© b2b-compliance.com 2013 1
The EFPIA
Transparency
Code
A critical view on the new EFPIA Pharma Transparency (Disclosure) ...
Your benefits from this presentation
 Get an overview over the pharma transparency initiative in the
EU that will be bind...
The EFPIA HCP/HCO Disclosure Code was
announced July 2, 2013
• The European Federation of Pharmaceutical Industries and As...
Scope of application
• EFPIA members include national pharmaceutical associations in over
thirty European nations and near...
Motivation for Code development
• The public perception in Europe – fueled by many cases reported in the
mass media - of i...
Code Content (Articles)
1. Disclosure Obligation
2. Form of Disclosure
3. Individual and Aggregate Disclosure
4. Enforceme...
Article 1 – Disclosure obligation
• Member companies shall disclose all transfers of value, directly and
indirectly to HCP...
Article 2 – Form of Disclosure
• Disclosures shall be made on an annual basis, the first reporting period
is the calendar ...
Article 3 – Individual and Aggregate Spend
• As a general rule, transfers of value must be disclosed on an individual
basi...
Article 3 – Individual Spend disclosure for HCO’s
• Donations & Grants to HCO’s
• Contribution to costs of events
• Sponso...
Article 3 – Individual Spend disclosure for HCP’s
• Contribution to costs of events
• Registration fees
• Travel & accommo...
Article 3 – Aggregate disclosures
• Research & Development: Transfers of value to HCP’s/HCO’s related to
the planning and ...
Article 4 – Enforcement
• National EFPIA member organizations shall adopt implementation and
procedure rules – requirement...
How much sunshine are we seeing?
14© b2b-compliance.com 2013
How much sunshine are we seeing? 10 red flags
1. The EFPIA transparency code is definitely a step into the right direction...
How much sunshine are we seeing? 10 red flags
16© b2b-compliance.com 2013
4. The success of the initiative depends on the ...
How much sunshine are we seeing? 10 red flags
5. The disclosed transactions will not be subject to statutory audits by
ext...
How much sunshine are we seeing? 10 red flags
8. Experience in the past has proven that HCP’s can be very creative to
set ...
Resume
• The transparency initiative of EFPIA is a logic step following
international trends and pressure from the public ...
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EFPIA Pharma Transparency Code - EFPIA Disclosure Code

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This presentation gives an overview over the EFPIA transparency / disclosure code that requires pharmaceutical companies to disclose payments to doctors and healthcare institutions as of 2015. It supports a critical view on the initiative compared to similar sunshine requirements in other countries.

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EFPIA Pharma Transparency Code - EFPIA Disclosure Code

  1. 1. © b2b-compliance.com 2013 1 The EFPIA Transparency Code A critical view on the new EFPIA Pharma Transparency (Disclosure) Code
  2. 2. Your benefits from this presentation  Get an overview over the pharma transparency initiative in the EU that will be binding for all EFPIA members as of 2015  Understand the red flags that are related to this approach compared to other pharma sunshine laws in the world © b2b-compliance.com 2013 2
  3. 3. The EFPIA HCP/HCO Disclosure Code was announced July 2, 2013 • The European Federation of Pharmaceutical Industries and Associations (EFPIA) announced on July 2, 2013, the release of its disclosure code of transfers of value to healthcare professionals and organizations. • The code* requires all members of EFPIA to disclose transfers of value to Healthcare Professionals (HCP’s) and Healthcare Organizations (HCO’s) as of 2016 regarding all transfers in 2015 (=first reporting period). *Full title: ”EFPIA Code on disclosure of transfers of value from pharmaceutical companies to healthcare professionals and healthcare organizations (EFPIA HCP/HCO Disclosure Code)” 3© b2b-compliance.com 2013
  4. 4. Scope of application • EFPIA members include national pharmaceutical associations in over thirty European nations and nearly forty leading multinational pharmaceutical manufacturers. • Due to its broad membership, EFPIA is able to exert significant influence over European pharmaceutical codes and, consequently, pharmaceutical manufacturers operating in Europe. 4© b2b-compliance.com 2013
  5. 5. Motivation for Code development • The public perception in Europe – fueled by many cases reported in the mass media - of interactions between the pharma industry and doctors is still driven by a subliminal suspicion of corruption (pharma companies paying doctors to prescribe their medicines). • Similar to all other EFPIA initiatives, EFPIA’s goal is to develop standards for self-regulation across the pharmaceutical industry in Europe in order to avoid that national and/or EU legislation implements applicable laws and regulations. • In the U.S. pharma companies are forced by law (so called sunshine laws) to disclose payments to doctors - EFPIA is trying to prevent disclosure obligations by law with this voluntary disclosure code. 5© b2b-compliance.com 2013
  6. 6. Code Content (Articles) 1. Disclosure Obligation 2. Form of Disclosure 3. Individual and Aggregate Disclosure 4. Enforcement 5. Amendments to, and guidance regarding compliance with, the code 6© b2b-compliance.com 2013
  7. 7. Article 1 – Disclosure obligation • Member companies shall disclose all transfers of value, directly and indirectly to HCP’s and HCO’s. • Excluded from disclosure requirements: • Items that are solely related to over-the-counter medicines • Items not listed in Article 3 of the Code, such as items of medical utility • Meals and drinks • Gifts • Samples • Products that are part of ordinary course purchases and sales of Medicinal Products by and between a Member Company and an HCP (such as a pharmacist) or an HCO 7© b2b-compliance.com 2013
  8. 8. Article 2 – Form of Disclosure • Disclosures shall be made on an annual basis, the first reporting period is the calendar year 2015 (to be reported in 2016). • Disclosures shall be made by each member company within 6 months after the end of the relevant reporting period and the information shall remain publicly available for a minimum of 3 years (exceptions apply). • Disclosure can be made via members’ website or a central platform. • Disclosures shall be made pursuant to the national code of the country where the recipient has its physical address. • Supporting documentation for disclosed transactions must be archived for at minimum 5 years (e.g. agenda of medical event, contracts etc.). 8© b2b-compliance.com 2013
  9. 9. Article 3 – Individual and Aggregate Spend • As a general rule, transfers of value must be disclosed on an individual basis. The reporting entities are either individual HCP’s (doctors, nurses etc.) or HCO’s (hospitals, research organizations etc.). • Aggregate (non-individual) disclosure for transfers of value is only permitted if legal restrictions apply (i.e. data privacy) or if the transaction can not be reasonably allocated to the categories defined for individual spend. 9© b2b-compliance.com 2013
  10. 10. Article 3 – Individual Spend disclosure for HCO’s • Donations & Grants to HCO’s • Contribution to costs of events • Sponsorship agreements with HCO’s and third parties appointed by HCO’s to manage an event • Registration fees • Travel & accommodation • Fee-for-service & consultancy • Fees • Related expenses agreed in the fees for service or consultancy contract 10© b2b-compliance.com 2013
  11. 11. Article 3 – Individual Spend disclosure for HCP’s • Contribution to costs of events • Registration fees • Travel & accommodation • Fees for service & consultancy • Fees (e.g. for speaker engagements, advisory boards etc.) • Related expenses agreed in the fees for service or consultancy contract 11© b2b-compliance.com 2013
  12. 12. Article 3 – Aggregate disclosures • Research & Development: Transfers of value to HCP’s/HCO’s related to the planning and conduct of: • Non-clinical studies (as defined in the Organization for Economic Cooperation and Development (OECD) Principles of Good Laboratory Practice) • Clinical trials (as defined in Directive 2001/20/EC) • 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 HCP’s, specifically for the study 12© b2b-compliance.com 2013
  13. 13. Article 4 – Enforcement • National EFPIA member organizations shall adopt implementation and procedure rules – requirements must be included in national codes by December 31, 2013. • Deviations are only permitted where needed based on national laws and regulations. EFPIA Code is setting minimum standards. • Each national member organization shall define the sanctions for infringements. Financial fines and public disclosure is recommended as most effective method of sanction. • EFPIA shall report annually on the transposition into national codes and on the implementation for the first reporting period (2015). 13© b2b-compliance.com 2013
  14. 14. How much sunshine are we seeing? 14© b2b-compliance.com 2013
  15. 15. How much sunshine are we seeing? 10 red flags 1. The EFPIA transparency code is definitely a step into the right direction; however, a self-regulation is never as powerful as a law to build trust and to create confidence in the public opinion. 2. Like with other EFPIA requirements (e.g. hospitality), the sanctions for breaches of the code are soft compared to the risk of legal liability (civil and criminal). 3. The EFPIA transparency code has a significant scope limitation compared to other “sunshine laws” in the world. For instance, there are no reporting obligations for gifts and hospitality to individual HCP’s. 15© b2b-compliance.com 2013
  16. 16. How much sunshine are we seeing? 10 red flags 16© b2b-compliance.com 2013 4. The success of the initiative depends on the willingness of the HCP’s to cooperate. Following the EU Data Privacy Requirements, HCP’s have to give their consent before data can be disclosed. HCP’s might even revoke their consent after a transaction was realized which would prevent the pharma company from disclosure. As long as there is no legal basis, disclosure of HCP transactions can not be enforced. The transparency initiative will fail, if a significant number of HCP’s decides against disclosure of their legally protected personal data.
  17. 17. How much sunshine are we seeing? 10 red flags 5. The disclosed transactions will not be subject to statutory audits by external auditors as long as they are not legally required. Independent control of disclosures is missing. 6. To assess the quality of disclosed data, interested parties should compare marketing expenses reported per P&L statements(as of FY 2015) with disclosed transactions to HCP’s and HCO’s. The bigger the gap, the more reason there will be to challenge the quality of the disclosed data. 7. The EFPIA code is not proposing to apply a cap (threshold) to individual HCP or HCO spend. However, disclosure obligations might put pressure on member companies to implement caps voluntarily. 17© b2b-compliance.com 2013
  18. 18. How much sunshine are we seeing? 10 red flags 8. Experience in the past has proven that HCP’s can be very creative to set up business models to conceal direct payment flows. Payments via third party entities might be used to conceal direct relationships between pharma companies and final recipients. 9. Multinational pharma companies can use their international structures to make payments to HCP’s from subsidiaries that are not subject to the EU transparency regulations. 10. Pharma companies based outside the EU, operating purely with agents on EU markets, are not tied to EU transparency obligations. 18© b2b-compliance.com 2013
  19. 19. Resume • The transparency initiative of EFPIA is a logic step following international trends and pressure from the public opinion. • In the current form, there are significant red flags the can seriously jeopardize the success of the initiative. • All affected parties should seriously work on proper implementation and accept the obligations under the self-regulation. • If stakeholders in the pharma industry fail to do so, it will just be a question of time until a “sunshine law” will be implemented. 19© b2b-compliance.com 2013 http://unsere-erfahrung-mit-jetzthaus.blogspot.de/

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