Off Label Marketing
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Transcript of Off Label Marketing
CorporateGovernance
Miryam Ompusunggu (1506809721)Nadia Nur Fadilla (1506809785)
Salsa Andiani (1506809873)Sindy Millatina Putri (1506809910)
Zaki Tanrere (1506809980)
ScandalPoor management
practicesFraudulent
financial reporting
Corporate
governance
WHO?
Process by which
organizations are directed &
controlled
Managers/OwnersHire professional managers
Development of a separate corporate entity allowed organization to raise funds from individual shareholders to enlarge their operations
- Is concerned w/how well organizations meet their obligations- Underpinning the integrity & efficiency of financial markets
Governance of the Modern Corporation
OwnersPublic shareholders
Institutional invertorsOther corporations
CEO, CFO, COO
StakeholdersCostumers, vendor partners, state & local entities, community partners
CreditorFinancial institution
Bondholder
Managers, employees
Audit committee
Compensation committee
Corporate governance committee
Board of directors
Represent their interest in the effective running
of the corporations, appointed for specific
periods of time
Oversee the financial reporting process, monitor internal
controls, monitor the choices of accounting policies & procedures, oversee the hiring & performance of external auditor in producing
the company’s financial statement
Oversee compensation packages for the senior
executives of the corporation
Monitors the ethical performance of the
corporation & oversees compliance
w/the company’s internal code of ethics,
federal, & state regulations
To be truly effective, boardsshould follow these six steps•Create a climate of trust and candor•Foster a culture of open dissent•Mix up roles•Ensure individual accountability•Let the board assess leadership talent•Evaluate the board’s performance
QUESTIONS FORDIAGNOSING YOUR
BOARD• If you answer yes to all
questions, you have an exemplary board.• Even with a board that
passes all the tests and meets all the established criteria, ethical misconduct can still come down to the individual personalities involved
Fiduciary Responsibilities
Based on trust
“Corporate Governance is about managers fulfilling a fiduciary responsibilities to the owners of their company”
Agency Theory Conflict of interest Shareholders VS Managers
Oversight Process and Machanism Check and Balance
To support
Prinsip DasarPedoman Good Corporate Governance Indonesia
Perbankan
Transparansi Disclosure Tepat waktu, memadai, jelas, akurat
Akuntabilitas Kejelasan Fungsi dan cara mempertanggungjawabkannya
Responsibilitas Compliance Undang-undang dan peraturan lainnya
Independensi No other party intervention Objektif
Kewajaran dan Kesetaraan Adil Stakeholders
Asas Good Corporate Governance
Mencapai suntainabilitas usaha dengan memperhatian kepentingan Shareholder, nasabah, dan stakeholders lainnya
Good Corporate Governance Payoff
More attractive to investor and lenders• Purchase from firms with strongest shareholder rights• Sell the stocks from firm with weakest shareholder rights
More profitable
Faster Sales GrowthResearch from Harvard – Warthon and Deuthce Bank Study
Research from McKinsey
Institutional investors would pay Premiums to well governed companies
• 30% Eastern Companies• 22% Asia and Latin America
OFF LABEL MARKETING
Case Study: Off- Label Marketing
Bextra Pain Killer
Meningkatkan risiko serangan jantung dan stroke
Depakote
Dementia & Schizophrenia
• Unawful promotion of drug’s prescription
• Failure to report safety data
• False price reportingPaxil Wellburtin
Epilepsi, Bipolar, dan Migrain
Off- Label DrugsTidak sesuai indikasi atau tidak sesuai dengan
“Label” yang ditetapkan oleh FDA atau BPPOM
LEGAL?Hak Prerogatif Dokter
Doctors must inform the patients
Evil Doctors
Revenue and Profit<Fines
Case Study: Off- Label Marketing
Millions $$ VS Billions $$
Lanjoooooooot!!!
Case Study: Off- Label Marketing
Internal Control
Board of Diretors’ Responsibility
Firm Corporate Governance
DOJ/Government Firms, Doctors, Drugstores
Maximizing Profits supported by inffective sanctions or fines
Unlawful and Unethical Practices
Why would illegal marketing activities feature so frequently in the pharmaceutical industry?At what point they be considered endemic?
Illegal marketing sudah tidak dapat dipungkiri Meningkatkan profit Pengguna tidak mengetahui, tetapi membutuhkan obatnya dan dijual bebas Sanksi dirasa tidak berat
Endemik: Praktik terus dilakukan tanpa adanya tindakan hukum yang efektif Dilakukan masal. Dianggap wajar untuk menghasilkan profit besar tanpa perlu biaya yang tinggi
Leading Organizational
Change
4. Critics argue that fines are too affordable. In other words, a $1 billion fine for activities that generate several billions of dollars in illegal sales simply becomes a cost of doing business. Should fines be more punitive? How much would be enough?✖ Pemberian denda dapat menjadi salah satu cara meminimalisir praktik ilegal.✖ angka denda tersebut dapat ditinggikan dengan misalnya hitungan denda ialah sebesar cost
sekian tahun ke depan
5. Is the payment of a monetary fine sufficient restitution for these offenses? Why or why not?
✖ sanksi denda kami anggap tidak dapat mewakili tindak illegal yang dilakukan oleh perusahaan✖ Bisa diberikan sanksi yang lebih lagi misalnya memberikan skorsing produksi, atau melarang
penjualan produk tersebut.
6. How could this apparently endemic problem be approached differently?
✖ seharusnya sanksi yang diberikan bukan hanya denda.✖ Pemerintah juga dapat melakukan pendekatan tidak hanya ke perusahaan farmasi, namun
juga ke dokter-dokter dan rumah sakit dengan menetapkan peraturan agar para dokter memberikan resep obat-obat yang hanya dibutuhkan sesuai dengan indikasi penyakit pasien saja
✖ pemerintah dapat memperketat peraturan terhadap distributor obat-obatan✖ Untuk pencegahannya, pihak manajemen perusahaan seharusnya membuat kontrol internal
perusahaan✖ membentuk corporate governance committee