Following the 2010 adoption of the US ‘Sunshine Act’, several EU member states have recently introduced statutory obligations for life sciences companies to report and publicly disclose information concerning their interactions with healthcare professionals and healthcare organisations. These initiatives have complemented the transparency requirements established by the so-called EFPIA Disclosure Code and other self-regulatory measures adopted by industry in various EU member states.
A proposal for an Italian Sunshine Act is now pending before the Italian parliament. If adopted – as it is likely to be – pharmaceutical and medical device companies will be required to report specific information concerning their financial relationships with healthcare professionals and a broad range of other healthcare actors. The reported information will be made public in a database accessible from the regulator's website. The proposal enjoys widespread political support and is likely to be adopted. However, the proposed text falls short on a number of fronts, including the definition of the exact scope of application of the proposed act.
In this report, Marco provides a first overview of the upcoming transparency obligations and he identifies a few points for improvement while the bill is undergoing the legislative process. Hopefully the Italian legislator will be able to address those in order to reduce the potential amount of administrative litigation arising from the new act and bring more legal certainty for the life sciences industry.
Meanwhile, life sciences companies doing business in Italy should take their sunscreen out and prepare for the upcoming Sunshine statutory obligations.