Transparency and Disclosure – Law 4316/2014
Overview: SFEE member companies adhere to and strictly comply with national legislation (Law 4316/2014, Article 66, paragraph 7, Government Gazette A 270/24.12.2014), the SFEE Disclosure Code and the EFPIA Disclosure Code. In this context, pharmaceutical companies are required to disclose all the transfers of value, direct and indirect, monetary and in kind, they have made to healthcare professionals (HCPs) and healthcare organisations (HCOs) relating to the development and promotion of prescription medicines for human use.
How will transfers of value be disclosed in Greece? Under Law 4316/2014, 30 June 2016 was the deadline for pharmaceutical companies in Greece and throughout Europe to disclose transfers of value to HCPs and HCOs. The Hellenic Data Protection Authority, following a request from the Athens Medical Association (ISA) and SFEE and an intervention by EOF regarding the procedure for implementing the provision, delivered its Opinion no. 5/2016 on 29 June 2016. According to this Opinion, the provision of Article 77 paragraph 7 of Law 4316/2014 is compatible with the Greek Constitution, but its scope is interpreted to only include promotional events of type B, as defined by a recent EOF Circular (17702/2016). SFEE member companies fully adhere to national legislation and will strictly comply with any directive to be issued by EOF on this matter. Disclosure has therefore been put on hold until the issuance of final guidance from relevant government authorities.
Why do pharmaceutical companies invest in HCPs and HCOs? Pharmaceutical companies, HCPs and HCOs collaborate in a range of activities in the best interests of society and patients. Close cooperation and continuous education of healthcare professionals are key to ensuring the best outcomes for patients. Moreover, the investment of pharmaceutical companies in healthcare and international-calibre scientific and research workforce enables the development of new and innovative medicines through sharing best clinical practice, exchanging information on how new medicines fit into the patient pathway and shaping the future of clinical research.
Level of remuneration: As with any professional group providing services, it is fair and appropriate to remunerate HCPs for their time and expertise and for the services they provide to pharmaceutical companies in the interest of patients. The level of remuneration and transfers depends on the type of activity, the level of expertise, scientific knowledge, specialty and the time devoted by HCPs, as stipulated by the law.
Why disclosure? Disclosure highlights the investment of pharmaceutical companies in the continuing education of healthcare professionals for the benefit of patients and brings greater transparency to this, already well-regulated, vital relationship between industry and HCPs/HCOs. At the same time, it builds understanding of industry-HCPs/HCOs interactions for the benefit of patients and enhances the transparency and integrity of transactions between them. The aim is to raise awareness of the value of this relationship and the benefits of increased transparency between industry and HCPs, as an essential element in the quality of treatment and the value of clinical research, and to strengthen the reputation and credibility of all parties involved. Finally, this is an effort aimed to enhance the transparency and integrity of this relationship and a step towards greater trust between pharmaceutical companies, the medical community and Greek society.