it may be put - does raise ethical questions . Aspects
 such as personal privacy must be weighed against general health
 care considerations ; the ability to diagnose disease will outrun
 the possibilities of treating it . These and many other issues
 must be given serious consideration .
 2
 ---pagebreak--- RESEARCH PROGRAMME IN THE FIELD OF HEALTH s PREDICTIVE MEDICINE-
 HUMAN GENOME ANALYSIS
 1 . REASONS FOR PROPOSAL
 1.1 WHAT IS PREDICTIVE MEDICINE ?
 Fifty years ago the principal cause of morbidity and mortality
 was infectious disease but with the discovery of antibiotics , and
 improvements in hygiene and pest control , it is now a minor one
 in industrialized countries . Apart from the consequences of
 accident or war , much disease today has a genetic component which
 may be of greater or lesser importance . Over the past few years
 a great deal has been learned about those diseases which are due
 to the inheritance of a single defective gene , though in most
 cases we are still very far from a remedy .
 However , when it comes to the common diseases such as coronary
 artery disease , diabetes , cancer , autoimmune diseases , the major
 psychoses and other important diseases of Western society , the
 position is far less clear . These conditions have a strong
 environmental component and although genetic factors are
 undoubtedly involved , they do not follow any clear-cut pattern of
 inheritance . Put another way , the disease results from the
 exposure of genetically susceptible individuals or populations to
 environmental causes ; prevention will depend on reducing the
 levels of exposure either in populations or , more probably , in
 susceptible individuals . As it is most unlikely that we will be
 able to remove completely the environmental risk factors , it is
 important that we learn as much as possible about the genetically
 determined predisposing f'cfcrs and hence identify high-risk
 individuals . In summary , Predictive Medicine seeks to protect
 individuals from the kinds of illnesses to which they are
 genetically most vulnerable and , where appropriate , to prevent
 the transmission of the genetic susceptibilities to the next
 generation .
 1.2 SCIENTIFIC BASIS FOR PREDICTIVE MEDICINE
 1.2.1 THE ORGANIZATION OF GENETIC INFORMATION :
 MAPPING HUMAN GENES
 The human genome is the complete set of genetic material -
 deoxyribonucleic acid ( DNA ) - which embodies the instructions
 describing each human being . It is now within the realms of
 possibility to " read " these instructions in their entirety and ,
 in doing so , to make fundamental new discoveries in
 biology , to learn to predict and ultimately treat genetic
 diseases , and to acquire new technology for medicine .
 Each human being has two sets of 23 chromosomes along which are
 arranged an unknown number of genes (a seguence of bases in DNA
 which codes for one protein ), the best total estimate of which is
 50,000 to 100,000 . Each gone is composed of DNA , which is a
 3
 ---pagebreak--- thread - like substance made up of nucleotides (a purine or
 pyrimidine base attached to a sugar and phosphate group ), and
 generally found as two strands wrapped around each other in the
 form of a double helix . The two strands are held together by
 bonds between base pairs of nucleotides . The linear pattern of
 nucleotides in the genome is known as the DNA sequence and its
 length is measured in base pairs of DNA . The human genome
 contains about 3,000 million base pairs .
 A variation in this hereditary set of instructions occurs when
 there is a mutation , or change in the sequence or number of
 nucleotides in one or more genes . The challenge is to find the
 genes which , having mutated , give rise to a particular disease .
 Logically , this must be achieved by first locating the position
 of the genes along the chromosomes and then defining the
 sequence of nucleotides that determine normal genetic
 characteristics ; only by defining the normal genetic structure
 can the abnormal then be recognized . Such a genetic map is the
 equivalent of a dictionary since it provides a unique ordering of
 the genes . We need only think of the problem of looking up a
 word without a dictionary or of finding a book in a library
 without a catalogue . Having access to this " human gene
 dictionary " is thus absolutely fundamental to the speed with
 which we can analyse human genetic variation and to our
 understanding of the complex ways in which genes interrelate to
 determine human development .
 1.2.2 THE OCCURRENCE OF GENETIC DISEASE
 Genetic variation giving rise to disease can be present in all
 body cells , including the germ ( egg and sperm ) cells , and can be
 transmitted from one generation to the next . Other variation is
 present only in somatic ( non-sexual ) cells and has consequences
 only for that person . Many types of cancer arise as a result of
 mutations of the latter type .
 In broad terms , disease involving inherited genetic factors can
 be divided into three categories :
 single gene defects ( monofactorial ) which show simple
 Mendelian inheritance patterns . Most of these conditions are
 rare in themselves but since there are many of them , they
 represent in total a substantial burden of disease . Currently
 some 4,200 single gene defects are recognized and manifest in
 2.5% of all liveborn in Western European populations ;
 multiple gene defects ( multifactorial ), in which multiple
 genetic and environmental factors are involved . Many common
 debilitating diseases fall into this category ;
 abnormalities of chromosome number and structure , as in Down 's
 syndrome .
 4
 ---pagebreak--- The incidence of some diseases which are due to single gene
 defects is given in Table 1 ; that of some common diseases of
 multifactorial origin is in Table 2 .
 Table 1 : Occurrence of some single gene defect diseases in
 Europe
 Disease Occurrence related to Prognosis
 number of births
 Cystic fibrosis 1 / 2,500 Life rarely
 exceeds 20 years
 Sickle cell disease 1 / 6,000 * Variable serious ¬
 ness , often lethal
 Phenylketonuria 1 / 15,000 Favourable if early
 diagnosis
 Lesch-Nyhan Syndrome 1 / 16,000 Kidney and brain
 disturbance ,
 generally lethal
 Beta-thalassemia ** Life rarely exceeds
 20 years
 Duchenne muscular 1 / 7,000 *** Myopathy after the
 dystrophy the age of four ,
 fatal outcome
 around 20 years
 Immunodef iciencies *Ar High death rate
 * Infrequent in Europeans , sickle cell disease (a haemolytic
 anaemia ) may have a frequency exceeding 1 / 100 in some African
 populations , 1 / 400 in Caribbean islanders and 1 / 2,500 in black
 Americans .
 ** Infrequent in Northern Europe , beta-thals.ssaemia ( another
 haemolytic anaemia ) is widespread in the Mediterranean basin ,
 with a maximal occurrence in Cyprus (1 to 2 / 100 ).
 *** Linked to the X chromosome , this disease occurs only in boys ,
 with a frequency of 1 / 3,500 ( 1 / 7,000 for all births ).
 **** The occurrence of genetic immunodeficiencies is low .
 Table 2 : Common chronic diseases with a multifactorial
 genetic component
 Disease Frequency Frequency in 1st
 in general degree relatives
 population of affected persons
 Peptic ulcer 1 / 25 1 / 10
 Rheumatoid arthritis 1 / 50 1 / 20
 Diabetes mellitus :
 insu lin - dependent 1 / 500 1 / 33
 in s ul in - independent 1 / 50 1 / 10
 Ischaemic heart disease < 65 yrs 1 / 50 1 / 10
 Severe manic-depressive psychosis 1 / 100 1/6
 Epilepsy ( grand mal ) 1 / 200 1 / 25
 5
 ---pagebreak--- 1.2.3 TECHNOLOGIES FOR MAPPING GENES
 There are different ways of constructing maps of the human
 genome . In its most simple form gene mapping means assigning a
 gene to a specific chromosome . The first such assignment , made
 in 1911 , was of the gene for colour-blindness to the X chromosome
 and this depended on the observation that males and not females
 were affected . In the same way . several other X-linked genes
 were discovered but some fifty years passed before the
 development of new techniques allowed the assignment of genes tc
 the other 22 pairs of chromosomes . Even then there was no way of
 locating genes whose product was unknown until , in the 1970s ,
 recombinant DNA technology provided a new approach . This
 approach , called reverse genetics , depends on first localizing a
 disease gene to a particular chromosome by its association with
 genetic markers ( identifiable regions on a chromosome ) within
 families exhibiting the disease . This process is expedited by
 the availability of genetic linkage maps for each chromosome .
 1 . 2.3.1 GENETIC LINKAGE MAPS
 A genetic linkage map shows the distance between genes , and
 other genetic markers , on the basis of the frequency with which
 they are inherited together . Genes that are close together on a
 chromosome usually stay together , or linked , during the division
 of egg and sperm cells , a process during which some parts of the
 chromosomes recombine . The distance along genetic maps ,
 represented by recombination frequency , is measured by how often
 a particular gene is inherited separately from some marker and is
 expressed in centimorgans . If a gene and a marker on the same
 chromosome are separated only 1% of the time , the distance
 between them is 1 centimorgan and this distance is on average 1
 million base pairs of DNA , although there will be major
 differences from this depending upon which chromosome region is
 under consideration . Such observations are made by studying the
 cosegregation of genetic markers within families , and very
 large pedigrees are required to establish linkage relationships
 between genetic markers with sufficient reliability . For
 example , currently about 600 individuals in 40 large families
 have been used to establish a linkage map to the 9 centimorgan
 level . An improvement to between 1 and 5 centimorgans will
 necessitate an expansion of the total number of large families by
 a further 20 .
 Recombinant DNA technology introduced a new dimension to genetic
 linkage mapping . Scientists discovered that restriction enzymes
 - the tools used to recognise a particular , short DNA sequence
 and cut it at that site - sometimes failed to cut the DNA of some
 people in the expected places . As a result , fragments of a
 different length were produced and these variations were
 inherited . Known as restriction fragment length polymorphisms
 ( RFLPs ) , they are used as reference points along the genome
 6
 ---pagebreak--- To identify RFLPs generated from very large pieces of DNA , it is
 necessary to use radioactively labelled , single-stranded
 sequences of DNA called DNA probes , which form base pairs
 ( hybridize ) with complementary sequences in the RFLP markers .
 Some useful probes for RFLP mapping are fragments of genes ,
 others are complementary to a new generation of markers ,
 "v triable number tandem repeats ", which make use of the clusters
 of repetitive DNA sequences found , in varying numbers , throughout
 the human genome .
 1.2 . 3 . 2 PHYSICAL MAPS
 A physical map of the human genome shows the actual distance ,
 measured in base pairs of DNA , between genes or markers . Various
 low resolution methods of physical mapping are known which are
 dependant upon dividing single human chromosomes into several
 fragments . However , they locate only very large pieces of DNA ,
 into which either a few or thousands of genes might fit .
 Mechanisms for finding a gene of interest in long stretches of
 DNA remain primitive .
 New methods of separation of very large DNA fragments produced by
 restriction enzymes which cut at very rare sites allow the
 construction of long-range restriction fragment maps , which have
 a considerably higher resolution and bridge the gap between the
 single gene and the entire chromosome .
 1.2 . 3 . 3 ORDERED CLONE LIBRARIES
 Development of higher resolution physical maps is extremely
 valuable in helping to locate genes of medical importance . Also ,
 for physical mapping projects , it is necessary to have access to
 large stocks of DNA and clone libraries can provide such a
 source .
 Cloning is making multiple copies of a DNA fragment by
 incorporating it into a self-replicating molecule which can then
 be introduced into a host cell . Libraries are collections of
 cloned DNA fragments from a common source . To construct a
 physical map , the order of the cloned DNA fragments relative to
 one another along the chromosomes must be known . The goal is to
 create a complete set of overlapping clones , whose order is
 known , to cover the entire human genome . Once the physical
 relationship between cloned fragments has been established , their
 nucleotide sequence can be determined .
 1.2 . 3 . 4 SEQUENCING
 The ultimate physical map will be the total DNA sequence of the
 human genome . Although it is feasible to consider sequencing the
 genome , to determine the total sequence of 3,000 million base
 pairs in a reasonable time would require a very considerable
 improvement in existing techniques .
 7
 ---pagebreak--- However , there is a case for first sequencing those regions of
 the genome which are believed to be clinically or scientifically
 important . These would include chromosome regions xn which
 clinically important genes are either expressed - i.e.
 transcribed into messenger ribonucleic acids ( mRNAs ) which are in
 turn translated into proteins - or serve some regulatory
 function . One method which has been proposed is first to sequence
 DNA copies ( cDNA ) of cellular messenger RNA transcripts , with a
 view to using that information to identify which genes are
 expressed in the genome .
 1.2.3.5 MANAGEMENT OF INFORMATION AND MATERIALS
 The production of higher resolution genetic and physical maps
 will each generate an enormous amount of data ; establishing the
 correlations between them will generate even more . In both cases
 there will also be a considerable requirement for the
 distribution and collection of materials , e.g. probes , DNA
 clones . The efficient management ( and integration ) of the
 information and of the handling of materials will be of prime
 importance , and argues for the identification of a number of
 central facilities each to become the centre of a research
 network .
 1.2.4 APPLICATIONS OF GENE MAPPING IN PREDICTIVE MEDICINE .
 1 t2.4.1 DIAGNOSTIC APPLICATIONS
 Tests for genetic disorders are generally used in prenatal
 diagnosis of abnormalities such as Down 's syndrome or in
 screening the newborn for conditions amenable to treatment , such
 as phenylketonuria . They are also used in screening adults
 ( often from particular ethnic groups ) for increased risks of
 transmitting genetic disease to the next generation - for
 instance , by identifying carriers of diseases such as sickle cell
 anaemia , beta-thalassaemia , Tay-Sachs disease , etc .
 Most of the currently available tests are based not on
 identifying the abnormal gene(s ) but on detecting the gene
 product ; hence they are limited to some 200 disorders where a
 gene product or biochemical marker is known , a small number in
 comparison to the 4,200 known single gene defects . Other
 limitations to this approach lie in the inaccessibility of some
 tissues to sampling ( eye , brain ) and the probability that the
 disease will have manifested itself - perhaps irreversibly - by
 the time that the genetic defect is detected . Tests which
 directly detect the genetic lesion in the DNA overcome many of
 these limitations .
 In the last five years , 400 or more genetic disorders have been
 mapped to a particular chromosome ; of these , some 40 have been
 defined in depth and include Huntington 's disease ( chorea ),
 cystic fibrosis and Duchenne muscular dystrophy . In each of
 these cases , a diagnosis can be made by a DNA-based test without
 knowing the gene 's product or function . Further , the test can
 be used for preclinical diagnosis of a disease of late onset
 8
 ---pagebreak--- ( such as Huntington 's ), for prenatal diagnosis and for detecting
 carrier status .
 1.2 . 4 . 2 IDENTIFICATION OF GENES ASSOCIATED WITH DISEASE
 Importantly , detection of the gene by reverse genetics can lead
 tc. our understanding its function and its role in the pathology
 of the disease concerned . Examples where this has already
 occurred include Duchenne muscular dystrophy , chronic
 granulomatous disease (a white blood cell disorder ) and
 retinoblastoma (a form of eye cancer ). It can be expected that
 in the coming years many other disease genes will be isolated ,
 including those involved in such disorders as colon carcinoma and
 severe mental retardation . The availability of a higher
 resolution genetic linkage map would simplify considerably the
 identification of the genes involved in many common diseases
 which , as mentioned above , are caused by multiple gene defects .
 Computational methods exist which permit the subpartitioning of
 genetic linkage data and identification of those genes
 contributing to multiple gene detects .
 This information , when combined with that derived from
 overlapping clone libraries , will permit the rapid isolation and
 structural analysis of the genes concerned . Improved prediction
 of disease susceptibility will result . One of the most important
 disease categories is that involving heart and vascular disease .
 1.2.4.3 GENE THERAPY
 It is hoped that eventually it may be possible to correct a
 defective gene by inserting normal DNA directly into a cell - a
 process known as gene therapy . This ultimately depends on the
 discovery of safe methods of inserting the DNA and of a means of
 ensuring that the DNA corrects the target defect without
 producing any other adverse effects . Gene mapping will not have
 any direct effect on the prospects for gene therapy but the
 knowledge gained about the function of genes may have an
 indirect benefit .
 1.3 SOCIAL AND ETHICAL CONSIDERATIONS
 Information about human genetic make-up will increase enormously
 in the course of mapping the human genome ; simpler , faster and
 less costly methods of screening for genetic susceptibility to
 disease will be developed . This will provide the possibility of
 therapeutic intervention to prevent the manifestations of
 disease . As genes are identified which are associated with an
 increased risk of common diseases , such as heart disease ,
 diabetes and arthritis , population screening will become a
 possibility . In Western Europe , where there is a steadily ageing
 population and an associated ever-increasing cost of health care ,
 the prospects both of cheaper testing and of earlier intervention
 making possible a decrease in morbidity are very attractive ones .
 This enormous increase in genetic information does raise ethical
 questions . Improvements in diagnosis and risk prediction will
 9
 ---pagebreak--- inevitably precede the development of therape -. tic remedies ,
 creating a growing gap between diagnosis and treatment . The
 information about an individual 's genetic const ! tut icv will be
 more precise , more detailed and more easily obtained ; it will
 benefit individuals by informing them about health risks but it
 could also be used to their detriment by third parties such as
 employers or insurance companies . Further ethical considerations
 wiil arise from the increased range of prenatal diagnoses which
 will become easily available - parents may seek to choose the
 sex of their children , for instance . These questions do not
 arise directly from the information which is collected but from
 the uses to which it is put . This implies that , independently of
 the technical possibilities and benefits offered by human genome
 analysis , it is vital that politicians and Society as a whole
 consider seriously the dilemmas presented . Aspects such as
 personal privacy , including the right of the individual to know
 or not to know , must be weighed against general health care
 considerations .
 Dialogue and information transfer on the social consequences and
 ethical aspects of such research will be organised , in a
 systematic manner , with the various interested parties .
 There is a unanimous opinion that , also for ethical reasons ,
 there must be a rejection of any possibility of modifying the
 genetic constitution of human germ cells , even for purely
 therapeutic reasons ; this topic will be excluded from this
 European Community research programme .
 2. THE PREDICTIVE MEDICINE PROGRAMME : HUMAN GENOME ANALYSIS
 The framework programmed ) originally stated that the technical
 content of the Predictive Medicine Programme would " mainly be
 oriented towards better knowledge of the human genome , immunity
 techniques ( applicable to cancer , autoimmune diseases ,
 infections ), genetic engineering processes aiming at repairing
 DNA defects ( e.g. in congenital diseases of genetic origin ) and
 development of diagnostic test kits ( e.g. for AIDS)” . Since a
 choice has to be made , it seems appropriate to concentrate
 endeavours on definition of the human genome .
 The programme will have these aims :
 1) To achieve a high-resolution genetic map ( at 1 to 5
 centimorgan level ) of the human genome . This will require an
 increase from 40 to 60 in the number of large families currently
 under study in Europe , the extra 20 , where possible , to be
 families known to have a genetic modification of medical
 interest ; the setting up of a network of 10 to 15 European
 laboratories with both the interest in and the capability of
 working with material from these families ; the establishment of
 1 Framework Programme for Community Activities in the field of
 Research and Technological Development ( 1987-1991 ).
 OJ N° L 302 , 24.10.1987 , p. 1-23 .
 10
 ---pagebreak--- one or two centres which would provide DNA prepared from the
 families to the members of the collaborating network , and also
 maintain and distribute to them a collection of the necessary
 probes ; and consideration of the role of computing facilities
 both to enable participants to handle the collection and
 reduction of these data and also to carry out the preparation of
 ths map .
 2) To set up collections of ordered DNA clones either from the
 entire genome or from selected chromosomes . These ordered clone
 libraries , which might be produced in several centres , will
 require the establishment of facilities for maintaining the
 stocks of cloned DNA fragments , and for distributing DNA - free
 of charge - to a network of European laboratories interested in
 matching genetic material to these cloned fragments . A related
 project could be the sequencing of cDNA clones isolated
 independently and mapping them with an ordered clone library .
 3) To improve advanced genetic technologies , with the further
 aim of spreading them more evenly among European laboratories .
 Examples are : production of new biochemical reagents ( restriction
 enzymes ), procedures for labelling DNA probes , amplification of
 genes , vectors for the transfer of human genes , methods of
 cloning long DNA segments , development of software to help
 sequencing , development of new strategies for sequencing , and
 creation of overlapping clone banks . The best way to support
 this kind of work is by research contracts , with priority given
 to collaborations between laboratories in different Member States
 working on a common subject , and also to those where there is
 participation by industrial laboratories . Communication between
 the contracting laboratories will be so managed as to achieve a
 collaborative research network .
 In the process of improving the genetic map and creating the
 ordered clone libraries , due attention will be given to those
 chromosomes or chromosome regions known to contain the genes
 responsible for specific genetic diseases , especially where this
 will optimize the use of existing family material . There is also
 a need to learn more about the location and function of the
 currently unknown groups of genes involved in the multi ¬
 factorial disorders which form the major part of the burden of
 disease and where risk prediction is particularly important . A
 pragmatic approach will be adopted to maintaining a suitable
 balance between these objectives , and to avoiding unnecessary
 overlaps with other genome analysis programmes .
 A European pilot network for the prevention of one particular
 disease taken as a model would be a valuable goal for medical
 research in the Community , but this kind of project would need
 careful preparation ( both in choice of target and of methods ),
 and the setting up of a large-scale programme would be premature .
 However , the Predictive Medicine Programme could support the
 organization of a collaborative action for the preparation of a
 more detailed project . The development of an extensive European
 network might be an objective for the follow-up to this
 11
 ---pagebreak--- programme . Diseases of particular interest in this respect might
 be cystic fibrosis and phenylketonuria .
 3. JUSTIFICATION OF THE CONFORMITY OF THE PROGRAMME WITH THE
 OBJECTIVES AND METHODS OF THE EUROPEAN COMMUNITY
 3.1 CONFORMITY WITH THE OBJECTIVES OF THE FRAMEWORK PROGRAMME OF
 RESEARCH AND TECHNOLOGICAL DEVELOPMENT
 The Predictive Medicine Programme involves both technological
 research and training actions which will contribute to the
 achievement of many of the aims listed in the framework
 programme .
 1) The activity " Quality of life” includes the Predictive
 Medicine Programme in its " Health " line . This aspect is obvious ,
 because the development of Predictive Medicine will decrease the
 prevalence of many diseases which are very distressing for the
 patient and his family , ( incapacitating or painful chronic
 diseases , often with a fatal outcome ), as well as being socially
 very expensive for the Community .
 2) The goal " to promote scientific research and technological
 development at Community level in order to strengthen the
 scientific and technological basis of its industry " is also
 explicitly addressed by the programme , which aims to promote
 advanced technologies with a high added value ( e.g. DNA probes
 for diagnostic kits ). Informed estimates of the potential
 European market for DNA probes in the next decade suggest that it
 is worth between 1,000 and 2,000 million ECU /year .
 3) The goal of " participation of small and medium-sized
 enterprises " will also be met because most of the high
 technology enterprises which are able and willing to collaborate
 in the programme are in this category .
 4 ) The goal of " harmonious development of the Community with a
 view to strengthening its economic and social cohesion " is
 especially important in this field , where the state of scientific
 development differs widely between Member States . The provision
 of a large number of grants for intra-Community exchanges of
 scientists , together with obligatory trans-national
 collaboration , will aim at promoting greater contact between
 individual scientists and at technology transfer to the currently
 less advanced laboratories in Member States .
 For the future , a follow-up to this programme might include the
 launching of a large-scale operation concerning one of the main
 diseases of children ( coordinated action including research ,
 forecasting , prevention and treatment ). This would be the best
 way to convince Europeans in general that the creation of a
 " Europe of health " is not merely a matter of public relations but
 a living reality .
 12
 ---pagebreak--- 3.2 JUSTIFICATION OF THE SCIENTIFIC CONTENT OF THE PROGRAMME :
 THE INTERNATIONAL CHALLENGE AND EUROPEAN SCIENTIFIC
 COHESION
 The justification of the scientific content of the programme was
 set out in the discussion of the scientific basis for Predictive
 Mv.dicine ( cf . 1.2 ). It is argued that the ability to understand
 normal genetic function , and hence to recognize the abnormal and
 then predict disease susceptibility , rests on having access to a
 " human gene dictionary ", i.e. a detailed map of the position of
 the genes on the chromosomes . This involves improvement of the
 genetic map and the physical map , and the setting-up of ordered
 clone libraries of the human genome - in the short-term perhaps
 of either selected chromosome regions or genes . The total
 sequencing of the genome , which is the next logical step , is
 still a remote goal because existing techniques are too slow to
 allow the sequencing of the 3,000 million base pairs in an
 acceptable time ; a start could , however , be made on sequencing
 the cDNA .
 The Predictive Medicine Programme would thus enable Europe to
 accept the challenge of remaining a vital international
 scientific force in human genetics .
 The United States ( US ) report " Mapping and Sequencing the Human
 Genome " ( 2 ) is a wide-ranging plan which includes the genetic map ,
 the physical map , an ordered DNA clone library and , ultimately ,
 sequencing . This impressive and prestigious programme - it has
 been compared to the " Apollo " project in the field of space - has
 captured the imagination of many scientists and politicians . For
 Japan , the " Human Frontier Science Programme " is a proposal for
 an international research programme in basic biology and the
 development of associated key technologies . At the time of
 writing the content of this programme has not been agreed , but it
 may well include a commitment to human genome analysis and / or the
 development of fast automatic DNA sequencing equipment .
 Whatever view one may have of these projects , the European
 Community cannot remain indifferent . Furthermore , in the case of
 the American programme , active European participation is
 explicitly sought . The Predictive Medicine Programme provides the
 means for Europe to participate in an exciting project in one of
 the most advanced sectors of biological research .
 3.3 RELATION TO OTHER COMMUNITY PROGRAMMES OF RESEARCH
 Within the framework programme , the Predictive Medicine Programme
 will be coordinated with the following specific Community
 programmes of research and technological development , in order to
 avoid overlap and to ensure coherence of research efforts :
 2 " Mapping and Sequencing the Human Genome ", Report of the Board
 of Basic Biology Commission on Life Sciences , National Research
 Council . National Academy Press Publisher , Washington D.C. , 1988 .
 13
 ---pagebreak--- The " Medical and Health Research " Programme 1987-1991 , and
 especially its area 1.1.4 " Early detection and diagnosis of
 Cancer " which is closely related to the genetic field
 through the topic of oncogenes . Both programmes f orm an
 important part of the " Europe against Cancer " Programme ,( ^ ) .
 The " Advanced Informatics in Medicine in Europe " ( AIM )
 programme , especially its Action Line II " Strengthening
 Europe 's position in Medical and Bioinformatics ( MBI ) and
 health care ", which could give support for the development of
 effective communication and information processing within the
 proposed networks .
 The biotechnology programmes , especially the programme
 BRIDGE , being prepared at present , with which it would be
 carefully coordinated in respect of expression vectors , gene
 transfer and , more generally , the genetic engineering of
 animal and human cells .
 The " Environmental Protection " Programme , especially its
 research areas : " Environment and Human Health " and " Genetic
 Effects of Environmental Chemicals ".
 The " Radiation Protection " Programme , especially its
 mutagenesis area .
 The " Stimulation " Programme , especially its
 " Biocommunication " area .
 The programme will also benefit from synergy with other
 activities of the Community in the field of Information
 Technology and Telecommunication ( IT&T ).
 3.4 PRECOMPETITIVE NATURE OF THE RESEARCH
 The programme is one of basic precompetitive research . However ,
 both new information and new materials of potential commercial
 value will result . It is generally agreed that all the mapping
 and sequence information should be freely available but that
 associated technological developments - of instruments ,
 equipment , reagents or software - should be protected in the
 usual way by patents , copyright , etc .
 3.5 . MANAGEMENT AND EVALUATION
 The existing CGC on Medical and Health Research should deal with
 the Predictive Medicine Programme and will advise the Commission
 in the manner defined in the Council decision creating CGCs . The
 programme will be submitted to evaluation procedures in
 accordance with the " Community plan of action relating to the
 3 Decision of the Council and of the representatives of Member
 States of 7 July 1986 , concerning an action programme of the
 European Communities against cancer . O.J. N° C 184 , 23.7.87 , p.19 .
 14
 ---pagebreak--- evaluation of Community research and development activities "^).
 The CGC may wish to obtain specialized advice and meet in
 variable configurations ; it may also wish to set up a Working
 Party to advise the Commission on the management of the
 Predictive Medicine Programme .
 4 . IMPLEMENTATION AND FINANCIAL MEANS
 After the approval of the Medical and Health Research Programme ,
 15 million ECU remain on the sub-activity " 1.1 Health " of the
 framework programme for the implementation of the Predictive
 Medicine Programme . Four main chapters of expenditure are
 proposed , for two networks ( human genetic map and ordered clone
 library of the human genome ), research contracts for work in
 advanced genetic technologies , and training grants . In addition
 there would be overheads and staff expenses . The indicative
 budget distribution is :
 CHAPTER MODE OF ACTION BUDGET
 ( Million ECU )
 Improvement of the human Support to a network of 4.0
 genetic map centralized facilities
 Ordered clone library As above 4.0
 Research on advanced Research contracts 3.5
 genetic technologies :
 e.g. reagents ( restriction
 enzymes ), gene detection , gene
 vectors , cloning , computer
 software , cDNA cloning and
 sequencing .
 Grants ( particularly post - Grants 2.5
 doctoral , 100 scientist-years )
 Scientific management , including 0.45
 eva luation
 Staf f 0.55
 TOTAL 15.0
 4.1 . NETWORKS OF FACILITIES
 Progress with the human genetic map and the creation of ordered
 clone libraries of the human genome will be achieved most
 effectively by building on existing laboratories through the
 creation of networks . Efficient management , both of information
 and of biological materials , will be of prime importance for both
 4 Communication to the Council concerning a Community plan of
 action relating to the evaluation of Community research and
 development activities for the years 1987 to 1991 .
 0 . J . N " C 14 , 20.1.87 , p. 5 .
 15
 ---pagebreak--- actions , and it is proposed therefore to identify a central
 laboratory in each case to act as the focus for management , i.e.
 to become the centre of a network of laboratories .
 Four million ECU will be used for the development of a European
 network for the improvement of the human genetic map , and another
 four million ECU for setting up a network of laboratories
 concerned with an ordered clone library of human DNA . These sums
 amount to approximately 10% of the sums suggested in the report
 of the US Office of Technology Assessment as appropriate for the
 US Human Genome Project . Although modest , at least in the
 exploratory phase of these activities , Europe 's contribution to
 the international effort will be a significant one .
 4 .2 RESEARCH CONTRACTS
 The basic research on advanced genetic technologies in the
 programme will be funded through cost-shared and marginal cost
 contracts with public and private institutions in the Member
 States . The contribution to research contract funding from the
 Community budget is estimated at 3,500,000 ECU . This figure is
 based on an estimate of 20 research contracts on advanced
 technologies , of about 150,000 to 200,000 ECU per contract ( for
 three years ) according to the size of the project . It corresponds
 to the expected response from European laboratories in the field .
 In the selection process , priority will be given to proposals
 involving a number of Member States and /or participation by
 private enterprises . The management of communication between the
 various contracting laboratories will be a first step towards the
 establishment of a European network in molecular genetics .
 Although the sum involved in each contract may seem small , the
 impact will be amplified by the complementarity of the programme
 to national research efforts . It should be noted that no single
 European country would be able to develop the complete range of
 research facilities and networks described above .
 4.3 . TRAINING
 An average estimate of the requirements for training in the
 period under consideration is about 100 scientist-years , i.e.
 2,500,000 ECU . Two aspects deserve special consideration :
 (i) Steps must be taken to ensure that those Member States which
 currently lack a capability in the techniques of modern
 molecular genetics are given the opportunity to acquire it ;
 ( ii ) Only if there are very compelling reasons will scientists be
 permitted to train outside the proposed European networks ;
 in order to smooth the path for the transfer of technology ,
 and for the return of the individual newly-trained
 scientist , it is expected that 30 to 50% of such a
 scientist 's time will be spent introducing the new
 techniques into his own laboratory setting .
 16
 ---pagebreak--- 4.4 . SCIENTIFIC MANAGEMENT
 Budgetary provision of 450,000 ECU is considered necessary for
 the external scientific management of the programme . This
 assessment , based upon an analysis of current annual needs in
 similar programmes , covers the expenses of meetings ,
 p<-. •. ticipation in symposia , travel and subsistence costs of
 experts and Commission staff , visits to laboratories
 participating in the programme ( two visits to each contracting
 laboratory , i.e. about 50 visits in the course of the programme ),
 and the convening of six workshops during the same period . Funds
 are also included for the preparation of a follow-up to the
 present programme ( studies and preparatory meetings ) which might
 include inter alia the setting up , as mentioned previously , of a
 large network of research , forecasting , prevention and treatment
 for one of the major genetic diseases of children .
 The cost for scientific management amounts to 3% of the total
 budget requested for the programme , including the cost of
 evaluation .
 4.5 COMMISSION STAFF
 Expenditure of 550,000 ECU for a staff of two is considered
 necessary for the execution of the programme . This estimate
 includes new staff only , i.e. one official of category A ( 93,000
 ECU /year ) and one of category C ( 37,000 ECU /year ), inflation
 being estimated at 4% per year ; this estimate includes only the
 minimal requirements necessary for the management of the
 programme .
 4.6 SUMMARY OF FINANCIAL MEANS
 ( Million ECU )
 Networks of facilities 8.0
 Research contracts 3.5
 Training 2.5
 Scientific management 0.45
 Staff 0.55
 TOTAL 15.00
 ---pagebreak--- PROPOSTA DE DECISÃO DO CONSELHO
 que adopta um programa de investigação
 e desenvolvimento tecnológico no domínio da saúde :
 Medicina Predictiva - análise do genoma humano ( 1989-1991 )
 0 CONSELHO DAS COMUNIDADES EUROPEIAS ,
 Tendo em conta o Tratado que institui a Comunidade Económica Europeia , nomeada¬
 mente , o nQ 2 do seu artigo 130Q Q,
 Tendo em conta a proposta da Comissão ( 1 ),
 Em cooperação com o Parlamento Europeu ( 2 ),
 Tendo em conta o parecer do Comité Económico e Social (3 ),
 Considerando que o artigo 130Q K do Tratado estabelece que será aplicado um
 programa-quadro através de programas especificos , desenvolvidos no âmbito de
 cada actividade ;
 Considerando que , pela sua Decisão de 28 de Setembro de 1987 (4 ), o
 Conselho adoptou um programa-quadro de investigação e desenvolvimento tecnoló¬
 gico da Comunidade ( 1987-1991 ), no qual prevê actividades no domínio da saúde ,
 Considerando que , para a avaliação de cada programa especifico e para a selec -
 ção de acções comunitárias , o programa-quadro estabelece critérios entre os
 quais se encontra a contribuição para o reforço da coesão económica e social da
 Comunidade , em conjungação com a procura de qualidade cientifica e técnica ;
 ( 1 ) JO nû
 ( 2 ) JO nû
 ( 3 ) JO nQ
 ( 4 ) JO nû L 302 , de 24.10.87, p. 1 .
 Ù
 ---pagebreak--- - 2 -
 Considerando que dois programas plurianuais sucessivos de investigação e forma ¬
 ção para a Comunidade Económica Europeia no domínio da biotecnologia ( 5 ), o úl ¬
 timo dos quais ainda a decorrer , demonstraram a possibilidade e a utilidade de
 uma acçâo comunitária para promover a utilização da biologia moderna para fins
 científicos e industriais ;
 Considerando que o programa de biotecnologia actualmente em curso não inclui
 alguns domínios de investigação importantes para a saúde do homem e a qualidade
 de vida , para o desenvolvimento industrial da biotecnologia para fins médicos e
 para o controlo do aumento das despesas sociais e de saúde ;
 Considerando que o programa-quadro prevê no ponto 1.1 . " Saúde " da sua acção
 "Qualidade de vida " o " Inicio de novas actividades relacionadas com o desenvol ¬
 vimento da medicina predictiva ;
 Considerando que , em consequência , é unanimemente aceite a necessidade de um
 programa especifico de investigação e desenvolvimento tecnológico no domínio
 da medicina predictiva e que , em especial , é necessário :
 desenvolver as tecnologias de base respeitantes ao estudo do genoma humano
 como requisito prévio para um grande número de desenvolvimentos em biotecno
 logia para a saúde e para garantir a ampla distribuição dessas tecnologias
 pelos laboratórios europeus , e
 melhorar a resolução do mapa genético humano e aperfeiçoar o mapa fisico
 através da criação de bibliotecas organizadas de clones como base para lo¬
 calizar genes de importância médica e para uma melhor compreensão global
 da função de gene ;
 Considerando que , para atingir os objectivos supracitados , é necessário efectuar
 acções a nivel comunitário no sentido de :
 prencher algumas lacunas existentes no conhecimento cientifico e tecnológi ¬
 co , as quais constituem um obstáculo ao pleno desenvolvimento dos recursos
 da biotecnologia moderna no dominio da medicina , e
 promover , através de acções concertadas entre laboratórios públicos e pri ¬
 vados , a cooperação europeia transnacional com o objectivo de acelerar a
 aplicação de tecnologias já disponíveis , promovendo simultaneamente áreas
 cientificas europeias que favorecerão novas abordagens a desenvolver ;
 Considerando que o Comité de Investigação Cientifica e Técnica ( CREST ) foi con
 sultado sobre estas medidas ,
 ( 5 ) JO nQ L 375 , de 20.12.1981 , p. 1 .
 JO nQ L 83 , de 25.3.1985 , p. 1 .
 ---pagebreak--- - 3 -
 - ADOPTOU A PRESENTE DECISÃO :
 Artigo 1Q
 É adoptado por um período de três anos , a partir de 1 de Janeiro de 1989, um
 programa especifico de investigação e desenvolvimento tecnológico para a Comu¬
 nidade Económica Europeia no domínio da Medicina Predictiva - análise do genoma
 humana, tal . como definido no Anexo .
 Artigo 22
 0 montante considerado necessário para a execução do programa é de 15
 milhões de ECUs , incluindo despesas com um efectivo de duas pessoas .
 Artigo 32
 0 Anexo Técnico estabelece as disposições pormenorizadas para a execução do
 programa .
 Artigo 4Q
 1. No segundo ano de execução do programa, a Comissão efectuará a sua revisão,
 cujos resultados comunicará ao Conselho, e ao Parlamento Europeu , conjunta ¬
 mente , se for caso disso , com quaisquer propostas de alteração ou prolon¬
 gamento .
 2. Será efectuada uma avaliação dos resultados obtidos por peritos independen¬
 tes , a qual será publicada sob a forma de comunicação ao Conselho e ao Par¬
 lamento Europeu .
 3. Os relatórios supracitados serão pst^bel^cidps tendo. emt conta os objectiuos e os cri ¬
 térios de avaliação fixados no Anexo II da presente decisão e em conformidade com as disposi ¬
 ções do nQ 2 do artigo 22 do programa-quadro .
 Artigo 52
 1. A Comissão é responsável pela execução do programa e será assistida pelo
 Comité Consultivo de Gestão e Coordenação ( CGC ) no domínio da Investigação
 Médica e de Saúde , instituído pela Decisão 84 /338 / EURATOM / CECA / CEE (6 ).
 2. Os contratos celebrados pela Comissão regulamentarão os direitos e obriga¬
 ções de cada parte e , em especial , os métodos de divulgação , protecção e
 exploração dos resultados da investigação .
 ( 6 ) JO n2 L 177 de 4.7.1984 , p. 25 .
 20
 ---pagebreak--- 4
 Artigo 6Q
 A Comissão está autorizada a negociar , em conformidade com o artigo 130Q N do
 Tratado CEE , acordos com países não comunitários e organizações internacional s ,
 em especial com os países não comunitários participantes na Cooperação Europeia
 no domínio da Investigação Cientifica e Técnica ( COST ) e com os países que
 concluíram acordos-quadro de cooperação cientifica e técnica com a Comunidade ,
 a fim de os associar plena ou parcialmente ao programa .
 Artigo 7Q
 Os Estados-membros são destinatários da presente decisão .
 Feito em 1988
 Pelo Conselho
 0 Présidente
 2 'Ζ
 ---pagebreak--- 5
 ANEXO
 para um programa espec-ffico de investigação no domínio da saúde :
 Medicina Predictiva - análise do genoma humano
 1. OBJECTIVOS
 Utilização e aperfeiçoamento de novas biotecnologias para a previsão de riscos
 mIn^Ór iC° precoce' Prevenção, prognóstico e tratamento de algumas doenças hu¬
 manas e para uma melhor compreensão da hereditariedade .
 2. CONTEÚDO
 Investigação comunitária pré-competitiva , estabelecimento e reforço de redes de
 laboratórios europeus e formação destinada a permitir a utilização da biotecno¬
 logia moderna para aperfeiçoar a previsão de riscos, diagnóstico precoce, pro¬
 gnóstico e tratamento de algumas doenças humanas (em especial , as doenças here¬
 ditárias e o cancro ).
 2.1 . APERFEIÇOAMENTO DO MAPA GENÉTICO DO HOMEM
 Estabelecimento de uma rede de alcance mundial situada na Europa para a recolha
 de grandes familias de ADN com vista ao fornecimento gratuito a investigadores
 de material genético bem caracteri zado e de um conjunto de sondas para determi ¬
 nar a localização das posições relativas de genes nos cromossomas . Possível
 fornecimento de instalações informáticas para o tratamento dos dados .
 2.2 . ESTABELECIMENTO DE UMA BIBLIOTECA ORGANIZADA DE CLONES DE ADN HUMANO
 Estabelecimento de uma rede europeia de laboratórios que efectuem trabalho de
 estabelecimentp de bibliotecas de clones abrangentes e de apoio à sequenciação
 limitada de ADNc .
 2.3 . INVESTIGAÇÃO SOBRE 0 APERFEIÇOAMENTO DE TECNOLOGIAS GENÉTICAS AVANÇADAS
 Novos reagentes bioquímicos ( enzimas de restrição , etc .). Aperfeiçoamento dos
 métodos de detecção e localização de marcadores genéticos ( técnicas de rotula -
 gem de sondas de ADN , amplificação de genes , etc .). Desenvolvimento de novos
 sectores para a clonagem de grandes fragmentos de ADN e de processos de trans-
 dução de cromossomas . Desenvolvimento de sistemas modelo para a expressão
 reprodutível e estável de genes importantes do ponto de vista médico tanto
 in vivo como in vitro . Desenvolvimento de novo suporte lógico para a recolha e
 tratamento de dados de sequenciação e mapas de genomas .
 2.4 . FORMAÇÃO
 Estabelecimento de um programa de formação para dar apoio , conjuntamente com a
 transferência de tecnologia de métodos de genética molecular , aos Estados-membros
 em que estas técnicas se encontram actualmente pouco desenvolvidas e , em especial ,
 a transf erência de técnicas para a área clínica .
 ---pagebreak--- - 6 -
 3. EXECUÇÃO
 O programa será executado através de contratos de acções a custos repartidos ou
 de custos marginais , apoio a instalações e redes centralizadas , contratos de for_
 mação , subsídios de formação , cursos , consultas con peritos nacionais , organiza ¬
 ção de reuniqes de grupos de estudo , participação em seminários e simpdsios e
 publicações .
 A participação da Comissão pode variar desde cerca de 50 % para os contratos a
 custos repartidos e pode elevar -se a 100 % noutros casos .
 Os participantes podem ser instituições de investigação , universidades , empresas
 privadas ou combinações das mesmas , localizadas em Estados-membros ou nos países
 terceiros referidos no artigo 6Q .
 Os projectos devem ser executados por participantes provenientes de mais de um
 país e incluir , pelo menos , um participante de um Estado-membro .
 ---pagebreak--- - 7-
 CRITÉRIOS DE AVALIAÇÃO
 O plano de acção comunitária respeitante à avaliação dos programas comunitários
 de investigação e desenvolvimento ( 7 ) previ que os marcos e objectivos de cada
 programa de investigação sejam estabelecidos de forma verificável e , se
 for caso disso, quantitativa . Esses critérios são os seguintes :
 1. 0 objectivo a longo prazo do presente programa consiste em contribuir para
 a luta contra as doenças humanas decorrentes da variação genética ( incluin¬
 do doenças genéticas sensu stricto e muitas doenças comuns com uma componen^
 te genética , tais como doenças cardiacas e o cancro ), através da previsão
 dos riscos , diagnóstico precoce , prevenção , aperfeiçoamento de prognóstico
 e , por último, terapia . A Comissão propõerse atingir este objectivo através
 de :
 - gestão de uma rede de laboratórios estabelecida em torno de instalações
 europeias para : a ) o aperfeiçoamento do mapa genético humano e b ) o es¬
 tabelecimento de bibliotecas ordenadas de clones de ADN humano , quer do
 genoma completo quer de cromossomas" escolhidos , conjuntamente com a se¬
 quência de ADNc ;
 - lançamento de um programa de contratos de investigação pré-competitiva
 sobre tecnologia genética avançada ;
 - estabelecimento de um programa de formação para o aumento da distribuição
 de modernas tecnologias genéticas e para melhorar o conhecimento tecnológico
 nos laboratórios europeus .
 2. 0 principal objectivo a curto prazo consiste no estabelecimento, por inter¬
 médio do programa , das redes europeias de laboratórios anteriormente refe¬
 ridas nos seguintes domínios :
 - mapa genético humano
 - bibliotecas organizadas de clones de ADNchumanoi e sequenciação de ADNc
 - tecnologias genéticas avançadas .
 Estes objectivos devem ser verificados em 1990-1991 .
 3. Os objectivos específicos a alcançar no espaço de três anos de duração do pro¬
 grama são os seguintes :
 3.1 Respeitantes ao mapa genético humano :
 - o total actual de 40 grandes famílias bem estudadas , as quais formam a
 base do mapa genético , deve ser aumentado para 60 famílias ;
 (7 ) JO nQ C 14 de 20.1.87 , p. 5 .
 24
 ---pagebreak--- - 8 -
 - o material genético dessas famílias e as sondas de ADN devem, ser gratui ¬
 tamente postos à disposição dos laboratórios europeus interessados ;
 - deve ser estabelecida uma instalação central para apuramento de resulta ¬
 dos e elaborar um mapa genético aperfeiçoado ao nível de 1 a 5 centimorgan .
 3.2 As estratégias para o estabelecimento de bibliotecas organizadas de clones
 de ADN humano devem ser comparadas com uma abordagem definida , devem ser
 estabelecidas instalações para a manutenção de existências de fragmentos
 clonados de ADN e os clones disponíveis elevem ser enviados gratutitamente
 aos laboratórios europeus interessados .
 3.3 Devem ser obtidos aperfeiçoamentos significativos nas seguintes tecnologias
 genéticas avançadas :
 - Novos reagentes , tais como enzimas de restrição ,
 - Metodologia para clonagem de grandes fragmentos de ADN e para a transdução
 de cromossomas ,
 - Vectores de genes adaptados a células humanas in vitro ,
 - Metodologia para a detecção de um gene especifico numa célula ( exemplos :
 como tornar mais fácil a utilização de sondas de ADN e a amplificação de
 genes ) ,
 - Localização , clonagem e sequenciação de novos genes , especialmente os re ¬
 lacionados com doenças ,
 - Novo suporte lógico para armazenar , reunir e analisar dados de sequências
 de ADN .
 4. Além disso , o programa deve corresponder aos seguintes critérios :
 4.1 Durante a execução do programa , devem ser tidos em devida consideração
 os aspectos éticos complexos da genética humana , evitando quaisquer riscos
 para o ambiente .
 4.2 Os desenvolvimentos de carácter médico devem ser real ou potencialmente
 favorecidos pelos resultados obtidos .
 4.3 Devem ser obtidas oportunidades potenciais para desenvolvimentos comerciais .
 4.4 0 nivel tecnológico global dos laboratórios europeus participantes deve ter
 aumentado .
 4.5 Tendo em conta os resultados de actividades de investigação comunitários
 no sector público ou privado no dominio da genética humana , o grupo de
 avaliação determinará se o Programa de Medicina f¥edictiva contribuiu
 para a aplicação dos resultados das referidas actividades noutras regiões
 da Comunidade que não aquelas em que a investigação foi realizada .
 2 S
 ---pagebreak--- 1
 FINANCIAL RECORD
 PREDICTIVE MEDICINE PROGRAMME
 1. RELEVANT BUDGET HEADING
 - Post : Line 7312
 - Title : Specific research and technological development
 programme in the field of health - Predictive Medicine .
 2. LEGAL BASIS
 Article 130 of the Treaty ,
 Council Decision .
 3 . DESCRIPTION OF ACTION AND OBJECTIVES
 3 . 1 Description
 Community programme (1 January 1989-31 December 1991 ) for
 research and training in predictive medicine , carried out by
 means of implementation of laboratory networks , research and
 training contracts , consultancies by experts , organization
 of workshops , contribution to symposia , and studies .
 3 . 2 Objectives
 The objectives of the programme are the following : Community
 research and technological development in molecular genetics
 to achieve a better understanding of genetic disease and
 hence improve the prospects for diagnosis and therapy .
 4 . JUSTIFICATION OF ACTION
 The choice of predictive medicine as one of the targets for
 Community efforts in health matters takes into account three
 elements :
 - The priority to be given to advanced technologies , and
 particularly to modern biotechnologies , the importance of
 which for European economic development is an indisputable
 fact .
 - The seriousness of the human and social aspects of some
 diseases - in particular the common diseases which result
 from a combination of genetic factors interacting with the
 environment .
 - The economic importance of health expenditure , which is
 constantly increasing in Europe and is a serious problem
 for the governments involved .
 26
 ---pagebreak--- 2
 These three elements come together in the definition of a
 research action programme in the field of biotechnologies to be
 applied to predictive medicine : this field covers diseases often
 of long duration , socially expensive and very distressing in
 hu nan terms , where it is now possible to anticipate their early
 decoction . This will lead to their prevention and eventual
 treatment , through using the resources of modern biotechnology
 while stimulating European industry .
 5 . FINANCIAL INCIDENCE OF ACTION ON EXPENDITURES
 ( including costs for staff and expenses for administrative
 and technical management )
 Million ECU
 5.1 . Total cost over the whole of the expected duration 30
 5.2 . Participation in funding :
 - From the Community budget 15
 - From national budgets and other sectors
 at national level 15
 5.3 . Multiannual Schedule of Commitment Appropriations and
 Payments from the Community budget
 5.3.1 . Commitment Appropriations
 1989 1990 1991 TOTAL
 Staff 0.14 0.20 0.21 0.55
 Administration 0 . 20 0.12 0.13 0.45
 Contracts and
 training grants 1.66 6 . 68 5.66 14 . 00
 Total 2.00 7 . 00 6.00 15 . 00
 5.3.2 . Payments
 1989 1990 1991 1992 1993 TOTAL
 Staff 0.14 0.20 0.21 _ _
 0.55
 Administration 0.20 0.12 0.13 - -
 0.45
 Contracts and
 training grants 0.46 2.98 5.36 4 . 10 1.10 14 . 00
 Total 0.80 3.30 5.70 4 . 10 1 . 10 15 . 00
 27
 27
 ---pagebreak--- 3
 5.3.3 . Methods of calculation
 5 . 3 . 3.1 . Staff expenditure
 The staff requirements for the implementation of this programme
 are :
 1 category A staff , (*)
 1 category C staff . (*)
 The above-mentioned calculation of staff expenses is based on the
 following annual figures for 1989-1991 : 93,000 ECU for an A post ,
 37,000 ECU for a C post , inflation being allowed for at 4% per
 year . Expenditure for missions of Commission staff , for national
 experts and auxiliary staff are also included under this heading .
 5 . 3 . 3 . 2 . Expenditure for administrative and technical operation
 This heading covers the expenses of meetings , participation in
 symposia , and travel and subsistence costs of experts , as well as
 the publication and dissemination of results and information ,
 together with the cost of scientific and technical assistance
 whenever it proves necessary for the implementation of the
 programme .
 5 . 3 . 3 . 3 . Expenditure in respect of contracts
 The budget foreseen for contracts and training grants ( 14 million
 ECU ) should permit the conclusion of research and development
 contracts ( for a total amount of 11.5 million ECU ) with an
 average length of 2.5 years ( the duration of the programme being
 three years , but allowance being made for the period of the call
 for proposals and the period of administrative negotiation ), and
 for a variable amount according to the subject of the research .
 With regard to training contracts and the short-term training
 grants , the method of calculation is based upon an average cost
 of 29,000 ECU per year per scientist . It is foreseen that
 approximately 20-22 training contracts and 10-15 short-term
 training grants will be allocated each year . The total amount
 devoted to training actions will be 2.5 million ECU .
 6. Financing of expenditure
 The appropriations required to cover the Community 's contribution
 to this project are to be entered in the Community 's future
 budgets .
 (*) 6 months in 1989 .
 28
 ---pagebreak--- 4
 Type of Control
 Administrative control by the Director-General for
 Financial Control ( DG XX ) as regards budget
 implementation , and by the Contracts Division of DG XII .
 Scientific Control by the responsible officials in
 DG XII assisted by the CGC .
 Audit by the Court of Auditors in accordance with the
 provisions of the Treaty .
 Evaluation in accordance with the Community plan of
 action * See also the Evaluation Criteria in the Annex
 to the Council Decision .
 Financial Record
 Summary
 Action : Research and technical development in
 Predictive Medicine .
 Expenses Staff
 ( Million ECU ) ABC
 ( Number of posts )
 TOTAL : 15 . 1-1 .
 29
 ---pagebreak--- STATEMENT ON THE IMPACT ON SMALL AND MEDIUM-SIZED ENTERPRISES ,
 COMPETITIVENESS AND EMPLOYMENT
 Although not primarily aimed either at the support of small and
 medium-sized enterprises or at the solution of the problems of
 industrial competitiveness and employment , the Predictive
 Medicine Programme should nevertheless have some positive results
 in this respect :
 1. The improvement in advanced genetic technologies should
 lead to worthwhile developments :
 The production of new reagents ( such as restriction
 enzymes ) could provide a good opportunity for the
 commercialization of high added value substances .
 The obtaining of new DNA probes , and the
 simplification of their practical use , should permit
 the development of new diagnostic kits . Informal
 estimates of the potential market for DNA probes in
 the next decade in Europe indicate that it is worth
 between 1,000 and 2,000 million ECU/year .
 New techniques for gene amplification might also give
 rise to development of commercial kits .
 2. Most of the high technology enterprises which are both
 able and willing to collaborate belong to the category
 of small and medium-sized enterprises , and should be
 stimulated by the implementation of the programme .
 3. In the longer term , the Predictive Medicine Programme
 can be considered as a valuable contribution to an
 alternative approach to the problem of steadily
 increasing health expenditure in European society , and
 this should ultimately result in an increase in the
 competitiveness of the Community .
 30


type: contracts

jurisdiction: EU

text:
 11.3.2010
 NL
 Publicatieblad van de Europese Unie
 L 62/45
 BESLUIT VAN HET GEMENGD COMITÉ VAN DE EER
 Nr. 147/2009
 van 4 december 2009
 tot wijziging van bijlage XVIII (Gezondheid en veiligheid op het werk, arbeidsrecht en gelijke behandeling van mannen en vrouwen) bij de EER-overeenkomst
 HET GEMENGD COMITÉ VAN DE EER,
 Gelet op de Overeenkomst betreffende de Europese Economische Ruimte, gewijzigd bij het Protocol tot aanpassing van de Overeenkomst betreffende de Europese Economische Ruimte, hierna „de Overeenkomst” genoemd, en met name op artikel 98,
 Overwegende hetgeen volgt:
 (1)
 Bijlage XVIII bij de Overeenkomst werd gewijzigd bij Besluit nr. 51/2009 van het Gemengd Comité van de EER van 24 april 2009 (1).
 (2)
 Richtlijn 2004/113/EG van de Raad van 13 december 2004 houdende toepassing van het beginsel van gelijke behandeling van mannen en vrouwen bij de toegang tot en het aanbod van goederen en diensten (2) moet in de Overeenkomst worden opgenomen,
 BESLUIT:
 Artikel 1
 In bijlage XVIII bij de Overeenkomst wordt na punt 21b (Richtlijn 2006/54/EG van het Europees Parlement en de Raad) het volgende punt ingevoegd:
 „21c.
 32004 L 0113: Richtlijn 2004/113/EG van de Raad van 13 december 2004 houdende toepassing van het beginsel van gelijke behandeling van mannen en vrouwen bij de toegang tot en het aanbod van goederen en diensten (PB L 373 van 21.12.2004, blz. 37).
 Voor de toepassing van deze Overeenkomst worden de bepalingen van de richtlijn als volgt gelezen:
 In de artikelen 5 en 7 worden de verwijzingen naar „21 december 2007” gelezen als „30 juni 2010”.”.
 Artikel 2
 De in het EER-supplement bij het Publicatieblad van de Europese Unie bekend te maken teksten in de IJslandse en de Noorse taal van Richtlijn 2004/113/EG zijn authentiek.
 Artikel 3
 Dit besluit treedt in werking op 5 december 2009, op voorwaarde dat alle in artikel 103, lid 1, van de Overeenkomst bedoelde kennisgevingen aan het Gemengd Comité van de EER hebben plaatsgevonden (3).
 Artikel 4
 Dit besluit wordt bekendgemaakt in het EER-gedeelte van en in het EER-supplement bij het Publicatieblad van de Europese Unie.
 Gedaan te Brussel, 4 december 2009.
 Voor het Gemengd Comité van de EER
 De voorzitster
 Oda Helen SLETNES
 (1) PB L 162 van 25.6.2009, blz. 32.
 (2) PB L 373 van 21.12.2004, blz. 37.
 (3) Grondwettelijke vereisten aangegeven.
 Gemeenschappelijke verklaring van de overeenkomstsluitende partijen bij Besluit nr. 147/2009, waarbij Richtlijn 2004/113/EG in de Overeenkomst wordt opgenomen
 „Richtlijn 2004/113/EG is gebaseerd op artikel 13 van het EG-Verdrag dat is ingevoegd bij het Verdrag van Amsterdam en niet in de EER-overeenkomst is opgenomen. Het feit dat Richtlijn 2004/113/EG in de EER-overeenkomst wordt opgenomen, doet geen afbreuk aan het toepassingsgebied van deze Overeenkomst.”


type: wikipedia

text:
13. veebruar on Gregoriuse kalendri 44. päev. Juliuse kalendri järgi 31. jaanuar (1901–2100).
 Sündmused
 Eestis
 1567 – Liivi sõda: toimus Ruunavere lahing. Harjumaal Ruunavere veski lähedal toimunud Poola ja Rootsi teenistuses olnud kohalike mõisameeste lahingus jäid võitjaks Poola poolel võidelnud, kes võidu järel rüüstasid nii Lääne- kui ka Harjumaad kuni Tallinna lähisteni.
 1809 – Tallinna saksa teater alustas tegevust.
 1919 – Eesti Vabadussõda: Rahvavägi alustas lõunarindel uusi pealetunge, et tõrjuda venelane Eesti piiridest kaugemale. Eestimaale jõudis Rootsi vabatahtlike väegrupp, kuhu kuulus 178 meest, ning kelle juhiks oli major Carl Axel Mothander.
 1920 – Asutav Kogu ratifitseeris Tartu rahulepingu.
 1920 – Vabariigi Valitsus nimetas Henrik Koppeli Tartu Ülikooli rektoriks.
 1922 – Varssavis sai alguse 17. veebruarini kestnud Soome, Eesti, Läti ja Poola välisministrite konverents. Sõlmitud lepingud pidid aluse panema Balti liidule, kuid Soome vastuseisu tõttu see ei realiseerunud.
 1928 – Sankt Moritzi taliolümpiamängud: sel päeval võistlesid kiiruisutajad Christfried Burmeister ja Aleksander Mitt. Kahe mehe parim koht oli 15.
 1931 – Eesti Spordileht avaldas 1930. aasta parimate sportlaste nimekirja, mis koostati rahvahääletuse tulemusena. Aasta sportlaseks valiti kergejõustiklane Elmar Rähn 856 häälega.
 1940 – Sõjaväe Kõrgem Kohus mõistis Nõukogude Liidu spiooni Aleksei Brovkini kaheks kuuks vanglasse; see oli teadaolevalt viimane Eestis toimunud Nõukogude Liidu spioonide protsess.
 1959 – asutati Välismaaga Sõpruse ja Kultuurisidemete Arendamise Ühing.
 1966 – Eesti NSV Riiklik Noorsooteater andis J. Tombi nimelises Kultuuripalees oma esimese etenduse "Otsustage meie üle, inimesed!" (autorid Aleksandr Andrejev ja Mikk Mikiver).
 1992 – sõlmiti Eesti-Soome vabakaubanduse kokkulepe.
 1994 – NATO Põhja-Euroopa töörühma delegatsioon saabus Eestisse.
 1996 – Riigikogu eestvõttel moodustati erikomisjon rublamüügi asjaolude väljaselgitamiseks.
 1996 – Eesti Filmiajakirjanike Ühing valis aasta parimaks filmiks Priit Pärna ja Janno Põldma joonisfilmi "1895".
 1999 – Tallinna ööklubis Hollywood toimus rootslaste algatusel suur kaklus.
 2003 – asutati Sihtasutus Tartu Vaimse Tervise Hooldekeskus
 2007 – Tallinna Ülikooli uueks rektoriks sai Rein Raud, kelle ametiaeg algas 15. mail.
 Maailmas
 1542 – Inglismaa kuningas Henry VIII käskis hukata kuninganna Catherine Howardi, keda süüdistati abielurikkumises.
 1633 – Galileo Galilei vahistati Roomas katoliku inkvisitsiooni poolt.
 1668 – Hispaania tunnustas Lissaboni lepinguga Portugali iseseisvust.
 1689 – Oranje Willem ja tema abikaasa Mary II said Inglismaa, Šotimaa ja Iirimaa valitsejaiks.
 1692 – Glencoe veresaun: Inglise väed tapsid Glencoe all hulgaliselt šoti mägilasi, kes ei vandunud kuningas William III-le truudust.
 1741 – ilmumist alustas esimene Ameerika Ühendriikide ajakiri The American Magazine, or a Monthly View of the Political State of the British Colonies.
 1858 – kapten John Speke ja Sir Richard Burton avastasid esimeste eurooplastena Aafrikas asuva Tanganjika järve.
 1861 – Mõlema Sitsiilia kuningas Francesco II alistus Gaeta lähedal Giuseppe Garibaldi juhitud vägedele.
 1895 – vennad Lumiere'id patenteerisid Pariisis kinematograafi.
 1945 – Teine maailmasõda: liitlasväed vallutasid Budapesti.
 1945 – Teine maailmasõda: algas Dresdeni pommitamine.
 1946 – ÜRO Peaassamblee võttis vastu resolutsiooni ÜRO Raadio asutamise kohta.
 1960 – Prantsusmaa korraldas Alžeerias Sahara kõrbes oma esimese tuumapommikatsetuse.
 1968 – USA viis 10 000 sõdurit Vietnami, kus lahingud olid ägenenud.
 1974 – dissident ja kirjanik Aleksander Solženitsõn saadeti välja Nõukogude Liidust ning temalt võeti ära riigi kodakondsus.
 1980 – Lake Placid'is algasid 24. veebruarini toimunud XIII taliolümpiamängud.
 1984 – Konstantin Tšernenko valiti NLKP KK peasekretäriks ning riigipeaks.
 1988 – Calgarys algasid 28. veebruarini kestnud XV taliolümpiamängud.
 1989 – Nõukogude-Afganistani sõda: Nõukogude Liidu väed lahkusid Afganistani pealinnast Kabulist.
 1990 – Suurbritannia, Nõukogude Liit, Prantsusmaa ja Ida- ning Lääne-Saksamaa leppisid kokku järgnevad läbirääkimised Saksamaa taasühendamise kohta.
 1991 – Ameerika Ühendriikide lennukid purustasid Bagdadis asunud punkri, mida esialgu peeti sõjaliseks objektiks. Hiljem selgus, et tegu oli elamuga, hukkus eri allikate väitel 50–500 tsiviilisikut.
 1992 – Ford Motor Co. teatas oma suurimast – 2,3 miljardi USA dollari suurusest kahjumist.
 1993 – Angola valitsusväed ründasid UNITA sisside valduses olevat mägismaad, mille eesmärgiks oli avada ühendustee Huambo linnaga.
 1994 – Somaalia sissid röövisid kaht Itaalia humanitaartöötajat ning mõrvasid ÜRO rahuvalvaja.
 1995 – Peruu valitsus deklareeris, et riigi relvajõud olid vallutanud viimase Peruu territooriumil asuva Ecuadori sõjaväebaasi – kuulutati välja ühepoolne vaherahu.
 1997 – USA Dow Jonesi indeks tõusis esmakordselt üle 7000 punkti.
 1998 – Aafrika rahukaitseväed, mida juhtis Nigeeria, alustasid Sierra Leone sõjaväelise valitsuse kukutamist, hõivates pealinna Freetowni parlamendihoone.
 2004 – Asutati Kia Motorsi esimene tehas Euroopas – Kia Motors Slovakia.
 Sündinud
 1769 – Ivan Krõlov, vene kirjanik
 1805 – Peter Gustav Lejeune Dirichlet, saksa matemaatik
 1873 – Fjodor Šaljapin, vene ooperilaulja
 1882 – Tadeusz Banachiewicz, Poola astronoom ja matemaatik
 1903 – Georges Simenon, belgia kirjanik
 1910 – William Bradford Shockley, USA füüsik, Nobeli auhind 1956
 1912 – Harald Riipalu, eesti sõjaväelane
 1933 – Kim Novak, ameerika filminäitleja
 1934 – George Segal, ameerika näitleja
 1937 – Enn Soosaar, eesti tõlkija
 1937 – Rupiah Banda, Sambia poliitik ja diplomaat
 1944 – Heino Lill, eesti korvpallur ja korvpallitreener
 1950 – Peter Gabriel, inglise muusik
 1960 – Pierluigi Collina, itaalia jalgpallikohtunik
 1961 – Henry Rollins, ameerika muusik
 1972 – Virgilijus Alekna, leedu kergejõustiklane
 1974 – Robbie Williams, briti poplaulja
 1980 – Sebastian Kehl, saksa jalgpallur
 1984 – Eveli Saue, eesti laskesuusataja
 Surnud
 1883 – Richard Wagner, saksa helilooja
 1905 – Konstantin Savitski, vene maalikunstnik ja pedagoog
 1952 – Josephine Tey, šoti kirjanik
 1991 – Gunnar Hultgren, rootsi vaimulik
 1997 – Viivi Timm, eesti zooloog ja hüdrobioloog
 2006 – Sir Peter Strawson, briti filosoof
 2006 – Kunnar Allikvee, eesti fotograaf ja pedagoog
 Pühad
 Rahvusvaheline raadiopäev
 Ilmarekordid
 Tallinna maksimumtemperatuur +6,5 °C (1925)
 Tallinna miinimumtemperatuur –30,0 °C (1977)
 Tartu maksimumtemperatuur +5,3 °C (1974)
 Tartu miinimumtemperatuur –31,5 °C (1871)
 Viited
 Veebruar 13


type: legislation

text:
 7.2.2017
 SK
 Úradný vestník Európskej únie
 L 32/15
 VYKONÁVACIE NARIADENIE KOMISIE (EÚ) 2017/200
 z 1. februára 2017
 o zatriedení určitého tovaru do kombinovanej nomenklatúry
 EURÓPSKA KOMISIA,
 so zreteľom na Zmluvu o fungovaní Európskej únie,
 so zreteľom na nariadenie Európskeho parlamentu a Rady (EÚ) č. 952/2013 z 9. októbra 2013, ktorým sa ustanovuje Colný kódex Únie (1), a najmä na jeho článok 57 ods. 4 a článok 58 ods. 2,
 keďže:
 (1)
 S cieľom zabezpečiť jednotné uplatňovanie kombinovanej nomenklatúry, ktorá tvorí prílohu k nariadeniu Rady (EHS) č. 2658/87 (2), je potrebné prijať opatrenia týkajúce sa zatriedenia tovaru uvedeného v prílohe k tomuto nariadeniu.
 (2)
 V nariadení (EHS) č. 2658/87 sa stanovili všeobecné pravidlá na interpretáciu kombinovanej nomenklatúry. Tieto pravidlá sa takisto uplatňujú na akúkoľvek inú nomenklatúru, ktorá sa na kombinovanej nomenklatúre celkovo alebo čiastočne zakladá alebo ktorá k nej pridáva akékoľvek ďalšie rozdelenie a ktorá je stanovená v osobitných ustanoveniach Únie s ohľadom na uplatňovanie colných a iných opatrení vzťahujúcich sa na obchod s tovarom.
 (3)
 Podľa uvedených všeobecných pravidiel by sa tovar opísaný v stĺpci 1 tabuľky uvedenej v prílohe mal zatriediť pod číselný znak KN uvedený v stĺpci 2 na základe odôvodnenia uvedeného v stĺpci 3 danej tabuľky.
 (4)
 Je potrebné umožniť, aby sa držiteľ záväzných informácií o nomenklatúrnom zatriedení tovaru vydaných v súvislosti s tovarom, na ktorý sa vzťahuje toto nariadenie, ktoré nie sú v súlade s týmto nariadením, mohol na tieto informácie aj naďalej odvolávať počas určitého obdobia v súlade s článkom 34 ods. 9 nariadenia (EÚ) č. 952/2013. Toto obdobie by malo byť stanovené na tri mesiace.
 (5)
 Opatrenia stanovené v tomto nariadení sú v súlade so stanoviskom Výboru pre colný kódex,
 PRIJALA TOTO NARIADENIE:
 Článok 1
 Tovar opísaný v stĺpci 1 tabuľky uvedenej v prílohe sa zatriedi v rámci kombinovanej nomenklatúry pod číselný znak KN uvedený v stĺpci 2 tejto tabuľky.
 Článok 2
 Na záväzné informácie o nomenklatúrnom zatriedení tovaru, ktoré nie sú v súlade s týmto nariadením, je možné odvolávať sa aj naďalej v súlade s článkom 34 ods. 9 nariadenia (EÚ) č. 952/2013 počas troch mesiacov odo dňa nadobudnutia účinnosti tohto nariadenia.
 Článok 3
 Toto nariadenie nadobúda účinnosť dvadsiatym dňom po jeho uverejnení v Úradnom vestníku Európskej únie.
 Toto nariadenie je záväzné v celom rozsahu a priamo uplatniteľné vo všetkých členských štátoch.
 V Bruseli 1. februára 2017
 Za Komisiu
 v mene predsedu
 Stephen QUEST
 generálny riaditeľ
 Generálne riaditeľstvo pre dane a colnú úniu
 (1) Ú. v. EÚ L 269, 10.10.2013, s. 1.
 (2) Nariadenie Rady (EHS) č. 2658/87 z 23. júla 1987 o colnej a štatistickej nomenklatúre a o Spoločnom colnom sadzobníku (Ú. v. ES L 256, 7.9.1987, s. 1).
 PRÍLOHA
 Opis tovaru
 Zatriedenie
 (číselný znak KN)
 Odôvodnenie
 (1)
 (2)
 (3)
 Elektrický prístroj, ktorý používa digitálne rozhlasové vysielanie (DAB) a technológiu frekvenčnej modulácie (FM) na príjem rádiového vysielania. Celkové rozmery prístroja sú približne 115 × 180 × 120 mm a je schopný prevádzky bez vonkajšieho zdroja energie.
 Prístroj je vybavený zabudovaným reproduktorom, profilom Bluetooth/A2DP (Advanced Audio Distribution Profile) [ktorý prístroju umožňuje bezdrôtový prenos zvuku zo zvukových reprodukčných zariadení (napr. z MP3 prehrávačov), ktoré sú tiež vybavené profilom Bluetooth/A2DP], vstupom na pripojenie slúchadiel a vstupom na pripojenie vonkajšieho napájania.
 8527 19 00
 Zatriedenie je určené všeobecnými pravidlami 1 a 6 na interpretáciu kombinovanej nomenklatúry, poznámkou 3 k XVI triede a znením číselných znakov KN 8527 a 8527 19 00 .
 Prístroj okrem funkcie príjmu rádiového vysielania prijíma, konvertuje a prenáša údaje (prostredníctvom profilu A2DP), pričom táto funkcia spadá do položky 8517 (pozri vykonávacie nariadenie Komisie (EÚ) 2016/2224 (1)). Prístroj sa teda nemôže kombinovať s prístrojmi na reprodukciu zvuku (funkcia položky 8519 ).
 Prístroj sa má preto zatriediť ako rozhlasový prijímač, nekombinovaný s prístrojom na reprodukciu zvuku, pod číselný znak 8527 19 00 .
 (1) Vykonávacie nariadenie Komisie (EÚ) 2016/2224 z 5. decembra 2016 o zatriedení určitého tovaru do kombinovanej nomenklatúry (Ú. v. EÚ L 336, 10.12.2016, s. 22).


text:
 EUROPSKA KOMISIJA
 Bruxelles, 3.6.2019.
 COM(2019) 262 final
 Prijedlog
 ODLUKE VIJEĆA
 o stajalištu koje u ime Europske unije treba zauzeti u Vijeću Svjetske carinske organizacije u vezi s preporukom Svjetske carinske organizacije o izmjeni Harmoniziranog sustava iz članka 16.
 OBRAZLOŽENJE
 1.
 Predmet prijedloga
 Ovaj se prijedlog odnosi na odluku o utvrđivanju stajališta koje u ime Unije treba zauzeti u Vijeću Svjetske carinske organizacije u vezi s predviđenim donošenjem nacrta preporuke u pogledu izmjene nomenklature Harmoniziranog sustava (HS).
 2.
 Kontekst prijedloga
 2.1.
 Međunarodna konvencija o Harmoniziranom sustavu nazivlja i brojčanog označivanja robe
 Cilj je Međunarodne konvencije o harmoniziranom sustavu nazivlja i brojčanog označavanja robe („Sporazum”) olakšavanje međunarodne trgovine te prikupljanje, usporedba i analiza statističkih podataka, a posebno onih o međunarodnoj trgovini. Prilog Sporazumu uključuje nomenklaturu HS-a, to jest međunarodni harmonizirani sustav kojim se zemljama sudionicama omogućuje da na zajedničkoj osnovi u carinske svrhe razvrstaju robu kojom se trguje. Nomenklatura HS-a konkretno uključuje opise robe navedene pod tarifnim brojevima i podbrojevima na temelju sustava šesteroznamenkastih oznaka. Nomenklatura HS-a revidira se svakih pet godina
 1
 . Primjenjuje je više od 190 uprava diljem svijeta; stoga je više od 98 % ukupne robe kojom se u svijetu trguje razvrstano u skladu s tom nomenklaturom.
 Sporazum je stupio na snagu 1. siječnja 1988.
 Europska unija i sve njezine države članice stranke su Sporazuma
 2
 .
 2.2.
 Svjetska carinska organizacija (WCO)
 Svjetska carinska organizacija (WCO), osnovana 1952. kao Vijeće za carinsku suradnju, neovisno je međuvladino tijelo čija je misija poboljšati djelotvornost i učinkovitost carinskih uprava. Svojim članicama WCO nudi niz konvencija i drugih međunarodnih instrumenata, kao i tehničku pomoć i usluge osposobljavanja. WCO danas predstavlja 182 carinske uprave diljem svijeta.
 Upravno tijelo WCO-a je Vijeće, koje se za ostvarivanje svoje misije oslanja na stručnost i sposobnosti Tajništva i niza tehničkih i savjetodavnih odbora.
 Tehnički odbor koji je u okviru WCO-a zadužen za pripremne poslove povezane sa Sporazumom jest Odbor za HS. Glavne su zadaće Odbora za HS sljedeće:
 ·osiguravanje ujednačenog tumačenja i primjene pravnih tekstova Harmoniziranog sustava, među ostalim i rješavanjem sporova o razvrstavanju među ugovornim strankama, čime se olakšava trgovina,
 ·predlaganje izmjena i ažuriranja Harmoniziranog sustava kako bi se u obzir uzeli tehnološki razvoj i promjene u trgovinskim tokovima te druge potrebe korisnika Harmoniziranog sustava,
 ·promicanje raširene primjene Harmoniziranog sustava i razmatranje općih pitanja i pitanja politike koja se na njega odnose.
 Vijeće WCO-a razmatra prijedloge izmjena Sporazuma koje je pripremio Odbor za HS te ih može preporučiti ugovornim strankama. Izmjene koje preporučuje Vijeće WCO-a smatraju se prihvaćenima ako nijedna ugovorna stranka ne uloži prigovor u roku od šest mjeseci od zaprimanja izmjena.
 Stajališta koja Unija treba zauzeti u WCO-u u pogledu HS-a usklađuju se s državama članicama. Unija i njezine države članice zajedno imaju samo jedan glas u Vijeću WCO-a.
 2.3.
 Predviđeni akt Vijeća WCO-a
 Na svojoj 133. i 134. sjednici (koje će se održati u razdoblju od 27. do 29. lipnja 2019.) Vijeće WCO-a treba donijeti preporuku o izmjeni nomenklature Harmoniziranog sustava iz članka 16. Konvencije o HS-u („predviđeni akt”). Revidirana nomenklatura HS-a stupit će na snagu 2022.
 Preporuka je pripremljena tijekom 63. sjednice Odbora za HS, koja je održana od 19. do 29. ožujka 2019.
 Nacrt preporuke uključuje 355 skupova izmjena nomenklature HS-a s ciljem odražavanja promjena u trgovinskim tokovima, tehnološkog razvoja te potreba za modernizacijom ili prilagodbom nomenklature njezinu okruženju. Predložene su izmjene posebno namijenjene sljedećem:
 –pojednostavnjivanju nomenklature brisanjem tarifnih brojeva i podbrojeva kojima se rijetko trguje, čineći time Harmonizirani sustav ažurnim i usklađenim s razvojem proizvoda,
 –olakšavanju razvrstavanja u skladu s primjenjivim međunarodnim standardima ili uzimajući u obzir nove proizvode ili razvoj sastava proizvoda (proizvodi za staničnu terapiju, 3D pisači, ravni pokaznici, jogurti, prehrambeni proizvodi od kukaca, djevičansko maslinovo ulje, novi duhanski proizvodi, dronovi, poluvodiči i pretvornici itd.),
 –boljem usklađivanju francuske i engleske verzije nomenklature radi osiguravanja jedinstvene primjene i smanjenja postojećih ili mogućih razlika u razvrstavanju,
 –pospješivanju borbe protiv prijevara i nezakonite trgovine te zaštite zdravlja i okoliša uvođenjem tarifnih brojeva i podbrojeva u različita područja (sintetički dijamanti, kemikalije, kulturna dobra, fentanil, otpad itd.).
 Prijedloge su predstavili Tajništvo WCO-a, ugovorne stranke i međunarodne organizacije (Kimberley Process, FAO, Baselska i Rotterdamska konvencija, Međunarodno vijeće za maslinovo ulje itd.). Nekoliko tih izmjena predložio je EU (na primjer fotoosjetljive i termoosjetljive ploče, laminirane tkanine, brodice na napuhavanje, tkanine s ugrađenom elektronikom, staklena vlakna, 3D pisači, vatrostalna keramika, kovački strojevi, jogurt, napomena 3. uz poglavlje 27, savitljive olovke).
 Nacrt preporuke priložen je izvješću sa 63. sjednice Odbora za HS održane u ožujku 2019. kao Prilog R (dokument NC2626B1b-HSC/63/March 2019).
 3.
 Stajalište koje treba zauzeti u ime Unije
 Cilj je predloženog stajališta izraziti potporu nacrtu preporuke u pogledu izmjene nomenklature Harmoniziranog sustava.
 Donošenje takve preporuke važno je za EU jer se njome želi ažurirati i modernizirati nomenklatura HS-a te pojednostavniti i olakšati razvrstavanje proizvoda. Važno je napomenuti i da je veliki doprinos toj modernizaciji dao EU jer je podnio veliku većinu prijedloga u tom pogledu u ovom ciklusu revizije.
 Savjetovanja s državama članicama provodila su se neprekidno unutar carinske stručne skupine za koordinaciju HS-a/WCO-a i unutar Vijeća te prema potrebi sa službama Komisije.
 Kad je riječ o izmjeni koja se odnosi na nove duhanske proizvode, stajalište EU-a utvrđeno je odlukom Vijeća prije navedene sjednice Odbora za HS
 3
 . Budući da je odluka Vijeća odstupala od prijedloga Komisije, Komisija je dala izjavu
 4
 u kojoj je podsjetila da je u tijeku rad u okviru Okvirne konvencije Svjetske zdravstvene organizacije o nadzoru nad duhanom u pogledu prirode emisija novih duhanskih proizvoda te da će se to pitanje, ako se pojave novi dokazi bitni za ocjenjivanje objektivnih karakteristika i svojstava takvih proizvoda u carinske svrhe, možda morati riješiti u kasnijoj fazi.
 Predloženo je stajalište stoga sljedeće:
 –kad je riječ o preporuci, Unija treba poduprijeti njezino donošenje,
 –Unija isto tako treba poduprijeti daljnje uredničke izmjene koje bi prema potrebi moglo predložiti Tajništvo WCO-a.
 Predloženo stajalište EU-a u skladu je s utvrđenom carinskom politikom i sudskom praksom Suda Europske unije za razvrstavanje robe pri uvozu u skladu s njezinim objektivnim karakteristikama i svojstvima.
 Predloženo stajalište nužno je kako bi EU mogao izraziti stajalište na sljedećoj sjednici Vijeća WCO-a.
 4.
 Pravna osnova
 4.1.1.
 Načela
 Člankom 218. stavkom 9. Ugovora o funkcioniranju Europske unije (UFEU) predviđeno je donošenje odluka kojima se utvrđuju „stajališta koja u ime Unije treba donijeti tijelo osnovano na temelju sporazuma kada je to tijelo pozvano donositi akte koji proizvode pravne učinke, uz iznimku akata kojima se dopunjuje ili mijenja institucionalni okvir sporazuma”.
 Pojam „akti koji proizvode pravne učinke” obuhvaća akte koji proizvode pravne učinke na temelju pravila međunarodnog prava kojima se uređuje predmetno tijelo. Obuhvaća i instrumente koji nemaju obvezujući učinak na temelju međunarodnog prava, ali mogu „presudno utjecati na sadržaj propisa koje donese zakonodavac Unije”
 5
 .
 Stoga je postupovna pravna osnova predložene odluke o utvrđivanju stajališta koje treba zauzeti u ime Unije i u vezi s predviđenim aktom članak 218. stavak 9. UFEU-a.
 4.1.2.
 Primjena u predmetnom slučaju
 Vijeće WCO-a tijelo je osnovano na temelju Sporazuma, konkretno na temelju Konvencije o osnivanju Vijeća za carinsku suradnju od 15. prosinca 1950. U skladu s Međunarodnom konvencijom o Harmoniziranom sustavu nazivlja i brojčanog označivanja robe, to je tijelo odgovorno za izdavanje preporuka ugovornim strankama o izmjenama te Konvencije.
 Očekuje se da će Vijeće WCO-a, u skladu s člankom 16. Konvencije o HS-u, na svojem lipanjskom sastanku preporučiti strankama HS-a izmjenu Priloga navedenoj Konvenciji (nomenklatura HS-a), koja će se smatrati prihvaćenom u roku od šest mjeseci ako se tome ne usprotivi neka od ugovornih stranaka. Prihvaćene izmjene obvezujuće su na temelju međunarodnog prava za sve ugovorne stranke jednom kada stupe na snagu, a carinska/statistička nomenklatura svake ugovorne stranke mora se uskladiti s izmijenjenim Harmoniziranim sustavom. Nakon prihvaćanja, preporuka će biti uključena u zakonodavstvo EU-a, konkretno u: Prilog 1. Uredbi Vijeća (EEZ) br. 2658/87 o tarifnoj i statističkoj nomenklaturi i o Zajedničkoj carinskoj tarifi. Razlog je tome to što je u članku 2. točki (a) te uredbe navedeno: „2. Kombinirana nomenklatura obuhvaća: (a) nomenklaturu harmoniziranog sustava;”.
 Predviđenim aktom ne dopunjuje se niti mijenja institucionalni okvir Sporazuma.
 Stoga je postupovna pravna osnova za predloženu odluku članak 218. stavak 9. UFEU-a.
 4.2.
 Materijalnopravna osnova
 4.2.1.
 Načela
 Materijalnopravna osnova odluke na temelju članka 218. stavka 9. UFEU-a prije svega ovisi o cilju i sadržaju predviđenog akta o kojemu se zauzima stajalište u ime Unije. Ako predviđeni akt ima dva cilja ili dva elementa te ako se može utvrditi da je jedan od tih dvaju ciljeva ili elemenata glavni, a drugi samo sporedan, odluka na temelju članka 218. stavka 9. UFEU-a mora se temeljiti na samo jednoj materijalnoj pravnoj osnovi, to jest onoj koju zahtijeva glavni ili prevladavajući cilj ili element.
 4.2.2.
 Primjena u predmetnom slučaju
 S obzirom na to da se glavni cilj i sadržaj predviđenog akta odnosi na carinsku uniju, materijalnopravna osnova predložene odluke jest članak 28. stavak 1. UFEU-a.
 4.3. Zaključak
 Pravna osnova predložene odluke trebao bi biti članak 28. stavak 1. UFEU-a u vezi s člankom 218. stavkom 9. UFEU-a.
 5.
 Utjecaj na proračun
 Prijedlog ne utječe na proračun Europske unije.
 6.
 Objava predviđenog akta
 Ne primjenjuje se.
 2019/XXX (NLE)
 Prijedlog
 ODLUKE VIJEĆA
 o stajalištu koje u ime Europske unije treba zauzeti u Vijeću Svjetske carinske organizacije u vezi s preporukom Svjetske carinske organizacije o izmjeni Harmoniziranog sustava iz članka 16.
 VIJEĆE EUROPSKE UNIJE,
 uzimajući u obzir Ugovor o funkcioniranju Europske unije, a posebno njegov članak 28. stavak 1. u vezi s člankom 218. stavkom 9.,
 uzimajući u obzir prijedlog Europske komisije,
 budući da:
 (1)
 Odlukom Vijeća 87/369
 61 Unija je sklopila Međunarodnu konvenciju o Harmoniziranom sustavu nazivlja i brojčanog označivanja robe („Sporazum”), koja je stupila na snagu 1. siječnja 1988.
 (2)
 U skladu s člankom 7. Sporazuma Odbor za Harmonizirani sustav može za Vijeće Svjetske carinske organizacije (WCO) pripremiti prijedloge izmjene nomenklature HS-a. U skladu s člankom 16. Sporazuma Vijeće WCO-a može preporučiti tu izmjenu ugovornim strankama.
 (3)
 Očekuje se da će Vijeće WCO-a na lipanjskim zasjedanjima odlučiti o preporuci ugovornim strankama o izmjeni nomenklature HS-a. Ta će se preporuka donijeti na temelju prijedloga koji je pripremio Odbor za Harmonizirani sustav i dovršio na svojoj 63. sjednici održanoj od 19. do 29. ožujka 2019. Stupiti će na snagu 1. siječnja 2022.
 (4)
 Od iznimne je važnosti da nomenklatura HS-a bude ažurirana i u skladu s promjenama u trgovinskim tokovima i tehnološkim razvojem te da što vjernije odražava potrebe korisnika. Predložena preporuka uključuje brojne skupove izmjena kojima se u obzir uzima potreba za modernizacijom ili prilagodbom nomenklature njezinu okruženju.
 (5)
 Budući da preporuku za izmjenu nomenklature HS-a treba donijeti Vijeće WCO-a, primjereno je utvrditi stajalište koje treba zauzeti u ime Unije jer će preporuka, nakon što je se prihvati u skladu s člankom 16. Sporazuma, biti obvezujuća za Uniju i moći će presudno utjecati na sadržaj prava Unije, konkretno na Prilog I. Uredbi Vijeća (EEZ) br. 2658/87
 72.
 (6)
 Djelomično je stajalište EU-a koje treba zauzeti u Vijeću WCO-a već utvrđeno prije 63. sjednice Odbora za Harmonizirani sustav
 83.
 (7)
 Primjereno je poduprijeti nacrt izmjene nomenklature HS-a i sve manje uredničke izmjene koje bi se mogle smatrati potrebnima,
 DONIJELO JE OVU ODLUKU:
 Članak 1.
 Stajalište koje treba zauzeti u ime Unije na sjednicama Vijeća WCO-a koje će se održati u lipnju 2019. jest da se podupire nacrt preporuke iz članka 16. o izmjeni Harmoniziranog sustava, kako je utvrđeno u Prilogu R dokumentu NC2626B1b (izvješće HSC/63/March 2019).
 Predstavnici Unije mogu bez daljnje odluke Vijeća pristati na manje uredničke izmjene nacrta preporuke iz članka 16. u kontekstu razvoja događaja na nadolazećim sjednicama Vijeća WCO-a, u dogovoru s državama članicama ili tijekom koordinacijskih sastanaka na licu mjesta.
 Članak 2.
 Ova je Odluka upućena Komisiji.
 Sastavljeno u Bruxellesu
 Za Vijeće
 Predsjednik
 (1)
 Nomenklatura HS-a je od uvođenja 1988. revidirana pet puta. Te su revizije stupile na snagu 1996., 2002., 2007., 2012. i 2017.
 (2)
 Odluka Vijeća 87/369/EEZ od 7. travnja 1987. o sklapanju Međunarodne konvencije o Harmoniziranom sustavu nazivlja i brojčanog označavanja robe i Protokola o izmjenama te Konvencije (SL L 198, 20.7.1987., str. 1.).
 (3)
 ST 7138 2019 INIT, Odluka Vijeća o stajalištu koje treba zauzeti u ime Europske unije u Svjetskoj carinskoj organizaciji u vezi s Harmoniziranim sustavom.
 (4)
 ST 7208 2019 ADD 1, Odluka Vijeća o stajalištu koje treba zauzeti u ime Europske unije u Svjetskoj carinskoj organizaciji u vezi s Harmoniziranim sustavom – Donošenje – Izjava Komisije.
 (5)
 Presuda Suda od 7. listopada 2014., Njemačka protiv Vijeća, Predmet C-399/12, ECLI:EU:C:2014:2258, točke od 61. do 64.
 (6)
 1
 Odluka Vijeća 87/369/EEZ od 7. travnja 1987. o sklapanju Međunarodne konvencije o Harmoniziranom sustavu nazivlja i brojčanog označavanja robe i Protokola o izmjenama te Konvencije (SL L 198, 20.7.1987., str. 1.).
 (7)
 2
 Uredba Vijeća (EEZ) br. 2658/87 od 23. srpnja 1987. o tarifnoj i statističkoj nomenklaturi i o Zajedničkoj carinskoj tarifi (SL L 256, 7.9.1987., str. 1.).
 (8)
 3
 ST 7138 2019 INIT, Odluka Vijeća o stajalištu koje treba zauzeti u ime Europske unije u Svjetskoj carinskoj organizaciji u vezi s Harmoniziranim sustavom; ST 7208 2019 ADD 1, Odluka Vijeća o stajalištu koje treba zauzeti u ime Europske unije u Svjetskoj carinskoj organizaciji u vezi s Harmoniziranim sustavom – Donošenje – Izjava Komisije.