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Trends and developments

Legal developments

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

There are many legislative initiatives and discussions within the area of medicinal products at an EU level. For example, a new EU regulation on clinical trials will come into operation in 2018. In addition, there are ongoing discussions relating to online cross-border sales of medicinal products within the European Union.

Legal framework

Legislation

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

Sweden is a member of the European Union and, as such, all legislation introduced at an EU level also applies to the Swedish market. Directives issued by the European Union are transposed into Swedish acts, ordinances or regulations. Regulations issued by the European Union are directly applicable in Sweden and no transposition is required.

The primary legal framework governing medicinal products in Sweden is the Medicinal Products Act and the Medicinal Products Ordinance. Trading in medicinal products in Sweden (eg, wholesale distribution and the sale of medicinal products to pharmacies) is governed by the Medicinal Products (Trading) Act. The legal framework includes regulations primarily issued by the Medical Products Agency.

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

See above.

Regulation

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

The Medical Products Agency is the national authority responsible for the regulation and surveillance of the development, manufacture and marketing of drugs and other medicinal products in Sweden.

The Dental and Pharmaceutical Benefits Agency is responsible for:

  • deciding whether a pharmaceutical product or medical device should be subsidised by the state;
  • determining retail margins for all pharmacies in Sweden;
  • regulating the substitution of medicines at pharmacies; and
  • supervising 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)?

The Personal Data Act applies to the processing of personal data in connection with the trade of medicinal products.

Regarding parallel imports, please refer to the section on “Import and export”. Regarding consumer protection, please refer to the sections on “Advertising” and “Labelling”.

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

The Medicinal Products Act covers medicinal products for human use and medicinal products for animals. Certain exemptions apply to homeopathic medicinal products and traditional herbal medicinal products.

Supply

Manufacture

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

The manufacture of medicinal products in Sweden requires a licence from the Medical Products Agency. Detailed provisions regarding, for example, the information to be included in the application are set out in the Medical Products Agency’s provisions and guidelines for marketing authorisation to manufacture and import medicinal products. The Medical Products Agency provides a form for the application on its website which may simplify the application process. The Medical Products Agency must make its decision no later than 90 days after a complete application is submitted and the application fee is paid.

Other authorisations for manufacturing may be required, such as a permit under the Environmental Code. The application process under the Environmental Code is more time consuming than the application process with the Medical Products Agency.

What is the fee for obtaining authorisation?

According to the State Control of Medicinal Products (Fees) Ordinance, the application fee for a manufacturing licence is Skr65,000. Some variations apply to, for example, the manufacture of traditional herbal medicinal products.

What is the validity period for authorisation?

A manufacturing licence is valid either indefinitely or for a specified term. The Medical Products Agency may withdraw a licence if:

  • any of the significant prerequisites which were met when the licence was issued is no longer met;
  • the annual fee has not been paid; or
  • any other requirement of importance is not observed.

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

Good manufacturing practice (GMP) constitutes the most important guidance for the issuance of a manufacturing licence and is used when conducting inspections of manufacturing sites. Inspections by the Medical Products Agency include regular site visits by an inspector and reviews of the routines and other documentation relating to GMP requirements. Such inspections focus, for example, on quality systems, internal organisation, manufacturing facilities and laboratories.

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

A dismissal of an application for a manufacturing licence issued by the Medical Products Agency may be appealed. The manufacture of medicinal products without a valid licence is a criminal offence.

Where a deviation from GMP is discovered during an inspection, there are different ways for the Medical Products Agency to proceed. In most cases, the deviations are listed in an inspection report and the manufacturer is permitted to respond and explain how these deviations will be remedied. If the Medical Products Agency is satisfied with the manufacturer’s response, a new licence will be issued. The manufacturer may be ordered to take further action in order to remedy any such deviations.

In more severe cases, the Medical Products Agency may withdraw the existing manufacturing licence and issue a statement of non-compliance with GMP.

An order to take further action or a decision to withdraw a licence may be appealed.

Distribution

How are the distribution and storage of medicinal products regulated?

According to the Medicinal Products (Trading) Act, a wholesaler of medicinal products is required to hold a licence for the wholesale of medicinal products. An application for a wholesale licence is submitted to the Medical Products Agency. The fee for obtaining a wholesale licence is Skr40,000.

A wholesaler must comply with good distribution practices (GDP), which include requirements on how medicinal products are handled and control of the distribution chain.

More detailed requirements are included in the Medicinal Products Wholesale Regulation.

Import and export

How are the import and export of medicinal products regulated?

Imports from a third country (ie, a country outside the European Union or European Economic Area (EEA)) are covered by the same regulation that applies to the manufacture of medicinal products. Imports from a third country therefore require a licence from the Medical Products Agency. In order to obtain a licence, an importer must, for example, comply with GMP. The application fee is Skr65,000.

Imports from an EU or EEA country are regulated in the Medicinal Products Wholesale Regulation and other equivalent regulations in other EU and EEA countries.

The regulation states that wholesale of medicinal products in Sweden may be carried out only by a person holding a wholesale licence in an EU or EEA country. GDP must be observed.

Are parallel imports permitted in your jurisdiction?

Parallel imports are permitted. However, a licence issued by the Medical Products Agency is required and must be obtained before the medicinal product is marketed. The licence is valid for five years.

The Provisions on Parallel Imported Medicinal Products set out four principal conditions for the issuance of a licence:

  • Direct imports must have a market authorisation in Sweden.
  • Parallel imports must have a market authorisation in the exporting state.
  • The exporting state must be a member of the EEA.
  • There must be no therapeutic difference between a parallel import and the equivalent nationally-authorised product.

Sale and purchase

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

According to the Trade in Certain Non-prescription Medicines Act, certain medicinal products which do not require a prescription may be sold in outlets other than a pharmacy - for example, in a supermarket or petrol station. A notification to the Medical Products Agency is required.

In order to dispense medicinal products, a permit under the Medicinal Products (Trading) Act is required. The application is submitted to the Medical Products Agency. The fee is Skr20,000 and the turnaround time is 90 days from the date that the application is completed and the fee is paid. 

There are limitations on who may obtain a permit to dispense medicinal products. For example, a legal entity with a controlling influence on the manufacture of medicinal products or a person with the right to prescribe medicinal products may not be granted a permit.

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

Online sales must be notified to the Medical Products Agency. The notification of online sales may be made in connection with the application for a permit under the Medicinal Products (Trading) Act or separately.

Named patient supply

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

A pharmacy may apply for a licence to sell a medicinal product not approved in Sweden to a named patient. The person prescribing the medicinal product must specify clear reasons for the need for the licensed medicinal product.

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.

An application is primarily assessed by experts at the Medical Products Agency. Generally, such assessment is made within 30 days. The applicant may amend the application in respect of any unclear points identified during the preliminary assessment. If no unclear points are identified, authorisation is granted. If unclear points remain after the amendment is provided, the application may be dismissed. In general, the turnaround time for an application does not exceed 60 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 Medical Products Agency, the person in charge of clinical trials must have relevant knowledge and training in good clinical practice (GCP). GCP must be applied. The Medical Products Agency 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?

According to the Provisions on Clinical Trials of Medicinal Products for Human Use, the holder of the authorisation must notify the Medical Products Agency and the ethical board that the clinical trial has been finalised. Such notification must be given within 90 days of finalisation of the clinical trial. If the clinical trial is suspended before finalisation, the holder of the authorisation must inform the Medical Products Agency and the ethical board within 15 days, using EU common forms in electronic format. In addition, there are requirements for reporting during clinical testing.

No later than 12 months after the clinical trial has been finalised, a comprehensive report must be submitted to the Medical Products Agency.

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

According to the Medicinal Products Act, consent must at all times be obtained from a clinical trial subject, the subject’s guardian or a trustee. Such consent may be withdrawn at any time with immediate effect.

Insurance

What are the insurance requirements for clinical trials?

The sponsor must ensure that all trial subjects are covered by insurance or guaranteed adequate financial protection by other means.

Data protection

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

The Personal Data Act applies to the processing of personal data in connection with clinical trials. Clinical trials normally involve the processing of health information, which is regarded as sensitive personal data. The processing of sensitive personal data normally requires express consent from the individuals concerned. However, it may be possible to justify the processing of sensitive personal data without consent if this has been approved by an ethics committee. The individuals concerned shall also be informed regarding the processing of their data. The information to be provided must include:

  • the identity of the data controller;
  • the purpose of the processing; and
  • any other information necessary for the individuals concerned to protect their right to privacy.

The following general data protection requirements should also be considered:

  • Personal data must be adequate, relevant and non-excessive in relation to the purpose of the processing.
  • Personal data must not be processed for any purpose that is incompatible with that for which the information is collected.
  • Adequate security measures for the protection of personal data must be implemented.
  • Data processing and data transfer agreements may be necessary.

Marketing authorisation

Authorisation

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

There are four different procedures to obtain authorisation to market medicinal products in Sweden, all of which follow EU-level procedures:

  • Centralised procedure ‒ the application is submitted to the European Medicines Agency. Authorisation of medicinal products via the centralised procedure entitles the applicant to sell the products throughout the EEA. The centralised procedure is mandatory for some products and optional for others.
  • Mutual recognition procedure ‒ the application is assessed by a competent authority in one EU member state. By using the mutual recognition procedure, the applicant may request recognition in other EEA countries of a national authorisation which is already in force. The national authority’s assessment is used as a basis for licensing in other countries.
  • Decentralised procedure ‒ this is used where the applicant wishes to obtain marketing authorisation in a number of EEA countries for a medicinal product that has no previous authorisation. The application is sent to the national authority in one member state, which distributes the documentation to the competent authorities in the other relevant member states.
  • National procedure ‒ applicable to a medicinal product intended for marketing in one market only.

What criteria are considered in granting marketing authorisation?

The criteria relate to the safety, efficacy and quality of the medicinal product. According to the Medicinal Products Act, a medicinal product must be of good quality and well -adapted to its purpose. Further, a medicinal product must have an acceptable and distinctive name and be provided with a clear label ‒ including safety details for prescription drugs ‒ and a complete statement of (for example) active substances.

What is the fee for obtaining marketing authorisation?

The fee for obtaining marketing authorisation through the decentralised procedure or the mutual recognition procedure when Sweden is the concerned member state is Skr100,000. For more information regarding fees, please visit https://lakemedelsverket.se/english/product/Medicinal-products/Fees--/.

What is the validity period for marketing authorisation?

Marketing authorisations for medicinal products are valid for five years from the date of authorisation. A company seeking to renew an authorisation must submit a renewal application. If a renewed authorisation is approved, the authorisation remains valid indefinitely, unless the competent authority decides, on justified grounds, to proceed with an additional five-year renewal.

What are the consequences of failure to obtain marketing authorisation?

No medicinal product may be placed on the market of an EU member state unless a marketing authorisation has been issued by a competent authority. It is a criminal offence to put a medicinal product on the market without a marketing authorisation.

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 system to monitor the security of its product – a so-called ‘pharmacovigilance’ system.

The Medical Products Agency conducts inspections of market authorisation holders in order to verify that they have implemented a pharmacovigilance system that complies with applicable laws and regulations.

Data protection

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

The Personal Data Act applies to the processing of personal data in connection with pharmacovigilance activities. Pharmacovigilance activities normally include the processing of health information, which is regarded as sensitive personal data. The processing of sensitive personal data normally requires express consent from the individuals concerned. The individuals concerned shall also be informed regarding the processing of their data. The information to be provided must include:

  • the identity of the data controller;
  • the purpose of the processing; and
  • any other information necessary for the individuals concerned to protect their right to privacy.

 The following general data protection requirements should also be considered:

  • Personal data must be adequate, relevant and non-excessive in relation to the purpose of the processing.
  • Personal data must not be processed for any purpose that is incompatible with that for which the information is collected.
  • Adequate security measures for the protection of personal data must be implemented.
  • Data processing and data transfer agreements may be necessary.

Pricing and reimbursement

Pricing

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

The pricing of medicinal products included in the medicinal products benefit scheme is regulated.

The Dental and Pharmaceutical Benefits Agency decides whether a certain medicinal product will be included in the benefit scheme. For included products, a price is determined based on an application from the market authorisation holder.

Reimbursement

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

If a person has purchased prescribed medicinal products in an amount exceeding Skr2,200 within the last 12 months, the costs exceeding Skr2,200 will be borne by the county council. Commencing January 1 2016, all prescribed medicinal products within the benefit scheme for children under 18 years are free of charge.

Advertising and labelling

Advertising

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

The advertising of medicinal products is regulated by the Medicinal Products Act and the Medical Products Agency Regulations on the Marketing of Medicinal Products for Human Use. These rules are complemented by the general provisions of the Marketing Practices Act, which apply to the advertising of all products and services, including medicinal products. Moreover, the ethical rules adopted by the Swedish Association of the Pharmaceutical Industry contain detailed provisions for advertising medicinal products. While the ethical rules are not legally binding, they are recognised by the industry and applied by courts as an expression of good marketing practice in the field of medicinal products.

The general clause of the Medicinal Products Act states that advertisements for a medicinal product should encourage the rational use of the product. Product presentations must be up to date, factual and balanced, must not be misleading and must generally comply with good marketing practice.

All advertising must contain information that is of particular importance to the general public and to persons qualified to prescribe or supply medicinal products, as the case may be.

The following practices are expressly prohibited:

  • advertising of a medicinal product in respect of which marketing authorisation has not been granted;
  • medicinal product advertising directed at children; and
  • advertising to the general public of medicinal products which are available on medical prescription only (with the exception of campaigns promoting vaccinations against infectious diseases).

In addition, according to the Medical Products Agency regulations, all aspects of the advertising of a medicinal product must comply with the particulars listed in the summary of product characteristics.

According to the Medicinal Products Act, advertising to the general public must clearly indicate that the message is an advertisement and the product must be clearly identified as medicinal. Such advertising must not be designed to incite a use that could cause harm or is otherwise inappropriate, or in such a way that people may not seek appropriate care. Detailed provisions in the Medical Products Agency regulations specify the information to be included when advertising to the general public.   

Advertising to persons who are qualified to prescribe or supply medicinal products must be sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the medicinal product concerned. Such advertising must always contain essential information that is compatible with the summary of product characteristics and on the classification of the medicinal product. Moreover, advertising must always state the date on which the documentation was drawn up or last revised.

In addition, the Marketing Practices Act requires that all advertising be consistent with good marketing practice. Misleading marketing is expressly prohibited. Whether marketing is misleading depends on how it is understood by the relevant public. As a general rule, claims which cannot be substantiated by relevant and appropriate scientific evidence will be deemed misleading.

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

In general, the Swedish rules on advertising of medicinal products (see above) apply to any form of marketing, including online advertising.

The ethical rules adopted by the Swedish Association of the Pharmaceutical Industry state that information on medicinal products on websites must clearly show to whom the information is addressed and ensure that the presentation (eg, content, links) is adapted for the intended target audience. These rules also state that medicinal product information online must contain a clear statement of the date on which the site was most recently updated.

The Swedish Association of the Pharmaceutical Industry has also issued a detailed document presenting the association’s views on how the ethical rules relate to social media. Whether a certain advertising measure complies with the ethical rules will ultimately be determined by the association’s information examiner and the Information Practices Committee.

Labelling

What are the packaging and labelling requirements for medicinal products?

Comprehensive and detailed packaging and labelling requirements are found in the Medical Products Agency Provisions on Labelling and Package Leaflets for Medicinal Products, as amended. These rules essentially reflect the mandatory information requirements under Title V of EU Directive 2001/83/EC, as amended by EU Directive 2004/27/EC.

The rules require, among other things, that specified information appear on the outer packaging of the medicinal product or, where there is no outer packaging, on the immediate packaging.

The name of the medicinal product shall appear in Braille on the outer packaging. If the medicinal product exists in several strengths, the strength shall also appear in Braille.

The labelling on the outer packaging and immediate packaging shall be in Swedish. Other languages may also be used if the information provided is the same in all languages.

The labelling on the outer packaging and immediate packaging must be easily legible, clearly comprehensible and indelible. Certain information shall be given a prominent position and a clear design, especially the product’s name, directions for storage and use and any warnings. The marketing authorisation holder shall also ensure that the labelling is kept up to date with the current scientific knowledge.

How is the promotion of off-label use regulated?

The prohibitions and requirements under the Medicinal Products Act, the regulations of the Medical Products Agency and Swedish Association of the Pharmaceutical Industry’s ethical rules implicate a ban on off-label promotions in advertising. The marketing of a medicinal product for uses that differ from the approved summary of product characteristics is not allowed. This does not prevent physicians from prescribing 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 provision of gifts, discounts and other incentives to healthcare professionals is not specifically regulated in law. However, it is regulated through self-regulation (see the Swedish Association of the Pharmaceutical Industry’s ethical rules above).

These ethical rules complement the Swedish anti-bribery legislation. Under the Swedish anti-bribery legislation, the giving of bribes is the criminal act of giving, promising or offering a bribe for the performance of duties, while the taking of bribes is the criminal act of receiving, accepting a promise of or demanding an improper benefit for the performance of duties. Anything of direct or indirect value to the recipient can be considered an improper benefit (ie, a bribe). The term ‘improper’ is not defined and an individual assessment is necessary in each case. Benefits given to recipients such as healthcare professionals in the public sector are generally looked upon more stringently than those given in the private sector.

Liability

Defect products

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

A specific type of insurance is available in Sweden for those suffering from adverse effects of pharmaceutical treatment. This pharmaceutical insurance is provided by an insurance company that is predominantly owned and financed (reportedly 98%) by a group of companies that manufacture and market medicinal products in Sweden. As a general rule, damage must be reported to the insurer no later than 10 years from the date on which the injured party becomes aware that the damage was possibly caused by the medicinal product. The injured party can also choose to bring a claim before a court of general jurisdiction.

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

According to a committee report (SOU 2013:23), nearly all medicinal products sold in Sweden (99%) are covered by pharmaceutical insurance. Therefore, most claims for damage caused by medicinal products in Sweden may be made under this insurance should the injured party so wish.

Remedies

What remedies are available to successful claimants?

Compensation under pharmaceutical insurance may be claimed, for example, for healthcare, pain and suffering, disability, disfigurement and loss of income.

Exclusion and limitation

On what grounds can liability be excluded?

Among other things, pharmaceutical insurance does not cover injuries from misuse, incorrect dosage or improper handling. Furthermore, consequences which are no more severe than basic sickness will not be compensated. 

What preventive steps can be taken to limit liability?

One way to limit liability is by implementing a system that facilitates continuous monitoring of compliance with laws and regulations which might affect liability.

Compliance and enforcement

Enforcement

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

The Medical Products Agency has enforcement powers – for example, it can conduct inspections, order corrections, withdraw licences and report certain actions as criminal offences, as well as naming and shaming in relation to non-compliance reports in EudraGMPD.

Dishonest practices

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

The Swedish anti-bribery legislation is the main mechanism in place to combat bribery, fraud and other dishonest practices. The Swedish Prosecution Authority has a national unit, the National Anti-corruption Unit, which investigates corruption crimes. The unit also promotes uniformity in legal proceedings by working on judicial matters within the area. The ethical rules (see above) complement the Swedish anti-bribery legislation, which also provides the pharmaceutical sector with guidelines on, for example, interactions with representatives of the public and healthcare sectors.

The Swedish Association of the Pharmaceutical Industry is a member of the European Federation of Pharmaceutical Industries and Associations (EFPIA), and is part of the EFPIA initiative on disclosure of transfers of value from pharmaceutical companies to healthcare professionals and healthcare organisations.

In addition, the Swedish Anti-corruption Institute – a self-regulatory business body – has issued a general and non-binding Code of Business Conduct for best practice in matters relating to fraud and corruption.

Based on registered IP rights, holders can request customs action against suspected counterfeit goods in Sweden or in designated EU member states (depending on the territory covered by the registered rights). In order to prevent manipulation of the packaging of prescription drugs, an identification number and certain security details will become mandatory. Websites of legally operating online pharmacies/retailers must use a common logo that is recognisable throughout the European Union (Directive 2011/62/EU).

Sweden has competition laws which prevent unlawful collusion between competitors.