NTA Level 5 • Semester 1 • PST05105

Legal limitations on Medicines Marketing and Promotion

Rational Use of Medicines • Source Session/Topic 11

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Session 11: Legal limitations on Medicines Marketing and Promotion

Total Session Time: 120 minutes

Prerequisites

• None

Students Learning Tasks

By the end of this session students are expected to be able to:

• Define the terms used in legal limitations on medicines marketing and

promotion.

• Give general understanding of legal limitations on medicines

marketing and promotion.

• Identify responsibilities of TFDA on medicines marketing and

promotion

• Describe pharmaceuticals promotion control

• Identify importance of promotion and marketing in pharmacy

• Describe pharmaceuticals advertisement control

Resources Needed:

• Flip charts, marker pens, and masking tape

• Black/white board and chalk/whiteboard markers

SESSION OVERVIEW

SESSION CONTENTS

STEP 1: Presentation of Session Title and Learning Tasks (05 Minutes)

READ or ASK students to read the learning objectives and clarify

ASK students if they have any questions before continuing.

STEP 2: Definition of Terms inLegal limitations on Medicines Marketing and

Promotion. (20 Minutes)

• Pharmaceuticals Promotion: refers to all informational and convincing

activities by manufacturers and distributors, the effect of which is to

encourage the prescription, supply, purchase and/or use of medicinal

drugs.

• The important of Promotion is to create an image, to modify attitudes to

support sales increases and to create awareness

• Marketing: creating customer value and satisfaction. It is a process by

which individuals or groups obtain what they need and want through

creating and exchanging products and value with others. i.e. It is simply

the delivery of customer satisfaction at a profit

• Advertising: Any form of communication using any form of mass media or a

controlled message in purchased time or space. It is non-personal and

paid. The forms of advertising include journals, direct mail & e-mail,

bill boards, newspapers and TV. It includes every form of advertising,

whether in a publication, or by the display of any notice or by means of

any catalogue, price list, letter, whether circular or addressed to a

particular person, or by the exhibition of a photograph or a

cinematograph film, or by way of sound recording, sound broadcasting, or

television or any other means of communication.

STEP 3: Introduction to Legal Limitations on Medicines Marketing and

Promotion. (15 Minutes)

• Medicines have the potential for benefit to individuals who use them and

to the public health. But all effective medicines may be associated with

adverse effects.

• The law recognizes that medicines should not be treated as an ordinary

general commodity by placing specific restrictions on them.

• Activities conducted as part of pharmaceutical marketing and promotions

are an important component of educating and informing consumers and

health care professionals about new treatments.

• Direct-to-consumer (DTC) advertisements aim to inform patients of

important treatment options, while pharmaceutical sales representatives

work to get accurate, up-to-date information on medicines to health care

professionals.

STEP 4: Responsibilities of TFDA on Medicines Marketing and Promotion

(30minutes)

|Activity: Brainstorming (15 Minutes) |

|Ask students to brainstorm on the following question: |

|What are the responsibilities of TFDA on medicines marketing and |

|promotion? |

|ALLOW few students to respond |

|WRITE their responses on the flip chart/ board |

|CLARIFY and SUMMARISE by using the content below |

TFDA is the effective medicines regulatory body which promotes and protects

public health by ensuring that:

• Medicines are of the required quality, safety and efficacy, medicines are

appropriately manufactured, stored, distributed and dispensed, illegal

manufacturing and trade are detected and adequately sanctioned, health

professionals and patients have the necessary information to enable them

to use medicines rationally.

• Ensure that promotion and advertising is fair, balanced and aimed at

rational drug use, access to medicines is not hindered by unjustified

regulatory work.

STEP 5: Pharmaceuticals Promotion Control (10 Minutes)

• Product promotion means any activity undertaken by a company or

individual to promote and encourage the prescription, supply, sale,

administration or purchase of food, drugs, herbal drugs, cosmetics, and

medical devices. (in relation to products regulated by TFDA such as

medicines)

• Such promotion can be presented in various forms like:

o Brochures, posters, leaflets, TV, radio, newspaper, magazine, and

internet advertisement, Journal or direct mail advertising,

supply of free samples, sponsorship of promotional meeting and

sponsorship of scientific meeting

• Product promotion Control section of the TFDA routinely scrutinizes

promotional materials before approval is granted.

• Promotion of food, drugs, herbal drugs, cosmetics, and medical devices is

controlled under the Tanzania Food, Drugs and Cosmetics Act, 2003

sections 95 to 98 and 122(1) (r) regulations, 2010.

• No promotional activity should be conducted in Tanzania mainland unless

it is approved by the TFDA.

• In order to get approval, two copies of the promotional materials should

be submitted to the Director General, TFDA. Upon approval, one copy will

remain with the TFDA.

STEP 6: Importance of Promotion and Marketing in Pharmacy (20 Minutes)

|Activity: Buzzing (10 minutes) |

|ASK students to pair up and buzz on the following question for 2 |

|minutes |

|What are the Importance of promotion and marketing in Pharmacy? |

|ALLOW few pairs to respond and let other pairs to add on points not |

|mentioned |

|WRITE their response on the flip chart/board |

|CLARIFY and SUMMARIZE by using the content below |

The following are the importance of promotion and marketing in Pharmacy

• It informs healthcare professionals about new treatment options, helping

them to provide the most appropriate solutions for each of their

patients.

• It simplifies the direct purchase of drugs, due to the information

provided on the drug’s price and location to the public

• It updates pharmaceutical personnel with the information about the new

products of drugs in the market

• Marketing ensures a good lasting connection with customers.

• The marketing activities stimulates exchange with patients who need and

likely benefit from the services provided by the pharmacy

• It helps companies to identify the need for the community with respect to

diseases in an area

• It helps companies to obtain an adequate return on their sizeable

Research &Development investment during the limited period of market

exclusivity granted by intellectual property rights – so that they can

continue to invent new treatments.

• Campaigns to promote the rational use of medicines have much less money

to spend if promotion and marketing is conducted ethically.

• Drug promotion and marketing creates demand for medicines as it defines

illness conditions that need treatment.

• It promotes the idea that medicines are the best remedy as opposed to non-

drug alternatives.

• It tends to emphasize a medicine’s efficacy while minimizing possible

health risks.

Targets of pharmaceuticals promotion

The subsequent are the target workforces to be promoted with medicine:

• Pharmaceutical personnel,

• Doctors

• Nurses

• Dentists

• Insurance companies

• Hospital managers

• Company managers

STEP 7: Pharmaceuticals Advertisement Control (10 Minutes)

• Drug advertised need to be checked if it’s essential on sense of

efficacy, safety and quality also affordable to the public

• Drug advertisement needs to care on the clients benefits first before

owners’ benefits.

• No drugs must be advertised if the information and side effects of the

drug are unknown.

• Advertising of medicines is acceptable provided it is in line with

legislation and agreed standards of good practice.

• Society demands that advertising of any commodity, service or anything

that may be of interest to the consumer, should be of a high standard.

• It should not include anything that could cause serious or widespread

offence, create unrealistic expectations in the consumer or be

misleading.

• Rules and regulations need to be taken into account when advertising a

medicine, to ensure required standards are met and that consumer

protection is not compromised.

• All advertising and promotion of medicines, both for self-medication

and to healthcare professionals where medical prescription is

required, must be responsible and of the highest standard.

• All means and media used in the promotional marketing of medicines are

subject to the legislation controlling advertising. This includes

evolving digital communications channels as well as more conventional

communications.

• The legislation lays down the requirements and restrictions for

advertising, aimed at either prescribers or suppliers of medicines to

the public, or at the public as purchasers of over-the-counter

medicines.

• Central to this is the principle that advertising of prescription only

medicines to the public is prohibited.

• The decision to prescribe a certain medicine is taken by a qualified

healthcare professional on the basis of informed discussion with the

patient

• Advertised drug must be authorized by the Drug authority (i.e. TFDA)

STEP 8: Key Points ( 05 Minutes)

• Rules and regulations need to be taken into account when advertising

medicines, to ensure required standards are met and that consumer

protection is not compromised.

• Advertising of medicines is acceptable provided it is in line with

legislation and agreed standards of good practice.

• In the absence of effective regulation of drug promotion, community

interventions to promote rational drug use will have insufficient

impact hence, leading to irrational use of medicines.

STEP 9: Evaluation (05 Minutes)

• What is pharmaceutical promotion?

• List the importance of promotion and marketing in pharmacy?

• What are the responsibilities of TFDA on medicines marketing and

promotion?

References:

MoHSW (2003), Tanzania, Food, Drugs and Cosmetics Act, Government Printer,

Dar essalaam Tanzania.

Caudill T, Johnson M, Rich E, McKinney W. (1996), Physicians,

Pharmaceutical Sales representatives, and the Cost ofPrescribing. Archives

of Family Medicine; 5: 201-206.

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