Select Committee on Health Written Evidence


Memorandum by the Proprietary Association of Great Britain (PI 94)


  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.


  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.


  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.


  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.


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

  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.


  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.



  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.


  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.


  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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