Italian ‘Sunshine Act’ Makes Transparency Reporting Mandatory For Pharma

Companies operating in Italy could face heavy fines if they fail to comply with a new law on disclosing the transfers of value they make, either directly or indirectly, to health care professionals and health care organizations.

Close-up Of Doctor And Businessman Shaking Hands In Office
Italy: Financial relationships between companies and health care professionals must be disclosed • Source: Alamy

Italy has become the latest country in Europe to introduce legislation that aims to strengthen transparency in the financial relationships between pharma companies and health care professionals and health care organizations

Law No 62/22, which is due to enter into force on 26 June, will supersede the existing self-regulating code of...

Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

More from Marketing & Advertising

India And Pakistan Boost Transparency In Industry-Doctor Interactions

 
• By 

Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.

Celebs Bring Extra Scrutiny To Advertisements, US FDA Tells AbbVie

 

AbbVie’s migraine ad overstates the drug’s benefit, a problem that is amplified by using a celebrity, the agency says. 

Misconstruing Single-Arm Study Data Lands BMS In Trouble With US FDA

 

The lung cancer drug Krazati from Bristol Myers Squibb’s Mirati Therapeutics drew an FDA ad/promo untitled letter, highlighting the agency's trend of pursuing false or misleading efficacy claims, particularly when data comes from outside approved labeling.

Severe Misconduct, Repeat Offending And Underreporting: UK/EU Codes Come Under Fire

 

The UK and EU pharma industry associations have defended their respective codes of practice despite alarming study results. Meanwhile, a consultation on proposals to revise the UK code received over 3,500 comments.

More from Compliance

HTA Regulation: EU Publishes Guidance On Validity Of Clinical Studies For Joint Clinical Assessments

 

Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.

India And Pakistan Boost Transparency In Industry-Doctor Interactions

 
• By 

Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.

Draft US FDA Innovative Manufacturing Strategy Takes On Global Inconsistency

 

The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.