Medicinal product regulation and product liability in Sweden: overview

A Q&A guide to medicinal product regulation and product liability law in Sweden.

The Q&A gives a high level overview of key issues including pricing and state funding, manufacturing, marketing, clinical trials, advertising, labelling, and product recall and liability.

For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, visit Pharmaceutical IP and Competition Law in Sweden: overview.

To compare answers across multiple jurisdictions, visit the Medicinal product regulation and product liability Country Q&A tool.

The Q&A is part of the global guide to Life Sciences law. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-guide.

Contents

Regulatory overview

1. What are the main legislation and regulatory authorities for pharmaceuticals in your jurisdiction?

Legislation

The Swedish pharmaceutical market is extensively regulated in the interest of protecting public health.

The national regulatory framework for medicinal products is largely based on EU legislation, namely Directive 2001/83/EC on the Community code relating to medicinal products for human use as amended (Code for Human Medicines Directive).

The main Swedish legislation regulating medicinal products is the:

  • Medicinal Products Act (SFS 2015:315).

  • Decree on Medicinal Products (SFS 2015:458).

  • Regulations issued by the Medical Products Agency (MPA).

Rules regarding pricing and reimbursement of drugs are stated in:

  • The Pharmaceutical Benefits Act (SFS 2002:160).

  • The Decree on Pharmaceutical Benefits (SFS 2002:687).

  • Regulations issued by the MPA.

  • Regulations issued by the Dental and Pharmaceutical Benefits Agency (Tandvårds-och läkemedelsförmånsverket) (DPBA).

Regulatory authorities

MPA (Läkemedelsverket). The MPA (www.lakemedelsverket.se) is the Swedish national authority responsible for regulation and surveillance of the development, manufacturing and sale of drugs and other medicinal products. Its main obligation is to ensure that both the individual patient and healthcare professionals (HCPs) have access to safe and effective medicinal products and that these are used in a rational and cost-effective manner. The MPA is a government body under the Ministry of Health and Social Affairs. Its operations are largely financed through fees. The MPA's main areas of responsibility are:

  • Approval of clinical trials, new medicines and licences.

  • Monitoring adverse drug reactions.

  • Laboratory quality control.

  • Regulating advertising.

  • Issuing the list of substitutable products.

  • Medical devices which include market surveillance, product safety, audits of manufacturers and review of clinical trials.

  • Regulating herbal medicinal products and homeopathic, cosmetic and hygiene products, as well as alcohol and narcotics.

DPBA (Tandvårds-och läkemedelsförmånsverket). The DPBA (www.tvl.se) is a central government agency that determines whether a pharmaceutical product or dental care procedure will be subsidised by the state and included in the Swedish reimbursement scheme. The DPBA monitors profitability in the reformed pharmacy market. The DPBA:

  • Examines which medicines, medical devices and dental care treatments are subsidised by the state.

  • Determines the pricing of new medicines and sets the purchase price (AIP) and the sales price (AUP) to be applied by the open care pharmacies, that is, the DPBA determines the pharmacies' margin.

  • Re-evaluates medicines included in the reimbursement system in order to determine whether their reimbursement should be maintained or restricted.

  • Tracks profitability in the pharmacy market, in conjunction with the re-regulation of the pharmacy market.

The Association of the Pharmaceutical Industry (Läkemedelsindustriföreningen) (LIF). LIF (www.lif.se) is the trade association for the research-based pharmaceutical industry and it:

  • Has about 85 members and associate companies who represent about 80% of the total pharmaceutical sales in Sweden.

  • Represents its members in issues of common concern.

  • Is a service organisation for the member companies, informing them on questions vital to the industry.

Its main areas of responsibility include:

  • Issuing the Ethical Rules for the Pharmaceutical Industry in Sweden (LER Rules).

  • Monitoring the market (for example, examination of marketing activities on own initiative or through complaints).

  • Assessing cases, as well as pre-examining vaccine campaigns and information about prescription drugs on web pages to the general public.

 
2. Briefly outline how biologicals and combination products are regulated in your jurisdiction.

Under Regulation (EC) 726/2004 on the authorisation and supervision of medicinal products and establishing a European Medicines Agency (EMA Regulation), biologicals must be authorised under the centralised EU system if they are produced using one of the following methods:

  • Recombinant DNA-technique.

  • Cellular transformation.

  • Hybridoma and methods for monoclonal antibodies.

There are no laws or rules that specifically regulate biological medicinal products. The MPA does not consider biosimilars to be medically equivalent with the original biological medicinal product. Therefore, the MPA's current assessment of biological medicinal products is that substitution is not possible. However, there is no formal prohibition against substitution of biological medicinal products.

Combination products are assessed under the rules and regulations that apply to the main function of the product. In addition, the underlying product must also comply with the regulatory framework applicable to that product. Therefore, for example, a single use pre-filled injection pen must comply with the pharmaceutical regulations and the injection pen must fulfil the requirements applicable to medical devices.

 
3. Briefly outline how medical devices and diagnostics are regulated in your jurisdiction. Is there any specific regulation of health IT issues and mobile medical applications?

For medical devices, the main regulatory framework is based on:

  • Directive 90/385/EEC on active implantable medical devices (Active Implantable Medical Devices Directive).

  • Directive 93/42/EEC concerning medical devices (Medical Devices Directive).

  • Directive 98/79/EC on in vitro diagnostic medical devices (IVD Directive).

The main Swedish legislation regulating medical devices is the:

  • Act on Medical Devices (SFS 1993:584)

  • Decree on Medical Devices (SFS 1993:876)

In addition, the MPA issues regulations and general recommendations for medical devices.

There are no rules that specifically regulate health IT and mobile medical applications. However, the MPA has issued a guide regarding medical information technology, which provides guidance regarding the classification of, among other things, mobile medical applications.

 

Pricing, state funding and reimbursement

4. What is the structure of the national healthcare system, and how is it funded?

Structure

The responsibility for health and medical care in the Swedish healthcare system is shared between the state, county councils and municipalities. Most hospitals and health service entities are public, although private healthcare exists.

On 1 July 2009, Apoteket's (the state-owned pharmacy) monopoly over the retail of medicinal products to consumers in Sweden was abolished. Since then, new players have entered the Swedish pharmacy market. The MPA approves and monitors the establishment and operations of pharmacies under the Act on Trade with Pharmaceuticals (SFS 2009:366).

In addition, since 1 November 2009, other types of retailers (for example, grocery stores and convenience shops) can sell over-the-counter (OTC) medicinal products, subject to regulations issued under the Act on Trade with Non-Prescription Medicines (SFS 2009:730).

Before the reform of the pharmacy market in 2009, most pharmaceutical companies operating on the market used a "one-channel" model for pharmaceutical distribution. Despite the reform, there are still only two main distributors on the market, although new players progressively enter the wholesale market. Also, there are examples of pharmacies setting up their own distribution channels. In addition, before the reform, the distributors acted as logistic service companies and not as traditional wholesalers. Now, pharmaceutical companies can deliver their products to pharmacies and hospitals directly, but few choose to do so.

Funding

On a national level, the county councils are responsible for providing healthcare to the population. The funding of the county councils' healthcare system is funded by:

  • The tax imposed on the people living in the county council.

  • Patient fees.

  • Revenues from different types of services sold by the county council.

In addition, the government can provide funding for certain specific healthcare projects, for example to improve accessibility to the Swedish healthcare system.

 
5. How are the prices of medicinal products regulated?

The DPBA sets the sale price of medicinal products included in the benefits scheme.

The company that markets a medicinal product can apply for the product to be included in the national benefits scheme under the Pharmaceutical Benefits Act. The DPBA:

  • Is authorised to determine whether or not the medicinal product qualifies for the benefits system.

  • Sets the price for the medicinal product.

The applicant and the county councils (that carry the costs of the pharmaceutical benefits system) can participate in deliberations with the DPBA before a decision is made. The DPBA considers a number of principles within the healthcare system, including:

  • Care on equal terms.

  • Giving priority to those in greatest need of care.

  • Cost-effectiveness.

  • The suitability of the medicinal product.

  • The marginal utility of the medicinal product.

The DPBA generally determines whether the medicinal product's cost is reasonable in relation to the achieved health advantages. The DPBA's decision can be appealed to the Administrative Court.

Only prescription medicinal products usually qualify for inclusion in the national benefits scheme. An OTC medicinal product normally qualifies only if it is needed for either:

  • The treatment of a long-term illness demanding continuous treatment for at least one year.

  • Recurrent treatment for at least three months per treatment period.

A system for generic substitution was introduced in 2002 under which a pharmacy has a duty to substitute a medicinal product with the least expensive medicinal product available, provided the following four conditions are fulfilled:

  • The medicinal product is included in the Pharmaceutical Benefits Scheme (that is, the DPBA has found that the medicinal product fulfils the specific criteria for reimbursement and a sale price has been set by the DPBA).

  • A prescription has been issued for the medicinal product.

  • One (or more) less expensive and substitutable medicinal product(s) are available. The MPA issues a list of substitutable medicinal products.

  • The prescribing physician has not objected to the substitution of a medicinal product on medical grounds. The patient can also refuse to have the substitute medicinal product if he pays the price difference between the prescribed medicinal product and the substitutable medicinal product.

 
6. When is the cost of a medicinal product funded by the state or reimbursed? How is the pharmacist compensated for his dispensing services?

The reimbursement system means that the cost of medicinal products is gradually reduced for the individual patient over a 12-month period. The patient carries the full cost if the total expenditure for medicinal products does not exceed SEK1,100. The costs are then gradually reduced by subsidies. The maximum aggregated amount an individual patient can be liable to pay during a 12-month period is SEK2,200.

Pharmacies are mainly compensated through the retail margin for selling medicinal products. The retail margin is the difference between the purchase price (AUP) paid by pharmacies and the sale price (AIP) the pharmacies can charge customers. The retail margin is fixed by the DPBA (DPBA' s regulation TLVFS 2009:3, on the retail margins for pharmaceuticals and other goods that are part of the reimbursement system).

 

Clinical trials

7. Outline the regulation of clinical trials.

Legislation and regulatory authorities

Clinical trials are regulated by a number of regulations, including:

  • The Medicinal Products Act.

  • The Decree on Medicinal Products.

  • The Regulation LVFS 2011:19 on clinical trials issued by the MPA (which implements Directive 2001/20/EC on the conduct of clinical trials (Clinical Trials Directive).

In addition, the ethical rules for the pharmaceutical industry (LER Rules) issued by the Swedish Association of the Pharmaceutical Industry (Läkemedelsindustriföreningen) contain specific rules on the conduct of clinical trials.

Authorisations

Under the MPA regulations, the sponsor must ensure that the necessary authorisations from the MPA and the competent ethics committee are obtained. Applications must be made on the specific EudraCT application form. A valid application is normally reviewed and a decision issued by the MPA within 60 days of receipt of the application.

Consent

Potential clinical trial subjects must receive clear and comprehensive information on the trial to enable them to make an informed decision on whether or not to take part in the trial. If the clinical trial subject is underage, both parents must give their consent. Patient consent must be in writing.

Trial pre-conditions

Sponsors must provide adequate insurance protection for injuries caused to patients during a clinical study. Public hospitals must take out insurance for patient injuries under the Patient Injury Act (SFS 1996:799), including injuries occurring during participation in a clinical trial. However, this only covers injuries caused by medical treatment, not those caused by the medicinal product itself. Therefore, the primary function of insurance taken out by sponsors for clinical trials is to provide economic compensation for injuries caused by the investigational medicinal product.

Procedural requirements

Clinical trials must be planned, conducted and reported according to the latest version of the Declaration of Helsinki and the Note for Guidance on Good Clinical Practice (GCP) (CPMP/ICH/135/95).

Any personal data collected in the clinical trial must be processed according to the Swedish Personal Data Act (SFS 1998:204) and the Swedish Patient Data Act (SFS 2008:355).

 

Manufacturing

8. What is the authorisation process for manufacturing medicinal products?

Application

A manufacturer or importer of medicinal products from third countries must obtain authorisation from the MPA before initiating any sales activities.

Conditions

The MPA has set the conditions that must be met to obtain a manufacturing authorisation. Among other things, the applicant must specify:

  • Whether the application concerns the manufacture or import of a specific medicinal product, certain kind(s) of medicinal products or medicinal products in general.

  • The pharmaceutical forms that are to be manufactured or imported.

  • The place where the products are to be manufactured and controlled.

The applicant must appoint a qualified person, who is responsible for, among other things, ensuring that the products are manufactured according to Good Manufacturing Practices (GMP) and applicable legislation.

Restrictions on foreign applicants

There are no specific restrictions on foreign ownership. However, an applicant for a manufacturing authorisation who is not resident within the EU or the European Economic Area (EEA) must appoint a local representative.

Key stages and timing

An application must be in writing and contain certain information and documentation. The procedure for granting the authorisation must not exceed 90 days from the day on which the MPA received the application. The applicant can appeal a rejection by the MPA to the Administrative Court.

Fee

An application fee and an annual fee are applicable. The application fee is currently SEK65,000 and the annual fee is SEK46,000. Information on fees is also available on the MPA website (www.lakemedelsverket.se).

Period of authorisation and renewals

A manufacturing authorisation is valid for a specified period on condition that the annual fee is paid. The MPA carries out inspections at the premises on a regular basis.

Monitoring compliance and imposing penalties

The MPA can monitor compliance with the manufacturing authorisation and applicable law by:

  • Carrying out inspections.

  • Taking samples.

  • Examining any document relating to the object of the inspection, including GMP.

Inspections are carried out on a regular basis by a special unit within the MPA, which is the Department of Inspection. The Department of Inspection conducts about 300 inspections each year. These relate to manufacturers, wholesalers and other entities developing, storing and distributing medicinal products. The licence holder must provide necessary assistance in connection with the MPA's inspections.

A manufacturing authorisation can be revoked if the licence holder:

  • Breaches any requirement of particular importance for the safety or quality of the medicinal product.

  • No longer fulfils one or more of the essential conditions for the authorisation.

  • Has not paid the annual fees.

The MPA can also temporarily debar a qualified person from his appointment, if the person does not fulfil his duties.

A decision by the MPA to revoke a licence or debar a qualified person from his duties can be appealed to the Administrative Court.

 

Marketing

Authorisation and abridged procedure

9. What is the authorisation process for marketing medicinal products?

Application

The MPA is responsible for granting marketing authorisations (MAs) under the following procedures:

  • Mutual recognition (MRP).

  • Decentralised (DCP).

  • National.

Applications can also be submitted to the European Medicines Agency (EMA) under the centralised EU system.

Authorisation conditions

The conditions that must be satisfied by the applicant under the national procedure are set out in regulations issued by the MPA. These also apply if Sweden is the reference member state (RMS) under the MRP or the DCP. The applicant must demonstrate that the medicinal product does not have any harmful effects disproportionate to its intended effect and is of satisfactory:

  • Quality.

  • Safety.

  • Efficacy.

Key stages and timing

An application is needed for each single pharmaceutical formulation and strength. The application should be made on a specific form supplied by the MPA. The MPA has 210 days to assess the application starting from the date a complete application is filed. If the application is rejected, the applicant can appeal to the Administrative Court.

Fee

An application fee and an annual fee apply. The fee amount depends on the application procedure. Information on fees is available on the MPA website (www.lakemedelsverket.se).

Period of authorisation and renewals

An MA is valid for five years and is renewable. A renewed authorisation is normally unlimited in time. Renewal applications must both:

  • Be submitted to the MPA no later than nine months before the expiry date of the existing authorisation period.

  • Include an updated and consolidated version of the documentation regarding quality, safety and efficacy.

The existing MA is valid during the processing of the renewal application.

Monitoring compliance and imposing penalties

The MPA can monitor compliance with applicable law by:

  • Carrying out inspections.

  • Taking samples.

  • Examining any document relating to the object of the inspection.

Inspections are carried out on a regular basis by the Department of Inspection at the MPA. The MPA can also order the licence holder to prove that it still fulfils relevant requirements for an MA. The licence holder has a duty to provide necessary assistance in connection with the MPA's inspections.

An MA can be revoked temporarily or permanently if any of the following apply:

  • The holder fails to prove, on an order by the MPA, that it continues to fulfil relevant requirements for the authorisation.

  • The holder breaches any of the specific conditions relating to the authorisation.

  • The holder does not recall the product despite an order by the MPA to do so.

  • For any other reason one or more of the essential conditions for the authorisation are no longer fulfilled.

A decision by the MPA to revoke an MA can be appealed to the Administrative Court.

 
10. What commitments and pharmacovigilance obligations apply after a company has obtained marketing authorisation? Are there further conditions concerning how the drug is distributed and accessible to patients?

Post-marketing commitments and pharmacovigilance obligations

Swedish pharmaceutical regulations impose a large number of vigilance and post-marketing surveillance requirements on MA holders. These requirements include the obligation to:

  • Submit periodic safety reports to the MPA.

  • Establish systems to secure that all information on adverse events are reported to the MPA.

  • Ensure requests from the MPA are properly answered.

Other conditions

Following the re-regulation of the Swedish pharmacy market a strict supply obligation on wholesalers, which include MA holders, has been implemented into Swedish law. Under the supply obligation, if a pharmacy places an order with a wholesale distributor the wholesale distributor must fulfil and deliver the pharmaceutical product ordered. Under the MPA regulations wholesale distributors must deliver pharmaceutical products in an "adequate and continuous way" to prevent any shortage of pharmaceutical products. The supply obligation is limited to the pharmaceutical products covered by the wholesale distribution licence.

 
11. Which medicinal products can benefit from the abridged procedure for marketing authorisation and what conditions and procedure apply? What information can the applicant rely on?

The Code for Human Medicines Directive has been fully transposed into Swedish legislation through amendments to the Medicinal Products Act. As a result, if an applicant can demonstrate that the relevant medicinal product is a generic of a referenced medicinal product, which is or has been authorised for not less than eight years in an EEA member state, the applicant can refer to the results of pre-clinical or clinical trials conducted in relation to the reference medicinal product. Under the Notice to Applicants (NTA) Volume 2A, reference must be made to the dossier of a reference product for which an MA has been granted in the EU (based on a complete dossier under Articles 8(3), 10a, 10b or 10c, Code for Human Medicines Directive).

In a ruling of March 2006, the Swedish Supreme Administrative Court confirmed that the innovative pharmaceutical industry has standing to appeal decisions by the MPA relating to MAs granted for a generic product based on the abridged procedure. Before this judgment, the owner of the reference product, who was not a party to the generic MA matter before the MPA, was not entitled to appeal against the MPA's decision. Swedish courts had previously dismissed appeals filed by the innovative industry because of a lack of standing. As a result of the Supreme Administrative Court's decision it appears that the following should also be sent to the owner of the reference product immediately after any grant of MA for a generic product:

  • The generic MA granted for Sweden by the MPA.

  • Instructions on how to appeal.

 
12. Are foreign marketing authorisations recognised in your jurisdiction?

A medicinal product can only be placed on the Swedish market when either:

  • An MA has been issued or recognised by the MPA.

  • An MA has been granted for the entire EU.

 

Parallel imports

13. Are parallel imports of medicinal products into your jurisdiction allowed?

Under intellectual property law, a patent or trade mark can only be relied on to stop parallel imports from outside the EEA. Intellectual property rights are exhausted in the EEA once the product has been put on the market anywhere in the EEA by the holder, or with its consent. Therefore, parallel trade in medicinal products within the EEA is possible provided the parallel import is undertaken according to applicable regulations and case law.

The sale of parallel imported medicinal products requires an authorisation from the MPA. An authorisation is granted if the following conditions are fulfilled:

  • The directly imported product is authorised for sale in Sweden at the time when the application for a parallel import authorisation is first submitted to the MPA.

  • The parallel imported product is authorised for sale in the exporting country.

  • The exporting country is a member state within the EEA.

  • The parallel imported product is sufficiently similar to the directly imported product.

An MA for a parallel imported product is granted for five years and can be extended for an indefinite period.

Repackaging or re-labelling of the product requires a specific manufacturing authorisation from the MPA. The labelling and package leaflet must be designed according to the MPA Regulation on Packaging and Labelling of Medicinal Products (LVFS 2005:11), including a requirement that information is written in Swedish. Foreign text on packages may be accepted if it does not conflict with the Swedish text. The name of the parallel imported product must also be approved by the MPA.

The Swedish MA for the parallel imported product expires if either:

  • The MA for the parallel imported product expires in the exporting country.

  • The MA for the directly imported product in Sweden is revoked for quality, efficacy or safety reasons.

For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, see Pharmaceutical IP and Competition Law in Sweden: overview ( www.practicallaw.com/2-560-7525) .

 

Restrictions on dealings with healthcare professionals

14. What are the restrictions on marketing practices such as gifts, sponsoring, consultancy agreements or incentive schemes for healthcare establishments or individual medical practitioners?

Great care must be taken when gifts or other benefits are offered to public or private medical practitioners as what can be received is strictly regulated.

Any individual who gives, promises or offers any improper remuneration to an employee in relation to his services may be guilty of bribery under the Criminal Code. Bribery is broadly interpreted and cash benefits are generally considered improper, including, for example:

  • Vouchers.

  • Hotel visits.

  • Gifts to relatives.

  • Club memberships.

Benefits directly related to and constituting a natural and useful part of the employee's service are not normally considered improper, provided they fulfil the applicable requirements. Such benefits include:

  • Samples.

  • Serious and short study tours or courses.

  • Ordinary working lunches.

The LER Rules provide that the basis for all co-operation between pharmaceutical companies and healthcare is documentation, moderation, transparency and reasonability, and must benefit all parties.

The LER Rules provide restrictions relating to gifts and hospitality. They include a general requirement that all hospitality offered to healthcare personnel attending meetings arranged by a pharmaceutical company must be of such a kind and on such a scale that there is no risk that the recipients will let themselves be influenced by them in the execution of their professional duties. Pharmaceutical companies can pay for the venue, speakers, study materials and similar, as necessary to carry out a meeting. The provisions regarding travel, accommodation and participation fees have been altered. A prohibition on paying for travel, accommodation and participation fees entered into force on 1 January 2015.

In addition, the LER rules provide that no gifts or financial benefits can be supplied, offered or promised to healthcare personnel.

The LER Rules, last amended on 16 February 2015 (the amendments effective from 1 March 2015) include:

  • Prohibition on paying for travel, accommodation and participation fees for HCPs attending scientific conferences, congresses or other meetings (effective 1 January 2015).

  • Detailed provisions on the drafting and submission of invitations to scientific conferences, congresses or other meetings.

  • Prohibition on providing gifts to healthcare establishments or their employees, except for information and educational materials of low value and directly relevant to the practice of the recipient, and directly beneficial to the care of the patients.

The LER rules apply to information from pharmaceutical companies that is targeted at or otherwise may reach physicians, dentists, veterinarians, pharmacists or other personnel within the Swedish healthcare sector or distribution of pharmaceuticals in Sweden.

 

Sales and marketing

15. What are the restrictions on selling medicinal products? Are there specific regulations for the sale of medicinal products on the internet, by e-mail and by mail order?

Since 1 July 2009, new players can enter the Swedish pharmacy market as a result of the abolition of Apoteket's exclusive right to sell prescription and OTC medicinal products to Swedish consumers. In addition, since 1 November 2009, retailers other than pharmacists (for example, grocery stores and convenience shops) can sell OTC medicinal products.

A private individual can order medicinal products from outside Sweden by, for example, mail order or the internet, if the individual can prove that the product:

  • Is ordered in the EEA.

  • Is approved both in Sweden and its country of origin.

  • Is intended for personal use.

  • Has been purchased from a pharmacy.

  • Does not contain more than one year's worth of consumption.

If the product is a prescription medicinal product, the individual must also prove that he received the prescription from a person authorised to issue prescriptions within the EEA.

The import of medicinal products from a non-EEA country requires a Swedish marketing and/or manufacturing authorisation or a particular import licence. It is illegal to order medicinal products from a non-EEA country through the internet or mail order without an import licence, regardless of whether the products are intended for personal consumption. The MPA can grant exemptions but in practice these are rarely given.

 

Advertising

16. What are the restrictions on advertising medicinal products?

Legislation and regulatory authority

The Medicinal Products Act provides rules on medicinal products' advertising. In addition, the MPA issued a regulation clarifying and specifying the rules governing the advertising of medicinal products for human use in Sweden. Also, the general provisions of the Market Practices Act (SFS 2008:486) apply to advertising of all kinds of products and services, including medicinal products. The Market Practices Act provides the general requirement that all marketing must be compatible with good marketing practice and fair towards consumers and the industry.

Detailed rules relating to pharmaceutical advertising can also be found in the LER Rules. Although not legally-binding, the LER Rules are widely recognised by the pharmaceutical industry and applied by courts as an expression of fair and ethical marketing.

Restrictions

The Medicinal Products Act includes a basic provision that all medicinal products' advertising must be up to date, factual, balanced and not misleading. Advertising medicinal products must also be compatible with good marketing practice.

The following is not allowed:

  • Advertising of medicinal products that are not authorised for sale in Sweden.

  • Advertising aimed at children.

  • Advertising aimed at the general public of medicinal products that are only available on prescription (except for campaigns for vaccination against human infection diseases).

In addition, the general provisions of the Market Practices Act apply to the promotion of all kinds of products and services, including medicinal products. It contains a general requirement that all marketing must be both:

  • Compatible with good marketing practice.

  • Fair towards consumers and the industry.

The Market Practices Act also sets out specific rules on, among other things, misleading advertising, comparative advertising and special offers.

The LER Rules also contain detailed provisions for pharmaceutical advertising. The LER Rules include prohibitions on, among other things:

  • Promotion of prescription medicinal products to the general public.

  • Off-label promotion.

  • Pre-launch marketing.

They also contain rules about, for example, comparative advertising, misleading, incomplete or unsubstantiated information, and disguised promotion.

Internet advertising

Generally, the same rules apply to advertising on the internet as for traditional advertising channels.

In addition, to ensure public access to requested and easily comprehensible information on prescription medicinal products, this information can, under certain conditions, be provided by pharmaceutical companies on pre-examined and approved websites (Förhandsgodkänd hemsida) under the LER Rules.

According to established case law from the Information Practices Committee (NBL), a pharmaceutical company should divide its website into different sites intended for, for example, HCPs, the general public and the press. The website visitor should be clearly informed of the addressees of each of the sites. There is no legal requirement to make web pages intended for HCPs password protected.

 

Data protection

17. Do data protection laws impact on pharmaceutical regulation in your jurisdiction?

The relevant legislation for data protection in Sweden is:

  • The Personal Data Act (SFS 1998:204).

  • The Patient Data Act (SFS 2008:355).

  • Regulations issued by the Swedish Data Inspection Board.

Research which involves processing sensitive personal data must be authorised by an ethics committee. It is not permitted to collect sensitive personal data in a database for research purposes not determined at the time of the data collection.

The controller of the personal data must notify the Data Inspection Board about the processing. However, the data controller is exempted from this if either:

  • The data controller has appointed a personal data representative who will independently ensure that the personal data is processed in a correct and lawful manner.

  • The data subject has consented to the processing of his personal data.

Since 1 July 2009 new players can enter the Swedish pharmacy market. All open care pharmacies must have a safe electronic system for the handling of customer- and prescription registries. The pharmacies are allowed to process sensitive personal data provided they comply with the safety requirements set out in the Act on the Prescription Registry (SFS 1996:1156) and the Act on the Pharmaceutical Registry (SFS 2005:258).

Personal data submitted to the MPA for adverse event reporting is treated as confidential by the MPA.

 

Packaging and labelling

18. Outline the regulation of the packaging and labelling of medicinal products.

Legislation and regulatory authority

The relevant requirements are contained in the MPA Regulation on the Labelling and Package Inserts for Medicinal Products (LVFS 2005:11) enforced by the MPA.

Information requirements

The labelling of a medicinal product must, among other things, show the following information in Swedish:

  • The name, strength and pharmaceutical form of the product.

  • A declaration of the active ingredients.

  • The formula, weight, volume or dose quantity of the product.

  • The method of administration.

  • Directions for use and storage precautions where appropriate.

  • A specific warning that the product should be kept out of reach of children.

  • Other relevant warnings.

  • A specific reference to the package insert.

  • Expiry date.

  • Batch number.

  • The name and address of the MA holder.

  • The MA number.

The name and strength (if there is more than one strength) of the product must be written in Braille on the outer package.

Certain information must be clearly and specifically worded, and prominently positioned, on the label, including:

  • The name of the product.

  • Storage and user instructions.

  • Important warnings.

Other conditions

It is not permitted to include text, symbols or pictures of a promotional nature on the label or the package insert. Samples of packaging and labelling text, including package inserts, must be provided to the MPA when submitting an application for an MA.

 

Product liability

19. Outline the key regulators and their powers in relation to medicinal product liability.

The Consumer Agency has overall responsibility to supervise manufacturers' compliance with the Product Liability Act (SFS 1992:18). The Consumer Agency shares the responsibility with other authorities which are responsible for certain products or risks.

The MPA monitors the pharmaceutical market and is responsible for the regulation and surveillance of the development, manufacturing and sale of medicinal products. The MPA can:

  • Order a recall if a medicinal product is found to cause damage or inconvenience for patients.

  • Perform audits of manufacturing facilitates and inspect procedures and documentation for GMP requirements.

  • Take action in cases of non-compliance and issue a prohibitive injunction subject to fines for non-compliance. Decisions by the MPA can be appealed to the Administrative Court.

 
20. Are there any mandatory requirements relating to medicinal product safety?

The following mandatory requirements apply:

  • The MA holder must have a safety surveillance programme in place.

  • Serious suspected adverse reactions must be reported to the EudraVigilance database within 15 days.

  • Non-serious suspected adverse reactions must be reported to the EudraVigilance database within 90 days.

  • The MA holder must submit periodical safety reports to the MPA.

  • The MA holder must consult with the MPA before initiating a product recall. The recall notice must be approved by the MPA before being sent to customers.

  • The MPA can take action in cases of non-compliance and can issue a prohibitive injunction subject to fines for non-compliance. Decisions by the MPA can be appealed to the Administrative Court.

 
21. Outline the key areas of law applicable to medicinal product liability, including key legislation and recent case law.

Legal provisions

A patient who suffers personal injury from using a particular medicinal product can bring an action under the Product Liability Act. Damages can be claimed for injuries caused by a product due to a safety deficiency (that is, the injuries were caused because the product was not as safe as can reasonably be expected). A patient can also bring a claim under the Tort Act (SFS 1972:207).

The Pharmaceutical Insurance Association (Läkemedelsförsäkringen) (LFF) provides a voluntary no-fault insurance scheme for its members through the insurance company LFF Service AB. The insurance covers damages caused by adverse effects of:

  • Pharmaceuticals purchased at a pharmacy in Sweden.

  • Pharmaceuticals received in the healthcare system.

  • Investigational medicinal products in clinical trials.

A large majority of pharmaceutical companies conducting business in Sweden are members of the LFF.

Substantive test

To be entitled to compensation under the Product Liability Act the claimant must prove that both:

  • The injury is caused by the medicinal product due to a safety deficiency.

  • There is a causal link between the injury and safety deficiency.

Under the Tort Act, the claimant must prove that there is a causal link between the injury and use of the medicinal product. No-fault liability does not apply (as it does under the Product Liability Act), so the claimant must usually prove negligence.

Personal injury that has most probably been caused by a pharmaceutical product's adverse effects and which could not reasonably have been predicted by the prescribing physician is covered under the pharmaceutical insurance.

 
22. Who is potentially liable for defective medicinal products?

The following can be held liable for damages:

  • A manufacturer.

  • An importer.

  • Any individual who identifies himself as the producer by affixing his company name, trade mark or other distinguishable sign to a product.

The Patient Safety Act (SFS 2010:659) provides that healthcare professionals are required to perform their work in accordance with medical findings and well-established practices. The Health and Social Care Inspectorate (Inspektionen för vård och omsorg) supervises healthcare professionals. If a healthcare professional is considered not to perform his or her duties in accordance with the requirements of the Patient Safety Act, the Health and Social Care Inspectorate can report the healthcare professional to the Healthcare and Medical Services Disciplinary Board (Hälso och sjukvårdens ansvarsnämnd, HSAN), which has the authority to revoke a healthcare professional's licence. A decision of the Healthcare and Medical Services Disciplinary Board can be appealed to the Administrative Court.

Due to the difficulties of receiving compensation under the Tort Act there are very few cases where patients claim damages directly from the hospital or physician. Patients usually turn to the patient insurance, which hospitals are required to take out under the Patient Injury Act (SFS 1996:799), or to the LFF insurance scheme to receive compensation for injuries caused by treatment or medicinal products.

 
23. What defences are available to product liability claims? Is it possible to limit liability for defective medicinal products?

The defendant can avoid liability under the Product Liability Act if it can prove any one of the following:

  • There is no causal link between the injury and use of the medicinal product.

  • It did not put the product into circulation in the course of its business.

  • It is probable that the defect that caused the damage did not exist at the time when the product was put into circulation.

  • The defect is due to the product's compliance with mandatory regulations issued by the public authorities.

  • The state of the art defence, that is, the state of scientific and technical knowledge at the time when it put the product into circulation was not enough to enable the discovery of the defect.

In tort, the defendant can avoid liability if, for example:

  • It can prove that there is no causal link between the injury and use of the medicinal product.

  • It did not cause the injury by a wilful or negligent act.

 
24. How can a product liability claim be brought?

Limitation periods

The limitation period for a claim based on the Product Liability Act is three years after the party suffering the damage became aware of, or should reasonably have become aware of, the damage and the identity of the person liable. This claim cannot be made ten years after the product was put into circulation, regardless of the injured or damaged party's state of awareness. Claims based on the Tort Act have a limitation period of ten years.

Class actions

Private individuals, certain non-profit organisations and certain authorities can initiate a group claim under the Group Claims Act (SFS 2002:599) if, among other things:

  • Several common disputes exist.

  • The action cannot be equally, or more effectively, processed in another way.

  • The representative of the group is suitable to conduct the group action.

  • Certain other requirements are met.

The group claim covers group members who declare within a certain period that they want to be included in the claim. The members are not part of the trial but the judgment is binding for all group members.

The Group Claims Act came into force on 1 January 2003 and no pharmaceutical case law has been developed to date.

 
25. What remedies are available to the claimant? Are punitive damages allowed for product liability claims?

A company held liable under the Product Liability Act or in tort must pay damages for injury caused. There is no upper limit for the amount of damages. However, damages paid as a result of a court action are generally low compared to those in other jurisdictions.

Punitive damages are not allowed for product liability claims.

 

Reform

26. Are there proposals for reform and when are they likely to come into force?

On 17 December 2015, the Supreme Administrative Court issued its ruling in the high profile Cimzia case. The court concluded that the DPBA has no authority to prohibit county councils from entering into price agreements with pharmaceutical companies. In light of the Cimzia case and the discussions that have followed the ruling, the price and reimbursement system is under review by the government. However, it is not possible to conclude now what the review will result in.

For information on pharmaceutical patents, trade marks, competition law, patent licensing, generic entry, abuse of dominance and parallel imports, see Pharmaceutical IP and Competition Law in Sweden: overview ( www.practicallaw.com/2-560-7525) .

 

Online resources

Swedish government website

W www.government.se/sb/d/3288

Description. The official website of the Swedish government. English translations of Swedish legislation can be found here.

Other relevant legislation is available on the website of the relevant regulatory authority (see Question 1).

Translations of legislation are for guidance only. Translations are not binding.



Contributor profiles

Helén Waxberg, Partner

Mannheimer Swartling Advokatbyrå

T +46 8 595 064 14
F +46 8 595 060 01
E helen.waxberg@msa.se
W www.mannheimerswartling.se

Professional qualifications. Qualified in Sweden, 1990

Areas of practice. Competition, distribution, marketing and regulatory issues in the pharmaceutical sector; originator pharmaceutical products, medical devices, food, cosmetics and corporate compliance and investigations.

Recent transactions

  • Representing pharmaceutical companies in issues brought before the Information Practices Committee and national authorities.
  • Litigation concerning reimbursement, substitution, regulatory data protection and pharmaceutical advertisement.

Camilla Nortoft, Associate

Mannheimer Swartling Advokatbyrå

T +46 8 595 063 94
F +46 8 595 060 01
E camilla.nortoft@msa.se
W www.mannheimerswartling.se

Areas of practice. Medicinal products, medical devices, food, cosmetics and borderline products.

Recent transactions

  • Representing pharmaceutical companies in issues brought before the Information Practices Committee and national authorities.
  • Litigation concerning reimbursement, substitution, regulatory data protection and pharmaceutical advertisement.

Åsa Edlund, Associate

Mannheimer Swartling Advokatbyrå

T +46 8 595 060 39
F +46 8 595 060 01
E asa.edlund@msa.se
W www.mannheimerswartling.se

Areas of practice. Intellectual property; media and marketing law.

Recent transactions

  • Representing patent holders in litigation.
  • Administrative proceedings relating to trade marks.

Sarah Hoskins, Senior Associate

Mannheimer Swartling Advokatbyrå

T +46 8 595 063 34
F +46 8 595 060 01
E saho@msa.se

W www.mannheimerswartling.se
Professional qualifications. UK-qualified solicitor and EU-advokat.

Areas of practice. EU and competition law, with a particular emphasis on cartel investigations, competition compliance, abuse of dominance and merger control.

Recent transactions

  • Representing a client in an ongoing market manipulation cartel case under investigation by the European Commission.
  • Advising in mergers concerning the pharmaceutical sector.

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