- Michalopoulou & Associates
The call to systemic reform in the healthcare industry towards more compliance is loud and clear in both the EU and the US. It could easily therefore make a great policy opportunity in the Greek case.
But the prerequisite to any reform is actual forming in the first place. Unfortunately, the recent Health Transparency Law 4316/2014 is in dire need of guidance, however solid in its base principles. Expected Ministerial Decisions and EOF circulars have not been issued yet in order to facilitate its implementation by pharmaceutical companies. Other issues, such as data protection and the consent option or obligation for disclosure by healthcare professionals and organizations have not yet been demarcated.
Still, a policy challenge that’s not being entirely met should not be a missed great business opportunity. Greece’s ongoing efforts towards a more conclusive legislative framework should still be the source of inspiration and an important priority for every Greek company inside the healthcare industry to form its own compliance program. But successful ones must be tailored to the unique needs and risks faced by each company; the lack of compliance programs on the rack makes guidance for their effective implementation all the more vital.
To begin with, any business should be encouraged to observe the ten hallmarks of good Compliance Programs. These are:
1. High‐level commitment
2. Written Policies
3. Periodic Risk‐Based Review
4. Proper Oversight and Independence
5. Training and Guidance
6. Internal Reporting
8. Enforcement and Discipline
9. Third‐Party Relationships and
10. Monitoring and Testing
Robust compliance programs, essential to support and act in addition to standing laws in order to deter and detect violations, need guidance in order for the Health Industry to achieve the aforementioned hallmarks. Moreover, guidance is what will make these program elements truly complementary and create an impenetrable compliance culture which will be immune to misinformation or legislative ambiguities.
Reform in Healthcare Compliance needs above all inspiration, time, monitoring and legal expertise.
IOANNA MICHALOPOULOU LL.M.FOUNDING PARTNER
Published on Business Partners issue No. 78, May-June 2015