Life Sciences Report May 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

Guest column:
Anti-corruption efforts: more than a regulatory compliance issue

There is a clear international trend in anti-corruption measures. Increasing numbers of countries are adopting tougher anti-bribery legislation and imposing greater requirements on companies to take a preventive and systematic approach to combatting corruption. For example, France has recently introduced new legislation, known as Sapin II, requiring companies of a certain size to have anti-corruption programmes in place or face fines. In addition, large fines are issued every year for taking bribes. Total fines issued by US authorities under the Foreign Corrupt Practices Act (FCPA) are consistently high and amounted to a record USD 2.5 billion in 2016. In 2017, the amount was just under USD 2 billion. Continue reading

Incident reporting of medical device products and the GDPR

On 25 May 2018 the General Data Protection Regulation (GDPR) will become enforceable in all EU Member States. GDPR is designed to harmonise data privacy laws across Europe and to protect the data privacy of all EU citizens. Although GDPR might seem daunting at first, the changes for those already compliant with the Swedish Personal Act aren’t huge. Setterwalls welcomes the change and believes it is a good way for companies to review their processing of personal data and create procedures to ensure proper processing. Continue reading

Good to know about “best before” and “use by” dates

The Swedish National Food Agency (SNFA) recently published updated recommendations on this slightly tricky subject. So we thought it would be a good time to remind our readers in the food industry of the rules that apply on some of these issues. We have put together the following based on the SNFA’s own Q&As. Continue reading

Inquiry of the protection of research results in Sweden

In March 2017, the Swedish Government appointed an investigator to review confidentiality rules on research results at Swedish universities and other higher-education institutions. The aim of the investigator’s work was to propose how to handle research results in future in order to make Sweden an attractive country in which to conduct research. The investigator submitted the assignment to the Swedish Ministry of Education in December 2017. Continue reading

Striking a fair balance between indication patents and skinny labelled drugs

When a patent for a medically active compound expires, it’s not uncommon for other patents protecting various uses of the active compound to remain in force for significant periods of time. This leads to a situation where generic pharma companies are free to market the compound for indication A, while only the originator is allowed to market the compound for indication B. Continue reading

Swedish Match challenges the EU prohibition on snus

Snus has been banned within the EU (with the exception of Sweden) since 1993. Swedish Match is a Swedish company that essentially sells smokeless tobacco products, and mainly snus. On a number of occasions, Swedish Match has challenged the prohibition, and most recently in a case before the High Court of Justice (England and Wales). Continue reading

Harmonised European whistleblower protection rules: a proposed new directive and implications for life sciences

The European Commission has presented a proposal for a new Whistleblower Protection Directive. It’s ambitious, wide-ranging and will likely have a substantial impact on companies, individuals and authorities in the life sciences sector. Continue reading

Article 9(4) of the EU’s trade mark regulation regarding European customs’ seizure of counterfeit goods in transit

Article 9(4) of Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark, which came into force on 1 October 2017, is a complete turnaround from the Court of Justice’s latest ruling on European customs’ seizure of such goods in transit. However, will it provide sufficient protection for pro-prietors in their struggle to stop counterfeit goods in transit? Continue reading