Human Genome Project: Legal, Ethical and Social Implications

Human Genome Project: Legal, Ethical and Social Implications In this dissertation we consider the human genome project in its wider context. We take a brief overview of the aims, the working and the sequencing techniques used together with the timeline achieved. The ability to sequence genes has given a greater understanding of the human genome. This understanding has thrown up a great many legal, social medical and ethical problems and dilemmas which clearly need tube both addressed and solved. This dissertation looks at many of the issues, analyses them, and considers some of the possible solutions. We primarily consider the situation in the UK, but comparisons are drawn with the arguably more litigious society in the USA, particularly in consideration of the legal implications of the subject. We make a consideration of the ethical position of researchers, medical professionals and also individuals whether they are considered as research subjects or simply as private citizens. We draw conclusions from our findings and present them. Introduction The Human Genome Project (HGP) was a vast and ambitious concept which was conceived in the 1980s and formally started in 1990, the main stated aim of which was to achieve the mapping of the entire human genome. It was originally anticipated that the process would take approximately 15 years and was therefore scheduled to be complete in2005/6 but the advances in technological hard and software improved sequencing ability to the extent that the entire undertaking was actually completed in 2003. The project itself involved over 1,000 principal scientists in over 200Universities, Government laboratories and private facilities. The stated and defined primary goals of the project were to: identify all the approximately 20,000-25,000 genes in human DNA, determine the sequences of the 3 billion chemical base pairs that make up human DNA, store this information in databases, improve tools for data analysis, transfer related technologies to the private sector, and address the ethical, legal, and social issues that may arise from the project. (after Collins FS et al 1998), Although the project was primarily about the sequencing of the human genome, part of the intrinsic preparatory work was carried out in the sequencing techniques of other organisms such as E Coli and Drosophila(the fruit fly) Brief description of the genome The genome of an organism is a term which relates to the sum total of the DNA of the organism. This is replicated in virtually every cell in the organism and it should be noted that it includes not only the nuclear DNA but the extra-nuclear DNA as well. It is the basic code for making all of the constituent proteins and thereby it is the ultimate determinant of the various processes that occur within the organism. The human genome has approximately 3 billion base pairs (abbreviated as A T G C). These are arranged in sequential style in the DNA double helix and are unique to an individual. There are large areas of repetition and large areas which appear to be â€Å"biologically silent† but we shall discuss this in rather greater detail later in this dissertation. (Nichols, E.K. 1998) Sequencing techniques used The eventual sequence derived in the human genome project does not represent anyone individual’s genome. The original samples were taken from multiple sperm and blood (from females) donations which were mixed and sent to labs across the world. The differences were comparatively insignificant as the vast majority (99.7+%) of the genomic sequence is identical in every individual.(Collins et al 2001) Sperm is used, as the DNA : protein ratio is higher in sperm than for other cells and is therefore easier to prepare. It should be noted that sperm contains both the male and female sex chromosomes (X Y) so equal numbers of each were added to the samples and the blood DNA was added to ensure that female derived DNA was also present. The original sequencing techniques (in the 1990s) were primarily those of gel electrophoresis, which is slow, labour intensive and expensive. It was reported that the entire human genome project team managed to sequence 200Mb of gene in 1998. Advances in technology and automotive processing allowed one participant (DOE Joint genome institute) to sequence 1.5 billion bases in one month in January 2003. (Soga, Kakazuet al 2004) It was the discovery and large-scale implementation of the capillary gel electrophoresis technique that was mainly responsible for these advances. One of the major advantages of the capillary tube method is that the comparatively larger surface area of the capillary tube allows for greater heat dissipation which was the rate limiting step for the older models as too much heat would melt the gel carrier. (Tsai et al.2004) The actual mechanism for sequencing is extremely complex but in essence each chromosome, which comprises between 50 and 250 million base pairs, is fragmented into more manageable size pieces. (the sub cloning step).Each piece is then set up as a template from which a set of smaller fragments are generated, each one is a base pair shorter than the parent (the template preparation and sequencing reaction steps). (Marsha et al 2004) The resulting fragments are separated by electrophoresis which is an ideal method because of their differing size (separation step). The end base of each fragment is then identified (base-calling step). Automated sequencers then can analyse the resulting patterns which will give representation of the base order which is then â€Å"reassembled† into blocks of about 500 bases each (for ease of handling the data) . Number of very sophisticated computer programmes then analyse the raw data for potential errors and can identify specific genes and silent areas (Krill P et al 2000) Once sequenced, the final details are placed in the public domain such as Embank for open access to all. We have made several references to the draft and final sequences. The explanation of the difference lies in the fact that there are both intrinsic errors in the processing and also in the variability of the genetic material used. The original draft sequence was published in June 2000. This was the result of each area being analysed at least 4-5times to minimise the errors. This original data was presented inspections of about 10,000 base pairs and the chromosomal locations of the genes were known at this stage. A higher quality â€Å"final† reference sequence was published in April 2003which represented a 8-9 fold sequencing of every chromosome to fill in gaps and to minimise errors which were quoted as being no more than one in 10,000 bases (Kaiser et al 2004) Human genome project timeline 1990 Official commencement of HGP work Apr. 1998 HGP passes sequencing midpoint March 1999 Target completion date for â€Å"Human genome Working Draft† accelerated to early 2000 Dec 1999 Human Chromosome 22 sequenced (first human chromosome ever sequenced) May 2000 Human Chromosome 21 sequenced March 2000 Drosophila genome completed April 2000 Draft sequences of Human Chromosome 5, 16 19 completed June 2000 Working draft of DNA sequence achieved Dec 2001 Human Chromosome 20 sequenced Dec 2002 Complete Mouse genome draft publication Jan 2003 Human Chromosome 14 sequenced June 2003 Human Chromosome Y sequenced July 2003 Human Chromosome 7 sequenced Oct 2003 Human Chromosome 6 sequenced March 2004 Human Chromosome 13 19 sequenced May 2004 Human Chromosome 9 10 sequenced Sept 2004 Human Chromosome 5 sequenced Oct 2004 Human gene count estimates changed from 20,000 to 25,000 Dec 2004 Human Chromosome 16 sequenced March 2004 Human Chromosome X sequenced April 2005 Human Chromosome 2 4 sequenced Legal issues Patenting The whole issue of patenting the genome and the offshoots of the project caused an enormous furore in medical, scientific and pharmaceutical circles. The opposing ends of the spectrum argued that, on the one hand, the benefits of such a fundamentally important piece of work should be freely available for the human race in general and the scientific community in particular, to the other who believed that the money to be made by the commercial exploitation of the genome could be used to finance other related projects. (Nuffield 2002) The culmination of the argument was that the genome was fragmented and patented piecemeal. In order to fully understand the implications of this we must explore the workings of the patent system. In the UK, patents are issued by the Patent Office. Applications must be received within 18 months of the discovery (it is 3 years in the USA). Once granted, they remain in force for 20 years from the date of issue. In order to be considered suitable for a patent to be issued a product must generally satisfy four criteria, namely: Useful – the patent application must be accompanied by some practical application of the invention (whether it has actually been applied or has been proposed in a purely theoretical sense) Novel – it must be a new, or previously unknown entity. Non-obvious –it must be a significant modification that is not simply a minor adjustment made by someone with appropriate skill and training in that particular area Detailed – the item must be described in sufficient detail to allow person who has appropriate training in the field to use it for the purpose for which it was designed. This is often referred to as the â€Å"enablement criterion† ( after Cochran and Cox. 1997) The academic argument referred to earlier was intensified by the knowledge that raw products of nature are not generally patentable. Special provision had to be made by the agencies on both sides of the Atlantic to allow for patents to be issued for genetic material. The general guiding principal in issuing patents is that they are issued on a â€Å"first to invent† basis. Where a specific application is not immediately obvious (as is the case with many pharmaceutical and bio-tech products), provisional patents can be applied for and enforced for up to one year after either discovery or publication of the findings. This is a mechanism to allow for the full implications of the finding to be worked out and patented.(Nickols F 2004) In specific reference to our considerations here, we should note that with bio-tech discoveries in general and DNA patents in particular, coincident with the application for a patent, the applicant is required to deposit a sample of their discovery in any one of 26 designated biological culture repositories which are distributed throughout the world. (Bjorn tad DJ, et al. 2002) It is a reflection of both the scale and importance of this work to appreciate that to date, there have been over 3 million separate genome-related applications for patents received on file throughout the world. The legal ramifications of this process are huge. In the UK, USA and Japan (where the bulk of the applications for genome-related patents are filed) the system requires that the details of the applications are kept completely confidential until the full patent is finally issued. As we have discussed, this process can take up to a year. (Brown,2000) The corollary of this fact is that those scientists and companies who utilise the data ( which is available on the Internet) to evaluate clinical or pharmaceutical applications of gene sequences risk the issuing of a future injunction if it transpires that those particular sequences have been the subject of a previous patent application which has subsequently turned out to be successful. (Morris AH 2002) The 3 million genome related patents include the genes themselves, gene fragments, tests for specific genes, various proteins and stem cells. To satisfy the Patent Office the four tests set out above are specifically modified to accommodate genetic material thus: (1) identify novel genetic sequences, (2) specify the sequences product, (3) specify how the product functions in nature i.e., its use (4) enable one skilled in the field to use the sequence for its stated purpose (after Caulfield 2003) Even this is not completely sufficient for the current needs of science. If we take the example of gene fragments. Their function is often not known although their structure almost invariably is. The practical applications can be extremely vague. A quoted utility of a gene fragment has been cited as â€Å"providing a scientific probe to help find another gene†. Clearly it could cause substantial practical difficulties if a patent were to be issued on such a basis, and the subsequent usage was found to be substantially different, it would not invalidate the patent. The significance of this can be fully appreciated if we consider that the typical gene fragment, comprising about 500 bases (known as expressed sequence tags or ESTs) actually represent typically about20-30% of the active chromosomal genetic material, the full chromosome may be about 40-60 times larger than this. The active chromosomal genetic material is often referred to as canal and typically only contains its information-rich (or exon) regions. The scientific importance of these gene segments are that they represent very useful tools for research as they can duplicate the actions of genes, can be synthesised in the laboratory, and remove the need for scientists to manipulate the entire gene. (HUGO 2000) It can therefore be clearly be appreciated that such gene fragments are very useful tools in genetic research and the granting of patents touch entities has sparked off another major controversy in the scientific community. There have been major representations to the various Patent Offices throughout the world not to grant such patents to these universally important entities to applicants who have neither determined the base sequence of the genes nor yet determined their function and possible uses. As a result of this, the UK and USA Patent Offices decided to issue more stringent guidelines (effective as from 2001) which required that an application for patent of a gene fragment must now specifically state how the fragment functions before a patent can be issued. The wording is specific and substantial utility that is credible, but is still considered by many to be too indeterminate. (Thompson 1992) The basis behind the objections stem from the two main arguments already put forward. Firstly the patenting of such a â€Å"bottleneck or gatekeeper† product can seriously hinder the eventual development or even the characterisation of more complex molecules. Secondly, scientists are obviously wary of utilising such entities because of the possible financial constraints and penalties that would be imposed if the particular entity that they were using subsequently was found to bathe subject of a provisional (and therefore initially secret) patent application. In essence the patent of the gene fragment could be taken out after a comparatively small amount of scientific work and exert totally disproportionate control over the possible commercial and scientific development of more advanced genome research. (Schwarz D teal 1997), There are also less obvious, but very practical, implications to this type of patenting. Let us consider the situation where patents have been separately applied for, and granted to gene fragments, the gene and various proteins that the gene expresses. Any scientist wishing to-do research in that area has not only to pay the various license holders for permission to use their patented entity, but there are also hidden costs in the research necessary to determine where (and whether)the patents have been granted. (Short ell SM et al 1998), Not all research has been hampered or driven by the restrictive practices that the issuing of patents inevitably promotes. Let us consider the case of the Welcome Foundation who, in collaboration with ten other smaller pharmaceutical concerns, agreed to form a non-profitmaking consortium whose stated goal was to find and map out an initial300,000 common single nucleotide polymorphisms (SNPs). To date they have discovered nearly 2 million. In a truly philanthropic gesture they generated a publicly available SNP map of the human genome in which they patented every SNP found solely for the purpose of preventing others from making financial profit from them and making the information available to the public domain. The SNP is a single variation in the base sequence in the genome and they are found, on average, about one in every 500 base units. It can occur in an active or in a non-coding region. The effect will clearly vary depending upon the actual site of the variation but they are believed to be a fundamental cause of genetic variation which could give researchers important clues into the genetic basis of disease process or variations in responsiveness to pharmaceuticals. (Russell SJ1997) In addition it is believed that SNPs are responsible for variations in the way that humans respond to a multitude of potential pathogens and toxins. The SNP is therefore an invaluable tool in the research behind multifactorial disease process where complex environmental and genetic interactions are responsible for the overall phenotypic expression of the clinical disease state. (Santis,G et al 1994). We have referred in passing to the arguments that are currently raging relating to the issues on patenting genetic material. We should therefore consider the question of why patent at all? Would we be better off if the patent offices did not accept patents of genetic material? On first examination of the situation one might think that scientific investigation, in general terms, might proceed faster if all scientists had unlimited and free access to all information in the public domain. More careful consideration suggests however, the laws relating to intellectual property are built on the assumption that unless ownership and commercial profits can be reasonably secure (by means such as patents) few organisations would be willing to make the substantial investment that is typically necessary for development and research. The reasoning behind the mechanism of patenting intellectual property is therefore the marrying together of the need to secure a potential income from one’s work with the ability to allow the transparency of full publication of one’s discoveries which will therefore allow others to consider and utilise the information in their own research. (Berwick. 1996) Consideration of this point will suggest that the only other effective means of safeguarding the costs of one’s research would be total secrecy which clearly would not be in the general interest of the scientific community. If we add to the general thrust of this argument, the fact that, in general terms, the costs of development(post-invention) far outweigh the costs of research (pre-invention) we can see the economic sense in allowing innovative research-based firms the financial security of development by preserving the profit incentives by means of the Patent. (DGP 2002) In general terms we could view the patent mechanism as a positive development.(McGregor D 1965). Perhaps it is the breadth and number of the patents allowed in the field of genomic research that is the prime cause of unease in the scientific community. Special cases The arguments presented above can be broadened further if one of the natural extensions of the human genome project is the research into the possibility of cloning. We will not consider the (currently totally illegal) possibility of human cloning per se, but the therapeutic embryo cloning for the purposes of harvesting human stem cells. Such cells have immense potential for the study and therapy of a great number of disease process. As such they have enormous value as both intellectual and commercial property. The background to our discussion here includes consideration of the fact that courts in both the UK and the USA (Diamond v. Chakrabarty1980) have set precedents that single celled organisms (genetically modified bacteria) were intrinsically patentable. Legal argument then followed and shortly after there were similar rulings in favour of the patentability of simian stem cells. It logically follows that human stem cells should be afforded the same legal protection. The problem arises then that such a move would offend other legal principles such as technical ownership of another human being.(PGA 2001) Clearly there are enormous, and some would say insurmountable, difficulties in this region. We present this point simply to illustrate the potential difficulties surrounding ownership of the human genome. Broader legal issues Matters relating to the legal implications arising from the human genome project already fill countless volumes and we do not propose to make an exhaustive examination of the subject. There are however, number of major issues that arise either directly or indirectly from this project. They are largely interlinked with major social and ethical considerations and society, as a whole, has looked to the law to provide authoritative answers to some of them. (Stripling R et al.1992) One of the major problems associated with the potential ability to decipher the human genome is what to do with the information that it gives us. The ability to â€Å"read genes† brings with it the ability to discriminate with increasing degrees of subtlety. Discrimination is inevitably linked (historically, at least) with varying degrees of injustice. Whether it is the more obvious forms of discrimination such as insurance loading on the basis of predisposition to disease traits or more insidious and pernicious scenarios such as the ability to discriminate by genetic association with various ethnic groups, the ability is there. Will it become acceptable to refuse a mortgage application on the grounds that a person has been found to have a genetic disposition towards gastric cancer? Could health insurance premiums be based on an interpretation of various aspects of one’s genome? Some lawyers have already voiced their concerns about the ability of the law to provide genetic defences where it may be possible to challenge prosecutions on the ability to undermine the ethical principle of the validity of individual responsibility. The concept of free-will may be legally challenged in the prospect of discovery of various genetic traits that may predispose the individual to any one oaf number of behaviour patterns such as antisocial or thrill-seeking behaviour or violence. (Laurie G 2004) We currently accept that some manifestations of the human genome are now routinely enshrined in virtually unchallengeable law. DNA identification in criminal law is commonplace and scarcely questioned. Paternity suits are settled on the basis of genetic make-up. It doesn’t take a quantum leap of intuition to appreciate that there may soon be potential negligence cases brought against physicians and the like who fail to warn patients against the possibility of developing the ever increasing number of disease processes that are thought to have a genetic predisposition or component. The converse of that dilemma is should we expect physicians to suppress information found by genetic testing if there is no known cure? It follows that if we do not then people could be condemned to live with the knowledge that they are statistically likely to develop any one oaf number of diseases that they may very well, in other circumstances, have chosen to live in ignorance of. (Hyde, SC et al. 1993) Such cases have already surfaced, unsurprisingly in the USA. The estate of a colonic cancer victim unsuccessfully tried to sue a physician who failed to warn him about a genetic predisposition to colonic cancer from which he subsequently died. (Safer v Estate of Peck 1996) Some measures have been taken to try to protect exploitation of the genetic status of individuals where it is known. In the USA, some 16states have enacted laws to prevent both health and other insurance companies from using any form of genetic information to load premiums or to refuse cover. The initial reaction to these moves was one of delight, but it soon became clear that this was only of any potential value when the individual was asymptomatic. There was no bar to premium levels once the symptoms became apparent. To some extent, although the same level of legal prohibition does not apply in the UK, there is little difference. In this country, insurance companies will still load premiums or refuse cover once symptoms are apparent. (Rothstein MR1999) Social and medical considerations As we have implied earlier in this piece, the fundamental nature and importance of the human genome project to humanity as a whole means that its impact has great implications for the fields of law, ethics and social considerations. This is hardly surprising as, at the most basic level, all these three considerations are inextricably linked. Many of the social implications are also tied up with medical considerations and therefore we shall consider both of these elements together. Humans, as a race, have about 3 million pairs of bases that determine their genetic identity. Interpersonal differences between individual humans however, are determined by only one tenth of one present of our collective DNA. These three million base pairs are ultimately responsible for the physical and perhaps behavioural diversity that we observe in our species. (Erickson 1993) It is in the nature of inheritance that this variation has accumulated across the generations by small mutations or variations in the base sequences. These small differences are ultimately responsible for all human diversity including many overt disease process and predisposition or resistance to others. It is clearly important where these mutations take place as some have no functional effect, others may confer some form of advantage or benefit (and thereby the motive factor behind the evolutionary processes) others may cause disease or even be incompatible with life.(Griesenbach U et al 2002), It can be argued that all disease process have at least a genetic component. It can be completely due to a genetic malfunction such as the defect in the single gene for the cystic fibrosis transmembraneconductance regulator (CFTR) which results in an abnormal expression of one protein (the protein is still expressed, but due to one amino acid irregularity it folds in a different way) which results in the clinical situation of cystic fibrosis. (Piteous DJ et al 1997). Equally it may be due to a variation in the genetic code that modifies how the immune system responds to a particular pathogen (Yoshimura, K et al. 1992). As we understand how our genome influences literally every aspect of our health we will inevitably discover more ways to combat and tackle the diseases of mankind. Before we move on to discuss overtly social and ethical considerations we should logically extend the appraisal and examination of the medical issues, as they have a pronounced bearing on these other areas. With the advent of a greater understanding of the human genome and the cellular mechanisms of regulation and disease comes the prospect of gene therapy. On the one hand, the potential benefits for the sufferers of single gene mutation syndromes such as Tay Asch’s disease and Sickle Cell Anaemia are clear and undisputed, and yet the same technology has enormous social and ethical ramifications. There are thought to be about 4,000 single gene defect syndromes known to medical science at present (Termite, S et al 1998). These are the prime targets for the gene therapy researchers There are also an enormous number of more complex, but still primarily genetically determined disease process, such as Alzheimers Disease and schizophrenia, together with the commoner Diabetes Mellitus and hypertension variants which, although having a genetic component, are thought to be manifested after a period of interaction with environmental factors. It is quite possible that the techniques of gene therapy could ultimately be applied to these conditions as well.(Sikorski R et al 1998), Social and medical benefits The advent of understanding of gene function leads to other developments in the fields of both diagnostics and possibly preventative medicine. There is already considerable debate in pharmaceutical circles about the ability of researchers to utilise genetic information to make predictive assumptions about the ability of individuals to metabolise drugs. (Sailor R et al. 1998).One of the big problems with pharmacology is that, although a normal response to a particular drug can be predicted reasonably accurately, there are variations in genetic make-up which cause marked differences in threat of metabolism and excretion of some drugs. In many cases, these differences are of minor clinical importance, but in anaesthetic and cytotoxic drugs, the differences can be lethal. (Wriggle DJ 2004). As extension of this thread of argument is that it is known that some malignancies will respond well to some cytotoxic agents while others will show no response at all. The point behind these comments is that there are considerable efforts in the pharmaceutical industry to identify the particular regions of the genome which are ultimately responsible for these differences. If they can be found it follows that they may either be capable of modification (by gene therapy or other mechanism) or their effect can be measured so that the dose (or even the type) of medication can be adjusted with far more confidence in the knowledge of the likely pharmacodynamics of that individual patient.(Spindle et al 2002). It is the ultimate hope and goal of these efforts that the pharmaceutical industry will ultimately be able to speed up the process of drug development, make the drugs faster and more effective while dramatically reducing the number of adverse drug reactions observed. Social and medical difficulties Gene tests are currently in the process of being developed as a direct result of the human genome project. Some are already commercially available. the social implications here are huge. Quite apart from the medical implications of being able to predict the likelihood of possibly developing certain disease processes, there are legal and social applications as well. Courts have been presented with the results of gene tests in cases as diverse as medical malpractice, privacy violations, criminal cases and even child custody battles.(Diamond. B. 2001) The immediate difficulty in this area is, firstly that there is insufficient knowledge to be able to interpret the results of the gene tests with 100% accuracy. This, when combined with the knowledge that many of the conditions that currently can be tested for have no known or successful treatment, leads to enormous social and ethical dilemmas. While it may be considered quite reasonable to tell a person that they are carrying a defective gene for cystic fibrosis ( as a carrier state, rather than a symptomatic individual) and thereby allow them to make positive decisions with regard to whether they choose to run the risk of passing that particular gene on to future generations. Is it reasonable to tell someone in their 20s that they are likely to develop Alzheimer’s Disease in their 60s? How will that knowledge impinge upon their approach to life? (Douglas C 2002) Equally how will such knowledge affect the eventual application and acceptance of health insurance policies which are currently worked out on Citizen Service Centres (KEP): Perceptions of Customers Citizen Service Centres (KEP): Perceptions of Customers 1. Introduction 1.1 Importance of the Research According to the philosophical bases of marketing customer wants satisfaction. As the consumer is the key for a firm, the voter is the central element for a government or party (Lock and Harri,1996).In this context the citizen voter wants satisfaction and searching his satisfaction from the services that are offered to him is ‘‘ a lens through which government and public managers can gain a better perspective on how citizens respond to the performance of public services, (Van Ryzin , 2004) and offers important findings for the policy makers. Citizen satisfaction surveys are frequently used by U.S. local governments and public administration researchers in order to measure the quality of local government services (Hatry et al., 1992; Miller and Kobayashi, 2000). A big number of U.S. cities use surveys regularly (New York , San Francisco, Phoenix etc.),in order to analyze in a descriptive and unvaried way , the level of perceived quality of services ,within a locality and over time (Van Ryzin et al., 2004). Recent studies have compared citizen satisfaction with benchmarks that were developed from data collected across many localities (Miller and Miller 1991; Miller and Kobayashi 2000), and have focused on the individual, jurisdictional, and city-specific determinants of citizen ratings of service quality (De Hoog, Lowery, and Lyons 1990; Hero and Durand 1985),like taxes and expenditure ,and also on demographic and socioeconomic characteristics of respondents such as race (Schuman and Gruenberg, 1972). Other investigations have negotiated the citizen satisfaction from the police according to their ethnoracial characteristics (Brad W. S. 2005), or satisfaction from the education system or from hospitals (Amyx,Bristow ,2001, Suda Anita D.,1998). The importance of the public services quality became popular in the United Kingdom at 1990s when the political parties put an emphasis on the subject ,but even in our days the need for quality services that meet â€Å"customer† citizens needs and expectations, is more and more obvious .This need for quality public services is even expressed by the European Social Fund, as the implementation of the strategy and policies of the European Committee at Member States ,is strongly related with the public service organizations, which many of them are responsible for (ESF,2009). And although, in the marketing research exist a number of well-developed models of approaching customer satisfaction, there has been little development of a model that would test citizens satisfaction. As a result, it would be valuable to test such a model in the framework of Greek public services. 1.2 The Research Objectives The overall objective of this research is to examine the Greek citizens perceptions and expectations of service quality concerning the Citizen Service Centres (KEP) -a Greek public service based on servqual model. From this overall objective a number of more specific aims can be identified: Investigate consumer expectations towards the service offered from public services Examine citizen perceptions about Citizen Service Centres(KEP) Asses the factors that play an important role in the service quality of Citizen Service Centres (KEP) 2. Literature Review 2.1 Politics and the marketing concept It has often been argued that the application of ‘marketing tools and instruments in politics is nothing new (Perloff, 1999; Baines and Egan, 2001).In the last twenty-five years what have changed about the political marketing is not just the size of political marketing management but also the belief that political actors act and think in political terms. Political actors are them that they try to do marketing management in a frame of integration of marketing instruments in a coherent marketing strategy (Newman, 1994a; Dermody and Scullion, 2001). It is supposed that the selling of politicians and the selling of a product is linked (OShaughnessy, 2001) and that commercial and political contexts are essentially similar (Kotler, 1999). Many marketers believe that the tools and concepts of marketing can be transferred directly to the political arena (Lock and Harris ,1996) .The applications of political marketing are used as a tool of managing politics, developing policy (Nimmo, 1999), or even governing (OShaughnessy, 2003). The marketing concept in commercial terms is based on the principle that all company planning and operations will be customer oriented. As such the philosophical basis of the marketing concept is that customer want satisfaction (OCass, 1996). When a political party or candidate applies this concept to the political process, they must be in a position to adapt to and satisfy voters needs (Mauser, 1983; Newman and Sheth, 1987; Reid, 1988). For major mainstream parties, the overriding objective is to attract voters, win elections and hold power (Lock and Harris, 1996).In this extent knowing the degree of satisfaction of citizens seems to be important. 2.2 Citizen Citizen is every person of a state that has the citizenship of it (New Encyclopaedia, 2006). According the place and the time different criteria were used to define the citizen .The genealogical criterion, which is the oldest, the legal criterion and the economic (taxation) criterion .According to the first, citizen is the son of citizen that hasnt lost his rights. This definition was used in the ancient cities in order to distinguish the mass from the public. According to the second criterion citizen is each one that is recognized like that from the law. And finally, according to the last , citizen is each one that owns property or a quantity of goods and contributes to the governmental budget (Encyclopaedia Papyrus Larousse Britannica, 1992).Citizens have some rights and obligations .Their rights are political such as the right to vote, to be member of the jury or public servant , and personal such as the right to live ,to have free speech , to work, to live in freedom ,etc . ,that are protected from the state and are given to everyone. Citizens obligations such as taxation are set in order to protect the privileges that are offered to citizens from the government and they emerge from the need of the States existence (New Encyclopaedia, 2006). One of the governmental works is the provision of goods and services. All the modern governments take part directly to the economy by providing goods and services , organising industrial enterprises I promoting economic activities .Providing sanitary, education, and social insurance services , is one of the modern states concerns (Heinz Eulau ,1992). 2.3 Citizens as Customers, Customers as Citizens The classic definition of customer is â€Å"one who purchases or receives a product or service† (Carlson, 1997). The concept of customer is often more complicated in the public sector. For example, the city of Coral Springs in Florida, refined the idea by considering two distinct categories of external customers. Moreover, a building permit applicant is a direct customer while the applicants neighbors are among the indirect customers who will benefit if the decision helps to ensure a safer city and more appropriate land use and construction practices. But even with these refinements, â€Å"citizen† sometimes has a broader meaning. Citizens enjoy rights and take on responsibilities that extend well beyond those commonly recognized to customers (Popovich, 1999). Despite the passage of generations, the fact that government cannot succeed without the peoples trust and support, is a true even today. These essential elements of civil society shape the capacity and help determine the actual performance of government. Societys efforts to accomplish its highest priority and most practical goals are likely to fall short in the absence of the peoples agreement in the functions of government. As the customer is the key for a firm, the citizen -voter is the central element for a government. 2.4 Public services A service is a non material product (education, health safety etc).The meaning of public services isnt constrained in the area of Public and Αdministrative law .The public service is a known significance in the economy, as an appropriate tool of the states expansion in the social relations, for the preservation of stabilized provisions for the welfare state. Beyond the needs of the of practical policy, the interest of the political science with the expansions of the political philosophy is expressed , as the public service is characterized as the expansion of the state in its social activity . In other words , it is the way by which the state contacts the citizens in order to cover their direct needs .After the two World Wars this phenomenon is observed in the European area .In Germany , this works as ‘‘Anstalten (institutions) and the ‘‘ offentlichen Unternehmungen (public enterprises) . The administration (the welfare state) undertakes and guarantees ben efits even for the preservation of life of human who live massively in big cities such as transportation ,cleanliness , water , electricity etc. ÃŽ ¤he principles of function of the public services are connected with the needs and social aims that are tended to fulfil. Therefore, services are provided to everyone in the same way in order to cover the needs, under conditions that change from time to time (Encyclopaedia Papyrus Larousse Britannica ,1992 ). According to the Europa Glossary that is being updated given the recent signing of the Treaty of Lisbon ,the concept of public service is >. At the same time the Europa Glossary defines that continuity of service quality security of supply equal access affordable prices social , cultural and environmental acceptability Article 16 of the EC Treaty, introduced by the Treaty of Amsterdam, confirms the role of public services in the European Union. The EU policy on operators of public services is still shaped by the desire to liberalise network public services and to widen the scope of competition on national markets, be this, in the areas of rail transport, postal services, energy or telecommunications>>. 2.5 Citizen Service Centres (KEP) The institution of KEP was founded in 2002, based on an idea of the Deputy Minister Mr Beno. The KEP were founded according to the article 31 of law 3013/2002 and were staffed with short term labour agreement workers, according to the processes of article 6 of law 2527/1997. According to the Ministry of Internal Affairs (2007), over 60.000 of citizens visit every day Citizen Service Centres (KEP) for certified or not processes, ratifications of registrations, certifications of genuine signature and every kind of administrative information. The last three years 40 new KEP were founded and now they are 1035 at their total. The centres are open Monday to Friday, 8:00 to 20:00, and Saturday, 8:00 to 14:00. At Citizen Service Centres (KEP) citizens can:  · obtain information on what they need to do in order to manage their transactions with the municipality * submit applications for the processing of matters that involve the City that the KEP is registered and state agencies in accordance with joint decisions issued by the Interior Minister or other competent Minister >(City of Athens ,2007). Some of the procedures (about 1.014 at total) that Citizens can carry out at Citizen Service Centres are the following:  · The registration or transfer of registration of a passenger vehicle or motorcycle  · The issuance of a birth certificate duplicate  · The issuance of a criminal record duplicate for general or legal use  · The issuance of a marital status certificate  · The issuance of a birth certificate duplicate for those registered with the City of Athens  · The application for a rent subsidy for the year 2006 to Workers Housing Organisation beneficiaries (former recipients)  · The issuance of a registry birth certificate duplicate for an adult or minor  · The issuance of a public transport pass for individuals with disabilities  · The application for the seasonal unemployment benefit in accordance with Article 22 of Law 1836/89 OAED (Greek Manpower Employment Organisation)  · The issuance of a marital status certificate for individuals registered with the City of Athens (online)  · The application for a rent subsidy for the year 2006 to Workers Housing Organization beneficiaries (new recipients)  · The issuance of a marriage license duplicate  · The application for the OAED (Greek Manpower Employment Organization) family subsidy  · The issuance of a drivers license  · The issuance of a Type A military status certificate (full)  · The renewal of a drivers license  · The issuance of a registry death certificate duplicate  · The application for change in passenger vehicle or motorcycle ownership  · The issuance of a permanent residence certificate  · The issuance of a judicial interdiction certificate See Appendix 1 Progressively KEP were transformed to Centres of Completed Transactions, bringing the Public Administration more near to citizen. According to the Ministry of Internal Affairs (2007), citizens trust KEP and are in general satisfied from them. Nowadays they have permanent staff which possesses about 2588 positions. The number of affairs that KEP handled the last years is presented at the table below: PERIOD NUMBER OF AFFAIRS SERVED CITIZENS 2006 3.042.509 1.154.554 2005 2.305.195 1.527.516 2004 1.643.313 1.316.505 2003 423.759 356.872 Medium number of affairs per day from Monday to Friday: 11.805 Medium number of affairs per day (Saturday): 821 According to the Ministry KEP are recognizable from about the 80% of citizens. Equally big are the visits to them that they exceed 60%, since they were enriched with new, more attractive for the citizen processes. But more interesting are the numbers linked with the subject of satisfaction of citizens, which according to the ministry exceeds the 90%. The problems that the Public Administration was facing when KEP were created were multiple. The most serious of them were the bad organization and the centralism of public services, lack of confidence in the government owned services, lack of evaluation, lack of meritocracy, weakening of ASEP, fragmentary, and consequently unsuccessful, efforts of application of Electronic Governing, absence of controls and sanctions and finally inflation of bureaucracy and corruptness. For this reason in 2007 a number of regulations of the article 15 of the law for Citizen Service Centres (KEP) were introduced, in order to fight the difficulties and dysfunctions of citizens service (Ministry of Internal Affairs, 2007). Some of the regulations were the following:  · The foundation of the Direction of Organization and Operation of KEP in the General Secretariat of Public Administration and Electronic Governing. The Direction was founded in order to guarantee the proper operation of KEP, but also their evolution in Centres of Completed Administrative Transactions, and the resolution of problems that emerges, because of their big number, the crowd of subjects and processes that they realize and the recent enlargement of their competences. The monitoring and the co-ordination of the operation of KEP is practiced , up today, at fragmentary way from the existing Direction of General Secretariat of Public Administration and Electronic Governing, fact which creates difficulties as far as it concerns the united confrontation of problems.  · The regulation of subjects of mobility of permanent personnel. The employees will stay in the KEP of their placement, for at least a five-year period, so that the experience, which has been acquired in the particular KEP, not to get lost.  · The simplification and acceleration of processes  · The restriction of joint responsibilities between the Ministries. It is indicatively reported that Minister of Internal Affairs does not act jointly in more than 25 different regulatory actions  · The obligatory deadline of 50 days for the transaction of the affairs of citizens  · The payment of complete compensation in the citizen in case of delay  · The self appointed search of supporting documents from the service on behalf of the citizen. 208 certificates can be requested from the service without the citizens presence, for 18 of them the self appointed search is obligatory. Indicative is the progress that took place in the case of self appointed search of certificates of birth from KEP, where, while in 2005 they had 231.327 certificates and medium time of transaction the 8 days, in the end of 2006 the transaction reached 432.188 certificates, that is to say almost double, with medium time of transaction the 5 days. Same is the acceleration as far as it concerns the certificates of familial situation, where while in 2005 were published 253.071 certificates, in 2006 until 2007, 373.219 certificates have been published  · The suppression of submission of supporting documents and their replacement with a personal declaration form for 7 cases  · The videoconference of administrative bodies  · The generalization of electronic communication and exchange of documents between the services. The network â€Å"SIZEFKSIS† ensures 50.000 digital certificates (under form of card) in civil servants equal in number. With this way is provided the possibility of electronic distribution of document, with simultaneous place of signature on this, with electronic way, without a problem of genuineness, after the distribution becomes from the above permitted employees with the use of digital certificate of (card). This electronic distribution involves big acceleration of process of publication and mission of document and contributes considerably in the fighting of bureaucracy.  · The application of a plan of restriction of state expenses and the enlarged public sector, by reforming the public services, so that they become more functional and effective  · The promotion of a regulatory reform, with the establishment of rules of good legislation as well as a system of evaluation of the results of legislative regulations in the competitiveness and the entrepreneurship The City of Athens operates a total of seven (7) Citizen Service Centres (KEP), one in each City District. Citizen Service Centres provide an online service for Athens citizens with regards the following: * City of Athens municipal roll certificates * Permanent residence certificates * Certification TAP property fee payment (in cases where agreement exists on the number of square metres registered with the Public Power Corporation and the contract of purchase) The Citizens Helpline 1595 provides information on documents required for all procedures processed by Citizen Service Centres. 2.6 Service marketing Usually marketing had been seen as having dual dimension.On the one hand, there is the notion which supports that the existence of an organization in economical and social content is based on the satisfaction of customer needs and wants, and on the other hand there is the â€Å" set of activities † which serve this philosophy in order to be implemented (CromptonLamb,1986). The marketing of services is a sector with particular characteristics .The expenditure on services is growing in most industrialized economies. According to the European Commission , â€Å"the percentage share of gross domestic product attributable to the services sector rose from 38 per cent in 1970 to almost 50 percent by 1990†. Crowell supports that â€Å"what is significant about services is the relative dominance of intangible attributes in the make up of the service product†. Services as a special kind of product usually they do not result in ownership but they can be linked to a physical good require special treatment. According to Jobber, as many offerings may combine tangible and intangible characteristics the distinction between them is >. For example, a marketing research study provides a physical good, which is the report that comes out, but also is the result of a number of service activities such as interviews with respondents, analysis of results, designing of the research, etc. Products such as a skirt or a pair of socks usually are not accompanied by a service so they can be characterised as pure goods, but also a visit to a doctor or psychotherapy can be regarded as a pure service as there is nothing tangible that the client receives. 2.6.1 THE NATURE OF SERVICES Service characteristics can be summarised to the following four: intangibility, variability, perishability and inseparability. 2.6.1.1 Intangibility As intangibility can be characterised the fact that services cant be smelled, touched, tasted or seen. Service is â€Å"a deed, performance or effort and not an object device or thing† (Berry, 1980). In other words customer cant evaluate a service before buying it and sometimes cant evaluate it even after consuming it. For this reason the challenge for the service providers is to prove the quality of the service by communicating tangible benefits to consumers. Another characteristic of intangibility is the fact that the service cant be owned so customers pay for the use of product or the performance. 2.6.1.2 Variability The provision of service quality may vary depending to the person who provides it. In other words important factors are the capabilities the person has, his physical and mental situation (tiredness, attitude etc.) the location the service is provided .So, in order to control quality variation , methods such as evaluation systems , tight quality controls and service standardization methods are necessary (Jobber,2004). 2.6.1.3 Inseparability In contrast with physical goods services cant be stored in order to be used later. Services are characterised by the â€Å"simultaneous production and consumption.† Because of this characteristic service providers role is very important to the satisfaction of consumer, as many times he is supposed to be himself the company in the eyes of customer (Berry, 1980). For this reason â€Å"the importance of service provider is an integral part of the satisfaction gained by the consumer†. The behaviour of the service provider is also important for the experience that the customer has for the provided service .So, great importance must be given to the training and rewarding of the staff and its selection (Aijo,1996). Another element that is connected to inseparability is the fact that the customer may experience the service in combination with other customers because of the nature of the service and the place it is offered. At this case marketing managers should take into consideration the role of customer interactions between them, but also the inter customer conflicts and nuisance (Barron et al., 1996). 2.6.1.4 Perishability Unlike the physical goods, services cant be stored in order to be used in the future or at peak times. So service providers should take into consideration the combination of demand and supply and use methods such as multi-skilling of the staff in order to be used at peak seasons or part time employees, supply flexibility, differential pricing and reservation system in order to minimize time waiting (Jobber, 2004). Today one of the greater challenges that the sector of services has to face is the increasing competition in combination with the growing expectations of customers and the developing demands of customers as service improves (Joseph Walker, 1988). 2.6.2 SERVICE MARKETING MIX Models had to explain the relationship between the market and the organisation in order to maximize the seconds performance (Gronrooss C, 1982). To certain extent managing services are more complicated than managing products, as products can be standardised. The standardisation of a service is far more difficult as there are more input factors i.e. process, people, physical evidence, to manage than with a product. The service marketing mix consists of the 7Ps model. These include except from the classical 4 Ps that stands for: Product, Price, Place, Promotion, three more Ps which are People, Process and Physical evidence. 2.6.2.1 People People participate and deliver the service experience, the efficiency and effectiveness, the availability and capability, the customer interaction and the internal marketing. Any provision of service includes as an essential part the use of appropriate staff and people. In order to gain an organisation competitive advantage it is important that it recruits the right staff that is well trained in the delivery of service. Usually consumers perceptions and judgements are affected by the employees they interact with. Consumers wait from the staff to have the appropriate attitude, service knowledge and interpersonal skills that they are paying for. So many organisations train their staff to certain standards. Physical Evidence Physical evidence concerns the place where the service is delivered, infrastructure, facilities, surroundings, essential evidence and peripheral evidence ,equipment and premises. It is an element of the service mix that contributes to the formation of the opinion of the consumer about the organization .So the judgments and the perceptions of the consumers are formed by the sight of the service provision .For example if you walk in an office you expect a friendly environment neat and tie. Process The systems used to assist the organisation in delivering the service, constitute the process. So process refers to the operating process that takes the customer through ,from the initial contact till the service experience and evaluation , database management, service delivery, queuing systems, ordering ,standardization .The customer usually expects efficiency and quickness at the process of the service delivery and this fosters consumers loyalty and confidence in the organization. 2.6.3 Quality Quality is important to business organisations and their consumers, because quality products or services can and will secure consumers business. In addition, linking quality with expensive spending is not absolute, as price will not determine always quality. The high or low quality of a product or service is usually determined, â€Å"by how it made the consumer feel and whether consumer expectations were satisfied or exceeded† (Kotler P. et al, 2008). Quality was very popular in the marketing literature,  « where the notion of satisfying the customer was a dominant model of quality of service provided and consumer satisfaction  » (Raftopoulos V., 2005). The US Strategic Planning Institute in 1972 developed the concept of relative perceived quality (RPQ),  «that is the perception of quality as defined by customers, relative to the offerings of competitors. In other words quality is what a customer perceives it to be and this is a dynamic and complex notion.  » 2.6.3.1 Public service quality The need for quality public services is also expressed by the European Commission through the European Social Fund in its program for 2007-2013.The reason is that the quality of public services affects the implementation of policies and the strategy design as public sector organizations are responsible for them at a big degree at the Member States ,e.g. government ministries , local authority departments and special agencies (ESF,2009). The fact of how important is the quality of public services and the need to be improved, became popular, in Britain, at 1990s when the Government gave clear > on the subject, by the proposal of the Conservative Prime Minister John Major enclosed in his Citizens Charter White Paper (Prime Minister, 1991). The issue faced great consensus from the political parties as the same year both Liberal and Labour parties published their own citizen charter proposals. The citizen driven improvement of the quality of public services was a fact (Black et al., 1994). This policy which faced the citizen as user and needed the reporting of performance from the service providers was continued for a long period it was enriched with best value new policies and was popular as>.According to this concept public services is better to be managed than administrated (Black et al.,2001). At the same time another reason that public service quality is important is that the needs and expectations of the users change and increase. Service quality and how to measure it developed to be a critical issue ,so during the 1990s performance measurement techniques developed as a result of >such as government legislation ,regulatory activity by industry keepers and major policy initiatives, as Black St. et al. , characterize them, and not as a result of the needs of the service provider. Meanwhile , all the efforts of understanding and measuring public service quality where characterized as weak and an increasing interest for quality improvement models techniques , certification and awards developed .So a number of new significances appeared such as total quality management and continuous improvement, process mapping techniques, Institution Standards and Charters. The revolution of the commercial service sector that took place the previous decades influenced also public sector organizations that faced the need to provide quality services that meet ‘customer needs and expectations. As Wisniewski remarks, > (Wisniewski, 2001). The notion of treating the customers has started to change as they dont receive passively uniform services without their voice or influence being considered (Skelcher, 1992). At the opposite side, the adoption of traditional methods may lead to the delivery of a service distant from customer needs. So organizations many times, after a more profound search, discover that the needs and values of customers are different from what they assume before searching (Farquhar C.R. ,1993). In order to discover customer perceptions and collect data concerning the attitudes o