Celebrating 100 years of self-regulation

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This advertisement for the carbolic smoke ball is an example of the types of unsubstantiated claims that demanded a new approach to medicines advertising. It caused a sensation in the 1890s and was the subject of a famous court case. It was featured in Clive Coleman’s ‘The Cases That Changed Our World’, broadcast on BBC Radio 4 (2009)

Medicines self-regulation milestones 1919-2019

 

 

1919192019241926
Association of Manufacturers of British Proprietaries established. Rules agreed for MembershipAll new materials to be submitted for reviewAMBP changes its name to Proprietary Association of Great Britain

The early years

The motivation for companies to unite in forming a trade association was to demonstrate the responsibility of the industry in the face of accusations of exaggeration and quackery. Before the formation of PAGB, and the subsequent advertising rules it developed for its members, medicines advertising was unregulated and some manufacturers made outrageous and unsubstantiated claims about their products. The British Medical Association had published a criticism of proprietary medicines called Secret Remedies: What they cost and what they contain and a newly formed Ministry of Health was expected to take forward recommendations of the House of Commons Select Committee Report on Patent Medicines (1914) potentially introducing legislation that would address their concerns.

A group of business leaders decided to act and on 2 June 1919 representatives of around fifty companies met to discuss forming a trade association that would effectively self-regulate medicines advertising. Membership was not automatic and required companies to demonstrate responsible advertising practice. 15 companies were admitted into membership of the Association of the Manufacturers of British Proprietaries (AMBP) with William Harrison Woodward appointed Chair.

From its beginnings in 1919, the association’s Members established rules on advertising:

Preparations must not be offered or intended directly or indirectly for use as abortifacients or for any other immoral or illegal purposes; or advertised or recommended as a cure for diseases or conditions which are generally recognised as incurable by the simple administration of drugs.

Accurate advertising was the foundation on which the association was built, and the AMBP not only addressed recommendations made in the select committee report, it went further. In addition to compiling a register of each medicine with a list of ingredients and therapeutic claims to be made, it also required members to provide evidence of efficacy. It was a provision of membership that “composition, origin, place of manufacturer etc and therapeutic dietary effects” were submitted.

The AMBP recognised the need to effect and implement standards quickly to demonstrate its valuable role in self-regulating the industry, reducing the need for proposed legislation. It focused on quality of membership, not quantity and demanded high standards from its members. In September 1919 Proud and Harsant became the first company to be formally rejected pending modification of its advertising; Bates & Co was required to delete “recommended for cancerous and scrofulus wounds” from its advertising to meet membership eligibility standards.

Later that year, a sub-committee was established to review specimen packaging for membership and a definition of ‘cure’ was added to the AMBP’s principles – it was permitted provided there was “no claim, direct or implied to infallibility, certainty or guarantee”.

Being a Member of the Association of Manufacturers of British Proprietaries did not automatically entitle companies to a stamp of approval on its advertising. The Association enforced high standards and was already recognised for this just a few years into its existence.

In 1924, the AMBP made the first change to its advertising rules. Since 1919 it had been a requirement to have materials reviewed by the association but now all new materials had to be submitted for review not only the existing advertising at the time of membership application.

Members noted that their advertising was being held to a higher standard than non-members, and the AMBP addressed this by securing support from press organisations which included coming to AMBP for advice on non-member advertising, and some agreeing not to accept certain ads. The AMBP began monitoring non-members advertising and raised objections with newspapers where it identified misleading or non-compliant advertising.

193619471948
PAGB publishes world's first self-regulatory advertising codePAGB appoints advertising advisory panelBritish Code of Standards of Advertising Related to the Advertising of Medicines and Treatments

1930s – the world’s first self-regulatory advertising code

The Proprietary Association of Great Britain (as it was renamed in 1926) had been closely involved in drafting the 1934 Medicines and Surgical Appliances (Advertisement) Bill. When this failed to pass into legislation in 1936, PAGB remodelled its own advertising rules along the lines of the proposed bill, launching a self-regulatory advertising code in 1936.

It was a first for PAGB, a first for a trade association and the world’s first ever self-regulated advertising code.

The 10 Principles of the PAGB Code of Advertising Practice

  1. Advertising must be truthful
  2. It should not infer the prevention, cure or relief of serious diseases which should be under the care of a medical practitioner. Nor should it diagnose by correspondence or treat such ailments by correspondence
  3. It mustn’t suggest to the customer that they are suffering from any serious ailments
  4. Testimonial should be honest and limited to the actual view of the user and should be unpaid. No foreign doctor testimonials should imply they are a British doctor
  5. No prize competitions or schemes should lower the tone of the Industry
  6. Illustrations should be in good taste and should not be distorted or exaggerated
  7. It should not imitate trademarks or competitor names or either directly or indirectly disparage or criticize other advertised goods or services
  8. No advertising, without authority should infer that the product recommended emanates from any hospital or official source
  9. Every member of the Association must take steps to provide his advertising agent with copies of this code
  10. Any infringement of the provisions of the code can mean suspension or expulsion.

 

PAGB began to increase capacity for advertising review and employed its first medical advisor: ex-BMA secretary Dr Alfred Cox.

I have found that the leading spirits in the Proprietary Association are thoroughly convinced that it is better to do your own reforming than have to have it forced on you…its own members are subject to as stringent a code as is applied in any medical publication, and I am sure that its influence on patent medicine advertising has been far-reaching and salutary.”- Dr Alfred Cox, first PAGB Medical Advisory and ex-BMA Secretary, in his autobiography.

Russell Chapman, the Advertising Association General Secretary was also appointed to PAGB’s Executive Committee. Further links with the Advertising Association followed and by 1939, the AA had adopted the PAGB Code and recommended it to other organisations.

The war years and post-war Britain

Unsurprisingly, advertising volumes declined in the war years. Partly this was a response to shortages in supply; for example in March 1942 PAGB members were asked to reduce their aspirin advertising by 50% to ensure continued availability. PAGB refocused on the war effort, and on maintaining supplies of ingredients and raw materials at home and across the British Empire.

Post-war, self-regulation of advertising again became PAGB’s priority activity. Standards remained high and new members continued to be rejected if they wouldn’t or couldn’t adhere to the rules. PAGB also took steps to make its approval processes more robust. In 1947 it set up an advisory panel with an independent chairman (James Milner MP), a doctor (Dr Ross Lynch), a pharmacologist and two members of industry. The panel would review copy where the claims were doubtful – both for PAGB members and companies referred by the Newspaper Association.

The British Code of Standards of Advertising Related to the Advertising of Medicines and Treatments was issued in 1948. This in effect meant that all companies, members or non-members, effectively had to adhere to the rules in the PAGB code. Current PAGB secretary JS Walmsley felt that PAGB:

“can take fair credit for the code. it is based entirely on that of this Association and in substance it conforms with the standards set up by us over many years”

195519551950s-60s1962
Commercial TV begins with ITVPAGB advisory panel dissolvedNew versions of the PAGB codeAdvertising Standards Authority established
people watching TV

1950s – PAGB responds to the birth of TV advertising

Commercial television began broadcasting with the launch of ITV in 1955. PAGB broadly supported this new advertising medium and soon saw an increase in copy submissions which had an impact on resources – by the end of the 1950s half of the secretariat’s time was spent on advertising approval.

Broadcast advertising presented its own challenges. Comsistency of messaging to consumers was critical and PAGB worked closely with advertising associations including the Screen Advertising Association to ensure that PAGB’s Code remained central to all other medicines advertising codes.

Over time, PAGB’s internal expertise developed to the extent that it no longer needed an advertising advisory panel and it was dissolved in 1955. From this point, the PAGB secretariat took responsibility for pre-vetting all materials.

The PAGB Code in the 1950s and 1960s

Medicines and advertising regulation are closely linked, particularly in the area of safety. In the 1950s, PAGB added new measures to its Code to protect the public. This new version of the Code was adopted by members with little opposition, showing the extent to which members valued the self-regulatory system.

In fact, several new advertising Codes were published during the 1960s as PAGB worked to keep up to date with changes in medicines regulation. This flexibility helped maintain a good reputation for PAGB and its self-regulatory system.

We do not think it necessary to propose a further statutory control, whether as an alternative or as a supplement to the voluntary sector” Report of the Molony Committee on Consumer Protection 1963.

PAGB also produced a series of guidance notes covering treatments for rheumatism, laxatives and vitamin preparations to help its members navigate the grey areas of varying interpretations.

PAGB was very much involved in the establishment of the Advertising Standards Authority (ASA) in 1962, and became one of the ‘sponsoring’ bodies. The resulting advertising Code published by the ASA closely reflected PAGB’s Code.

196819731978
The Medicines ActUK joins the European Economic AreaLabelling and Medicines Advertising to the Public Regulations

1970s the impact of the Medicines Act (1968)

The 1970s saw a huge volume of work implementing the requirements of The Medicines Act (1968) which introduced statutory legislation relating to medicines licensing, manufacture, marketing, importation, distribution and clinical testing. The Act defined three categories of medicines prescription only medicines:

PAGB saw the provisions within the Medicines Act as a significant burden on all involved not least because of the economic consequences for its members. It didn’t oppose statutory control underpinning the principles of its advertising Code but it remained convinced that self-regulation was the most appropriate route for OTC medicines.

In 1978 the Labelling and Medicines Advertising to the Public Regulations came into force. This marked a change from 60 years of self-regulation governed by the industry, to a situation where the PAGB Code was underpinned by legislation but managed by self-regulation. PAGB concluded in 1978:

it has effectively given statutory force to the requirements of the PAGB Code” (PAGB Annual Report 1977-78)

This was also the decade in which the UK was admitted into the European Economic Community (EEC) which brought its own regulatory challenges related to pharmaceuticals.

As a result of all these changes, PAGB revised its advertising Code several times during the 1970s.

1990199319981999
PAGB food supplements advertising guideline launchedEuropean Directive on advertisingInternet advertising added to the PAGB codePAGB Professional Code for Medicines

1980s and 1990s – a European challenge

A European Directive on advertising in 1993 was a potential threat to PAGB’s 70+ years of self-regulation of OTC medicines advertising in the UK. In the end, the Directive didn’t exclude voluntary control by self-regulatory bodies and a number of the provisions in the Directive were already in the PAGB Code, showing again how the consumer healthcare industry implemented a responsible and robust self-regulatory system.

Nevertheless, PAGB revised its code to reflect the EU directives in 1996. It further amended the code in 1998 after a UK consultation on advertising regulations. Again PAGB demonstrated its efficacy and its record on responsible advertising. Data from 1975-1990 showed that only 43 of over 90,000 complaints about UK advertising were against PAGB members, and just eight of these were upheld.

The 1998 version of PAGB’s Code included guidelines to help advertisers get copy approved. It also added internet advertising to the code’s remit for the first time. It was soon joined by a new Professional Code for Medicines, setting out the rules applying to the promotion of OTC medicines to health professionals.

Food and nutrition – a joint approach to health claims

PAGB produced its first food supplements advertising guideline in 1990 and joined other leading health and nutrition bodies in launching the Joint Health Claims Initiative to address the need for a code of practice for health claims for foods more widely.

2007201420162019
PAGB Pack Design Code launchedPAGB brings self care medical devices into membershipSelf Care Medical Devices Guideline publishedPAGB Medical Devices Consumer Code

The noughties – bringing the advertising codes up to date

PAGB’s advertising code has adapted over time to acknowledge the advertising media adopted by its members. In the ’00s it was updated to include more guidance on web materials such as viral advertising, social networking and message boards. Changes in the medicines landscape also affected advertising regulation. As more medicines were reclassified from POM to P status changes were needed to allow marketing of these products.

In 2007, PAGB launched its Pack Design Code, which formalised the packaging and labelling advice provided to Members and which set out clearly the requirements of packaging for consumer healthcare products.

Following the adoption of medical device products into membership in 2014, advertising guidelines for self care medical devices were introduced in 2016.  This year, 2019, the Self Care Medical Devices Guideline was replaced by the Medical Devices Consumer Code, a new addition to PAGB’s Codes. A revised version of the Consumer Code for Medicines was also published showing that one hundred years on, PAGB continues to help its members produce advertising that is honest, truthful and responsible to support people to self care.

 

Compiled from historical sources in the PAGB archive.