On 31 May 2022, the Italian Parliament approved Law 62/2022, also known as the Sunshine Act. The Sunshine Act entered into force on 26 June 2022. However, it will become fully enforceable once the Ministry of Health sets up the Public Register where companies will have to disclose their data and issues the necessary implementing acts. This means that realistically the new transparency system will not be operational before 2023. Nonetheless, it is critical that companies operating in Italy make sure that they are ready when the time comes. Here, we outline some of the key features of the new Sunshine Act and the steps that companies could take in preparation.
In a long-running legal case challenging the European Medicines Agency’s approach to disclosure of clinical trial data, Advocate General Hogan has recommended that the Court of Justice find that such data are presumptively confidential when handling disclosure requests under the Transparency Regulation 1049/2001.
PTC Therapeutics International Limited (“PTC”) had argued before the General Court that…
French “anti-gift” rules strictly regulate the relationship between the life sciences industry and healthcare professionals (“HCP”) and the possibility for companies active in the health sector to offer benefits, in cash or in kind to healthcare professionals, medical students or associations representing them. This includes a general prohibition against offering such benefits.
To strengthen the…
On 2 March 2016, the European Medicines Agency (EMA) published guidance on aspects of the Agency’s proactive disclosure policy for clinical reports (Policy 0070). The latest Proactive Disclosure Guidance can be found here and focuses on:
- Procedural aspects of submitting clinical reports.
- The anonymisation of clinical reports.
- The identification and redaction of commercially confidential information (CCI) in clinical reports, i.e. the disclosure of information that is not in the public domain and may undermine the legitimate economic interest of the applicant.
The Guidance is accompanied by a number of annexes, including template cover letters, template anonymisation reports and process flowcharts.
Continue Reading EMA Publishes Proactive Disclosure Guidance
Raj Gathani, a Trainee Solicitor in Covington’s London office, contributed to this post.
On 1 September 2015 the General Court issued an interim order in favour of Pari Pharma GmbH (“Pari”) to suspend the European Medicines Agency’s (“EMA”) decision to grant a third-party, Novartis Europharm Ltd (“Novartis”), access to certain documents prepared during the Marketing Authorisation (“MA”) application process (the “MA Documents”). The MA Documents at issue included EMA Assessment Reports on similarity and superiority between Pari’s product (Vantobra) and Novartis’ product (TOBI Podhaler), which has an EU MA as an orphan medicine. Novartis made the request to the EMA for access to the MA Documents under the Transparency Regulation 1049/2001. The main case is currently pending before the General Court (Case T-235/15).
The thrust of Pari’s argument before the General Court was that the MA Documents contain Pari’s regulatory strategy for obtaining MA approval, disclosure of which might cause Pari serious and irreparable financial damage. The President of the General Court acknowledged that the case raised complex issues in the area of confidentiality and stated that the main proceedings (rather than an interim hearing) is the appropriate forum to address such issues.. As such the President considered that the MA Documents fell under a presumption of confidentiality and ordered the EMA not to disclose the MA Documents.
Continue Reading General Court Makes Interim Order to Protect Confidentiality in Pari Pharma Transparency Case
On 21 January 2015, the European Medicines Agency (“EMA”) launched a public consultation on how the transparency rules of Regulation EU No 536/2014 (the “Clinical Trials Regulation”) should apply to the new clinical trials database. The consultation document of the EMA discusses the practical application of the new transparency rules, sets different options on the application of the exceptions to the disclosure of information, and invites stakeholders to comment.
Continue Reading EMA Transparency Policy – EMA Launches Public Consultation On The Publication Of Information Under The New EU Clinical Trials Regulation