Life Sciences Report May 2019

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

AI in Health & Life Sciences & the Medicus L(ex) Machina
By Timo Minssen

There is no doubt that Artificial Intelligence (AI) is at the centre of what is often referred to as the Fourth Industrial Revolution.  Although still in its infancy, we are already seeing enormous advances in a great variety of scientific and industrial areas. The impact of AI can be felt across industries and professional sectors, from military, transport and agriculture to transport, media, communication, entertainment and in the legal profession. Everything becomes smarter and interconnected. That surely also applies to health and life sciences. Continue reading…

Pricing and financing of pharmaceuticals

The Swedish government has recently published an investigation into the pricing and financing of pharmaceuticals. In this article, we will summarize the main features of this investigation. Continue reading…

Patents on life?

First, a brief history and background of the topic “Patents on life” – or, more specifically, on plants – are they possible? Traditionally, plants (and other patents “on life”) have been seen as excluded from patentability, both in national legislation and under the European Patent Convention (EPC). Continue reading…

Collaborative model for introduction of medtech

In mid-March 2019, the Swedish Association of Local Authorities and Regions (“SALAR”, known as SKL in Swedish) decided to recommend that the regions establish a collaborative model for the orderly introduction of medtech. A similar model already exists for pharmaceuticals, which has served as a model for the recommendation. Continue reading…

Processing of personal data for research purposes

Private entities in the life sciences industry commonly process both sensitive and non-sensitive personal data within research and development for research purposes. Such research could be related to the development of new pharmaceuticals or medical devices, for example. Continue reading…

Restricted access to statistics – a threat to the pharmaceutical market in Sweden?

Following a court decision in the summer, the National Board of Health and Welfare and the Swedish eHealth Agency have stated that they will restrict access to statistics relating to sales volumes of individual pharmaceuticals. The judgement and statement have been met with wide criticism among market players. Continue reading…

Strengthening life science brands through copyright

Swedish life science companies with a market in the US should consider the opportunity to register copyright protection for the design of their product brands. A registered copyright in the US will strengthen the company’s position against potential infringers and counterfeiters as compared to only relying on trademark protection. Continue reading…

Government mandate to Swedish Medical Products Agency regarding off-label prescribing

In April 2019 the Government gave the Swedish Medical Products Agency directives to conduct a pilot project regarding a risk-benefit assessment of off-label prescription of drugs. The project will submit a finalized report by 31 December 2019. Continue reading…