8
Feb 19
Using medicinal product trademarks in clinical trials prior to marketing authorization does not amount to genuine use, states advocate general szpunar
On January 9, 2019, Advocate General (AG) of the Court of Justice of the European Union (CJEU) Maciej Szpunar gave his opinion on case C-668/17 (“Opinion”), a trademark dispute that, while focusing on medicinal products, raised two other far-reaching issues concerning the scope and definition of the requirement of genuine use within the provisions of Article 58 of Regulation (EU) 2017/1001 of the European Parliament and of the Council of June 14, 2017 on the European Union trade mark (“EUTMR”).
7
Feb 19
New law to settle the long-lasting dispute on the pharmaceutical payback for 2013-2017
On February 11, 2019, Italian Law no. 12/2019 was published in the Official Gazette of Italy, converting into law, with amendments, Italian Law Decree no. 135 of December 14, 2018 (also called the Simplifications Decree) aimed at simplifying certain administrative responsibilities for both private and public entities.
6
Feb 19
No deal brexit’s impact on the pharmaceutical and medical devices industries: guidance from the ema and the european commission
On January 15, 2019, the UK House of Commons rejected the withdrawal agreement reached by Theresa May and the EU after a long and exhausting negotiation period of almost 2 years.
5
Feb 19
Benefit companies: an overview from a corporate perspective
Italy was the first European country to issue a regulation on benefit companies (in Italian “società benefit”), importing the model from the US.
EMA has launched a public consultation on key principles for the electronic product information of EU medicines
4
Feb 19
The European Commission issues a recommendation on a European electronic health record exchange format
On February 6, 2019, the European Commission issued a Recommendation concerning the development of a European Electronic Health Record (EHR) exchange format (Recommendation no 243/2019), which can be found on the following website: https://bit.ly/2X2qhAq.
