1.the overall principles of the medicines advertising in

THE OVERALL PRINCIPLES OF

MEDICINES ADVERTISING IN MALAYSIA

and

MAB EXPERIENCES IN REGULATING THE HEALTHCARE INDUSTRY ON MEDICINES

ADVERTISING

UMIKALSOM IBRAHIM

SENIOR PRINCIPAL ASSISTANT DIRECTOR

PHARMACEUTICAL SERVICES DIVISION

MINISTRY OF HEALTH

23 APRIL 2013MEDICAL DEVICE INDUSTRY SEMINAR

THE OVERALL PRINCIPLES OF THE MEDICINES ADVERTISING IN MALAYSIA

Legislation:

• Medicines (Advertisement & Sale)

Act, 1956 - to prohibit certain advertisements relating to medical matters and to regulate sale of substances recommended as a medicine.

• Medicine Advertisements Board

Regulations, 1976

ADVERTISEMENTS; DEFINITION

Section 2 of the Medicines (Advertisement andSale) Act 1956:

“Advertisements” includes any

notice, circular, report, commentary, pamphlet, label,

wrapper or other document, and any announcement

made orally or by any means of producing or

transmitting light or sound

Examples:

Advertisements in the printed media, broadcast

media, banners, billboard, internet media

to regulate the content of advertising -ensuring that advertising is truthful and does not undermine or contravene social norms.to protect public health by promoting the safe use of medicinesensuring that they are honestly promoted as to their benefits, uses and effects, in compliance with current legislation.

OBJECTIVE OF MEDICINES ADVERTISEMENT CONTROL:

WHY ? Unlawful ads

- without approval number- false approval number- edited approval format

Irresponsible ads- unregistered products- false indication- induce unnecessary use- over claimed - mislead or deceive the consumer

General Principle:

Information provided in the ads must be: Factually accurate and capable of being

substantiated

Must not be: exaggerated, false, misleading or deceptive

PROHIBITED CLAIMS / ADVERTISEMENT

Section 3(1):

Prohibition of any advertisement referring to any

article in terms calculated to lead to the use of that article

as a medicine, appliance or remedy for the purpose of

• prevention or treatment or diagnosis of certain diseases

and condition of human being as specified in the

Schedule (20 Diseases)

• Contraception

• Improve condition or functioning of kidney or heart or

improving sexual function/performance of human beings

Section 4:

Prohibition of advertisement relating to abortion.

PROHIBITED CLAIMS / ADVERTISEMENT

* Schedule Section 3 (20 Diseases)

9

1. Diseases or defects of the kidney

2. Diseases or defects of the heart

3. Diabetes4. Epilepsy or fits5. Paralysis6. Tuberculosis7. Asthma8. Leprosy9. Cancer10. Deafness

11.Drug addiction12.Hernia 13.Diseases of the eye14.Hypertension15. Mental disorder16. Infertility17. Frigidity18. Impairment of the sexual

function or impotency19. Venereal disease20. Nervous debility, or other

complaint or infirmity, arising from or relating to sexual intercourse

PROHIBITED ADVERTISEMENTSection 4A :

Prohibition of advertisements relating to skill or service

relating to treatment, prevention or diagnosis of any

ailment, disease, injury, infirmity or condition affecting the human

body.

Unless :

With the approval of the Minister, by any professional body related

to the medical profession or to any other allied profession which is

established by or registered under any written law,

Or

With the approval of the MAB, by any private hospital, private

clinic, private radiological clinic, private medical laboratory

operated by a registered medical practitioner having a valid

annual practicing certificate under the Medical Act 197110

Medicines (Advertisement and Sale) Act 1956

Section 4A

Skill & Service

Private hospital

Private clinic

Private radiological clinic

Private medical laboratory

Approval from MAB

Section 4B

Medicine, appliance,

remedy

(products registered with Drug

Control Authority)

Approval from MAB

Sections

3(1) & 4

20 Diseases

Contraception

Improving kidney/heart/sexual

performances

Procuring miscarriage

PENALTY / FINE……

Section 5(1) – PENALTY

If any person contravenes any of the provisions of sections 3, 4, 4A and 4B, he shall, subject to the provisions of this Act; be liable on summary conviction-

a. first conviction

fine not exceeding RM3,000 or to imprisonment for any term not exceeding one year or to both.

b. subsequent conviction

fine not exceeding RM5,000 or to imprisonment for any term not exceeding two years or to both.

a) Establish the Medicine Advertisements Board (MAB) for the purpose of sections 4A and 4B

b) Provide the manner of submitting advertisements for approval and impose fees (RM100.00 per application)

c) Provide the procedure to be followed by the Medicine

Advertisements Board

d) Provide the manner of appeal against the decision of the Board and that appeal shall lie to the Minister

MEDICINE ADVERTISEMENTS BOARD REGULATIONS 1976

cont.

Authority:

The Medicines Advertisement Board, at its discretion;

a. issue or refuse to issue approvals for advertisements to bepublicized or may cancel any approval previously issued.

b. reserves the right to delete from any advertisements acts which could bring about undesirable thoughts and impression to the viewers or listeners.

c. can change the Guidelines from time to time without giving prior notice.

14

MEDICINE ADVERTISEMENTS BOARD: MEMBERS

1. Director General of Health (Chairman)

2. Director of Pharmaceutical Services (Alternate chairman)

3. Director of Medical Services

4. Secretary of Malaysian Medical Association

5. Secretary of Association of Private Hospitals of Malaysia

6. Secretary of Federation of Private Medical Practitioners Association

7. One Physician in Public Service

8. One Pharmacologist

9. One Pharmacist in Public Service

10. One Officer From Ministry of Information

**(One Pharmacist in the Public Service to be appointed as the

Secretary to the Board who shall not be a member of the Board)

• send in a complete application form with payment (RM100/application)

• fulfill all the criteria needed

APPLICATION FOR APPROVALS:

www.pharmacy .gov.my - to download application form and advertisement

guidelines

Advertisement that requires MAB’s Approval

Products Registered by Drug Control Authority (DCA)

- Product with MAL registration no, e.g- MAL19912607X

Healthcare services (handled by Medical Practitioners)

-private hospital-private clinic-private radiological clinic-private medical laboratory

-Advertisement Guidelines for products-MAB’s Policy & Decision

-Advertisement Guidelines for Healthcare Services-MAB’s Policy & Decision

1 2

CONT.

Current Charter – Follows MAB’s advertisement

guidelines/policies : approved in 5 days

– Serial number will be given: e.g KKLIU 1234/2013

– The approval serial number shall be legibly displayed in every advertisement published in print or in the form of a hoarding, illuminated sign or printed matter

MAB’s Guidelines/Policies

MAB EXPERIENCES IN REGULATING

THE HEALTHCARE INDUSTRY ON MEDICINES ADVERTISING

• Medical Devices

• By the Medical Devices Bureau

• Food

• By the Food Safety & Quality Division

• Pharmaceutical Products

• By the Pharmaceutical Services Division

• Cosmetics

• By the National Pharmaceutical Control Bureau

Medical

Products

CONTROL OF MEDICINES ADVERTISEMENT :

Controlled medicines

Tradisional medicines

Over the counter (OTC)

Cosmetics

CONTROL OF DRUGS

AND COSMETIC

REGULATIONS 1984:

s.7(1)(a) : No person shall

manufacture, sell, supply,

import, possess or

administer any product

unless the product is a

registered product

NOT03023343KE/K

Please ensure that all pharmaceutical products bear a registration number

COMPLIANCE: Advertisements Applications

for 2012

DescriptionApplications

ReceivedApproved

Deferred

(Required

additional

information/

explanation/

MAB

Meeting)

Not

Approved

Approval

Not

Required

Product Advertisements

1576 1282 276 10 8

Medical

ServicesAdvertisements

557 394 146 7 10

Total 2133 1676 422 17 18

Cont. : Advertisement Approvals for 2012

Description/Year 2012

Total number of applications 2133

Total number of applications approved within

client charter period2078

Total number of applications approved outside

of client charter period55

Percentage of applications approvals within

client charter period (Target > 90%)97.4%

SANCTION: ACTION TAKEN ON

MEDICINES ADVERTISEMENT

BY PHARMACEUTICAL SERVICES DIVISION, MOH

&

STATE PHARMACY ENFORCEMENT BRANCH

YEAR NO. OF WARNING

LETTER ISSUED

NO. OF CASE INVESTIGATED

NO. OF CASE PROSECUTED

CUMULATIVE FINE (RM)

2010 171 140 39 41,250

2011 204 150 39 56,800

2012 314 114 69 178,850

Source : Pharmaceutical Services Division, MOH

Total number of screened ads by the HQ: 3821

0

50

100

150

200

250

300

350

1 2 3

Nu

mb

er

Year

ACTION TAKEN

NO. OF WARNING LETTER ISSUED

NO. OF CASE INVESTIGATED

NO. OF CASE PROSECUTED

2010 2011 2012

Source : Pharmaceutical Services Division, MOH

41,250

56,800

178,850

0

20,000

40,000

60,000

80,000

100,000

120,000

140,000

160,000

180,000

200,000

1 2 3

CUMULATIVE FINE (RM)

2010 2011 2012

YEARSource : Pharmaceutical Services Division, MOH

Recommendation From A Study* By The MITI

• Adopt self-regulatory framework to fulfill requirement of medical advertisements’ guidelines-

i.e advertising requirements are still bound by the regulations but industry self-regulates their own advertising as long as its within the scope of the regulation

( could be adapted from South Korea and Philippines)

Challenges: Food-drug, Device-drug, Cosmetic-drug inter-phase

• In line with modern technology various of health product emerge

• The classification of inter-phase product need to be identified

• Different products are controlled by different division using different set of laws and regulation

Cont. : Internet & Social media

• Information technologies are developing at a dizzying pace;

• The technologies may change the marketplace significantly for consumers -- giving them access to potentially unlimited amounts of information, a global marketplace, and more shopping convenience;

• New technologies are pushing some consumer issues such as privacy, security, and marketing to children to the forefront of public debate;

• Social media eg facebook, twitter, blogs etc

Conclusion

• acting responsibly, sensibly, and cooperatively

• Ethics play a major role in every trade - without a set of ethical principles in place chaos would reign supreme and social order would crumble.

• Likewise, advertising professionals have to adhere to a standard set of practices.

Ethical rule that is supposed to be followed by advertising agencies is :

- not to give undue benefit to the clients by compromising their own share in the benefits they receive from the media in lieu of their services.

Thereby, limiting the role of giants in cannibalizing smaller advertising agencies with predatory policies.

‘if the facts don’t fit the theory, change the facts’

- Albert Einstein

Thank you

www.pharmacy.gov.my

BAHAGIAN PENGUATKUASAAN FARMASI

KEMENTERIAN KESIHATAN MALAYSIA

LOT 36, JALAN UNIVERSITI

46350 PETALING JAYA

SELANGOR

03-78413200