Advertising of nonprescription medicines WSMI - Position David E. Webber PhD Director-General World Self-Medication Industry (WSMI)

The World Self-Medication Industry (WSMI) WSMI is a federation of around 55 member associations representing manufacturers and distributors of nonprescription (OTC) medicines on all continents. CAMESIP through ILAR is an important member, as are ALL companies. Based near Geneva Switzerland, WSMI aims to help communicate the value, at the international level, of self-care and responsible self-medication using OTCs. WSMI is in official relations with WHO, WMA, FIP, ICN, WIPO, Codex Alimentarius, ICH and the UN.

Why is OTC advertising important, really? Advertising is important in encouraging people to look after themselves through self-care Self-care is essential for tackling the ‘chronic disease’ future of Venezuela People undertake better self-care if they are aware of, and ‘armed with the tools’ of self-care – OTCs To support people’s awareness of the opportunity and need for self-care, OTC advertising is essential OTC (not Rx) advertising…plus public health advertising, which is different

Chronic diseases = the future Non-communicable (chronic) diseases are emerging as the primary source of disease burden in both developed and developing countries. Cardiovascular diseases Cancer Chronic respiratory diseases Diabetes

Chronic respiratory diseases Cardiovascular diseases Projected global deaths by cause, all ages, 2005 (WHO 2005) 7 586 000 deaths 17 528 000 deaths 4 057 000 deaths 2 830 000 deaths 1 607 000 deaths 833 000 deaths 1 125 000 deaths Chronic respiratory diseases Cardiovascular diseases HIV/ AIDS Tuberculosis Malaria Cancer Diabetes

Projected main causes of death, WHO Region of the Americas, all ages, 2005 Injuries 9% Cardiovascular disease 33% Communicable, maternal and perinatal, nutritional deficiences 13% Other chronic diseases 14% Diabetes 5% Chronic respiratory disease 7% Cancer 19% Ref: www.who.int/chp/chronic_disease_report/en/

Venezuela is similar to the Region*: Cardiovascular disease is no. 1 cause of death Cancer is 2nd Diabetes is 5th What has this got to do with OTCs and OTC advertising? (*see http://www.paho.org/English/DD/AIS/cp_862.htm)

Causes of chronic diseases (WHO 2005) Social, cultural, political etc factors Risk factors Intermediate risk factors Main chronic diseases Globalization Urbanization Population ageing Unhealthy diet Physical inactivity Tobacco use (Age & heredity) Raised blood pressure Raised blood glucose Abnormal blood lipids Overweight/obesity Heart disease Stroke Cancer Chronic respiratory diseases Diabetes

How well will health systems cope with chronic disease? Chronic diseases are substantially determined by lifestyle-related factors - unhealthy diet, physical inactivity, tobacco use - where health, education and culture are intimately related. Current health systems are oriented to treatment of communicable disease (sickness services), not prevention or management of chronic disease.

Chronic diseases are substantially preventable At least 80% of premature heart disease, stroke and type 2 diabetes, and 40% of cancer could be prevented through healthy diet, regular physical activity and avoidance of tobacco. But how?

But the current model is inadequate Medical professionals (and governments) cannot alone solve the world’s problems with obesity, smoking habits, risky lifestyles etc. Developing better health must inevitably involve actions and measures lying outside the current reach of health systems. Self-care and self-medication by individuals themselves has a particularly important role to play. People have to be motivated themselves, and be supported. How?

Passive patient or proactive self-care participant? Vicious circle Virtuous circle Passive patient Proactive participant ? Less effort to improve his own health Engages in improvement in his health Unable to influence his own health Able to influence his own health (The biomedical model)

Passive Patients or Proactive Participants? QUESTION: How do you get people to change from being Passive patients, to being Proactive participants in self-care? Passive Patient Proactive Participants The answer is to encourage and support self-care…

“Self-care is the care taken by individuals towards their own health and well being, including the care extended to their family members and others.” Self-Care is a broad concept including: Hygiene (general and personal) Nutrition (type and quality of food eaten) Physical exercise Avoidance of risk (e.g. smoking) Psychological health Environmental factors (living conditions) Socioeconomic factors (income level, cultural beliefs, etc) Self-medication

The elements of self-care Physical activity Good nutrition Psychological health Self-care Risk factor avoidance How do you encourage people to undertake self-care?

Osteoporosis (Calcium) OTC medicines are ‘tools’ of self-care – helping to change intention into action Osteoporosis (Calcium) Derms, sunblock Tonics Cough & cold Gastrointest. Physical activity Analgesics Functional foods Anti-Migraine Good nutrition Psychological health Self-care Herbals Sleep aids Vitamins Risk factor avoidance Quit smoking (NRT) Minerals & supplm Anti-cholesterol Water purifiers Anti-obesity

In summary, Give people better access to more self-medication products – OTCs – in support of self-care. Make people aware through advertising. Develop public health education programmes – public advertising important

What does OTC advertising achieve? (for the patient) Brings to people’s attention a medical condition, plus the fact that there is something they can do about it for themselves. Alerts consumer to new products and new indications Introduces or reinforces other forms of communication about a product and brand Develops brand recognition that can provide the consumer with confidence in the brand and the company Facilitates product search and helps consumer make informed selections Fundamentally, OTC advertising raises peoples’ involvement in their own self-care. Without this, the chronic disease epidemic will not be stopped.

Advertising brands recruits people into selfcare Anti-smoking advertising has become so effective that it is now more powerful than doctors (General Practitioners, GPs) in persuading smokers to kick their habit Advertising campaigns prompted 32% of recent attempts to kick the habit while GPs were responsible for just 21%

Advertising cannot: Provide comprehensive education about health, a disease or its treatment Not same as public health education Encourage or force people to buy something they don’t want or need Advertising is an important tool to develop knowledge about new products, but it is not a general consumption incentive. OTCs are not ‘aspirational goods’, people do not rush out to buy medicines if they have no need for them.

Advertising is just one element in the mix People receive information about minor illnesses and OTC medicines from: Doctors, pharmacists and other healthcare professionals Friends, family and colleagues Health books/manuals or TV health shows TV and radio advertising Newspapers, magazines Internet Advertising is just one element in the mix

Mechanisms of control of advertising Two dimensions to consider: Who leads on control? Government, self-regulatory, or co-regulatory controls When control and enforce? Pre-publication vs post-publication

Who leads on control? Industry self-regulation in promotion WSMI position – put responsibility on industry Industry self-regulation works well because: Companies know that the alternative is undesirable (government control is slower and more costly) Companies are in competition and are the first to complain about any advertising by a competitor Penalties can be substantial An intermediate step can be co-regulatory systems

1. Who leads on control? Industry self-regulation in promotion WSMI supports the development of country-specific industry “codes of practice”. Examples: AESGP “Guidelines for the advertising of nonprescription products” NDMAC “Code of Marketing Practices” (47pp) PAGB “Medicines Advertising Codes” (68pp) Codes typically contain procedures for judging complaints along with measures for non-compliance. Codes of practice can be agreed with the local Ministry of Health or other government body.

1. Who leads on control? In practice self-regulation works well: General government satisfaction with the system There are relatively few complaints and even fewer are upheld by the various bodies reviewing them, both governmental and non-governmental. In a number of developing countries self-regulatory schemes are being negotiated with the authorities to provide greater flexibility in control, and they are beginning to be put in place. This will allow hard-pressed authorities to concentrate on issues only they should handle.

2. When control? Pre-publication vs post-publication enforcement Pre-publication approval requires the review of all material and can result in substantial delays and the highest operating costs Post-publication complaints systems work because Companies are in competition and are the first to complain about any advertising by a competitor Companies know that the alternative is undesirable (government control is slower and more costly) Are cost efficient. Punishment mechanisms can be very effective.

2. When control? Some post-publication control mechanisms: Companies breaching advertising laws and or self-regulatory codes could be punished by a variety of penalties e.g: Discontinuation of the advertisement Circulation of retraction statement Imposition of fines (can be large) Publication of the decision/formal admonition Referral to Ministry of Health Withdrawal of Association membership Withdrawal of right to advertise Withdrawal of marketing authority for product But note - these penalties are rarely necessary!

Country examples Countries with industry-self-regulated, post-publication advertising controls include Argentina, Austria, Croatia, Denmark, Finland, Hungary, Ireland, Mexico, Poland, Portugal, Slovak Republic, Slovenia, Sweden, Switzerland, USA. The global trend is in this direction e.g. in 2005 Argentina changed from pre-control to post-control system. In Mexico in 2003 the local association AFAMELA developed a code of advertising practice and member companies are exempted from pre-approval.

Summary of WSMI’s position OTC advertising makes an important contribution to public health through encouraging self-care Effective regulation of advertising can be achieved through various mechanisms, with the most efficient and effective being industry self-regulation or co-regulation, and post-publication controls.

For more details…

Advertising of nonprescription medicines WSMI - Position Gracias! David E. Webber PhD Director-General World Self-Medication Industry (WSMI)