Trends and developments

Legal developments

Are there any notable trends or recent legal developments in your jurisdiction’s pharmaceutical industry?

It is likely that digitalisation will continue to have a significant effect on the life sciences sector. In Sweden, digital healthcare providers and e-pharmacies have been strengthening their role on the market. E-health is a responsibility of the National Board of Health and Welfare – a government agency under the Ministry of Health and Social Affairs. The National Board of Health and Welfare recently published the principles that service providers must comply with when performing digital healthcare services. Due to technical developments and the recent introduction of the EU General Data Protection Regulation, further guidelines, laws, ordinances and regulations that govern healthcare activities are expected to be adopted or reviewed in order to reflect digitalisation and the need for safety, efficiency and protecting the integrity of individuals.

The Swedish healthcare market is divided into 21 county councils (regions), which are responsible for healthcare within their respective council/region. The government is focusing on reducing regional disparities in the quality of care provided and finding solutions for a more equal offering of healthcare to patients. The National Board of Health and Welfare has been appointed to coordinate and support the work on patient safety at a national level.

As one example of a trend within the field of pharmaceuticals, the Public Health Agency of Sweden has been appointed to conduct a national study with the aim of securing access to antibiotics of special medical value, including an assessment of the economic compensation models for these antibiotics.

Legal framework

Legislation

What is the primary legislation governing medicinal products in your jurisdiction?

The primary legislations governing medicinal products in Sweden are the Medicinal Products Act (SFS 2015:315) and the Medicinal Products Ordinance (SFS 2015:458). The Act on Sales of Medicinal Products (SFS 2009:366 amended through SFS 2018:1275) regulates the trade of medicinal products in Sweden (eg, wholesale distribution and the sale of medicinal products to pharmacies).

Are any legislative changes proposed or expected in the near future?

The application of the new EU Clinical Trials Regulation (536/2014) is expected to enter into force in 2019. This regulation will be directly applicable in Sweden.

There is an ongoing government review of responsibility between the state and the county councils when it comes to the financing, reimbursement and pricing of pharmaceuticals. The review is the first comprehensive review of the financing and reimbursement scheme since 1998.

Regulation

Which bodies regulate medicinal products in your jurisdiction and what is the scope of their powers?

The Medical Products Agency (MPA) is the Swedish national authority responsible for the regulation and surveillance of the development, manufacturing and marketing of pharmaceuticals and other medicinal products. The Swedish regulatory framework for medicinal products is largely based on, and harmonised with, EU legislation. EU directives are transposed into acts and ordinances by the Swedish government and into provisions by the MPA. These provisions are published in the MPA Regulations (LVFS). Regulations issued by the European Union are directly applicable in Sweden.

The Swedish Dental and Pharmaceutical Benefits Agency (TLV) is responsible for:

  • the benefit scheme relating to medicinal products;
  • retail margins for Swedish pharmacies; and
  • decisions on the substitution of medicinal products at Swedish pharmacies.

The TLV also supervises certain areas of the pharmaceutical market.

Are any other legal regimes applicable to the trade of medicinal products (eg, competition, international trade, data protection, consumer protection)?

Trade in medicinal products must comply with the general national and EU provisions governing, among other things:

  • trademarks;
  • competition;
  • international trade;
  • data protection;
  • consumer protection; and
  • marketing.

Are any medicinal products exempt from regulation (eg, complementary and alternative medicines)?

According to the Swedish Medicinal Products Act (SFS 2015:315), a ‘medicinal product’ is any substance or combination of substances presented as having properties for preventing or treating diseases in humans or animals. All products classified as medicinal products (including homeopathic medicinal products, herbal medicinal products, traditional herbal medicinal products and natural remedies) are governed by the legislation for medicinal products. The previous special regulations for marketing authorisation and certain exemptions for so-called ‘anthroposophic’ medicines were abolished on 1 July 2018.

Supply

Manufacture

What is the authorisation procedure for the manufacture of medicinal products in your jurisdiction?

The manufacturing of medicinal products requires a valid manufacturing authorisation (licence) granted by the Medical Products Agency (MPA). The MPA has issued detailed provisions and guidelines for the licence application, which specify the relevant documents and information to be included in the application. The MPA's review of an application includes:

  • a formal examination of the application;
  • an assessment according to good manufacturing practices (GMPs), including on-site inspection; and
  • an assessment of the suitability of the appointed qualified person.

On receipt of a complete application and payment of the application fee, the MPA has 90 days to render its decision. A dismissal of an application by the MPA can be appealed to the county administrative court.

What is the fee for obtaining authorisation?

The standard fee for obtaining a licence for the manufacture of medicinal products is Skr65,000.

What is the validity period for authorisation?

A manufacturing licence can be granted for either an indefinite or a specified period. The MPA may withdraw a licence:

  • on non-payment of the annual fee;
  • on failure to observe the requirements imposed by the MPA; or
  • if the conditions for licence are no longer met.

How robust are the standard good manufacturing practices followed in your jurisdiction?

The standard GMPs are very robust. GMP is an important factor in the MPA’s assessment of an application for a manufacturing licence. The MPA continuously monitors manufacturers’ compliance with the EU principles and guidelines of GMP, and performs regular inspections of premises, equipment and control facilities. A licence can be revoked on the basis of failure to comply with GMP.

What are the consequences of failure to obtain manufacturing authorisation and/or follow good manufacturing practices?

Manufacturing medicinal products without a valid authorisation (licence) from the MPA is prohibited by law. Anyone who intentionally or negligently violates this requirement may be issued with a fine or sentenced to imprisonment for a maximum of one year.

Failure to comply with GMP can result in a temporary or permanent withdrawal of the licence by the MPA. In less severe cases of failure to meet GMP, the MPA may order a manufacturer to remedy any deviation. In more severe cases, the MPA can issue a statement of non-compliance containing, for example, a recommendation that no new or ongoing application should be approved before a re-inspection has confirmed GMP compliance.

Distribution

How are the distribution and storage of medicinal products regulated?

The Act on Sales of Medicinal Products (SFS 2009:366 amended through SFS 2018:1275) regulates the trade of medicinal products in Sweden (eg, wholesale distribution and the sale of medicinal products to pharmacies).

The wholesale of medicinal products requires authorisation by the MPA. The authorisation holder is subject to rules and requirements on GMP, which also apply to the storage of medicinal products. The MPA has issued detailed guidance for such authorisation.

Import and export

How are the import and export of medicinal products regulated?

Imports from countries outside the European Union or European Economic Area (EEA) are subject to the rules relating to the manufacture of medicinal products and require a manufacturing authorisation (licence) from the MPA.

Imports from EU or EEA countries are governed by EU law and must comply with the requirements of the European Medicines Agency’s notification procedure for parallel distribution.

Are parallel imports permitted in your jurisdiction?

Yes, parallel imports of medicinal products that are authorised in other EU member states are permitted in Sweden, but are subject to a valid licence for parallel import from the MPA and market authorisation in the exporting state. The imported medicinal product must have no therapeutic difference from the equivalent nationally authorised product.

Sale and purchase

What rules govern the dispensing, sale and purchase of medicinal products?

The Act on Sales of Medicinal Products (SFS 2009:366 amended through SFS 2018:1275) regulates the sale of medicinal products in Sweden (eg, wholesale distribution and the sale of medicinal products to pharmacies).

The Act on Trade in Certain Non-prescription Medicines Act (SFS 2009:730) and the MPA Regulation on Trade in Certain Non-prescription Medicinal Products (LVFS 2009:20) contain specific rules relating to the sale of over-the-counter medicinal products.

Are there any restrictions on the online sale and purchase of medicinal products?

In addition to the licence to market and sell medicinal products, the online sale of medicinal products requires prior notification to the MPA.

Named patient supply

What rules govern named patient supply of pre-launch medicinal products?

An unauthorised medicinal product may be prescribed when:

  • medical conditions cannot be treated with approved drugs or approved drugs have shown to be ineffective; and
  • the unauthorised medicinal product has been approved in other EU countries, among other things.

The MPA can grant special permission on an application from a prescriber to a pharmacy, which in turn submits an electronic application to the MPA. The system is restrictive; authorised medicinal products should first and foremost be used. A named patient authorisation granted by the MPA is valid for one year, unless stated otherwise, and the prescriber is responsible for informing the patient about the product. Any adverse effects must be reported to the MPA. The named patient basis procedure is regulated in MPA Regulation LVFS 2008:1.

Clinical trials

Authorisation

What is the authorisation procedure for conducting clinical trials in your jurisdiction?

Clinical trials in Sweden require authorisation from the Medical Products Agency (MPA). The application is made electronically. If the application is complete and no unclear points are identified, the authorisation is granted within 30 days.

Clinical practices

How robust are the standard good clinical practices followed in your jurisdiction?

According to the Provisions on Clinical Trials of Medicinal Products for Human Use issued by the MPA, the person in charge of clinical trials must have relevant knowledge and training in good clinical practice (GCP). The MPA has the authority to conduct inspections to ensure compliance with GCP.

Reporting, disclosure and consent

What are the reporting and disclosure requirements for the results of clinical trials?

The sponsor must report to the MPA and the relevant ethics review board within 90 days after completion of a clinical trial at all trial sites, using EU common forms in electronic format.

If the sponsor concludes an ongoing trial in advance, they must inform the MPA and the relevant ethics review board as soon as possible and no later than within 15 days. The sponsor must state the reasons for termination of the trial and, where appropriate, the follow-up measures taken for safety reasons, using EU common forms in electronic format.

In addition, the sponsor must inform the MPA and the relevant ethics review board of any urgent safety measures that the investigator or sponsor has taken as soon as possible.

A comprehensive summary report must be submitted to the MPA no later than 12 months after the clinical trial has been finalised.

What are the informed consent obligations with respect to clinical trial subjects?

The Medicinal Products Act sets forth the rules regarding consent. Consent must always be obtained from the subjects and may be revoked. Further, the sponsor must comply with the rules on consent under the EU General Data Protection Regulation (GDPR).

Insurance

What are the insurance requirements for clinical trials?

The sponsor is responsible for ensuring that the subjects are guaranteed adequate financial protection, whether through insurance or otherwise.

Data protection

What data protection issues should be considered when conducting clinical trials?

Non-compliance with the GDPR, completed by the Swedish Act (2018:218), can lead to fines of up to 4% of a company’s sales in the previous year or €20 million. Under the GDPR, sponsors and investigators must consider how personal data can be processed under GDPR rules in clinical trials. The sponsor of a clinical trial is commonly considered to be the data controller under the GDPR and must therefore adopt appropriate measures concerning the processing of study subjects’ personal data and document these. The responsibility of the data controller or data processor of each actor involved in a clinical trial should be carefully considered and documented – in particular, in light of precedents such as the Roche AB decision adopted by the Swedish Data Protection Agency on 3 March 2015. The fundamental basis of the GDPR is for sponsors of clinical trials to obtain the study subjects’ consent to process their personal data. How the notice of information should be adapted for study subjects taking part in clinic trials after 25 May 2018 should be considered in order to obtain distinct legal consent under the GDPR. Alternatively, the processing of sensitive personal data can be permitted if it is necessary in specific circumstances for reasons of public interest in the area of public health (eg, ensuring high standards of quality and the safety of healthcare and medicinal products or medical devices). The large-scale processing of sensitive personal data is subject to conducting a data protection impact assessment and designating a data protection officer.

Sponsors of clinical trials should also be aware of specific rules under the GDPR for the transfer of personal data outside the European Union.

Marketing authorisation

Authorisation

What is the marketing authorisation procedure for medicinal products in your jurisdiction?

There are four different procedures for marketing authorisation (corresponding to EU procedures):

  • Mutual recognition procedure – the application is submitted to a competent authority in an EU member state. Authorisations granted under the mutual recognition procedure can be formally recognised in other European Economic Area (EEA) countries as a national authorisation.
  • Decentralised procedure – the application is submitted to a competent national authority in an EEA member state, which distributes the documentation of the application to the competent authorities in the other relevant member states. The decentralised procedure is used when the applicant wishes to obtain marketing authorisation in a number of EU or EEA countries for a medicinal product that has no previous authorisation.
  • Centralised procedure – the application is submitted to the European Medicines Agency. The authorisation of medicinal products via the centralised procedure enables the sale of such products throughout the EEA. The centralised procedure can be mandatory for some products.
  • National procedure – the application is submitted to the national competent authority – in Sweden, the Medical Products Agency (MPA). The procedure allows for marketing only in that member state.

What criteria are considered in granting marketing authorisation?

The assessment of an application for marketing authorisation is based on several criteria relating to the safety, efficacy and quality of the medicinal product. In addition, the MPA’s assessment covers the name (which must be acceptable and distinct), labelling and safety details of the medicinal product.

What is the fee for obtaining marketing authorisation?

The fee for obtaining marketing authorisation varies depending on the procedure. The fee for complete national authorisation is Skr500,000.

What is the validity period for marketing authorisation?

An initial marketing authorisation is valid for five years from the date of approval. Renewal of a marketing authorisation requires a renewed application. A renewed marketing authorisation can be granted by the MPA for a new period of five years or indefinitely.

What are the consequences of failure to obtain marketing authorisation?

Placing medical products on the market without marketing authorisation by the MPA or another competent EU authority is prohibited and constitutes a criminal offence.

Pharmacovigilance

Monitoring

What post-market monitoring mechanisms are in place to ensure the ongoing safety and efficacy of medicinal products after marketing authorisation has been granted?

A market authorisation holder is required to implement a pharmacovigilance system for monitoring the security of its product in accordance with the applicable EU regulation and directive. The Medical Products Agency conducts inspections to verify the compliance of implemented pharmacovigilance systems with applicable laws and regulations.

Data protection

What data protection issues should be considered when conducting pharmacovigilance activities?

The EU General Data Protection Regulation (GDPR) applies to pharmacovigilance activities in Sweden. The application of the GDPR in pharmacovigilance activities raises specific challenges with regard to consent as it may be difficult to obtain consent from data subjects in most cases for the purpose of processing their personal data. Alternatively, the processing of sensitive personal data can be permitted if it is necessary in specific circumstances for reasons of public interest in the area of public health (eg, ensuring high standards of quality and the safety of healthcare and medicinal products or medical devices). Regarding clinical trials, the large-scale processing of sensitive personal data is subject to conducting a data protection impact assessment and designating a data protection officer.

Pricing and reimbursement

Pricing Reimbursement

What is the structure for state reimbursement of medicinal product costs?

Sweden has adopted a value-based pricing reimbursement model for medicinal products. The TLV decides on the prescription medicinal products for out-patient care to be included in the reimbursement system. There are three main criteria which must be fulfilled if a medicinal product (including generic products and biosimilars) should be reimbursed:

  • the human value principle, which underlines the respect for equality of all human beings and the integrity of every individual (ie, prohibiting discrimination against people on the grounds of sex, race or age, among other things, when making decisions on reimbursement);
  • the need and solidarity principle, which provides that those in greatest need take precedence when it comes to reimbursing medicinal products; and
  • the cost-effectiveness principle (ie, that the cost for using a medicine should be reasonable from a medical, humanitarian and social-economic perspective).

An application of a specific product to take part of the reimbursement system must be made to the TLV. The TLV then decides whether to include the product in the reimbursement system and consequently the price of the product.

Are there rules governing the pricing of medicinal products in your jurisdiction?

The Swedish Dental and Pharmaceutical Benefits Agency (TLV) sets the reimbursement price (eg, the sales price) for prescription pharmaceuticals that are subject to the cost-reduction systems (see “Reimbursement” below). The price set by the TLV is valid throughout Sweden. Superior cost-effectiveness in comparison to other products must be proved in order to obtain a listing under the pharmaceutical benefit scheme. Further, pharmacies are obliged to substitute prescription pharmaceuticals for the cheapest generic product on the market (the so-called ‘product of the period’ – established on a monthly basis by the TLV).

Advertising and labelling

Advertising

How is the advertising of medicinal products to healthcare professionals and the general public regulated in your jurisdiction?

The following legislations cover the marketing of medicinal products:

  • The Medicinal Products Act lays down the general requirements which marketing activities relating to medical products must comply with. The act also contains provisions which are directed at certain marketing activities. It follows from the general provision of the Medical Products Act that the marketing of medical products must be objective, up to date and balanced, and must encourage the appropriate use of the product. Moreover, the marketing must not be misleading and must remain consistent with generally accepted practices for such marketing.
  • The Marketing Practices Act (SFS 2008:486) relates to marketing in general and applies to the advertising and marketing of medicinal products when other specific rules do not follow from the Medicinal Products Act.

Clarifications of the rules on marketing under the Medicinal Products Act are made in Medical Products Agency (MPA) Regulation LVFS 2009:6 regarding the marketing of medical products.

In addition, the Trade Association for the Research-Based Pharmaceutical Industry in Sweden (LIF) has established ethical rules governing, among other things, information on medical products. The LIF rules aim to lay down more precisely the responsibility of the pharmaceutical industry for information on medical products and provide the basis for the interaction between the pharmaceutical industry and healthcare professionals. The rules are not legally binding on non-members but are regularly applied by the courts as an expression of good marketing practice.

Do any special rules apply to online advertising of medicinal products?

No, online advertising is subject to the same rules as other advertising. The Medical Products Act does not include a definition of what constitutes advertising or marketing of medical products. However, according to LVFS 2009:6, the term “marketing of medical products” includes any form of door-to-door information, canvassing activity or inducement designed to promote the prescription, supply, sale or consumption of medical products.

In addition, the LIF has established so-called ‘ethical rules’ specifying, among other things, that online information on medicinal products must be clear regarding to whom the information is addressed and must be suitable for the intended addressees. According to the LIF rules, online information on medicinal products must also contain a clear statement of the date on which the site was most recently updated.

Labelling

What are the packaging and labelling requirements for medicinal products?

There are specific and detailed rules on the packaging and labelling of medicinal products. The MPA’s provisions and guidelines concerning the labelling and packaging leaflets for medicinal products provide explanations and examples of how the current regulations should be interpreted. The purpose of the regulations is to ensure that patients receive clear and relevant information, and to reduce the risk of confusion and misuse. Requirements include the following:

  • The name and strength of the medicinal product and specified information must appear on the outer packaging of the medicinal product or, for specified information where there is no outer packaging, on the immediate packaging.
  • The labelling must be in Swedish.
  • The labelling must be:
    • easily legible;
    • clearly comprehensible; and
    • indelible.

In addition, certain information must be given a prominent position and have a clear design. It is the responsibility of the marketing authorisation holder to keep labelling up to date with current scientific knowledge.

All medicinal products will require serialisation in 2019.

How is the promotion of off-label use regulated?

It is prohibited to promote a medicinal product for uses other than those that have been approved. However, physicians can prescribe off-label use.

Relations with healthcare professionals

Gifts and incentives

What rules apply to the provision of gifts, discounts and other incentives to healthcare professionals?

The Trade Association for the Research-Based Pharmaceutical Industry in Sweden (LIF) has established ethical rules governing, among other things, gifts, discounts and other incentives to healthcare professionals. The LIF rules aim to lay down more precisely the responsibility of the pharmaceutical industry and regulate the basis for the interaction between the pharmaceutical industry and healthcare professionals. The rules are based on:

  • codified laws, pharmaceutical legislation and other enactments and regulations issued by government agencies; and
  • non-statutory provisions, such as the International Code of Advertising Practice issued by the International Chamber of Commerce and the Code of Practice on the Promotion of Medicines adopted by the European Federation of Pharmaceutical Industries and Associations.

However, these rules are applied on a self-regulation basis (ie, they can be enforced only on LIF members).

The LIF rules should be regarded as complementary to current legislations, regulations and codes of statutes issued by government bodies, such as the Marketing Practices Act, the Medical Products Act and the Medical Devices Act, as well as anti-bribery legislation and the Code on Gifts, Rewards and Other Benefits issued by the Swedish Anti-corruption Institute and the rules on public procurement.

Liability

Defect products

How can a liability claim for a defective medicinal product be brought?

A patient who suffers injury due to the safety deficiency of a medicinal product can bring action for damages under the Product Liability Act (SFS 1992:18) or a claim under the Tort Act (SFS 1972:207). If a patient suffers an injury while in the healthcare system, they may be entitled to financial compensation under the Patient Injury Act (SFS 1996:799).

Which parties can be held liable for a defective medicinal product?

In principle, the manufacturer, importer or any other company or individual identified as the producer can be held liable. The Pharmaceutical Insurance Association provides a voluntary no-fault insurance scheme for its members. Alternatively, the patient may bring a claim before the court under the Product Liability Act or the Tort Act.

Remedies

What remedies are available to successful claimants?

Remedies include damages or insurance compensation for personal injury, including compensation for:

  • healthcare;
  • pain and suffering;
  • disability; and
  • loss of income.

Exclusion and limitation

On what grounds can liability be excluded?

Liability can be excluded if:

  • there is no causal link between the injury and use of the medicinal product; or
  • the injury was caused by:
    • misuse;
    • incorrect dosage; or
    • improper handling.

What preventive steps can be taken to limit liability?

There are no special rules with regard to preventive steps; however, manufacturers and importers should implement compliance programmes applicable to their respective businesses, which also cover compliance with specific life sciences regulations.

Compliance and enforcement

Enforcement

What measures are in place to enforce the laws governing medicinal products?

The Medical Products Agency (MPA) is responsible for the regulation and surveillance of the development, manufacturing and sale of medicinal products. The MPA has certain enforcement powers and can, for example:

  • order the recall of a medicinal product;
  • perform audits of manufacturing facilitates and inspect procedures and documentation for good manufacturing practice requirements; and
  • take action in cases of non-compliance and issue injunctions subject to penalty fines for non-compliance.

Decisions by the MPA can be appealed to the administrative court.

Dishonest practices

What mechanisms are in place to combat bribery, fraud, collusion, counterfeiting and other dishonest practices in the pharmaceutical sector?

The Swedish Prosecution Authority investigates fraud and corruption crimes under the Swedish anti-bribery legislation. In addition to the Swedish anti-bribery, competition (antitrust) and fraud legislations, the rules of the Trade Association for the Research-Based Pharmaceutical Industry in Sweden provide the healthcare sector with ethical self-regulating rules and guidelines for avoiding dishonest practices.