Life Sciences Report November 2018

We have the pleasure of presenting the latest issue of Setterwalls’ Life Sciences report. The report presents our view on selected current issues with respect to life sciences. The enclosed report, together with earlier editions, is also available on our web site, www.setterwalls.se.

We hope you will find the report of interest.

Yours sincerely,
Helena Nilsson and Per Lidman

New EU regulation refuses certain health claims

A new EU Regulation on health claims about foods came into force in November 2018.  The regulation refuses certain health claims that will not be included in the EU’s list of permitted claims. Hence, these claims will be listed as non-authorised in the EU’s register of evaluated health claims. Continue reading

Medical device regulation: halfway there?

Halfway through the implementation period of the EU Medical Device Regulation (MDR), important actions are still to be taken by both the EU and other organisations in this field, in particular companies that supply medical devices. The EU has recently published a new rolling plan for the imple-menting measures, as well as guidance documents. Continue reading

Can you show use of your trademarks?

On 1 January 2019 an amended trademark law will enter into force in Sweden. The main purpose of the modified law is to implement the new EU Trademark Directive. Overall, the modified law will result in modernized and simplified trademark legislation. The amended trademark law introduces a number of changes, including stricter requirements on use in cases of opposition, infringement and invalidity proceedings. Furthermore, we will see changes regarding what may constitute a trademark. Another important change is that trademark owners will be able to explicitly stop transit and similar customs actions of infringing goods without having to prove that the infringing goods are intended for the Swedish market. The purpose of this article is to highlight the most important changes introduced by the amended trademark law. Continue reading

Joint ownership could block use of research results

Joint research generally leads to joint ownership of the developed research results. If the joint owners do not enter into an agreement, Swedish legislation requires almost every use of the results to be subject to mutual consent by all the owners. In cases where the parties have differing opinions, the lack of a comprehensive contract could therefore prevent life science operators from using research results as background information for new projects, patenting their inventions and even using their findings in their own activities. Continue reading

Sweden’s new national life sciences strategy: addressing major challenges

To achieve the goal of Sweden becoming a leader in life sciences, the government is developing a new Swedish life sciences strategy. The government has established an office for life sciences and tasked it with developing the new strategy. A new status report on the sector concludes that many issues have not been handled properly, leading to shortcomings in areas such as legislation. The aim is for the newly established office to help solve these issues. Continue reading

Insurance coverage when medications are prescribed off-label

As off-label prescriptions become increasingly common, the Swedish Pharmaceutical Insurance (Läkemedelsförsäkringen) is questioning insurance coverage in relation to incidents after off-label use.

Sweden has a unique system that involves the industry taking joint responsibility for patients that suffer from medication-related illness or injury. This means that patients who suffer adverse effects from pharmaceutical treatment can receive financial compensation from the Swedish Pharmaceutical Insurance. The requirement for such insurance is that patients are treated with prescribed medication or medication purchased from a legitimate dealer in Sweden. Continue reading