Department of Health
MEDICINES CONTROL AGENCY
Market Towers
1 Nine Elms Lane
 020 7273 0689
London SW8 5NQ
020 7273 0293
Date: 4 November 2002
To: Interested Organisations
CONSULTATION LETTER: MLX 288
ADVERTISING OF MEDICINES TO THE PUBLIC:
PROPOSED AMENDMENTS TO THE MEDICINES (ADVERTISING)
REGULATIONS 1994
INTRODUCTION
I am writing to consult you on a proposal to amend the Medicines (Advertising)
Regulations 1994. The Regulations apply across the United Kingdom.
It is proposed to remove the UK-specific controls on diseases in respect of which
advertisements to the public are prohibited. Should this proposal be accepted,
advertisements will be prohibited only for the list of diseases required by European
law.
BACKGROUND
The current regulatory framework
Current regulations
All advertising for medicines in the UK is subject to the requirements of the
Medicines (Advertising) Regulations 1994 (SI 1994/1932 as amended – the
Advertising Regulations).
These Regulations, together with the Medicines
(Monitoring of Advertising) Regulations 1994 (SI 1994/1933 as amended), implement
Directive 92/28/EC, codified as Title VIII of Directive 2001/83/EC.
All advertising is required to be in accordance with the Summary of Product
Characteristics approved by the MCA after an evaluation of the safety, quality and
MLX.288.SCH1.011002
1
efficacy of the medicinal product. It must also encourage the rational use of the
product by presenting it objectively and without exaggeration and not to be
misleading. The promotion to the public of medicines available only on prescription
is prohibited.
The Regulations apply both to advertising for any medicines to health professionals
and to advertising to the public for medicines available over the counter (OTC).
How is advertising to the public controlled?
The MCA enforces the advertising regulations by investigating complaints, scrutiny
of published advertising and approving certain advertising before publication. The
Agency also has powers to take out injunctions or prosecute should this prove
necessary.
The day to day system of advertising control in the UK relies on self regulation,
backed up by the statutory controls. The Proprietary Association of Great Britain
(PAGB), the trade association for manufacturers of OTC medicines and food
supplements, operates a ‘Code of Practice of Advertising Over-the-Counter
Medicines’ for its members. The Code reflects and goes beyond the statutory
requirements for medicines advertising, covering such issues as taste and decency and
marketing practices. The PAGB also operates a pre-publication clearance system for
OTC medicines advertising aimed at the public, first introduced in 1919.
Companies who are not members of the PAGB have to comply with the British Code
of Advertising Practice, which covers all non-broadcast advertising. Separate Codes
of Practice, pre-publication clearance and complaint and monitoring systems also
cover broadcast advertising.
Restrictions on advertising to the public
The current regulations prohibit all advertising to the public of medicines for: bone
diseases; cardiovascular diseases; chronic insomnia; diabetes and other metabolic
diseases; diseases of the liver, biliary system and pancreas; endocrine diseases;
genetic disorders; joint, rheumatic and collagen diseases; malignant diseases;
psychiatric diseases, and sexually transmitted diseases.
For a further list of conditions advertising to the public is permitted for products to
treat mild or moderate manifestations of a condition but not for serious conditions.
The list of diseases for which products may not be advertised for serious conditions
comprises: disorders of the eye and ear; gastrointestinal diseases; infectious diseases
including HIV-related diseases and tuberculosis; neurological and muscular diseases;
renal diseases; respiratory diseases, and skin disorders.
Many products for treatment of these diseases are not suitable for over the counter
(OTC) sale because they are indicated for serious conditions requiring intervention
and ongoing supervision by a medical practitioner. However, there are also a number
of less serious conditions included in these wide general disease categories and these
may be suitable for self medication with appropriate safeguards.
The prohibitions on therapeutic indications which may not be advertised to the public
that are included in European legislation are not affected by this consultation and will
MLX.288.SCH1.011002
2
be retained at this time. These cover chronic insomnia, diabetes and other metabolic
diseases, malignant diseases, serious infectious diseases including HIV-related
diseases and tuberculosis and sexually transmitted diseases. We are required to retain
these restrictions at the present time. In the future it may be possible to remove them
and the European Commission has made proposals to this effect, as part of their
general review of Community medicines legislation. These proposals were included
in a previous consultation (MLX 282) and their implementation will depend on the
outcome of negotiations at a European level.
Medicines information and patients – changing views
History of regulation
Advertising is one of the ways consumers obtain information about medicines
available for purchase OTC through pharmacies or on general sale. The first UK
regulations on advertising medicines to the public were introduced in 1978. These
included extensive and detailed rules covering the conditions and purposes for which
medicines could be advertised to the public. They reflected rules which had evolved
through codes of practice dating back to the 1920s and the general view then that
information about medicines should primarily be provided by doctors.
In 1994, a much reduced and simplified list of diseases in respect of which
advertisements to the public are prohibited was incorporated into revised regulations.
The Regulations were amended in 1996, following a further public consultation, when
advertisements of products for treatment of the symptoms of sprains and strains and
the pain and stiffness of rheumatic or non-serious arthritic conditions were permitted.
These changes reflect changing consumer expectations of what information they
should receive and developing views among both healthcare professionals and the
public about the range of products and conditions suitable for self medication and for
promotion to the public.
Recent healthcare developments
The recent report by the European High Level Group on innovation and provision of
medicines1 recognised that patients have a right, and an increasing expectation, to
have access to good quality objective information about the medicines they take and
to be actively involved in decisions about their treatment. They concluded that:
“There should be no restrictions on advertising of non-prescription medicines … in
line with existing requirements for advertising to encourage the rational use of the
product and not to be misleading.”
Over the past few years there has been a move to make more medicines available to
patients and to allow patients to be more involved in the management of their
condition. Products are now available for patients to buy to treat conditions such as
vaginal thrush, eczema, irritable bowel syndrome, emergency hormonal contraception
and temporary sleeplessness which used to be available only on prescription. All of
them can be advertised to the public because they are not used to treat diseases within
the list of prohibitions. These reflect the commitments in the NHS Plan for a more
1
High Level Group on innovation and provision of medicines: recommendations for action. European
Commission. 2002. Available at http://pharmacos.eudra.org.
MLX.288.SCH1.011002
3
patient centred health service. For pharmacy, this has included a commitment to
make more medicines available OTC through pharmacies as set out in ‘Pharmacy in
the Future’2, recognising the need to make more medicines and advice more available
to patients and provide more support in using medicines from pharmacists.
Patients now receive far more information with their medicines through improved
patient information leaflets and information on packaging, approved by the MCA.
This includes information on indications, dosage, side effects, contraindications,
duration of use and when to seek medical advice. The leaflet may include information
on the illness in general and on lifestyle changes, which the patient can adopt to
reduce the need for medication.
The Expert Patient report3 on a new approach to chronic disease management
recognises that patients can become key decision-makers in the treatment process. By
ensuring that knowledge of their condition is developed to a point where they are
empowered to take some responsibility for its management and work in partnership
with their health and social care providers, patients can be given greater control over
their lives.
A patient centred health service is one in which patients can receive information,
including advertising information, about medicines they can purchase OTC,
empowering them to manage their own conditions where it is safe to do so. The
proposal to remove the restrictions on advertising OTC medicines discussed in this
consultation will contribute to this. It will also contribute to measures to increase
freedom of information and contribute to the Government’s agenda to reduce
regulatory burdens on industry.
PROPOSAL
This consultation seeks views on the removal of the prohibition on the advertising of
medicinal products available over the counter (OTC), for the diseases listed in Annex
A.
Effect on products currently available OTC
This proposed change will not mean that advertising to the public will be permitted
for all medicinal products in the disease categories listed in Annex A. Most products
in these categories are available only on prescription and the general prohibition in
European and UK legislation on the promotion of any prescription only medicine to
the public will remain.
The vast majority of products available for OTC purchase may already be advertised
to the public. These are not affected by the proposals in this consultation. However,
there is a small list of products currently authorised as pharmacy (P) or general sale
(GSL) medicines with indications on the licence for which the product cannot be
2
Pharmacy in the Future. Department of Health. 2000. Available at
http://www.doh.gov.uk/pharmacyfuture.
3
The Expert Patient: A new approach to chronic disease management for the 21st Century.
Department of Health. 2002. Available at http://www.doh.gov.uk/healthinequalities.
MLX.288.SCH1.011002
4
advertised to the public. The change to the Regulations proposed in this consultation
would permit these products to be promoted.
Pharmacists are already able to sell these products to customers when they consider it
to be appropriate. As with all P medicines, pharmacists are required to supervise sales
directly, or with the help of a trained assistant. They refuse sales and direct patients to
their doctor if they feel self-medication is not appropriate.
Examples of affected medicines
For some of the OTC products with prohibited indications, promotion to the public
may be considered to bring public health benefits. Potential examples in this category
include the promotion of aspirin 75 mg tablets for secondary prevention of heart
attack or stroke and the use of products containing calcium and vitamin D by patients
with osteoporosis.
There are other products which currently have P legal status which would require care
if they were to be promoted to the public to ensure that patients are referred for further
medical investigation where necessary rather than purchasing products for self
medication. These include theophylline and aminophylline for asthma, fish oils and
ispaghula for hyperlipidaemia and nitrates for angina.
Further safeguards
Companies may need to invest in pharmacist training and education before promoting
the medicines discussed here to the public. Further professional guidelines covering
the supply of these products from pharmacies could be developed, if considered
necessary. This reflects a similar approach to that taken for a POM product being
reclassified to be available for the first time for OTC purchase.
We will be establishing a priority list and working with stakeholders to draw up
guidelines on best practice for the promotion of specific classes of product. This may
include extensions of the existing codes of practice or separate, category or product
specific guidelines.
Initial advertisements for products being advertised to the public for the first time,
following reclassification, are regularly reviewed by the Agency before issue.
Subsequent advertising is not reviewed prior to publication but will be in accordance
with the principles identified during the initial review period. This procedure may
also be used for products being first advertised to the public if the advertising
restrictions discussed in this consultation are removed.
COMMENTS
You are invited to comment on these proposals and respond to the specific questions
below. A form is attached for your reply.
Question 1: Do you agree with the proposals to remove the restriction
on diseases for which medicines classified Pharmacy or General Sales List
(P or GSL) supply cannot be promoted to the public?
MLX.288.SCH1.011002
5
Question 2: Do you think that the restriction should be removed for
only some of these diseases? Please give specific details.
Question 3: What, if any, additional safeguards should be considered
for products that will be affected by this consultation (i.e. those which are
currently legally classified as P or GSL but which may not be advertised
to the public under the present law) and which products or disease
categories should they be applied to?
You are also invited to comment on the possible impact on business of the proposed
changes and draft Regulatory Impact Assessment, which is attached at Annex C.
Copies of the final version would be made available to Ministers, Parliament and to
the public. It would therefore be helpful if you could identify and quantify any direct
or indirect costs (recurring or non-recurring) or any profits which would be likely to
arise for business in your sector if these changes are made.
Comments should be addressed to Aisha Dewangree, in room 14-150 at the above
address or by email (aisha.dewangree@mca.gsi.gov.uk), to arrive by 27 January 2003.
Contributions received after that date cannot be included in the exercise.
MAKING COPIES OF REPLIES AVAILABLE TO THE PUBLIC
To help informed debate on the issues raised by this consultation exercise, and within
the terms of the Code of Practice on Access to Government Information ("Open
Government"), the Agency intends to make copies of replies received publicly
available. Copies will be available shortly after the public consultation has ended.
The Agency's Information Centre at Market Towers will supply copies upon request.
Copies may be further reproduced. An administrative charge, to cover the cost of
photocopying and postage, may be applied. Alternatively, personal callers can inspect
the replies at the Information Centre by prior appointment. To make an appointment,
telephone 020 7273 0351.
It will be assumed that your reply can be made publicly available in this way unless
you indicate that you wish all, or part of it, to be treated as confidential and excluded
from this arrangement. Under the Code of Practice on Access to Government
Information, the Agency will not release confidential replies or replies containing
personal confidential information.
Yours faithfully,
BERYL KEELEY
POST-LICENSING DIVISION
 14-150 Market Towers
MLX.288.SCH1.011002
6
Annex A
DISEASES IN RESPECT OF WHICH ADVERTISEMENTS TO THE PUBLIC
FOR OVER THE COUNTER MEDICINES WILL BE PERMITTED BY THE
CHANGE PROPOSED IN THIS CONSULTATION
Bone diseases
Cardiovascular diseases
Diseases of the liver, biliary system and pancreas
Endocrine diseasesGenetic disorders
Joint, rheumatic and collagen diseases
Psychiatric diseases
Serious disorders of the eye and ear
Serious gastrointestinal diseases
Serious neurological and muscular diseases
Serious renal diseases
Serious respiratory diseases
Serious skin disorders
MLX.288.SCH1.011002
7
Annex B
DISEASES IN RESPECT OF WHICH ADVERTISEMENTS TO THE PUBLIC
FOR OVER THE COUNTER MEDICINES WILL REMAIN PROHIBITED
Chronic insomnia
Diabetes and other metabolic diseases
Malignant diseases
Serious infectious diseases including HIV-related diseases and tuberculosis
Sexually transmitted diseases
MLX.288.SCH1.011002
8
Annex C
DRAFT REGULATORY IMPACT ASSESSMENT
ADVERTISING OF MEDICINES TO THE PUBLIC:
PROPOSED AMENDMENTS TO THE MEDICINES (ADVERTISING)
REGULATIONS 1994
Purpose and intended effect of the measures
The Issue
Consultation on proposed amendments to the Medicines (Advertising) Regulations
1994 to reduce the restrictions on diseases in respect of which advertisements to the
public are prohibited.
Objective
The aim of the proposal is to remove the UK-specific controls on diseases in respect
of which advertising to the public is prohibited.
Background
All advertising for medicines in the UK is subject to the requirements of the
Medicines (Advertising) Regulations 1994 (SI 1994/1932 as amended). These
Regulations, together with the Medicines (Monitoring of Advertising) Regulations
1994 (SI 1994/1933 as amended), implement Directive 92/28/EC, codified as Title
VIII of Directive 2001/83/EC.
The Directive provides that certain therapeutic indications should not be mentioned in
advertising to the general public. These indications are listed in MLX 288 Annex B.
As provided for in the Directive, the UK Regulations also include a further list of
diseases in respect of which advertisements to the public are prohibited, as listed in
MLX 288 Annex A. This consultation proposes the removal of these UK specific
restrictions. The existing prohibition on the advertising of prescription only
medicines to the public is not affected by this proposal.
Options
Three options have been identified:
Option 1 – Do nothing.
Option 2 – Remove some of the restrictions on the diseases in respect of which
advertisements to the public are prohibited, as identified during the consultation.
Option 3 – Remove all the UK specific restrictions on the diseases in respect of
which advertisements to the public are prohibited.
MLX.288.SCH1.011002
9
Benefits Identified and Quantified
Option 1 – None.
Option 2 – Patients will be made aware of the availability of medicinal products
which have already been classified as suitable for OTC sale.
Option 3 – Patients will be made aware of the availability of medicinal products
which have already been classified as suitable for OTC sale.
Compliance Costs for Business
Option 1 – No associated cost but would do nothing to increase the availability of
medicines for self medication where it is safe to do so.
Option 2 – The principal cost would be in the promotion of the product to the public
and any training and education for pharmacy staff to enable the product to be made
available safely. This should offset by the increased sales of the product resulting
from the ability to advertise it to the public.
Option 3 – The principal cost would be in the promotion of the product to the public
and any training and education for pharmacy staff to enable the product to be made
available safely. This should offset by the increased sales of the product resulting
from the ability to advertise it to the public.
Business Sector Affected
Community pharmacies and other retail outlets where medicines are available for
general sale, including supermarkets and convenience stores. Manufacturers and
suppliers of medicines which are classified as available for pharmacy or general sale.
The final version of this RIA will include an assessment of the impact on small
business of this proposal based on responses to this consultation. Comments are
specifically invited on the effects of these proposals on businesses.
Contact point
For further information please contact:
Aisha Dewangree
POST-LICENSING DIVISION
Medicines Control Agency
 14-150 Market Towers,1 Nine Elms Lane, LONDON SW8 5NQ
 020 7273 0689
020 7273 0293
MLX.288.SCH1.011002
10
To:
Aisha Dewangree
Medicines Control Agency
Room 14-150 Market Towers
1 Nine Elms Lane
LONDON SW8 5NQ
Email: aisha.dewangree@mca.gsi.gov.uk
From : ______________________________
______________________________
______________________________
______________________________
______________________________
CONSULTATION LETTER MLX 288
ADVERTISING OF MEDICINES TO THE PUBLIC:
PROPOSED AMENDMENTS TO THE MEDICINES (ADVERTISING)
REGULATIONS 1994
*
1.
We have no comment to make on the proposals in MLX 288
*
2.
Our comments
below/attached.
on
the
proposals
in
MLX
288
are
Question 1: Do you agree with the proposals to remove the restriction on
diseases for which medicines classified Pharmacy or General Sales List (P or
GSL) supply cannot be promoted to the public?
Question 2: Do you think that the restriction should be removed for only
some of these diseases? Please give specific details.
Question 3: What, if any, additional safeguards should be considered for
products that will be affected by this consultation (i.e. those which are
currently legally classified as P or GSL but which may not be advertised to the
public under the present law) and which products or disease categories should
they be applied to?
* My reply may be made freely available.
* My reply is confidential.
* My reply is partially confidential (indicate clearly in the text any confidential elements)
Signed : _____________________________________________
* Delete as appropriate
MLX.288.SCH1.011002
11
MLX CONSULTATION LIST : MLX 288
Advertising Association
Advertising Standards Authority
Advisory Committee on Misuse of Drugs
Age Concern
All-Party Pharmacy Group
Arthritis Care
Association of Anaesthetists of Great Britain and Northern Ireland
Association of British Cardiac Nurses
Association of British Health Care Industries
Association of British Pharmaceutical Industries
Association of Community Health Councils of England & Wales
Association of Pharmaceutical Importers
Association of Surgeons of Great Britain and Ireland
Asthma & Allergy Research
British Association of Dermatologists
British Association of European Pharmaceutical Distributors
British Association of Pharmaceutical Physicians
British Association of Pharmaceutical Wholesalers
British Cardiac Patients Association
British Contact Dermatitis Group
British Dental Association
British Dental Association (Northern Ireland)
British Dental Association (Wales)
British Dental Trade Association
British Diabetic Association
British Epilepsy Association
British Generic Manufacturers Association
British Heart Foundation
British Institute of Regulatory Affairs
British Medical Association
British Medical Association (Northern Ireland)
British Medical Association (Scottish Branch)
British Medical Association (Welsh Office)
British Oncological Association
British Pharmacological Society
British Retail Consortium
British Society for Allergy and Clinical Immunology
British Society for Rheumatology
British Society of Gastroenterology
British Toxicology Society
Broadcast Advertising Clearance Centre
Central Medical Advisory Committee
Chemist & Druggist
College of Health
College of Optometrists
College of Pharmacy Practice
Committee on Advertising Practice
MLX.288.SCH1.011002
12
Committee for Practitioners & Health Visitors Association (NI)
Community Pharmacy Magazine
Community Services Pharmacists Group
Company Chemist Association Ltd
Consolidated Communications
Consumers Association
Co-operative Pharmacy Technical Panel
CWS Ltd (Trade Liaison Department)
Department of Agriculture & Rural Development [N Ireland]
Department of Health, Social Services & Public Safety - Public Health Branch [N
Ireland]
Department of Trade & Industry
Dispensing Doctors Association
Doctor Magazine
Drug & Therapeutics Bulletin
Drug Information Pharmacists Group
English Board for Nursing, Midwifery & Health Visiting
European Association of Hospital Pharmacists
FDC Reports (Elsevier Science)
General Medical Council
General Medical Services Committee
General Medical Services Committee (Wales)
General Practitioners Association (NI)
Genetic Interest Group
Guild of Healthcare Pharmacists
Health & Safety Executive
Health Service Commissioner
Health Which?
Help the Aged
Home Office - Action Against Drugs Unit
Imperial Cancer Research Fund
Independent Healthcare Association
Independent Television Commission
Insulin-Dependent Diabetics Trust
International Research Consultants
Joint Consultants Committee
Local Authority Central Office of Trading Standards (LACOTS)
Long-Term Medical Conditions Alliance
Medical Defence Union
Medical Protection Society Ltd
Medical Research Council
Medical Women's Federation
MIMS (Haymarket Medical Publishing Ltd)
National AIDS Trust
National Assembly for Wales, Health Department
National Association of GP Co-operatives
National Association of Women Pharmacists
National Back Pain Association
National Board for Nursing, Midwifery & Health Visiting (NI)
National Consumer Council
MLX.288.SCH1.011002
13
National Eczema Society
National Federation of Retail Newsagents
National Pharmaceutical Association
National Pharmaceutical Supplies Group
Neonatal and Paediatric Pharmacists Group
Neurological Alliance
NHS Information Authority (Coding & Classification)
NHS Litigation Authority
NHS Regional Pharmacy QC Group
Northern Ireland Consumer Council
Office of Fair Trading
Ophthalmic Group Committee
OTC Bulletin
OTC Business News (Informa Publishing Group Ltd)
OTC News & Market Report
Overseas Doctors Association in the UK Ltd
Paediatric Chief Pharmacists Group
Patients Association
Pharmaceutical Contractors Committee (Northern Ireland)
Pharmaceutical Journal
Pharmaceutical Services Negotiating Committee
Pharmaceutical Society for Northern Ireland
Prescription Medicines Code of Practice Authority
Prescription Pricing Authority
Proprietary Association of Great Britain
Radio Authority
Radio Advertising Clearance Centre
Royal College of Anaesthetists
Royal College of General Practitioners
Royal College of Midwives
Royal College of Nursing
Royal College of Nursing (Northern Ireland)
Royal College of Nursing (Wales)
Royal College of Obstetricians & Gynaecologists
Royal College of Ophthalmologists
Royal College of Paediatrics and Child Health
Royal College of Pathologists
Royal College of Physicians & Surgeons (Glasgow)
Royal College of Physicians (Edinburgh)
Royal College of Physicians (London)
Royal College of Psychiatrists
Royal College of Radiologists
Royal College of Surgeons (Edinburgh)
Royal College of Surgeons (England)
Royal College of Surgeons (Faculty of Dental Surgery)
Royal Colleges of Physicians : Faculty of Pharmaceutical Medicine
Royal Colleges of Physicians : Faculty of Public Health Medicine
Royal Pharmaceutical Society of Great Britain
Royal Pharmaceutical Society of Great Britain (Scotland)
Royal Pharmaceutical Society of Great Britain (Welsh Executive)
MLX.288.SCH1.011002
14
Royal Society for the Promotion of Health
Scottish Consumer Council
Scottish Executive, Department of Health
Scottish General Medical Services Committee
Scottish Pharmaceutical General Council
Scottish Wholesale Druggists Association
Scrip Ltd
Social Audit Unit
Society of Pharmaceutical Medicine
St Andrew’s Ambulance
St John Ambulance
St John Ambulance (NI)
Switch
Terrance Higgins Trust
Tic-Tac Administration
Tutsells Enterprise IG (The Brand Union Limited)
UK Committee for Nursing, Midwifery & Health Visiting
UK Clinical Pharmacy Association
UK Homoeopathic Medical Association
UK Inter-Professional Group
University of Aberdeen : Department of General Practice & Primary Care
Veterinary Medicines Directorate (VMD)
Welsh Consumer Council
Women in Medicine
MLX.288.SCH1.011002
15