Life Science Compliance Update

October 11, 2017

MedTech Europe Changes Ethical Code

Playbytherules

MedTech Europe represents the medical technology industries as a joint venture between EDMA and Eucomed and promotes a balanced policy environment that helps the medical technology industry meet Europe’s growing healthcare needs and expectations.

In 2015, MedTech Europe implemented a revised version of the 2008 Code of Ethical Business Practice to regulate interactions between members of the group and healthcare professionals. To help implement the code, in 2012, MedTech Europe created the Conference Vetting System. The Conference Vetting System attempted to address MedTech Europe members’ divergent interpretation of the Code and to reduce the risks associated to industry sponsorship of healthcare providers to third-party educational events.

The new MedTech Europe Code of Ethical Business Practice sets strict, clear and transparent rules for the industry’s relationship with Healthcare professionals (HCPs) and Healthcare Organizations (HCOs), including company-organized events, arrangements with consultants, research and financial support to medical education.

The Code of Ethical Business Practice has six big changes: (1) the phasing out of direct sponsorships; (2) transparency of educational grants; (3) creating a common chapter on general criteria for events; (4) creating a new chapter on demonstration products and samples; (5) agreed definitions; and (6) a common independent enforcement mechanism.

According to MedTech Europe, the new Code is a message from the medical technology industry to safeguard and protect the relationship with healthcare professionals by adopting clear and strict self-regulations.

The largest change coming from the new educational grant system is that it adds a significant amount of work onto the shoulders of the healthcare organization.

  1. Conferences supported by medical device companies will need to apply and be in compliance with the Ethical Vetting System;
  2. Healthcare organizations will need to write and submit grant requests to each medical device company that sponsors delegations to their medical meeting;
  3. Once awarded the grant, healthcare organizations will be responsible for choosing the healthcare providers that will receive support, following the guidelines as set forth on the grant requested;
  4. Healthcare organizations will be responsible for the management of the sponsored healthcare providers, including figuring out how to contact them, gather their information, manage their travel requirements, etc.; and
  5. Healthcare organizations and medical device companies will need to submit reconciliation and disclosure reports to MedTech Europe.

The rules will change in several ways, including: by forcing the public disclosure of grants, ensuring increased transparency of the funds allocated to medical education; by requiring conferences to comply with specific requirements and the Conference Vetting System; by allowing grants to be provided only to legal entities and never individuals, requiring a written contract and other related documentation; by allowing companies to define the types of recipients eligible for the grants; and by requiring companies to have internal and independent processes based on objective criteria to assess grant requests.

While most of the changes will affect European meetings, the most important change for the United States medical meeting industry is that MedTech Europe member companies will not be able to directly sponsor a healthcare provider, neither as a delegate nor as a speaker.

As of 2018, MedTech Europe will require all meetings to be vetted through its Conference Vetting System, and only these meetings will be eligible to receive funds from MedTech Europe member companies — and only through educational grants.

Healthcare organizations should brace themselves for an impact and will need to plan for a loss in revenue from any international delegations sponsored by Medical Technology Companies in Europe.

December 16, 2013

CME Grant Disclosures for 2012 to 3rd Quarter of 2013

We have compiled a chart of companies that have disclosed their educational grant payments for 2012-2013. Some companies have disclosure information for several years. Now that grants are subject to Sunshine Act reporting requirements for teaching hospitals, it is likely more companies will begin to post such payments to teaching hospitals. We will add additional information as it becomes available.

Company

2013 

2012 

2011 

2010

2009

Abbott

 

Q1

Q1

Q1

Q1

   

Q2

Q2

Q2

Q2

   

Q3

Q3

Q3

Q3

     

Q4

Q4

Q4

           

Allergan

Q1 & Q2

Q1 & Q2

Q1 & Q2

   
   

Q3 & Q4

Q3 & Q4

Q3

 
           

Amgen

Q1

Q1

Q1

Q1

Q1

 

Q2

Q2

Q2

Q2

Q2

 

Q3

Q3

Q3

Q3

Q3

   

Q4

Q4

Q4

Q4

           

Astellas Pharma US, Inc.

 

Q1

Q1

Q1

 
 

Q2

Q2

Q2

Q2

 
 

Q3

Q3

Q3

Q3

 
   

Q4

Q4

Q4

Q4

           

Astra Zeneca

Q1 & Q2

Q1& Q2

Q1 & Q2

Q1 & Q2

Q1 & Q2

   

Q3 & Q4

Q3 &Q4

Q3 &Q4

Q3 &Q4

           

Bristol-Myers Squibb

Q1

Q1

     
 

Q2

Q2

     
 

Q3

Q3

     
   

Q4

     
           

Forest Labs

Q1

2012 Full Year

2011 Full Year

2010 Full Year

 
 

Q2

       
 

Q3

       
           

Genentech

 

2012 Full Year

2011 Full Year

2010 Full Year

 
           

Biosense Webster

Q1 & Q2

Q3 & Q4 (starting page 3)

     

Janssen Biotech

Q1-Q3

 

 

   

Cordis

Q1 & Q2

Q3 & Q4 (starting page 3)

     
           

Depuy Mitek, Inc.

Q1 & Q2

Q3 & Q4 (starting page 3)

     
           

Depuy Orthopaedics, Inc.

Q1 & Q2

Q3 & Q4 (starting page 3)

     
           

Depuy Spine, Inc.

Q1 & Q2

Q3 & Q4 (starting page 3)

     
           

Codman and Shurtleff, Inc.

Q1 & Q2

Q3 & Q4 (starting page 3)

     
           

Ethicon

Q1 & Q2

Q3 & Q4 (starting page 3)

     
           

Janssen Pharmaceuticals, Inc.

Q1-Q3

       
           

Janessen Biotech, Inc.

Q1-Q3

 

Q1 2011

   
           

Janssen Therapeutics

Q1-Q3

       
           

Therakos

 

2012:
Q1 & Q2

2011:
Q3 & Q4 (starts page 3)

   
           

Eli Lilly

Q1-Q3

2012 Full Year

2011 Full Year

2010 Full Year

 
           

Merck

2013 Full Year (all reports available mid-page)

2012 Full Year

2011 Full Year

2010 Full Year

2009 Full Year

           

Pfizer

Q1

2012 Full Year

2011 Full Year

2010 Full Year

2009 Full Year

 

Q2

       
 

Q3

       
           

Sanofi Aventis

 

Q1

Q1

Q1

Q1

   

Q2

Q2

Q2

Q2

     

Q3

Q3

Q3

     

Q4

Q4

Q4

           

Shire

Q1

Q1

Q1

Q1

Q1

 

Q2

Q2

Q2

Q2

Q2

 

Q3

Q3

Q3

Q3

Q3

   

Q4

Q4

Q4

Q4

   

September 26, 2012

CME Grant Disclosure 2011 and 1st ½ of 2102

List


We have compiled a chart of companies that disclose their educational grant payments for  2011 and 2012.  Once the final Physician Payment Sunshine Act regulations are, it is likely that more companies will begin to post such payments to teaching hospitals in anticipation of
the rules to assist with implementation and compliance. It should be noted that many companies are posting rolling grants payments rather than cumulative grants payments. This means that current postings may not reflect historical transparency posting, but instead current year or last 4 quarters (2 common methods used).  So, for example, Janssen Pharmaceuticals has posted grants payments since 2010 but only current year Q1-Q2 (the most recent report) is available on our site.

Company

2012

2011

2010

2009

2008

Abbott

 

Q1

Q1

Q1

 
 

 

Q2

Q2

Q2

 
 

 

Q3

Q3

Q3

Q3

 

 

Q4

Q4

Q4

Q4

 

 

 

     

Allergan

Q1 & Q2

Q1 & Q2

     
 

 

Q3 & Q4

Q3

   
 

 

 

     

Amgen

Q1

Q1

Q1

Q1

Q1

 

Q2

Q2

Q2

Q2

Q2

 

 

Q3

Q3

Q3

Q3

 

 

Q4

Q4

Q4

Q4

 

 

 

     

Amilyn

Q1 & Q2

 2011

Q1

Q1

 
 

 

 

Q2

Q2

 
 

 

 

Q3

Q3

 
 

 

 

 

Q4

 
 

 

 

     

Amilyn Lilly Grant Office

 

 

Q1

Q1

 
 

 

 

Q2

Q2

 
 

 

 

Q3

Q3

 
 

 

 

 

Q4

 

Astellas Pharma US, Inc.

Q1

Q1

Q1

Q4

 
 

Q2

Q2

Q2

   
 

 

Q3

Q3

   
 

 

Q4

Q4

   
 

 

 

     

Astra Zeneca

Q1& Q2 2012

Q1 & Q2 2011

Q1 & Q2 2010

Q1 & Q2 2009

Q1 & Q2 2008

 

 

Q3 &Q4 2011

 Q3 &Q4 2010

 Q3 &Q4 2009

 Q3 &Q4 2008

 

 

 

     

Bristol-Myers Squibb

Q1

Q1

Q1

   
 

Q2

Q2

Q2

   
 

 

Q3

Q3

   
 

 

Q4

Q4

   
 

 

 

     

GlaxoSmithKline

Q1 & Q2 2012

Full Year

Full Year

Full Year

Full Year 2008

 

 

 

     

Genentech

 

Q1

Q1

   
 

 

Q2

Q2

   
 

 

 

Q3

   
 

 

 

Q4

   
 

 

 

     

Forest Labs

Q1

Full Year

Full Year

   

Johnson and Johnson Companies

 

 

     
 

 

 

     

Biosense Webster

Q1 2012; Q2-Q4 2011

 

     

Janssen Biotech

Q1 & Q2

Q1 & Q2 2011

     

Cordis

Q1 2012; Q2-Q4 2011

 

     

Depuy Mitek, Inc.

Q1 2012; Q2-Q4 2011

 

     

Depuy Orthopaedics, Inc.

Q1 2012; Q2-Q4 2011

Q1 2011 – Q1 2010

     

Depuy Spine, Inc.

Q1 2012; Q2-Q4 2011

Q1 2011 – Q2 2010

     

Codman and Shurtleff, Inc.

Q1 2012; Q2-Q4 2011

Q1 2011 – Q2 2010

     

Ethicon

Q1 2012; Q2-Q4 2011

Q1 2011 – Q2 2010

     

Ethicon Endo Surgery, Inc.

 

 

     

Janssen Pharmaceuticals, Inc.

Q2

 

     

Janessen Biotech, Inc.

 

Q1 2011

     

Janssen Therapeutics

Q2

 

     

Therakos

Q1 2012; Q2-Q4 2011

 

     

Eli Lilly

 

Full Year

Full Year

Full Year

 
 

 

 

     

Merck

Q1

Q1

Q1

Q1

Q3

 

Q2

Q2

Q2

Q2

Q4

 

 

Q3

Q3

Q3

 
 

 

Q4

Q4

Q4

 
 

 

 

     

Pfizer

Q1 &Q2

2011

2010

2009

2008

 

 

 

     

Sanofi Aventis

Q1

Q1

Q1

Q1

 
 

 

Q2

Q2

Q2

 
 

 

Q3

Q3

Q3

 
 

 

Q4

Q4

Q4

 
 

 

 

     

Shire

Q1

Q1

Q1

Q1

 
 

Q2

Q2

Q2

Q2

 
 

 

Q3

Q3

Q3

 
 

 

Q4

Q4

Q4

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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