sou · H9B319 · 2021-03-31 00:00:00 — The system rests on there being funda- mentally robust supplies and stockpiles in normal circumstances based on the responsibility of healthcare authorities, community pharmacies and the patients to safeguard certain access to the healthcare pro- ducts that they require. In addition to this, the Inquiry identifies a need for expanded stockpiling of certain healthcare products as are required for health- care that cannot be postponed. This should be designed as a stock- piling obligation regulated by law. Such stockpiles should be kept near end users, as cycle stock, in the ordinary logistics chain. The Inquiry also sees a certain need for stockpiling in national security stockpiles such products that cannot normally be consumed and re- placed (cycled). This mainly concerns products that are not usually used or which are needed in such large amounts in certain situations that they cannot be cycled. The Inquiry also sees a need to ensure manufacturing readiness for certain products or product categories. This may involve both ensuring deliveries of such goods as are normally manufactured in , but also converting production to manufacture certain pro- ducts or product groups. Healthcare products are covered by many different regulations to safeguard patient safety, and therefore it is important that such production, as far as possible, is prepared for and that the support processes that are required are in place. Clarifying the requirement for all healthcare providers and authorities to have access to essentials The Inquiry’s remit includes considering and analysing which mea- sures are needed to prevent and manage situations involving a shortage of healthcare products in circumstances where no serious event otherwise affects supplies. In autumn , problems arose with the supplies of consumable healthcare products in five regions when a new supplier, following joint procurement by the regions concerned, took over responsibility for deliveries of consumables. The widespread shortage of products had rapid consequences for healthcare. Equivalent vulnerabilities in the healthcare system’s supplies of healthcare pro- ducts have emerged during the COVID-19 outbreak. Reducing vul- nerability in the healthcare system’s supplies of healthcare products and strengthening capacity to cope with disruptions in the supply chain requires basic stockpiling of healthcare products. This basic stockpiling is also the cornerstone of the healthcare system’s capac- ity to tackle peacetime crises and heightened alerts. There is already a requirement in Chapter 5, Section 2 of the Health and Act, which applies to all healthcare providers, stating that where healthcare operations are carried out, there must be the premises, staff and equipment required to provide good health- care. The Inquiry proposes that this provision be made clearer such that it states that “equipment” means the drugs, the blood, the supplies and other equipment necessary to provide good healthcare. Additionally, it is proposed that a provision be introduced in the Health and Act requiring municipalities and regions in their capacity as healthcare authorities to have expanded stock- piles of more or less all the categories of healthcare products used in normal operations. What is to be stockpiled and the amounts that are to be stockpiled may be determined by the Government. The In- quiry proposes that the scope of this obligation to maintain stock is not to exceed one month’s normal consumption in the municipal- ity’s or the region’s area of responsibility. However, this obligation does not prevent regions and municipalities from holding more than one month’s stock. Stockpiling also includes covering the consump- tion that takes place within such publicly-financed healthcare that the municipality or region has contracted out to private actors. is to compensate the municipalities and regions for the major part of such stockpiling. New requirements governing stockpiles kept by pharmacies A large amount of all drug treatment is via prescription drugs col- lected by consumers from a pharmacy. Certain healthcare products in the form of consumables for self-checks, drug administration and stoma products, as well as certain food for special purposes, are also provided on prescription from community pharmacies. There are currently no provisions stating that community pharmacies must maintain certain amounts of stock. There is a requirement on phar- macies to order in prescription drugs and consumables that are sought by consumers, but no requirement to keep them in stock. There is such a large number of healthcare products on the market that it is unreasonable to demand that a pharmacy keeps all products in stock. The Inquiry nevertheless judges that it is important that the phar- macies have local stockpiles to reduce vulnerability in the supply chain. Therefore, it is proposed that the pharmacy’s basic mandate in the Act on of be changed so that it also states that the pharmacy’s stockpiling is to be adapted to consumer needs in the market in which the community pharmacy operates such that as many as possible are to be able to be served immediately. In its Total Defence , the Government has stated that individuals who do not have an immediate need of assistance in a serious event and who have the capacity and resources to cope on their own should be able to take responsibility for their own supplies for a period of a week and in solidarity and collaboration with others assist each other to the extent possible. () has asserted the importance of good home preparedness so that the public will be able to cope for a certain period of social disruption without support from society. The Inquiry considers that a certain amount of home preparedness is also important in the field of healthcare. This means, among other things, that people on a stable drug regime should collect their prescribed medication from the pharmacy in good time before the pack at home runs out. Within current regulations, the Inquiry therefore judges that chronically ill people on a stable drug regime should have access to drugs for at least one month’s consumption in the home, provided that this does not place patient safety at risk. The same should apply to other health- care products, including such non-prescription drugs that the patients needs for their own treatment. Written information recommending this should be provided by the healthcare system to such patients when prescriptions are issued and by community pharmacies. It should also be included as part of the information on home preparedness from MSB. The Inquiry considers that should be tasked with producing such information in consultation with the , the Dental and . An act on a stockpiling obligation To achieve expanded stockpiling of such healthcare products required in crises and times of war for such healthcare that cannot be post- poned, the Inquiry proposes a new act on a stockpiling obligation. The act will mean that the market authorization holder and those who import or sell licensed drugs to pharmacies will be covered by an obligation to maintain a certain stated level of stock in . Furthermore, the act includes an obligation for municipalities and regions to ensure that other healthcare products for such healthcare are stockpiled in . The Inquiry has proposed that the amount of stock kept is to meet a basic level that corresponds to six months’ normal cycling, but that the Government is to be able to order that specific amounts are kept in stock in certain product areas. quiry considers that the State is to compensate municipalities, regions and private actors concerned for such costs that are associated with stockpiling in the form of cycle stock. The Inquiry considers that it is the Government that is to manage stock and decide on its use. The Inquiry proposes that the be mandated to make decisions on the use of individual products from such stock to protect life and health in normal times. The Inquiry proposes that be tasked, in consultation with other actors concerned, es- pecially municipalities, regions, the and the Swedish Armed Forces, with producing such data as is re- quired to enable the Government to decide on which healthcare pro- ducts are to be stockpiled. Such a mandate would also include con- stantly assessing whether the scope of this range should be changed considering ’s preparedness needs or developments. The Inquiry considers that this legislation would significantly improve ’s preparedness regarding healthcare products when faced with a crisis or war. Since this stockpiling is generally to be organised as cycle stock in the ordinary supply chain, this would min- imise the risks of waste and enable the stockpile to be adapted to developments. Establishing national security stockpiles The new act on the obligation to maintain stockpiles will also contain provisions on national security stockpiles and on the State being able to establish such stockpiles for products that cannot be cycled. The Inquiry has analysed the current emergency stockpile and can con- firm that it is based on a number of separate Government mandates spread across several government agencies. The Inquiry can also confirm that the stockpile is limited and is mainly focused on such products that cannot be cycled. The Inquiry considers that the parts that are able to be cycled should be able to be incorporated within the remit of the cycle-based stockpiling obligation proposed above, while the State should retain responsibility for such products that cannot be cycled or for other reasons should not be accounted for openly for reasons of security policy. The Inquiry also considers that the responsibility for a national security stockpile should be brought under one agency, , to ensure that there is expertise on the functioning of the market and the special regulations that govern it. Other expert agencies should support regarding the content of the stockpile. A need for manufacturing readiness There is a need to ensure preparedness to manufacture certain pro- ducts or categories of products. This may both involve safeguarding deliveries of such goods as are normally manufactured in but also converting production to manufacture certain products or pro- duct groups. Healthcare products are covered by many different re- gulations to safeguard patient safety, for example, and therefore it is important that such production, as far as possible, is prepared for and that the support processes required are in place. The Inquiry proposes that the be tasked with producing a survey of the production of drugs and devices that takes place in and its dependence on inputs. Further- more, the Inquiry considers that should be tasked with entering into contracts with such companies as are judged to be relevant for the products where man- ufacturing needs to be safeguarded. This may involve both contracts with rights-holders and contract manufacturers to enable produc- tion to take place. The Inquiry has noted that during the COVID-19 outbreak, there was great willingness to switch various forms of production to meet society’s needs for healthcare products. Healthcare products are subject to many different regulations that seek to uphold patient safety, and various support measures are needed to enable such a change in pro- duction. The Inquiry therefore proposes that the State-owned com- pany () be tasked with firstly supporting the switching of industry in times of crisis or war by using new technologies, for example, and that the company maintain such capacity as is required to certify healthcare products. Extending the societal mandate of APL It is not merely access to approved or licensed drugs that is crucial to life and health. Some drugs are manufactured to order for a par- ticular patient, known as extemporaneous manufacturing. Some of these drugs are standardised, known as stock preparations, and are made in somewhat larger volumes but not on an industrial scale. These drugs fulfil a function where already approved drugs or licensed drugs are not sufficient. They may be used for specific groups of patients, such as children, where drugs in the right strength or dosage form are unavailable. The State-owned company () has a societal mandate to manufacture extemporaneous drugs for individual patients whose needs cannot be met by ap- proved drugs. Before the reregulation of the pharmacy market, APL was part of the State-owned pharmacy company and was thus part of total defence planning. The Inquiry considers that APL needs to be able to maintain its operations within its societal mandate in times of crises or war. The Inquiry therefore proposes that APL be given an expanded societal mandate wherein the company is to maintain its operations within its mandate throughout the entire threat spectrum. Coordination of measures that promote international trade In the event of global or security policy crises, international trade conflicts or war, countries close their borders or otherwise introduce trade barriers or make international trade more difficult. This has become particularly evident during the outbreak of COVID-19. The Inquiry therefore considers that it should be made clear who has responsibility for ensuring that international trade can be maintained, and that this actor needs to be in ongoing dialogue with other actors affected so that an accurate picture of the situation can be maintained at all times. This is an important instrument for being able to take the right measures using the other tools available to safeguard func- tioning supply chains. National purchasing function in times of crisis and war Purchasing is best managed where it takes place in normal times, but there are situations where such global shortages occur that purchas- ing must be coordinated and run nationally. A national function should therefore be created for purchasing healthcare products that is able to intervene and safeguard the healthcare system’s need for such products or product areas in the event of a global shortage or other peacetime crisis, or in the event of war. Such a function is to act on behalf of the whole of and needs to have good aware- ness of the nature of operations and the requirements made of the products being purchased. The function should be subordinate to and be staffed with ex- pertise, e.g. from the regions. A government agency taking respon- sibility for this mandate will mean that purchasing will be made by the State and the products can be allocated to different actors according to need. Such a function should not take over such purchasing that can continue to take place through ordinary supply channels. There is a need to monitor the external situation and for capacity to obtain national status updates regarding availability of products in It is proposed that the be tasked with monitoring the external situation in order to identify and analyse at an early stage events in the national and global arena that will affect or risk affecting access to drugs and products. If such events occur, the long and short-term effects are to be assessed with the aim of enabling the sector to take the relevant steps to prevent negative consequences for the population. Here the is to collaborate with relevant agencies, regions and the pharmaceutical industry. Whether or not there are large or small amounts of healthcare products in , the resources that exist must be able to be used efficiently to achieve the greatest possible societal benefit. Doing so will require national status updates on access to healthcare products and rules that support prioritisation, rationing and redistribution of healthcare products. It is also proposed that the be tasked with producing a national status update on access to drugs and devices in . To obtain a picture of the status of access to such products in , the actors that stockpile products will need to report their stock levels. It is there- fore proposed that an expanded obligation to provide information be included in the Act on of for anyone who is a wholesaler of drugs and for community pharmacies whereby these actors must also submit information on their stock levels of such drugs. Information must also be sent to the eHealth Agency in the same way that these actors already provide information on the sale of drugs. An equivalent obligation for municipalities and regions to provide information on stock levels to the eHealth agency will be introduced in the Health and Act. Measures to distribute healthcare products Tools are needed to distribute available resources. There are tools in existing regulations that can be used to distribute healthcare pro- ducts. Furthermore, the Inquiry proposes a new mandate for redis- tributing resources. The Rationing Act can be used but needs to be reviewed The Rationing Act is the central legislation in for deciding on sales restrictions and steering existing products to certain prior- itised operations. It is of great value that there is a general statute that can be applied for rationing in different sectors, but the current design of the Rationing Act means that it is not entirely appropriate for shortage situations in peacetime. The Inquiry judges that the Rationing Act is in need of modernisation and needs to be reviewed before it is capable of also being an effective tool in crises in peacetime. Existing regulations on drugs contain certain rationing tools Different tools can be used to steer the use of existing products in a shortage situation. This may be by soft steering, e.g. through re- commendations and industry agreements, or through hard steering, such as regulations. The Government and the Pro- ducts Agency have certain possibilities, pursuant to the Pharma- ceuticals Act, the Act on of and the new Act containing supplementary provisions to the EU’s Regulations on devices, to issue regulations necessary to protect human health. These should be able to be used, in peacetime crises and times of war, to decide on restrictions on the right to prescribe drugs and to provide them at community pharmacies and, in certain circum- stances, on possibilities to divide packs or to sell drugs with a shorter shelf-life than normal. They should also be able to justify decisions to control the sale of healthcare products to certain prioritised actors, e.g. regions, municipalities and the Swedish Armed Forces in peace- time crises and times of war. Where there is a shortage of resources, prioritisation and redistribu- tion of resources should primarily be handled at local and regional level and voluntarily between regions and other actors. For those situations where the shortage of resources is so severe that priorities need to be made at national level, there needs to be a mandate for a Government agency to decide which operations are to be prioritised and, where necessary, whether available products in public operations are to be redistributed to such operations. The decision as to which operations and which actors are to be prioritised in allocating re- sources has to be based on which healthcare is to be prioritised. The actor that is best placed to decide on such priorities is therefore . It is proposed that expanded authorisation in the Health and Act grant the possibility to issue regula- tions on healthcare in peacetime if, in peacetime crises, there is a need for other nationally coordinated measures to protect the health of in- dividuals. The regulations surrounding trade in drugs normally prevent drugs being sent between hospital pharmacies and community pharmacies. The Inquiry proposes that the time-limited regulations determined by the regarding the redistribu- tion of drugs between community pharmacies and hospital pharmacies during COVID-19 should continue to apply until further notice. This would mean an established structure for how decisions on re- distribution of drugs are to be handled in the event of serious situa- tions in peacetime or when shortages arise. The distribution of healthcare products needs to be able to be maintained Functioning distribution is essential to ensure that necessary health- care products are available for patients and healthcare providers. This means that there must be access to pharmacies, but also that the major distributors responsible for a large proportion of supplies of both drugs and other healthcare products must be able to function. Public access to prescribed healthcare products must be ensured through emergency pharmacies Prior to the reregulation of the pharmacy market, had a central role in supplying drugs both in peacetime and in times of war. Operations were to be maintained as far as possible. The com- pany had an overview of the drugs held by all ’s pharmacies and was in charge of all pharmacy stock. In times of war, the com- pany had responsibility for central and distributor stock in . was an integrated part of the management structure for total defence at all levels. Following reregulation, there is no longer any designated actor with corresponding preparedness responsibilities in the field of pharmaceuticals. are there currently any equivalent obligations for pharmacy actors in statutes nor through agreements. To safeguard public access to drugs via pharmacies even in peace- time crises and in times of war, the Inquiry proposes that special emergency pharmacies be established with an appropriate geograph- ical spread throughout the country. The emergency pharmacies are to be obliged to stay open and operate during peacetime crises and times of war, and they are to operate in premises that are suitable for the special duties that are to be performed in such circumstances. There are to be special requirements for emergency pharmacies regard- ing expanded stockpiling and operational reliability capabilities. It is proposed that be given a societal mandate imposing it with establishing emergency pharmacies. not have operations in all locations where there may be a need for an emergency pharmacy, is to take responsibility for supplementary procurement of emergency pharmacies. If the need for an emergency pharmacy cannot be met by procurement, is to be given responsibility for estab- lishing such pharmacies. The obligation of wholesalers to deliver must also encompass hospital pharmacies Anyone working as a drug wholesaler currently has both a public obligation to maintain sufficient deliveries of drugs and an explicit obligation to deliver drugs to community pharmacies. Community pharmacies are obliged to provide drugs irrespective of whether it is to individual patients or to healthcare. Following the deregulation of the pharmacy market, the health- care authorities gained the opportunity to choose for themselves how they wished to organise the supply of drugs to hospitals. However, there is currently no obligation for wholesalers to provide drugs to healthcare authorities or hospitals. The Inquiry therefore proposes that the obligation, that anyone working as a drug wholesaler currently has to deliver drugs to community pharmacies, be expanded such that the obligation to deliver also includes deliveries to hospital pharmacies. The operations of the major distributors need to be maintained in crises and in times of war Healthcare authorities, private healthcare providers and pharmacies need continued deliveries of healthcare products. For this to be pos- sible, the distributors must be able to maintain their operations in the same way as the healthcare system and community pharmacies. The Inquiry therefore proposes that the State, through , enters into agreements with the largest distributors of drugs and other healthcare products on their involve- ment in contingency planning and total defence.