REQUIREMENTS AS TO STANDARDS AND PRACTICE ON PROGRAMMES INVOLVING THE PARTICIPATION OF CERTAIN HEALTH

METHODS OF ADVERTISING AND DIRECTIONS APPLICABLE TO MEDICINAL

PRODUCTS AND TREATMENTS

SUBSIDIARY LEGISLATION 350.30

REQUIREMENTS AS TO STANDARDS AND

PRACTICE ON PROGRAMMES INVOLVING THE

PARTICIPATION OF CERTAIN HEALTH

PROFESSIONALS IN THE BROADCASTING MEDIA

AND REQUIREMENTS AS TO ADVERTISEMENTS,

METHODS OF ADVERTISING AND DIRECTIONS

APPLICABLE TO MEDICINAL PRODUCTS AND

TREATMENTS

29th January, 2008

GOVERNMENT NOTICE 88 of 2008.

The title of these requirements is the Requirements as to

Standards and Practice on Programmes Involving the Participation

of Certain Health Care Professionals in the Broadcasting Media and

Requirements as to Advertisements, Methods of Advertising and

Directions Applicable to Medicinal Products and Treatments.

Background

1.1. These requirements as to Standards and Practice have been

made by the Broadcasting Authority in virtue of the powers

conferred by article 20(3) of the Broadcasting Act.

1.2. These requirements as to Advertisements, Methods of

Advertising and Directions have been made by the Broadcasting

Authority in virtue of the powers conferred by article 19(3) and (5)

of the Broadcasting Act.

1.3. Programmes, advertisements, programme sponsorship and

teleshopping that are within the scope of these Requirements shall

comply with all relevant Maltese legislation.

1.4. These Requirements shall be read in the light of existing

la ws. For ea se of re fere nc e s uc h la ws are availa ble on the

Broadcasting Authority’s website at: www.ba-malta.org.

Part One

Advertising of Medicinal Products

Medicinal Products and Prescription

2.1. For the purpose of paragraph 16 of the Third Schedule to

the Broadcasting Act it is hereby declared that the medicinal

products which can be advertised are those medicinal products

which have a marketing authorisation and which are not classified

as products which require a prescription except in the case of

vaccination campaigns carried out by the industry after having

obtained the approval of the licensing authority set up under the

Medicines Act.

Advertising of Medicinal Products Not Supplied on

PRODUCTS AND TREATMENTS

Prescription

3.1. With regard to those medicinal products which are not

supplied on prescription and which have a marketing authorisation,

these medicinal products may be advertised on a broadcasting

medium only if they comply with the requirements listed in

(a) paragraph 18 of

the

Third

Schedule

to

the

Broadcasting Act;

(b) the Medicinal Products (Advertising) Regulations;

(c) the provisions of this Part of the Requirements as to

Advertisements, Methods of Advertising and

Directions.

Part Two

Advertising for Medical Treatments

Definition of "Medical Treatment"

4.1. For the purpose of paragraphs 16 to 18 of the Third

Schedule to the Broadcasting Act, "medical treatment" includes

any form of advice relating to the treatment or cure of maladies or

ailment, or any advice relating to health.

Part Three

Medical Treatments, Medicinal Services

and Cosmetic Treatments and Services

General Rules on Medical Treatments, Medicinal Services

and Cosmetic Treatments and Service

5.1. No advertisement of a medical service may be made unless

such service is licensed in terms of article 98(1) of the Medical and

Kindred Professions Ordinance. Such services are provided by

hospitals, clinics, maternity homes, nursing homes, homes for the

a g e d , m e d i c a l d i a g n o s t i c l a b o r a t o r i es , X - r a y d e p a r t m e n t s ,

chiropody clinics, acupuncture and medical diagnostic labs,

tattooists, dental clinics and physiotherapy clinics.

5.2. Advertisements shall not make reference to a service listed

in paragraph 5.1 or to any other similar body unless a bona fide

establishment corresponding to the description used does in fact

exist.

5.3. References to a prize, competition or similar scheme are

not permitted in advertisements for medical treatment, medicinal

services and cosmetic treatments and services.

5.4. No claims may be made in respect of prevention, treatment

or cure of a disease unless they are supported by sound scientific

evidence.

Cosmetic Treatments and Services (surgical and non-

surgical)

6.1. Advertisements for surgical and non-surgical cosmetic

treatments and services shall comply with legislation in force at the

time pertaining to advertisements for medical treatments, medicinal

METHODS OF ADVERTISING AND DIRECTIONS APPLICABLE TO MEDICINAL

PRODUCTS AND TREATMENTS

services and cosmetic treatments and services.

6.2. Advertisements for surgical cosmetic treatments and

services may contain the address of the service provider and factual

descriptions of services available but shall not contain anything

which could be deemed an encouragement to use the surgical

t r e a t m e n t o r s e r v i c e . I n f o r m a t i o n d e t a i l i n g s p e c i a l o ff e r s ,

discounts, references to credit facilities available or any other

promotional offers intended to encourage the use of cosmetic

treatments or services of this nature are not permitted.

Hypnosis, Hypnotherapy, Psychology or Psychoanalysis

7.1. Advertisements for hypnosis, hypnotherapy, psychology or

psychoanalysis shall comply with the general rules pertaining to

advertisements for medical treatments, medicinal services and

cosmetic treatments and services.

7.2. Advertisements of this nature may contain the address of

the service provider and factual descriptions of services available

but shall not contain anything which could be deemed an

encouragement to use the service. Information detailing special

offers, discounts or any other promotional offers intended to

encourage the use of services of this nature are not permitted.

Advertising of Cessation of Smoking Products or Services

(other than Medicinal Products)

8.1. Advertisements for products (other than medicinal

products) or services purporting to assist people to quit smoking

shall state that

(a) such product or service

does

not

address

pharmacological dependence;

(b) no clinical tests have been performed on this product

(other than medicinal products) to prove the

effectiveness of treatment in helping people give up

smoking;

(c) the smoking aid can give positive results only in

conjunction with the consumer’s will power.

8.2. The advertising of smoking on the broadcasting media is

prohibited in terms of the Tobacco (Smoking Control) Act, and the

B a n o n A d v e r t i s i n g a n d P r o m o t i o n o f To b a c c o P r o d u c t s

Regulations.

Slimming Treatments and Services

9.1. Advertisements shall not contain any offer of a treatment

or service for slimming (i.e. weight reduction, limitation or control)

which

(a) in itself can lead to harmful effects, and

(b) does not follow a varied, balanced and health diet, and

(c) does not clearly state in a scientific manner how

slimming will be achieved.

9.2. Advertisements

for

dietary

supplements,

including

PRODUCTS AND TREATMENTS

vitam ins or minerals, shall not state or imply that they are

necessary to avoid dietary deficiency or that they can enhance

normal good health.

9.3. Subject to qualified advice from a health care professional,

claims for vitamins or minerals, may be accepted where they relate

to

(a) restricted, unsupplemented or low-food-energy diets;

(b) women who are planning to become pregnant, or are

pregnant or lactating;

(c) growing children; and

(d) some people over fifty years old.

Sanitary Towels and Tampons

10.1. Particular care is required when scheduling advertisements

for sanitary protection products.

10.2. The advertisement shall not contain anything likely to

embarrass or undermine an individual’s confidence in her own

personal hygiene standards.

10.3. Care shall be taken to ensure that any detailed description

of the product avoids anything which might offend or embarrass

listeners or viewers.

10.4. No implication of, or appeal to, sexual or social insecurity

is acceptable.

Advertising of Health Promotion Campaigns

11.1. Advertising of campaigns aimed at reducing/stopping

sexual risk taking behavior and/or drug misuse shall be allowed if

the material to be used is approved by the competent public health

authority and such campaigns abide by ethical standards set out by

the said authority and in any relevant applicable legislation.

Nutrition and Health Claims made on Food

12.1. Nutrition and health claims made on foods in

advertisements may only be allowed if they comply with the

provisions of Regulation (EC) No 1924/2006 of the European

Parliament and of the Council of 20 December 2006 on nutrition

and health claims made on foods.

Part Four

Programmes involving Participation

of Certain Health Care Professionals

Programme

Participation

by

Certain

Health

Care

Professionals

13.1. It is contrary to the public interest and discreditable to

certain health care professionals to advertise or canvass, directly or

indirectly, for the purpose of obtaining patients or promoting his or

her own professional advantage.

13.2. Careful consideration must be given to the ethical and legal

METHODS OF ADVERTISING AND DIRECTIONS APPLICABLE TO MEDICINAL

PRODUCTS AND TREATMENTS

implications of endorsements by certain health care professionals

of a commercial product or service as happens for instance when

new services are introduced which patients are not well informed

about.

13.3. Certain health care professionals must never overtly and

publicly endorse advertisements for health-related services, such as

nursing homes and private clinics.

13.4. Certain health care professionals may participate in any

programme on the broadcasting media which involves medical,

semi-medical, dental or veterinary topics; listeners and viewers are

entitled to be given information as to the professional academic

qualifications of a practitioner who writes a book or article or gives

a talk and/or participates on radio and television; no information

shall be however given which implies any unique or outstanding

qualities or any greater experience in a particular field. However, it

shall be permissible to bring the name of the health care

professional by way of a caption at the beginning of his or her

intervention.

13.5. Health care professionals including also health care

professionals complementary to medicine as listed in the Third

Schedule to the Heath Care Professions Act shall refrain from

discussing a medicinal p roduct on the broadcastin g media.

However, such professionals shall, when discussing a therapeutic

modality, refer also to its side effects and when discussing a

medical treatment refer to the need for the viewer or listener to call

at a registered health care professional, prior to receiving such

treatment for advice. The ill effects of such treatment are to be

stated as well.

13.6. For the purposes of these Requirements, the expression

"certain health care professionals" means medical practitioners,

dental surgeons, pharmacists, pharmacy technicians, nurses and

midwives but does not include professions complementary to

medicine as listed in the Third Schedule to the Health Care

Professions Act.

Part Five

Programmes involving or concerning Medical Matters

Programmes involving Medical Matters

14.1. Programmes involving medical matters should be guided

by the following

(a) the purpose of such programme should not be

advertorial, whether implicit or explicit, but should be

informative, educational or entertaining;

(b) uniforms or logos of hospitals or clinics should not be

allowed as they are considered to constitute

surreptitious advertising;

(c) it is allowed to refer to a medical treatment provided

its positive and negative aspects are mentioned but it

will not be acceptable to mention only the positive

PRODUCTS AND TREATMENTS

aspects of such treatments. The producer must also

ensure that the programme is balanced when dealing

with such positive and negative features;

(d) a representative of the hospital or clinic which

sponsors or advertises in that programme shall not

administer a particular treatment.

14.2. Health care professionals and programme producers should

consult the websites of the Medical Council, the Pharmacy Council

and the Council for Professions Complementary to Medicine as to

the laws which these Councils administer and as to any codes and

guidelines which may be issued from time to time. Such persons

should also consult the websites of the Medicines Authority and of

the Health Division and any related websites for relevant applicable

legislation.

14.3. By way of guidelines, before a health care professional

participates in a programme, s/he should consider the following

(a) the context of the programme - is it sponsored by a

commercial medical entity, clinic or hospital?

(b) is the programme aimed at publicizing the services

provided by any medical entity, clinic or hospital?

(c) can the programme be considered as an advertisement

for the medical entity, clinic or hospital sponsoring the

programme?

(d) can the presence of the medical practitioner, dental

practitioner or pharmacist be perceived or interpreted

as an endorsement of the facilities or services provided

by the medical entity, clinic or hospital?

(e) is the role of the health care professional an

educational one or is s/he using such appearance to

publicise his or her skills in a specific area?

(f)

is the information given by the practitioner on the

medical topic s/he discusses adequate for a lay person

to take an informed decision?

14.4. Persons who are not registered or warranted by the Medical

Council, the Pharmacy Council, the Council for Nurses and

Midwives, or the Council for Professions Complementary to

Medicine may not provide advice on the broadcasting media on

those subjects which fall within the remit of the registered or

warranted professionals by the said Councils.

Giving of Details of a Transplant Donor

15.1. It shall be permissible to provide the details which identify

a transplant donor during a news bulletin or any other programme

only when the donor or the donor’s family consent thereto. The

same applies to a recipient of such an organ.

Part Six

Sponsorship by undertaking involved in manufacturing

or sale of medicinal products and medical treatment

METHODS OF ADVERTISING AND DIRECTIONS APPLICABLE TO MEDICINAL

PRODUCTS AND TREATMENTS

Sponsorship of Programmes

16.1. Sponsorship of programmes by undertakings whose

activities include the manufacturing or sale of medicinal products

and med ical treatm ent shal l co mp ly wi th the provi sion s of

paragraph 22 of the Third Schedule of the Broadcasting Act.

Part VII - Teleshopping for Medicinal Products

and Medical Treatments

Teleshopping

of

Medicinal

Products

and

Medical

Treatments

17.1. Teleshopping for medicinal products and teleshopping for

medical treatments are prohibited in terms of paragraph 17 of the

Third Schedule to the Broadcasting Act.

Part Eight

Health Warning

Health Warning

18.1. All advertisements of medicinal products or medicinal

treatm ents shall contain wording to the effect that prior to

purchasing the medicinal product or taking the medicinal treatment

in question, the advice of the health care professional is sought as

such medicine or treatment might have ill effects on one’s health

and well-being.

18.2. This health warning applies to all medicinal products

which do not need a prescription and which may be bought over the

counter as well as to any type of medicinal treatment.

Part Nine

Guidelines

Non-Enforceability

of

Paragraph

14.3

of

these

Requirements

19.1. Paragraph 14.3 of these Requirements is not enforceable as

it is by way of guidelines addressed to health care professionals.