sou · GMB328 · 1999-01-01 00:00:00 — Lagen bör lämpligen träda i kraft när avtalet mellan staten och Apoteksbolaget upphör att gälla. Det nuvarande avtalet gäller, som dess lydelse får förstås, t.o.m. , om det inte sägs upp . Genom den föreslagna lagen upphävs de gällande, centrala författning- arna på läkemedelsområdet. Beslut som fattats med stöd av de upphävda författningarna skall tillämpas som om besluten före lagens ikraftträdande fattats med stöd av motsvarande bestämmelser i lagen. Regeringen bemyndigas att med- dela föreskrifter om annan ordning. Regeringen kan delegera före- skriftsmöjligheten till den myndighet som närmast ansvarar för det område av läkemedelsförsörjningen som frågan hör under. Genom regeln klargörs hur eventuella, kvarstående hänvisningar till föreskrifter som ersätts genom föreskrifter i den nya lagen skall tydas. Det finns nämligen anledning att räkna med att det kan bli svårt att i ett sammanhang se över alla de hänvisningar av detta slag som före- kommer. Strävan bör dock givetvis vara att man under följdlag- stiftningsarbetet ser över så många som möjligt av hänvisningarna och anpassar dem till den nya lagen innan den träder i kraft. För det fall har meddelat beslut före ikraft- trädandet skall äldre bestämmelser tillämpas beträffande överklagande av beslutet och prövningen i överinstans. Det innebär att regeringen skall pröva sådana beslut. Apoteksbolagets rätt enligt lagen (1996:1152) om handel med läke- medel m.m. skall gälla som tillstånd enligt den föreslagna lagen intill dess att tillstånd erhållits. Den rätt för bolaget som avses är dess möjligheter att bedriva detaljhandel med läkemedel eller att driva sjukhusapoteken innan tillstånd enligt den föreslagna lagen för sådana verksamheter har hunnit behandlas av . Ifrågavarande rättigheter gäller dock längst till utgången av det tredje året efter lagens ikraftträdande. Sanktioner avseende dessa tillstånd prövas enligt den nya lagen redan från och med ikraftträdandet. Likaså skall avgifter uttas redan från och med . Möjligheten för Apoteksbolaget att enligt 16 § läkemedelslagen (1992:859) på apotek tillverka läkemedel för ett visst tillfälle utan särskilt tillstånd upphör i och med den nya lagen. För att sådan verk- samhet inte skall behöva avbrytas vid lagens ikraftträdande i väntan på tillstånd, föreskrivs att ifrågavarande rättigheter skall gälla efter ikraftträdandet. Sanktioner avseende sådant tillstånd prövas enligt den nya lagen redan från och med ikraftträdandet. Enligt den föreslagna lagen skall verksamhetschefen för ett apotek eller ett sjukhusapotek vara apotekare. Vid lagens ikraftträdande finns i Apoteksbolagets anställning apotekschefer som inte uppfyller dessa krav. Dessa personer kan genom övergångsbestämmelsen kvarstå i sådana befattningar om det företes ett intyg om att de vid lagens ikraftträdande var apotekschefer. Sålunda kan en sådan person byta tjänst till att vara chef för annat apotek än det som han eller hon förestod vid lagens ikraftträdande. Rätten att enligt förevarande bestämmelse vara verksamhetschef är således personlig och inte knuten till den aktuella tjänsten. Enligt 9 kap. 8 § tredje stycket skall apoteksombud ha särskilt tillstånd till försäljning av receptfria läkemedel. Den rätt som ett apoteksombud f.n. har att sälja receptfria läkemedel skall gälla som tillstånd enligt den föreslagna lagen intill dess att tillstånd erhållits. Ifrågavarande rättighet gäller dock endast efter ikraftträdandet. Sanktioner avseende sådant tillstånd prövas enligt den nya lagen redan från och med ikraftträdandet. Likaså skall avgifter uttas redan från och med . 13.2Förslaget till Lag om ändring i lagen (1994:953) om åligganden för personal inom hälso- och sjukvården Ändringsförslaget är en följd av förslaget till avmonopolisering av apoteksverksamheten. All personal inom sådan verksamhet, oavsett om denna bedrivs av Apoteksbolaget eller någon annan, som tillverkar eller expedierar läkemedel eller lämnar råd eller upplysningar skall anses som hälso- och sjukvårdspersonal. Detsamma gäller för personal vid sjukhusapoteken, liksom för personal vid den särskilda giftinforma- tionsverksamheten. bereds ett förslag års behörighetskommitté (SOU 1996:138) om legitimation för apotekare och receptarier. Skulle sådan legitimation införas måste före- varande bestämmelse ändras (jfr 1 § första stycket 1). har f.ö. lagt ett förslag till lag om yrkesverksamhet på hälso- och sjukvårdens område, vilken avses ersätta bl.a. åliggandelagen. 13.3Förslaget till Lag om ändring i lagen (1991:425) om viss uppgiftsskyldighet inom hälso- och sjukvården Ändringsförslaget innebär att inte är mottagare för uppgifter som lämnas med stöd av denna lag. I stället har uppgifts- skyldigheten i förhållande till reglerats i förslaget till 7 kap. 3 § lagen om läkemedelsförsörjning. 13.4Förslaget till Lag om ändring i sekretesslagen (1980:100) Ändringsförslaget följer av förslaget i 7 kap. 3 § lagen om läkemedels- försörjning rörande biverkningsrapportering. Biverkningsrapport- eringen till föreslås alltså inte regleras i lagen (1991:425) om viss uppgiftsskyldighet inom hälso- och sjukvården. Biverkningsrapporteringen har behandlats i avsnitt 10.3. Förevarande ändring avser att inom det allmännas verksamhet möjliggöra uppgifts- skyldigheten enligt såväl den sistnämnda lagen som 7 kap. 3 § lagen om läkemedelsförsörjning. Ändringsförslaget är föranlett av utredarens förslag att i lagen om läkemedelsförsörjning inta frågor om prisreglering av produkter inom läkemedelsförmånen. Förslaget innebär inte någon ändring i sak. 13.5Förslaget till Lag om ändring i lagen (1992:860) om kontroll av narkotika Förslaget innebär att undantaget från kravet på tillstånd avseende beredningar på apotek med narkotiska ämnen som verksamma beståndsdelar har utgått. Förslaget föranleds av att utredaren i 5 kap. 2 § lagen om läkemedelsförsörjning föreslagit att tillstånd för yrkes- mässig tillverkning av läkemedel skall omfatta även tillverkning på apotek. Bestämmelsen föreslås få ny lydelse enbart med anledning av förslaget till ny lag om läkemedelsförsörjning. Den nuvarande lydelsen hänvisar till lagen (1970:205) om detaljhandel med läkemedel. Den lagen upphörde att gälla , då lagen (1996:1152) om handel med läkemedel trädde i kraft. Den senare lagen innehåller dock inte någon övergångsbestämmelse motsvarande den i fjärde punkten över- gångsbestämmelserna till förslaget till lag om läkemedelsförsörjning. Den föreslagna lagändringen bör därför komma till stånd. Någon ändring i sak är inte avsedd. 13.6Förslaget till Lag om ändring i förordningen (1968:70) med vissa bestämmelser om injektionssprutor och kanyler Bestämmelsen föreslås få ny lydelse enbart med anledning av förslaget till ny lag om läkemedelsförsörjning. Den nuvarande lydelsen hänvisar till lagen (1970:205) om detaljhandel med läkemedel. hörde att gälla , då lagen (1996:1152) om handel med läkemedel trädde i kraft. Den senare lagen innehåller dock inte någon övergångsbestämmelse motsvarande den i fjärde punkten över- gångsbestämmelserna till förslaget till lag om läkemedelsförsörjning. Den föreslagna ändringen i förordningen bör därför komma till stånd. Någon ändring i sak är inte avsedd. The Commissions remit is defined in its terms of reference (Dir. 1996:119), which, according to my interpretation, lay down three principal tasks: -to define objectives for future supply of medicinal products, -to propose a future organisation for the distribution of medicinal products, and -to analyse the forms of future drug information and propose guidelines for the same. The supply of medicinal products is a many-sided issue and can be viewed in a variety of perspectives, e.g. , logistical (transport- related), commercial or distributive. A brief, overall description of medicinal product supply should start with the needs of the patient. Examination of a patient can result in a physician prescribing a certain treatment and making out a prescription for a medicine. Doctors generally have a free right of prescription, i.e. can decide in favour of any medicinal product whatsoever. There are other prescribers - e.g. midwives, district nurses and dentists - whose prescriptive powers are in some cases restricted. Veterinary surgeons have full powers of prescription concerning drugs for veterinary use. In order for the use of a medicinal product to be permitted in , the product must have been approved, for sale, by the . has a pharmaceutical industry of its own, but most of the medicinal products on sale in are imported. Armed with his or her prescription, the patient turns to one of the 900 or so pharmacies in , where the medicine required can be supplied either instantly or within 24 hours. The patient himself can choose a non-prescriptive medicine; these too are approved by the . Swedish pharmacies, unlike those of most other countries, are owned by a State-owned retailing monopoly, Apoteksbolaget AB121. At present the State owns two-thirds of Apoteksbolaget, the remaining one-third being held by Apoteksbolagets pension foundation. Each pharmacy has one or more pharmacists (pharmaceutical or dispensing chemists) who are responsible for safe distribution, which among other things means supplying the customer with the right medicine. The pharmacists also supply with information about medicinal products and their use. Distribution from manufacturer to pharmacy is managed by wholesalers. In-patients receive their medicines through hospitals. authorities are now entitled to purchase medicinal products directly from manufacturers. In this respect Apoteksbolaget no longer has a monopoly of sales, just as it has no monopoly of naturopathic medicines; the latter can be sold through other retail outlets besides pharmacies. To enable all patients to afford the most efficacious medicine they need, the main cost of prescribed medicines is defrayed through medicinal benefits. As from 1st January 1998, this expense devolves entirely on the country councils, although for a transitional period the benefit is being State-financed. Medicinal products are supplied entirely free of charge to in-patients. The responsibilities of concern the supervision of prescribers and their medication decisions and, secondly, the follow-up and evaluation of the use made of medicinal products, e.g. by prescribers, pharmacy personnel and other health care and personnel, as well as by patients themselves. The responsibilities of the focus on the products, but are also problem-oriented and are concerned with ensuring that medicinal products used in are safe and efficacious. also evaluates and follows up drug use, e.g. through the notifiability of adverse effects. In the course of this inquiry my aim has been to view medicinal product supply in a holistic perspective rather than to focus on each individual aspect or stage of supply. I have in particular been guided by two of approach: ·putting the individual first, and 121 Called as from 1st January 1998, but for present purposes referred to by its old name. The main emphasis of official inquiries in recent years has been on certain particular aspects, though general conspectuses of the system as a whole have also been presented, e.g. in !POTEKSBOLAGETS FRAMTIDA ROLL (Ds 1995:82) and /MSORG OCH KONKURRENS (SOU 1994:110), both of which focused on the status of Apoteksbolaget, and 2EFORM P¥ RECEPT (SOU 1995:122), which was mainly concerned with changes in medicinal benefits. The terms of reference for this inquiry emphasised a particular aspect, namely the distribution process, but also allowed scope for a wide-ranging approach. I have endeavoured to indicate a number of respects in which the overall supply system may be in need of development. The economic perspectives are indicated by the terms of reference. I have supplemented that perspective with a flow- analytical approach with the aid of which one can consider the respects in which control is in need of reinforcement. Strong emphasis on putting people first is prompted by the excessive ease with which attention, where professional and official environments are concerned, can be made to focus on technocratic aspects and lines of demarcation between specialities and . Changes are liable to result in tactical thinking and demands for compensation on the part of various interests feeling themselves to have been overlooked. Instead the focus of attention must be on the needs of the individual 'ENERAL OBJECTIVES CHAPTER ·As I see it, these objectives should be defined from the following POINTS OF DEPARTURE: -The statement in Section 2 of the Health and Act concerning good health and care on equal terms for the entire population, -overarching health policy and economic assessments as a basis of medicinal development, -the need for greater knowledge concerning the use of medicinal products, and especially physical use of medicinal products in out- patient care, and the cost of these products. I propose the following OVERARCHING OBJECTIVES for the medicinal sector: - a secure supply of safe, efficacious medicinal products, -appropriate use of medicinal products -at the lowest possible cost to the economy. The following MEANS, and the ends associated with them, described important strategies for achieving the overarching objectives of medicinal product supply: -The distribution of medicinal products shall be flexible, efficient and safe. -The approval of medicinal products shall provide access to safe and efficacious medicinal products of good quality. -Control and supervision shall effectively ensure that production, distribution, handling and consumption are safe and of high quality. -Relevant, properly understood and accepted information about medicinal products shall be available both to prescribers and to consumers. -The aim is for civic use of medicinal products to have the desired effect. -Medicinal benefits shall help to safeguard the health of the individual and provide the individual with economic support in connection with extensive medicinal products use, shall meet the requirements of health care policy and shall allow the true cost of medicinal products to impact as far as possible. The objectives for the medicinal sector are to a great extent also applicable to regional authorities. In addition, the latter can be said to have objectives of their own within their fields of responsibility. 4HE RESPONSIBILITIES OF THE 3TATE IN THE MEDICINAL CONTEXT are above all concerned with ensuring ·that patients are assured of safe, efficacious and readily available medicinal products at reasonable prices, ·that safety and quality are high at all stages of supply, i.e. in manufacture and distribution as well as in prescription, handling and consumption, ·that the medicinal products subsidy is used efficiently and furthers the achievement of the objectives of health care policy, ·that commercial and competitive thinking is applied in order to ensure logistical efficiency, at the same time as provision is made for the objectives of health care policy, ·that there is an appropriate allocation of responsibilities between the different agencies. ·The Medicinal Products Committees should be responsible for regional drug information to health care and personnel within their field of responsibility. That responsibility should be statute-codified. ·The lists and recommendations compiled by the Committees concerning medicinal products should be collated in a national conspectus. ·Patients shall be given adequate information about relevant medication in conjunction with treatment and consultations. ·Persons with special medicinal knowledge, particularly dispensing chemists and clinical pharmacologists, should take part in the provision of information for patients by services, as consultants to other personnel and, in certain connections, by informing patients directly. ·A certain amount of theoretical and practical information training should be added to the training of pharmacists. ·Civic use of medicinal products should be systematically and continuously followed up with the aid of accepted scientific methodology and should, for example, include collective national sample studies, register studies and targeted qualitative studies. -EDICINAL PRODUCT PROFILES CHAPTER ·At the pharmacy, all patients receiving medicines on prescription shall be offered the possibility of having the dispensation of the medicinal products recorded and stored, to keep the information available for subsequent, advisory, use with the patient concerned. %XPOSURE TO COMPETITION CHAPTER ·Apoteksbolaget is to be retained as a State-owned enterprise but exposed to competition, both locally and in the form of new technology, e.g. remote sales at national level. ·The influence of regional authorities is guaranteed through their decision of regional price lists for distribution services, possibly on different levels for different parts of a region, depending on each regional authoritys availability policy. ·Acceptable rural services will in future be guaranteed through a national undertaking to finance rural services, primarily through a special prescription charge. Services in rural areas shall normally be a responsibility of regional authorities and shall be realised through the authorities offering favourable price lists to those wishing to open pharmacies in rural areas. In the case of certain counties with large, sparsely populated rural areas, support for services of this kind will need to be a national commitment. ·The regional authority will be at to appoint for a hospital dispensary a management other than that of the authority itself or Apoteksbolaget. ·In order to facilitate a gradual and properly controlled exposure to competition, it is proposed that the scope for sales of non- prescription medicines outside pharmacies should not be enlarged for the time being. ,ICENSING REQUIREMENTS CHAPTER ·It will be possible for pharmacies to be owned by both natural and legal persons. ·A pharmacy shall be headed by a manager who shall be a pharmaceutical chemist or, for a transitional period, a dispensing chemist. ·A dispensing chemist or another person with higher pharmaceutical training shall be available in the pharmacy. ·The pharmacy shall have appropriate premises and equipment, shall be able to make up certain basic preparations and shall have computer equipment of good quality. ·It shall be the duty of pharmacies to supply medicinal products and prescribed disposable articles at the earliest possible opportunity. ·Remote purchasing of medicinal products shall be possible if there is no risk involved of harm to human beings, animals or the environment. ·Pharmacy agents in localities with no pharmacy shall be allowed to sell certain non-prescription medicines on behalf of pharmacies. Pharmacy agents will otherwise be entitled to procure medicinal products made up by pharmacies. ·The opening of a pharmacy shall be subject to an application fee. In addition, the pharmacy shall pay an annual charge. These charges shall be low. ·The proposed Supply Act should be made to include rules requiring professional practitioners in both privately and publicly provided care to report to the any adverse effects of drugs and other products to which the Act applies. ·In the longer term, pricing of medicinal products should be derestricted in the sense that payments to manufacturers should not be fixed by the State, even as regards discounted medicines. A national authority should, on the other hand, be empowered to intervene against unreasonably high prices. ·The price paid by the customer consists of the purchase price of the product and a special payment for the dispensing service. ·It is proposed that the principle of uniform sale price to the general public be altered in such a way that the pharmacies may not sell products at a price exceeding the sum total of cost price and payment for basic pharmacy services (handling charges). It is proposed that the price of basic pharmacy services be made variable, both from one county council area to another and in one and the same county council area. ·Remuneration for the distribution service may not exceed the price fixed by the county council. ·Generic substitution should be introduced, in the sense of pharmacies being entitled, on the patient so requesting after being informed by the pharmacy, to choose a cheaper generic medicinal product, unless the prescriber has determined that no such substitution is to take place. ·The 25 per cent mark-up to which veterinary practitioners are entitled by resolution of should be substantially reduced or, if possible, converted into a true cost reimbursement in connection with an executory procedure. ·It is proposed that, as far as is possible, all prescriptions be e-mailed as from the year 2001. ·In a more long-term perspective, the grounds for continued State ownership of Apoteksbolaget may need to be reappraised. 3TRUCTURE OF AUTHORITIES CHAPTER ·It is proposed that the central statutory instruments relating to the medicinal products sector be gathered into a Supply Act. ·Official sectorial functions to be allotted to the central authorities include the following: -definition and follow-up of national medicinal policy objectives and other sectorial official functions in the medicinal products sector, -approval and control of medicinal products, quasi-medicinal and medico-technical products, -sanctioning and supervision of wholesale and retail trading as part of the distribution process, -supervision of the distribution and use of medicinal products as a part of health care and services, -national price controls (in collaboration with authorities) concerning products included in medicinal benefits, -national responsibility for following up medicinal benefits, -main central responsibility for national medicinal information to prescribers and consumers -monitoring of all aspects of the use of medicinal products, including their handling and consumption by patients, and -the statistical supply and record maintenance responsibility at present devolving on Apoteksbolaget. -It is proposed that supervision of the pharmacies be apportioned in such a way as to include considerable elements of co-operation between the and . Among other things, this means both authorities being responsible for the supervision of the pharmacies, from their respective points of departure, the pharmacies are regarded both as a part of health care and as part of the distribution chain. ·Supervision of medicinal products highlights the need for a concerted health and care authority, but this question requires further investigation in order to establish a basis for decision-making. ·An inquiry should be made concerning the feasibility of transferring the Medico-Technical Section of , which is responsible for market control and supervision of medico-technical products, to the , so as to achieve a clearer line of demarcation between the two national authorities. ·It is proposed that the either be organised as a foundation with part-financing from the enterprise sector (pharmaceutical industry and chemical industry) or be constituted as a separate authority under the Welfare. #ONSEQUENCES AND FUNDING CHAPTER ·The effects of exposure to competition and connected changes will be followed up through biennial evaluations. The following questions may need to be kept under special observation: -changes in the availability of medicinal products in different types of community and the possibility of maintaining an acceptable standard of service with regard to both rural communities and semi- central locations, -the development by the regional authorities of a rural policy capable of forming the basis of a State-administered system of charges, -the safety and quality of distribution, -price movements, -distribution costs, -the provision made for demand for ex tempore and other preparations.