Health services framework and competent authorities
Healthcare bodiesDescribe the bodies and their responsibilities (public and private sector) concerned with the delivery of healthcare and appropriate products for treatment.
The responsibility for healthcare in Sweden is divided between the government, the Swedish county councils and local municipalities. On a governmental level, the Ministry of Health and Social Affairs is responsible for all policies related to social welfare in Sweden, including policies regarding the delivery of healthcare. The Ministry of Health and Social Affairs works in concert with various national government agencies, such as the National Board of Health and Welfare, which is responsible for all social services, health and medical services, patient safety and epidemiology, and the Health and Social Care Inspectorate, which is responsible for supervising healthcare and social care, as well as healthcare care staff. On a regional level, the Swedish county councils are responsible for the financing and delivering of healthcare services to citizens. The healthcare is then, by agreement with the county councils, provided by private and public healthcare providers. Care of elderly and disabled persons is, however, provided locally by the Swedish municipalities.
When it comes to appropriate products for treatment, the Medical Products Agency (MPA) is responsible for regulation and surveillance of the development, manufacturing and sale of medicinal drugs, medical devices and cosmetics. The Social Care Inspectorate is responsible for the supervision of self-made medical devices as well as the way in which medical devices and medicinal products are prescribed, put into use, used and handled.
Competent authorities for authorisationIdentify the competent authorities for approval of the marketing of medicinal products and medical devices. What rules apply to deciding whether a product falls into either category or other regulated categories?
The MPA is the competent authority for approval of the marketing of new medicinal products and market entry for medical devices in Sweden.
The main regulatory frameworks for medicinal products are the Medicinal Products Act (2015:315) and the Medicinal Products Ordinance (2015:458), which are based on EU Directives 2001/83/EC and 2001/82/EC (the Medicinal Products Directives). The definition of ‘medicinal product’ corresponds with the definition in the Medicinal Products Directives. For more details regarding the framework for medicinal products, see the EU chapter.
The main regulatory frameworks for medical devices are the Medical Devices Act (1993:584) and Medical Devices Ordinance (1993:876), which are based on EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC (the Medical Device Directives). For more details regarding the framework for medical devices in the Medical Device Directives, and the new EU Regulations 2017/745 and 2017/746 coming into force in May 2020, see the EU chapter. In short, the intended use and the mechanisms of action of the device control whether a device constitutes a medical device or not. The difference between a medicinal product and medical device is that, whereas the mode of action of a medicinal product is pharmacological, immunological or metabolic, medical devices work by other means; for example, by a physical or mechanical mode of action.
As for cosmetics, EU Regulation (EC) No. 1223/2009 on cosmetic products is implemented in Swedish law by the Ordinance on cosmetic products (2013:413). The Regulation (and the Ordinance) defines cosmetic products as any substance or mixture intended to be placed in contact with the external parts of the human body exclusively or mainly to clean it, perfume it, change its appearance, protect it, keep it in good condition or to correct body odours. The main distinction between medicinal products and cosmetic products is thus that cosmetic products are applied externally without any intended internal effects; if a product is applied externally but has an intended internal effect it is no longer a cosmetic product. All cosmetic products must comply with the Swedish Environmental Code (1998:808) and the Swedish Environmental Inspection Regulation (2011:13).
Food supplements are regulated by food laws and regulations in Sweden. However, if the purpose of a food supplement is to prevent or treat disease, or to adjust or modify physiological functions by pharmacological, immunological or metabolic mode of action (ie, in accordance with the definition of ‘medicinal product’ mentioned above), it shall be classified as a medicinal product.
Approval frameworkDescribe the general legislative and regulatory framework for approval of marketing of medicinal products and medical devices.
All medicinal products in Sweden must be approved by the MPA, sometimes in concert with other medicinal products agencies in other EU member states, or the EU Commission.
The requirements for the approval of new medicinal products included in the Medicinal Products Act are based on and correspond with the requirements set forth in the Medicinal Products Directives. For more details regarding the requirements for approval of new medicinal products in the Medicinal Products Directives, see the EU chapter. All medicinal products need to be of good quality and be appropriate as well as effective in order to obtain a marketing authorisation. The application procedure for clearance by the MPA is included in MPA Regulation LVFS 2011:19.
Medical devices do not need approval by the MPA. Instead, market access is conditional upon CE marking. According to MPA Regulation LVFS 2003:11, some medical devices must, however, be registered by the MPA; for example, in vitro diagnostic products and some categories of medical devices as set out in the Regulation. This registration does not mean, however, that the MPA has approved the medical device. All medical devices must, however, comply with the requirements in the Medical Devices Act, which is based on and corresponds with the Medical Device Directives. For more details regarding the requirements for medical devices, see the EU chapter. A medical device needs to be safe and fit for its designated purpose. A medical device that meets the requirements shall be provided with a CE marking.
All labelling and instructions for use of medical devices must be written in Swedish according to MPA Regulations LVFS 2001:5, LVFS 2003:11 and LVFS 2001:7. As for medicinal products, there are detailed provisions regarding labelling in LVFS 2005:11, which prescribes that the labelling on the outer package and the container shall be in Swedish.
Clinical practice
Applicable rulesWhat legislation controls and which rules apply to ethics committee approval and performance of clinical trials in your territory for medicinal products and medical devices?
Primarily, the Medicinal Products Act, the Medicinal Products Ordinance, the Ethical Review Act (2003:460) and MPA Regulation LVFS 2011:19 on clinical trials, which refers to Directives 2001/20/EC and 2005/28/EC regarding good clinical practice, apply to ethics committee approval and performance of clinical trials. The Swedish Association of the Pharmaceutical Industry (LIF) has also issued a framework for ethical rules for the pharmaceutical industry in Sweden (the LER Rules), which contain specific rules on conducting clinical trials. All clinical trials of medicinal products must follow the European Medicines Agency (EMA) Guideline on Strategies to Identify and Mitigate Risks for First-in-Human Clinical Trials with Investigational Medicinal Products. Applications are filed with the Swedish Ethical Review Authority.
New EU Regulation No. 536/2014 on clinical trials, replacing EU Directive 2001/20/EC, entered into force on 16 June 2014. However, its application is awaiting the development of a fully functional EU clinical trials portal and database. For the purpose of implementing the new Regulation, the Swedish government has prepared the Additional Provisions on Ethical Review for the EU Regulation on Clinical Trials Act 2018:1091, which is ready to come into force.
As for medical devices, clinical trials for the purpose of creating documentation for CE marking are primarily regulated by the Medical Devices Act, the Medical Devices Ordinance, MPA Regulations LVFS 2003:11 on active implants and LVFS 2001:5 on medical devices. All clinical trials for medical devices should be in line with the Swedish standards SS-EN 12155:2011 (for clinical trials) and SS-EN ISO 14971:2012 (for risk management).
Furthermore, all clinical trials for medicinal products and medical devices must be conducted in accordance with the latest version of the World Medical Association’s Declaration of Helsinki and be registered with the European Clinical Trials Register.
Reporting requirementsWhat requirements exist for reporting the commencement of a trial and its results to the competent authorities or the public?
Clinical trials for medicinal products and medical devices require prior approval from both the MPA and an ethics committee (the Swedish Ethical Review Authority).
For medicinal products, the reporting of the commencement of a trial to the MPA shall be made through an application document accompanied with a clinical investigation plan and other required information in accordance with the Medicinal Products Act and MPA Regulation LVFS 2011:9.
For medical devices, the reporting of the commencement of a trial to the MPA shall be made through an application document accompanied with a clinical investigation plan and other required information in accordance with the Medical Devices Act and MPA Regulations LVFS 2003:11 on medical devices and LVFS 2001:5 on active implants.
The results of clinical trials for medicinal products shall be reported to the European Clinical Trials Database (EudraCT); for more information, see the EU chapter. The results of clinical trials of medical devices shall be concluded in a complete report to be provided to the MPA upon request.
Consent and insuranceAre there mandatory rules for obtaining trial subjects’ consent to participate? Must sponsors arrange personal injury insurance to a particular limit?
For clinical trials on medicinal products, consent must be obtained from all trial subjects according to the Medicinal Products Act. Furthermore, the sponsor of the clinical trial for medicinal products must guarantee financial protection for potential damages or reimbursements, through insurance or otherwise.
For medical devices, MPA Regulations LVFS 2003:11 on medical devices and LVFS 2001:5 on active implants require that clinical trials are conducted in accordance with the Declaration of Helsinki, which requires consent from all trial subjects.
Marketing authorisation
Time frameHow long does it take, in general, to obtain an authorisation from application to grant, what fees are payable and what is the normal period of validity of the authorisation?
In Sweden, being a part of the EU, an application to obtain market authorisation for medicinal products can be made by four different procedures;
- a centralised procedure;
- a mutual recognition procedure;
- a decentralised procedure; and
- a national procedure.
In the centralised procedure, the assessment is made by the two national competent authorities appointed by the Committee for Veterinary Medicinal Products or the Committee for Medicinal Products for Human Use. The assessment shall be completed within 210 days. The final opinion is forwarded to the EU Commission for decision. Authorisation of medicinal products via the centralised procedure will entitle the companies in question to sell these products throughout the European Economic Area (EEA).
By the mutual recognition procedure, a company may request that an existing national authorisation shall be recognised in other EEA countries. The application is assessed by the competent authority where authorisation has already been granted (reference member state (RMS)) and the competent authority in the country where the authorisation shall be extended (concerned member state (CMS)). The total processing time may not exceed 90 days. The general application fee for a complete application is 120,000 Swedish kronor when Sweden is the CMS and 200,000 Swedish kroner when Sweden is the RMS. An extension of an existing authorisation is 200,000 Swedish kronor if Sweden is the RMS or 65,000 Swedish kronor if Sweden is the CMS. There is also a yearly fee, in general, amounting to 51,000 Swedish kronor for authorised medicinal products.
The decentralised procedure is applicable in cases where a company wishes to obtain marketing authorisations in a number of EEA countries for a medicinal product that has no previous authorisation. The application is assessed and approved by an RMS selected by the company and approved concurrently by the selected countries (CMS). The assessment shall be completed within 210 days. The application fees are the same as for the mutual recognition procedure.
Through the national procedure, a right to marketing in one single country only can be obtained. The assessment by the MPA shall be completed within 210 days after the MPA has validated the application as complete (the validation period is 14 days). The general application fee is 500,000 Swedish kronor, an extension of an existing authorisation amounts to 200,000 Swedish kronor, and the yearly fee amounts to 51,000 Swedish kronor.
There is no requirement for marketing authorisation for medical devices. For some categories of medical devices, both the company and the product must, however, be registered with the MPA. The review period is approximately two months from the time a complete application is received. According to the Ordinance on Medical Devices, the company registration fee is 2,150 Swedish kronor per year. Annual registration fees for products are as follows:
- for 10 products: 1,000 Swedish kronor;
- for 100 products: 2,000 Swedish kronor;
- for 500 products: 5,000 Swedish kronor; and
- for more than 500 products: 10,000 Swedish kronor.
What protection or exclusivities apply to the data submitted by originators to gain initial approval and, on variation or new application, to add indications or pharmaceutical forms?
Data exclusivity is regulated by EU Regulation (EC) No. 726/2004; see the EU chapter.
Freedom of informationTo what extent and when can third parties make freedom of information applications for copies of research data submitted by applicants for authorisation to market medicinal products or medical devices?
This is regulated by EU Regulation (EC) No. 726/2004; see the EU chapter.
Regulation of specific medicinal productsAre there specific rules for approval, and rewards or incentives for approval, of particular types of medicinal products, such as traditional herbal and homeopathic products, biologicals and biosimilars, controlled drugs, orphan drugs and those for paediatric use?
MPA Regulation HSLF-FS 2017:75 shall be complied with when registering homeopathic medicinal products. The Regulation is based on articles 14 and 15 of the Medicinal Products Directives.
As for herbal medicinal products (ie, medicinal products in which the active ingredient consists exclusively of herbal materials or herbal preparations), these also fall within the scope of the Medicinal Products Directives. Furthermore, MPA Regulation LVFS 2006:3 applies.
When it comes to biologicals and biosimilars, the criteria for approval is specified in various guidance papers issued by the EMA.
As regards orphan drugs and products for paediatric use, see the EU chapter.
Post-marketing surveillance of safetyWhat pharmacovigilance or device vigilance obligations apply to the holder of a relevant authorisation once the product is placed on the market?
For medical devices, authorisation holders are required to continuously monitor how their products work in practical use and are obliged to report accidents and incidents when there is a suspicion that the medical device may be involved in the event, according to the Medical Devices Directives, which are implemented by MPA Regulations LVFS 2003:11, 2001:5 and 2001:7. Authorisation holders must also report any corrective safety measures on products that have been placed on the market.
For medicinal products, there is a requirement to update product information in relation to new knowledge. In cases of non-compliance, the MPA may send a request regarding post-authorisation control of a medicinal product with demands for updates. Avoiding answering such a request might result in an injunction and other consequences, such as deregistration of the product.
Furthermore, there is a requirement for periodic safety update recording in accordance with EU Regulation No. 1235/2010, Directive 2010/84/EU and Commission Implementing Regulation (EU) No. 520/2012, implemented by MPA Regulation LVFS 2012:14. See the EU chapter for more details regarding periodic safety update recording.
Other authorisationsWhat authorisations are required to manufacture, import, export or conduct wholesale distribution and storage of medicinal products and medical devices? What type of information needs to be provided to the authorities with an application, what are the fees, and what is the normal period of validity?
For medicinal products, a licence from the MPA is required for the manufacturing, import from and export to a country outside the EEA of medicinal products according to the Medicinal Products Act. The requirements for such authorisation are included in MPA Regulation LVFS 2004:7. For example, the application needs to include:
- general information regarding the applicant (such as name, registration certificate and billing address);
- whether the application concerns a certain medicinal product or medicinal products in general;
- the form of medicinal product or products;
- the location of the premises;
- details regarding the premises and equipment;
- a description of potential contract manufacturing or contractual analysis; and
- a proposal for an expert or adviser and his or her curriculum vitae.
A decision on an application shall in general be made by the MPA within 30 days of the submission of a complete application (this period can be prolonged to 90 days). The general application fee for manufacturing is 65,000 Swedish kronor and the yearly fee is, in general, 60,000 to 80,000 Swedish kronor. The licence is valid for as long as the yearly fees are paid; however, not for a period longer than that indicated in the decision.
For medical devices, manufacturers are obliged to register certain forms of medical devices with the MPA in accordance with that outlined under section 3 (the term ‘manufacturer’ also includes import of products outside the EEA). There is, however, no licence required for manufacturing or importing medical devices. Naturally, and in accordance with the Medical Devices Directives, medical devices with the appropriate CE marking may be exported freely within the EEA. Countries outside the EEA may, however, request a ‘free sales certificate’, which ensures that the product may be exported without any legal restrictions. The MPA can issue such certificates. The application fee is 950 Swedish kronor. The period of validity is commonly three years or the time period of the CE marking.
SanctionsWhat civil, administrative or criminal sanctions can authorities impose on entities or their directors and officers for breach of the requirements concerning controlled activities?
The MPA has the authority to issue injunctions and prohibitions necessary to ensure compliance with the Medicinal Products Act and Medical Devices Act, and may combine such injunctions with a penalty fine.
As for criminal sanctions, violations of the Medicinal Products Act and the Medical Devices Act are penalised with a fine or imprisonment for a maximum of one year.
ExemptionsWhat, if any, manufacture and supply of medicinal products is exempt from the requirement to obtain an approval to market?
There is an exemption from the marketing authorisation requirement for advanced therapy medicinal products defined in article 2 of EU Regulation (EC) No. 1394/2007, which are produced in Sweden in accordance with a non-routine procedure, for a certain patient in accordance with a prescription, and which are used in Swedish hospitals. A licence is required in accordance with the Medicinal Products Act and MPA Regulation LVFS 2011:3.
For unlicensed medicinal products, see question 27.
Parallel tradeAre imports allowed into your jurisdiction of finished products already authorised in another jurisdiction, without the importer having to provide the full particulars normally required to obtain an authorisation to market? What are the requirements?
Parallel import of medicinal products from other EEA countries to Sweden (which have been approved in the other EEA country through the national procedure, the mutual recognition procedure or the decentralised procedure) is allowed but requires authorisation from the MPA in accordance with Regulation LVFS 2012:19, and must comply with the labelling requirements in the Regulation. Medicinal products that have been approved through the central procedure may instead be parallel distributed, which is authorised by the EMA; see the EU chapter for more details.
Parallel import of medical devices does not require authorisation from the MPA. However, all labelling and instructions for use of medical devices must be written in Swedish (MPA Regulations LVFS 2001:5, LVFS 2003:11 and LVFS 2001:7).
Amending authorisations
VariationWhat are the main requirements relating to variation of authorisations for medicinal products and medical devices?
EU Regulation (EC) No. 1234/2008 regulates variations to a marketing authorisation for approved medicinal products; see the EU chapter.
This is not applicable to medical devices.
RenewalWhat are the main requirements relating to renewal of authorisations for medicinal products and medical devices?
A marketing authorisation for medicinal products is valid for five years and may be renewed after this period. One renewal after five years is usually sufficient for continued validity until further notice; however, the authority may, for safety reasons, decide that a further renewal is required. The application for a renewal must be received by the MPA no later than nine months before the renewal date for medicinal products for human use, and six months before the renewal date for veterinary medicinal products. The application must include documentation regarding the efficacy, safety and quality (including detailed pharmacovigilance data) as well as a list of all changes made since the first authorisation or last renewal.
This is not applicable to medical devices.
TransferHow easy is it to transfer the existing approvals or rights to market medicines and medical devices? How long does this take in general?
Application for transfer requires submission of an application form (available on the MPA’s website), which shall be accompanied by a wholesale licence for the new marketing authorisation holder, proof of establishment of the new marketing authorisation holder, summary of product characteristics and patient information leaflet and labelling text with tracked changes (if applicable), the latest approved version of the mock-ups and the new final version (if applicable). The time period of assessment by the MPA is three months.
This is not applicable to medical devices.
Recall
Defective and unsafe productsWhat are the normal requirements for handling cases of defective or possibly unsafe products, including approvals required for recall and communication with health professionals?
Manufacturers of medical devices are obliged to report serious incidents with CE-marked devices in Sweden to the MPA, according to MPA Regulations LVFS 2001:5, LVFS 2003:11 and LVFS 2001:7 (and the corresponding Medical Device Directives). The manufacturer shall also be informed of corrective safety measures that are taken by the manufacturer, including recalls (field safety corrective actions). Requirements on the vigilance reporting system are to be found in the EU Commission Guide MEDDEV 2.12/1.
For medicinal products, according to the Medicinal Products Act, the MPA is authorised to make decisions regarding their recall. The provisions regarding recall in the Medicinal Products Act are based on the Medicinal Products Directives.
Promotion
RegulationSummarise the rules relating to advertising and promotion of medicinal products and medical devices, explaining when the provision of information will be treated as promotional. Do special rules apply to online advertising?
The Medicinal Products Act contains specific provisions on marketing of medicinal products, while the Marketing Practices Act relates to marketing in general (thus, including marketing of medicinal products and medical devices). The new EU Regulations 2017/745 and 2017/746 on medical devices prescribe a prohibition on misleading marketing of medical devices.
In short, the definition ‘advertising of medicinal products’ described in the Medical Products Directives corresponds to the interpretation of when the provision of information will be treated as promotional according to the Medicinal Products Act. In addition, MPA Regulation LVFS 2009:6 lists several measures that specifically should be included in the definition of marketing of medicinal products. MPA Regulation LVFS 2009:6 also lists several measures that are not to be deemed as marketing of medicinal products. These measures also correspond to the measures mentioned in the Directives; see the EU chapter.
The Marketing Practices Act applies to any kind of marketing, including online marketing. Under the Marketing Practices Act, the term ‘advertising’ is seen as part of the broader term ‘marketing’. Even the sale itself, even though entirely passive, is considered to be a marketing measure. In addition, measures that aim to promote the supply of products are included in the definition.
The LER Rules by LIF also include rules regarding information of medicinal products. Further, if a company is subject to the LER Rules, it will be able to apply for a prior permission from the Swedish Pharmaceutical Industry’s Information Examiner Committee (IGN) to provide information regarding the medicinal product on a special website. The information provided on the website has to be reviewed by the IGN before it is published and before any changes can be made. Due to the prohibition of advertising of medicinal products directly towards consumers, companies are not allowed to refer to, or in any way promote, their informational website. This means that consumers will have to find the website on their own.
InducementWhat regulations exist to discourage the provision of inducements to healthcare professionals to prescribe, sell, supply or recommend use of a particular medicinal product or medical device?
In addition to general criminal rules on bribes that follow from the Swedish Penal Code (1962:700), the LER Rules provide for specific regulations relating to inducements to healthcare professionals in regard to medicinal products.
Any form of cooperation between healthcare professionals and pharmaceutical companies where there has been some kind of remuneration shall be documented. Donations made by the company are only permitted if they are supporting research and development. The only gifts that are permitted are informational and educational material, under the condition that the material is of low value, directly relevant to the practice of the recipient and directly beneficial to the care of patients. Items of medical utility may be provided for purposes of educating employees and for the care of patients under the condition that the item is of low value and not such that it is routinely used in the recipient’s business. Furthermore, it is not permitted to provide healthcare professionals with an inexpensive gift unrelated to the practice of medicine on an infrequent basis in acknowledgement of significant national, cultural or religious holidays.
For medical device companies, according to the cooperation agreement entered into with, inter alia, LIF, it is not permitted to offer benefits, gifts or other compensation to healthcare professionals. Gifts offered to medical entities (such as hospitals) that could be considered as indirect gifts to the healthcare professionals working within the medical entity are, accordingly, also prohibited. Donations may never be offered or requested to fund healthcare’s internal or regular activities. Donations to healthcare are allowed only if they are made to support research and development and under the condition that the donation is transparent, well-documented and in accordance with the cooperation agreement and its intentions.
There is a specific rule in the industry code stating that ‘donations and grants to healthcare shall not be connected to past, present or potential future use, recommendation, sale or prescription of the donor’s products or services, and may not constitute an inducement to recommend, prescribe, purchase, supply, sell or administer specific medicinal products’.
Reporting transfers of valueWhat requirements apply to recording and publishing details of transfers of value to healthcare professionals and organisations by companies marketing medicinal products or medical devices?
LIF’s ethical rules correspond to the European Federation of Pharmaceutical Industries and Associations’ Discloser Code in this matter. Direct or indirect transfers of value, whether in cash, in kind or otherwise, made for promotional purposes or otherwise, in connection with the development and sale of prescription-only medicinal products exclusively for human use, to a healthcare professional or organisation shall be recorded and published by the pharmaceutical company. In accordance with the cooperation agreement between, inter alia, LIF and the trade association, Swedish Medtech, the principle of documentation applies to (connected) medical device companies in regard to value transfers. These companies are, therefore, obliged to document information about value transfers, but they do not have to publish this information.
Enforcement of advertising rules
EnforcersDescribe the bodies involved in monitoring and ensuring compliance with advertising controls for medicinal products and medical devices, distinguishing between any self-regulatory framework and control by the authorities.
As regards law enforcement, the Swedish Medical Products Agency is responsible for the supervision of compliance with the Medicinal Products Act and the Medical Devices Act. The Swedish Marketing Practices Act is enforced by the Swedish Consumer Agency.
For the self-regulatory LIF, the IGN and the Information Practices Committee have a duty to ensure LIF members’ compliance with the LER Rules.
SanctionsWhat are the possible financial or other sanctions for breach of advertising and promotional controls for medicinal products or medical devices?
The MPA is entitled to demand information and issue orders and prohibitions necessary to ensure the compliance with the Medicinal Products Act, the Medical Devices Act and any regulations issued based on the acts in question. Such demands, orders and prohibitions can be coupled with a fine.
Sanctions available under the Marketing Practices Act consist of prohibitions or orders coupled with a penalty fine, fines for disruptive marketing practices and damages.
Pricing and reimbursement
PricingWhat are the controls imposed on pricing of medicines and medical devices and reimbursement by national social security systems that are applicable to manufacturers, distributors and pharmacists?
The Dental and Pharmaceutical Benefits Agency (TLV) is responsible for deciding whether a pharmaceutical product or medical device should be eligible for reimbursement and included in the Swedish benefits scheme. The TLV is responsible for setting the purchase and selling price of such products. These decisions are made in accordance with the Act on Pharmaceutical Benefits (2002:160). Prices are based on an ethical platform with three basic principles:
- the human value principle;
- the need and solidarity principle; and
- the cost-effectiveness principle.
The Swedish medical benefit scheme consists of two parts: subsidising of medicinal products and medical devices, and a ‘high-cost threshold’. Sweden applies a high-cost threshold for prescription medicinal products and medical devices, which means that patients only have to pay for such products up to a certain threshold; all prescription medicinal products and medical devices are free thereafter. The high-cost threshold starts to apply after purchases amounting to 1,150 Swedish kronor for prescription medicinal products and medical devices during a 12-month period. However, not all products are included in the high-cost threshold scheme, although the scheme includes numerous types of medicinal products and medical devices.
Off-label use and unlicensed products
Off-label useMay health professionals prescribe or use products for ‘off-label’ indications? May pharmaceutical companies draw health professionals’ attention to potential off-label uses?
The MPA recommends that products that have been authorised for a specific indication are used if available. However, as a general rule, doctors have the right to freely prescribe or use products they deem fit for a particular purpose, including for ‘off-label’ indications, if such use can be motivated based on scientific findings and proven experience. Certain limitations apply to, inter alia, narcotic pharmaceutical products authorised for the treatment of ADHD.
Pharmaceutical companies have to be careful in drawing health professionals’ attention to potential off-label uses, as the provision of such information would likely be considered as marketing. For the restrictions on marketing of medicinal products and medical devices, see questions 20 and 21.
Unlicensed productsWhat rules apply to the manufacture and importation and supply to healthcare providers of unlicensed medicines or medical devices?
Unlicensed medicinal products (ie, medicinal products that have not been granted marketing authorisation by the MPA), may, under certain circumstances, be dispensed after obtaining a special licence from the MPA if there is a need that cannot be satisfied with approved medicinal products on the market. The licence may apply to a certain patient (individual licence) or to one or more healthcare entities (general licence).
Furthermore, there is a separate licence to be obtained for the manufacturing of extempore medicinal products (ie, non-standardised medicinal products to be produced by a pharmacy for a certain patient or animal, which is regulated by MPA Regulation LVFS 2010:12 (for extempore pharmacies) or LVFS 2009:8 (for standard pharmacies)). Hospitals may manufacture extempore medicinal products without a licence from the MPA, but must notify the MPA of their supply of medicinal products to the public. The manufacturing of extempore medicinal products that are produced for a certain patient but not for a certain occasion (ie, stock preparations of extempore medicinal products) also requires a licence from the MPA according to Regulation LVFS 2004:7.
Compassionate useWhat rules apply to the establishment of compassionate use programmes for unlicensed products?
Compassionate use programmes (CUPs) for unlicensed products can be established in Sweden in accordance with EU Regulation (EC) No. 726/2004 for a group of patients with a life-threatening, chronically or seriously debilitating disease, which cannot be treated satisfactorily by currently authorised medicinal products. The medicinal product concerned must either be the subject of an application for a marketing authorisation or be undergoing clinical trials.
The manufacturer or the applicant for market authorisation must apply to the MPA before establishing a CUP. The application is free of charge and can be made through a standard form, which can be obtained from the MPA’s website. Patients participating in the CUP must be provided the product free of charge.
Sale and supply
RegulationAre there special rules governing the dispensing or sale of particular types of medicinal products or medical devices?
To dispense or sale prescription-free medicinal products or medical devices, the Trade with Prescription Free Medicinal Products Act (2009:730) applies. For dispensing or sale of prescription medicinal products and medical devices, the Trade with Prescription Medicinal Products Act (2009:366) applies as well as MPA Regulation LVFS 2009:8. Each respective act specifies which medicinal products and medical devices can be sold under the Act. Both the dispensing or sale of prescription-free medicinal products or medical devices, and the dispensing or sale of prescription medicinal products and medical devices, requires authorisation from the MPA.
Online supplyWhat laws and guidelines govern online dispensing, sale and supply of medicinal products and medical devices?
There are no additional laws or guidelines relating to e-pharmacies.
Update and trends
Forthcoming legislation and regulationIs there any current or foreseeable draft legislation or other rules that will affect the regulation of pharmaceuticals and medical devices? What is likely to change, and what steps need to be taken in preparation?
Forthcoming legislation and regulation31 Is there any current or foreseeable draft legislation or other rules that will affect the regulation of pharmaceuticals and medical devices? What is likely to change, and what steps need to be taken in preparation?The MPA has recently been tasked by the government with establishing a structure for cooperation between national players within the healthcare sector regarding medicine shortages and with further developing the MPA’s supply of information during a period when a medicine is not accessible on the Swedish market.
The MPA has also been tasked with conducting a pilot study in which a risk-benefit assessment of a pharmaceutical product of the MPA’s choosing, that is commonly prescribed or used for ‘off-label’ indication, will be carried out. The purpose of the pilot study is to assess whether the MPA should start to continuously conduct risk-benefit assessments of common off-label products and to suggest a process for such assessments.
In September 2019, Sweden’s plan to join the impending International Horizon Scanning Initiative (IHSI) was announced. IHSI is an international cooperation seeking to identify unauthorised innovative medicinal products. The cooperation, expected to start in late October 2019, will inform decision-making on treatment and budgets in the participating countries. IHSI is a good example of a broader trend of expanding international cooperation on medicinal products.
