Many stakeholders expressed concerns about the influence the pharmaceutical or device industry has over healthcare actors including healthcare professionals and organizations, families, patients, service providers and the public. Up until a few years ago, there was little regulation governing these relationships and Pharma/Device companies did not need to disclose whether they, for example, sponsored events or made transfers of value (i.e. donations, gifts etc.) to healthcare professionals and organizations.
Following the introduction by the US of the ground-breaking Physicians Payments Sunshine Act in 2010, the transparency landscape has rapidly shifted in Europe.
This TRIUM training provides a map as created by the Mental Health Europe (MHE) organization © 2017, which aims to give a glimpse into the situation in Europe where many countries have introduced Sunshine Laws, Regulations and Rules which require transparency around ‘transfers of value’ between Pharma and healthcare professionals. The legislation and rules adopted vary from regulations to attempts at better self-regulation from Pharma and the healthcare profession through the adoption of voluntary Disclosure Codes (which are not mandatory to follow). A brief introduction of what country has a Sunshine Act regulation or not, and if not, what Codes are followed and their requirements will be the core of this session, enabling you to ensure compliance when conducting trials in Europe.
By the end of this TRIUM Training you should be able to:
- Explain the difference between a Sunshine law and Disclosure Codes
- List the requirements for the European country of your interest using the map included in the training handouts
Can perform task or skill independently, consistently, accurately, and has a moderate level of expertise. Efficient and high quality work. Able to independently navigate resources and uses tools well.