What does this mean for pharmaceutical brand owners?

In the coming year the TGA will aim to change the way pharmaceuticals can be labelled to restrict some brand extensions. There will be new obligations to clear trade marks for use on new products. There will also be prescribed harmonisation of the “look and feel” of packaging.

The Therapeutic Goods Administration

The Therapeutic Goods Administration (TGA) is the regulatory authority that regulates medicines supplied in Australia.

The TGA regulates prescription, OTC, and complementary medicines, medical devices and biological medical products such as blood products. The TGA regulates these goods through pre-market assessment, monitoring and enforcing standards, licensing Australian manufacturers and verifying compliance of overseas manufacturers.

Review of packaging and labelling regulations

In July last year, the TGA initiated a review of the regulatory framework for packaging and labelling of medicines. The public reason for this review is to enhance consumer safety by making the packaging of pharmaceuticals more standardised and user-friendly.

 An external reference group was established, comprising of consumer, industry and health care professional representatives. On 26 October 2011, the group met to identify key issues and make suggestions for regulatory reform.

In April 2012, the TGA released a consultation paper with eight key recommendations (detailed below) and sought feedback as part of the consultation process. Submissions on the consultation paper closed on 24 August 2012 and have been recently published by the TGA.

Proposed changes

The TGA has proposed the following changes:

  • active ingredients be listed on at least three sides of the packaging, with equal prominence to the brand name, that is, in the same font size and position, with the first letters aligned;
  • a ban on look-alike and sound-alike medicines, for example “BRAND headache” “BRAND backache” “BRAND joint pain”, with sponsors of new medicines required to submit evidence of risk assessment of the proposed labelling and packaging;
  • the introduction of a ‘medicine information box’ to standardise information formatting;
  • designated clear spaces on packaging for pharmacists to attach dispensing labels to prescription medicines;
  • blister strip labelling on the back of tablet packets, to take into account the fact that many consumers do not store their medicines with the outer packaging;
  • compulsory labelling and pack inserts for small containers to compensate for the smaller space available on the container;
  • tighter regulation for pack inserts to ensure information is clear and concise with no advertising material included; and
  • the formation of a Labels and Packaging Advisory Committee consisting of consumers, carers, community and hospital pharmacists, nurses, doctors, health care practitioners and the pharmaceutical industry.

Issues for brand owners

These changes will greatly impact brand owners in the pharmaceutical industry, restricting the use of intellectual property in relation to packaging and labelling. While brand owners in the pharmaceutical space are accustomed to complying with existing packaging and marketing regulation, these changes, if accepted, will go much further than the current regulation.

Importantly, the TGA has stated that it is looking into methods of electronically screening proposed brand names against already existing names to identify look-alike, sound-alike names. It is unclear how this process will interact with the Australian Trade Marks Register and the role IP Australia plays in determining the registrability of pharmaceutical brand names.

There are a large number of pending and registered trade marks in class 5 (covering medicines and pharmaceuticals) on the Australian Trade Marks Register and it remains to be seen how the TGA’s recommendation will apply in practice. Brand owners could be faced with an inconsistent decision making process between IP Australia and the TGA, with a proposed brand being approved by one and rejected by the other.

The changes will also require brand owners to not only review the way they use their intellectual property on medicine packaging, but also the relationship between trade mark usage on packaging and its corresponding use in the marketplace. For example, the changes will curb the current industry trend of marketing differing formulations of the same active ingredient for specific purposes, as it will no longer be possible to describe medicine as “BRAND headache”, “BRAND backache”, “BRAND joint pain.” This will affect the ability of a number of pharmaceutical companies to use their series trade mark registrations, and will require a potentially costly rebranding of existing products.

Response to recommendations

The TGA has received 110 submissions, from consumers, consumer representative groups, health care professionals and their organisations, academics and industry. Generally, the intention behind the TGA’s recommendations has been supported. However, there has been significant opposition to some of the proposed approaches, especially in relation look-alike sound-alike branding, pack inserts, small containers and blister strips.

The TGA identified six issues consistently raised by the submissions. This included the need for different requirements for different types of medicines, further evidence that the changes will improve safety and clarification of mandatory requirements compared to best practice recommendations. The submissions also called for more detail around the implementation of the proposed requirements, through costs assessments, harmonisation with other jurisdictions and independent consumer testing, education and awareness programs.

What happens next?

The TGA has committed to refining the initial recommendations to specifically reflect the needs of registered prescription and OTC medicines. After consulting one on one with major stakeholders, it intends to release a specific discussion paper in the coming months.

The TGA anticipates that consumer testing will begin in early 2013, with a revised Therapeutic Goods Order for medicine labeling introduced in the middle of 2013. Current medicines will have a proposed transition period of three years, but new medicines will need to be compliant as soon as the Therapeutic Goods Order comes into force.