The key facts about regulatory reforms in Italy. Prepared in association with DLA Piper, a leading law firm in Italy, this is an extract from The Pharma Legal Handbook: Italy, available to purchase here for USD 99.
1. Are there proposals for reform or significant change to the healthcare system?
The most relevant reforms to the Italian healthcare system expected to enter into force in the near future are the following:
- the new EU regulations on medical devices, namely Regulation (EU) 745/2017 and Regulation (EU) 746/2017 which will apply starting from May 26, 2020 and May 26, 2022, respectively and will gradually replace the existing national legislation on medical devices;
- a new law setting out rules on the transparency of relations between pharmaceutical companies, healthcare professionals and healthcare organizations (so called “Italian Sunshine Act”). The Italian Sunshine Act aims at imposing on pharmaceutical companies the obligation to disclose the transfers of value they make in favor of healthcare professionals and healthcare organizations when such transfers are above a certain threshold;
- the decree intended to replace CIPE’s Resolution 3/2001, which currently sets the criteria to be followed for the negotiation of the price of the medicinal products.
2. When are they likely to come into force?
In relation to the above, the following applies:
- Regulation (EU) 745/2017 and Regulation (EU) 746/2017 are already in force; however, their provisions will apply starting from rom May 26, 2020 and May 26, 2022, respectively;
- the Italian Sunshine Act is currently under exam by the Italian Senate and it is likely to be approved in the next months. However, the disclosure obligations will apply from the third quarter following the one in which the notice on the operation of the Transparent Health Care Register is published in the Italian Official Journal;
- the decree intended to replace CIPE’s Resolution 3/2001 has already been approved by the Ministry of Health and Ministry of Economy and Finance on July 2019. It will enter into force after the publication in the Official Journal, which is expected at the end of 2019 or beginning of 2020.