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Advertising of Advertising of nonprescription medicinesnonprescription medicines

WSMI - PositionWSMI - Position

David E. Webber PhDDavid E. Webber PhD

Director-GeneralDirector-General

World Self-Medication Industry World Self-Medication Industry (WSMI)(WSMI)

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The World Self-Medication The World Self-Medication Industry (WSMI)Industry (WSMI)

• WSMI is a federation of around 55 member WSMI is a federation of around 55 member associations representing manufacturers and associations representing manufacturers and distributors of nonprescription (OTC) medicines distributors of nonprescription (OTC) medicines on all continents. CAMESIP through ILAR is an on all continents. CAMESIP through ILAR is an important member, as are ALL companies.important member, as are ALL companies.

• Based near Geneva Switzerland, WSMI aims to Based near Geneva Switzerland, WSMI aims to help communicate the value, at the help communicate the value, at the international level, of self-care and responsible international level, of self-care and responsible self-medication using OTCs. self-medication using OTCs.

• WSMI is in official relations with WHO, WMA, WSMI is in official relations with WHO, WMA, FIP, ICN, WIPO, Codex Alimentarius, ICH and the FIP, ICN, WIPO, Codex Alimentarius, ICH and the UN. UN.

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Why is OTC advertising important, Why is OTC advertising important, really?really?

• Advertising is important in encouraging people to Advertising is important in encouraging people to look after themselves through self-carelook after themselves through self-care

• Self-care is essential for tackling the ‘chronic Self-care is essential for tackling the ‘chronic disease’ future of Venezuela disease’ future of Venezuela

• People undertake better self-care if they are People undertake better self-care if they are aware of, and ‘armed with the tools’ of self-care – aware of, and ‘armed with the tools’ of self-care – OTCsOTCs

• To support people’s awareness of the opportunity To support people’s awareness of the opportunity and need for self-care, and need for self-care, OTC advertising is OTC advertising is essentialessential

• OTC (not Rx) advertising…plus public health OTC (not Rx) advertising…plus public health advertising, which is differentadvertising, which is different

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Chronic diseases = the Chronic diseases = the futurefuture

• Non-communicable (chronic) diseases Non-communicable (chronic) diseases are emerging as the primary source are emerging as the primary source of disease burden in both developed of disease burden in both developed and developing countries. and developing countries. – Cardiovascular diseasesCardiovascular diseases– CancerCancer– Chronic respiratory diseasesChronic respiratory diseases– DiabetesDiabetes

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Projected global deaths by cause, all ages, 2005 (WHO 2005)

HIV/ AIDS Tuberculosis Cancer

Chronic respiratory

diseases Diabetes

2 83

0 00

0 d

eath

s

1 60

7 00

0 d

eath

s

Cardiovascular diseases

833

000

dea

ths

17 5

28 0

00 d

eath

s

7 58

6 00

0 d

eath

s

Malaria

4 05

7 00

0 d

eath

s

1 12

5 00

0 d

eath

s

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Projected main causes of death, WHO Region of the Americas, all ages, 2005

Cardiovasculardisease

33%

Cancer 19%

Chronic respiratory disease

7%

Diabetes5%

Other chronicdiseases

14%

Communicable,maternal and

perinatal, nutritional

deficiences13%

Injuries9%

Ref: www.who.int/chp/chronic_disease_report/en/

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• Venezuela is similar to the Region*:Venezuela is similar to the Region*:

– Cardiovascular disease is no. 1 cause of Cardiovascular disease is no. 1 cause of deathdeath

– Cancer is 2Cancer is 2ndnd

– Diabetes is 5Diabetes is 5thth

• What has this got to do with OTCs What has this got to do with OTCs and OTC advertising?and OTC advertising?

(*see http://www.paho.org/English/DD/AIS/cp_862.htm)

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Causes of chronic diseases Causes of chronic diseases (WHO (WHO 2005)2005)

Social, Social, cultural, cultural, political etc political etc factorsfactors

Risk factorsRisk factors IntermediatIntermediate risk e risk factorsfactors

Main Main chronic chronic diseasesdiseases

GlobalizatioGlobalizationn

UrbanizatioUrbanizationn

Population Population ageingageing

Unhealthy Unhealthy dietdiet

Physical Physical inactivityinactivity

Tobacco Tobacco useuse

(Age & (Age & heredity)heredity)

Raised Raised blood blood pressurepressure

Raised Raised blood blood glucoseglucose

Abnormal Abnormal blood lipidsblood lipids

Overweight/Overweight/obesityobesity

Heart Heart diseasedisease

StrokeStroke

CancerCancer

Chronic Chronic respiratory respiratory diseasesdiseases

DiabetesDiabetes

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How well will health systems cope How well will health systems cope with chronic disease?with chronic disease?

• Chronic diseases are substantially Chronic diseases are substantially determined by lifestyle-related factors - determined by lifestyle-related factors - unhealthy diet, physical inactivity, unhealthy diet, physical inactivity, tobacco use - where health, education tobacco use - where health, education and culture are intimately related.and culture are intimately related.

• Current health systems are oriented to Current health systems are oriented to treatment of communicable disease treatment of communicable disease (sickness services), not prevention or (sickness services), not prevention or management of chronic disease.management of chronic disease.

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Chronic diseases are Chronic diseases are substantially preventablesubstantially preventable

• At least 80% of premature heart At least 80% of premature heart disease, stroke and type 2 diabetes, disease, stroke and type 2 diabetes, and 40% of cancer could be and 40% of cancer could be prevented through healthy diet, prevented through healthy diet, regular physical activity and regular physical activity and avoidance of tobacco.avoidance of tobacco.

• But how? But how?

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But the current model is inadequateBut the current model is inadequate

• Medical professionals (and governments) Medical professionals (and governments) cannot alone solve the world’s problems with cannot alone solve the world’s problems with obesity, smoking habits, risky lifestyles etc. obesity, smoking habits, risky lifestyles etc.

• Developing better health must inevitably Developing better health must inevitably involve actions and measures lying involve actions and measures lying outside the outside the current reach of health systems.current reach of health systems.

• Self-care and self-medication by Self-care and self-medication by individuals themselves has a particularly individuals themselves has a particularly important role to playimportant role to play. . People have to be People have to be motivated themselves, and be supported. motivated themselves, and be supported. How?How?

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Passive patient or proactive Passive patient or proactive self-care participant?self-care participant?

Less effort to improve his own health

Passive patient

Unable to influence his own health

Engages in improvement in his health

Proactive participant

Able to influence his own health

Vicious circle Virtuous circle

?

(The biomedical model)

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Passive Patients or Proactive Passive Patients or Proactive Participants?Participants?

• QUESTION:QUESTION: How do you get people to How do you get people to change from being Passive patients, to change from being Passive patients, to being Proactive participants in self-care?being Proactive participants in self-care?

Passive Patient

Proactive Participants

The answer is to encourage and support self-care…

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““Self-care is tSelf-care is the care taken by individuals he care taken by individuals towards their own health and well being, towards their own health and well being, including the care extended to their family including the care extended to their family members and others.members and others.””

Self-Care is a broad concept including:Self-Care is a broad concept including:• Hygiene (general and personal)Hygiene (general and personal)• Nutrition (type and quality of food eaten)Nutrition (type and quality of food eaten)• Physical exercisePhysical exercise• Avoidance of risk (e.g. smoking)Avoidance of risk (e.g. smoking)• Psychological healthPsychological health• Environmental factors (living conditions)Environmental factors (living conditions)• Socioeconomic factors (income level, Socioeconomic factors (income level,

cultural beliefs, etc)cultural beliefs, etc)• Self-medicationSelf-medication

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The elements of self-careThe elements of self-care

Physical activity

Psychological health

Good nutrition

Risk factor avoidance

Self-care

How do you encourage people to undertake self-care?

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OTC medicines are ‘tools’ of self-OTC medicines are ‘tools’ of self-care – helping to change care – helping to change intentionintention

into into actionaction

Physical activity

Psychological health

Good nutrition

Risk factor avoidance

Self-care

Minerals & supplm

Vitamins

Herbals

Functional foods

Gastrointest.

TonicsDerms, sunblock

Cough & cold

Analgesics

Sleep aids

Water purifiers

Anti-obesity

Anti-cholesterol

Quit smoking (NRT)

Anti-Migraine

Osteoporosis (Calcium)

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In summary,In summary,

1.1. Give people better access to more Give people better access to more self-medication products – OTCs – in self-medication products – OTCs – in support of self-care. support of self-care.

2.2. Make people aware through Make people aware through advertising.advertising.

3.3. Develop public health education Develop public health education programmes – public advertising programmes – public advertising importantimportant

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What does OTC advertising What does OTC advertising achieve? (for the patient)achieve? (for the patient)

• Brings to people’s attention a medical condition, plus Brings to people’s attention a medical condition, plus the fact that there is something they can do about it the fact that there is something they can do about it for themselves.for themselves.

• Alerts consumer to new products and new indicationsAlerts consumer to new products and new indications• Introduces or reinforces other forms of Introduces or reinforces other forms of

communication about a product and brandcommunication about a product and brand• Develops brand recognition that can provide the Develops brand recognition that can provide the

consumer with confidence in the brand and the consumer with confidence in the brand and the companycompany

• Facilitates product search and helps consumer make Facilitates product search and helps consumer make informed selectionsinformed selections

• Fundamentally, OTC advertising raises peoples’ Fundamentally, OTC advertising raises peoples’ involvement in their own self-care. Without this, the involvement in their own self-care. Without this, the chronic disease epidemic will not be stopped.chronic disease epidemic will not be stopped.

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Advertising brands recruits Advertising brands recruits people into selfcarepeople into selfcare

• Anti-smoking advertising has become so Anti-smoking advertising has become so effective that it is now more powerful effective that it is now more powerful than doctors (General Practitioners, GPs) than doctors (General Practitioners, GPs) in persuading smokers to kick their habitin persuading smokers to kick their habit

• Advertising campaigns prompted 32% of Advertising campaigns prompted 32% of recent attempts to kick the habit while recent attempts to kick the habit while GPs were responsible for just 21%GPs were responsible for just 21%

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Advertising cannot:Advertising cannot:

• Provide comprehensive education about Provide comprehensive education about health, a disease or its treatment health, a disease or its treatment – Not same as public health educationNot same as public health education

• Encourage or force people to buy something Encourage or force people to buy something they don’t want or needthey don’t want or need– Advertising is an important tool to develop Advertising is an important tool to develop

knowledge about new products, but it is not a knowledge about new products, but it is not a general consumption incentive. general consumption incentive.

– OTCs are not ‘aspirational goods’, people do not OTCs are not ‘aspirational goods’, people do not rush out to buy medicines if they have no need rush out to buy medicines if they have no need for them.for them.

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People receive information about People receive information about minor illnesses and OTC medicines minor illnesses and OTC medicines

from:from:• Doctors, pharmacists and other healthcare Doctors, pharmacists and other healthcare

professionalsprofessionals• Friends, family and colleaguesFriends, family and colleagues• Health books/manuals or TV health showsHealth books/manuals or TV health shows• TV and radio advertisingTV and radio advertising• Newspapers, magazinesNewspapers, magazines• InternetInternet

Advertising is just one element in the mixAdvertising is just one element in the mix

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Mechanisms of control of Mechanisms of control of advertisingadvertising

• Two dimensions to consider:Two dimensions to consider:

1.1. WhoWho leadsleads on control? on control?• Government, self-regulatory, or co-Government, self-regulatory, or co-

regulatory controlsregulatory controls

2.2. WhenWhen control and enforce? control and enforce?• Pre-publication vs post-publicationPre-publication vs post-publication

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1.1. Who leadsWho leads on control? on control? Industry self-regulation in Industry self-regulation in

promotion promotion • WSMI position – put responsibility on industryWSMI position – put responsibility on industry

• Industry self-regulation works well because:Industry self-regulation works well because:– Companies know that the alternative is undesirable Companies know that the alternative is undesirable

(government control is slower and more costly)(government control is slower and more costly)– Companies are in competition and are the first to Companies are in competition and are the first to

complain about any advertising by a competitorcomplain about any advertising by a competitor– Penalties can be substantialPenalties can be substantial

• An intermediate step can be co-regulatory An intermediate step can be co-regulatory systemssystems

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1. 1. Who leadsWho leads on control? Industry on control? Industry self-regulation in promotionself-regulation in promotion

• WSMI supports the development of country-WSMI supports the development of country-specific industry “specific industry “codes of practicecodes of practice”. ”. Examples:Examples:– AESGPAESGP “Guidelines for the advertising of “Guidelines for the advertising of

nonprescription productsnonprescription products””– NDMACNDMAC “Code of Marketing Practices “Code of Marketing Practices” ” (47pp)(47pp)

– PAGB PAGB “Medicines Advertising Codes”“Medicines Advertising Codes” (68pp)(68pp)

• Codes typically contain procedures for judging Codes typically contain procedures for judging complaints along with measures for non-complaints along with measures for non-compliance.compliance.

• Codes of practice can be agreed with the local Codes of practice can be agreed with the local Ministry of Health or other government body.Ministry of Health or other government body.

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1. Who leads on control? In 1. Who leads on control? In practice self-regulation works practice self-regulation works

well:well:• General government satisfaction with the systemGeneral government satisfaction with the system• There are relatively few complaints and even There are relatively few complaints and even

fewer are upheld by the various bodies reviewing fewer are upheld by the various bodies reviewing them, both governmental and non-them, both governmental and non-governmental. governmental.

• In a number of developing countries self-In a number of developing countries self-regulatory schemes are being negotiated with regulatory schemes are being negotiated with the authorities to provide greater flexibility in the authorities to provide greater flexibility in control, and they are beginning to be put in control, and they are beginning to be put in place. place.

• This will allow hard-pressed authorities to This will allow hard-pressed authorities to concentrate on issues only they should handle. concentrate on issues only they should handle.

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2. 2. When controlWhen control? Pre-? Pre-publication vs publication vs

post-publication enforcementpost-publication enforcement• Pre-publication approval requires the review Pre-publication approval requires the review

of all material and can result in substantial of all material and can result in substantial delays and the highest operating costsdelays and the highest operating costs

• Post-publication complaints systems work Post-publication complaints systems work becausebecause– Companies are in competition and are the first to Companies are in competition and are the first to

complain about any advertising by a competitorcomplain about any advertising by a competitor– Companies know that the alternative is undesirable Companies know that the alternative is undesirable

(government control is slower and more costly)(government control is slower and more costly)– Are cost efficient.Are cost efficient.– Punishment mechanisms can be very effective.Punishment mechanisms can be very effective.

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2. When control?2. When control? Some post- Some post-publication control mechanisms:publication control mechanisms:

• Companies breaching advertising laws and or Companies breaching advertising laws and or self-regulatory codes could be punished by a self-regulatory codes could be punished by a variety of penalties e.g:variety of penalties e.g:– Discontinuation of the advertisementDiscontinuation of the advertisement– Circulation of retraction statementCirculation of retraction statement– Imposition of fines (can be large)Imposition of fines (can be large)– Publication of the decision/formal admonitionPublication of the decision/formal admonition– Referral to Ministry of HealthReferral to Ministry of Health– Withdrawal of Association membershipWithdrawal of Association membership– Withdrawal of right to advertiseWithdrawal of right to advertise– Withdrawal of marketing authority for productWithdrawal of marketing authority for product

• But note - these penalties are rarely necessary!But note - these penalties are rarely necessary!

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Country examplesCountry examples

• Countries with Countries with industry-self-regulated, post-industry-self-regulated, post-publication advertising controlspublication advertising controls include include Argentina, Austria, Croatia, Denmark, Finland, Argentina, Austria, Croatia, Denmark, Finland, Hungary, Ireland, Mexico, Poland, Portugal, Hungary, Ireland, Mexico, Poland, Portugal, Slovak Republic, Slovenia, Sweden, Switzerland, Slovak Republic, Slovenia, Sweden, Switzerland, USA.USA.

• The global trend is in this direction e.g. in 2005 The global trend is in this direction e.g. in 2005 Argentina changed from pre-control to post-Argentina changed from pre-control to post-control system. In Mexico in 2003 the local control system. In Mexico in 2003 the local association AFAMELA developed a code of association AFAMELA developed a code of advertising practice and member companies are advertising practice and member companies are exempted from pre-approval.exempted from pre-approval.

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Summary of WSMI’s positionSummary of WSMI’s position

• OTC advertising makes an important OTC advertising makes an important contribution to public health through contribution to public health through encouraging self-care encouraging self-care

• Effective regulation of advertising Effective regulation of advertising can be achieved through various can be achieved through various mechanisms, with the most efficient mechanisms, with the most efficient and effective being industry self-and effective being industry self-regulation or co-regulation, and post-regulation or co-regulation, and post-publication controls. publication controls.

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For more details…

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Advertising of Advertising of nonprescription medicinesnonprescription medicines

WSMI - PositionWSMI - Position

Gracias!Gracias!

David E. Webber PhDDavid E. Webber PhDDirector-GeneralDirector-General

World Self-Medication Industry World Self-Medication Industry (WSMI)(WSMI)