sou · H7B328 · 2019-06-05 00:00:00 — Sekretariatet har dessutom träffat varje expert i enskilda möten och experterna har lämnat skriftliga och muntliga synpunkter. En särskild arbetsgrupp har behandlat frågor kring psykisk ohälsa. Utredningen har i enlighet med direktiven samrått med (och ), Kommuner och Landsting (SKL), företrädare för ett antal landsting, berörda myndigheter och övriga aktörer inom området. Vi har också samrått med flera andra offentliga utredningar. Flera av våra förslag rör och myndighetens uppdrag har på olika sätt beröringspunkter med . Därför har vi haft flera möten med , som också haft en representant i utredningens expertkommitté. Utredningen har haft möten med norska Helseog omsorgsdepartementet och Helsedirektoratet samt med Styrelsen for Patientsikkerhed i , där erfarenheterna av norsk respektive dansk lagstiftning på KAV-området diskuterats. Därutöver har utredningen genomfört ett stort antal möten med personer verksamma inom /KAV-området, hälso- och sjukvården, företrädare för professionsföreningar, fackliga organisationer, forskning, intresseorganisationer, forskningsfinansiärer, patientorganisationer, media, försäkringsbolag och politiker. Vid de flesta av dessa möten har frågor som rör lagstiftningen tagits upp. För att slutföra tilläggsuppdraget om lagöversyn har vi anlitat tre externa rådgivare med särskild kompetens inom juridik och policyfrågor inom hälso- och sjukvård och KAV. Skriftligt underlag har inhämtats från juridisk litteratur, offentliga utredningar, gällande rätt och tidigare förarbeten samt från rättspraxis. Some of the inquiry’s proposals in brief: •Today, legislation on complementary and alternative care is included in the Patient . We propose that it is compiled in a new separate law, Act on Certain Restrictions in the to Professionally Provide Care. •The present prohibition for others than healthcare professionals to treat cancer, epilepsy and diabetes is replaced by a general prohibition to treat serious disorders, encompassing both somatic and mental disorders. Whereas treatment of serious disorders as such will be banned, interventions to relieve symptoms will be permitted. •Irrespective of the level of the seriousness of the disorder, investigation and treatment of disorders in children below the age of 15 years and of disorders during pregnancy will be prohibited. Interventions to relieve symptoms in children, pregnant women and during delivery will be permitted. •Surgical procedures, blood and tissue sampling that involve penetration of all layers of skin, general anaesthesia and injecttions as well as treatment of certain communicable diseases by others than healthcare professionals will be prohibited. Some of the present bans are outdated and are proposed to be discarded. •The penal provisions presently included in the Patient will be transferred essentially unchanged to the new law. However, a provision of penal responsibility for those who not only wilfully but also by negligence cause injury or risk of injury will be included. Lack of knowledge or experience will not be exempted from responsibility. The inquiry has been commissioned by the Swedish government to investigate a number of questions concerning care provided outside of regular healthcare. In the first report by the inquiry (SOU 2019:15), we reviewed and made proposals on some of the tasks that we were commissioned to investigate. This included information to the general public on complementary and alternative medicine () and care (CAC), a policy for the possible introduction of methods in healthcare, actions to improve the understanding between healthcare and CAC and to improve the position of people seeking CAC and their safety. In our first report, we also mapped Swedish and international and CAC research and Swedish education and training programmes to become a CAC provider. An English summary of the report is available at / rattsliga-dokument/statens-offentliga-utredningar/2019/03/sou- 201915/, pp. 31–46. In this final report, we present analyses and conclusions concerning legislation on complementary and alternative care. From the government’s first terms of reference: …to investigate whether the right to treat certain serious mental disorders for non-licenced healthcare staff should be limited. From the government’s additional terms of reference: The investigator is commissioned to review the regulations in the 5th and 10th chapters of the Patient and other legislations that are relevant to this task [...]. The investigator should also, as necessary, provide proposals for legislation. Fact Box 1. To comply with the government’s terms of reference, we have used operational definitions. Our definitions are close to those used in Norwegian and Danish legislation. The definition of healthcare is that of the Patient . Complementary and alternative medicine () is the conceptual and knowledge basis of complementary and alternative care (CAC). Complementary and alternative medicine/care means healthcare-related methods and other interventions that are entirely or mostly applied outside of healthcare. Integrative care aims at integrating complementary methods with the methods used in healthcare under certain conditions. Healthcare is care provided by professionals that are subject to inspection by , the Health and Social Care Inspectorate, and is based on either scientific evidence or proven experience among the healthcare professions. Proposal for a new law Presently, legislation on care in the healthcare field provided by others than licenced healthcare staff is included in the Patient (2010:659, 5th and 10th chapters). The inquiry has found this construction not to be purposeful. We, therefore, propose that the regulations are compiled in a new separate law. In our terms of reference, issues on patient safety and the individual’s possibilities to make well-informed choices of care are emphasised. In work on a new law, we have strived for a regulation that balances these two aspects on CAC. When reviewing the present legislation on CAC, we have identified several reasons to modernise it: (a) it is problematic that regulations of interventions by non-healthcare people are included in a law that otherwise concerns healthcare, (b) there is a need to modernise key regulations as to both content and form, (c) there are regulations that are outdated and therefore should be discarded, (d) inconsequences in the legislation have appeared over the years and should be corrected, (e) the present legislation is somewhat difficult to follow, not least concerning how the penal provisions are related to the lists of disorders forbidden to treat and methods that are forbidden to use. We thus propose a separate, modernised law on care provided outside of healthcare, termed as Act on Certain Restrictions in the to Professionally Provide Care. The law will encompass not only healthcare-related interventions but also dental care interventions. The Patient includes a number of prohibitions for nonhealthcare people to treat certain conditions or to use certain methods. We propose that the present ban on the treatment of cancer, epilepsy and diabetes is replaced by a general prohibition to treat serious disorders. Whereas treatment of serious disorders as such will be banned, interventions to relieve symptoms will be permitted. A definition of the term serious disorder is included in the new Act, and intervention aimed at symptom relief is delineated in the comments to the Act. Our inquiry has been commissioned to review if serious mental disorders should be a ”forbidden area” for the treatment outside of healthcare. The overriding ban on treatment of serious disorders that we propose will cover not only serious somatic disorders but also serious mental disorders. The Patient includes a ban on the treatment of those communicable diseases that are compulsory to report according to the Communicable Diseases Act (2004:168). We propose that this ban is preserved. Symptomatic treatment will, however, be permitted also in communicable diseases compulsory to report. With a few modifications of the corresponding provisions in the Patient , we propose that treatment of a disorder in conjunction with pregnancy and delivery should be prohibited, regardless of the seriousness of the disorder. Interventions aimed at relieving symptoms during pregnancy and delivery should, however, be permitted. Our inquiry emphasises that children should have special protection. Today, there is a ban for others than healthcare professionals to investigate and treat children below the age of 8 years. We propose that this is replaced by a prohibition to investigate and treat disorders in children below the age of 15 years, regardless of the seriousness of the disorder. Interventions aimed at relieving symptoms in children should, however, be permitted, irrespective of age. Presently, this is not permitted. We propose that preventive interventions should generally be permitted for CAC providers. Such interventions are, nevertheless, performed under legal responsibility, that is, injury or risk of injury that is not minor shall not be inflicted. Further, we propose that it should be forbidden for non-healthcare professionals to perform surgical procedures, blood and tissue sampling that involve penetration of all layers of skin, provide general anaesthesia and give injections. Other regulations that are in place make it unnecessary to transfer regulations on radiological treatment and testing of contact lenses to the new Act. Today’s bans of treatment under hypnosis and providing written advice without a face-to-face meeting appear to be outdated and are suggested to be deleted. Some of our proposals, primarily those on treatments aimed at symptom relief, will imply extended possibilities for CAC practitioners to intervene. Other proposals will imply more clearcut restrictions in the possibilities for CAC practitioners to offer certain services. The aim is to improve safety for those using CAC services and to clarify for CAC providers the legal frames within which they are allowed to work. The penal provisions presently included in the Patient will be transferred essentially unchanged to the new Act. However, a provision of penal responsibility for those who not only wilfully but also by negligence cause injury or risk of injury will be included. This will apply whether the injury or the risk is caused by inappropriate treatment or by interruption of treatment in healthcare. The penalty should be fines or a maximum of one year of imprisonment. Lack of knowledge or experience will not exempt from responsibility. Information and guidance on legislation Our proposals on new legislation will imply a greater responsibility for the individual CAC provider to make assessments needed for safe care. The branch organisations will have an important role to ensure that their members have the competence and education that is needed and that their members are well informed on the new legislation. We propose that the government commissions to develop guidelines on the legislation with CAC providers as the target group. In this work, appropriate governmental agencies and CAC organisations should be consulted. In addition, we propose that the Board, as an extension of the guideline work, initiates a dialogue with the CAC organisations on how they may adopt the guidelines to their respective areas. In our previous report (SOU 2019:15), we have presented suggestions on potential actions by the , including the possibility to make branch agreements with CAC organisations. Legal space for licensed healthcare professionals to use certain methods From the government’s terms of reference: The investigator shall […] report his assessment if the legal responsibility for healthcare staff to perform the work in accordance with scientific evidence and proven experience implies that there is room to use therapeutic methods solely based on evidence that the methods are safe. As stated in the Patient , healthcare professionals should conduct their work according to science and proven experience. Legal cases decided by the Supreme Administrative Court have, however, shown that he or she who deviates from science and proven experience may, in certain cases, escape delicensing or restrictions. Then, the only remaining possibilities for sanctions are of labour law nature. Other assessments by the inquiry During the work of the inquiry, we encountered a number of questions related to the regulation of complementary and alternative care that were not included in our terms of reference. We have not explored them more closely, but we find that they would need attention from the government. •To reinforce the position of CAC consumers/clients, their possibilities to complain should be improved. In this, the Health and Social Care Inspectorate (), the and the CAC organisations are important stakeholders. •The possibilities to make well-informed decisions should be strengthened by strict delineations between licensed and nonlicensed professionals. A review of the regulation on protected professional titles is required, especially regarding providers of various forms of psychotherapy. •The Patient includes special penal provisions for physicians and dentists who have been delicensed or otherwise restricted in their competence but who still practice. Weaknesses in this legislation have repeatedly been pointed out, but they have not been resolved. For instance, there is no regulation about delicenced healthcare professionals other than physicians and dentists. A review of the special penal provisions should be considered. •If the proposals of this inquiry are implemented they need to be followed up. few of the proposals by previous governmental inquiries on /CAC have been implemented. The implementation or not of the pragmatically oriented proposals will be dependent on political will, to a large extent. If our proposals are accepted by the government and the parliament, it is imperative that the implementation is followed up. Previous governmental inquiries and legislation From the 1950s and onwards, several governmental inquiries have addressed legal aspects of and CAC. Today’s legislation has its main roots in the Quackery Inquiry report Act on the to Practice Medicine (SOU 1956:29). This resulted in the Act on Prohibition Against Professional Activities in (1960:409). Largely, this regulation is valid currently, although it is now included in the Patient (2010:659). The 1960 Act included a ban for persons other than licensed healthcare professionals to treat certain disorders (cancer, epilepsy and diabetes) and to treat disorders during pregnancy and delivery. The Act also included prohibitions to provide treatment in writing without face-to-face consultation (what was then called ”quackery by the letter”), to provide general or local anaesthesia by injections and to treat during hypnosis or using radiological methods. A ban for non-healthcare people to treat children below the age of 8 years was introduced. The Act also included a general ban towards inflicting injury or risk of injury, linked to penal provisions. Ensuing inquires, (SOU 1989:60), New Regulation of Competence in the Healthcare Area (SOU 1996:138) and the Patient (SOU 2008:117) have suggested certain changes of the 1960 Act. For instance, proposals have concerned expansion of the prohibition to treat certain disorders, such as serious mental disorders, changes in age limits for treatment of children and modifications of other details of the Act. None of these proposals has been implemented. However, the regulations on investigation and treatment by others than healthcare professionals have been transferred from a separate law to, first, the Act on Professional Activities in the Healthcare Area (LYHS) and, from 2010 onwards, to the Patient . In 1999, was commissioned by the government to investigate if new overall legislation on the inspection of all psychological interventions was needed, that is, an inspection of all psychological interventions regardless of being conducted within or outside of healthcare. found no reason to introduce inspections by the state of providers of psychological treatments outside of healthcare. Concomitantly, was commissioned to review the need to restrict the right to treat certain serious mental disorders outside of healthcare. saw a number of difficulties in such restrictions, including delineation problems as to diagnoses, methods and patient groups. The conclusion was that it was not possible to find an unambiguous definition that targeted “the right patient group” and was legally manageable. Instead, the Board referred to the general regulation on penal provisions if injury or risk of injury was inflicted. Legislation in other Nordic countries Since the mid-2000s, , and have special legislations on CAC. In , only voluntary registration of providers of such care is regulated, whereas the specific legislation is more extensive in and . Common to these Nordic countries are restrictions for others than licensed healthcare professionals to provide CAC. For instance, in the three countries, it is prohibited to treat communicable diseases that confer risk for the public. In and , there are restrictions regarding treatment of serious disorders and the provision of surgical procedures or treatments that may confer a serious health risk for the patient. In both countries, there are, however, exemptions that permit others than licensed healthcare professionals to treat serious disorders under certain specified circumstances. Norwegian legislation permits interventions aimed at relief of symptoms also in people with serious disorders. In , some specified methods and interventions are reserved for licensed healthcare professionals. In addition, someone who is not a healthcare professional may not expose a client to a recognisable risk caused by a treatment. How we have worked The investigator appointed an expert committee with insights into (both proponents and an opponent), a representative of practitioners and representatives of governmental agencies, healthcare professions and healthcare providers. The investigator did not strive for consensus in the expert committee. Although the present report is partly based on discussions with expert committee members, they are not responsible for the content of the report. In addition to meetings with the expert committee and its individual members, they have commented on preliminary versions of the text. A special working group was appointed for questions on treatment of mental disorders. We have consulted the Affairs and the , governmental agencies concerned, representatives of regional healthcare providers and other stakeholders in the area. consulted other governmental inquiries working on topics potentially related to . Several of our proposals concern . We have therefore had several meetings with the Board, which also has had a representative in the expert committee. The experiences of national legislations have been discussed at meetings with Helseog omsorgsdepartementet and Helsedirektoratet in and Styrelsen for Patientsikkerhed in . In addition, we have had a large number of meetings with practitioners, healthcare professionals and their representatives, labour unions, researchers, research funding organisations, patient organisations, media, insurance companies and politicians. In most of these meetings, legislation issues have been discussed. To conclude the work on legislation, we have, in the final phase, consulted three external experts with special competence in healthcare regulations and CAC policy issues. Information was collected from legal literature, governmental reports, existing regulations and their preparatory work as well as court decisions. Regeringen tillsatte en utredning med flera uppdrag rörande ”annan vård och behandling än den som bedrivs inom den etablerade vården”. Utredningen antog namnet , där står för komplementär och alternativ medicin, den internationellt mest förekommande benämningen. I utredningen har vi använt uttrycket komplementär och alternativ vård (KAV) när vi avser det praktiska utövandet av . Dessutom har vi i utredningens arbete använt begreppet integrativ vård när KAV integreras med hälso- och sjukvård. Utredningen presenterade ett delbetänkande (SOU 2019:15). Där redovisade vi de uppdrag som handlade om information till allmänheten om och , policy för att föra in KAM-metoder i hälso- och sjukvården, insatser för att förbättra förståelsen mellan hälso- och sjukvården och den komplementära och alternativa vården samt åtgärder för att stärka den vårdsökandes ställning och patientsäkerheten. Delbetänkandet innehöll även kartläggningar av svensk och internationell forskning inom och samt av svenska utbildningar riktade mot KAV-aktörer. fick utredningen ett tilläggsuppdrag att se över den del av patientsäkerhetslagen som reglerar begränsningar i rätten för andra än hälso- och sjukvårdspersonal att vidta vissa hälso- och sjukvårdande åtgärder och de straffåtgärder som är knutna till dessa begränsningar. Detta uppdrag redovisas nu i detta slutbetänkande, tillsammans med uppdraget direktiv att ”utreda om rätten att behandla vissa allvarliga psykiska sjukdomar och störningar för den som inte är legitimerad hälso- och sjukvårdspersonal bör begränsas”. I arbetet med reviderad lagstiftning har vi sökt respektera de vårdsökandes rätt att själva välja den typ av vård de önskar, som vi sökt värna säkerheten för de vårdsökande, framför allt grupper med särskilt skyddsvärde, som barn. Bestämmelserna i tidigare lagstiftning har anpassats till dagens förutsättningar. Jämfört med gällande lagstiftning innebär våra förslag i vissa avseenden ökade behandlingsmöjligheter för KAM-utövare. För de allvarliga sjukdomar som inte omfattas av förbud innebär våra förslag vissa inskränkningar i behandlingsmöjligheterna. Utredaren bakgrund redovisades i inledningen till delbetänkandet. Till utredningen har en expertkommitté knutits. Även om betänkandet i många avseenden bygger på diskussioner med expertkommitténs medlemmar, har den särskilde utredaren ensam ansvaret för innehållet. 1.1Förslag till lag om vissa begränsningar i rätten att yrkesmässigt utföra vård Härigenom föreskrivs följande. 1 § Bestämmelserna i denna lag gäller när någon yrkesmässigt vidtar åtgärder i syfte att förebygga, utreda eller behandla sjukdomar. Vad som i denna lag sägs om sjukdomar gäller även med sjukdomar jämförliga tillstånd. Bestämmelserna i lagen gäller inte för den som enligt 1 kap. 4 § patientsäkerhetslagen (2010:659) tillhör hälso- och sjukvårdspersonalen eller för läkare eller tandläkare vars legitimation har återkallats eller vars behörighet annars har upphört eller begränsats. Förbud som avser behandling av vissa sjukdomar 2 § Det är förbjudet att behandla sådana smittsamma sjukdomar som enligt smittskyddslagen (2004:168) är anmälningspliktiga sjukdomar. 3 § Det är förbjudet att behandla allvarliga sjukdomar. Med allvarliga sjukdomar avses i första stycket sådana sjukdomstillstånd som med eller utan behandling inom hälso- och sjukvården uppfyller minst ett av följande kriterier: 1.tillståndet är livshotande, 2.tillståndet medför eller kommer att medföra en mycket omfattande funktionsnedsättning. Förbud som avser gravida och barn 4 § Det är förbjudet att utreda eller behandla sjukdomar i samband med graviditet eller förlossning. 5 § Det är förbjudet att utreda eller behandla sjukdomar hos barn som inte har fyllt . Förbud som avser användning av vissa vårdmetoder 6 § Det är förbjudet 1.att utföra kirurgiska ingrepp och provtagningar som inbegriper fullständig penetration av kroppens samtliga hudlager, och 2.att ge allmän bedövning och injektioner.