1.the overall principles of the medicines advertising in
TRANSCRIPT
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