On January 29, Andy Bender and Greg Hawley discussed the most recent developments in aggregate spend reporting for pharmaceutical, biotech, and medical device companies worldwide. The presentation was held at the Polaris Transparency Expert Roundtable in Frankfurt, Germany, and focused on trends in EFPIA transcription, and national law updates in France and other European countries.
The central topic discussed was trends and observations from the transcriptions of the EFPIA Disclosure Code by the various EFPIA member associations. The EFPIA Code, mandating disclosure of most transfers of values by member companies to European HCPs and HCOs, instructed member associations in 33 countries to integrate the Code into their national codes of conduct. The deadline for transcription was December 31, 2013.
Polaris performed an in-detail survey of published codes of conduct in all 33 member associations, and discovered that, at the time of the presentation, only 10 countries had published updated codes. Those countries were Bulgaria, Estonia, Finland, Ireland, Italy, Norway, Slovenia, Spain, Switzerland, and the UK. Polaris also learned, from industry sources, that most other member associations had agreed on updated codes, but were delaying final approval and/or publication while waiting for authorization from several governmental organizations. The transcribed codes gave companies several clues regarding how EFPIA disclosure would happen in practice:
1. No major additions to reporting requirements
2. Various implications of consent and non-consent:
- Each country dealt with consent differently. Many countries did not discuss. Some countries (Italy, Norway, Serbia, and Poland) will require aggregated disclosure where an HCP has not given, or subsequently revoked, his/her consent to disclosure. Other countries (Slovenia, Greece) are making contractual consent a requirement to make a contract with, and pay, an HCP.
3. Minimal further guidance on compliance with national privacy laws
4. Mandated steps for cross-border disclosure
5. Publication on company website – for now
6. Broad or no definitions of research
Other National Developments
Polaris also noted other developments. One development is that the French Health Ministry has launched its central online disclosure portal. As a result, companies no longer need to publish on their company website, nor disclose data to the professional boards. More importantly, companies must now disclose the existence of contracts with HCPs and HCOs within 15 days of execution; that rule had been suspended until the launching of the site. Finally, the Ministry announced that the deadline for reporting data for the second half of 2013 would be postponed until February 28, 2014 (originally February 1).
Other developments include the passage of a new code of conduct by Medicines Australia, which follows the EFPIA Disclosure Code closely, and expected developments to the Danish Medicines Act which could expand national law disclosure rules in Denmark soon.