“GMiA and the government have a common interest in continued and reliable access to affordable generic and biosimilar medicines, a strong PBS capable of meeting the current and future needs of Australians and a sustainable generic medicines sector,” he said. In January 2018, the Commonwealth released a review report on the LDP, which proposes some changes to the criteria for inclusion in the program and how it is managed. On 8 May 2018, the Australian Government and Medicines Australia (on behalf of drug sponsors in the LDP) entered into an agreement valid from 1 July 2018 to 30 June 2022 regarding each party`s commitments to implement the reforms set out therein. These include the establishment of an expert group to advise and assist the Commonwealth Chief Medical Officer in the evaluation of orphan medicinal products to be included in the LDP, and to support Medicines Australia in the reviews of LDP medicinal products, including the assessment of use, financial costs and other relevant information related to the inclusion of a medicinal product9. in the country with a population of about 25.5 million people.1 It is a generally healthy nation. with life expectancy in the top 10 OECD countries. Australians have access to a state-funded universal health care system, which includes subsidized access to many medicines through PBS. The 2016-2017 federal budget confirms that the Pharmaceutical Benefits Scheme is stable and will continue to ensure, after years of significant reforms in this sector, that Australian patients have access to safe and effective medicines. The first such agreement was a Memorandum of Understanding concluded in 2010 between Medicines Australia and the Commonwealth for a period of four years33.
“Every time a patient or healthcare professional uses a generic drug or biosimilar, they save money that can be used to pay for newer PBS drugs. GMiA members have and continue to provide billions of dollars in PBS savings,” said Mark Crotty, President of GMiA (2015). As described above under “Policy Issues Impacting Pricing and Reimbursement”, “Legal Price Reductions and Strategic Agreements”, Medicines Australia and the Commonwealth have signed a five-year strategic agreement. The objective of this strategic agreement was to give some security to the pharmaceutical industry subject to medical prescription and to the government. Since pricing mechanisms were (necessarily) introduced into legislation, there have been some cases where the expectations of the sector did not match the understanding of the role of the strategic agreement and the agreement reached with the government. . . .