sou · GSB320 · 2005-01-01 00:00:00 — Moreover, it is the opinion of the committee that insurance com- panies should not be entitled to make the stipulation that a person applying for insurance should have to undergo a genetic examination as a requirement for being insured or for extending an existing insurance agreement. Insurance companies should only be allowed to enquire after or use genetic information to the extent permitted by government regulations issued subject to the statutory legisla- tion. A basic principle of constitutional regulation should be that insurance companies, as is principally prescribed in current agreements between the insurance industry and the state, may only enquire after and use genetic information with respect to risky personal insurance policies involving very large sums of money. In contrast to what applies according to the agreement, insurance companies should not in the future be allowed to enquire after or use genetic information where insurance policies for children are concerned. In addition, there should be a raising of the upper limit above which genetic information may be used. At the present time there should thus not be any legitimate area of application in the general field for genetic information, apart from the field, the judicature and other areas that are subject to special regulation. Neither, with respect to any other private enter- prise in addition to those that already mentioned, is there any such legitimate area of use. However, it is the opinion of the committee that in the area of family life it can sometimes be legitimate to enquire after and make use of genetic information. proposes that it should be laid down in a new law on genetic integrity, that nobody may stipulate as a condition for entering into an agreement, that another party should undergo a genetic examination or submit genetic information about themselves. It is proposed that in the same legislation there should also be a general prohibition to the effect that without support in law, genetic information may not be sought after or used by anyone other than the person that the information is about. This applies even if the person concerned has given his or her consent to such an investiga- tion or use, but not if they themselves have requested it. Informa- tion that only contains data concerning the state of health of the person examined is beyond the scope of the application of the legisla- The customary regulations concerning patient confidentiality are deemed to be sufficient with respect to such information. If genetic information is sought after or used for purposes, for scientific or genealogical research or in order to obtain evidence for legal proceedings however, the proposed prohibition is not to be applicable. Exceptions are also to be made for those cases where genetic information is sought or used by a relative or someone close to the person concerned, provided the latter has given his or her consent to this. In those cases where an enquiry concerning genetic information merely consists of information about a persons bio- logical relatives, the prohibition shall only apply when the informa- tion is the result of a genetic examination that was carried out for purposes. These prohibitions should be enforced by a scale of penalties that includes fines or a term of imprisonment not ex- ceeding six months. In addition the committee proposes that where the insurance industry is concerned, the government should promulgate excep- tions from the regulations concerned in a new decree concerning the use of genetic information in the field of insurance. This would entail that insurance companies would be entitled to enquire after and use genetic information with respect to personal insurance poli- cies where the risk is evaluated if the insured is over 18 years of age and if the sum payable exceeds certain large amounts (30 Swedish standard base amounts for a one-off payment and four base amounts per year for regular payments). Insurance companies shall also be entitled to enquire after and use genetic information if it is needed for control purposes when an insurance claim has been made. Finally it is proposed that a confidentiality should be included in the Act (försäkringsrörelselagen [1982:713]) to the effect that an individuals circumstances with respect to an insurance company may not be revealed without autho- rization to do so. Who is to be permitted to carry out genetic examinations? It is the opinion of the committee that it is not possible to prevent laboratories that are not part of the health and care system from making available the results of various genetic tests when particular individuals ask them to do so. under the supervision of a Swedish public body is not feasible either. Kits that enable individuals to carry out genetic testing by them- selves, are being sold to the Swedish public from abroad via the Internet. Given the public interest in products of this nature and taking account of developments in other countries, it is not impro- bable that test kits will soon be marketed within itself. For various reasons, among them the difficulties in interpreting the results of a genetic test, it is not acceptable that such sales should take place to any greater extent without there being some form of supervision. proposes that genetic tests intended for selftesting should be subject to the Devices Act (lagen om medicin- tekniska produkter [1993:584]). The general regulations in the act concerning suitability would thus apply to the tests in question. The test will have to be suitable for the use to which it is put. This will be deemed to be the case if, when put to normal use for the purposes for which it is intended, it achieves the performance intended by the manufacturer and satisfies demanding criteria with respect to protecting the life, personal safety and health of patients, users and others. In addition the committee proposes that the investigates the possibility of producing a proposal for legislation that would require that there be insurance in order for a device to be marketed to the general public. Genetic examinations and genetic information with respect to the health service and care has published guidelines and recommendations with respect to genetic exami- nations. As far as people who are fully able to make decisions are concerned it is stipulated, among other things, that informed con- sent should always be obtained; that genetic information and coun- selling should be offered whenever tests are carried out; and that information should be given which provides facts that are as objective and adequate as possible. evaluations made and decisions taken should be left to the person being examined. As far as the testing of children is concerned, the guidelines mean, among other things, that custodians should be asked for their opinion and that account should be taken of the childs opinions and wishes on the basis of its age, maturity and development. In addition it is pointed out in the guidelines that genetic diagnostics can provide knowledge about hereditary diseases in the family that would be significant for siblings, for example. It is recommended that if no effective treatment for a particular disease exists, the child should not be subjected to pre- symptomatic testing before the child itself can give its informed consent as a result of increasing age, maturity and development. proposes that be authorized to issue regulations concerning genetic examinations with respect to the health service and care facilities, that essentially correspond its current guidelines for such examinations. It is presumed that will continue to monitor developments in the field and note any need for change. The emphasis in the regulations should be on genetic examinations that are not carried out with the intention of establishing the diagnosis of an illness. also proposes that a regulation should be incorporated into the new law on genetic integrity to the effect that a request for a genetic examination that is not medically motivated is to have no legal effect when put forward by a custodian of a child. Genetic screening is regulated in the law (1991:114) about the use of certain genetic techniques in the course of general examinations. In order to examine the human genetic make- up by analysing the deoxyribonucleic acid (DNA) or ribonucleic acid (RNA), the law requires special permission from if the examination constitutes, or comprises part of, a general examination. Permission may only be given if the examination is designed to acquire know- ledge about maladies that are serious in nature or are otherwise of particular significance as far as the health service and care are concerned. When the issue of permission is being scrutinised, a matter to be given particular attention is whether those who are to direct and carry out the investigation have the competence needed for the purpose and if it can be presumed that there is sufficient protection for the integrity of the information concerning the genetic circumstances of the participants in the examination. permit must be subject to those conditions needed to limit or control the examination. The intention of special regulation has been to protect indivi- duals from gratuitous encroachment upon genetic integrity. Given this background it is the opinion of the committee that it would be irrational to specify DNA and RNA analyses, since the same results can be achieved by using other methods. regulation in this area should, as a matter of principle, be neutral with respect to the method used. proposes that the requirement that a special permit be obtained in accordance with the law in question, should be exten- ded to include all examinations that constitute a general examination or are included as part of one, and which aim to acquire information about a persons genetic make-up by means of mole- cular genetics by using molecular-genetic, microbiological, bio- chemical, cytogenetic or comparable methods of analysis or by acquiring information about that persons biological relatives. It should be possible to exempt certain examinations from the require- ment that a permit be obtained. Moreover it is proposed that when the issue of a permit is vetted by , in addition to the current prerequisites for a permit, the board should especially take into consideration if the proposed examination is intended to demonstrate or exclude the risk of a disease that can be prevented or treated and if the examination can be presumed to indicate a palpably increased risk for the illness in question. The law is not considered to be applicable to exami- nations of foetuses, since special regulations are deemed to apply to prenatal examinations. Informing the relatives concerned According to the prevailing regulations concerning confidentiality, health-care professionals, nursing and staff may inform any affected relatives about the result of a genetic examination, but only if the person examined consents to this. does not propose any changes in this respect. The question then arises as to whether the relatives should be informed about the result of an examination. If so, should it be the responsibility of the person examined to convey this information to the relatives or should this task be carried out by the health service with the consent of the person examined? It is the opinion of the committee that each particular case should be judged on its merits. The Swedish parliament has adopted guidelines concerning foetal diagnostics. Among other things these guidelines state that infor- mation shall be offered and that certain groups shall be offered more detailed information. This is to contain information about the opportunities provided by prenatal diagnosis, the conditions that apply to the examinations and what the limitations and risks are. Admittedly there is scope for certain adjustments to the parliamen- tary guidelines, but they establish the principal aim that the enter- prise should have. It is the judgement of the committee that there is no need to formulate any new general guidelines. However, the increase in knowledge about the significance of genes makes it possible to implement prenatal diagnosis to a greater extent. considers that information about examinations for more specific purposes should primarily be offered to those risk- groups that have particular reasons for considering the examination in question. proposes that should be authorized to issue regulations concerning prenatal genetic diagnosis. Although general advice about prenatal diagnosis reflects the opinion of should prevail, the committee considers it important to issue regulations that are bin- ding (in contrast to the general advice). would then also be able to issue regulations to counteract an expansion of prenatal diagnosis that would generally be considered to be dubious. The general advice of should still provide guidance with respect to prenatal diagnosis in general. Apart from legal regulation there are a number of ethical questions that should be the subject of ongoing discussion when considering developments in the fields of research and treatment. The com- mittee proposes that ongoing discussions should take place under the auspices of . In addition the committee considers that of Health and Welfare should especially monitor the development of alternative methods to investigate the risk of Downs syndrome. Preimplantation genetic diagnosis (PGD) involves the genetic examination of a fertilised egg before it is transferred to a womans uterus to develop into a foetus. PGD may be performed for several purposes. One is the use of PGD to diagnose serious hereditary diseases. The purpose of the examination is to avoid passing on a specific disease-causing mutation to the next generation, which, given the knowledge about the genes or chromosomes of the parents, might be contained in a fertilised egg. Preimplantation genetic screening (PGS) is a new application of PGD that can be used to diagnose chromosomal abnormalities in fertilised eggs. The method has been introduced in order to increase the chances of pregnancy in those cases where this is reduced because of a womans advanced age, for example. PGD can also be used to ensure that a child-to-be has a genetic makeup that enables it to be a donor to a sibling with a serious disease. This is known as PGD/HLA for siblings of children with a serious disease. proposes that current guidelines with respect to PGD for the diagnosis of serious hereditary diseases should be amended as follows. Preimplantation genetic diagnosis (PGD) may only be used in the case of couples who carry the trait for a specific, serious monogenic or chromosomal hereditary disease that entails a high risk of having a child with a genetic disease or injury. The purpose of treatment should only be to prevent a child from inheriting traits for the disease or injury in question. It is not to be used in order to choose character- ristics. Prior to treatment the couple should be provided with detailed information, both written and oral, about the nature of the disease in question (prognosis, possibilities of treatment etc.), how great the risk of inheriting the condition is, how PGD is carried out and the advan- tages and disadvantages of PGD compared to alternative approaches. Given the current state of knowledge, PGS should not be deve- loped into a routine procedure, but should be restricted to clearly defined research projects that are preceded by an ethical evaluation by a board that deals with ethical matters pertaining to research. This will not prevent chromosomes from being studied in connec- tion with PGD to diagnose serious hereditary diseases. With respect to PGD/HLA, there are several questions that remain unresolved. Given the current situation, more data is required before a final decision can be taken. emphasizes how important it is that continues to deliberate on the subject. proposes that it should be the task of , taking account of the guidelines that have been mentioned, to issue regulations concerning PGD. All cases where PGD will be used shall be reported to . Pharmaceutical products and genetic analyses With the help of so-called pharmacogenetic tests, the genetic make- up of individuals can be analysed in order to predict which pharma- ceutical product would be most beneficial for them and which dose would give the best effect. The test is a form of genetic examination. It is the judgement of the committee that there are considerable advantages to genetic tests, the aim of which is to tailor the pre- scription of pharmaceuticals to the individual. Given appropriate development and correct application this will have major clinical significance and could result in considerable savings for the com- munity as well. For the time being the committee does not consider that any special regulation is called for concerning genetic analyses with respect to pharmaceutical products, over and above what is pro- posed for all genetic examinations. therapy on body cells is deemed to be ethically acceptable and permissible to carry out in on the basis of what is stated in the draft legislation pertaining to this field. However, the method must still be considered experimental and any clinical application is generally lacking. It is the opinion of the committee that until more experience of the method has been acquired, there is no reason to propose any special regulation of the issue. According to section 2 of the Act concerning measures taken for research and treatment involving the use of fertilised human eggs (1991:115), experiments for the purposes of research or treatment using fertilised eggs may not have the aim of developing methods to achieve genetic effects that may be hereditary. From section 4 of the same Act, it is clear that it is forbidden to introduce into a womans body, fertilised or unfertilised egg cells or sperms that have been subjected to experiments. From the regulations concerned it has hitherto been considered that in practice gene therapy on gametes is not permitted. It is the opinion of the committee that those issues targeted by the prohibition against research could be regulated in a more suitable fashion by an inquiry into the ethics of the research in question. proposes that it should no longer be forbidden to carry out experiments in the course of research for the purpose of developing methods to achieve genetic effects that can be inherited. The prohibition in section 2 of the Act of 1991 should therefore be struck out. On the other hand, attempting to achieve such effects in practice should still be forbidden. In order to remedy any possible defects in the latter prohibition, it is proposed that there be a regulation in the new law on genetic integrity that includes an express prohibition against methods of treatment, irrespective of their nature, the purpose of which is to achieve genetic changes that can be inherited. The solution recommended by the committee would open the way for research that would provide better knowledge in the future. At the same time it guarantees that methods of treat- ment with these effects cannot be brought into use without the issue becoming the subject of detailed consideration from the ethical viewpoint, among others, the basis of which is currently insufficient. Those who are to use, interpret and explain the test results from genetic examinations, need in-depth knowledge about the signi- ficance of heredity with respect to the origin of disease. Since there is, as a general rule, a palpable lack of knowledge about genetics in the field, (including specialist knowledge about ethics, counselling and so forth), additional efforts to improve the level of education are necessary. The general public also needs some basic knowledge about genetics. This makes it easier for individuals to understand and decide about genetic examinations and genetically determined diseases. proposes that the county councils ensure that doctors, nurses and other professionals within the health service are given the opportunity for further training within the areas in question to a level corresponding to the demands made upon these groups. In addition it is suggested that universities which train doc- tors should revise the courses on genetics given to trainee doctors and that universities and institutes of higher education that train nurses should implement basic courses in genetics for trainee nurses. also proposes that (via ment of Physicians in ) arranges a course for doctors under- going advanced training in order to enable them to learn more about clinical genetics. should also consider whether genetic counsellors and hospital geneticists should be able to obtain autho- rization and/or a professional title protected by law. Finally the committee emphasizes the importance of paying attention to genetic matters as part of the ongoing review of curricula and syllabi for the public educational system. The issue should also be taken into consideration as part of the current evaluation of whether the aims of the state with respect to the standard of general education have been achieved. Ratification of convention on Human Rights and Biomedicine It is the judgement of the committee that it is possible for to ratify the convention on human rights and biomedicine with respect to that part of the convention that touches upon the com- mittees mandate: namely the regulations concerning the human genome (articles 11–14), satisfactory protection for the embryo when research is carried out on the embryo in vitro (article 18.1) and the prohibition of financial gain and disposal of a part of the human body (article 21). However, as was proposed in the committees interim report (SOU 2002:119), should express its reser- vations with respect to article 18.2, the purport of which is that the creation of human embryos for research purposes is prohibited. The proposals submitted by the committee are in agreement with the other provisions of the convention. The committees proposals should not give rise to costs requiring additional appropriations with respect to the state or other public bodies. As far as any other consequences for public finances are concerned, developments in the field of insurance in particular should be carefully followed. It is presumed that the proposals will not result in any consequences of the type stated in section 15 of the Committee Ordinance (1998:1474). The proposed statutes should be able to come into force on 1 2005. No provisional regulations will be necessary. lag (2004:000) om genetisk integritet Härigenom föreskrivs följande. 1 § I denna lag avses med genetisk undersökning: en undersökning som syftar till att ge upplysning om en människas arvsmassa genom molekylärgenetisk, mikrobiologisk, biokemisk, cytogenetisk eller därmed jämförlig analysmetod eller genom inhämtande av upplysningar om hans eller hennes biologiska släktingar, genetisk information: information om resultatet av en genetisk undersökning, dock inte till den del informationen endast innefattar upplysning om den undersöktes aktuella hälsotillstånd. 2 § Ingen får ställa som villkor för att ingå ett avtal att den andra parten genomgår en genetisk undersökning eller lämnar genetisk information om sig själv. 3 § Genetisk information får inte utan stöd i lag efterforskas eller användas av någon annan än den som informationen avser. Detta gäller även om denne har gett sitt samtycke till sådant efterforskande eller användande men inte om han eller hon själv begärt det. Första stycket gäller inte, om genetisk information efterforskas eller används 1.för medicinskt ändamål, 2.för ändamål som har anknytning till vetenskaplig eller släkt- historisk forskning, 3.i syfte att erhålla bevisning i rättegång,