Healthcare & Life Sciences, Sweden updates

Cannabis causes confusion in Sweden
Westerberg & Partners Advokatbyrå Ab
  • 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
Westerberg & Partners Advokatbyrå Ab
  • 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
Westerberg & Partners Advokatbyrå Ab
  • 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
Westerberg & Partners Advokatbyrå Ab
  • 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
Westerberg & Partners Advokatbyrå Ab
  • 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
Westerberg & Partners Advokatbyrå Ab
  • 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.

Off-label use: a comparator in health technology assessments
Westerberg & Partners Advokatbyrå Ab
  • Sweden
  • 28 September 2016

The Dental and Pharmaceutical Benefits Agency (TLV) recently denied reimbursement for an orphan drug for the treatment of chronic thromboembolic pulmonary hypertension based on a health technology assessment which took into account off-label use of treatments for pulmonary arterial hypertension (PAH). The Stockholm Administrative Court has since upheld the TLV decision, agreeing with the TLV's reasoning that the orphan drug should be compared with available PAH treatments.

E-cigarettes no longer considered medicinal products in Sweden
Westerberg & Partners Advokatbyrå Ab
  • Sweden
  • 25 May 2016

The Supreme Administrative Court recently ruled that e-cigarettes not marketed for smoking cessation purposes should not be classified as medicinal products. The court stated that in order to be classified as a medicinal product, the product, if used as intended, must be capable of appreciably restoring, correcting or modifying physiological functions in human beings. It is not sufficient that the product has a pharmacological effect on the body's functions.

Pricing agreements for products in reimbursement scheme
Westerberg & Partners Advokatbyrå Ab
  • Sweden
  • 10 February 2016

The Supreme Administrative Court recently handed down a long-awaited judgment in the case between the Dental and Pharmaceutical Benefits Agency and the Skane Region. The court departed from earlier judgments and stated that county councils and regions are permitted to enter into discount agreements with pharmaceutical companies for medicinal products which are included in the reimbursement scheme.

Named patient permission for unauthorised medicinal products – financial considerations
Westerberg & Partners Advokatbyrå Ab
  • Sweden
  • 18 November 2015

The Stockholm Administrative Court of Appeal recently clarified the possibility to consider financial aspects when determining whether there are special requirements for granting a named patient permission. The court dismissed arguments that high prices and limited availability of an authorised medicinal product could constitute special requirements for a named patient permission for an unauthorised medicinal product.

Orphan drug denied reimbursement in health technology assessment
Westerberg & Partners Advokatbyrå Ab
  • Sweden
  • 05 August 2015

A pharmaceutical company's recent application to the Dental and Pharmaceutical Benefits Agency (TLV) for a pricing and reimbursement decision regarding a medicinal product with orphan drug status was rejected. The decision appears to be the first in which a product under off-label use has been used as a comparator in the TLV's health technology assessment.

Medicinal products' approved indications irrelevant to substitutability
Westerberg & Partners Advokatbyrå Ab
  • Sweden
  • 27 May 2015

The Uppsala Administrative Court has upheld a Medical Products Agency decision that a generic inhaler was not considered substitutable within the substitutability groups for which the generic company had applied. The court denied substitutability based on the generic inhaler's incompatibility with a spacer mentioned in the original inhaler's summary of product characteristics.

Pricing uncertainty for orphan drugs and innovative new drugs
Westerberg & Partners Advokatbyrå Ab
  • Sweden
  • 11 February 2015

The Administrative Court of Appeal recently issued a judgment on the pricing of orphan drugs in the reimbursement system. The court considered whether a maximum price cap exists with regard to the cost-effectiveness calculation within the health technology assessment. The outcome is unsatisfactory for pharmaceutical companies, particularly those with orphan drugs or innovative new drugs in their product portfolio.

Agreement to limit distribution of private healthcare providers' profits
Westerberg & Partners Advokatbyrå Ab
  • Sweden
  • 05 November 2014

The government and the Left Party recently reached agreement on initiatives aimed at restricting private companies from engaging in certain publicly funded healthcare, care and educational services and, as part of that limit, their right to distribute profits. Much of the criticisms leading up to the suggested initiatives may be addressed by stricter tender procedures.

Discount agreements for medicinal products in reimbursement system
Westerberg & Partners Advokatbyrå Ab
  • Sweden
  • 10 September 2014

The Administrative Court of Appeal recently held that it is not possible for county councils and regions to acquire a discount on the price of medicinal products in the reimbursement system. The decision has been appealed to the Supreme Administrative Court. It remains to be seen what will happen to existing discount agreements within the reimbursement system should leave to appeal not be granted.

Cooperation framework for introduction of new innovative medicinal products
Westerberg & Partners Advokatbyrå Ab
  • Sweden
  • 25 June 2014

The Swedish Association of Local Authorities and Regions (SKL) represents the county councils which operate the majority of Swedish hospitals. The SKL has put in place a new cooperation framework for the introduction of new innovative medicinal products. The framework seeks to enable county councils to act as strong buyers of medicinal products, which would lead to, among other things, faster access to new treatments.

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