efpia disclosure code: securing the basis for collaboration in the future
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Author: Andrew Powrie-Smith * Date: 29/09/2015 * Version: FINAL
Securing the basis for collaboration in the future
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Disclosure
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Collaboration between industry and health professionals benefits patients. It is a relationship that has delivered numerous innovative medicines and changed the way many diseases impact on our lives.
Industry and health professionals collaborate in a range of activities from clinical research to sharing best clinical practice and exchanging information on how new medicines fit into the patient pathway.
You can find out more about how and why industry and health professionals work together in the video on the next slide or by going to www.efpia.eu/disclosure
Working together for patients
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Bringing greater transparency to this, already well-regulated, vital relationship is about strengthening the basis for collaboration in the future. Industry is being proactive, based on its commitment to this relationship.
Society has increasingly high expectations for transparency, none more so than in healthcare. We want to ensure we meet those expectations going forward.
You can find out more about how the relationship between industry and health professionals is regulated at www.transparency.efpia.eu
Why introduce greater transparency?
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Across Europe, by 30 June 2016, companies will disclose payments made to health professionals, such as sponsorship to attend meetings, speaker fees, consultancy and advisory boards.
How this data will be disclosed will vary according to country. Disclosures could be made on company websites or, where available, on a central platform for disclosure.
European Data Protection Regulation requires health professionals to give their consent to publish disclosure payment information.
You can find out more about disclosure in the video on the next slide or by going to www.efpia.eu/disclosure
About disclosure
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What will companies disclose?Level of Disclosure Categories of payment
At an aggregate level. i.e the total by country Naming individual recipients is not required
Research & DevelopmentToV to HCPs/HCOs that didn’t grant consent to disclose paymentsToV to HCPs/HCOs related to the planning and conduct of:
a. Non-clinical studies (as defined in the OECD Principles of GLP)b.Clinical trials (as defined in Directive 2001/20/EC)c. Non-interventional studies that are prospective in nature and that involve the collection of patient data
from or on behalf of individual, or groups of, HCPs specifically for the study (cfr Section 15.02 of the EFPIA HCP Code)
Naming individual recipient healthcare organisations (HCOs)
Donations & Grants to HCOsContribution to costs of eventsSponsorship agreements with HCOs/third parties appointed by HCOs to manage an eventRegistration feesTravel & accommodation
Fee-for-service & consultancyFeesRelated expenses agreed in the fees for service or consultancy contract
Naming individual recipient healthcare professionals
Contribution to costs of eventsRegistration feesTravel & accommodation
Fees for service & consultancyFeesRelated expenses agreed in the fees for service or consultancy contract
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EFPIA, it Member Associations and Companies are keen to work with individuals, healthcare systems, professional and representative bodies, to manage this transformational step in the relationship between industry and health professionals.
You can get the latest information and updates on disclosure by following the hashtag
#pharmadisclosure
To find out more please contact EFPIA at [email protected] or find out more at www.efpia.eu/disclosure
Working together through this transformational step
EFPIA Brussels Office
Leopold Plaza Building * Rue du Trône 108
B-1050 Brussels * Belgium
Tel: + 32 (0)2 626 25 55
www.efpia.eu * [email protected]