Ch 7: Managing and developing the pharmaceutical pipeline ll and CSR

Question 1

What is the Pharmacuetical Supply chain?

Answer 1

see slide 6

Question 2

How has the COVID-19 pandemic has affect the global supply chains & international R&D activities?

Answer 2

Covid-19 has affected the global supply chains by reducing manufacturing activity. For example, lockdown of manufacturing facility leads to staff shortages, and missing of raw materials causes a reduce manufacturing capacity

Question 3

Regulatory authorities must balance the interests of different parties in order to maximize public health gains, how?

Answer 3

Pharmaceutical Companies
* Short & convenient process
* No bureaucracy
* Standardisation
* Competent authorities
* Openness for innovation
* Profit

Patients
* Quality
* Safety
* Efficacy
* Quick availability of drug

Regulators
*Regulator decides on the strictness of the authorization process
* Quick introduction of new drugs vs. potential risk of not predicted side-effects
* Also to consider: Labour market, Insurance companies & other regulatory
aspects (pricing, distribution…)

Question 4

Depending on the new drug and the decision, which market to enter, four distinct procedures are considered by regulators which are?

Answer 4

1. Centralised Procedure:
   ingle application
   for Market access
   (MA) in entire EU
   * EC makes final
   decision
   * Mandatory for
   certain
   pharmaceuticals
2. Decentralised Procedure:
   Market access for
   more than one
   state within EU
   * Concerned
   Member States
   make final
   decision
   * Possible if neither
   MA available nor
   CP mandatory
3. Mutual Recognition Procedure:
   * Market access for
   an additional
   state in EU
   * Concerned
   Member States
   make final
   decision
   * Applicable if a
   MA already exists
   in a EU state
4. National Procedure:
   * Market access
   for Germany only
   * BfArM, PEI or
   BVL makes final
   decision
   * Possible if
   neither MA
   available nor CP
   mandatory

Question 5

The pharmaceuitcal market has a special demand and pricing structure which is?

Answer 5

Regulatory authorities: Physician, Patient, Insurance

1. Physician:
   -Key decision maker
   -Small/no price sensitivity since he does not pay
2. Patient:
   -End consumer
   -Small/no price sensitivity
   -Information asymetry between patient < - > physician
3. Insurance:
   -Actual payer of drugs
   -Sensitive to prices
   -Can not decide which drug gets prescribed but can narrow the set of possibilities for physician

Question 6

What is Corporate Social Responsibility?

Answer 6

• CSR mandates that the corporation has not only economic and legal
  obligations, but also certain responsibilities to society that extend
  beyond these obligations (McGuire)
• Complex social construct with manifold unclear and interdependent
  assumptions and interpretatio

Question 7

What Corporate Social Responsibility is not?

Answer 7

• synonymous with “Business Ethics”
• limited to community involvement
• exclusive of environmental sustainability

Question 8

What is Strategic CSR?

Answer 8

“Strategic Corporate Social Responsibility: A business strategy that is integrated with core business objectives and core competencies of the firm, and from the outset is designed to create business value and positive social change, and is embedded in day-to-day business culture and operations.”

Question 9

What is a key driver of CSR?

Answer 9

Employee motivation

Question 10

What is the link between CSR and Financial Performance?

Answer 10

Empirical Approaches:
– Portfolio analyses
– Event studies/Best practice approach
– Multiple regression studies (Problem: Causality? Timing?)

Insufficient measures, especially for CSR
– Researchers have tended to create their own CSR measure rather than making
use of one of the many existing ones
– Most researchers use one aggregated CSR variable
– Various accounting- and market-based measures for financial performance
Prediction Mixed results, no definitive consensus