PHRM4021 Integrated Pharmaceutical Development 1

Table of Contents


Prepare a report of critical analysis on the following topic:

“The Australian Pharmaceutical Benefits Scheme” and the use of Australian medicines.



The Australian Government has created a pharmaceutical benefit program (PBS), which provides prescription drugs at reduced rates to Australian citizens.

The Pharmaceutical Benefits Act, 1947 established this scheme in 1948.

PBS was established to ensure that Australians have access to reliable, affordable, and needed drugs.

The cost of drugs has increased in recent years and PBS is under scrutiny (Cheng and al., 2012).

PBS is a community-based program that does not focus on the hospital. This area falls under the responsibility of both the state and local governments.

It can be concluded that the PBS scheme, along with Medicare, is a fundamental component of Australian Healthcare.

Medicare is available to those medications which are not included in the pharmaceutical benefit list.

There are both opportunities and challenges to the PBS scheme.

The enlistment of new pharmaceuticals is one of the main challenges facing the PBS scheme.

The cabinet must approve the 10 million annual.

Due to budget constraints, listing several pharmaceuticals such as schizophrenia, severe asthma, chronic pain, and schizophrenia has been delayed ( (2018)).

This study was based on a critical analysis of Australia’s Pharmaceutical Benefit Scheme and the consumption of Australian medicines.

General Discussion of the Issue

The Pharmaceutical Benefit Scheme (PBS), which was introduced in healthcare facilities, allowed for the provision of medications to patients in their time of need.

ThisPBS chart includes both PBS and non PBS medications. It is based upon the best evidence (Clarke 2012).

These PBS medication charts, which are divided into several sections depending on the demand or availability of the drug in question, have not seen much change in recent years.

This chart (Mellish and al., 2015) gives a more detailed overview of the process.

It is evident that the PBS List restrictions have decreased over time. Patients and their health conditions were affected by the delay in allowing the inclusion of new lifesaving drugs on the PBS List.

The National Health Act 1953, and the National Health (Pharmaceutical benefits) Regulations 1960 stipulate that one medicine can be included in the PBS List only if it has been registered under the Therapeutic Goods Administration.

The Government has established the Pharmaceutical Benefits Advisory Committee (a non-governmental organization) to decide whether medicines are included in the PBS List.

The following table shows the Australian government’s total PBS expenditure and the incorporation of new drugs into the list over the years (Cheng, et al. 2012).

This table shows that there has been a steady increase in the generation, participation, and updating of the PBS since 2005.

The annual growth rate has increased steadily over the years. However, section 100 has seen an average increase of nearly 20%.

The table below shows the average annual growth rate from annual growth rate to expenditure.




Expenditure (millions).

Annual Growth Rate

The chemotherapy section was the most popular section of the medication section, accounting for 63% of the total PBS budget.

These are just a few of the issues that need to be discussed when discussing the financial implications.

Questions explored

PBS issues – Between 2005 and 2014, the annual cost of PBS has risen from 6 billion to 9 billion dollars.

This is an increase of 52 percent, which means that each year the price has risen by about 6 percent.

The prices of highly subsidised drugs have increased 200 percent, which means that each year the increase is 23 percent.

This is due to the emergence of costly pharmaceuticals and antiviral therapies (HIV) as well as small molecules that inhibit the growth of the cancer (Vitry&Roughead 2014).

The enlistment of new pharmaceuticals has been delayed due to budget pressures.

The new drugs relate to pharmaceuticals that treat severe asthma, chronic pain, and schizophrenia (Page, et al. 2015).

Other issues include whether taxpayers are getting the right value for their money, adequate funds for the treatment and care of the elderly population, cost effectiveness of expensive medicines, the prediction of long-term outcomes, inadequate or inadequate long-term trials, and insufficient or inadequate long-term testing of drugs.

The justification of drugs for rare patients, which require expensive drugs, is not easy. Resources and relocation are also challenges (Mellish and co., 2015).

What can we do better/differently?

– Pharmaceutical companies are profit-driven industries, and Australians love affordable drugs.

The patents covering expensive and costly therapies are likely to expire soon.

The solution is possible and includes biosimilar molecules that act like mimic molecules.

To save cost, the biosimilar therapies and drugs could be used.

It is important to remember that biosimilar products are not identical and must be evaluated before being released (Denaro& Martin 2016, 2016).

Price rise can also be caused by the fact that most of the prescribed drugs belong to the generic category, while only a few of them belong to the therapeutic classes.

Price disclosure is one way to reduce the price of drugs yet to be granted patents.

This will greatly reduce the price (Clarke 2012).

Drug overuse: The most commonly overused and abused drugs are sedatives, analgesics ( 2018, 2018).

Due to their increasing availability, these drugs are often misused.


The Australian government has implemented the Pharmaceutical Benefit Scheme for betterment and high-quality healthcare. It should revive its declining reliability and benefits.

PBS has several sections that need to be modified in order to increase its reliability.

The section on incorporating drugs into the PBS list will be the first to be addressed.

Patients who have a serious medical need will not be able to access the subsidy because it takes a long time and they must spend a lot of money to get the best treatment.

Implementing a quick incorporation strategy is essential.

The availability of the drug must be properly monitored so that the unavailability PBS-enlisted drug doesn’t become a problem for Australians.

These are the recommendations of the PBS authority that should be implemented to improve the reliability of this scheme.

Refer to

Australia: Successful regulation allows for control of fluoroquinolone resistant bacteria.

Emerging infectious diseases 18(9), 1453.

The Pharmaceutical Benefits Scheme: Challenges and Opportunities

The Medical Journal of Australia, 193(3), 153-154.

The problem of expensive drugs.

Australian prescriber, 39(3): 72.

Drug abuse.

A practical guide for researchers: Australian Pharmaceutical Benefits Scheme data collection.

BMC research notes 8(1), 634.

Public Health Res Pract 25(4), e2541546.



Managed entry agreements in Australia for pharmaceuticals.

Health Policy, 117(3): 345-352.

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