1
HSA BRIEFING
REGULATION OF THERAPEUTIC PRODUCTS UNDER
THE HEALTH PRODUCTS ACT
MATRIX AUDITORIUM @ BIOPOLIS | 19 AUG 2016
OVERVIEW OF MAIN CHANGES TO
ADVERTISEMENT CONTROLS FOR
THERAPEUTIC PRODUCTS
Copyright © HSA, All rights reserved
2
OUTLINE
• Overview of current advertisement controls under the
Medicines Act
• Advertisement controls upon the transfer of controls to
the Health Products Act (HPA) for pharmaceutical
products (therapeutic products)
 Basic requirements under the HPA
 Further requirements for
therapeutic products (TP)
advertisements
of
 Corrective measures in relation to contravening
advertisements
Copyright © HSA, All rights reserved
3
OVERVIEW OF ADVERTISEMENT CONTROLS
UNDER THE MEDICINES ACT
• Objectives of advertisement controls for health products (“HP”) is to
ensure that:
 Accurate and truthful information about the product is disseminated
 Advertisements and sales promotion activities do not mislead
consumers
 Advertisement and sales promotion activities do not induce
unnecessary purchase or consumption of the HP
• Under the Medicines Act
 Sn 50 - Prohibition of false and misleading advertisements and
representations
 Sn 51 - Prohibition of advertisements which directly or indirectly
claims, indicates or suggest that the article advertised will prevent,
alleviate or cure any disease or condition specified in the First
Schedule
Copyright © HSA, All rights reserved
OVERVIEW OF ADVERTISEMENT CONTROLS
UNDER THE MEDICINES ACT
• Under the Medicines (Medical Advertisements) Regulations, all medical
advertisements and sales promotions are subject to pre-publish permit
issuance to ensure that content is appropriate for direct to consumer
advertising
• Evaluation of medical advertisements
 Prohibition of false and misleading claims (e.g. false indications)
 Categories of products not allowed for direct to consumer advertising
 Prohibited advertisements / objectionable claims e.g. advertisements for
chronic diseases
• Evaluation of sales promotions - Appropriateness of sales promotion
mechanics
 Medicinal products are not allowed to be distributed as ‘gifts’
 No distribution of samples allowed for western pharmaceuticals or
Chinese Proprietary Medicines
Copyright © HSA, All rights reserved
4
5
MAIN CHANGES FOR PORT-OVER TO
HEALTH PRODUCTS ACT FOR ADVERTISEMENTS OF
THERAPEUTIC PRODUCTS (“TP”)
Guiding principles :
Objectives and principles of advertisement controls remain the same
Health Products Act
Medicines Act
• Pre-publish permit
issuance
• Post-publish
surveillance
Copyright © HSA, All rights reserved
• Remove permit issuance
 Same regulatory
controls via a set of
prescribed
requirements
• Post-publish surveillance
 Penalties
 Corrective measures to
be taken
6
ADVERTISEMENT REQUIREMENTS UNDER THE HPA
“Advertisement” means the publication, dissemination or conveyance of
any information for the purpose of promoting whether directly or indirectly,
the sale or use of that health product by any means or in any forms
Broad Advertisement Principles Prescribed under the HPA
• Sn 19(1)(a) - No advertising of any product as a health product if it is
not defined as one under the HPA;
• Sn 19(1)(b) - No advertising of any registered health product in a way
that represents it being used in any way other than for which it has been
registered; and
• Sn 20 (1) - No false or misleading advertisement about the health
product
 Falsely describes the health product or gives any false information
concerning the health product
 Likely to create an erroneous impression regarding the formulation,
composition, design specification, quality, safety, efficacy or uses of the
health product
Copyright © HSA, All rights reserved
7
ADVERTISEMENT REQUIREMENTS UNDER THE HPA
•
Prescribed in the Health Products (Advertisement of Therapeutic Products)
Regulations (“the Regulations”)
•
Main controls in place:
 Matters to be excluded in TP advertisements
 Requirement for substantiation for claims
 Compliance with relevant conditions of registration
 Restriction on promoting TP for specified diseases and conditions*
 Prohibition against advertisements of Prescription-only Medicines (POM)*
 Advisories and warnings for advertisements of Pharmacy-only medicines*
 Requirements for sales promotions
 Requirements for advertisements of unregistered TPs
* Does not apply:
a) if advertisement is directed at specified classes of relevant health professionals
b) if advertisement is published at trade fairs / scientific conferences that are not accessible by general
public
c) to reference and trade advertisements
d) to informational statements on (i) corporate websites with no discussion forums (ii) part of product
launch not accessible to general public (iii) Press / media release
Copyright © HSA, All rights reserved
8
ADVERTISEMENT REQUIREMENTS UNDER THE HPA
•
Prescribed in the Health Products (Advertisement of Therapeutic Products)
Regulations (“the Regulations”)
•
Main controls in place:
 Matters to be excluded in TP advertisements
 Requirement for substantiation for claims
 Compliance with relevant conditions of registration
 Restriction on promoting TP for specified diseases and conditions*
 Prohibition against advertisements of Prescription-only Medicines (POM)*
 Advisories and warnings for advertisements of Pharmacy-only medicines*
 Requirements for sales promotions
 Requirements for advertisements of unregistered TPs
* Does not apply:
a) if advertisement is directed at specified classes of relevant health professionals
b) if advertisement is published at trade fairs / scientific conferences that are not accessible by general
public
c) to reference and trade advertisements
d) to informational statements on (i) corporate websites with no discussion forums (ii) part of product
launch not accessible to general public (iii) Press / media release
Copyright © HSA, All rights reserved
9
ADVERTISEMENT REQUIREMENTS UNDER THE HPA
Matters to be excluded in TP advertisements
An advertisement of a TP must not:
(a)
be likely to lead to a consumer of the therapeutic product self-diagnosing or
inappropriately treating any serious disease by himself or herself;
(b)
give the impression that advice from a registered pharmacist or qualified
practitioner on the use of the therapeutic product is not necessary;
(c)
give the impression that a medical consultation or surgical operation is not
necessary if the therapeutic product is used;
(d)
encourage, or be likely to encourage, inappropriate or excessive use of the
therapeutic product;
(e)
mislead, or be likely to mislead, directly or by implication or through emphasis,
contrast or omission, any person with regard to the quality or efficacy of the
therapeutic product;
(f)
compare or contrast the therapeutic product with any other named therapeutic
product or a brand thereof;
Copyright © HSA, All rights reserved
10
ADVERTISEMENT REQUIREMENTS UNDER THE HPA
Matters to be excluded in TP advertisements
An advertisement of a TP must not:
(g)
exploit the lack of knowledge of consumers, or contain any language or
image that causes or is likely to cause fear, alarm or distress to the public in
respect of any disease or condition;
(h)
claim or suggest that the therapeutic product is infallible, unfailing, magical or
miraculous, or that the effect of taking the therapeutic product is certain,
guaranteed or a sure cure;
(i)
claim or suggest that the therapeutic product is not accompanied by any side
effects;
(j)
be likely to arouse unwarranted or unrealistic expectations of the
effectiveness of the therapeutic product;
(k)
offer to fully or partially refund the purchase price of the therapeutic product,
or guarantee or suggest that a full or partial refund of the purchase price of
the therapeutic product will be given to any purchaser or user of the
therapeutic product;
Copyright © HSA, All rights reserved
11
ADVERTISEMENT REQUIREMENTS UNDER THE HPA
Matters to be excluded in TP advertisements
An advertisement of a TP must not:
(l)
falsely claim or suggest that the use of the therapeutic product is promoted
or endorsed by the Government or any public authority;
(m)
be directed, or contain any material that is directed, principally at any person
below the age of 14 years; or
(n)
contain, or give the impression of, any endorsement or recommendation of
the therapeutic product by —
(i) any healthcare professional; or
(ii) any person who, because of the person’s celebrity, social or
professional status, is likely to encourage the use of the therapeutic
product.
Copyright © HSA, All rights reserved
12
ADVERTISEMENT REQUIREMENTS UNDER THE HPA
•
Prescribed in the Health Products (Advertisement of Therapeutic Products)
Regulations (“the Regulations”)
•
Main controls in place:
 Matters to be excluded in TP advertisements
 Requirement for substantiation for claims
 Compliance with relevant conditions of registration
 Restriction on promoting TP for specified diseases and conditions*
 Prohibition against advertisements of Prescription-only Medicines (POM)*
 Advisories and warnings for advertisements of Pharmacy-only medicines*
 Requirements for sales promotions
 Requirements for advertisements of unregistered TPs
* Does not apply:
a) if advertisement is directed at specified classes of relevant health professionals
b) if advertisement is published at trade fairs / scientific conferences that are not accessible by general
public
c) to reference and trade advertisements
d) to informational statements on (i) corporate websites with no discussion forums (ii) part of product
launch not accessible to general public (iii) Press / media release
Copyright © HSA, All rights reserved
13
ADVERTISEMENT REQUIREMENTS UNDER THE HPA
Requirement for substantiation for claims & Compliance with relevant
conditions of registration
All promotional claims must be aligned with what has been registered with
HSA and the conditions of registration (where relevant)
1)
All promotional claims must be aligned with what has been registered with HSA
2)
Any representation relating to a TP’s safety, efficacy and quality must be verified by
HSA
– Prior approval by HSA (via product registration / variation submissions) must be obtained if
the proposed claim relates to the safety / efficacy / quality of the product
– E.g. ‘Works in x mins’ (efficacy), ‘indicated for xxx’ (efficacy), ‘suitable for use in children’
(efficacy, safety)
– All other information concerning the TP must be fully substantiated by relevant documents
e.g. best selling, top sales
3)
Advertisements of TPs also comply with any relevant conditions of registration that
may be imposed.
– E.g. A TP may be approved for certain uses, but its
advertisement of these approved uses to the public
Copyright © HSA, All rights reserved
conditions may prohibit the
14
ADVERTISEMENT REQUIREMENTS UNDER THE HPA
•
Prescribed in the Health Products (Advertisement of Therapeutic Products)
Regulations (“the Regulations”)
•
Main controls in place:
 Matters to be excluded in TP advertisements
 Requirement for substantiation for claims
 Compliance with relevant conditions of registration
 Restriction on promoting TP for specified diseases and conditions*
 Prohibition against advertisements of Prescription-only Medicines (POM)*
 Advisories and warnings for advertisements of Pharmacy-only medicines*
 Requirements for sales promotions
 Requirements for advertisements of unregistered TPs
* Does not apply:
a) if advertisement is directed at specified classes of relevant health professionals
b) if advertisement is published at trade fairs / scientific conferences that are not accessible by general
public
c) to reference and trade advertisements
d) to informational statements on (i) corporate websites with no discussion forums (ii) part of product
launch not accessible to general public (iii) Press / media release
Copyright © HSA, All rights reserved
15
ADVERTISEMENT REQUIREMENTS UNDER THE HPA
Restriction on Promoting TP for Specified Diseases and Conditions
Advertisements of TP must not expressly or implicitly claim, indicate or suggest that
the therapeutic product —
(a) will prevent, alleviate or cure any specified disease or condition;
(b) will prevent or alleviate any sign or symptom clinically attributable to any
specified disease or condition; or
(c) has similar properties or characteristics to, or works as well as, a product that is
commonly used for the purpose of treating any specified disease or condition.
“specified disease or condition” means any disease or medical condition falling
within any of the classes of diseases or medical conditions specified in the Second
Schedule
* Does not apply:
a) if advertisement is directed at specified classes of relevant health professionals
b) if advertisement is published at trade fairs / scientific conferences that are not accessible by
general public
c) to reference and trade advertisements
d) to informational statements on (i) corporate websites with no discussion forums (ii) part of
product launch not accessible to general public (iii) Press / media release Copyright © HSA, All rights reserved
16
ADVERTISEMENT REQUIREMENTS UNDER THE HPA
•
Prescribed in the Health Products (Advertisement of Therapeutic Products)
Regulations (“the Regulations”)
•
Main controls in place:
 Matters to be excluded in TP advertisements
 Requirement for substantiation for claims
 Compliance with relevant conditions of registration
 Restriction on promoting TP for specified diseases and conditions*
 Prohibition against advertisements of Prescription-only Medicines (POM)*
 Advisories and warnings for advertisements of Pharmacy-only medicines*
 Requirements for sales promotions
 Requirements for advertisements of unregistered TPs
* Does not apply:
a) if advertisement is directed at specified classes of relevant health professionals
b) if advertisement is published at trade fairs / scientific conferences that are not accessible by general
public
c) to reference and trade advertisements
d) to informational statements on (i) corporate websites with no discussion forums (ii) part of product
launch not accessible to general public (iii) Press / media release
Copyright © HSA, All rights reserved
17
ADVERTISEMENT REQUIREMENTS UNDER THE HPA
•
Prescribed in the Health Products (Advertisement of Therapeutic Products)
Regulations (“the Regulations”)
•
Main controls in place:
 Matters to be excluded in TP advertisements
 Requirement for substantiation for claims
 Compliance with relevant conditions of registration
 Restriction on promoting TP for specified diseases and conditions*
 Prohibition against advertisements of Prescription-only Medicines (POM)*
 Advisories and warnings for advertisements of Pharmacy-only medicines*
 Requirements for sales promotions
 Requirements for advertisements of unregistered TPs
* Does not apply:
a) if advertisement is directed at specified classes of relevant health professionals
b) if advertisement is published at trade fairs / scientific conferences that are not accessible by general
public
c) to reference and trade advertisements
d) to informational statements on (i) corporate websites with no discussion forums (ii) part of product
launch not accessible to general public (iii) Press / media release
Copyright © HSA, All rights reserved
18
ADVERTISEMENT REQUIREMENTS UNDER THE HPA
Advisories / Warnings for Advertisements of Pharmacy only Medicines
Advisories are required to be clearly and prominently displayed for all direct-toconsumers advertisements of pharmacy only medicines (P-medicines) :
a) Appropriate statements advising consumers to read the Patient Information
Leaflet (PIL) or the Product Insert (PI)
b) Appropriate statements advising consumers to consult their healthcare
professionals on the use of the medicine or if symptoms persist
Specific advisories or warning statements may be required for advertisements of
specific pharmacy only (P) medicines which will be communicated via written notice
* Does not apply:
a) if advertisement is directed at specified classes of relevant health professionals
b) if advertisement is published at trade fairs / scientific conferences that are not accessible by
general public
c) to reference and trade advertisements
d) to informational statements on (i) corporate websites with no discussion forums (ii) part of
product launch not accessible to general public (iii) Press / media release Copyright © HSA, All rights reserved
19
ADVERTISEMENT REQUIREMENTS UNDER THE HPA
•
Prescribed in the Health Products (Advertisement of Therapeutic Products)
Regulations (“the Regulations”)
•
Main controls in place:
 Matters to be excluded in TP advertisements
 Requirement for substantiation for claims
 Compliance with relevant conditions of registration
 Restriction on promoting TP for specified diseases and conditions*
 Prohibition against advertisements of Prescription-only Medicines (POM)*
 Advisories and warnings for advertisements of Pharmacy-only medicines*
 Requirements for sales promotions
 Requirements for advertisements of unregistered TPs
* Does not apply:
a) if advertisement is directed at specified classes of relevant health professionals
b) if advertisement is published at trade fairs / scientific conferences that are not accessible by general
public
c) to reference and trade advertisements
d) to informational statements on (i) corporate websites with no discussion forums (ii) part of product
launch not accessible to general public (iii) Press / media release
Copyright © HSA, All rights reserved
20
ADVERTISEMENT REQUIREMENTS UNDER THE HPA
Sales Promotions of TPs
Sales promotion activities or mechanics employed must not (i) encourage
inappropriate or excessive use of the TP; or (ii) contravene any other prescribed
requirements
The following sales promotion mechanics are not allowed:
(a) The offer of any prize as an inducement to purchase the TP;
(b) Offering any other health or medicinal products with the TP;
(c) Offer any sample of the TP
It is however not intended to prohibit:
a)
A qualified practitioner, or a person acting under his instructions, from giving a
sample of a TP to his patient
b)
The offer of samples of registered TPs to specified relevant health
professionals
c)
The offer of banded products / bonuses for purpose of wholesale dealings or
direct to doctors / pharmacists
Copyright © HSA, All rights reserved
21
ADVERTISEMENT REQUIREMENTS UNDER THE HPA
•
Prescribed in the Health Products (Advertisement of Therapeutic Products)
Regulations (“the Regulations”)
•
Main controls in place:
 Matters to be excluded in TP advertisements
 Requirement for substantiation for claims
 Compliance with relevant conditions of registration
 Restriction on promoting TP for specified diseases and conditions*
 Prohibition against advertisements of Prescription-only Medicines (POM)*
 Advisories and warnings for advertisements of Pharmacy-only medicines*
 Requirements for sales promotions
 Requirements for advertisements of unregistered TPs
* Does not apply:
a) if advertisement is directed at specified classes of relevant health professionals
b) if advertisement is published at trade fairs / scientific conferences that are not accessible by general
public
c) to reference and trade advertisements
d) to informational statements on (i) corporate websites with no discussion forums (ii) part of product
launch not accessible to general public (iii) Press / media release
Copyright © HSA, All rights reserved
22
ADVERTISEMENT REQUIREMENTS UNDER THE HPA
Requirements for Advertisements of Unregistered TPs
Advertisements of unregistered TPs or unapproved indications are
not allowed in all instances unless:
The advertisement is
1.
Made at a pharmaceutical trade fair, pharmaceutical trade exhibition, scientific
conference or scientific forum that is
•
Not accessible by the general public
•
The TP is not supplied (sold or offered for sale / given or offered as a sample)
•
The TP &/or its indication must be approved / licensed in at least one other
country
•
Advertisement contains a statement that the TP &/ indication is not registered in
Singapore.
2.
In the form of an article in a medical / scientific journal, review or publication
3.
Made in the course of scientific / medical exchange in accordance with the published
programme / agenda of, a scientific conference or forum that is
•
Not accessible by the general public
•
The TP is not supplied (sold or offered for sale / given or offered as a sample)
Copyright © HSA, All rights reserved
23
CORRECTIVE MEASURES IN RELATION TO
CONTRAVENING ADVERTISEMENTS
Health Products Act
23—(1) Where any person has advertised any health product or caused
any health product to be advertised in contravention of section 19, 20 or
21#, the Authority may order that person to do any or all of the following:
(a) to stop the advertisement with immediate effect;
(b) to take such measures as may be reasonable and necessary in the
circumstances to remove the advertisements that have already been
published;
(c) to publish a corrective advertisement in such manner and containing
such information as may be specified by the Authority.
(2) The person to whom an order under subsection (1) is directed shall
bear the costs and expenses arising from the taking of any measure that is
required of him under the order.
# Health
Products Act
19(1)(a) – No person shall advertise any product or cause any product to be advertised as a health product if it is not defined as one under the HPA;
19(1)(b) - No person shall advertise any registered health product or cause any registered health product to be advertised in a way that represents it
being used in any way other than for which it has been registered
20(1) – No person shall advertise any health product or cause any health product to be advertised in a false or misleading way.
21(1) - No person shall advertise any health product or cause any health product to be advertised unless the advertisement complies
with and is undertaken in accordance with prescribed requirements
Copyright © HSA, All rights reserved
24
CORRECTIVE MEASURES IN RELATION TO
CONTRAVENING ADVERTISEMENTS
Health Products Act
23—(3) If a person to whom an order under subsection (1) is directed fails
to comply with the order —
(a) he shall be guilty of an offence and shall be liable on conviction to a
fine not exceeding $20,000 or to imprisonment for a term not exceeding 12
months or to both; and
(b) the Authority may take such steps as it thinks reasonable and
necessary to implement the requirements of the order and recover any
costs and expenses reasonably incurred by it in so doing from that person.
Copyright © HSA, All rights reserved
REQUIREMENTS FOR
CORRECTIVE ADVERTISEMENTS
• A corrective advertisement will be considered if the content of the offending
advertisement provides
a) Inaccurate information pertaining to a TP’s safety, efficacy and quality
b) which may lead to inappropriate prescribing or use of the product, e.g.
advertising unapproved indications of a TP
• In instances where a corrective advertisement is assessed to be necessary,
the Authority will communicate the requirements for the corrective
advertisement to the affected companies via a written notice
a) Content
b) Size
c) Placement
d) Duration
Copyright © HSA, All rights reserved
25
REQUIREMENTS FOR
CORRECTIVE ADVERTISEMENTS
• In general, corrective advertisements are to be targeted at the audience who
saw the original advertisement and should adhere to the following content and
format:
1)
2)
3)
4)
5)
An expression of regret and apology as the header
Opening statement
This should clearly state that this is a corrective statement issued at the order of
HSA and the product concerned. E.g. “The HSA has ordered xxx to issue a
corrective advertisement regarding the promotion of xxx”
Statement on the breach
This should outline how the advertisement was in breach of the Act / Regulations
and give a description of the correct facts and the date that it has been ceased /
removed
Description of the case
When and where the offending advertisement was placed
Contact information
Details of the company contact should readers have any further questions about
these matters or about the product
Copyright © HSA, All rights reserved
26
HOW DO I FILE A COMPLAINT OR
PROVIDE A FEEDBACK?
• All complaints and feedback should be directed to the
Medical Advertisement Unit at hsa_ma@hsa.gov.sg.
• To facilitate reviews and follow-ups, all complaints /
feedback should provide the following information:
Details of where and when the advertisement was
published (a copy or image of the advertisement to be
provided)
Details of the concerns identified with the advertisement.
The identified non-compliance including the clause /
provision / prescribed requirements referred to should be
provided.
Copyright © HSA, All rights reserved
27
28
Thank you
For specific enquiries on TP advertisement controls,
please write to:
hsa_ma@hsa.gov.sg
Copyright © HSA, All rights reserved
29
MEDICINES ACT - FIRST SCHEDULE
Specified Diseases or Conditions
1
Blindness
11
Impotency
2
Cancer
12
Infertility
3
Cataract
13
Insanity
4
Conception & Pregnancy
14
Kidney diseases
5
Deafness
15
Leprosy
6
Diabetes
16
Menstrual disorders
7
Drug Addiction
17
Paralysis
8
Epilepsy or fits
18
Sexual function
9
Frigidity
19
Tuberculosis
10
Hypertension
Copyright © HSA, All rights reserved
Back
30
HEALTH PRODUCTS (ADVERTISEMENT OF TP)
REGULATIONS – SECOND SCHEDULE
Specified Diseases or Conditions
1
Blindness
11
Impotency
2
Cancer
12
Infertility
3
Cataract
13
Insanity
4
Conception & Pregnancy
14
Kidney diseases
5
Deafness
15
Leprosy
6
Diabetes
16
Menstrual disorders
7
Drug Addiction
17
Paralysis
8
Epilepsy or fits
18
Sexual function
9
Frigidity
19
Tuberculosis
10
Hypertension
Copyright © HSA, All rights reserved
Back
31
FIRST SCHEDULE
Relevant Health Professionals
1) Qualified practitioners
2) Registered pharmacists
3) Enrolled nurses, registered nurses and
registered midwives
4) Persons undergoing training with a view to
becoming qualified practitioners, registered
pharmacists, enrolled nurses, registered nurses
or registered midwives
Copyright © HSA, All rights reserved