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Cost recovery implementation statement: Blood, blood components and biologicals (human cell and tissue therapies), From 1 July 2015

Version 1.0, July 2015

2 July 2015

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Stakeholder engagement

The TGA external communication and education framework; Priorities and projects 2013-2015 describes the TGA's approach to providing:

  • Better information that is easily understood by consumers
  • Therapeutic goods information that can be received and shared by health professionals
  • Information that will provide greater certainty on regulatory arrangements for the therapeutic goods industry

It also details specific communication and education projects that will target consumers, health professionals or industry.

TGA consults with industry associations separately on regulatory matters and cost impacts relating to specific sectors. Industry associations are also consulted in the process of regulatory development and reform, and feedback is taken into account in developing regulatory implementation statements, and in developing cost recovery arrangements. Meetings are held with key industry representative bodies each year to discuss financial forecasts and as a part of the consultation process on cost recovery. The TGA also reports to stakeholders against a set of agreed Key Performance Indicators (KPIs).

TGA has worked with industry stakeholders regarding the development of new fees for OTC medicines that would align the business process reforms to a new fee schedule and as a result cease the use of the page count fee structure. In February 2015 TGA spoke with representatives from the Australian Self Medication Industry (ASMI) on the proposed new fee schedule where they raised concerns over the date of introduction resulting in an agreed start date of 1 January 2016.

In September and October 2014 meetings and teleconferences were held with key laboratory stakeholders to discuss the release of the IVD RIS and the proposed reforms for Class 4 in-house IVDs. The teleconferences were held with the National Association of Testing Authorities (NATA), the Public Health Laboratory Network (PHLN), the Royal College of Pathologists of Australasia (RCPA), the National Pathology Accreditation Advisory Council (NPAAC), the Australian Red Cross Blood Service (ARCBS) and the Biotherapeutics Association of Australia (BAA).

The TGA met with industry representative bodies in October and November 2014, and with consumer health advocacy groups in December 2014, to discuss proposed changes to annual charges exemption arrangements, and follow-up communications were done in writing. Subsequent sectoral meetings were held with these groups to discuss the proposed changes and a targeted industry information session was held in late March 2015.

Consultation also occurred at meetings with industry representative bodies in March 2015 for the proposed general increase to fees and charges from 1 July 2015, along with all other changes to fees and charges to take effect in 2015-16. At the meetings it was proposed that fees and charges would be increased from 1 July 2015 at a rate less than the relevant CPI/WPI rate (2.5 percent). Following the meetings, TGA wrote to industry representative bodies with the final rate proposed for a general increase to fees and charges of 2.12 percent.

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