Over the years PAGB developed a great reputation and ongoing working relationship with the MHRA. It prompted the creation of a number of guidance notes which were really useful to Industry. One of these was the naming guidance that addressed umbrella branding, an issue which had been a “stalemate” for so long, with the reasons for rejections by the regulator often unclear and many poor quality applications from companies. Whilst this remains a challenging area, the guidance sets out the principles for assessment in addition to what applicants should consider and address in their application to facilitate a better outcome and greater understanding on both sides.
The Better Regulation of Over the Counter Medicines (BROMI) was established in November 2005 to look at how unnecessary regulatory and administrative burdens in relation to OTC medicines could be eased. One key output of this work was the identification of where a simplified approach to the regulation of OTC medicines was appropriate. Initially the work focussed on how changes to labels and leaflets were processed and to see how administrative burdens could be reduced for both industry and the competent authority (MHRA). This resulted in the implementation of a self certification scheme and the development of BROMI principles for self certification which incorporated robust safeguards to protect public health. After the success of the labelling workstream, BROMI was extended to other areas including variations and copy licences. Annual BROMI progress reports to Ministers were produced by MHRA. This initiative was later extended to all medicines and subsequent European variation procedures were based on the BROMI principles.
PAGB also facilitated pre-approval of pack designs and developed a PAGB Code of Practice for Over the Counter Medicines which helps companies when designing their packaging. In 2008 BROMI won a National Business Award for better regulation and PAGB was acknowledged for its contribution to such an influential initiative. In 2013 the work of BROMI was concluded and a new group was formed to oversee burden reduction and simplification work which continues through the Medicines Industry Liaison group (MILG), now heavily involved in working through new licensing proposals post Brexit.
Reverse Switch of Pseudoephedrine and Ephedrine
Another notable success is the role PAGB plays in ingredient issues; by representing companies through a collaborative approach, it can have an impact companies cannot achieve by working individually. PAGB works closely with the MHRA to ensure that any regulatory action is proportionate to the risk. An excellent example of this was in 2008 when pseudoephedrine and ephedrine products were proposed for a reverse switch from P to POM due to misuse. Although this was prevalent in other geographies in the world, the evidence in the UK did not warrant a reverse switch. Through PAGB’s intervention, risk minimisation measures were agreed so that the products could remain available over the counter and monitoring continues to this day. There have been many other examples of PAGB’s contribution to the management of ingredient issues.
PAGB has also played a key role in reclassification and this goes back to the development of the European Community’s medicines regulatory system where PAGB convinced the European Commission that national regulatory systems were appropriate for areas such as legal classification, rather than all decisions being taken at EU level. Building on this, PAGB has continued to partner with industry and the MHRA, to build and improve POM to P and P to GSL switch processes such that the UK is one of the most favourable markets for switching and many ingredients and classes of products have successfully switched over the years.
PAGB’s role in advertising and its self-regulatory code of practice is well known. The codes produced by PAGB are excellent and have demonstrated the ability of the industry to self-regulate. This also enabled the MHRA to build the trust with industry to take the same approach with OTC medical devices that are now also under a PAGB self-regulatory code.
There is no denying the value PAGB brings, to companies, to regulators and the role they have played in Europe, including an active engagement with AESGP. Building on this success, PAGB is looking to the future and how it can continue to add value in an increasingly fast paced ever changing environment. It is even looking to see whether Brexit may offer opportunities for simplified approaches to regulating OTC medicines, a look back to those “BROMI” days.
Good luck for the next 100 years!
By Gill Peckham, Johnson and Johnson