APPENDIX 24
Memorandum by the Proprietary Association
of Great Britain (PI 94)
INTRODUCTION
1. The Proprietary Association of Great
Britain (PAGB) is the trade association representing the manufacturers
of over the counter medicines. Membership of the Association is
limited to companies whose primary interest is the manufacture
or marketing of branded non prescription (Over the Counter or
OTC) products. Annex 1 describes the way medicines are classified
as prescription sale, pharmacy sale or general sale and shows
the market size. Some of the companies in PAGB membership also
make prescription medicines and are members of the Association
of the British Pharmaceutical Industry in respect of their prescription
products. The interests of the generic industry are the responsibility
of the British Generic Manufacturers Association.
2. PAGB was created 85 years ago to control
the advertising of over the counter medicines through a self regulatory
code of advertising practice and this is still a core activity
for the association. It is a condition of membership that members
send all their advertising to PAGB for scrutiny and approval by
the PAGB secretariat before it is published. These days the PAGB
code of practice sits within a regulatory framework which is overseen
by the Medicines and Healthcare Products Regulatory Agency (MHRA)
who are responsible for the regulations, deal with complaints
and monitor advertising for compliance with the regulations.
3. In addition to this, PAGB provides general
regulatory advice to members, sponsors research into self medication
and primary care, organises stakeholder seminars and conferences,
identifies areas of common interest where it is efficient for
companies to work together and facilitates discussion and action.
These areas are ingredient safety issues, communications about
self-medication and food supplements and interaction with government
bodies and those representing health professionals, especially
doctors and pharmacists. PAGB is a member of the European Proprietary
Medicines Association ("AESGP")) and though this we
have interactions with the European Commission and Parliament
and input into EU legislation.
4. The Association is consulted by government
on aspects of regulation relevant to the industry and actively
works with organisations with similar interests with a view to
expanding the scope of self care and self medication. The major
point of contact is with the MHRA through our involvement in working
groups, regular liaison meetings and occasional meetings on specific
regulations or ingredient matters.
THE GOVERNMENT,
PATIENTS AND
POLICY ON
SELF CARE
AND SELF
MEDICATION
5. The National Health Services dominates
and shapes healthcare in the UK. Before it came into being, self
care and self medication was the family's main way of managing
illness, especially those who could not afford to see a doctor.
For over 50 years, since the NHS started, everyone has had access
to a general practitioner, free of charge. For many people going
to the doctor is their automatic choice for treating a health
problem. The OTC medicines market has therefore been limited to
the pool of symptoms which people are prepared to treat by self-medication.
This symptom pool is not as large as it could be, nor is it elastic,
as many people prefer not to treat their symptoms at all.
6. One of PAGB's long-term objectives is
to help expand the scope of self medication in the UK through
wider availability of OTC medicines and by encouraging people
to manage illnesses themselves without the control of a health
professional except where necessary.
7. This objective needs support from all
stakeholders, government, health professionals and the public
themselves. To engage their interest requires long-term thinking
and over the past 20 years PAGB has sponsored research, held conferences
and symposia and sought the champions for self care within the
different stakeholder groups. The key stakeholders are government
and the public.
Government
8. Until fairly recently it was not possible
to point to any government document which mentioned self care
or self medication much less spelt out a policy on it. The UK
is not unusual in this. Around the world, most governments begin
to take an interest in self medication as a way of reducing the
drug bill. In the UK, two attempts have been made to do so, in
1985 with the introduction of the Selected List and its extension
in 1993. The Selected List prohibits doctors from prescribing
certain branded products in 17 therapeutic categories, mostly
products in the self-medication sector. Other countries have gone
down the same route but in almost every country people are charged
for doctor visits. In the UK people can still see a doctor at
no charge and in the majority of cases they will receive a prescription
at the end of the consultation. There is no support from health
professionals or the public for any major change in this system.
General Public
9. Consumer research sponsored by PAGB and
others shows that the British public are cautious in their use
of medicines, preferring not to take them unless it is absolutely
necessary. Research in 1972, 1986 and 1996[83]
showed that people experience around five symptoms per person
in any two week period but 50% of these symptoms are not treated
at all or are managed with a home remedy, such as a hot toddy
for a cold. Around a quarter of illnesses are taken to a doctor
or treated with a prescription medicine, already in the home.
Purchase of the product is often stimulated by the need to treat
a person who is already sick, so there is a close relationship
between the incidence of symptoms within the population, and the
sales of medicines. It is most obvious at times of cold and flu
epidemics when manufacturers can schedule production by monitoring
the numbers of people reporting colds.
10. People seek professional advice when
they are unsure about an illness or when it has gone on for longer
than expected. They tend to see doctors as experts in illness
and pharmacists as experts in medicines and they use both as appropriate
to supplement their own knowledge and the advice they get from
their family and friends and the media. Patients are clear that
they want real empowerment and not to be passed from the control
of one health professional to be dependent on another.
11. The level of satisfaction with OTC medicines
is high with high levels of repeat purchasing. This means that
people generally use the medicines based on their own experience
and the information on the product label and leaflet. Research
shows that people generally value the advice they get from a pharmacist
and that pharmacists are trusted.
12. While PAGB member companies sponsor
a great deal of consumer research on the products and therapeutic
areas in which they are involved, it falls to PAGB to look at
self care as a whole and to conduct research across the whole
sector. We make this research available to anyone who wants to
use it and it is published on the PAGB website.
Patient representative bodies
13. While people who are newly diagnosed
with a chronic illness need a lot of medical support, those who
have had an illness for some time become very competent at managing
it. They view themselves as people whose illness is a part of
their lives, not the whole of their lives. The people who represent
patients in special interest groups are at the forefront of thinking
about how illness should be managed and this is an area where
industry learns from people who really know about medical conditions.
14. PAGB and its member companies have increasingly
involved such people in stakeholder groups talking about switching
ingredients from prescription control and their involvement has
improved the quality of patient information and training support.
Self Care policy
15. The NHS has dominated health policy
thinking since 1948. Since OTC medicines are self purchased they
were of little interest to policy makers. While policy proposals
in the late 1980s and early '90s addressed the need for some secondary
care interventions to be managed in GP surgeries the real changes
can be tracked from the late '90s when initiatives such as NHS
Direct showed over 30% of callers had a problem which could be
managed by self care. At the opposite end of the spectrum the
DoH Expert Patient Programme began to generate information which
shows that people with chronic conditions become very good at
managing them without much medical help.
16. In 2000, the NHS Plan set out an objective
of making better use of pharmacists and moving more medicines
from prescription control. This objective was picked up by the
MHRA but there was still no over riding strategy for self care
and self medication within the NHS. For the first time the NHS
Plan established self care as a level of care in the NHS, alongside
primary, intermediate and secondary care.
17. Derek Wanless, in his reports in 2001
and 2002, stressed the need for self care to be promoted within
an overall health policy and predicted that if people could not
be persuaded to fully engage with self care programmes then the
NHS would not be sustainable. This raised the profile of self
care and in 2002 the Department of Health mapped out all the work
programmes that had a self care element to them. This exercise
showed that although there were many such programmes, they did
not join up and opportunities for synergy were being missed. In
October 2003 Sarah Mullally, Chief Nursing Officer, was appointed
the first Director for Self Care with the task of ensuring that
the role of self care was recognised in appropriate ways.
18. Research commissioned by the Department
of Health in 2003 showed that around the country more and more
primary care trusts are introducing minor ailment schemes where
nurses or pharmacists are taking on the work of managing conditions
which are now being taken to the GP or Accident and Emergency.
The new GP contract specifically encourages doctors to try new
ways of working and money has been set aside to develop the evidence
base which these empirical schemes lack. It is now recognised
that self care underpins healthcare in this country and the more
people can safely do for themselves, the better the system will
work.
19. Doctors used to be very dismissive of
the role of pharmacists but are increasingly positive about their
role in managing minor ailments and repeat prescriptions. All
stakeholders qualify their support for more self medication by
the caveat that it must not be a way of rationing access to the
NHS which they want to see continue to be free at the point of
demand. They are concerned about inequalities of access in that
only those who can afford to buy OTC medicines really have a full
choice but they do not think this should inhibit the widening
of the scope of self care and self medication.
20. PAGB organises conferences which bring
together Ministers of Health, regulatory officials, health professionals
and patient representatives to discuss their experiences of self
care and self medication. Consumer interests have been represented
by charities such as the Kings Fund, the Pickering Institute and
the Consumers Association. The BMA, RCGP, GPC, Doctor Patient
Partnership and representatives of Health Authorities, primary
care trusts and general practice have given their views. Reviewing
the proceedings of these conferences it is notable that over the
past 10 years patient representatives have become more questioning
of health professionals, more confident in their own abilities
and more demanding of the right to have access to medicines.
21. PAGB has supplied all of this information
to parliamentarians, government, the NHS and the Department of
Health in response to the various consultations on modernising
the NHS and developing patient choice. The interest in self care
and self medication is developing from changes in clinical practice
and changes in the way people use health professionals. There
is no overall government strategy that spells out where self care
and primary care start and finish. Various research projects which
are now going on in primary care trusts may generate the evidence
base which will allow that strategy to be defined in the near
future.
22. In the meantime, government is putting
in place national standards and local action to measure self care
in practice and to move towards improvements being made in these
standards. There is increasingly explicit inclusion of self care
in National Service Frameworks and in NICE guidelines.
RESEARCH AND
INNOVATION
23. PAGB and its companies have little direct
involvement with research organisations or with the expert committees
in the MHRA with the exception of the POM to P programme. Improving
the process of reclassification and the climate for changing legal
classification (so called switching) has been a major objective
for PAGB. Member companies work with leading medical experts and
pharmacists to develop switch dossiers and training materials.
1987 British market Research Bureau, Everyday healthcare
Study,
1997 British Market Research Bureau, Everyday healthcare
Study.
Switches in legal status
24. The regulations which control medicines
in Europe require that all new active substances shall be control
as prescription only medicines when they are first marketed. This
enables their safety to be established in a larger population
of users after the preliminary evaluation before marketing. Medicines
can move from prescription control when they are considered to
be safe enough for people to use without medical supervision.
Sometimes companies carry out additional clinical work to establish
a new dosage form or a lower dose of ingredient but by and large
the supporting data to reclassify a medicine is a safety-based
evaluation.
25. In 1992, Medicines Control Agency (now
the MHRA) introduced new guidelines and a transparent process
for moving products from POM to P which was a stimulus to innovation.
In practice, until that time, most manufacturers of OTC medicines
had to formulate their products from a relatively small number
of active ingredients. As a result of the new guidelines, developed
by a working group led by the MHRA, involving PAGB and the Royal
Pharmaceutical Society of Great Britain, over 40 ingredients have
moved from prescription control since 1992.
26. The General Sales List was set up in the
mid 1970s, and for over 20 years there were few significant changes
in it. A guideline for switching products from Pharmacy Sale to
General Sale was launched in 1997 and, in a similar way, began
to stimulate P to GSL switching. Ibuprofen, Loperamide and Ranitidine
are all ingredients which have changed legal classification from
POM through P to GSL. A pattern is emerging of products moving
from POM through P to GSL after a period in each category to evaluate
their safety. In many cases the same products are available in
P and GSL categories differentiated only by pack size.
27. The CSM has been cautious about allowing
consumers access to medicines for indications if they think the
indications would be better managed under a doctor's supervision.
It often takes two or more attempts to make a case that persuades
the CSM. Hydrocortisone became available OTC in 1983 for insect
bites and stings but it was only after 10 years' experience as
a pharmacy medicine that it could be promoted to the public for
the treatment of eczema, a long established indication for the
ingredient when it was a POM. However, over the last 15 years
the products available for consumers to use in self-medication
have changed considerably.
28. While all new chemical entities are
prescription only medicines, and most remain so classified, the
OTC market is now benefiting from the introduction of new ingredients,
which were originally developed for use in prescription medicines.
People are managing illnesses such as vaginal thrush, insomnia,
irritable bowel syndrome, minor arthritic conditions without needing
to visit a doctor every time. The OTC availability of emergency
contraceptive tablets OTC a few years ago was a major change in
approach and with the availability of nicotine replacement products
and now statins for lowering cholesterol, people have new tools
to help towards healthier lifestyles.
29. In response to the NHS Plan targets
of wider access to OTC products the MHRA set up a new reclassification
group in 2001 which developed further proposals to improve the
process of switch, a new list of potential switch candidates and
proposals for information and training which will be provided
to pharmacists and the public. All of this information was subject
to public consultation and is on the MHRA website. The list of
switch products this time includes medicines for the management
of more serious conditions and chronic illnesses. The list is
not permission to develop an OTC product, ingredients will change
legal status if an application is submitted and approved by the
CSM. Some of the ingredients on that list are now beginning to
be evaluated. Companies are assessing the safety of the ingredient
and assessing whether consumers are ready to manage the relevant
condition themselves.
30. Changing legal classification is not
straightforward and requires time, resource, energy and long-term
commitment on the part of the manufacturer. Many of the new molecules
which are developed today have fewer side effects than the older
ingredients but it is recognised that the newer indications bring
a need for much better patient information and for training for
pharmacists and their staff and the industry supplies this with
input from professional bodies and the MHRA.
31. The PAGB input to the switch programme
was to work with the other stakeholders to help develop the guidelines
for standards for good consumer information and training for pharmacists
and to industry to work to these standards. This was done with
input from doctors, pharmacists and patients groups.
THE PROVISION
OF DRUG
INFORMATION AND
PROMOTION
Drug Information
32. Drug information is not the same as
promotion. Given the right information and support people can
often manage their ailments themselves. For example, doctors are
recognising that a patient with diabetes lives with it 365 days
a year and sees a health professional for only a few hours of
that year. Providing good information to patients and the health
professionals who support them is vital. Research shows that people
seek information from a variety of sources and their information
requirements are different for different illnesses.
33. The information provided by the pharmaceutical
industry is controlled by regulation. The Summary of Product Characteristics
sets out the indications, dosage and side effects. This controls
what is included in the product label and leaflets which have
to be submitted and approved by the MHRA before a product can
be marketed. In the near future new regulations will require that
all patient leaflets be tested for readability and ease of use
as a condition of getting a marketing authorisation.
34. As a contribution to safe use of medicines
PAGB sponsors the Consumer Health Information Centre which has
a panel of independent advisors who help develop materials to
encourage people to use medicines sensibly. PAGB also provides
a directory of OTC medicines to all GPs which has become the industry
standard and is also available on line. (These can be accessed
from www.pagb.co.uk)
35. Pharmacists and their staff are the
first line of contact for consumers with questions about OTC medicines
and manufacturers provide them with a lot of information, not
only about their products but about the category they fit into
and how different products work. This information is mainly provided
in printed format and a joint industry/pharmacy working group
has recently produced a guideline for the production of this material
to encourage better separation of training and marketing materials.
Promotion
36. In communicating the value of self care
and self treatment a balance needs to be struck between on the
one hand, encouraging people to treat themselves but, on the other
hand, the risk of encouraging over use. The regulations (The Medicines
(Advertising) Regulations 1994, as amended 1999) governing the
advertising of medicines in the UK recognise the need to moderate
promotions of medicines to the public. Within an overall requirement
that advertising should promote the rational use of medicines,
there are specific prohibitions on promotional methods which could
lead to unnecessary or excessive use of medicines.
37. Enforcement of the law and control of
medicines advertising in the UK is the responsibility of the Medicines
and Healthcare Products Regulatory Agency ("MHRA") (which
acts on behalf of the Ministers of Health who form the Licensing
Authority in the UK).[84]
In addition Ofcom has responsibilities for broadcast advertising
and the Advertising Standards Authority (which is a self-regulatory
body for non-broadcast advertising) deals with complaints about
medicines advertising.
38. The MHRA has primary responsibility
for regulations and providing guidelines to their interpretation,
but day to day advice to member companies on interpretation of
the regulations, through vetting their advertising, is still a
core activity of PAGB. The Association holds copies of the marketing
authorisations for all the products supplied by its membership
and checks all proposed advertising copy, for all media including
websites, to ensure it complies with the terms of the marketing
authorisation, the regulations and the Association's Code of Practice.
39. PAGB has frequent interaction with the
Medicines Control Agency (MHRA) on advertising and all other matters
relating to the regulation of medicines. The Code of Practice
was updated in 2004 with input from the MHRA and professional
bodies. Training in compliance with the code of practice is provided
by PAGB in monthly workshops.
REGULATORY REVIEW
OF DRUG
SAFETY AND
EFFICACY
Efficacy
40. Most OTC medicines are based on ingredients
which have been available for many years. There is no need to
conduct new clinical trials to establish that a well known ingredient
is effective. This concept was introduced in the 1980s across
Europe to reduce unnecessary toxicology and pharmacological testing
and to free up scare clinical trial resources. It is still the
approach today. A new directive for herbal medicines just adopted
in Europe will allow herbal products to be registered on the basis
that they have been on the market for 30 years and there is bibliographic
data to show that there is a reasonable expectation that they
will be effective.
41. When a new product based on established
ingredients is developed and submitted for evaluation by the MHRA,
it is usually examined by the MHRA assessors who rely on precedent
and established medical opinion to approve the product for marketing.
The CSM advice is sought in the case of medicines which contain
ingredients which are currently prescription only where it is
proposed that they should be available as pharmacy only medicines.
If the CSM approves the proposal, the basis for approval is a
public document and there is a period of public consultation and
often a re-evaluation by the CSM or the Medicines Commission before
regulations are changed to allow the wider access. Despite the
prevalence of old ingredients, the OTC market is not a static
one. In all the major categories today the brand leaders are based
on ingredients which were originally developed as prescription
products.
42. While single ingredient OTC products
are generally licensed on the basis of well established medicinal
use combination products containing two or more ingredients in
a single product need to be supported by clinical research. Most
combinations are put together to make it more convenient for consumers
to take two or more medicines but they can also lead to enhancement
of efficacy if one ingredient boosts the effectiveness of another
or prevents a side effect. Such combination products are not given
marketing authorisations unless clinical studies have been carried
out and the CSM is convinced that it is a rational treatment.
43. The Medicines Act requires each marketing
authorisation to be judged individually and comparative efficacy
may not be part of that assessment. Comparative safety can be
taken into account and it routinely happens in the assessment
of OTC products where a marketing authorisation will be refused
if in the opinion of the CSM there are products available which
offer efficacy with fewer side effects.
Safety
44. The safety review of OTC products is
an ongoing process. Marketing authorisations are issued for five
years and applications for renewal are submitted along with a
review of adverse event reports which have arisen in that period.
Companies are required by law to inform the MHRA of any adverse
events reported to them to enable follow up and entry in the central
data base. As well as this, doctors, nurses and pharmacists can
send reports of adverse reactions to the MHRA on "Yellow
cards"—a scheme which has been operating for 40 years.
This scheme is soon to be revised to allow the general public
to report any problems directly to the MHRA.
45. OTC products share a relatively small
number of ingredients and when problems arise it is common practice
for the MHRA to undertake a full safety review and to apply the
findings to all the products containing that ingredient. In the
past few years this happened with aspirin where there was concern
about the possibility of association with Reyes Syndrome. One
of the first POM to P switches, terfenidine—a hayfever and
allergy product, returned to POM status because new information
showed that if taken with grapefruit juice it could cause heart
problems in some people.
46. Research conducted by the National Audit
Office confirmed that few people taking over the counter medicines
experienced side effects. Those who did found they were minor
and stopped when they stopped taking the product. On the other
hand a recent report in the BMJ suggested that a significant number
of people in hospital had suffered adverse reactions which were
avoidable. Although the leaflets of medicines include information
about adverse effects there has been some criticism that the language
used is not understood by consumers. Over the next year or so,
new guidelines will be introduced by the MHRA to improve the way
the risks associated with the taking of a medicine are described.
47. All the advertisements for OTC medicines
include a reminder to read the label and leaflet but this needs
reinforcing. Since research shows that leaflet information is
not consistently read by users, this improvement in information
will have to be accompanied by a campaign to encourage people
to read them. PAGB is working with other stakeholders to help
achieve this objective.
Misuse of OTC Medicines
48. Any medicine with a potential for dependence
is required to be restricted to prescription only status so by
definition OTC medicines have a low potential for such problems.
Research shows that most people are cautious in their use of medicines,
preferring not to take them unless they really have to. In recent
years concerns have been raised about over consumption of analgesics
by some people. This is not related to wider availability of medicines,
indeed the pack sizes of analgesics have been reduced in the last
five years, but it may be linked to a condition called chronic
daily headache. In order to understand this better work is going
on with experts in the field and the hope is that in the near
future pharmacists and doctors will be provided with materials
to help them identify people with this problem and help them appropriately.
PRODUCT EVALUATION,
INCLUDING ASSESSMENTS
OF VALUE
FOR MONEY
49. Over the counter medicines are generally
not prescribed under the NHS. Those which doctors prescribe are
part of the PPRS scheme and their prices and profits are controlled
in the same way as any other NHS medicine. The medicines which
are bought over the counter by people are not price controlled
at all. People have a choice of medicines to treat their symptoms.
Some buy generics or pharmacy chain own labels, others prefer
brands. Until a few years ago manufacturers were allowed to set
the retail price which then had to be the price charged in every
retail outlet. This is no longer the case and large grocery retailers
and pharmacy chains routinely compete on price.
50. Resale price maintenance ended in 2002.
An extensive review of the OTC pharmaceutical and its pricing
and profits was conducted by the Office of Fair Trading in preparation
for the court case. Having conducted the review the Director General
of Fair Trading is on record as saying that it was no part of
his case that the OTC industry made excessive profits.
September 2004
83 1972 Dunnell and Cartwright, "Medicine Takers,
Prescribers and Hoarders", Back
84
The Licensing Authority is the Ministers for Health for England,
Scotland, Wales and Northern Ireland. Back
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