Healthcare & Life Sciences updates

Sweden

Contributed by Westerberg & Partners Advokatbyrå Ab
Biosimilars still not subject to mandatory substitution
  • Sweden
  • 08 April 2020

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 since 2007. This position has now been supported by an administrative court of appeal in a case relating to glatiramer acetate products used for the treatment of multiple sclerosis.

Marketing authorisation holder lacks standing to challenge off-label prescription for unlicensed products
  • Sweden
  • 11 December 2019

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.

Heavily discounted starter pack considered unethical grant to healthcare
  • Sweden
  • 30 October 2019

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.

Cannabis causes confusion in Sweden
  • Sweden
  • 14 August 2019

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.

Trilogue negotiations: originator company compensation for parallel imported products
  • Sweden
  • 27 February 2019

The Stockholm Administrative Court recently ruled that under the so-called 'trilogue negotiations' between pharmaceutical companies, the Dental and Pharmaceutical Benefits Agency and the Swedish regions could require an originator company to compensate them for products marketed by parallel importers.


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