Life Sciences Report November 2017

We have the pleasure to present 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

Guest column:
Commercial reality check – TLV needs to reconsider its’ current position on Side Agreements

The Swedish and Nordic life science industry comprises a vast number of companies and enterprises, both large and small, all of which play an important role in providing patients and healthcare providers with pharmaceutical, medtech and medical device products that are efficient, enhance quality of life and save lives. These companies range in size all the way from multinational corporations to local Nordic or Swedish enterprises, to individual entrepreneurs developing innovative products and technologies aimed at meeting medical needs or improving care and processes in the healthcare sector. Continue reading

EMA prepares for Brexit

On 29 March 2017, the UK notified the European Council of its intention to withdraw from the EU, the process we all know as ’Brexit’. No Member State has decided to leave the EU before, so there is no precedent for this situation. The European Medicines Agency (EMA) is making preparations to ensure that the agency can continue to deliver on its mission after the UK leaves the EU on 30 March 2019, the date currently set by the timeframe in Article 50 of the Treaty on European Union. Continue reading

New Measures to Help Food Companies Achieve Compliancy

EU and Swedish regulations regarding food processing are rigorous and sometimes difficult for even well-established companies to follow. Perhaps as a result thereof, there have been several food scandals in recent times both in Sweden and in other parts of the EU that have damaged public faith in the food processing industry. To address such problems, the Swedish National Food Agency (NFA) has prepared a report detailing measures to assist businesses in their efforts to achieve compliancy with applicable regulations. The following are some of the new measures recommended by the NFA to the Swedish government. Continue reading

Processing Personal Data in Health and Medical Care

Globalization, information society, digitization, integrity, automation, profiling, sensitive personal data, consent, objection, pseudonymization, personal data breach, principles, lawfulness of processing, rights, data protection officer, controller, processor, incident reporting and sanctions. Given the scope of the field, it is perhaps no wonder that the massive and, to some extent, complicated General Data Protection Regulation (GDPR) that will replace Sweden’s existing personal data regulations in May 2018 currently perplexes IT, legal and marketing departments across the country. This year alone, no less than 12 different Swedish Government Official Reports will be presented detailing how this new regulation will affect different fields. Continue reading

The status and future of the Unified Patent Court

In 2013, after much debate and numerous similar previous efforts, 25 of the 28 EU Member States agreed to establish a new patent court with the aim of unifying the fragmented patent landscape in the EU under the Unified Patent Court (UPC). The original plan was for the UPC to become a reality on 30 May 2014. There were only two requirements: 1) ratification by a total of 13 Member States; and 2) that three of these Member States be France, Germany and the United Kingdom. The UPC is still not a reality. Although there is some hope of progress in the near future, the final deadline is yet to be set. Continue reading

Restrictions of off-label use – an antitrust violation?

According to the opinion of the Advocate General, a medicinal product authorised for a particular indication and a medicinal product used off-label to treat the same indication belong to the same relevant product market irrespective of the lawfulness of the off-label use, provided there is effective demand-side substitutability between the products. The Advocate General also opined that collusion to disseminate scientifically unsupported and misleading information about the safety implications of off-label use may constitute a restriction by object and therefore violate competition law. Continue reading

Opinion from the Advocate General regarding classification of software as medical devices

For many companies digitalisation is one of the greatest challenges of this century. But as if that weren’t enough, companies must also grapple with a legal framework whose rules are not always adapted to the new digital age. A recent opinion from the Advocate General may, however, provide guidance on the question of when software may be considered a medical device. Continue reading