Regulatory

Digital-Media-Tech

Over the years, we have gained considerable experience with the regulatory framework for audiovisual media services, particularly television, as well as electronic communications and interactive services, Advertising, unfair commercial practices, and Internet service provider liability.

Our previous work includes:

• assistance for streaming platforms in relation to all regulatory aspects linked to launching video on-demand services in Italy;
• assistance in proceedings for the issuance and transfer of licenses for television channels (terrestrial, satellite, cable, and online);
• assistance on programming and investment obligations to promote European audiovisual works (including proceedings o get exemptions) and secondary rights;
• assistance in restructuring multinational television groups and consultancy on regulatory profiles for one-off transactions involving companies that own television channels and electronic communications networks;
• lobbying the AGCOM, Italian Parliament, and the government in relation to legislative proposals and draft regulations on audiovisual media services and the Internet and drafting documents for participation in public consultations held by the AGCOM and the European Union;
• assistance for a number of operators in relation to the allocation of positions in the automatic logical channel numbering (LCN) system for digital terrestrial television;
• assistance for 20% of participants—including the highest-rated participant—in the “beauty contest” for the assignment of 40% of Italy’s digital terrestrial transmission capacity;
• assistance for operators in obtaining the earliest authorization for trials of digital terrestrial television;
• consultancy on the implementation of fiber-optic communications networks;
• consultancy on unfair commercial practices and surreptitious, misleading, and comparative advertising;
• assistance with authorizations for electronic communications network and service providers;
• consultancy on Advertising and Marketing online, including user profiling, pay-per-click advertising, keyword advertising, and search engine marketing;
• consultancy on interactive television and addressable advertising;
• assistance on transactions involving the transfer of transmission systems and in relation to the digital switchover of analog broadcast networks;
• consultancy on regulatory aspects of product placement in television, film, and games, as well as advertiser-funded programming and branded content;
• consultancy and assistance on child protection issues (including advertising to minors) and in relation to proceedings before the Media and Minors Committee;
• consultancy on liabilities for Internet service providers;
• assistance in judicial proceedings and administrative proceedings relating to audience ratings;
• regulatory advice on various aspects of online gaming and betting, including casino games and cash poker;
• consultancy on foreign control of television networks and assistance in the resolution of related disputes;
• consultancy on interactive, dynamic, and virtual advertising;
• consultancy on the structure and organization of television auctions and TV call-in games;
• consultancy on prizecompetitions and sweepstakes;
• assistance in litigation and proceedings before the AGCOM and the AGCM on access to broadcasting platforms, carriage of television channels, government authorizations, automatic logical channel numbering (LCN), and use of terrestrial frequencies and transmission systems;
• assistance in advertising disputes before the national courts and the Giurì di Autodisciplina, the self-governing body of the Italian advertising authority, as well as proceedings before the AGCM on unfair commercial practices and before the AGCOM in relation to television advertising and limits on advertising concentration;
• assistance in proceedings for the grant and transfer of gaming and betting licenses.

Life Sciences-Healthcare

In the Life Sciences-Healthcare area, we have accrued extensive experience in regulatory matters concerning drugs and medical devices, as well as food supplements, cosmetics, and the other types of products classified as parapharmaceuticals, covering from the research and development to post-marketing activities.

Our previous work includes:

• assistance in the launch of new drugs and medical devices on the Italian market and conditions for importing drugs into Italy;
• assistance in evaluating market access strategies in Italy, including early access and compassionate use mechanisms;
• assistance in matters related to prices and reimbursement of drugs (including but not limited to negotiation issues, and payback mechanism);
• assistance in relation to off-label use of drugs;
• assistance in evaluating promotional campaigns and specific communications tools addressing healthcare providers, whether using traditional modes or more innovative and digitally focused methods;
• assistance in evaluating the relationship between drug and medical devices companies and patient associations;
• assistance in drawing up consultancy and cooperation contracts with healthcare professionals;
• assistance with regulatory matters involving Compliance and Privacy, Cyber Security and Data Protection in relation to the launch of Patient Support Programs (PSP);
• assistance in connection to the creation, use, and commercial exploitation of a biobank of biological samples and genetic data;
• assistance with evaluating offline and online communications and advertising campaigns, including social media campaigns, for non-prescription/OTC items, medical devices, and food supplements;
• assistance with the assessment of health and nutritional claims used in food supplements;
• assistance with correspondence with the Ministry of Health to dispute negative responses to requests for authorization to advertise drugs;
• assistance with matters arising during proceedings for homeopathic medicine authorization;
• assistance with launching Ecommerce sites for drugs, medical devices, and food supplements;
• assistance in evaluating and launching drug home delivery projects;
• assistance with the proceedings relating to reporting to the Ministry of Health and medical device recalls;
• assistance in evaluating classification of certain types of software/apps as medical devices;
• assistance in relation to various digital health projects and, specifically, in studying the feasibility of new businesses involved in telemedicine services and online prescriptions;
• assistance in reviewing contracts for clinical trials and observational studies of drugs and medical devices and other scientific research contracts;
• assistance in drawing up documentation to submit to the appropriate authorities, including ethics committees, for the purpose of undertaking scientific research, clinical trials, and observational studies of drugs and medical devices;
• assistance in managing drug shortages and the related correspondence with AIFA.