sou · H0B375 · 2012-10-31 00:00:00 — In summary, the proposed price model with its different parts leads to better preconditions for pharmaceuticals to be prioritised, priced and managed so that the cost effectiveness in general in- creases and so that as large patient groups as possible can therewith be provided with the medicinally appropriate treatment. Supply and dispensing obligation (Chapters 11–12) A central part of the mandate is that of describing how the supply and dispensing of pharmaceuticals and devices (förmånsva- ror), which are covered by the presently applicable supply and dis- pensing obligation, functions today with the aim of describing and analysing the problems that exist. According to the (2011), about 95 per cent of all pharmaceuticals could be issued directly (94 per cent for generic and 96 per cent for original pharmaceuti- cals). This is slightly lower than service level sur- veys for 2007 which then showed that 95.8 per cent of the consum- ers obtained their pharmaceuticals without needing to wait a fur- ther one or several days for an issue to take place. Certain phar- macy operators have carried out their own surveys that confirm a direct issue level of around 95 per cent. This is in line with the con- clusions concerning satisfactory pharmaceutical availability that the Dental and () drew in its re- port that reviewed the 2011-year model for pharmaceutical substi- tution at pharmacies (Översyn av modell för utbyte av läkemedel på apotek). Data from shows that the company, during the period from the start of 2009 until 2011, had a relatively even service level (the share of customer encounters when the pharmacy was able to issue the requested item directly) at 93–94 per cent. In the statistics, only those situations where the customer either obtains his/her pharmaceutical or makes an order, but not the occasions when the customer leaves the pharmacy empty-handed, are taken into account. What is not captured in a systematic way in surveys of the direct issue level is the share of that neither have their pharma- ceutical directly issued nor then order their pharmaceutical. This is probably no uncommon situation, above all in areas with high pharmacy density. In areas where the number of retail pharmacies has increased, the may decide to seek another pharmacy in order to obtain the pharmaceutical directly, rather than ordering it and coming back on another occasion. Moreover, such hidden statistics are not captured in the monitoring carried out prior to re- regulation. On the other hand, it can be stated that the pre- conditions now are different since, for example, there are more pharmacies for the to choose between and pharmacy operators do not have insight into each others stocks. The behaviour of may therefore have been affected, which may also have changed the share of who, instead of ordering the pharmaceutical, choose to visit another pharmacy. Even if such an assumption may be reasonable to make the Inquiry has not been able to find any facts that can offer guidance as to how large these hidden statistics are and if they have changed to any significant extent. It remains evident, however, that amongst consumers there is a perception of deterioration in the level of the direct issue service. In the customer survey undertaken by the (), which focuses on customer experi- ences of accessibility to pharmaceuticals over the latest 12-month period, 76 per cent of the prior to re-regulation stated that, if they looked back on the last year, they would say that they obtained their pharmaceuticals issued directly. This may be com- pared with own surveys prior to re-regulation where this level was measured at 96 per cent. In 2011, 71 per cent of the replied that, on looking back on the last year, they would say that they obtain their pharmaceuticals through di- rect issue, a decline of 5 percentage points compared with 2008. Both before and after re-regulation, the results in the survey therefore differ from the surveys car- ried out at pharmacies. A probable reason for this is that the con- sumer survey asks the question Looking back over the last year, how long have you normally had to wait for your chosen pharmacy to stock the pharmaceutical you have been prescribed where re- plies are categorised as follows: No time at all, It will come in during the day, within 24 hours, two-three days or > 3 days. What a customer should answer who e.g. collected pharma- ceuticals on four occasions during the year and, on one occasion, has had to wait two-three days is unclear. survey cannot therefore be used for estimating the size of the problem, but it does offer some indication that the per- ceive that the stock of pharmaceuticals by the pharmacies has deteriorated. Several of the patient associations interviewed in the investigation undertaken by the Inquiry also describe deterio- ration for their members with increased anxiety and less peace of mind as a result. This particularly applies to the groups encom- passing the elderly, those suffering rheumatism, people with psy- chological illnesses and Alzheimers disease. Several indications as to how different patient groups and phar- macy personnel perceive the situation are also given in the survey carried out by the for (Statskontoret). In this survey it emerged e.g. that many patient organisations consider that prescription pharmaceuticals or devices are only in stock to a small extent when requested. Many organisations consider that the stock has become worse compared to the situation prior to the re-regulation. In replies to the questionnaire distributed to pharmacy personnel a more posi- tive picture of the possibility of supplying pharmaceuticals and devices at the first visit was given; nevertheless, there were quite a number of pharmacy personnel, four of ten, who consid- ered that the preconditions had deteriorated since the time before re-regulation of the pharmacy sector. In connection with the re-regulation of the pharmacy market new IT support was developed for the pharmacy operators. The IT support which built up over many years, the so-called (), was replaced by new systems during the first years after re-regulation. New operators built up their own systems and also chose to leave ATS for a new solution. The background to this state of affairs included the fact that there were doubts concerning the long-term sustainability of ATS. The IT-related changeover in connection with the re- regulation should not be underestimated, since all data systems and systems for electronic management of prescriptions and stock during the monopoly period were interwoven. The separa- tion of the IT infrastructure, considered necessary for the supply of all operators in a re-regulated market in a competition-neutral , implies a far-reaching and complex transfer from to . The changeover from ATS to new data systems at each pharmacy involves additional changes, which also include systems for the management and control of inventory. In the opinion of the Inquiry, it cannot be excluded that the changeover from ATS to the pharmacy operators new IT support during certain periods has meant changes that have caused chal- lenges for pharmacy personnel and influenced the expe- rience of service and supply. A further record that can serve as background data for under- standing consumer experiences of the supply situation, now and before re-regulation, are the customer surveys made by . The question asked to the is whether their experi- ence is that the prescription pharmaceuticals required were availa- ble in stock. In 2007, 91 per cent of the stated that they thought that the pharmaceuticals requested were available in stock; in 2008 there were 88 per cent of the who thought it. It is not possible to draw any far-reaching conclusions from this background material, but it indicates that amongst the consumers there are perceptions of deficiencies in supply both now and during the monopoly period. To summarise, the Inquiry declares that available figures indi- cate marginal changes in percentage terms of the share of custom- ers who obtain their pharmaceuticals on the first visit to the phar- macy. Many patient organisations and a significant proportion of pharmacy personnel consider, however, that the preconditions for direct issue of pharmaceuticals have worsened. The Inquirys judgement is that the perceived deterioration is sufficient to justify proposals for change. Against the background of the discrepancy between available data surrounding the direct issue service and the experience of the consumers of deficiencies, both during the mo- nopoly period and in the re-regulated market, the Inquiry adjudges that it cannot be reduced to the single question concerning the direct issue of pharmaceuticals. There are surely a number of different factors which determine customer satisfaction, both in the re-regulated market and previ- ously, and which also encompass communication, advice and other relevant service. The available background material is not so une- quivocal as to enable one to conclude which points are most im- portant and proper understanding is required of possible causes for this in the entire distribution chain of pharmaceuticals, from the pharmaceutical companies to the end-user. It can, however, be es- tablished that each day there are a large number of pharmacy cus- tomers who do not have their prescribed pharmaceuticals or medi- cal devices issued on the first visit. This affects different customer groups in different ways and in varying degrees. The failure to hold expensive pharmaceuticals in stock may af- fect e.g. patients with Alzheimers disease, HIV, cancer or rheu- matism. The level of direct issue of pharmaceuticals, moreover, is lower for those patients who are opposed to generic substitution, since the pharmacy to a large extent must adapt its stocks in ac- cordance to the regulatory framework. The problem in not having the pharmaceutical directly issued naturally becomes greater for persons who have difficulties in moving, e.g. many older people and those with functional impairments. For the individual who has an acute need for a particular pharmaceutical it is also a greater problem not to be able to obtain the pharmaceutical directly than if one has the possibility of waiting or ordering the pharmaceutical in good time. Pharmacies which are run by smaller operators may find it more difficult to hold large stocks and to have expensive pharmaceuticals in stock owing to the tied up capital that this implies. Conditions for the return of pharmaceuticals to suppliers may also affect the possibilities or the inclination to hold in stock, above all, expensive and unusual pharmaceuticals. Newly established retail pharmacies, as a rule, do not possess knowledge about the needs of local . After the re-regula- tion of the pharmacy market, about 300 new retail pharmacies have been added since the start of 2010 and subsequently. A gradual improvement is probably taking place at the majority of these pharmacies. Service level and supply capacity is an important com- petitive factor. The pharmacy operators have a strong incentive for being able to directly issue pharmaceuticals to as many as possible within the framework of reasonable storage costs. The reason that a pharmaceutical cannot be issued may also be that it is backorder listed with the wholesaler (distributor) or man- ufacturer. This occurs both in respect of original and generic pharmaceuticals and may have different reasons, e.g. problems in connection with production. There are no statistics that clearly show that this type of problem has increased in . The issue has, however, attracted attention in several other European coun- tries and there are indications there may be a rising trend also in . As an example, it may be mentioned here that noted a sharp increase in the number of backorder listings which have been published on the companys Intranet from the year 2009 until 2012. In the case of generic substitution, it sometimes happens that the customer wishes to have the prescribed pharmaceutical issued, instead of having it substituted with the designated product of the period, but the prescribed pharmaceutical is not in stock at the pharmacy. This is not necessarily an issue where the pharmacy is failing in its supply and dispensing obligation, but may be per- ceived so by the customer. If the prescribed pharmaceutical is not in stock the pharmacy shall order it if the customer so wishes. The rule that the retail pharmacy shall issue a prescription pharmaceutical 24 hours at the latest after it is requested, unless noteworthy reasons exist, is very much affected by the wholesale trades so-called stop times. This is the time when the wholesale distributor contacts the pharmacys ordering system and deals with the orders placed since the previous stop time, normally once per 24 hours. Changes from the wholesale side in these stop times strongly influence the pharmacys possibilities of fulfilling the so- called 24-hour rule. Where a stop time, for example, is set at 13.00 h. this means, as a rule, that only orders the pharmacy has regis- tered before this time will be delivered on the following day. In connection with the re-regulation, former 24-hour practice was given statutory force and communicated to the public. The statutory regulation is also considered to have entailed a tight- ening of former practice. This has probably led to raised expecta- tions on the part of the consumers. In order to improve the supply of pharmaceuticals at pharmacies for the consumers the Inquiry proposes both clearer regulations and strengthened incentives. The Inquiry has considered instituting a supply obligation on the holders of marketing authorisations, but has considered that at the present time it is hard to justify such an obligation. It is therefore proposed that the Prod- ucts Agency () be commissioned to survey the deficiencies where backorder listing is concerned and where appro- priate suggest corrective measures. In order to clarify that the direct issue of pharmaceuticals shall be the principal rule, a regulation is proposed which entails that retail pharmacies shall hold the stock required to ensure good ac- cess for the to those pharmaceuticals and devices (förmånsvaror) that are covered by the supply obligation. The stock of the retail pharmacies is affected by the possibility of returning pharmaceuticals to suppliers and by costs for returns and rejects (spoilage). Therefore, the Inquiry considers that the Dental and () should review the regulations concerning gross and consider further spec- ification of what is included in the Pharmacy Purchase Price (AIP). (TLV) should consider whether it is appropriate to specify a mini- mum storage time. The costs for pharmacies for rejects and returns should also be taken into account in an appropriate way on deter- mination of the gross . The Inquiry also considers that retail pharmacy operators and the pharmaceutical industry should de- velop industry guidelines with the object of improving the terms and conditions for right of return, storage/shelf-life etc. The Inquiry proposes the clarification of the so-called 24 hour rule and its exemptions. It should be specified that the time limit of 24 hours should start to run when a pharmaceutical or device is demanded by the customer at the pharmacy. It should also be clarified that the demand on provision within 24 hours does not apply without exception. The most important exceptions should be stated in the statutes (in statutory form), namely if the pharma- ceutical or device is not available for order from the sup- plier (i.e. the pharmaceutical is backorder listed), the consumer demands the pharmaceutical at a time which means that delivery to the retail pharmacy cannot take place within 24 hours, there is a long transport distance to the retail pharmacy concerned, the pharmacy is not open on the following day, or where licensed or extempore pharmaceuticals are concerned. There shall also be a possibility for exemption in the event of special reasons. In certain emergency situations where the customer cannot wait for delivery to the following day and when it is not reasonable to expect the patient to go to another retail pharmacy it should be permitted for a pharmacy to deliver pharmaceuticals to a customer via another pharmacy. This may occur to a certain extent at pre- sent, but the scope for this should be regulated and expanded somewhat. In those cases where a customer requests a pharmaceutical which cannot be issued by the retail pharmacy concerned, an obli- gation is instituted for that pharmacy to then submit information to the customer concerning which pharmacy/ies have the particular pharmaceutical in stock. This gives the customer the possibility of going to another pharmacy, even a competitors, which has the pharmaceutical in stock instead of waiting for the first pharmacy to have received the relevant order. This proposal will also strengthen the incentive for the pharmacy to keep pharmaceuticals in demand in stock. In order to find information on which pharmacy holds the pharmaceutical requested in stock the pharmacy can use the search system that this Inquiry proposes that shall develop. Pharmaceuticals and devices must be made available to consumers as soon as this can take place; the principal rule must be that the product demanded shall be able to be issued when re- quested by the customer. This is also something on which the pharmacy place a high priority. To increase the possibil- ity for the customer of visiting a pharmacy where a pharmaceutical demanded is available, the Inquiry proposes that a search system shall be established where information on which pharmacy has a specific pharmaceutical can be obtained. It is proposed that be commissioned to develop a common search system that shall be open to everyone, e.g. consumers, pharmacy staff and the prescribing individual. The pharmacy shall be obliged to report whether the pharmacy has a certain product available. who carry out searches in the system can, where possible, choose to go to a pharmacy where the relevant pharmaceutical is available. In those cases where there is no alter- native pharmacy the relevant pharmacy can be contacted and the product then ordered. Such a system strengthens the incentive for the pharmacy to avoid stockouts (stock shortages); this is also positive for those who, for different reasons, do not use the search system. There are aspects from the viewpoint of competition law that must be taken into account on drawing up the search system. The infor- mation provided through the search system should therefore be limited, so that the possibilities for competing operators of gaining an insight into each others inventories and stock management is minimised. This can take place, for example, through not showing exactly how much of a particular product is in stock at an individ- ual pharmacy. The Inquiry is of the opinion that the supervisory authorities should strengthen the oversight into issues that concern the con- sumers access to pharmaceuticals. To facilitate the Prod- ucts Agencys supervision of the retail pharmacies supply obliga- tion, shall be under an obligation to supply certain information to the . In summary, the Inquirys proposals are as follows. is entrusted with describing the extent of backorder listing amongst the pharmaceutical compa- nies which supply pharmaceuticals in , how often backorder lists lead to serious shortages in the pharmacy supply chain and what the backorder lists are due to. This survey should then form the basis for a new assessment of a possible supply obligation on the pharmaceutical manufacturers. should consult with the Dental and () in this respect. A demand is introduced for reasonable stock at a phar- macy in order to ensure satisfactory access for the consumers to those pharmaceuticals and devices covered by the sup- ply obligation. A clarification is made that the supply obligation within 24 hours does not apply in certain situations. These situations were also exempted from the so-called 24-hour rule during the mo- nopoly period and were indicated in connection with the re- regulation. Enhanced possibilities are given for pharmacies to dispatch pharmaceuticals between each other in emergency situations with the object of improving the availability for the consumer. An obligation is introduced for the pharmacy to the effect that where the pharmacy does not have the pharmaceutical de- manded in stock, the consumer is informed at which retail pharmacy the pharmaceutical is available. It is proposed that develop a joint elec- tronic search system showing which pharmacy/ies hold a partic- ular pharmaceutical in stock. The search system shall be open to everyone to use, e.g. consumers, pharmacy personnel and pre- scribing individuals. An obligation is instituted for pharmacies to report to whether they hold in stock a certain pharmaceutical requested. of improved preconditions for the authorities con- cerned to carry out proper supervision. The Dental and () should review the regulations concerning the gross . The Inquiry also considers that the pharmacy operators should develop in- dustry guidelines with the object of improving conditions for the right of return, storage/shelf-life etc. All in all, the Inquiry adjudges that these proposals will lead to a better service for the pharmacy and that more will receive their pharmaceuticals and devices within a rea- sonable time. Pricing and substitution of generic pharmaceuticals (Chapters 13–14) Generic substitution of pharmaceuticals at pharmacies was intro- duced in 2002 and was changed in certain aspects in connection with the re-regulation of the pharmacy market in 2009. The system for generic substitution covers products which have been judged as being substitutable by the . The present system means that, each month, the Dental and Pharmaceutical () designates a so-called product of the pe- riod i.e. one product in a so-called pack size group that has the lowest price. It is this product with the lowest price that shall be issued by the pharmacy during the coming sales period, regardless of which product is prescribed in a substitution group. The pre- scribing professional may, nevertheless, go against the substitution if there are grounds for this. This is specified on the pre- scription. The pharmacy too is entitled, on the basis of pharma- ceutical judgement, to go against substitution and issue another product than the one with the lowest price that month. The patient may also decline substitution, but then must pay the difference between the prescribed pharmaceutical and the product of the period. Patients who choose another substitutable pharmaceutical than the product of the period must then pay the entire cost themselves. Todays generic substitution system ensures strong downward price pressure within the substitution groups and delivers major savings. The Swedish generic product prices are among the lowest in Europe and the system generates savings of around billion per year that directly benefit the public purse. Lower prices will benefit patients through it becoming cost-effective to treat more patients. The treatment of patients, that in 2010 entailed a cost of just over billion, would have meant a cost of over billion at the prices that prevailed before generic competition arose. The low generic prices together with a high level of generic pene- tration are one of the most important factors in determining the scale of the total pharmaceutical costs. From a patient viewpoint there are, nevertheless, disadvantages with the system.