Both the Medical Products Agency and the Dental and Benefits Agency (the authority which decides on reimbursement) have long held the position that biosimilars are not interchangeable or substitutable with their reference products, which has been reiterated in different policy papers issued since 2007. This position is now supported by an administrative court of appeal in a case relating to glatiramer acetate products used for the treatment of multiple sclerosis.
A landmark Supreme Court judgment has closed the book on the widely known 'iron pipe scandal'. The court confirmed that fundamental rights such as freedom of the press, no matter how fundamental, do not justify the use of copyrighted materials outside the scope of the existing exceptions and limitations as set out in the Copyright Act and the EU InfoSoc Directive.
The Supreme Court recently clarified that Chapter 32 of the Environmental Code can be applied between contracting parties and that it is possible to derogate from those provisions and even exclude their application through contractual provisions. While this ruling confirms that a contracting party can safely rely on terms which modify the liability rules in the Environmental Code, it also highlights the importance of ensuring that such provisions are clearly worded and well understood.
In late 2019 the European supervisory authorities released a joint consultation paper on proposed amendments to the EU Commission Delegated Regulation 2017/653 on packaged retail and insurance-based investment products. Insurance Europe and Insurance Sweden both submitted generally negative responses to the consultation paper. This article examines the proposed changes and the potential impact on the Swedish insurance market.
Workplace harassment between employees raises questions regarding employers' responsibility to maintain a healthy and sustainable work environment and what actions can be taken against disruptive employees. Employers and their representatives have an extensive responsibility to maintain a positive work environment, including assessing, preventing and acting against risk factors such as harassment.
In a case concerning the distribution of the cost of remediation of pollution caused by polychlorinated biphenyls, the Land and Environment Court of Appeal denied the operator compensation from the polluter for remediation costs. The case demonstrates that a civil law agreement can be deemed a relevant circumstance and be considered by a court when making its assessment of reasonableness regarding how costs for environmental damage should be distributed among joint and several liable operators.
The Swedish system for medicinal products is generally product based. Prescriptions as such are product based (ie, by brand name or generic product name) and the indication for which the product is intended cannot be filled in anywhere by the prescriber. Off-label prescriptions are therefore not generally possible in the 'official' prescription system. However, when it comes to accessing unlicensed medicinal products, the system for licences on a named-patient basis works differently.
Almost four years after the implementation of the EU Solvency II Directive in Sweden, insurers are still devoting significant resources to identifying, understanding and putting into practice the complex regulatory legislation governing outsourcing arrangements. This article outlines some of the Swedish Financial Supervisory Authority's recent clarifications and comments on outsourcing and the main requirements surrounding insurers' outsourcing arrangements.
Recent case law confirms that the Swedish courts uphold the general principle that awards finalise a dispute between parties. In order to successfully challenge an award, the challenging party must prove not only that the procedural error likely affected the outcome of the award, but also that the error is of essential importance.
The government recently decided to appoint a special investigator to explore the possibilities of modernising some of the basic regulations of Swedish labour law. The investigation aims to explore how Swedish labour law can be modernised and adapted to meet current market needs while maintaining the fundamental and historical balance between the various parties to the labour market.
The legislature has decided that official decisions which could have a major impact on future environmental conduct should be made at the political level rather than through a judicial review. Although there are benefits to politicians being accountable for decisions regarding businesses that have a significant environmental impact, it remains to be seen whether the legal uncertainty in this regard will inhibit the willingness of companies to expand into Sweden.
The Patent and Market Court of Appeal recently ordered several internet service providers to take blocking measures against Sci-Hub and LibGen. The case is interesting in light of the court's 2019 decision in a similar case on interim blocking measures in which it denied blocking injunctions due to a lack of proportionality and issued stern words about the evidence invoked by the claimant and the risk of overblocking legitimate content.
The Committee for the Review of Pharmaceutical Information recently confirmed the strict approach to the marketing of medicinal products in relation to pricing. The committee's findings serve as a reminder that companies should consider not only the intended purpose of offering a discount on a product, but also its actual effects. The case under review illustrates that an intended discount on a product may be considered contrary to the Ethical Rules for the Pharmaceutical Industry.
The Supreme Court has ruled that cannabidiol (CBD) oils containing tetrahydrocannabinol (THC) which originates from legally cultivated hemp constitute illegal narcotics. The court argued that since CBD oil can be defined as a preparation in accordance with the Convention on Psychotropic Substances and contains THC, it is an illegal substance. This decision is likely to affect several aspects of Swedish healthcare regulation, including that relating to medicinal products.
In the event of a hard Brexit, UK insurers must obtain authorisation as third-country insurers in Sweden in order to offer their products to the Swedish market. Notably, insurers that are uncertain of whether the business which they intend to conduct constitutes insurance business in Sweden and is thus subject to authorisation can apply for a preliminary ruling from the Swedish Financial Supervisory Authority on the issue.
In a long and extensive environmental liability suit in Sweden, approximately 800 Chileans sued a Swedish mining company. The claim was based on the grounds that the mining company had exported toxic waste to Chile which subsequently caused damage to the plaintiffs' health. The case regards a potentially tortious act which occurred more than 30 years ago and poses the question of whether a company can be liable for environmental damage disclosed long after the tortious act has taken place.
Company leaders such as CEOs are expressly excluded from the scope of the Employment Protection Act. Therefore, the parties to a CEO's employment agreement must agree its terms. However, the reasonability and validity of the agreed terms and conditions may be assessed or determined by the Swedish courts. Given the lack of applicable law in this area, the parties to a CEO's employment agreement must agree on the terms relating to both active employment and termination (by either party).
The Patent and Market Court of Appeal recently assessed the use of quotations from wine reviews in ads and found the terms 'bargain' and 'recommended' and the phrase 'an excellent alternative for the big party' acceptable under the applicable Swedish and EU law. This ruling marks a small but significant shift in the strict Swedish jurisprudence on the subject and may give market actors a reason to pop a celebratory bottle.
For the first time, the Patent and Market Court of Appeal has confirmed that a watch can be protected by copyright as a work of applied art, even in a crowded design field. The decision enables rights holders to not only pursue counterfeits on the basis of trademark infringement, but also to prosecute copycat watch models on the basis of copyright protection in physical and digital environments.
In a recent decision, the Supreme Court confirmed that Section 34(7) of the Arbitration Act – under which an arbitral award must be set aside if an irregularity occurred in the course of the proceedings and probably influenced the case's outcome – should be applied restrictively. This decision is a rare example of a Swedish court setting aside an award based on procedural irregularities under Section 34(7).