ASMI Senate Submission on Innovation argues for data protection arrangements for non-prescription medicines

07 August 2014

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7 August 2014 - The Australian Self Medication Industry (ASMI) called for improved data protection arrangements to drive innovation in the non-prescription medicines industry, in its submission to the Senate Standing Committee on Economics Inquiry into Australia's Innovation System.

Steve Scarff, ASMI Director of Regulatory and Scientific Affairs, said: "There are regulatory impediments to innovation in the non-prescription and complementary medicines industry in Australia and measures need to be implemented to address this market failure and to create an environment more conducive to investment in the generation of regulatory data to support innovative products.

"Currently there is no provision for data protection in relation to non-prescription medicines and where competitors benefit from the data generated by the innovator, the latter is placed at a significant commercial disadvantage.

"Data protection is a means by which a sponsor's data (new research and development) is protected for a period of time from competitors, and this includes from a subsequent sponsor seeking similar approval for an equivalent therapeutic good.

"Other countries, particularly the European Union and the United States, have data protection regimes that are quite favourable to sponsors and make Australia's look rather restrictive by comparison.

"In ASMI's view, there are two methods of implementing data protection - data exclusivity and market exclusivity.

"Data exclusivity is a defined period during which subsequent sponsors of equivalent therapeutic goods may not, during the period of data exclusivity, benefit from data provided by the first sponsor. Put simply, data exclusivity prevents Person B from using Person A's data package (as submitted to the Therapeutic Goods Administration (TGA) to register the same medicine.

"On the other hand, market exclusivity is a defined, enforced period during which a sponsor who is successful in obtaining some form of approval for a therapeutic good is granted an exclusive market status that prevents subsequent sponsors from obtaining similar approval for equivalent goods during the period of market exclusivity, even if new data is provided.

"ASMI argues that a period of marketplace exclusivity, commensurate with the degree of innovation and investment, is required to recoup investment costs and, importantly, act as an incentive to research new therapeutic claims and products.

"Through some form of data protection sponsors will be encouraged to invest in innovation if they have the opportunity to gain a return on their investment before competing products enter the market. Industry believes that appropriate data protection provisions in the Therapeutic Goods
Legislation will create an environment conducive to investment in research and development for this important range of medicines.

"Data protection will encourage investment in innovation, because it will give sponsors an opportunity to gain a return on their investment before competing products enter the market.

"It is important to note that the solutions proposed are intended to address issues of regulatory failure in relation to non-prescription and complementary medicines only and are not designed to impact on prescription medicines generally, and the PBS in particular. ASMI supports measures to prevent any unintended consequences resulting from the introduction of these reforms.

"As well, ASMI supports the principles of a free market and healthy competition. The proposed measures are not designed to restrict competition but to encourage investment in innovation through the ability of sponsors to recoup their investment in innovative products before competitor products enter the market.

"In ASMI's view, data protection and confidentiality can both be used collectively to incentivise and protect research into innovative consumer healthcare products," says Mr Scarff.

About ASMI: The Australian Self Medication Industry (ASMI) is the peak body representing sponsors of non-prescription medicines - over-the-counter (OTC) and complementary medicines. Its members make up 85 per cent of the $4bn self care market. Membership totals 60 companies and ASMI members employ approximately 18,000 people with exports estimated at $1.2 billion annually. 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.

For more information or to arrange a media interview, please contact:
Marie Kelly-Davies
PR Manager, Australian Self Medication Industry (ASMI)
M:0408 256 381 E: