EFPIA Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organizations Final Version

The European Federation of Pharmaceutical Industries and Associations (EFPIA) released the Final Version of the “EFPIA Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organizations” (Disclosure Code). The Disclosure Code was approved by the EFPIA General Assembly on June 24, 2013. We have covered the EFPIA previously on Policy and Medicine. A special thank you to Polaris Management for information regarding the EFPIA Code.

EFPIA is a Brussels-based trade association representing the research-based pharmaceutical industry operating in Europe. It is comprised of 34 national Member Associations, such as the Association of the British Pharmaceutical Industry, and 40 Member Companies, all leading pharmaceutical companies.

The Disclosure Code provides for the disclosure of Transfers of Value to healthcare professionals (HCPs) and healthcare organizations (HCOs), whether directly or indirectly, commencing in 2016 in respect to Transfers of Value for the calendar year 2015. The code sets out the minimum standards which EFPIA considers must apply to all EFPIA Member Associations in all member states. Those Member Associations will be required to transpose the code into their national codes by the end of 2013, whereupon Member Companies operating in those countries (whether directly or through relevant subsidiaries) will be bound by them. Below is a summary of the EFPIA Disclosure Code’s key points:

Disclosure Obligations: Each Member Company must disclose any of the Transfers of Value listed below that it makes to or for the benefit of an HCP or HCO in Europe:

• Transfers of Value HCOs
  
  • Donations and Grants
    
    • Donations and Grants to HCOs that support healthcare
      
  • Contributions to Costs Related to Events, including sponsorship to HCPs to attend events, such as:
    
    • Registration fees
      
    • Sponsorship agreements with HCOs or with third parties appointed by an HCO to manage an event, and
      
    • Travel and accommodation
      
  • Fees for Service and Consultancy
    
    • Fees and expenses agreed to in a written agreement to be disclosed separately
      
• Transfers of Value to HCPs
  
  • Contributions to Costs Related to Events, such as:
    
    • Registration fees
      
    • Travel and accommodation
      
  • Fees for Service and Consultancy
    
    • Fees and expenses agreed to in a written agreement to be disclosed separately
      
• Research and Development
  
  • Member Companies must disclose total Research and Development Transfers of Value in a reporting period on an aggregate basis
    

Individual Disclosure

• Disclosures of Transfers of Value must be made on an individual basis for each clearly identifiable covered recipient. Transfers of Value may be aggregated on a category-by-category basis (e.g. all consulting fees to a single HCP together), provided that itemized disclosure be made available upon request
  
• Exceptions:
  
  • Where individual disclosure is not permitted by the relevant national law, disclosure is to be made on an aggregate basis, though the Member Company must track the number of these unnamed recipients and total amount received by them.
    

• Research and Development Transfers of Value are to be reported as an aggregate total paid by the Member Company for the reporting period
  

Excluded Disclosures

• The following Transfers of Value do not need to be disclosed:
  
  • Meals and drinks
    
  • Medical Samples
    
  • Transfers of Value that are part of the ordinary course purchase and sales of medicinal products
    
  • Transfers of Value related to over-the-counter medicines
    

Form of Disclosure

• Member Companies must make disclosures of Transfers of Value:
  
  • Annually,
    
  • Beginning in 2016 (for Transfers of Value made in 2015),
    
  • Within 6 months of the end of the reporting period,
    
  • On the Member Company’s website or on a central platform such as one provided by the relevant government, regulatory or professional authority or body,
    
  • Using the template provided by EFPIA
    
• Selection of national disclosure rules is based on the national code where the recipient of the Transfer of Value has a physical address
  

• Document retention for a minimum of 5 years
  

Enforcement

• Each Member Association will determine a system of sanctions in its national code, and enforce those sanctions on its members
  

• Sanctions to be proportionate to the nature of infringement, have a deterrent effect, and take into account repeated offenses
  

Applicability

• When the Disclosure code is transposed in Member Association codes, Member Companies operating in those countries will be bound to comply with it
  

• Separate entities belonging to the same multinational company – whether parent company, subsidiary company or any other form of enterprise or organization – shall be deemed to constitute a single company, and is as such committed to compliance with the EFPIA Codes, if any part is a Member Company.
  

• If an Member Association where a Member Company operates fails to transpose this Code into its national code by the relevant deadline, such Member Company will be required to comply with this Code anyway
  

• If a Member Company is not a member of the Member Association in any given country in Europe, it agrees, as a consequence of its membership in EFPIA (either directly or through its relevant subsidiary), to be bound by that Member Association’s code (including any applicable sanctions that may be imposed under such code)
  

• Non-member associations and companies that decide to voluntarily implement this Code shall require that each of their respective members, affiliates and subsidiaries comply with all of the provisions of this Code.
  

Miscellaneous

• Whenever possible, track Transfers of Value to the individual HCP, rather than their HCO
  

• Where the Disclosure Code conflicts with national laws (e.g., data privacy) or is less stringent than national disclosure laws, follow the national law, while documenting legal issues limiting full implementation
  

• Summarize methodology used for identifying Transfers of Value and preparing disclosure
  

• Companies are encourage to include provisions in written contracts with HCPs/HCOs relating to the recipients’ consent to disclose Transfers of Value in accordance with the provisions of the Disclosure Code (including renegotiating existing contracts)
  

Definitions

• HCP
  
  • Any natural person that:
    
    • is a member of the medicinal, dental, pharmacy or nursing profession, OR
      
    • may prescribe, purchase, supply, recommend or administer a medicinal product, AND
      
    • whose primary practice, principal professional address or place of incorporation is in Europe
      
• HCO
  
  • Any legal person:
    
    • That is a healthcare, medical or scientific association or organization such as a hospital, clinic, foundation, university or other teaching institution or learned society (except for patient organizations), whose business address, place of incorporation or primary place of operation is in Europe, OR
      
    • Through which one or more HCPs provide services
      
• Transfers of Value
  
  • Direct and indirect payments, whether in cash, in kind or otherwise, made, whether for promotional purposes or otherwise, in connection with the development and sale of prescription-only medicinal products exclusively for human use