TGA revises approach to flawed OTC medicines labelling review

05 November 2012

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The Australian Self-Medication Industry (ASMI), the industry body representing evidence-based, non-prescription consumer healthcare products, has expressed its support for the Therapeutic Goods Administration's (TGA's) revised approach to the medicines labelling and packaging review.

Although ASMI was disappointed with the original approach taken by the TGA, it is expected that this revised approach will lead to appropriate reform and therefore better outcomes for all stakeholders.

"This is the biggest review that the industry has faced in the last 10 years and it is vital that we get it right, given the significant impact it will have on both consumers and the consumer healthcare industry," said the Executive Director of ASMI, Dr Deon Schoombie.

"ASMI welcomes the opportunity to work with stakeholders on ways to improve labelling and packaging to bring about quality use of non-prescription medicines.
"We view this review constructively, but given its importance, we urge a robust, evidence-based approach before proceeding down a potentially expensive and commercially damaging path," he said.

Dr Schoombie said that in regard to proposed changes to highlight active ingredients on medicines labels, it was critical to distinguish between prescription medicines and OTC medicines. Unlike prescription medicines, the label is the primary source of information about a non-prescription medicine.

"Consumers who shop for their medicines in pharmacies and retail outlets rely strongly on brand names to help decide what is appropriate for them.

"Unlike prescription medicines, which can only be obtained with the aid of a healthcare professional, non-prescription or OTC medicines are purchased often without assistance, and the brand name is the key identifier.

"There are other ways we can facilitate ingredient identification, while keeping it simple for consumers and protecting brand integrity," he said.

"This is why we are pleased to see the TGA abandon its blanket approach to reform in order to explore labelling requirements that are specific to each class of medicine. Such an approach was suggested by ASMI in its submission, and will properly embody a risk-based approach to reform.

ASMI is also pleased to see that the TGA has committed to an evidence-based approach, involving stakeholder consultation, which will incorporate independent consumer-testing, all consistent with the ASMI submission.

The TGA have also committed to working closely with industry to ensure a proper examination of the costs associated with the reforms.

Dr Schoombie also rejected the idea of a blanket approach to 'umbrella branding'. This practice has its place because it can aid consumer choice by speaking to different consumer needs. Industry would be better served with criteria for assessing umbrella branding risk rather than a blanket approach for all.

"An evidence-based approach to reform is essential. Evidence must be presented to both demonstrate the risk and to show that the proposed reforms will be effective.
"We stand ready to work with consumers, government, the TGA and other stakeholders to develop and implement reforms that will achieve the desired objectives," he said.
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About ASMI: The Australian Self-Medication Industry (ASMI) is the peak industry body for the Australian self care industry representing consumer healthcare products including over-the-counter medicines and complementary medicines. ASMI's mission is to promote better health through responsible self-care. This means ensuring that safe and effective self-care products are readily available to all Australians at a reasonable cost. ASMI works to encourage responsible use by consumers and an increasing role for cost-effective self-medication products as part of the broad national health strategy. www.asmi.com.au

Media contact: Bob Bowden, Foresight Communications (02) 9241 2811, 0412 753 298