Nicola Roxon (Gellibrand, Australian Labor Party, Minister for Health and Ageing) Share this | Link to this | Hansard source

by leave—The new safety net definition for spouse also applies for couples accessing pharmaceutical benefits under the Repatriation Pharmaceutical Benefits Scheme (RPBS). The amendment is proposed to commence on 1 January 2009, as the PBS and RPBS safety nets operate by calendar year.

The proposed safety net arrangements can provide significant benefits for the people involved. I also note that this measure of fairness comes at a modest cost to the PBS. The overall cost is estimated to be around $1.1 million per year, which is a small fraction of total PBS expenditure.

Illness-separated couples are provided for in other Commonwealth legislation such as the Social Security Act 1991 and the Veterans’ Entitlements Act 1986. The change to the PBS reflects a similar approach and will apply to couples in similar circumstances to those already recognised under those other acts.

This measure recognises that when couples need to live apart for reasons of ill health, frailty or dependent care they do not cease to be a family. The proposed amendment provides continuity for joint access to safety net entitlements for those couples despite their living circumstances having changed permanently. It will improve the affordability of PBS medicines for these people at a time when they may be most in need of the benefits of the PBS.

The amendment in schedule 2 proposes changes to provide access to the PBS for people working overseas as government officers, and for accompanying spouses and dependants. Only people who are otherwise eligible to receive PBS medicines will be able to take advantage of this measure.

Under the current legislation, access to the PBS is restricted in the following way:

• only Australian residents may receive PBS medicines;
• pharmacists must not dispense a PBS medicine for a person who is not in Australia; and
• it is prohibited to take or send PBS subsidised medicines to a person overseas.

The existing provisions are appropriately designed to protect the PBS by making it hard for ineligible people, such as nonresidents, tourists and visitors, to obtain PBS subsidised medicines. However, these safeguards also affect the ability of Australian government officers to obtain supplies of PBS medicines when working outside Australia.

Accessing medicines in some overseas locations may be difficult or uncertain. In some places where officers are sent to perform duties for an Australian government, the range and quality of medicines available locally may not match that of PBS medicines, supply of medicines may be unreliable, or medicines may only be available at a high cost.

This amendment provides that, for PBS purposes, a person who is working outside Australia as a Commonwealth, or a state or territory officer, is taken to reside in Australia. This will enable pharmacists to dispense PBS prescriptions for medicines required by these officers. It also provides for PBS medicines to be supplied for accompanying spouses and dependent children of these officers. PBS medicines for these officers and their families will be able to be taken or sent out of Australia in quantities required for personal use.

Under the proposed changes, access to pharmaceutical benefits outside Australia is extended only to government officers, spouses and dependants who are otherwise eligible to receive these benefits when in Australia. Around 3,000 people will be eligible.

The present prohibitions on export of PBS medicines for or to other persons outside Australia remain in place. The new arrangements do not cover people working overseas for private companies, studying overseas, providing services as an independent contractor to governments, conducting personal business, travelling as tourists, or living overseas permanently.

Established compliance and surveillance activities by Medicare Australia and the Australian Customs Service will continue to ensure that controls on access to PBS medicines are enforced appropriately. Arrangements will be established to identify those eligible and to ensure that non-eligible people cannot benefit from the measure.

The proposed changes will provide people working overseas as government officers with access to pharmaceutical benefits. It is important that this access be implemented as soon as practicable.

The amendment in schedule 1 expands the criteria for determining that brands of pharmaceutical items are co-marketed. This is to ensure that legislation in relation to co-marketing operates as it was originally intended.

PBS amendments to the National Health Act in 2007 introduced the concept of co-marketed brands. This concept permits two or more brands of a pharmaceutical item that are prescribed in the regulations, or meet certain criteria, to be treated as one brand of the pharmaceutical item. This is important, because while these brands are co-marketed they are not subject to statutory price reductions that would otherwise apply to the brands as multiple brand medicines.

The criteria for determining co-marketed brands require amendment so that co-marketed brands, in certain circumstances, may be co-marketed brands even if they are brands of more than one pharmaceutical item. As I said earlier, this simply ensures that the act operates as intended.

I will use a fictitious example to show how this amendment works.

• The drug Alpha 500mg tablet has the brands X and Y as co-marketed brands. The manufacturers of both X and Y want to list an Alpha 250mg tablet and want those brands to remain co-marketed.
• Currently this would not be possible because the 500mg tablet is a different pharmaceutical item to the 250mg tablet. The listing of the 250mg strength of tablet would stop brands of either pharmaceutical item being co-marketed and the brands would be subject to statutory price reductions.
• These amendments remove the requirement that there be no brands of other pharmaceutical items containing the same drug in order for brands of a new pharmaceutical item to be listed as co-marketed. This means that brands X and Y could remain co-marketed in the 500mg strength, and be listed as co-marketed brands in the 250mg strength. However, brands X and Y for both the 500mg strength and the 250mg strength would also need to meet the other co-marketing criteria.

This amendment also contains provisions for the minister to determine, by legislative instrument, that co-marketed brands cease to be co-marketed. This is an important amendment as it allows the minister’s determination ceasing a co-marketing arrangement to take precedence over the regulations which prescribe certain co-marketed brands. This is necessary to ensure that the co-marketed status of brands grandfathered into the regulations when the concept was introduced in 2007 can be adjusted in a timely fashion when new brands of pharmaceutical items are listed on the PBS. This will mean that once a determination ceasing co-marketing is made the prescribed co-marketed brands that no longer meet certain criteria for co-marketing can be treated as multiple brands.

And finally, to two miscellaneous amendments that are made by this bill:

• amendments that make minor changes to two PBS-related definitions; and
• amendments that remove provisions for the gazettal of determinations made in relation to pharmaceutical benefits which may be prescribed by participating dental practitioners and authorised optometrists.

With regard to provisions for gazettals, the legislation currently requires that the determinations which specify the pharmaceutical benefits that can be prescribed by participating dental practitioners and authorised optometrists, be published in the gazette. The amendment removes this requirement and provides that these determinations are legislative instruments.

Under the Legislative Instruments Act 2003, the registration of legislative instruments on the Federal Register of Legislative Instruments generally replaces the requirement for gazettal. The changes bring the requirements for the PBS determinations I mentioned into line with the Legislative Instruments Act. Inclusion of these determinations on the register is already occurring. There are no implications for consumers, business, or regulatory procedures associated with this change.

In conclusion, the bill contains amendments which recognise that the way the PBS operates is important to the health of Australians. The proposed changes demonstrate this government’s determination to ensure that the PBS continues to meet the needs of Australians as users of PBS medicines, while providing workable requirements for the pharmaceutical industry. This bill contains fair, sensible and practical changes which maintain that balance between the cost of the PBS for the community as a whole and the cost of medicines for individuals and families.

I commend the bill to the House.

Debate (on motion by Mrs Gash) adjourned.