The Italian Compliance Environment

The Italian Compliance Environment 6th Pharmaceutical Compliance Congress and Best Practices Forum Budapest, Hungary - May 14th - 16th 2012 Edoardo L...
Author: Egbert Chambers
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The Italian Compliance Environment

6th Pharmaceutical Compliance Congress and Best Practices Forum Budapest, Hungary - May 14th - 16th 2012 Edoardo Lazzarini EMEA Compliance Officer at BIOMET Europe The opinions of the speaker are personal and not necessarily represents the opinion of current or former employers or colleagues, or trade industry associations.

Proactive and Reactive Actions of Pharma Stakeholders (FARMINDUSTRIA) o Reinforce Code Requirements ƒ ƒ ƒ

i.e. HCP rehospitality (4 * Hotel; no business flights); disclosure terms in HCP contracts; patients associations lationship.

o Creation of Certification Guidelines to compliance to Code in promotional/educational practices (http://www.farmindustria.it/pubblico/lginfsci.pdf)

o Enforcement of the Code and Certification Guidelines ƒ ƒ ƒ ƒ

Members are annually mandatory audited by independent Compliance auditors Independent compliance auditors sent to congresses Creation of “Enforcement Body” [Jury] for evaluation of Complaints Material fines for members in case of violations

o Creation of “Compliance /231” working group o Review of “Law 231 Guidelines” for pharma companies

Proactive and Reactive Actions of Pharma Stakeholders (Pharma companies 1/2)

{ Create/review internal Modello Organizzativo 231 (MO) with support of high qualified compliance consultants „

MO in > 90% of pharma vs. 73% (middle-big size companies)

{ Increase Compliance professional resources „

~ 2 FTEs fully dedicated (+ Reg., Legal, HR resources PTE)

„

Create Compliance dept independent from other dept (i.e. Legal, Audit, HR,.) linked to 231 ODV Creation of Internal Compliance Committee for critical processes involving Senior managers (i.e. Country Compliance Executive Board)

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Proactive and Reactive Actions of Pharma Stakeholders (Pharma companies 2/2) { Rebalance Italian Compliance requirements versus Foreign regulation approach (i.e. FCPA) „ „ „ „

Training/awareness/communications to employees and ext. stakeholders Contract clause /terms with HCP and others Internal investigation Internal Disciplinary code

{ Multinational companies „ „ „

attention to foreign document wording to be aligned to local culture and stakeholder perception International meetings HCP hospitality (i.e. AD Boards, Investigator meetings) Privacy and TMS (Territory Management System)

Proactive and Reactive Actions of Pharma Stakeholders (Other stakeholders) { Spontaneous Compliance Professionals initiatives in HC sector „ „

Osservatorio 231 Farmaceutiche AODV231; AIIA; LinkedIn groups

{ National/ Regional Authorities regulations increase „ „ „

Compliance to 231 law is requirements in participation to hospital / regional/ Trust tenders (Lombardia, Calabria, Comune di Enna,..) Legality credit rating (new Italian government initiative) - on going Educational initiative in public HC administrations (i.e. Tuscany ASL 1)

{ Educational activities and others „ „ „ „

Compliance & ethics Congresses focused on 231 Law Qualification courses for Compliance professionals (3rd party, University,…) Awards for best Company Compliance Program and Compliance professionals (i.e. “231 Compliance Awards”; Coratella Legal firm) Journals (i.e. “Rivista 231”) and Books

231 Farmindustria Guidelines „ Business processes approach „ Identification Pharma critical process not addressed by other industry 231 Guidelines { For each area: o General considerations o Risk area/ processes/tasks o Organization/procedure profile o Summary

231 Farmindustria Guidelines „ „ „ „ „ „ „ „

„ „ „

Informatori Scientifici del Farmaco (ISF; Scientific Information Field Force Reps) Incentive/Bonus System Expense reimburse and others funding to ISF or District Managers Congress, Scientific educational courses and Scientific meetings (Company and Third Party) Hiring HCPs for educational event and other assignments Donations, Grants, Free loan of Equipment [Comodati d’uso] Gift [Omaggi], Brand reminders [Gadgets] and others Relationship with Public Administration { Public Affairs [Rapporti istituzionali] { Marketing Authorizations [AIC] Applications (New, Change and Termination) { Price and reimbursement negotiation { Inspections visits from Public Authorities Retail pharmacies and wholesaler: Direct commercial activities/sales with Direct sales to public institutions (Hospital/Trust/ASL) through Tenders or Private negotiations Due Diligence Anticorruption of Third Parties (agents/ distributors/customs agents,..) - on going

Thank you Edoardo Lazzarini, Ph.D. ; EMEA Compliance Officer at BIOMET Europe Present on LinkedIn.com

The opinions of the speaker are personal, and not necessarily represents the opinion of current or former employers or colleagues, or trade industry associations.