Advertising and Promotion (Ch. 3)

Question 1

Why is advertising of healthcare products subject to higher regulatory controls?

Answer 1

Because of the potential risk to public health

Question 2

What is the EU advertising regulatory framework?

Answer 2

Council Directive 2001/83/EC on medicinal products for human use (Medicinal Products Directive, MPD)
Title VIII: Advertising
Title VIIIa: Information and Advertising

Question 3

TRUE/FALSE: The goal of the MPD is to remove barriers to trade between Member States, setting out the minimum standards.

Answer 3

FALSE!
The goal of the MPD is to remove barriers to trade between Member States, setting out the MAXIMUM standards, except where it specifically allows Member States to adopt stricter legislation.

Question 4

What is the definition of advertising of medicinal products?

Answer 4

Advertising of medicinal products:
Any form of door-to-door information, canvassing activity, or inducement designed to promote the prescription, supply, sale, or consumption of medicinal products

Question 5

What is the European Federation of Pharmaceutical Industries and Associations (EFPIA)?

Answer 5

European Federation of Pharmaceutical Industries and Associations (EFPIA):
The representative body of pharmaceutical companies marketing products in the EU

Question 6

TRUE/FALSE: The pharmaceutical industry is based on a self-regulatory mechanism through which companies adhere to a set of ethical codes of conduct developed by various trade associations.

Answer 6

True!

Various trade associations = EFPIA & IFPMA

Question 7

What are the main principles of advertising under Directive 2001/83/EC?

Answer 7

1. Cannot advertise medicines without a market authorization
2. Cannot advertise off-label indications
3. Advertising must comply with the summary of product characteristics (SmPC)
4. Advertising shall encourage rational use and shall not be misleading
5. Prescription medicines may only be advertised to HCPs
6. OTC medicines may be advertised to the general public, following certain rules

Question 8

What do HCP, HCO, and PO stand for?

Answer 8

HCP: Healthcare professional
HCO: Healthcare organization
PO: Patient organization

Question 9

What is the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)?

Answer 9

International Federation of Pharmaceutical Manufacturers and Associations (IFPMA):
A non-profit, non-government organization representing research-based pharmaceutical companies and associations from both developed and developing countries

Question 10

What is the purpose of the IFPMA Code?

Answer 10

IFPMA Code:
Serves as a default regulatory framework where there are no local codes or relevant laws and regulations, or where a member company is not part of the local association
Based on integrity, values, principles, and patient trust
Core Values: Care, fairness, respect, and honesty

Question 11

What is required for advertising to HCPs?

Answer 11

Advertising to HCPs must include essential information compatible with the SmPC
(This mandatory info is defined more clearly by NATIONAL REGULATIONS.)

Question 12

TRUE/FALSE: Recommendations or endorsements by HCPs for medicinal products is allowed.

Answer 12

FALSE - HCP endorsements are unanimously prohibited throughout the EU.

Question 13

TRUE/FALSE: Member States may have specific requirements regarding the use of certain words and expressions in advertising materials.

Answer 13

True! (i.e. can’t say “fully safe” or “no risks”)

Question 14

TRUE/FALSE: Visits from sales representatives fall under the category of advertising.

Answer 14

True!
Sales representatives must be adequately trained and have sufficient scientific knowledge to be able to provide accurate information about the products being promoted.

Question 15

TRUE/FALSE: Free samples of medicinal products cannot be given to HCPs.

Answer 15

False - Free samples are permitted.
There are certain conditions for providing free samples to HCPs (limited number, written request, marked “free medical sample - not for sale”, and no samples of narcotics).
Member States may place their own restrictions on free samples.

Question 16

What is the purpose of restricting gifts, donations, and hospitality to HCPs?

Answer 16

To avoid any perceived potential influence of a HCP while prescribing pharmaceutical products

Question 17

What types of medicinal products can be advertised to the general public?

Answer 17

1. Over-the-counter medicines

2. Vaccination campaigns (approved by CA’s)

Question 18

What are the two main requirements for advertisements to the general public under the MPD?

Answer 18

1. Clearly identify the medicinal product

2. Include the trade name and common name, information for use, and invitation to read leaflet

Question 19

TRUE/FALSE: Press releases are considered to be advertising.

Answer 19

True

Question 20

What types of information/products cannot be advertised according to the MPD?

Answer 20

1. Non-authorized products

2. Off-label information

Question 21

What is off-label information?

Answer 21

Off-label information:

Covers advertising for indications or dosage forms not within the scope of an existing marketing authorization

Question 22

TRUE/FALSE: A doctor can decide to prescribe a medicine that has not been granted an MA.

Answer 22

TRUE - A doctor can prescribe a medicine that has not been granted an MA under their discretion and responsibility

Question 23

What is comparative advertising?

Answer 23

Comparative advertising:

Any advertising that explicitly or implicitly identifies a competitor or goods/services offered by a competitor

Question 24

What are the requirements for comparative advertising per Directive 2006/114/EEC?

Answer 24

1. Not misleading
2. Only compare products with the same intended purpose
3. Does not discredit trademarks etc. of a competitor

Question 25

TRUE/FALSE: Market surveillance by Member States is the only way advertising and promotional materials are regulated.

Answer 25

False!
Market surveillance - Member States are responsible for ensuring their are adequate and effective methods to monitor medicinal product advertising
AND ALSO: Self-regulatory bodies such as local trade associations

Question 26

TRUE/FALSE: Manufacturers must have promotional materials approved prior to use, per market surveillance regulations.

Answer 26

False - This is not a requirement for all Member States

Question 27

What is the regulatory framework for medical device advertising and promotion?

Answer 27

TRICK QUESTION!

There is not an over-arching regulatory framework for medical devices

Question 28

What is MedTech Europe?

Answer 28

MedTech Europe:

A trade association representing the medical technology industry

Question 29

What is the purpose of the Code for Ethical Business Practice by MedTech?

Answer 29

Provides guidelines for industry on interacting with HCPs

Question 30

What does the EU MDR say about medical device advertising?

Answer 30

Article 21: Medical devices can be displayed as long as it says “for demo purposes”
Article 7: Labeling cannot be misleading

Question 31

What is the purpose of the EU Directive on Misleading and Comparative Advertising, Directive 2006/114/EEC?

Answer 31

To protect traders from misleading advertising and adverse consequences

Question 32

What is Directive 2006/114/EEC?

Answer 32

EU Directive on Misleading and Comparative Advertising, Directive 2006/114/EEC

Question 33

What is the definition of misleading advertising (according to Directive 2006/114/EEC)?

Answer 33

Misleading Advertising:
A type of presentation that deceives a person, and by its deceptive nature, likely affects their economic behavior or injures, or may injure, a competitor

Question 34

TRUE/FALSE: Medical product advertising serves as a source of information on the product’s correct use.

Answer 34

True

Question 35

TRUE/FALSE: Advertising is regulated by EU implementation of regulations.

Answer 35

FALSE: Advertising is regulated by national implementation of an EU Directive.