Selfmed

Guiding Principles in Self-Medication
Executive Summary ................................................................................... 2
1. Roles and Responsibilities in Self-Medication .................................. 3
2. Social and Economic Value of Self-Medication ................................. 7
3. The Classification of Medicines ........................................................11
4. Prescription-to-Nonprescription Switch —
Change of Legal Classification .......................................................... 15
5. Consumer Information and Nonprescription Medicines.............. 19
6. The Advertising Environment ...........................................................23
7. Pricing Issues for Nonprescription Medicines ................................27
8. Visibility and the Retail Environment .............................................. 29
Conclusion ................................................................................................. 31
Appendix ....................................................................................................39
World Self-Medication Industsry 1

Executive Summary.
Every day people throughout the world act on their own on their health — they practice self-care. In some
instances they do so through self-medication. What areas can governments examine to help assure that self-
medication takes place in a responsible framework? How can governments further promote public health and
assure that products designed for self-medication are safe and effective?
This publication represents the views of the World Self-Medication Industry (WSMI), the world federation
representing manufacturers of nonprescription medicines and supplements. It discusses elements of a number of
government policies for promoting better health through responsible self-medication.
• A philosophy of individual participation and • Providing consumer information involves
empowerment underscores responsible self- different modes of communication which
medication — themes present in statements by can fill different roles, with labeling best
the World Health Organization, key regulatory suited to provide necessary information for
authorities, and others. Industry groups, health safe and effective use. Nonprescription drug
professionals, and ultimately individuals them- labeling (labels and/or leaflets) designed for
selves, all have roles and responsibilities in consumers is a fundamental requirement in
putting this philosophy into action. responsible self-medication. Other modes of
• The social and economic value of responsible self- communication — consulting with health
medication must be recognized. Responsible self- professionals, books or articles, brochures, or
medication has a positive health outcome for the newer electronic media — can also play a
individual, and also has additional positive conse- role in health education on medicines for
quences for society as a whole. Particularly in an consumers.
era when the demand for health care outpaces • Advertising, a lower involvement, less tar-
overall economic growth, consumers who prac- geted communication medium, is ill-suited
tice responsible self-medication free up to carry detailed information. It should,
healthcare resources for treating conditions not however, be subject to appropriate rules to
suitable for self-medication. be sure it is truthful and not misleading.
• The first key to developing a drug policy which • Given the competitive environment for
includes self-medication is to draw a distinction nonprescription medicines, consumers are
between those products which require more well-served through a free-market in which
active involvement by a doctor or other qualified manufacturers determine their own prices
health professional for safe and effective use — without government controls.
prescription medicines — and those products • The distribution of nonprescription medicines
which are safe and effective for use by consum- varies considerably around the world. Exam-
ers on the basis of their marketing authorization ining ways to improve the visibility of nonpre-
and labeling (package labels or leaflets) — non- scription medicines and access to them in
prescription medicines. existing channels of distribution where such
• As medical science advances and experience visibility or access is limited is one way to
with newer medicines evolves, mechanisms promote responsible self-medication.
need to be in place to allow the reclassification
or switch of ingredients (or indications) from The sections which follow examine each of these
prescription to nonprescription status. areas, and others, in greater detail.
2 Guiding Principles in Self-Medication

1. Roles and Responsibilities in
Self-Medication.
WORLD HEALTH ORGANIZATION. Many national and international organiza-
tions have looked at how best to establish and structure national drug policies
within their healthcare systems. As a starting point, one fundamental to keep in
mind was noted at an International Conference on Primary Health Care, held in
Alma-Ata in 1978:
“People have the right and duty to participate
individually and collectively in the planning and
implementation of their health care.”1
In line with a philosophy of individual participation and empowerment, the World
Health Organization has noted that responsible self-medication can:
• Help prevent and treat symptoms and ailments that do not require medical
consultation;
• Reduce the increasing pressure on medical services for the relief of minor
ailments, especially when financial and human resources are limited;
• Increase the availability of health care to populations living in rural or remote
areas where access to medical advice may be difficult; and
• Enable patients to control their own chronic conditions.2
GOVERNMENTS. Self-medication is one of the first lines of defense in health

care. It is the most accessible form of health care, and it fulfills a series of valu-
able and sometimes crucial functions for individuals and healthcare systems. That
healthcare systems as well as individuals benefit from self-medication emphasizes
the need for clear policies by national governments. Policies should recognize the
positive role played by products specifically intended for self-medication and
should meet their citizens’ interest—even demand — in taking an active role in
their health. As one U.S. official noted:
“The Food and Drug Administration accepts the concept of
self-medication.The consumer demands it; the law provides for it; and
it is in fact a vital part of our nation’s health care system.”3

1. Roles and Responsibilities in Self-Medication.
The European Parliament has adopted a resolution in which it:

“Considers that responsible self-medication should be further
promoted, which will foster the growing desire of the European
Union’s citizens to take responsibility for their own health and also
help reduce health expenditure. In recent years, responsible
self-medication has been identified as an important element in long
term health policy by the institutions of the European Community.”4
These same themes have been more and more recognized in the newly democratic
countries of central and eastern Europe which had previously developed systems
which did not foresee a high degree of individual responsibility in health care.5
PHARMACISTS AND DOCTORS. Within any system for self-care and self-medication,
as in health care systems as a whole, health professionals of course can and do take an
active role. As the European Commission has noted, pharmacists — in many countries
the most accessible health care professionals — play a key role in providing assistance,
advice, and information to the public about self-medication products and the circum-
stances in which a doctor should be consulted.6 Similarly, WHO has stressed the impor-
tance of collaboration among pharmacists and other health providers involved in patient
care and the safe and effective administration of medicines.7 Finally, WSMI has adopted a
Joint Statement on self-medication with the International Pharmaceutical Federation. The
statement notes the common goals of the two groups to provide high-quality service to
the public and to encourage the responsible use of medicines.8
Doctors can help their patients in managing some of their chronic or recurring
conditions with some nonprescription medicines, thus decreasing burdens on
doctors’ and other health care institutions’ time if it can be spent more valuably
elsewhere — a practice of integrating the complementary roles of professional care
and self-medication, sometimes referred to as collaborative care.9 Doctors can also
raise people’s awareness concerning the use of medicines, further contributing to
responsible self-medication.
One example recognizing these complementary roles comes from the U.K.,
where the British Medical Association and the Department of Health have endorsed
a Doctor/Patient Partnership campaign to encourage people to make better use of
their doctors’ time, including through telephone calls rather than doctor visits, or
increased self-reliance.10
CONSUMER ATTITUDES. Most importantly, governments can be reassured

that consumers can and do practice self-medication responsibly. Evidence
shows consumers recognize and respect nonprescription medicines. As a whole,
they use them appropriately, carefully, and safely; and they read nonprescription
drug labeling.

Consumer practice studies in 14 countries — including countries in Asia,

Europe, and the Americas — document this responsibility.
• As shown in tables 1 and 2, while there are some variations in the incidence
of studied health conditions and responses to them, people generally respond
to their everyday health problems in much the same way around the world.
They let the condition run its course roughly half the time; turn to nonpre-
scription products about a quarter of the time.11
TABLE 1
INCIDENCE OF COMMON CONDITIONS (AT LEAST ONCE A YEAR —
PERCENTAGE OF POPULATION)
Condition UK US India Australia Spain Canada

Colds 66 60 69 85 73 60
Headaches 59 N/A 48 83 71 40
Digestive problems 57 59 36 59 45 29
Muscle aches 52 37 42 38 40 40
TABLE 2
PERCENTAGE OF COMMON CONDITIONS TREATED WITH
NONPRESCRIPTION MEDICINES
35 33
30
28
25 24
22 21
20 20
16
15
10
0 US Australia/ Spain/UK/ Switz. Mexico Italy Japan

Germany Sweden
• Studies show people are cautious and careful when they do turn to nonpre-
scription medicines. As illustrated in table 3, they read labels, and an MRCA

study in the U.S. found they generally take products for less than the maximum
period of time indicated on the label.12 Similarly, a study in Japan found less
than half of one percent of consumers reported they do not read labels.13
TABLE 3
PERCENTAGE OF CONSUMERS REPORTING THEY READ LABELS
COMPLETELY THE FIRST TIME THEY USE A NONPRESCRIPTION MEDICINE.
97 96
90 87
83
UK US Canada Mexico Spain
With knowledgeable, responsible, motivated consumers interested in taking an

active role in their health, it is clearly advisable to have sound policies in place that
both allow and encourage responsible self-medication with products designed for
such use.

• Society benefits if citizens are more self-reliant and judicious in their use of
public health resources through use of self-medication, as this will ease
pressure on limited healthcare resources.
• Studies document savings from the use of nonprescription medicines with
methodologies measuring past behavior, hypothetical savings from a shift
from unnecessary doctor visits to appropriate self-treatment, or based on the
economic concept of consumer surplus.
• Self-medication fits with trends in citizens’ behavior, and fits with trends in
healthcare that governments want — and need — to encourage if their
health policies are to be successful.
2. Social and Economic Value of

Self-Medication.
Self-medication as a first-line therapy for appropriate conditions presents a range of benefits to
individuals and to society generally. First there is an economic value. This refers to the money
saved by the whole society when citizens treat common health ailments with OTC medicines
and by the improvement in overall health outcomes that this money can then buy. A second
contribution is self-medication’s social value. This can be expressed as the way self-medication
fits with and contributes to contemporary values and habits in a society. Today in more and
more countries citizens are taking greater personal control of their life, with shared decision-
making and increased overall self-responsibility. Where the alternative is a doctor consulta-
tion, the costs and benefits of self-medication for the individual and society are summarized
in the table below. The benefits to society are such that, in a world of scare government
resources but more affluent, educated, and empowered citizens, every health policy should
specify what use it will make of self-medication.
TABLE 4
CONCEPTUAL SUMMARY OF COSTS AND BENEFITS OF SELF-MEDICATION
INDIVIDUAL SOCIETY
COSTS • Cost of product • None

• Time and cost of transport to
obtain product
BENEFITS • Symptomatic relief or treatment • No ambulatory care costs

• Less time off work • No drug reimbursement costs
• Usually less expensive than a doctor • Reduced loss in output from absence from work
consultation and prescription • Usually no loss in quality of health outcome
• The individual becomes more • Citizens more self-reliant
knowledgeable about health and
medicines • Citizens more circumspect in their use of
“free” public health resources
• Health outcomes benefit from reallocation
of healthcare resources

2. Social and Economic Value of Self-Medication.
Self-medication is a fact of life. With its broad use and social acceptance, no
health policy should ignore self-medication. Rather, health policy should ask how
this momentum can be leveraged to help achieve its objective.
The individual bears the cost of the self-medication product and any time and
travel costs associated with obtaining it. However, these time and travel costs are
almost always less for self-medication than for a doctor consultation, and the actual
cost of the self-medication product to the individual may be lower than a prescrip-
tion, depending on the reimbursement and insurance position of the individual.
Society bears no costs but stands to receive financial and non-financial ben-
efits. Most obviously, the costs associated with a doctor visit and prescription are
avoided. These of course represent a net benefit only if the quality of the
healthcare outcome is not compromised by responsible self-medication. A num-
ber of studies cited in this publication give reassurance on this point. For ex-
ample, the study showing that women diagnose recurrence of vaginal yeast
infections as accurately as their physicians, and the studies showing that nearly
100% of consumers report reading the label of nonprescription medicines com-
pletely prior to first use (see notes 11 and 34).
Self-medication’s cost-saving potential has been documented in a range of studies.
These cost savings come from factors such as fewer unnecessary doctor visits, a
reduction in time off from work, and the typically lower cost of a nonprescription
medicine as compared to prescription costs.
A Canadian economic study found, for example, that the net savings in just
one province, Ontario, from the nonprescription availability of nonsedating
antihistamines was CAD16 million [USD10.4 million] in 1994, including saving
from fewer medical visits and pharmacy fees, plus time away from work.14 A U.S.
study found consumer healthcare savings attributable to self-care with nonpre-
scription medicines jumped from USD10.5 billion in 1987 to USD20.6 billion in
1996.15 Products switched from prescription to nonprescription status were
responsible for over 60 percent of these savings.16
In a more targeted study, researchers examined the costs to a 260,000-member
health care organization of treating nonsevere heartburn or nonulcer dyspepsia.
Over a five-year period, the costs were estimated at more than USD24 million. If
instead of prescribing medications for patients with these conditions their doctors
had recommended self-treatment, the organization would be expected to save up to
USD6 million over a similar time period—a 25 percent reduction in costs.17
A study in Germany examined what would happen if consumers shifted from
prescribed medicines for self-treatable conditions to nonprescription medicines
approximate six percent of the time. Adding savings to the statutory health
insurance program and working hours lost for doctor visits, and subtracting out
direct expenditures by patients, the study found DEM6.4 billion [USD4 billion]
in savings.18
In Italy, a similar university study estimated savings to the country’s National
Health Service from substitution of prescription products with nonprescription
products for self-treatable conditions in the range of LIT37.9 to 86.1 billion
[USD23.6 to 53.7 million].19

2. Social and Economic Value of Self-Medication.
In short, people are prepared to self-medicate, people can afford to self-medi-

cate, they use self-medication products responsibly, and encouraging self-medica-
tion releases resources which can be reallocated in other health areas. Another fact
is that citizens are seeking out more information about their health than ever
before, and in all likelihood this trend will continue.
Responsible self-medication offers benefits beyond cost-saving. Society benefits
from a citizenry that is better informed about healthcare and more self-reliant, and
from the improvement in overall health outcomes that would be possible if public
resources currently consumed treating common ailments were re-directed toward
illnesses with a larger impact on overall health. These non-financial benefits may be
considered as the social value of self-medication.
Finally, it is also possible to identify a financial benefit to society by using the
economic concept of consumer surplus. Consumer surplus is how economists
describe the gap between what people actually pay for an item versus the benefit
they receive (as measured by what they would have been willing to pay). Using
this concept, a Massachusetts Institute of Technology economist prepared an
estimated demand curve and found an annual gain in consumer welfare of
USD700 million based on prescription-to-nonprescription switches in the cough
and cold area alone.20

• WSMI advocates the drug classification approach taken by many countries, including
Japan, the U.S., Canada, EU as well as WHO with 2 classes of medicines: prescription
and nonprescription.
• Defining and listing criteria under which a product must be limited to prescription
status, and where a product will have nonprescription status, is key since such a
classification system governs legitimate public access and availability to medicines,
and frequently governs information for correct use.
• Classification can be seen as part of the market authorization or registration process,
or as a separate process. In either case, similar safety (including the assessment of
risk), efficacy, and quality considerations will apply.
• A specific product marketing authorization is not the sole method for product regis-
tration and classification. Category or ingredient monographs are alternatives, if
associated with quality controls.
3.The Classification of Medicines.

BASIC CRITERIA FOR A PRESCRIPTION-NONPRESCRIPTION DISTINC-
TION. As noted earlier, the World Health Organization recognizes the positive
contributions of self-medication. In its report on national drug policies, WHO goes
on to state that “while the specific ingredients or drugs authorized for self-medica-
tion may vary from country to country, the criteria for selection are common to all
and should be based on evidence of efficacy and evidence of a wide margin of
safety. In addition, the criteria and process should be transparent.”21
In many countries, these basic criteria are developed by establishing two classifi-
cations of medicines: those which require a prescription from a medical practitioner,
and those which do not — nonprescription (or over-the-counter — OTC) medicines.
In the case of the U.S., the European Union, and Canada, their rules begin with the
assumption or default status that medicines are nonprescription. The rules then spell
out criteria or conditions for drugs which require a prescription.
The European Union directive puts it this way:

“Medicinal products shall be subject to medical prescription where they:
• are likely to present a danger either directly or indirectly, even
when used correctly, if utilized without medical supervision, or
• are frequently and to a very wide extent used incorrectly, and as
a result are likely to present a direct or indirect danger to human
health, or
• contain substances or preparations thereof the activity and/or
side effects of which require further investigation, or
• are normally prescribed by a doctor to be administered
parenterally.”22
The United States law uses different language for a similar concept to define pre-
scription status:
“A drug intended for use by man which —
(A) is a habit-forming drug to which section 502(d) [concerning
specified narcotic substances] applies; or
3. The Classification of Medicines.
(B) because of its toxicity or other potentiality for harmful effect,

or the method of use, or the collateral measures necessary to its
use, is not safe for use except under the supervision of a practi-
tioner licensed by law to administer such drug; or
(C) is limited by an approved application under section 505 [the
section describing the process of approval for new drugs] to use
under professional supervision of a practitioner licensed by law
to administer such drug;
shall be dispensed only (I) upon a written prescription of a practitio-
ner licensed by law to administer such drug…”23
There are three key, common points to the EU and U.S. sets of rules: (1) They
start with the premise of nonprescription status, with prescription status specifi-
cally defined. (2) Safety considerations weigh strongly — based either on toxicity
or side effects, because the ingredient may be habit-forming, or because of the
dosage form a prescription is needed for safe use. (3) They do not subdivide non-
prescription products into categories such as pharmacist or pharmacy only, general
sale, etc. While some EU Member States subdivide nonprescription medicines, as
the European Court of Justice noted, the EU “acknowledges the existence of a
pharmacists’ monopoly in member states, but does not, in view of the fact that it is
not a [European] Community concept, give any definition to it.”24
In addition, both sets of rules require that medicines — prescription and
nonprescription — be effective and follow appropriate assurances for quality.25
MARKET AUTHORIZATION VERSUS CLASSIFICATION. Typically, a product’s

prescription or nonprescription status is considered as part of the market authorization
or registration process — which is most logical and efficient. However, separating
classification from authorization or registration is still practiced in some countries. In
the EU, for example, if a product is authorized in EU Member States through the
Mutual Recognition Procedure, individual Member States are still able to classify the
product differently than other Member States, although they should take the classifica-
tion in the Reference Member State into consideration.26 Two other examples are
Belarus and Argentina. Under a U.S. Food and Drug Administration-Belarus Health
Ministry Memorandum of Understanding, Belarus recognizes FDA approvals as the
basis for expediting registration of products in Belarus, but separates out a decision on
the product’s classification.27 In Argentina, products imported from 15 listed countries
go through an expedited application procedure, but the classification decision is made
independently by the Argentine health authorities.28 (The classification status in the
originating country is, however, a significant factor in the decision.) That said, there are
obviously efficiencies from considering market authorization and classification as a
whole, particularly since classification will typically flow from the assessment of the
level and degree of risk as the authorization is being considered. In addition, as dis-
cussed in section 5, the importance of labeling for consumer use can be studied more
efficiently when authorization and classification are considered together.

EXPEDITED AUTHORIZATION. A more basic consideration when classifying and

authorizing a product is the mechanism for authorization itself. While an indi-
vidual product license or individual registration with a full dossier of information
might be thought of as the primary mechanism, in fact regulatory authorities use a
number of other methods.
For many, if not most, nonprescription drugs, the U.S. FDA uses a Mono-
graph system based on a review of ingredients by class (antacids, internal analge-
sics, etc.) rather than individual product registrations. The Monograph system,
established through a process known as the OTC Drug Review, looks at nonpre-
scription drugs which are “Generally Recognized As Safe and Effective” by quali-
fied experts, and thus do not require an individual product authorization or
registration to be marketed.29 Instead, they can be sold by meeting the terms of
the Monograph for that class of ingredients, including references to other FDA
requirements, such as current Good Manufacturing Practice regulations, which
cover quality requirements.
A somewhat similar approach underlies how the Australian Therapeutic Goods
Administration (TGA) handles registration of certain types of low risk healthcare
products including sunscreens, vitamin and mineral products, and complementary
medicines. For these eligible medicines, a company may use the TGA’s Electronic
Lodgement Facility (ELF) where it submits only limited information about the
product and a signed declaration of the company’s compliance with required
standards. It may then, via this self-assessment approach, proceed to market the
product. The system is extremely time and resource efficient for industry and
government, and consumers benefit from more rapid availability. As a quality
assurance check, the TGA routinely audits a broadly representative sample of
products that have gained entry through the ELF system. Australia is considering
changes to its self-assessment and notification approach to further emphasize
sponsor responsibility and to make it even more efficient for the government.30
Finally, authorities can choose to rely on the approval of another specified
regulatory authority as the basis for registering a product in their own country. For
example, a working group from the authorities of a number of central and eastern
European countries has issued a standard operating procedure to facilitate accep-
tance of European Union-central marketing authorizations in these countries.
Memoranda of Understanding between the U.S. FDA and the Russian Ministry of
Health and the Belarus Ministry of Health are further examples, where the authori-
ties in the latter expedite the registration of pharmaceutical products based on
documentation of FDA approval with simplified information requirements that do
not include clinical, analytical, or other scientific review requirements.31 Many
other countries also accept registration in the country of origin as sufficient for
importation, especially where regulatory authority resources are very limited.
TRADITIONAL MEDICINES. In many parts of the world, traditional medicines

are an important part of self-medication. These medicines are closely related to
national culture and tradition. However, recent work by the World Health Orga-

nization demonstrated that for a large number of medicinal plants international

standards, such as monographs, can be developed.32 Such monographs reflect a
worldwide consensus on the assessment of safety, quality, and efficacy of certain
plants. These WHO monographs could provide a useful route to market for plant-
based medicines that meet monograph standards without unnecessary additional
regulatory requirements. Use and implementation of the WHO guidelines on the
assessment of plant-based medicines could further facilitate this process.33

• The reclassification or switch of medicines from prescription to nonprescription
status has a proven record of serving consumers well in many countries.
• Approaches that build on data developed under prescription drug use and
experience in other countries should be used in evaluating candidates for pre-
scription to nonprescription switch.
4. Prescription-to-Nonprescription
Switch.
With criteria to classify medicines as prescription or nonprescription to underpin
self-medication (as discussed in the previous section), there must also be a mecha-
nism (or mechanisms) to transfer ingredients, indications, or products from pre-
scription to nonprescription status if they are shown to be safe and effective for
consumer use without a prescription. This is typically referred to as prescription-
to-nonprescription (“Rx-to-OTC”) switch.
There are a number of social trends that support or promote prescription-to-

nonprescription switch:
• A trend toward self-medication and increased self-autonomy and reliance in
many parts of the world;
• The cost-effectiveness of nonprescription medicines (rather than placing in-
creased strains on the formal healthcare system for self-treatable illnesses or
conditions); and
• The aging of populations, since the elderly typically take more medicines than
other age groups and are more likely to suffer from chronic or recurring condi-
tions which can sometimes be helped through self-medication.
Prescription-to-nonprescription switch has received a good deal of attention

in many countries, particularly where switches have occurred for new classes of
medicines or for new or expanded indications not previously available on a
nonprescription basis. These switches have been based on solid evidence. Some
examples include:
• Nonprescription smoking cessation products to help those trying to stop
smoking — a serious individual as well as public health problem.
• H2 antagonists at the dose appropriate for heartburn not only treat, but can
prevent the condition.
• Nonprescription products can now help stimulate hair regrowth to turn back
certain types of baldness.
• Nonprescription topical antivirals can now treat cold sores.

4. Prescription-to-Nonprescription Switch.
• Many members of a class of antifungal ingredients, imidazoles, have been

switched from prescription to nonprescription status for women to treat recur-
ring vaginal yeast infections. Medicines for the condition were long thought to
always require a doctor’s prescription, but the switch applicants presented
studies to the regulatory authorities which first authorized the transfer demon-
strating that, after initial diagnosis by a doctor, women in whom the condition
recurred could diagnose it as accurately as their doctors.34
• A number of countries have authorized the prescription-to-nonprescription
switch of several nasal steroid sprays to both treat and prevent certain allergy
symptoms.
But while there is increased attention to prescription-to-nonprescription
switch, the switch trend is not new. Many prescription-to-nonprescription
switches now have a long record of bringing new self-medication opportunities
to consumers and a solid track record of safety and effectiveness. A few ex-
amples include acetaminophen/paracetamol — switched in the 1950s in a
number of countries as an analgesic; a number of countries switched a range of
nasal decongestants and antihistamines from prescription to nonprescription
status in the 1970s; athlete’s foot products — first to treat and later to prevent
the condition — were switched to nonprescription status in the 1970s in many
countries.
The appendix compares over 180 ingredients as to their prescription or
nonprescription (OTC) status in 22 countries. Where available as nonprescrip-
tion medicines, many of them have been switched to that status over the past
generation.
Those countries that have led the world in switching prescription products
to nonprescription status have been very thorough in that process, recognizing
that consumer safety remains the highest priority. While no product, medicine
or otherwise, is completely safe, regulatory authorities in these countries have
demanded appropriate evidence from applicants of a wide margin of safety,
“…THE LARGER POINT IS along with convincing evidence of effectiveness, before transferring the product
to nonprescription status.35 The safety profile has typically been established and
THAT THE DATA ON
documented through years of experience and an extensive number of uses as a
SAFETY AND prescription medicine.36
EFFECTIVENESS SHOULD In a few instances, the introduction of a new nonprescription ingredient
DRIVE SUCH A DECISION, does not come from the prescription-to-nonprescription switch route. Rather,
the new product comes directly to market as a nonprescription medicine. This
NOT AN ARBITRARY
is particularly true for expanded indications, different strengths, or new dosage
TIME-ON-THE-MARKET forms of an active ingredient. For example, some of the strengths or dosage
LIMITATION.” forms of products to treat vaginal yeast infections were originally introduced as
nonprescription products in the U.S., as was triclosan as an antigingivitis
ingredient. Bentoquatum for poison ivy protection is another U.S. example. In
Europe, the nicotine inhalator for smoking cessation is an example. While the
introduction of a product on nonprescription status without prescription
experience is fairly rare, the larger point is that the data on safety and effective-
ness should drive such a decision, not an arbitrary time-on-the-market limita-

4. Prescription-to-Nonprescription Switch.
tion. Direct nonprescription status without prior prescription experience ULTIMATELY, THE FINAL
should not, therefore, be automatically prohibited. IMPACT OF
As science advances and more is known about an ingredient, if new evidence
PRESCRIPTION-TO-
develops leading authorities to believe an ingredient on nonprescription status —
switched or otherwise — can no longer be considered safe or effective for nonpre- NONPRESCRIPTION
scription use, they can and indeed have an obligation to either return it to prescrip- SWITCHES IS THAT THEY
tion status or remove it from the marketplace altogether. The fact that very few OFFER CONSUMERS
ingredients have required reverse switches is testimony to the careful evaluation
given to applications for switch. One method for tracking what is known about MORE OPPORTUNITIES
ingredients is through adverse event reporting systems. Even where such systems AND CHOICES IN THEIR
are not formal government requirements for well-known, established nonprescrip- OWN HEALTH CARE.
tion medicines, nongovernmental systems, including poison control centers, or
published case studies in medical literature, serve a similar function.
Today, some regulatory authorities are looking at guidelines for prescription-
to-nonprescription switch. The EU, for example, has issued a “Guideline on
changing the classification for the supply of a medicinal product for human use.”
The guideline includes criteria for classifying a product as prescription or non-
prescription in the EU and recommendations on data requirements for applica-
tions for switch. The guideline is for use by switch applicants, and by national
authorities, to facilitate EU harmonization on prescription and nonprescription
classification.37 While the U.S. does not have formal switch guidelines, the U.S.
Food, Drug & Cosmetic Act and the requirements adopted through the OTC
Drug Review provide a complete framework for classifying or switching medi-
cines.38
With the extensive and data-driven nature of the prescription-to-nonprescrip-
tion switch process in those countries that have led in this trend, WSMI encour-
ages other authorities to consider these countries’ decisions and safe market
experience as an element in favor of switching such products to nonprescription
status in their own countries. For example, in 1998 the Mexican Ministry of
Health accepted a recommendation from AFAMELA, the WSMI member associa-
tion in Mexico, on the prescription-to-nonprescription switch of 31 ingredients.39
An international comparison of the prescription or nonprescription status of the
ingredients was the main element in the recommendation.
One final aspect of prescription-to-nonprescription switch is the need to
consider research incentives and the ability to protect proprietary data for those
firms who conduct research to first launch a prescription-to-nonprescription
switch. Recognizing that regulatory environments differ, WSMI encourages
systems that include an appropriate period of data protection in order to encour-
age innovation in new self-medication treatments.
Through prescription-to-nonprescription switches, hundreds of millions of
consumers from different cultures and countries around the globe have benefited
from wider appropriate self-treatment options. For the future, prescription-to-
nonprescription switches hold promise for governments by helping to ease
pressures on the formal healthcare system, as consumers can treat more of their

everyday health conditions without the costs associated with the formal system.
Future switches can enable doctors to spend more of their time and attention on
more involved illnesses.
Ultimately, the final impact of prescription-to-nonprescription switches is that
they offer consumers more opportunities and choices in their own health care.

• Different forms of communication are best suited to different roles. Labeling*
(label and/or leaflet) is the best way to deliver the information needed for
consumers to use nonprescription medicines correctly and without profes-
sional supervision.
• WSMI supports information standards or requirements for labeling needed
for safe use — either on product labels themselves or in package leaflets.
• WSMI recognizes that effective labeling is a fundamental requirement for
self-medication.
• Brand names are an efficient shorthand communication tool to aid consum-
ers in identifying the source of nonprescription medicines.
5. Consumer Information and

Nonprescription Medicines.
A demand and need for information about nonprescription medicines naturally
follows from the public interest in self-medication and a clear prescription-nonpre-
scription classification distinction. Information can come in various forms from
various sources, of course, including product labeling; product advertising; discus-
sions between consumers and pharmacists, doctors, or other health professionals;
and through consumer education. Some of the newer electronic media provide yet
another set of communication and information tools. One study estimated that
over 40 percent of Internet users were seeking health-related information.40 Each of
these information sources can fill different roles. Section 6 (p. 23) focuses on
advertising, including its role in alerting consumers to the availability of products
for conditions suitable for self-medication. But advertising is a low involvement
medium ill suited and demonstrably ineffective for carrying detailed or highly
specific information. Rather, detailed information is more relevant at the time a
product is selected for purchase, and later when the product is used. This more
detailed information can come from discussions with pharmacists, doctors, or other
knowledgeable trained sources, and needs to be in the labeling of nonprescription
medicines — the focus of this section.
The World Health Organization, summarizing a report by the International
Advertising Association, described the role and purpose of labeling this way:
“The purpose of labeling is to establish clearly the brand of the prod-
uct, and it should include all relevant information that the individual
purchaser must have to make proper use of it…Labeling is a ‘high
involvement medium’ and tends to carry a heavier load of product
information for the consumer than does advertising. Most readers of
labels are motivated to concentrate on them, to comprehend them, to
follow directions, and to take the indicated precautions. However,
what is important is not the extent to which consumers actually read
* In this publication, we use the term labeling to refer to the printed information that is provided with a product — be it
on a label on an outer package, a label on a product container inside an outer package, or on a leaflet that accompanies a product.
The precise definitions of these terms and precisely where the printed information appears varies among countries.

5. Consumer Information and Nonprescription Medicines.
each and every label, but that they know that the labels contain de-
tailed information about product use so that they can consult them on
questions of usage and safety.”41
Labeling for consumer use is a fundamental requirement for responsible self-
medication. It is often said that, in addition to the physical product itself, labeling
is an equally important product provided by the nonprescription medicine industry.
The information consumers need to use nonprescription medicines correctly and
without professional supervision must be on the label or in the leaflet which comes
with the product. WSMI and its member associations urge consumers to read the
outer label before purchasing, and to read all the labeling with nonprescription
medicines before the first use and before each period of use after that.42 The latter is
particularly important since labeling can change through new dose recommenda-
tions, warnings and other instructions, or because of a change in ingredients.
Some countries, such as the U.S., Canada, or Australia, require that the label
the consumer sees on the product at the point of purchase on the store shelf con-
tain the information required for correct use. This is particularly important when,
as in the U.S., consumers can self-select all nonprescription medicines directly off
store shelves. Other countries, including Japan and most countries in Europe,
require some information on the outer package label, with the rest of the informa-
tion needed for correct use included on a package leaflet or insert. In either event,
labels or leaflets for nonprescription medicines should include:
• The name of the product
• The active ingredient(s) in the product (by established name, if any, the
name from an authoritative pharmacopeia, or INN, for example)
• What the product will do — its purpose and/or its use
• Directions on how to use the medicine — the amount of each dose, how to
take it (by mouth, with water, etc.), and how often to take it
• Who the product is for and when not to take the product, including neces-
sary, relevant warnings for safe use by consumers — limits on use, if any;
side effects, if any; drug interactions, if any; circumstances which may
require a doctor’s advice before taking the medicine
• The net contents of the product
• The name and location of the manufacturer, distributor, or packager
• Other necessary information, such as certain inactive ingredients; special
storage instructions, if any; a batch or lot number; an expiration date, if
the product’s stability deteriorates over time; references to special packag-
ing (such as child-resistant packaging), if any.
A number of WSMI member associations are working with their regulatory
authorities to improve nonprescription medicine labeling — through increased
attention to technical factors which increase readability, through precisely what
information is presented, through the format of the information, and by paying
careful attention to consumer understandability. These efforts are aimed at making
nonprescription medicine labels even more consumer-friendly.

5. Consumer Information and Nonprescription Medicines.
The information in nonprescription medicine labeling is the key to safe and “[A MERCHANT’S]
effective use. Labeling tells consumers what the medicine is supposed to do, who
MARK IS HIS
should or should not take it, and how to use and not use it. Nonprescription
medicine makers want consumers to have the information they need to use such AUTHENTIC SEAL;
products safely and effectively. But industry efforts and government efforts cannot BY IT HE VOUCHES
help consumers unless they read and use the information. For this reason, a num- FOR THE GOODS
ber of projects have focused on public education in the responsible use of medi-
cines. While a description of these efforts is beyond the scope of this publication, WHICH BEAR IT; IT
contact WSMI for more information about education projects by member associa- CARRIES HIS NAME
tions. There are also consumer education sections in a number of web sites spon- FOR GOOD OR ILL.”
sored by member associations, including www.chic.org.uk, www.ndmac.ca, or
www.chpa-info.org.
THE IMPORTANCE OF BRAND NAMES. One final aspect of the label and how
manufacturers give consumers information about their products is the brand
name. A famous judge in the U.S. characterized the brand or trade name this way:
“[A merchant’s] mark is his authentic seal; by it he vouches for the goods which
bear it; it carries his name for good or ill.”43 Brand names communicate in a very
personal way with consumers. Brand names provide consumers with information
they can readily use to identify the source of a product as trusted and familiar.
But brands do not always communicate in a direct, tangible way. Rather, they are
usually a bundle of subjective thoughts we as consumers have when we see the
brand name and then think about the product. As a shorthand, subjective com-
munication tool, brand names can raise awareness about products and self-
medication categories, and manufacturers need flexibility in their presentation
and use of them.
In many instances, having built and established a brand, a manufacturer will
extend that brand through a line extension. By using an already known brand
name, line extensions can be the most effective and economical method by which a
company can recoup its earlier investment in developing the original core brand.
As with brand names and trade names in general, line extensions aid consumers by
providing immediate information to identify the source of a product. Similarly,
manufacturers will typically extend a brand name for products which are reclassi-
fied or switched from prescription to nonprescription status. The European Com-
mission has noted that relaxation on restrictions on the use of brand names for
switched products, where they exist, can help reduce marketing costs and reinforce
competition in the pharmaceutical sector.44

• The different and distinct roles of advertising and labeling need to be recognized.
• Basic standards for advertising should ensure that it is truthful (including appro-
priate substantiation for claims) and not misleading to consumers.
• A mix of government and self-regulatory tools that encourage greater industry
involvement, responsibility, and accountability can be used effectively to control
advertising.
• Government preclearance of advertising is the least efficient control system.
6. The Advertising Environment.

As noted in the previous section, another primary aspect of an information or com-
munication system — indeed, the initial, attention alerting aspect in such a system —
relates to advertising. As with brand names, advertising sometimes communicates
subjectively and in shorthand. It focuses on awareness. The World Health Organiza-
tion, summarizing a report by the International Advertising Association, describes the
purpose of advertising as:
“Attract[ing] attention, offering choices, and provid[ing] limited gen-
eral information to mass audiences of consumers. It must stimulate the
interest of prospective buyers in a…product [and] inform them of
what it may do for them…Therefore, advertising should not be over-
loaded with information to the point that the individual prospective
buyer may fail to comprehend it or may even ignore it.” 45
To look at it another way, advertising is a low involvement medium, and as
such, it is limited in how much it can reasonably convey. Recognizing these
limitations, it must be focused on what it can do: attract the viewer, listener, or
reader’s attention and communicate the availability of a product. A study by
Taylor Nelson Research Ltd. for the Proprietary Association of Great Britain
showed that consumers generally recall two or fewer messages from an advertise-
ment.46 While the study found that advertisements with full label information
were well recalled, recall was unspecific — that is, viewers did not remember
details. Further, the full text significantly decreased the communication of the
main product messages of the commercial: the product name and what it was for.
Full-text advertisements were also more likely to be described as unclear, compli-
cated, confusing, and with too much information.47 Similar results were obtained
in a parallel study in Thailand.48 A German university study of print advertise-
ments similarly found that the greater the volume of information, the smaller the
likelihood of a particular item being remembered.49 At the same time the number
of viewers who can remember not one item of information rises.50
In the 1970s and early 1980s, the U.S. Federal Trade Commission (FTC), which
is responsible for overseeing U.S. consumer advertising, recognized the limitations
of advertising when the five FTC Commissioners unanimously rejected a rule
which would have required warnings in advertising for certain nonprescription
drugs.51 FTC’s rejection concluded an eight-year proceeding which included over

three thousand pages of testimony. Quite simply, the FTC came to understand
advertising’s limitations, and that if too much information is included, listeners will
tune out the message, diminishing the impact of the information.
Rather than relying on advertising, labels or leaflets are the place to effectively
convey fuller information to consumers.
With this background in mind, the World Self-Medication Industry believes
that government policies which regulate advertising should, first of all, rest on two
basic standards:
(1) Claims must be truthful: Another way of saying this is that objective claims
made by advertisements should be supported by adequate substantiation. In the
U.S., for instance, the concept is examined by looking at the type of claim, the
product involved, consequences of a false claim, and the amount of substantia-
tion viewed as sufficient in determining what is adequate or reasonable.52
Similar criteria are used in many countries. In evaluating claim substantiation
for nonprescription medicines, the U.S. Federal Trade Commission, which has
authority in the area, generally looks to FDA determinations or works with the
FDA.53 The European Union takes the approach that a claim must be based on
information in a product’s government-approved marketing authorization — a
more narrow, alternative way to look at substantiation.54 A third approach
toward the same end is to assure that claims are not false, such as the require-
“WSMI STRONGLY ment in Japan that advertising must not, explicitly or implicitly, include false or
FAVORS SELF- exaggerated statements regarding the name, manufacturing process, indication
or effects, or properties of a drug.55
REGULATORY OR CO-
(2) Advertising should not be misleading: This may seem the same as saying an
REGULATORY
advertisement must be truthful, but in fact the focus is different. The U.S.
METHODS AND Federal Trade Commission approaches this aspect from the deception perspec-
GOVERNMENT POST- tive: material representations, omissions, or practices likely to mislead consum-
ers acting reasonably under the circumstances.56 An Australian court applied a
PUBLICATION
similar analysis in looking at their Trade Practices Act and its prohibition on
ENFORCEMENT.” “conduct that is misleading or deceptive.”57
There are a variety of mechanisms — both governmental and self-regulatory —
governments can use to that ensure that nonprescription drug advertisements are
truthful and nonmisleading. Where they can be applied effectively, WSMI strongly
favors self-regulatory or co-regulatory methods and government post-publication
enforcement (i.e., taking action against violations rather than government pre-
clearing or pre-vetting advertisements). Where adequate mechanisms to enforce
such systems are not present, WSMI encourages their adoption and is available to
advise on their creation.
The U.K. provides one example of a self-regulatory or co-regulatory system
(i.e., a system where an industry or self-regulatory body acts on behalf of the
government in enforcing or controlling advertising standards) for nonprescrip-
tion medicine advertising which is underpinned in law. Meanwhile, the govern-
ment continues to have oversight. The Proprietary Association of Great Britain
pre-vets member company advertising under a system started in 1919. Under the

association’s Code of Standards of Advertising Practice, member company non-

prescription drug advertisements to the public are submitted for prior approval
using both general and specific standards.58 In addition, television and radio
advertisements are approved in advance by either the Broadcast Advertising “WSMI ENCOURAGES
Clearance Centre or the Radio Advertising Clearance Centre. In turn, the PAGB THEIR ADOPTION AND IS
and the clearance centres take into account the legal requirements for medicine
AVAILABLE TO ADVISE ON
advertising in the U.K., such as the Medicines Advertising Regulations of 1994,
the Indepdendent Television Commission Code of Advertising Standards and THEIR CREATION.”
Practice, and the Radio Advertising Authority Advertising and Sponsorship Code.
Australia and Canada have similar systems, taking self-regulatory preclearance
one step further: the government has designated non-governmental bodies as de
facto agents of the government in preclearing nonprescription medicine adver-
tisements. In Australia an advisory council continues to advise the government
on oversight of the system.
Japan, Germany, and the U.S. are examples of post-publication control, includ-
ing both governmental and self-regulatory components. In all three cases, their
governments and other parties have ample enforcement tools against violative
advertisements.59
Finally, another method of monitoring advertising is through complaints by
competitors to either nongovernmental or governmental bodies (or to the company
itself, and including to the courts). As one company chief executive officer put it,
“there is no doubt in my mind that the best policeman on the beat is one’s
competitor…They never sleep.”60
In contrast to self-regulatory approaches — either including preclearance or
based on post-publication measures — and post-publication measures by govern-
ment, preclearance by government can be more costly and more prone to delays.
Experience in Australia with increased reliance on co-regulatory mechanisms
serves as an example of a shift away from government preclearance. An Austra-
lian official noted that “the Trade Practices Commission believes that codes of
practice can serve an important role in the overall regulatory mix, and in certain
circumstances can be a more cost-effective way of reaching the desired
outcome…The Commission supports initiatives such as the Proprietary Medi-
cines Association of Australia’s Code which are designed to achieve desirable
outcomes for consumers.”61
Regardless of the system or systems chosen, WSMI requires its member
associations to either introduce their own Codes of Advertising Practice or, where
such Codes already exist, to periodically re-examine them when necessary. WSMI
has prepared Guidelines for the Production of Voluntary Codes of Advertising
Practice to aid member associations in this area. WSMI does not believe, however,
that a single Code applicable to all parts of the world would be appropriate, given
the wide variety of advertising control systems in place, and the need to ensure
that national codes reflect cultural diversity in relation to healthcare generally
and the use of medicines specifically.

• Given the competitive environment for nonprescription medicines, consumers
are well-served through a free market in which manufacturers determine their
own prices without government controls.
7. Pricing Issues for Nonprescription

Medicines.
The pricing of nonprescription medicines, or at least those which are not reim-
bursed by national social security or health insurance coverage programs, is not
subject to price controls in most countries around the world. The European Com-
mission has stated on several occasions that the positive experience with free
pricing for manufacturers of nonprescription medicines should even be taken into
account when discussing prescription medicines and has therefore recommended
to all European Union Member States that they remove price controls for nonpre-
scription medicines.62 The Commission goes on to note that accompanying mea-
sures aimed at reinforcing competition could reduce costs.63 Given the high level of
competition among nonprescription medicine manufacturers, consumers have been
well-served through a free market in which manufacturers set prices based on
supply and demand. In Germany, for example, prices for nonprescription medicines
increased only 1.1 percent in 1995 and 1996.64 Canadian price increases have
averaged less than one percent per year for the past several years.
While recognizing that many governments have some form of price control or
cost-containment measures in place for reimbursed medicines (be they prescription
or nonprescription), the World Self-Medication Industry urges governments to
allow manufacturers to set their own prices for nonprescription medicines based on
market conditions.

• WSMI encourages examining ways to improve the visibility of nonprescription
medicines and access to them in countries that limit visibility and access.
• While access to safe and effective nonprescription medicines through a variety
of outlets and with self-selection encourages retail competition, brings savings
to consumers, and improves consumer choice, convenience, and autonomy,
WSMI recognizes that the distribution of nonprescription medicines has
evolved differently around the world. It is WSMI policy, therefore, to respect
national cultural differences.
8. Visibility and the Retail

Environment.
With past practices of the pharmaceutical industry, community pharmacists, and
others adopted over many, many years, retail distribution patterns for nonprescrip-
tion medicines vary significantly from country to country. In most instances, such
distribution patterns have been translated into national legislation. These distribu-
tion patterns range from limiting the sale of all nonprescription medicines solely to
pharmacies to allowing all nonprescription medicines to be sold in any retail outlet
with self-selection off store shelves by consumers. Where pharmacists are few, some
countries have developed specialized non-pharmacy outlets, such as drug seller
shops and traditional Chinese medicine shops in China or other parts of Asia.
Countries that allow consumers to self-select nonprescription medicines di-
rectly from store shelves include the United States, Nordic countries such as Nor-
way, Sweden, and Finland, and, for a more limited range of nonprescription medi-
cines, the United Kingdom, Canada, Australia, Argentina, Hong Kong, Malaysia,
Singapore, Switzerland, and Germany. The United States is most notable in its
openness, as it allows all nonprescription medicines to be sold with self-selection in
any and all retail outlets.65
A study done by the Proprietary Association of Great Britain with the National
Pharmaceutical Association showed that consumers welcome the opportunity to
self-select.66 Three out of four of the UK consumers in the study felt that re-config-
ured pharmacies with easier access to nonprescription medicines was a good idea,
half because it would save their own time or that of their doctor, and the remainder
because it offered greater choice.67
A number of countries and individual pharmacies have introduced changes in
recent years to either increase the visibility of nonprescription medicines or access
to them. Giving consumers more control and power in their own health care and
current economic trends have been among the forces behind these changes. Good
presentation and visibility of nonprescription medicines not only informs consum-
ers of the range of products available, it can encourage them to seek information
and advice from pharmacists or other health professionals, as demonstrated by
experience in Sweden.68
One example of broadened access is seen in the U.K., where the Medicines
Control Agency has noted increased interest in expanding the list of General Sales

8. Visibility and the Retail Environment
List medicines (those nonprescription medicines that can be sold in any retail
outlet) in that country, citing 35 applications for the year ending March 31, 1997.69
The U.K. has also developed a transparent system for such changes to sale in any
outlet.70
Brazil, Venezuela, the Czech Republic, and the Shanghai province in China are
four other areas where mechanisms are under development to allow some nonpre-
scription medicines to be sold outside of pharmacies. Finally, an advisory body to
Japan’s Ministry of Health — the Central Pharmaceutical Affairs Committee — has
recommended that fifteen OTC drug categories be shifted to “quasi-drug” status
with sale allowed in any retail outlet.71 The categories include throat lozenges,
antibacterial and wound care products, menthol or camphor-containing products,
and certain vitamin/mineral products, among others.72
WSMI believes examining ways to improve the visibility of nonprescription
medicines and access to them is in the public interest, but WSMI also recognizes
that an attempt to harmonize retail distribution patterns among countries would
not be practical. WSMI takes this view because of the many variations in practice
based on local circumstances (including ease of access to pharmacies, historical
patterns, or consumer preferences, among other considerations).

Conclusion.
WSMI hopes this publication can stimulate discussions that improve consumer
choice and interest in responsible self-medication. WSMI and its member associa-
tions welcome opportunities to discuss the issues raised and how they might be
adapted or implemented by regulatory authorities. Specifically, WSMI encourages
governments and interested stakeholders to focus on nine areas in developing
policies for self-medication and nonprescription medicines.
1. Consumers have demonstrated an interest and responsibility in self-care,
including the use of nonprescription medicines. This increasing self-reliance is
considered a positive social development. Statements from leading government
authorities and officials referenced in this document illustrate acceptance of
this fundamental fact.
2. Encouraging responsible self-medication can lead to more cost-effective utiliza-
tion of health care systems and benefit society as a whole.
3. A clear distinction should be drawn between medicines that are designed for
use under a doctor’s supervision — prescription — and those safe and effec-
tive for use on the basis of the marketing authorization and labeling —
nonprescription. Once drawn, this distinction must be enforced. Safety,
effectiveness, and quality considerations will apply in all cases. One clear way
to accomplish a prescription-nonprescription distinction is to define criteria
for prescription medicines, and to then define nonprescription medicines as
the opening assumption or default status. In registering and classifying
medicines, attention should be given to methods other than full individual
product licenses, such as expedited registration methods for well-known
substances (such as monographs, abridged registration, bibliographic applica-
tions, or mutual recognition).
4. With a prescription-nonprescription distinction in place, there must be a
mechanism to allow ingredients, products, or indications to transfer or switch
from prescription to nonprescription status. Prescription-to-nonprescription
switches have been the focus of increased regulatory attention in many coun-
tries in recent years. Many switched products now have a long track record of
bringing hundreds of millions of consumers more opportunities to self-treat
their everyday health conditions safely and effectively. We can do a better job of
benefiting and learning from prescription-to-nonprescription switch experi-
ences in countries other than where the switch initiated.
5. Nonprescription medicine labeling designed for consumer use is a fundamental
requirement for responsible self-medication. Labeling should tell consumers

Conclusion.
what the medicine is, what it is supposed to do, who should or should not take
it, and how to use or not use it. Nonprescription medicine manufacturers know
consumers should have the information needed to use such medicines safely
and effectively.
6. Brand names are an efficient shorthand communication tool to aid consumers
in identifying the source of nonprescription medicines. As an efficient means to
reach consumers, restrictions on the use of brand names should be relaxed.
7. Advertising must be truthful and not misleading. Advertising must be recog-
nized for both its strengths and weaknesses. It can attract attention and com-
municate the availability of a product, but, as a low-involvement medium in a
communication context filled with competing messages, it is ill-suited as an
effective vehicle for detailed information messages. A wide variety and mix of
government and self-regulatory tools exist to control or monitor advertising.
Especially where well-established, well-understood advertising regulation
systems do not already exist, WSMI urges governments to adopt self-regulatory
methods or government post-publication enforcement (i.e., taking action
against violations rather than government pre-clearance of advertisements,
which is costly and time-consuming).
8. Given the competitive environment for nonprescription medicines, a free
market in which manufacturers determine their own prices without govern-
ment controls can best serve consumers. This is supported by the fact that price
increases for nonprescription medicines have frequently been in the range of, or
lower than, inflation as a whole.
9. Increased visibility of nonprescription medicines in the retail setting provides
consumers with more information on the range of products available for self-
care, and can stimulate discussion between consumers and pharmacists or
other healthcare professionals. WSMI recognizes that the distribution of non-
prescription medicines has evolved differently around the world. Some coun-
tries allow self-selection and distribution of some or all nonprescription medi-
cines in any retail outlet. Others limit the sale of some or all nonprescription
medicines to pharmacies and limit self-selection. WSMI respects these national
cultural differences regarding where nonprescription medicines are sold.

Endnotes.
1
Primary Health Care. Report of the International Conference on Primary
Health Care, Alma-Ata, USSR, September 6-12, 1978. World Health Organization,
Geneva, Switzerland, 1978 (“Health for All” series, No. 1).
2
Report of the WHO Expert Committee on National Drug Policies, Geneva,
Switzerland, June 19-23, 1995. World Health Organization document WHO/DAP/
95.9.
3
Speech by FDA Commissioner Dr. Charles C. Edwards, 1972 (announcing the
start of a regulatory review of nonprescription medicines in the U.S.).
4
Report on the “Communication from the European Commission to the Coun-
cil and the European Parliament on the outlines of an industrial policy for the
pharmaceutical sector in the European Community,” adopted by the European
Parliament, April 16, 1996.
5
See Developing Self-Medication in Central and Eastern Europe, Association of
the European Self-Medication Industry (AESGP), Brussels, Belgium, 1993.
6
See “Communication from the European Commission concerning health
promotion, information, education and training within the framework for Commu-
nity action in the field of public health,” June 1, 1994. (COM (94) 202 final.)
7
See WHO resolution, “Role of the pharmacist in support of the WHO revised
drug strategy,” EB93.R12, 1994.
8
Joint Statement by the International Pharmaceutical Federation (FIP) and the
World Self-Medication Industry (WSMI) on Responsible Self-Medication, Novem-
ber 4, 1998.
9
See The individual and healthcare: Added value through self-medication,
AESGP, June 1994, at 24.
10
See Promoting Responsible Consumer Health Care: Proprietary Association of
Great Britain Annual Report–1997, PAGB, July 1997 (discussing the launch of the
program).

Endnotes.
11
Jerome A. Reinstein, Ph.D., “Worldwide Studies on Self-Medication: What Do
They show?” Swiss Pharma vol. 13, number 11a, 1991, 21-25; Consumer Usage
and Attitude Study 1991, Canadian Facts, Toronto, Ontario, 1991.
12
Id.
13 “
Report of 15th Survey of Consumer Awareness of OTC Drugs,” PAJ Newslet-
ter, Proprietary Association of Japan, November 14, 1997.
14
See The Economics of Self-Medication, Queen’s Health Policy, Queen’s Univer-
sity, Kingston, Ontario, Canada, June 1995.
15
See Economic Benefits of Self-Medication — A Report to NDMA, Kline &
Company, Inc., May 15, 1997.
16
Id.
17
Kimberly Kunz, et al., “Economic Implications of Self-Treatment of Heart-
burn/Nonulcer Dyspepsia with Nonprescription Famotidine in a Managed Care
Setting,” Journal of Managed Care Pharmacy, May/June 1996, at 263.
18
See U. May, “Die volkswirtschaftliche Bedeutung der Selbstmedikation in
Deutschland,” Pharm. Ind 59 HedH6 (1997), as summarized in Encouraging Self-
Medication Can Reduce the Healthcare Cost Burden: An Economic Analysis of Self-
Medication, AESGP, 1998.
19
See Dr. Giovanni Fattore, Bocconi University, “The Economic and Social
Value of Self-Medication: Italy,” AESGP Proceedings: From Paternalism to Au-
tonomy—The Importance of Responsible Self-Medication, Budapest, Hungary, June
18-21, 1997, at 39.
20
See Peter Temin, “Realized Benefits from Switching Drugs,” Journal of Law
and Economics, October 1992, at 351.
21
Report of the WHO Expert Committee on National Drug Policies, 1995,
supra.
22
Council Directive 92/26/EEC, art. 3, 1992 O.J. L 113/5.
23
21 U.S.C.353(b)(1) (1988) (also known as the Federal Food, Drug, and
Cosmetic Act, section 503(b)(1)).
24
Case C-369/88 Re Delattre, 1991 E.C.R. I-1487.
25
See Council Directives 65/65/EEC, 75/318/EEC, and 75/319/EEC, as
amended, which lay down the principles for granting marketing authorizations in
the European Union; and for the U.S., 21 U.S.C. 321(p) (referencing general
recognition of safety and effectiveness for drugs which are not new), 21 U.S.C.
355(b) and (j) (including evidence of effectiveness in drug applications), and 21
U.S.C. 351(a)(2)(B) (requiring conformance with good manufacturing practices).
In Japan, similar assurance is gained through a dual registration system. A
product must obtain: (1) Shonin — official confirmation that a product is registered
as a drug and that its safety and efficacy have been established; and (2) Kyoka —

Endnotes.
certification that the manufacturer is qualified as an applicant and meets both

personal requirements and structural/operational requirements from the Ministry of
Health and Welfare. See PAJ Guide, Proprietary Association of Japan, 1996, at 13.
26
See Council Directive 93/39/EEC, 1993 O.J. L 214, amending Directives 65/
65/EEC, 75/318/EEC, and 75/319/EEC re: the decentralized or Mutual Recognition
Procedure. (Under the decentralized procedure, an applicant obtains a marketing
authorization in one Member State and then applies for recognition of that market-
ing authorization in other Member States using an Assessment Report from the
initial (or Reference) Member State and the same registration dossier. The subse-
quent Member States then either recognize the initial decision or raise objections
on serious health concerns. In the latter case, an arbitration process conducted
through the European Agency for the Evaluation of Medicinal Products (EMEA)
Committee for Proprietary Medicinal Products follows.)
27
See “Memorandum of Understanding Between the Food and Drug Adminis-
tration of the United States and Ministry of Health of the Republic of Belarus,”
March 25, 1996. Under the Memo, applicants can seek expedited registration based
on documentation of U.S. approval (including via FDA Monographs, which are
discussed below) without clinical, analytical, or other scientific review require-
ments by Belarus.
28
See International Federation of Pharmaceutical Manufacturers Associations
Compendium, “Argentina,” 1994; and letter from the Latin American OTC Associa-
tion (ALPO) to Nonprescription Drug Manufacturers Association, January 5, 1998.
29
See 21 C.F.R. Part 330 for the detailed procedures covering the OTC Drug
Review. (The U.S. OTC Review Monograph process, largely completed but with
some Monographs still to be finalized, has been extremely extensive, involving over
22,000 volumes of data submitted by the industry. The FDA and Congressional
committees have noted that the Monographs serve as the government’s “stamp of
approval” for the products within the Monographs.)
30
See “Draft Model for a New Process for the Listing of Drug Products on The
Australian Register of Therapeutic Goods,” Therapeutic Goods Administration,
August 28, 1998.
31
See “U.S. FDA-Belarus Health Ministry Memo of Understanding,” supra; and
“Memorandum of Understanding Between the Food and Drug Administration of
the U.S. and the Ministry of Health and Medical Industry and the State Committee
for Sanitary and Epidemiological Surveillance of the Russian Federation,” 59
Federal Register 46054 (September 6, 1994).
32
See WHO Monographs of Widely Used Medicinal Plants, vol. I, Geneva [in press,
1999].
33
See WHO Guidelines for the Assessment of Herbal Medicines, Geneva, 1991.
34
See generally Kristie Egstrand, Schering-Plough HealthCare Products, “Case
Study on the Switch of Gyne-Lotrimin,” in NDMA Conference on Rx-to-OTC

Endnotes.
Switch: Proceedings, September 15, 1992 (Washington, D.C.), at 80 (describing the

prescription-to-nonprescription switch process in the U.S., including the studies
and company activities that went into that process).
35
See, for example, Dr. Debra Bowen, U.S. Food and Drug Administration, “Mak-
ing the Switch to OTC,” Cosmetics & Toiletries Magazine, May 1996, at 102, and
Tamar Nordenberg, U.S. Food and Drug Administration, “Now Available Without a
Prescription,” FDA Consumer (published by the U.S. Food and Drug Administra-
tion), November 1996, at 6, for general descriptions of the considerations FDA goes
through in evaluating nonprescription drug applications. See also Dr. Michael
Weintraub, U.S. Food and Drug Administration, “FDA’s Perspective on Switch Today,”
in NDMA Conference on Rx-to-OTC Switch: Proceedings, September 15, 1992
(Washington, D.C.), at 13, for a similar description of the prescription-to-nonpre-
scription switch process and what FDA looks for in switch applications.
36
Id.
37
See “A Guideline on changing the classification for the supply of a medicinal
product for human use,” European Commission, September 29, 1998. New
Zealand’s Guidelines on the classification of medicines are another example.
38
See R. William Soller, Ph.D., “OTCness,” Drug Information Journal, number
2, 1998, for a description of the U.S. framework used in assessing classification.
39
See letter from Dr. Guillermo Bierzwinsky, Director of Medicines Control,
Mexico Ministry of Health, to AFAMELA, February 25, 1998.
40
Thomas E. Miller, Interactive Demography, FIND/SVP, April 8, 1997, at
www.cyberatlas.com.
41
Report on the WHO Survey on Ethical Criteria for Medicinal Drug Promo-
tion, World Health Organization, at 16, WHO Doc. DGO/ETHCDP/87.3, summa-
rizing Labelling and Advertising: Their Functions in Consumer Information,
International Advertising Association, 1987.
42
See, for example, Expert Opinions on OTC Drugs — Proper Use of OTC
Drugs, Proprietary Association of Japan, 1997, which the assocation distributed
widely to consumer centers and local health authorities, describing proper use of
nonprescription medicines and their labeling.
43
Judge Learned Hand in Yale Electric Corp. v. Robertson, 26 F.2d 972 (2d Cir.
1928).
44
See “Commission Communication on the Single Market in Pharmaceuticals,”
COM (98) 588, November 25, 1998, at 12.
45
International Advertising Association, Labelling and Advertising: Their
Functions in Consumer Information, as summarized in Report on the WHO Survey
on Ethical Criteria for Drug Promotion, supra.
46
See Taylor Nelson Research Ltd., Information or Communication? A Con-
sumer Study of Television Advertising (Proprietary Association of Great Britain,
1990).

Endnotes.
47
Id.
48
See V. Chirapravati in WFPMM 2nd Asia/Pacific meeting proceedings, No-
vember 20-22, 1995 (Bangkok, Thailand), at 63.
49
See H.M. Kepplinger, “Advertising — To inform or to communicate? How far
can advertising be used to inform?” Swiss Pharma 12 (1990), 73-77.
50
Id.
51
See 6 Trade Reg. Rep. (CCH) ¶ 38044.
52
See In re Pfizer Inc., 81 F.T.C. 23 (1972).
53
See Eve E. Bachrach, “Over-the-Counter Drug Advertising: FTC and FDA
Concerns,” 7 Food, Drug and Cosmetic Section Newsletter (New York State Bar
Association), September 1990, at 7.
54
See Council Directive 92/28/EEC, art. 2, 1992 O.J. L 113/13.
55
See “Standards for Fair Advertising Practices of Drugs, Quasi-drugs, Cosmet-
ics, and Medical Devices,” Pharmaceutical Affairs Bureau Notification No. 1339,
October 9, 1980, and “Comments on the Standards for Fair Advertising Practices of
Drugs, Quasi-drugs, Cosmetics, and Medical Devices,” Pharmaceutical Affairs
Bureau/Inspection and Guidance Division Notification No. 121, October 9, 1980.
56
See Bachrach, supra, at 7, and Thompson Medical Co., 104 FTC 648 (1984).
57
See PMAA submission to the Commonwealth Government, supra, at 20,
citing Trade Practices Act, section 52, and as analyzed in Farquhar v. Bottom, 2
NSWLR 380 (1980), where the court noted the test to be applied was one of rea-
sonableness. The opinion stressed that the test is one of what an ordinary, reason-
able reader would take from the advertisement, including based on its context and
the fact that ordinary readers can and do read between the lines in light of day-to-
day experience.
58
See European Advertising Standards Alliance, Advertising Self-Regulation in
Europe Medicine Advertising Regulation and Self-Regulation in 54 Countries,
Brussels, Belgium (1997).
59
See, for example, “Standards for Fair Advertising Practices of Drugs, Quasi-
drugs, Cosmetics, and Medical Devices,” Pharmaceutical Affairs Bureau Notifica-
tion No. 1339, October 9, 1980, and “Comments on the Standards for Fair Adver-
tising Practices of Drugs, Quasi-drugs, Cosmetics, and Medical Devices,” Pharma-
ceutical Affairs Bureau/Inspection and Guidance Division Notification No. 121,
October 9, 1980, describing Japanese advertising standards. See James D. Cope,
“Nonprescription Drugs and the Regulation of Advertising,” Journal of Drug Issues,
at 257 (1992), for a description of U.S. advertising controls.
60
William E. LaMothe, “Over-Regulation vs. Self-Regulation,” The Advertiser
(Association of National Advertisers), fall 1991, at 24.
61
Trade Practices Commissioner Allan Asher to the Proprietary Medicines
Association of Australia members meeting, May 1994.

Endnotes.
62
See “Communication from the Commission to the Council and the European
Parliament on the Outlines of an Industrial Policy for the Pharmaceutical sector in
the European Community,” COM (93) 718, March 2, 1994, at 17; and “Commission
Communication on the Single Market in Pharmaceuticals,” COM (98) 588, Novem-
ber 25, 1998, at 12.
63
Id.
64
See Dr. Hermann Kortland, BAH, “Health Economics,” in AESGP Proceed-
ings: From Paternalism to Autonomy — The Importance of Responsible Self-
Medication, Budapest, Hungary, June 18-21, 1997, at 80.
65
As a matter of individual state law in the U.S., some states limit certain
controlled substances with a low level of abuse potential to sale in pharmacies.
These nonprescription Schedule 5 controlled substances are not the focus of this
publication, and more information is available from WSMI’s U.S. member associa-
tion, the Consumer Healthcare Products Association.
As to where consumers choose to purchase nonprescription medicines, for the
three largest classes of trade, the market research firm Information Resources, Inc.,
estimates 34% of nonprescription medicines and other health-related items are
purchased from mass merchandise outlets, 33% from pharmacy outlets, and 32.5%
from food stores in the U.S. Many U.S. mass merchandisers and food stores have a
pharmacy within the store. “The OTC Marketplace: The Figures Suggest Competi-
tion is Fierce,” Drug Topics, 1998.
66
PAGB/NPA 1993 study.
67
PAGB/NPA supra
68
See Anders Uppfeldt, “Case Study Sweden,” Improving Visibility of Self-
Medication in Pharmacies, AESGP, May 1998.
69
See “High GSL Demand Experienced by UK MCA,” OTC Bulletin, August 29,
1997, at 9, reporting on the Medicine Control Agency’s annual report.
70
See “Changing the Legal Classification in the United Kingdom of Medicine
for Human Use from Pharmacy to General Sale List,” Medicines Act Leaflet 82,
March 1996.
71
PAJ Newsletter, No. 37-02-98, May 11, 1998, at 1-2.
72
Id.

Appendix.
Classification of Selected Ingredients in the
European Union (click here)
Classification of Selected Ingredients World-Wide

(click here)

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Guiding Principles in Self-Medication

Executive Summary ................................................................................... 2

1. Roles and Responsibilities in Self-Medication .................................. 3

2. Social and Economic Value of Self-Medication ................................. 7

3. The Classification of Medicines ........................................................11

5. Consumer Information and Nonprescription Medicines.............. 19

6. The Advertising Environment ...........................................................23

7. Pricing Issues for Nonprescription Medicines ................................27

8. Visibility and the Retail Environment .............................................. 29

World Self-Medication Industsry 1

2 Guiding Principles in Self-Medication

GOVERNMENTS. Self-medication is one of the first lines of defense in health

World Self-Medication Industsry 3

The European Parliament has adopted a resolution in which it:

CONSUMER ATTITUDES. Most importantly, governments can be reassured

4 Guiding Principles in Self-Medication

Consumer practice studies in 14 countries — including countries in Asia,

Condition UK US India Australia Spain Canada

0 US Australia/ Spain/UK/ Switz. Mexico Italy Japan

World Self-Medication Industsry 5

UK US Canada Mexico Spain

With knowledgeable, responsible, motivated consumers interested in taking an

6 Guiding Principles in Self-Medication

2. Social and Economic Value of

COSTS • Cost of product • None

BENEFITS • Symptomatic relief or treatment • No ambulatory care costs

World Self-Medication Industsry 7

8 Guiding Principles in Self-Medication

In short, people are prepared to self-medicate, people can afford to self-medi-

World Self-Medication Industsry 9

3.The Classification of Medicines.

The European Union directive puts it this way:

(B) because of its toxicity or other potentiality for harmful effect,

MARKET AUTHORIZATION VERSUS CLASSIFICATION. Typically, a product’s

12 Guiding Principles in Self-Medication

EXPEDITED AUTHORIZATION. A more basic consideration when classifying and

TRADITIONAL MEDICINES. In many parts of the world, traditional medicines

World Self-Medication Industsry 13

nization demonstrated that for a large number of medicinal plants international

14 Guiding Principles in Self-Medication

There are a number of social trends that support or promote prescription-to-

Prescription-to-nonprescription switch has received a good deal of attention

World Self-Medication Industsry 15

• Many members of a class of antifungal ingredients, imidazoles, have been

16 Guiding Principles in Self-Medication

World Self-Medication Industsry 17

18 Guiding Principles in Self-Medication

5. Consumer Information and

World Self-Medication Industsry 19

20 Guiding Principles in Self-Medication

World Self-Medication Industsry 21

6. The Advertising Environment.

World Self-Medication Industsry 23

24 Guiding Principles in Self-Medication

association’s Code of Standards of Advertising Practice, member company non-

World Self-Medication Industsry 25

7. Pricing Issues for Nonprescription

World Self-Medication Industsry 27

8. Visibility and the Retail

World Self-Medication Industsry 29

30 Guiding Principles in Self-Medication

World Self-Medication Industsry 31