sou · H1B323 · 2013-04-05 00:00:00 — Utredningen bedömer att försäljningssynergier kan förekomma, men i begränsad utsträckning. Till tänkbara kostnadssynergier hör bl.a. möjligheten för aktörer med stora inköpsvolymer att förhandla sig till bättre inköpspriser på läkemedel. Det finns flera omständigheter som talar för goda förut- sättningar för konkurrens: Flera nya aktörer har vunnit upphandlingar, vilket bl.a. tyder på överkomliga inträdesbarriärer. Konkurrens inom alla tjänsteområden. marknadsandel minskar betydligt –2014. Prispress och minskade kostnader för landstingen. Det finns dock även omständigheter som indikerar att konkurrensen är begränsad och att det råder en viss osäkerhet om den fortsatta utvecklingen: Få aktörer som lämnar anbud i varje upphandling. har vunnit flertalet av de senaste upp- handlingarna och har fortsatt en mycket stor marknadsandel. Geografiska skillnader när det gäller antalet aktörer som deltar i upphandlingar. Efter att alla landsting upphandlat eller tagit ställning till hur sjukhusens läkemedelsförsörjning m.m. ska skötas kan utvecklingen väntas stanna upp . Utredningens sammantagna bedömning är att viktiga steg har tagits mot en marknad med väl fungerande konkurrens. Det kan dock inte uteslutas att ställning på marknaden har en hämmande effekt på andra aktörers möjligheter att konkurrera. Vid utredningens fortsatta överväganden om tänkbara förslag och bedömningar har utgångspunkten varit att de så långt möjligt ska stödja följande mål: goda förutsättningar för väl fungerande konkurrens på hela apoteksmarknaden (inklusive goda förutsättningar för både små och stora aktörer) bevarande av det värde som staten byggt upp i låga läkemedelskostnader för samhället och låga kostnader för landstingens läkemedelsförsörjning säker och ändamålsenlig läkemedelsförsörjning och läkemedels- användning Utredningen bedömer att ägandestrukturen framför allt har betydelse för möjligheterna att uppnå de två första målen. När det gäller ägandefrågan har utredningen utvärderat fyra tänkbara alternativ utifrån hur de påverkar konkurrensen och bevarandet av det värde som byggts upp i verksamheten: 1.Apoteket fortsätter att äga verksamheten (med eller utan särskilda begränsningar). 2.Verksamheten avskiljs i sin helhet från och överförs till ett nytt direktägt statligt bolag. 3.Verksamheten avskiljs i sin helhet och överlåts till en privat aktör. 4.Apoteket delas i flera delar där behåller en del och övriga delar säljs. Utredningen har bedömt att förutsättningar för väl fungerande konkurrens finns i alla alternativ. För att bevara värdet i är alternativ 1 och 3 bäst, medan alternativ 4 medför stora transaktions- och engångskostnader i förhållande till värdet på verksamheten. Alternativ 2 medför bl.a. att vissa synergier försvinner. Utredningen bedömer sammantaget att bör kvarstå i ägo. Om även fortsättningsvis ska ägas av bör det övervägas om det av konkurrensskäl finns behov av fortsatta begränsningar eller särskilda krav på verksamheten. Enligt ägaranvisningen för får verksamhetens marknadsföring av tjänsten receptexpediering inte ske mot vårdinrättningar för hemgående patienter. Det anges vidare att begränsningen gäller fram till dess att samtliga landsting har slutfört upphandlingar avseende läkemedelsförsörjning. Utredningen bedömer att begränsningen av verksamhetens möjligheter att marknadsföra receptexpediering bör kvarstå till dess att en uppföljning av samtliga landstings upphandlingar genomförts och konsekvenserna av de nya avtalen blivit kända. När en sådan uppföljning kunnat genomföras bör ett nytt ställningstagande göras. Utredningen anser vidare att det krävs särskilda åtgärder för att öka transparensen när det gäller . Det kan ske genom krav på särredovisning av kostnader och intäkter eller genom att verksamheten följs upp av ägaren på liknande sätt som man följer utvecklingen av marknadsandel på öppenvårdsapoteksmarknaden. Compensation for injuries caused by pharmaceuticals (Chapters 2–3) The Inquirys remit is to submit proposals that ensure acceptable protection for individuals with regard to injuries caused by pharmaceuticals that come under the pharmaceutical reimbursement system. The proposals must not lead to the undermining of the compensation scheme for pharmaceutical injuries (Läkemedelsförsäkringen). may the proposals come into conflict with EU law. Cover against injuries caused by pharmaceuticals is an important component of pharmaceutical treatment and an important aspect of patient safety. Uncertainty for the patient about what applies in the event of injuries caused by pharmaceuticals may result in poorer compliance and thus put patient safety at risk. Differences in compensation cover (e.g. burden of proof, statutory limitation, examination by a committee and court proceedings) may be of crucial importance to a person having suffered injuries caused by pharmaceuticals. The Swedish compensation scheme for pharmaceutical injuries is an insurance scheme for pharmaceutical companies, but it usually provides greater benefits to individuals suffering from injuries caused by pharmaceuticals than if the pharmaceutical company were not covered by this insurance. In order for a pharmaceutical product to be covered by the scheme, the pharmaceutical company must be a shareholder in . However, membership is voluntary and not all companies that operate in are covered by the compensation scheme for pharmaceutical injuries. Pharmaceutical products are thus sold with varying levels of cover for patients. At the current time, approximately 99 per cent of the total sales value of pharmaceuticals in is covered by the compensation scheme for pharmaceutical injuries. Of a total of approximately 83.3 million packs sold in 2012 within the scope of the pharmaceutical reimbursement system, approximately 349 000 packs were not covered by the compensation scheme for pharmaceutical injuries. An estimated 165 000 of these 349 000 packs were sold after having been substituted for another product. The remaining packs were ones that had been prescribed but that were not covered by the compensation scheme for pharmaceutical injuries. These pharmaceuticals were primarily original products without any generic competition, but also parallel-imported pharmaceuticals and generics. The Inquiry has noted that there is a need to improve individuals cover in the event of injuries caused by pharmaceuticals. The current legislation – the Product Liability Act (1992:18) and the Tort Liability Act (1972:207) – does not provide sufficient cover for individuals. Furthermore, membership of the compensation scheme for pharmaceutical injuries (which provides greater benefits to individuals than the two acts mentioned above) is only voluntary for pharmaceutical companies. At the current time, prescribers do not routinely inform patients about compensation cover. The system of substitution at pharmacies means that a prescribed pharmaceutical product that is covered by the compensation scheme for pharmaceutical injuries may be substituted by a pharmaceutical product that is not covered by this scheme. Patients are therefore at risk of a lesser degree of cover than would have been the case if there were no system of substitution of pharmaceuticals at pharmacies. Moreover, patients do not routinely receive information in cases where the pharmaceutical product prescribed is substituted by a pharmaceutical product with a lesser degree of cover. The Inquiry has considered a number of measures to achieve better cover for individuals in the event of injuries caused by pharmaceuticals. Liability Directive (Council Directive 85/374/EEC of 25 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products) is a maximum directive that sets a limit on the compensation requirements that the Member States are allowed to place on pharmaceutical companies. for pharmaceutical injuries provides greater benefits to the individual than is required under the Product Liability Directive, which is possible as membership of the scheme is voluntary. cannot demand that the pharmaceutical companies offer acceptable cover if this means cover that is more beneficial to individuals than follows from the Directive. It is thus not possible to demand that pharmaceutical companies – as a prerequisite for being allowed to produce pharmaceutical products or to have a pharmaceutical product approved, for example – be included in an insurance scheme or compensation cover that is more beneficial to individuals than what is required under the Directive. is it possible, as proposed in Ministry Publications Series (Ds) 2010:11 Pharmaceuticals and insurance cover in the event of personal injury, to require as a prerequisite for a pharmaceutical product to be included in the pharmaceutical reimbursement system that the pharmaceutical product be included in an insurance scheme or compensation cover that is more beneficial to individuals than follows from the Directive. Finally, the Dental and Pharmaceutical may not, when determining the product of the period, demand that the pharmaceutical product be included in an insurance scheme or compensation cover that is more beneficial than the Directive. The Inquiry proposes that the Government work at EU level to bring about a change in the Product Liability Directive. It is possible under the Product Liability Directive for Member States to demand liability for what are known as development risks, which has not done. Development risks refer to defects that were present in the product when it was put into circulation, but that were impossible to detect at the time because scientific and technical knowledge was not sufficiently developed. On an overall assessment, we do not consider that there are sufficiently strong grounds for introducing such liability for development risks. Such a regulation would not guarantee the individual acceptable cover equivalent to the cover that applies within the compensation scheme for pharmaceutical injuries, and there would also be the risk of adverse effects concerning the extent to which companies choose to operate in . The Inquiry has also discussed whether the compensation scheme for pharmaceutical injuries should take joint responsibility, i.e. compensate for injuries caused by pharmaceuticals that are not covered by the compensation scheme for pharmaceutical injuries. Another consideration was whether to introduce across the board a system of ex compensation in the event of injuries caused by pharmaceuticals. Both of these alternatives were rejected, as there is a risk that they would undermine the compensation scheme for pharmaceutical injuries and thus place people having suffered injuries caused by pharmaceuticals in a worse situation. Moreover, the Inquiry considers that it would be much too great an interference in independent prescribing rights if these rights were restricted to pharmaceuticals that are covered by the compensation scheme for pharmaceutical injuries or similar. The Inquiry has also considered an obligatory collective insurance scheme with a level of cover in line with the Product Liability Directive. However, such a proposal would run the risk of undermining the compensation scheme for pharmaceutical injuries and thus worsening the situation for individuals; it cannot, therefore, be regarded as a suitable measure. On the whole, patients do not know whether or not the pharmaceuticals they are using are covered by the compensation scheme for pharmaceutical injuries. Some of the pharmaceuticals dispensed that are not covered by the compensation scheme for pharmaceutical injuries are original products without generic competition, i.e. pharmaceuticals that are not included in the substitution system. In these cases, therefore, the prescriber has chosen to prescribe a pharmaceutical product that is not covered by the compensation scheme for pharmaceutical injuries. In some county councils, such as , prescribers are recommended to only prescribe pharmaceuticals covered by the compensation scheme for pharmaceutical injuries. The Swedish system of substitution at pharmacies, which has been in place since 2002, means that a prescribed product covered by the compensation scheme may be substituted at the pharmacy by a product that is not covered by the scheme – without the patient being informed. The pharmaceuticals are indeed interchangeable from a medicinal perspective, but they differ where compensation cover is concerned. The Inquiry believes that it is important to inform the patient in such situations. Since it is the pharmacies that carry out the substitution, it is reasonable that they are the ones to provide the patient with this information. But it is also important for the patient to receive information about compensation cover concerning pharmaceuticals that are not included in the substitution system. This responsibility should lie with the prescriber and the Inquiry is therefore proposing that prescribers have an obligation to provide information. The details of the prescribers obligation to provide information should be considered further. It is proposed that information concerning compensation cover be available in Apotekens Service ABs system VARA, to which both pharmacy actors and health and care services have access. The Inquiry also believes that in cases where there are differences in compensation cover between alternative equivalent products, measures should be taken that empower individuals and give them the opportunity to make an choice. Such choices can be made possible within the framework of the substitution system, as there are several equivalent alternatives in this system. The Inquiry therefore considers it appropriate for individuals to be able to contest a substitution if they find that the substituted pharmaceutical product enjoys a lesser degree of cover in the event of pharmaceutical injury than the product that has been prescribed. It is reasonable that if the patient has this information they should also be in a position to use it. The patient should not have to pay the difference between the pharmaceutical product prescribed and the substituted product; the prescribed product is to be reimbursed under the pharmaceutical reimbursement system. Pharmacies may choose which parallel-imported pharmaceuticals they wish to buy and dispense to patients and have thus an opportunity to influence the level of cover that will apply concerning these products. In 2013, the presented an industry agreement in which the companies party to the agreement committed to requiring, when signing contracts with companies that carry out parallel imports of pharmaceuticals, that these companies and their products be covered by the Swedish compensation scheme for pharmaceutical injuries. On the whole, the Inquiry considers that these proposals will lead to better cover for individuals in the event of pharmaceutical injury. The obligation of prescribers and pharmacies to provide information will lead to a greater awareness among prescribers, pharmacies and patients when choosing pharmaceutical products to take into account the level of cover in the event of pharmaceutical injury. In the Inquirys view, the combined effect of all of the proposals presented here will be to create incentives for companies to provide pharmaceuticals that are covered by more beneficial cover in the event of pharmaceutical injury than follows from the current regulations. It is proposed that the legislation enter into force on 1 January 2015. Pharmaceutical products and the environment (Chapters 4–5) The Inquirys remit is to analyse whether the Dental and should consider environmental aspects when deciding to include any pharmaceutical product in the pharmaceutical reimbursement system. The practical conditions that need to be met for this to be possible are to be described. Moreover, the expected impact on the costs of pharmaceuticals and the environment in producing countries outside Europe are to be highlighted. The Inquiry also has the task of analysing and examining whether access to small pharmaceutical packs could lead to a reduction in pharmaceutical discards. In , approximately 1 200 pharmaceutical substances are used, corresponding to approximately 10 000 different pharmaceutical products for people and animals. Pharmaceutical products and pharmaceutical residues seep into the natural environment and eventually reach the water. There are two main pathways – production and consumption. When pharmaceuticals are consumed, substances are excreted through urine and faeces. Some unused pharmaceuticals are also discarded into the environment. Just over 150 different pharmaceutical substances have been reported in surface water and in processed municipal waste water in and other western countries. Another possible pathway is via sludge into the soil environment. The spread of pharmaceutical products and pharmaceutical residues may also occur through discharges in the pharmaceutical production process. There is data available concerning concentrations of pharmaceutical substances in industrial waste. The environmental impact caused by the production process is a major global challenge. The direct impact is greatest in the countries in which pharmaceutical production is located, mainly emerging economies, such as and , but in the long run there is a risk that these problems could spread to other countries. high concentrations of pharmaceutical substances have been measured in the waste water from production plants in and , but also in the . A fundamental principle is that an activity that has a negative impact on the environment must bear the costs of this. Public measures to prevent market failures in the area of the environment are regulations, e.g. concerning discharge levels, other forms of environmental legislation and economic instruments, in the form of taxes, fees and subsidies. The Inquiry considers, like several experts in the past, that transnational environmental problems require international solutions and that resources must be used where they can be expected to have the greatest effect. The Inquiry thus supports the proposals of to work for the inclusion of environmental impact in the EU regulatory framework on good manufacturing practice (GMP). In principle it is possible for the Dental and to consider environmental impact when deciding which pharmaceutical products to reimburse, but only in theory. In practice, documentation on environmental impact is required so that all pharmaceutical products can be given environmental classification; such documentation does not exist at the current time. Requiring environmental classification is not possible in the view of the expert group of , as it would be in breach of EU law. The Inquiry shares this view. An alternative way of creating incentives for environmental adaptation within the framework of the pharmaceutical reimbursement system is through voluntary environmental classification and an environmental premium. The Inquiry notes that there is a project under way with this focus within the framework of the national pharmaceuticals strategy (NLS 7.2). Within this framework, has had an analysis carried out of how incentives for voluntary environmental adaptation can be created within the framework of the substitution system by allowing pharmaceuticals that fulfil set environmental requirements to be allocated an environmental premium. However, a good deal of work and issues remain before such a system can be introduced. designing a model for environmental assessment, including criteria for environmental classification; establishing criteria and rules for conformity assessment; calculating environmental damage and establishing the level of the environmental premium; and choosing a model for a system of incentives: an environmental premium paid by society or consumers. Once these measures have been implemented, the practical preconditions will be in place to begin a pilot project linked to an environmental premium and evaluation. The Inquiry proposes that when has reported back on project 7.2 in the national pharmaceuticals strategy to , the be instructed to consult with the Dental and and other relevant agencies – also with external consultants if need be – to evaluate the proposed model for environmental assessment and then establish criteria for environmental classification and rules for conformity assessment. An evaluation of the model should include a valuation of the environmental damage and an evaluation of how well the model for environmental assessments and incentives can help to reduce this environmental damage. Consideration should also be given to how the proposed system contributes to the objectives of the Governments policy for global development. A valuation of environmental damage will also provide necessary data for the Dental and to be able to establish the level of the environmental premium. In addition, the Inquiry proposes that the Dental and be given the task of establishing – based on the criteria and assessment rules – the level of the environmental premium and working out the details of how an environmental premium pilot project could be carried out for a limited part of the substitution system. This also includes deciding whether the premium should be paid by society or by consumers. The Inquiry considers that the proposed pilot project, once followed up, should be able to contribute to knowledge about the possibilities of reducing the negative environmental impact of pharmaceuticals through the subsidy system and thus form the basis of a decision on forms of future activity. The pilot project will also provide knowledge of how competition is affected in the substitution system. Discarding pharmaceutical products can mean both unnecessary use of resources and an unnecessary burden on the environment. Excessive dispensing and discarding of pharmaceuticals paid for by the public purse (products covered by the pharmaceutical reimbursement system and inpatient pharmaceuticals) mean that public resources are used unnecessarily. Discarding pharmaceutical products also means an unnecessary burden on the environment in the countries where they are produced, e.g. through emissions from the production process and transportation, as well as an increased environmental burden locally if leftover pharmaceuticals are not taken care of in the correct way (e.g. if they are poured down the drain). Concerning the remit to investigate access to small pharmaceutical packs and their contribution to reduced discards, the Inquiry considers that access to starter packs is relatively good and that there are other factors contributing to low take-up. Increased use of starter packs when a pharmaceutical product is used for the first time for long-term treatment may reduce discards of pharmaceuticals when treatment is discontinued due to unsatisfactory results or side effects, for example. The Inquirys remit does not include submitting proposals for measures to increase the use of starter packs. However, the Inquiry has noted several potential measures that could increase the use of starter packs, which are described below: require that pharmaceutical companies provide small packs for all pharmaceuticals that are used in the long term; ensure that starter packs of pharmaceuticals for long-term use are covered by the pharmaceutical reimbursement system; make starter packs obligatory when a subsidised pharmaceutical product intended for long-term use is used for the first time (e.g. by obliging pharmacies to sell a starter pack for initial treatment or obliging the prescriber to state special reasons in cases where a starter pack is not to be used);