Regulators

Regulators

Levels of Regulation (ILNIG)

• Institutional

• Local

• National

• International

• Global

Nature of Regulation

• Regulation can be (RIPR):

  • Restrictive

  • Inhibiting

  • Promoting

  • Rewarding

Main Industry Issues of Government Regulation (CCHNL)

• Collaboration

• Compliance

• Harmonization

• Negotiation

• Lobbying

Aspects of Government Influence on the Pharmaceutical Industry (FRPR)

1. Funding (RSF)

   • R&D grants

   • Social security

   • Facility creation

2. Regulation (PRRP)

   • Patent protection

   • Registration

   • Reimbursement

   • Pricing

3. Promoting (ILSDMMPT)

   • Influence on other governments

   • Local industry incentives

   • Substitution legislation

   • Disease diagnosis campaigns

   • Manufacturing

   • Marketing

   • Prescribing decisions

   • Trade barriers

4. Rewarding (IEQO)

   • Innovation awards

   • Export awards

   • Quality awards

   • Orphan drug exclusivity