PHRM4021 Integrated Pharmaceutical Development 1


Create a critical analysis report about the following issue

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



A program known as the Pharmaceutical Benefit Scheme (PBS), it is a program that the Australian Government created to provide prescription drugs at subsidised rates to Australian citizens.

The Pharmaceutical Benefits Act (477) established the scheme.

PBS was created to ensure that every Australian has access to affordable, reliable and quality drugs.

PBS is currently under review due to rising drug prices (Cheng and al., 2012).

PBS focuses entirely on the community and not the hospital, which is the responsibility of the state or local government.

The PBS scheme is, together with Medicare, an essential component of Australian Healthcare.

Medicare covers medications that are not listed in the pharmaceutical benefit program.

Both the challenges and opportunities that PBS presents are there.

The PBS scheme faces a number of major challenges, including the need to include new pharmaceuticals.

The rule has been that 10 million pharmaceuticals per year must be approved by cabinet.

Budget pressures have prevented the listing of many pharmaceuticals like schizophrenia, chronic pain and severe asthma.

This study is based upon a critical analysis on Australia’s Pharmaceutical benefit scheme and Australian consumption of medicines.

Discussion General

In order to provide medication for patients who are in urgent need, the Pharmaceutical Benefit Scheme was established in the healthcare facility.

ThisPBS chart covers both PBS and non PBS drugs and is based only on the best evidence (Clarke (2012).

These PBS medication charts are not updated much, despite the fact that they are divided into different sections depending on demand and availability.

The following chart gives an overview of this process (Mellish, et al. 2015).

As you can see, as the PBS list grew in size and complexity, new lifesaving drugs were not included in the PBS lists. This negatively affected patients’ health and the patient’s overall well-being.

According to the National Health Act 1953 (Pharmaceutical Benefits Regulations 1960), one medicine may be included on the PBS list if it is registered under Therapeutic Goods Administration.

The government has created the Pharmaceutical Benefits Advisory Committee to make decisions about the inclusion of medicines on the PBS list.

The following table lists the Australian government’s total PBS and new drug incorporation expenditures over the years (Cheng and al., 2012).

From 2005 to 2013, there was a steady rise in generation, involvement, and up-to-date of the PBS.

Annual growth has been increasing in a steady fashion over these years. However, the rate of section 100 each year has been increasing at an average of almost 20%.

Below is a table that shows how the annual average growth rates of expenditure and annual growth rates are compared.




Expenditure in Millions

Annual Growth Rate

These include the chemotherapy section which was mentioned as the fastest-growing section in the medication section. It accounted for 63% (or 63%) of the entire PBS budget.

Apart from these, it is important to discuss the financial implications of changes in Australia’s health budget, MBS and DHS systems changes, increased medication use, and restrictions on usage.

Examined Issues

PBS Issues – From 2005 to 2014, annual costs for PBS have risen from 6 billion USD to 9 Billion USD.

This represents a 52 percent increase, and it means that the annual price rise has been approximately 6 percent.

The price of highly subsidized drugs has increased by 200 percent. This means that the annual increase in prices is 23 percent.

This has been due to the introduction of expensive drugs and therapies of Hepatitis C, HIV antiviral treatments, and small molecules that inhibit the growth of breast cancer (Vitry&Roughead (2014)).

A major problem is the delay in enlisting the new pharmaceuticals due to budget pressures.

The new drugs concern pharmaceuticals for severe asthma, chronic pain, schizophrenia (Page and al., 2015).

Other challenges include whether taxpayers get the correct value for money, appropriate funds for the treatment for the ageing population and cost effectiveness of costly medicines. They also need to be able to predict the long-term effects of these expensive drugs. There are also insufficient or inadequate long term trials.

The legality of expensive drugs for rare patients is not always easy. It’s also difficult to find the right resources or relocate them (Mellish et. al., 2015).

What could be done differently or better?

– Pharmaceutical companies are profit driven industries. The Australians want affordable drugs.

Therefore, it is likely that patents for expensive treatments will soon expire.

A possible solution lies in the development of biosimilar molecules that behave similarly to drugs.

Potentially, biosimilars of therapies and drugs can be used to reduce cost.

Important to remember is that these biosimilar drugs and therapies are not the same and need to be evaluated before they can be sold (Denaro& Martin 2016).

Another factor that causes price increases is the fact the majority of drugs prescribed are in the generic category and only a fraction of them are in the therapeutic classes.

Price disclosure may be one method to lower the cost of those drugs that have yet to receive a patent.

This will dramatically lower the price (Clarke (2012)

Reasons for drug abuse: Sedatives and analgesics are the most frequently misused or overused drugs ( 2018).

Because of their availability, these types of drugs are frequently misused.


The Australian government established the pharmaceutical benefit scheme to improve the quality and safety of healthcare for its citizens. However, the benefit and reliability have been declining.

PBS needs to be modified in several areas so it can be more reliable.

First, we will address the section regarding the inclusion of drugs in the PBS lists.

This process is lengthy and patients in severe need of the medicine cannot access the subsidy. They must also spend significant amounts of money on quality treatment.

It is important to have a fast incorporation strategy.

Second, it is important to monitor the availability of drugs so that people in Australia are not affected by drug shortages.

These are the PBS authorities’ recommendations to improve the reliability and efficacy of the scheme.


Australia, Controlling fluoroquinolone Resistance through Successful Regulation

Emerging infectious disease, 18(9): 1453.

The Pharmaceutical Benefits Scheme’s challenges and opportunities.

The Medical Journal of Australia 196(3): 153-154.

The challenge of expensive drugs.

Australian prescriber, 39(3) 72.

Drug abuse.

Data collection for the Australian Pharmaceutical Benefits Scheme: A guide for researchers.

BMC research Notes, 8(1): 634.

Public Health Res Pract. 25(4): e2541546.

Pharmaceutical Benefits Scheme


Managed entry agreements for Australian pharmaceuticals.

Health Policy, 345-352.