Effective development and implementation of a compliance programme

pharma, compliance, novo nordisk, policy

Kristine Aachmann Bethe, Corporate Counsel, Business Ethics Compliance Office, Novo Nordisk A/S just gave a presentation this morning at Pharma Compliance 2013 on the effective development and implementation of a compliance programme. 

Her presentation began by highlighting why compliance is so important to Novo Nordisk, explaining that now, as part of big pharma, there are increased demands and expectations to meet and exceed.  As well, Mrs. Aachmann Bethe mentioned that it is part of the promise to their patients as well as being "the right thing to do."

The development of a compliance programme team in Denmark thus began, which was eventually moved out into regional locations, with the introduction of regional officers who reported to the global compliance team.  This has now grown to +90 employees throughout the company who work on compliance globally.

After this was underway, Novo Nordisk introduced a Business Ethic Board, including representatives from 5 regions, and also with 3 members of executive management currently sitting on the board.  There have been pros and cons to consider with this structure, with pros being that compliance is closer to the business, while cons include the need for a central direction, with a focus on improving coordination and alignment in the regional teams.

 

Compliance Programme – 3 key elements

 

Directions

  • integrated ethics in values
  • code of conduct to set directions
  • should be core management

 

Values

  • not all about written policy and procedures
  • make sure they are implemented in practice- training of employees
  • global training framework- IBETS
  • one central system now to monitor all electronic and face to face training
  • Business Ethics Toolbox- plug and play training

 

Facilitation

  • happens every 1-3 years
  • part of joint audit
  • reports are presented to board of directors yearly
  • way to cultivate values in local managers
  • important to follow up and facilitate value- make sure policies and procedures are actually being preserved

 

Key takeaways from the presentation include:

increased challenges call for improved solutions

not all about procedures- need to ensure that they're put into practice

 

For more, join us today and tomorrow at the Royal Horseguards Hotel in London – contact Rachel Arthurson for last minute bookings on 44 20 7608 7045

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