Since 1990, members of the ICH  have co-operated to develop guidelines and standards for demonstration of the efficacy, safety and quality of new products. As membership has grown, the guidance documents have been increasingly adopted as the international standard. Consistently satisfying the data needs of reimbursement agencies is yet to reach this level of […]
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Entries by YeeHar
A recent study found no association between perfectionism and productivity at work. However, it did reveal that certain types of perfectionists are less popular with their colleagues. A “self-oriented perfectionist” sets very high standards only for him/herself; a “socially prescribed perfectionist” believes that the acceptance of others is dependent on his/her own perfection; while the […]
True transparency requires more than making information available. According to Rio Tinto, it was a ‘misunderstanding’ with the local Indigenous community that resulted in the destruction of 46,000 year-old sacred sites in May this year. The company had Government approval and stakeholders had been informed. All boxes checked. Obviously, that was not enough. Since 2015, […]
Patient engagement Patient input to HTA decision-making as a subject in the literature has peaked and plateaued in recent years (Figure 1). As a consequence of research and initiatives, such as those noted at the end of this article, the rationale for patient involvement in HTA is now well understood. However, there is still a […]
The current review of NICE is a useful foil upon which to consider the announced refresh of the Australian National Medicines Policy. Both are being driven by concern that access processes are not keeping pace with biomedical innovation. The table below provides a side by side comparison of the two appraisal systems and HTA reimbursement […]
Add periodic pandemics to the ageing populations, accelerating rates of chronic disease, innovative technologies and price increases that are already challenging the durability of healthcare systems and the phrase, ‘a perfect storm’ comes to mind. Prioritisation Prior to this recent challenge*, many countries have managed their health care system budgets by using a variety of […]
As the Sponsor of a new medicine seeking listing on the national Pharmaceutical Benefits Scheme (PBS), pricing used to be relatively straightforward once a positive Pharmaceutical Benefits Advisory Committee (PBAC) recommendation had been received. The Pharmaceutical Benefits Pricing Authority (PBPA), defunct as of 1 April 2014, would determine the price based on: (1) PBAC advice […]
First screened at the Tribeca Film Festival in April 2018, and still available on Netflix, The Bleeding Edge is a documentary that could have easily been made about any sector of the health care industry. No medical intervention is without risk, and although informed consent includes a discussion of potential negative outcomes, health consumers are […]
Yes, 2020; a Leap year; summer Olympics; US Presidential race; and UN International Year of Plant Health! Whatever is forecast with respect to Australia’s weather and economy in the coming year, here are a few predictions that haven’t quite come to fruition (Courtesy of BestLife): In 1937, Nikola Tesla predicted that “within a century, coffee, tea, and tobacco […]
As the purchasing of medicines moves towards a commodity model in Australia, with off-patent (F2) molecules a marketplace, and ‘me too’ R&D programs and associated payer behaviour creating as much in the patent (F1) space, providers all along the supply chain are being impacted. What are Community Pharmacists, as one of the key groups affected […]