“Secret Remedies” reported that many proprietary products contained poisons, or ineffective ingredients and that they were vastly overpriced. In 1914, this led to the House of Commons’ Select Committee Report on Patent Medicines which noted that the plethora of available products “are of a widely differing character” with “many secret remedies making grossly exaggerated claims of efficacy” that are “put upon the market by ignorant persons and, in many cases, by cunning swindlers who exploit, for their own profit, the apparently invincible credulity of the public”.
The Select Committee Report, which was published the day the First World War broke out, made several recommendations, the first of which was to set up a new Ministry for Public Health to administer the “law governing the advertisement and sale of patent, secret and proprietary medicines”. A second recommendation was for an “exact and complete statement of all the ingredients and proportions of remedies and their therapeutic claims”. This caused a great deal of concern at the time, amongst manufacturers, both reputable and otherwise, whose formulations were closely guarded secrets.
PAGB’s First Propaganda Programme
Implementation of the Select Committee’s recommendations was delayed until the war ended in 1919. This prompted pharmacists and reputable manufacturers of proprietary medicines to establish the forerunner to PAGB (the Association of Manufacturers of British Proprietaries (AMBP)) and the day after the AMBP’s inaugural meeting in June 1919, the new Ministry of Health came into being. The new Trade Association had to hit the ground running, not only to self-regulate the industry but also to stave off strict legislation on proprietary medicines advertising, which was its very first “propaganda” task.
The 1914 recommendations of the Select Committee Report reached fruition with a proposed Patent Medicines Bill in March 1920. Despite many of the medicines sold having no actual patent, the Association was firm in its opposition for any disclosure of product formulae and recognised the need to have a strong defence in place for what was expected to be a difficult battle ahead.
Its resulting plan of action looks very familiar, including many of the steps we would take today:
- Dedicated time and a Sub-Committee
AMBP began by forming a special sub-committee of experts to help with the campaign.
- Adequate funds to defend the Association’s position
Once the sub-committee was formed, a Special General Meeting was called to raise a £5,000 fighting fund (the equivalent of around £245,000 today).
- Partnerships with other affected organisations to have a stronger voice
By May 1920, AMBP was working with the London Chamber of Commerce to jointly oppose the Patent Medicines Bill and had involved a wider range of stakeholders, including wholesale Chemists and Druggists and Food Manufacturers.
- Lobbying of MPs with the support of a parliamentary agent
The Association employed a Parliamentary Agent to act on its behalf in September 1920.
- Generate media coverage to amplify the message by issuing a pro-industry pamphlet
Recognising the importance of the media to get its message out, PAGB circulated its first propaganda pamphlet to MPs and the press: “The Agitation Against Patent and Proprietary Medicines and Foods”.
This work proved effective. By November 1920, the Ministry of Health agreed to a revised Bill that removed the requirement to state the formulae. There was unanimous approval from members to this change. However, the Bill had been so altered that it was “practically a new one” and was subsequently withdrawn.
At just over a year old, the new Association had fought off a huge regulatory challenge for its members, the first of many over the years.
The legislation wasn’t dead however and returned in the 1930s; this time called the Proprietary Medicines Bill. Once again PAGB set its Parliamentary Agent to work; the Bill was blocked whenever it appeared on the Order Paper and was subsequently withdrawn, much to the satisfaction of member companies. The Bill reappeared at several points during the decade, with PAGB working with the Royal Pharmaceutical Society in 1936 to redraft the Bill to their mutual satisfaction. In 1939 the draft Proprietary Medicines and Appliances Bill was proposed, but as this went further than the 1936 draft, PAGB was not prepared to support it.
PAGB’s diligent and measured way of feeding back and managing the interests of its members had been noted; the 1939 draft Bill recommended PAGB had a seat on the Advisory Committee should the Bill become law, highlighting the high regard in which PAGB was held by the Government of the day.
PAGB continued to face numerous regulatory challenges through the years, working to influence and develop a favourable regulatory landscape which would be conducive to PAGB’s members to successfully grow their businesses.
Resale Price Maintenance
Over more than 40 years, between the 1950s and early 2000s, and in association with pharmacy organisations such as the Royal Pharmaceutical Society, National Pharmaceutical Union, Proprietary Articles Trade Association and the Company Chemists Association, PAGB fought challenges that would abolish resale price maintenance (RPM) – the practice which allowed manufacturers to set a fixed or minimum price for the resale of their products.
In 1963, RPM was largely abolished in the UK but a challenge by PAGB resulted in the Restrictive Practice Court granting an exemption for branded OTC medicines and vitamins. (Books were also permitted to continue with RPM).
However, in 2001, following a five-year campaign the Office of Fair Trading finally abolished RPM of over-the-counter medicines and vitamins. Within hours of the court’s decision, some supermarkets announced price cuts on leading brands of between 25 and 50 per cent. RPM on books had been abolished in 1997 and this ruling by the courts marked the end of an era for RPM with branded OTCs the last to enjoy such a system.
Better Regulation of Medicines Initiative (BROMI)
In 2005, PAGB sought to highlight to parliamentarians the overburden of regulations on medicines – particularly where packaging was concerned. At the time, the Government had set up a Better Regulation Executive to work in partnership with departments and regulators to improve and simplify regulations. It meant that the then Health Minister, Jane Kennedy, took up our case with the MHRA, prompting it to set up the Better Regulation of Medicines Initiative (BROMI). PAGB worked closely with the MHRA to reduce excessive regulations.
Under BROMI, a self-certification scheme for leaflet information was introduced, gaining an EU Better Regulation Award in 2007 and its principles are now reflected in EU legislation. PAGB also became responsible for pre-vetting changes to non-statutory packaging information before being self-certificated by companies. A new process for switching POM to P was also implemented, resulting in several innovative switches for new therapeutic indications such as emergency hormonal contraception, chlamydia, weight loss and the reduction of risk factors for cardiovascular disease.
Whilst BROMI has since been superseded by another initiative, today PAGB still works closely with MHRA to ensure better regulation for the industry. (See also Gill Peckham’s article “PAGB – making a difference”)
The All-Party Parliamentary Group on Primary Care and Public Health
From 2004 until 2017, as part of its parliamentary activity, PAGB took over the secretariat of the All-Party Parliamentary Group (APPG) on Primary Care and Public Health. The remit of the APPG was:
- to raise the profile of primary care and public health within Parliament;
- to speak within Parliament on behalf of users and those working in the NHS:
- to place primary care and public health on the Government’s agenda and to inform debate with outside bodies.
The annual receptions, roundtable discussions and select committee-style inquiries held by the APPG as part of its work provided PAGB with an opportunity to raise pertinent industry issues in the presence of parliamentarians and influential stakeholders.
The benefits of self care and self-medication were often a focus for APPG activity. In addition to raising the profile of self care, the APPG was also crucial in contributing to work on important ingredient issues. Two of its enquiries, held jointly with the APPG on the Misuse of Medicines helped to prevent the back-switching of a number of substances to prescription only.
The first inquiry, in 2007, entitled “addiction of prescription and OTC medicines” successfully made the case for retaining codeine as an ingredient in OTC products with
recommendations to limit pack size and ensure sales would only be made under a pharmacist’s supervision.
The second inquiry, the following year, reviewed the MHRA’s decision to reclassify pseudoephedrine (pse) and ephedrine to POM status. Following growing concern over crystal meth which is made using these ingredients, the joint inquiry report concluded that a back switch was too restrictive a response and would greatly hinder self care and increase primary care demand. Instead, it recommended a series of risk minimisation measures which the MHRA took on board.
Ever since the very first proposed legislation – the Patents Medicine Bill – in 1920 that threatened to stifle our industry, PAGB has fought to secure the best possible outcome for its members whilst never compromising industry values and standards. Through the years PAGB has managed to ensure that a wide range of proposed legislation and regulation that could have negatively affected the OTC industry has been amended and implemented in a proportionate way.
Today, our industry is facing one of its biggest ever challenges – the consequences of the UK leaving the EU. As with previous challenges, PAGB is working with Government, wider stakeholders and with its members to lobby for measures that will mitigate the impact this will have on the consumer health care industry.
By Libby Whittaker, Public Affairs Executive, PAGB