sou · H2B387 · 2014-12-19 00:00:00 — In accordance with Article 7 of Directive 2001/82/EC of Parliament and of code relating to veterinary medicinal products, the should be able to issue licences for the sale of pharmaceuti- cals for veterinary use that are not approved in but in another EEA state, if the health situation requires this. This possi- bility should be described in more detail in the Ordinance (2006:272). Matters concerning prescription databases and statistics The current national prescription database for animals should remain in place and the Swedish eHealth Agency should retain responsibility for the database. As to prescriptions for pharmaceuticals for animals, no special requirements for retail pharmacies prescription dispensing systems should be introduced. Retail pharmacies currently provide information to the Swedish eHealth Agency on prescriptions dispensed for animals. The Inquiry proposes that this become an obligation by law. should be instructed to review the prescription regulations (LVFS 2009:13) concerning which information should be required for a prescription for pharmaceuti- cals for animals to be considered valid. It should be specified in an ordinance that the Swedish eHealth Agency is to provide information to: veterinarians about their own prescriptions; county administrative boards for supervision of the veterinary prescription of pharma- ceuticals; and the for supervision of the obligation of retail pharmacies to provide pharmaceuticals for animals. We propose a new provision in the Act stating that the Swedish eHealth Agency is permitted to charge a fee to cover the costs of maintaining a national database of electronic prescriptions for animals. This fee should be charged to the licence holder. The government will decide on the amount of the fee. The Swedish eHealth Agency should continue to manage, com- pile and provide national pharmaceutical statistics on pharmaceuti- cals intended for animals. The Swedish eHealth Agency should be instructed to clarify which information on the sale of pharmaceuticals for animals it can provide and identify which additional statistical data should be collected. In line with its instructions, the Swedish eHealth Agency should also continue to charge fees for providing pharmaceutical statistics and systems for analysing such statistics. The Inquiry considers that this system can continue pending a review by the eHealth eHealth Agencys fees and financing model. Registration of certain information Under the remit, the Inquiry is to propose how Article 66.2 of Directive 2001/82/EC can be implemented in Swedish law with regard to all actors who have a licence to sell pharmaceuticals for animals. The Inquiry notes that the requirements of the Directive have already been largely met in Swedish law. Implementation of the requirements yet to be implemented should be achieved through amendments to the regulations. Veterinary provision of emergency doses should not be covered by the requirements for documentation under Article 66.2. Price, price pressure and price comparisons There should be greater awareness among animal owners and vet- erinarians that pharmaceutical prices can vary between pharmacies and that there are possibilities to compare prices. Pharmacies should strive to provide easily accessible price information. If changes are made to how prices and price information are dealt with concerning pharmaceuticals for human use not covered by the pharmaceutical reimbursement system, it should be consid- ered if pharmaceuticals for animals could be dealt with in the same way. The Inquiry considers that the supervision conducted by the Health and Social Care Inspectorate should also cover pharmacy staff who manufacture or dispense pharmaceuticals for animals or give advice or information. To make this clear for those concerned, the instructions of the Health and Social Care Inspectorate should state clearly that this is included in its supervision of health and care staff. Our proposals do not entail any major changes for animal owners. With regard to availability, the Inquiry highlights that measures such as the introduction of an obligation to provide information and search systems for in-stock status have also improved the situation for animal owners. The proposals on regulating information about the dispensing of pharmaceuticals for animals require measures by the Swedish eHealth Agency, the and , but they would improve opportunities for monitoring and supervision. It will only be possible to foresee the consequences for veterinarians and retail pharmacies following an analysis of what is to be reported and how this is to be done. For the Health and Social Care Inspectorate, the Inquirys proposals on clarifying supervisory responsibility indicate that its supervisory work may need adapting. Background and points of departure (Chapter 7) Dose dispensing means preparing pharmaceuticals for the needs of an individual patient for a given period by removing them from the manufacturers original packaging. Automated dose dispensing means that pharmaceuticals are repacked into dose bags that are labelled with information about the patient and the pharmaceutical product contained in the bag. Automated dose dispensing is regarded as manufacturing. Automated dose dispensing is procured by the county councils. The county councils previously had contracts with (the Pharmacies) for this. Three actors currently have contracts with individual county councils for the provision of automated dose dispensing. One hospital out automated dose dispensing for its own inpatient care needs. The number of patients who receive pharmaceuticals dispensed in doses (dose patients) has long been just under 200 000; many of these patients reside in the municipalities special forms of housing. The Swedish Prison and also procures automated dose dispensing. These pharmaceuticals are paid for in the same way as regular outpatient pharmaceuticals. The county councils pay the dose pro- viders for dose dispensing – known as the dose payment. This payment amounts to an estimated total of million based on the number of patients in 2011. The substitution rules in the pharmaceutical reimbursement system also apply to automatedly dispensed pharmaceuticals, but they are difficult and expensive to apply. Sometimes substitution does not occur, and so the savings the pharmaceuticals reimburse- ment system aims to achieve do not occur. The Inquirys point of departure was that the proposals sub- mitted are to help maintain good availability and support equitable care throughout the country, while ensuring that effective cost control is possible. Moreover, the Inquiry has endeavoured to use common solutions and to adapt the proposals as far as possible to the structures that apply to outpatient pharmaceuticals in general. Deliberations and proposals (Chapter 8) Automated dose dispensing should continue to be regarded as manufacturing under the Act (1992:859). Anyone wanting to conduct automated dose dispensing must have a licence from the . Licences may only be granted to those who have been granted a licence to run a retail pharmacy, or other care providers. In future too, applicants must be required to demonstrate that they are able to meet the requirements under Section 15, second paragraph of the Act. A licence is valid indefinitely and is issued to a particular retail pharmacy or, in the case of another care provider, a particular department for automated dose dispensing. Licences granted to care providers other than retail pharmacies may only meet the need for automated dose dispensing in inpatient care within that partic- ular organisation. The requirements concerning automated dose dispensing in the current regulations should remain in place. Only the retail pharma- cies conducting automated dose dispensing should have an obliga- tion to provide automatedly dispensed pharmaceuticals. However, the 24-hour rule should not apply to automatedly dispensed pharmaceuticals. The information regarding medication provided to the patient should be improved through requirements for medication reviews for dose patients. It is very important that all retail pharmacies conducting auto- mated dose dispensing compete on equal terms. The model of pharmaceutical substitution and the construction of the pharmacies retail mark-up in the pharmaceutical reimburse- ment system are not adapted to dose dispensing. The requirements concerning frequent changes in the range stocked when the pro- duct of the period is changed lead to practical problems and costs for actors dispensing doses. Another problem is that packaging intended only for automated dose dispensing may be the product of the period and must therefore be dispensed at regular retail pharmacies. However, the limited patient information provided with these pharmaceuticals means that they are not allowed to be dispensed to a patient by a retail pharmacy. The Inquiry has analysed alternative ways of addressing these problems. The Inquirys conclusion is that the pharmaceutical reimbursement system should continue to apply to automatedly dispensed pharmaceuticals, but that the substitution regulations should be adapted to doses. An actor involved in automated dose dispensing may substitute automatedly dispensed pharmaceuticals, but does not have to do so. A special pricing model, based on the lowest substance prices that the generic substitute would result in, should be applied to automatedly dispensed pharmaceuticals. This pricing model would mean that dose pharmacies must be allowed to negotiate the purchase price. If it is not considered possible to implement the Inquirys main proposal, one alternative may be to draw up a separate product of the period list intended to be used for automatedly dispensed pharmaceuticals. The current product of the period system will continue to apply and the substitution requirement will remain in place. Regardless of which model is chosen, the retail mark-up for automatedly dispensed pharmaceuticals should be reviewed. The Inquiry also describes three additional alternative ways of pricing pharmaceuticals for automated dose dispensing: allowing longer price periods for the product of the period; having retail pharmacies bear the cost when substitution does not occur; or the county councils taking over responsibility for automatedly dis- pensed pharmaceuticals, thus removing them from the pharma- ceutical reimbursement system. However, the Inquirys view is that the advantages of these alternatives do not outweigh the disadvant- ages. On the whole, the proposal on regulating automated dose dispen- sing would not entail any major changes for patients, county coun- cils and the actors currently conducting dose dispensing. The pro- posals for a new pricing model would mean more savings for the public sector than at present. The proposals would involve more administration for the Dental and . For the few dose dispensing actors currently in the market, this means that they would have the right to negotiate the purchase price for pharmaceuticals to be used for automated dose dispen- sing. The Inquiry considers that the right to negotiate would only have a negative impact on the market if the number of dose pati- ents increases considerably. Background and points of departure (Chapter 9) Orphan medicinal products are pharmaceuticals intended for pati- ents with rare and serious illnesses and defined as such under a special EU Regulation (141/2000/EC). These pharmaceuticals are often very expensive, especially as the development costs are spread across a very limited number of patients. The EU Regulation allows for favourable treatment of these pharmaceuticals in certain resp- ects. The number of orphan medicinal products is constantly rising. In 2013, the cost of orphan medicinal products amounted to million. To date, most applications for inclusion in the reimbursement system for orphan medicinal products have been approved by the Dental and , but in a few cases an application was rejected because the cost was considered too high. The current reimbursement system poses certain difficulties in dealing with both orphan medicinal products and other pharma- ceuticals for rare illnesses. The points of departure for the Inquirys deliberations and pro- posals have been to strive for good availability in the form of good access to relevant and crucial treatment, equal opportunities to receive care throughout the country, and cost control. Cost con- trol means having a system in place that meets the needs of public health care for a negotiating position and an effective role as buyer. In this respect, the Inquiry also considers it important to build on existing solutions and structures. Deliberations and proposals (Chapter 10) The Inquirys interpretation of the remit is that proposed solutions should focus on the problem of excessively high costs of pharma- ceuticals intended for very small patient groups with serious ill- nesses, even though these pharmaceuticals have not always been defined as orphan medicinal products. The Inquiry has identified three alternative courses of action to address the problem of high costs for pharmaceuticals intended for serious illnesses among small patient groups: maintain the existing pricing model, also for this group, but with a higher threshold than is currently accepted; design a special pricing model for carefully defined pharma- ceutical categories or patient groups; or create an alternative way of valuing and financing pharma- ceuticals that may not otherwise be used by the patients who need them. The Inquiry proposes that for certain pharmaceuticals that cannot be subsidised in the regular procedure, the possibility should be introduced to subsidise them under a special procedure. This would mean that the Dental and , toget- her with the county councils and the company concerned, would agree on more detailed terms for the subsidy decision. In such cases, the Dental and should be able to initiate special talks between companies and county coun- cils to agree on the terms that should apply for a pharmaceutical product to be included in the pharmaceutical reimbursement system and which price should apply. For the Dental and to take such an initiative, a pharmaceutical product considered not eligible for subsidy under the normal procedure must meet certain set criteria in terms of patient numbers, characteristics of the illness, long-term/lifelong treatment, lack of other relevant treatment, etc. However, this does not mean that such a pharmaceutical product would automatically be offered to a patient; it simply means that the product would be the subject of a special review. In this model, outpatient pharmaceutical products are distribu- ted through retail pharmacies and are included in the pharmaceuti- cal reimbursement system at a uniform price throughout the coun- try without needing to meet the conditions laid down in Section 15 of the Pharmaceutical Benefits Act (2002:160). Under the proposal, the Agencys decision would have to be linked to special terms. Examples of terms that may be relevant are follow-up requirements of various kinds, time limits, repayment due to lack of effect, renegotiation times for pricing, volume limits, etc. As the conditions of one pharmaceutical product can be completely different from those of another, it is important that there is scope for the parties involved to adapt the terms to the conditions in each individual case. In connection with the talks referred to in the proposal, the Dental and may need to disclose information submitted to it to the county councils and the appli- cant. The Inquiry proposes an amendment to the Public Access to Information and Secrecy Act (2009:400) so that the secrecy that applies to the Dental and Pharmaceutical Benefits Agency con- cerning such information would also apply to the county councils when information is disclosed to them. New opportunities will be created for equitable care for the patients affected and for better access for care providers to new and innovative treatments. As the number of pharmaceutical products affected by the proposal will be small – an estimated two to three per year – the Inquiry considers that the costs to the public purse for the pharmaceutical reimbursement system will increase only marginally. However, the Dental and will need to set aside resources for regulatory work, man- agement of the necessary negotiations and similar issues. Entry into force (Chapter 11) It is recommended that the proposals enter into force on 1 2016, with a few exceptions. Food and () Fördraget om Europeiska unionens funktionssätt Säkerhets- och utvecklingscentret för läkemedels- hälso- och sjukvårdslagen (1982:763) Inspektionen för vård och omsorg lagen (2007:1091) om offentlig upphandling lagen (1998:531) om yrkesverksamhet på hälso- och Nationella Funktionen Sällsynta Diagnoser Nationellt Produktregister för Läkemedel offentlighets- och sekretesslagen (2009:400) patientsäkerhetslagen (2010:659) personuppgiftslagen (1998:204) Quality-Adjusted Life Year, kvalitetsjusterat levnads- Tandvårds- och läkemedelsförmånsverkets författ- Nationellt produkt- och artikelregister lag om ändring i lagen (2002:160) om läkemedelsförmåner m.m. Härigenom föreskrivs i fråga om lagen (2002:160) om läkemedelsförmåner m.m. dels att 7, 13 och 25 a §§ ska ha följande lydelse, dels att nuvarande 21 a § ska betecknas 21 b §, dels att det i lagen ska införas fyra nya paragrafer, 7 c, 11 a, 15 a och 21 a §§ samt närmast före 21 a § en rubrik av följande lydelse. förmånsverket beslutar om ett förmånsverket beslutar om ett läkemedel eller en vara som avses läkemedel eller en vara som avses i 18 § ska ingå i i 18 § ska ingå i läkemedels- förmånerna och fastställer inköps- förmånerna och fastställer inköps- och försäljningspris som, pris och försäljningspris som, med de undantag som anges i med de undantag som anges i och 7 b §§, ska 7 a, 7 b och 7 c §§, ska tillämpas Regeringen, eller den myndighet som regeringen bestämmer, får meddela föreskrifter om hur inköpspris och försäljningspris ska fastställas. 1 Senaste lydelse 2009:373. Den som har tillstånd att bedriva maskinell dosdispenser- ing på öppenvårdsapotek får köpa in läkemedel som ska användas för maskinell dosdispensering till priser som understiger det inköpspris som Tandvårds- och läkemedels- förmånsverket har fastställt enligt 7 §. Tandvårds- och läkemedels- förmånsverket får för vissa läke- medel fastställa ett inköpspris och ett försäljningspris efter särskilda överläggningar med landsting och den som marknadsför läkemedlet. Myndighetens beslut får förenas med särskilda villkor. Regeringen får meddela före- skrifter om vilka läkemedel som omfattas av första stycket. En fråga om ändring av ett tidigare fastställt inköpspris eller försäljningspris får, förutom på eget initiativ av , tas upp av myndigheten på begäran av den som marknadsför läkemedlet eller varan eller av ett landsting. Den som begär ändringen har även rätt till överläggningar med myndigheten. Om överläggningar inte begärs, eller om överlägg- ningarna inte leder till en överenskommelse, kan myndigheten fastställa det nya inköpspriset eller försäljningspriset på grundval av tillgänglig utredning. Regeringen eller den myndighet som regeringen bestämmer får meddela föreskrifter om förutsättningar för ändring av inköpspris och försäljningspris för ett läkemedel som ingår i läkemedels- förmånerna om det 2 Senaste lydelse 2014:460. 1. har gått efter det att 1. har gått efter det att läkemedlet godkänts för försälj- läkemedlet godkänts för försälj- som marknadsförs till öppen- som marknadsförs till öppen- vårdsapotek i , eller 3. är fråga om ett läkemedel som ska användas för maskinell Om ett receptbelagt läkemedel inte uppfyller kraven i 15 § ska det ändå omfattas av läkemedels- förmånerna om Tandvårds- och het med 11 a § fastställer ett inköps- pris och ett försäljningspris för läke- medlet. Regeringen eller den myn- dighet som regeringen bestämmer får meddela föreskrifter om vilka förutsättningar som ska gälla för att ett sådant läkemedel ska ingå i läkemedelsförmånerna. Utbyte av maskinellt dosdispenserade läkemedel Ett öppenvårdsapotek som bedriver maskinell dosdispensering får byta ut ett läkemedel som har förskrivits inom läkemedels- förmånerna och som ska användas för maskinell dosdispensering mot ett läkemedel som det är utbytbart mot. Utbyte får dock inte ske om den som har utfärdat receptet på medicinska grunder har motsatt sig utbyte. Regeringen eller den myn- dighet som regeringen bestämmer får meddela föreskrifter om utbyte av maskinellt dosdispenserade läkemedel. får ta ut en sanktions- avgift av den 1. som har tillstånd att bedriva öppenvårdsapotek om öppen- vårdsapoteket inte byter ut läkemedel enligt bestämmelserna i 21 § eller enligt föreskrifter som har meddelats med stöd av 21 §, eller 2. som har ett godkännande 2. som har ett godkännande för försäljning som inte till- för försäljning som inte till- handahåller ett läkemedel enligt handahåller ett läkemedel enligt 21 a § eller enligt föreskrifter 21 b § eller enligt föreskrifter som har meddelats i anslutning som har meddelats i anslutning till 21 a §. till 21 b §. får besluta att ta ut sanktionsavgift av någon endast om denne, från det att överträdelsen ägde rum, har delgetts en underrättelse om att myn- digheten överväger att fatta ett sådant beslut. Innan en sanktions- avgift tas ut ska den som avgiften gäller ges tillfälle att yttra sig. Sanktionsavgiften tillfaller staten. Denna lag träder i kraft . 3 Senaste lydelse 2014:460. lag om ändring i lagen (2009:366) om handel med läkemedel Härigenom föreskrivs att 2 kap. 6 §, 6 kap. 1 och 2 §§, 8 kap. 1, 2, 2 a och 5 §§ lagen (2009:366) om handel med läkemedel ska ha följande lydelse. Den som har tillstånd enligt 1 § att bedriva detaljhandel med läkemedel till konsument ska 1.ha lokalen bemannad med en eller flera farmaceuter under öppethållandet, 2.bedriva verksamheten i lokaler som är lämpliga för sitt ändamål, 3.tillhandahålla samtliga förordnade läkemedel, och samtliga förordnade varor som omfattas av lagen (2002:160) om läkemedels- förmåner m.m., 4.ha en läkemedelsansvarig för , 5. vid expediering av en för- skrivning lämna de uppgifter som anges i 8 § lagen (1996:1156) om receptregister till E-hälsomyn- digheten, 5. vid expediering av en för- skrivning för människa, till E- hälsomyndigheten lämna de upp- gifter som anges i 8 § lagen (1996:1156) om receptregister och vid expediering av en förskrivning för djur de uppgifter som krävs för en sådan expediering, 6.ha ett elektroniskt system som gör det möjligt att få direkt- åtkomst till uppgifter hos , 7.till lämna de uppgifter som är nöd- vändiga för att myndigheten ska kunna föra statistik över detalj- handeln, 4 Senaste lydelse 2014:462. 8.utöva särskild kontroll (egenkontroll) över detaljhandeln och hanteringen i övrigt och se till att det finns ett för verksamheten lämpligt egenkontrollprogram, 9.på begäran utfärda intyg enligt 3 a § lagen (1992:860) om kontroll av narkotika, 10.på begäran erbjuda konsumenter delbetalning av läkemedel och varor som omfattas av lagen om läkemedelsförmåner m.m., 11.tillhandahålla individuell och producentoberoende information och rådgivning om läkemedel, läkemedelsanvändning och egenvård till konsumenter samt se till att informationen och rådgivningen endast lämnas av personal med tillräcklig kompetens för uppgiften, 12.ha ett för registrerat varumärke för öppen- vårdsapotek väl synligt på , och 13.i de fall tillståndshavaren inte direkt kan tillhandahålla ett läkemedel eller en vara som avses i 3, informera konsumenten om på vilket eller vilka öppenvårdsapotek läkemedlet eller varan finns för försäljning. Endast den som har fått Endast den som har fått ering på öppenvårdsapotek. Ett tillstånd får beviljas endast