Healthcare & Life Sciences, Westerberg & Partners Advokatbyrå Ab updates

Sweden

Contributed by Westerberg & Partners Advokatbyrå Ab
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.

Judgment on public procurement puts parallel importers at a disadvantage
  • Sweden
  • 17 October 2018

The Stockholm Administrative Court recently ruled that the obligation on tenderers of public procurements of medicinal products to have routines which ensure that the use and handling of active ingredients would have as little effect on the environment as possible, as well as the obligation that they routinely survey and have dialogue with their subcontractors, were permissible. The decision has been appealed to the Administrative Court of Appeal in Stockholm, which has yet to make a decision.

Pharmaceutical companies request Patent and Registration Office to reassess decisions
  • Sweden
  • 22 November 2017

In eight landmark decisions, the Patent and Market Court of Appeal decided that the terms for already granted supplementary protection certificates (SPCs) should be recalculated in order to reflect a 2015 European Court of Justice decision regarding the method for calculating SPC terms under EU Regulation 469/2009. Several pharmaceutical companies that had been granted SPCs noted that the Patent and Registration Office's method of calculating SPC terms was not in line with EU law.

New pricing principles applied in decision on orphan drugs
  • Sweden
  • 12 April 2017

The Dental and Pharmaceutical Benefits Agency recently reassessed the reimbursement status of Cerezyme and VPRIV – two products indicated against Gaucher's disease – and decided to decrease the products' prices. This caused the marketing authorisation holders behind the products to withdraw them from the reimbursement system. Consequently, there is no longer a product against Gaucher's disease that is nationally reimbursed in Sweden.

Sweden reviews financing and pricing
  • Sweden
  • 08 February 2017

The government recently issued new directives to review the pricing and reimbursement system and the national financing system for medicinal products. The government declared that the existing system is complex and complicated and must be improved in order to operate a modern healthcare system. The review seeks to find a clear division of responsibilities between the national government and local county councils and regions and to establish foreseeable processes for stakeholders.


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