Lecture 5 (ethical promotion) Flashcards
Why ethical promotion?
The biopharma industry plays a very important role in healthcare with existing drugs and developing innovative medications and therapies to improve and save lives
What kind of info should the biopharma companies provide regarding medicines to med professionals in order to ensure appropriate use of drugs for the patients?
accurate, balanced and updated information of their medicine
How is the perception of the biopharma industry?
before –> neutral to negative because of 1. profiteering and greed (high prices of new drugs)
2. improper/unethical promotion
3. negative media coverage on sponsored lavish trips for healthcare professionals
recently –> improved after covid pandemic due to R&D for covid vaccine
What law/act in the US requires pharma companies to report all direct payments, hospitality expenses and gifts made to physicians?
The Physician Payment Sunshine Act( 2010)
What is The Physician Payment Sunshine Act( 2010)?
requires pharma companies/ biotech and medical device industries that participate in the government health care programs to report all direct payments (honorarium, sponsorships, clinical trial fees etc) , hospitality expenses and gifts made to physicians.
What organisation established the code of marketing practices, including scope of promotion activities and communications to stakeholders, for the pharma industry?
IFMPA
International Federation of Pharmaceutical Manufacturers Association
What is IFMPA?
an organisation that established the code of marketing practices, including scope of promotion activities and communications to stakeholders, for the member pharma industry
What are the codes of local pharma association in regards to ethical promotion of medicine?
- Undesirable medical advertisement ordinance (UMAO)
- Public Health and Municipal Services Ordinance ( PHMSO)
What is the IFPMA member association in US?
PhRMA
(Pharmaceutical Research and Manufacturer of America)
What is the IFPMA member association in Europe?
European Federation of Pharmaceutical Industries and Associations (EFPIA)
What is the IFPMA member association in Hong Kong?
The Hong Kong Association of the Pharmaceutical Industry (HKAPI)
What team do multinational companies have internally to monitor and ensure following of marketing code of practice?
Compliance Team (Compliance Officers)
What actions do multinational companies take in order to ensure that their employees follow marketing code of practice?
- compliance team
- intensive training medical/sales/marketing staff on ethical promotion
- company codes which are stricter than IFPMA –> violation lead to dismissal
Summarize how marketing code is upheld in pharma industry
IFPMA Code –> Member Association Code –> Company Code
What happens if a HKAPI member has proven to have breached the HKAPI marketing code?
- fined HKD100,000
- HKAPI may inform regional office, headquarters, Food and Health Bureau, DoH, HA, medical societies and consumer council
- member company may be suspended or expelled from HKAPI membership
What is the scope of IFMPA code?
- interactions with HCPs
- interactions with medical institutions and patient organizations
- promotion of pharmaceutical products
What is the basis of interactions of member companies with HCPs and other stakeholders?
intended to benefit patients and to enhance the practice of medicine
What is the stance of IFMPA on off label use of pharmaceuticals?
No product promotion / off label use be allowed until the product gets product registration for such use in that country
What is the stance of IFMPA on standards of promotional information?
- Consistency of product information
- Should be clear, accurate, balanced, complete and not misleading
- Promotion should be substantiated by references or by scientific evidences
What is the stance of IFMPA on interactions with HCP such as symposia, congresses and meetings?
- For scientific informationto HCPs
- Should not be organized outside its own country unless appropriate and justified
- Sponsorship should be limited for travel, meals, accommodation and registration fees
- should not pay for the accompanied guest
- Payment to HCP who is engaged as consultants/ advisors may be given
- avoid using extravagant venues
- refreshment should be modest
- No entertainment
What is the stance of IFMPA on samples?
- should be marked as such they cannot be resold or misused
- Have adequate systems or control and accountability e.g. records
Apart from marketing code, what other codes does the IFPMA code of practice include?
- promotional materials
- Support for Continuing Medical Education(CME)
- Interactions with patient groups
- Company Compliance procedures
- Clinical Research / transparency and privacy
