Healthcare and Life sciences Focus Team Newsletter

Administrative | Public tenders: biologicals and biosimilars with the same therapeutic indications can be awarded through the same tender lot

The Council of State has confirmed (decision no. 3433 of 12 July 2017) that biological drugs and biosimilars with the same therapeutic indications can be included in the same tender lot. Read more

Tax | Signing of the OECD’s Multilateral Convention
On 7 June 2017, representatives from 68 countries and jurisdictions (included Italy) signed the OECD’s multilateral convention, introduced as part of the base erosion and profit shifting (BEPS) project. Read more

Labour  | When can badges they be considered tools to monitor employee performance?
Employers’ use of audio-visual equipment and other tools to remotely monitor employee performance has always been limited under Italian labour law. Read more

Regulatory | Contributions in this issue include
EU Commission initiative against Antimicrobial Re-sistance · Italian alliance for rare diseases · Last updates from EMA and EUnetHtA · EMA publishes draft guideline for the notification of serious breaches of clinical trial protocol · EMA enables patients & consumers aged under 18 to contribute to its activities · Joint trade association appeal on Brexit · UK Brexit Health Alliance Read more

Data Protection | Digital innovation in the health sector: call for stake-holders to express their opinion
With society becoming ever more information driven, new challenges arise, including in terms of data protection. Read more

Intellectual Property | Consequences Of Mistakes In The Italian Translation Of An European Patent
According to Art. 57, the text of an European Patent in the language of the procedure in front of the European Patent Office is the point of reference with regard to the national extension of the patent protection, even though patentees are required to file a translation within 3 months from the publication of the patent on the European bulletin. Read more