Industry welcomes landmark Bill in boosting patient access to novel medicines while protecting from medicine shortages

Pharma News: Australians will see improved access to new and innovative medicines, vaccines and treatments while being better protected against medicines shortages as a landmark Bill passes in Parliament yesterday.

The new legislation, The National Health Amendment (Enhancing the Pharmaceutical Benefits Scheme) Bill 2021, formalises elements of the five-year Strategic Agreement, which was signed by the Minister for Health and Aged Care, the Hon Greg Hunt MP, and the medicines industry peak bodies in September this year to be implemented and operational from 1 July 2022 to 30 June 2027.

The recently legislated laws will ensure funding for new medicines in the PBS, as well as several new initiatives that elevate Australian patients and their real-life experiences. Patients becoming more engaged in key decision-making processes is a progressive step forward that will benefit our whole health system. Involving more patients to share their real-world evidence will place a higher value on medicines and treatments that give patients better quality of life and improved health outcomes.

“Medicines Australia was pleased to see this legislation pass on the last sitting day of the year,” said Elizabeth de Somer, CEO of Medicines Australia. “At the centre of our Strategic Agreement are Australian patients, who will benefit from having fast access to new and innovative medicines and technologies, such as gene and cell therapies.”

The measures agreed with the medicines industry achieve significant savings while ensuring that PBS subsidy supports reliable medicines supply to Australia, and provide certainty to the medicines sector about PBS pricing policy for the next five years. The savings associated with these measures of around $1.9 billion over the terms of the agreements will be reinvested in the PBS, to support anticipated listing of more than $5 billion in new drugs and expanded patient access over the same period.

Ms de Somer added “This legislation has received a high level of bipartisan support and is an important piece in the stable footing of the PBS. It signals sustainability and predictability for the biopharmaceutical industry here in Australia and places a priority on new and innovative medicines through guaranteed funding.”

The Independent Chair of the Generic and Biosimilars Medicines Association (GBMA), Jane Halton AO PSM, said “Australians must be able to equitably access safe and affordable medicines, regardless of where they live. This legislation enables our members to increase their respective stock holdings of medicines to four to six months – creating a vital buffer against any threat of shortages.

“Our driving motivation is the health, safety and wellbeing of all Australians. Securing supply is the goal we have long aimed for and the one we have now have the ability to achieve,” said Ms Halton.

Right now, there are 250 medicines deemed at risk of shortages. These ‘at risk’ medicines treat infections, depression and anxiety to high cholesterol, hypertension and reflux. Through its new Strategic Agreement, the affordable medicines industry will ‘step up’ and onshore a substantial stockpile of medicines.

Victorian regional pharmacy owner, Steve Kastrinakas said knowing that the medicines prescribed, will actually be the ones available, is an incredible relief for patients, pharmacists and their doctors across regional
Australia

“Regional patients have borne the brunt of rolling medicine shortages,” Mr Kastrinakas said. “They deserve better and we now we know, that no matter how remote or disadvantaged our patients are; there is no risk to them being able to access the affordable medicines they need, when they need them”

The Chief Executive Officer of the GBMA, Marnie Peterson, hailed the passage of the legislation as a landmark moment in medicine policy. “Our members contribute more than two thirds of all the subsidised medicines
dispensed across Australia each day. Australians rely on us to ensure they can affordably and equitably access the medicines they need without
worrying about what is happening to international supply chains or whether companies will withdraw their medicines because it is no longer viable to supply Australia.”

Ms de Somer added “We will continue to work closely with the Government and the Department of Health as the Bill is implemented to ensure patients continue to receive the medicines they need when they need them.”

The Medicines Australia Strategic Agreement includes many pioneering initiatives such as the independent HTA review, enhanced consumer engagement in the PBAC and a first-ever horizon scanning forum so Australia is best placed to take advantage of the latest and greatest biopharmaceutical advances that are on the cusp of discovery.