Pharmaceuticals and pharmacy
Rebecca de
Boer
Pharmaceutical policy in Australia is a highly contested space
fuelled by debates over listing and pricing of medicines, costs to
the consumer and persistent concerns over the long-term
sustainability of the Pharmaceutical Benefits Scheme (PBS). Changes
to the PBS and the finalisation of the Fifth Community Pharmacy
Agreement (5CPA) announced in the Budget are expected to deliver
the Government net total savings of $2.5 billion between
2010–11 and 2014–15.[1] The Government has signed a Memorandum of
Understanding (MOU) with Medicines Australia which is designed to
ensure ‘a stable environment for business and continued
access to new medicines for all Australians’.[2] The 5CPA provides more than $15.4
billion over the next five years (2010–11 to 2014–15)
to pharmacists to ensure the timely and reliable supply of PBS
medicines and other professional services. According to the
Government, this also represents a saving of $1.0 billion across
the forward estimates.[3] Although measures announced in this Budget are predicted
to garner the Government $1.9 billion of savings over five years,
the MOU with Medicines Australia also includes a guarantee that the
Government will not seek to impose any further price savings on the
pharmaceutical industry before 30 June 2014 or introduce any
measure which favours the dispensing of generic medicines, thereby
possibly precluding further measures which could deliver additional
savings to the Government.
Changes to the Pharmaceutical Benefits Scheme
This Budget extends the PBS reforms of the 2006 PBS Reform
package. When first announced, the PBS Reform package was expected
to save more than $580 million over the succeeding four years and
more than $3 billion dollars over 10 years.[4] These savings have since been revised
down to $103 million over four years. This may be in part due to
the high cost of the structural adjustment package ($359.3 million
to date).[5]
The PBS Reform package signalled a radical change to the PBS.
Key features included the creation of two separate formularies,
Formulary 1 (F1) and Formulary 2 (F2), the imposition of price cuts
for products listed on F2, and the introduction of price disclosure
arrangements for products listed on F2. F1 are ‘single
brand’ medicines (only one medicine of its type listed on the
PBS) and typically includes patented drugs. No price cuts were
applied to products listed on F1. Products listed on F2 had
multiple brands and typically include medicines that are
interchangeable at the patient level and where generic drugs are
available. Perhaps the most significant change was the
‘de-linking’ between F1 and F2. This effectively
shielded most patented products from being subject to the price
cuts that would previously have flowed from the expiry of the
patents on products to which they were cost-minimised at the time
of their original PBS listing.
This Budget contains plans for further pricing changes to
medicines listed on F2, with expected savings of $1.9 million over
five years.[6] These
measures are the outcome of negotiations between Medicines
Australia and the Department of Health and Ageing reflected in the
MOU.[7] The MOU
brings forward implementation of price disclosure arrangements to
October 2010 from January 2011 and captures all products on F2.
Price disclosure was previously agreed in the context of the 2006
reform package. However, it was only applied at the time of listing
of a new brand on F2 and therefore was voluntary for existing
products. Price disclosure was designed to ensure that the
Government reaped the benefits of the discounting arrangements
between pharmacists and wholesalers. Manufacturers are required to
disclose the actual price at which medicines are supplied to
wholesalers and/or pharmacists. Price reductions occur if there is
a difference of more than ten per cent between the weighted average
disclosed price and the price paid by the Government.[8]
The MOU also provides agreement that further statutory price
reductions would be applied to F2 listings. There are two
sub-groups on F2, Formulary 2A (F2A) and Formulary 2T (F2T), which
will be combined from 1 October 2010. The following pricing
arrangements will apply:
- the statutory price reduction of 12.5 per cent when a product
moves from F1 to F2 will be increased to 16 per cent
- products formerly listed on F2A will be subject to a 2 per cent
reduction on 1 February 2011, as well as the scheduled reduction of
2 per cent on 1 August 2011 and
- products formerly listed on F2T will be subject to a 5 per cent
reduction on 1 February 2011.
These price cuts will be applied in addition to any reductions
that occur as a result of price disclosure. In short, generic
medicine manufacturers and pharmaceutical wholesalers are likely to
be most affected by this MOU, while the originator sector remains
largely protected.
Other features of the MOU include:
- improved access to information held by the Commonwealth by
Medicines Australia. This is of particular note as the MOU does not
require Medicines Australia to reciprocate
- a guarantee that the Commonwealth will not amend the existing
provisions for exemption from price disclosure
- a minimum price reduction of 23 per cent as a result of price
disclosure arrangements
- greater transparency for price disclosure arrangements
- a commitment from the Commonwealth that no new Therapeutic
Groups will be formed, other than in limited circumstances[9]
- sponsors will be provided with ‘reasonable notice’
of any additions to existing Therapeutic Groups
- an undertaking by the Commonwealth that it will not introduce
any measure that favours the prescribing or dispensing of generic
drugs over originator brands of the same drug, without the
agreement of Medicines Australia
- parallel Therapeutic Goods Administration (TGA) and
Pharmaceutical Benefits Advisory Committee (PBAC) evaluation
processes
- other arrangements to reduce the time between a positive
recommendation by the PBAC and approval by the Minister
- the development of a so-called ‘managed entry’
mechanism to facilitate the PBS listing of products for which there
is limited evidence of cost-effectiveness and
- a commitment to ‘work together’ formally on matters
such as pricing.
Comment
Despite the obvious support from Medicines Australia, this
announcement has generated considerable consternation within the
pharmaceutical supply chain in Australia. Generic manufacturers,
wholesalers and some pharmacists in particular have expressed
outrage at the lack of consultation and argue that these measures
will result in significant cuts to their revenue.[10] The Pharmacy Guild of Australia
cautiously welcomed the ‘increased certainty’ for
community pharmacy.[11] The Generic Medicines Industry of Australia (GMIA)
expressed disappointment that its savings proposals had been
ignored.[12]
There is no doubt that the pricing of generic medicines in
Australia represents a significant policy challenge. There is a
case for price reductions as the prices of generic medicines in
Australia are high by international standards. However, the MOU,
while offering some mechanistic savings, does little to re-engineer
the market. Commentators anticipate that the Australian Government
is therefore likely to continue to pay high prices for generic
medicines.[13] The
MOU also prevents the Government from introducing any additional
price cuts or new policy proposals beyond those agreed, further
limiting the capacity of the Government to garner savings from the
anticipated market entry of generic versions of several big ticket
PBS medicines over the next five years.
Furthermore, the record shows that, to date, implementation of
price disclosure arrangements has been fraught with both
administrative complexity and legal challenge.[14] The extension of price
disclosure arrangements to all products listed on F2 is likely to
create an additional administrative burden for Government. As there
is the likelihood of limited returns for products that are either
low volume, low value or have been listed on the PBS for a
considerable period of time (many of which are already subject to
discounting arrangements), one might question whether these
administrative costs will outweigh the benefits.
Questions have also been raised about the effectiveness of price
disclosure in a market which is not fully competitive.[15] International
experience suggests that price disclosure arrangements are
notoriously challenging to implement and are often
circumvented.[16]
In Australia there is a delay of six months from the date of the
price determination to when it takes effect for existing products.
A price reduction associated with the listing of a new brand
typically takes two years to take effect.[17] These delays would limit the savings
the Government is able to achieve under this proposal. The value of
extending the price disclosure arrangements therefore remains to be
seen.
The PBS reform package was introduced in 2007 in part to curb
the nominal growth of 12 per cent per annum in PBS expenditure that
had occurred between 1995 and 2004.[18] In 2009–10 the PBS is expected
to grow by 10.6 per cent, following a 9.2 per cent growth in
2008–09. Governments of all persuasions remain concerned
about programs with high growth rates and the PBS is no different.
Some stakeholders have suggested that the MOU provides
‘certainty’; however, there would appear to be no such
certainty for Government. The MOU does not contain a guarantee that
savings will be realised and it limits the capacity of the
Government to introduce new measures that potentially offer greater
value for money in PBS expenditure. Given that the estimated
savings from the previous reform measures have reduced from $540
million to $103 million over four years, it remains to be seen
whether the projected savings of $1.9 billion over five years will
be realised.
Furthermore, these price cuts require legislative amendment and
the position of the Opposition and the minor parties is not yet
clear.[19] The
2009–10 Budget included a proposal to create a therapeutic
group for two cholesterol-lowering drugs that had previously been
exempt from therapeutic pricing arrangements.[20] This was subject to significant
opposition from Medicines Australia and the federal Opposition. It
culminated in a disallowance motion and a referral to the Senate
Committee on Community Affairs for inquiry. To date, the Senate
Committee has not yet reported, but the disallowance motion has
been passed.
Fifth Community Pharmacy Agreement
The Government has consistently highlighted the need to
‘carefully consider’ health expenditure in light of the
‘Government’s significant reform agenda’.[21] During the
negotiations for the Fifth Community Pharmacy Agreement (5CPA),
Minister Roxon approached the Pharmacy Guild of Australia (the
Guild) to advise that the Government would demand
‘significant savings’ from the 5CPA.[22] In late December 2009, the
Government announced that agreement on the key areas of the 5CPA
had been reached, with a total value of $15.1 billion over five
years, and with savings of $1.0 billion over the forecast funding
for community pharmacy.[23] The 5CPA was finalised on 3 May 2010 and the full
details have been released with this Budget. The total value of the
5CPA is now $15.4 billon, around $300 million higher than
originally announced. The projected savings are unchanged,
highlighting the strong negotiating skills of the Guild.
With one notable exception, the 5CPA does not appear to
materially differ from past agreements. Many of the provisions in
the 5CPA, such as the Home Medicines Review and Residential
Medication Management Reviews, seek to refine and improve existing
arrangements. There is also provision to improve services for
Aboriginal and Torres Strait Islander people, more support for
pharmacies that supply Aboriginal Health Services and the
Aboriginal and Torres Strait Islander pharmacy workforce.[24] Other features include
Rural Pharmacy Programs which are designed to provide a number of
incentives and support for the rural pharmacy workforce and improve
access and availability of services for those living in rural
areas. Some Pharmacy Practice Incentive Program payments will now
be subject to accreditation and demonstrated delivery of defined
services which are designed to promote the quality use of
medicines.
The notable exception is that pharmacists will be allowed to
dispense a single standard pack of medicines to patients without
prescription, known as ‘medication continuance’
(subject to legislative change in all States and
Territories).[25]
It is envisaged that this will initially apply to two therapeutic
categories, oral contraceptives and lipid modifying agents
(cholesterol-lowering drugs).[26] The Australian Medical Association
considers this would be ‘putting patients at risk’,
arguing that there was no evidence to suggest that it was safe for
pharmacists to dispense medication without a prescription or any
review of the patient’s condition.[27] Others have described the program as
a ‘pragmatic’ way to ensure medication adherence as
pharmacists will only be able to dispense prescriptions in limited
circumstances, such as the inability to make an appointment with a
general practitioner.[28]
Three features of the 5CPA which benefit pharmacy remain
relatively unchanged from previous agreements and each of these is
not without controversy—the location rules, the continuation
of the wholesaler Community Service Obligations payment in full
(with a pause on indexation until 2011), and a dispensing fee for
each PBS prescription dispensed. A new fee has also been added.
This provides for $0.15 per transaction to be paid to pharmacists
dispensing scripts under the Repatriation Pharmaceutical Benefits
Scheme (RPBS) and under co-payment prescriptions that are generated
electronically.[29]
This is expected to cost around $75.5 million during the life of
the 5CPA.
The retention of the community pharmacy location rules includes
the prohibition on a community pharmacy being co-located in a
supermarket. The location rules were first introduced in 2000 as
part of the Third Community Pharmacy Agreement and were amended in
2004 to prevent supermarkets from operating pharmacies.[30] Critics have argued
that these arrangements are anti-competitive, limit access and
choice in rural and remote areas and prevent young pharmacists from
owning their own business as a result of the high cost.[31] Due to the location
rules, there are limited opportunities to open a pharmacy in most
capital cites and major towns, resulting in a concentration of
ownership and a relatively constant number of pharmacies across
Australia since 1990.[32]
Prior to the negotiations, media reports had suggested that the
Government was prepared to ‘reassess’ the location
rules.[33] It was
argued that population growth and lack of competition within the
sector warranted a systematic review. The preservation of location
rules, however, does raise questions about the influence of the
Guild and why, despite widespread deregulation and increased market
competition in the broader economy, pharmacy continues to be
protected by successive governments.
Both pharmacists and wholesalers were given significant
compensation arrangements under the PBS Reform package introduced
in 2007. Pharmacists were eligible for a $0.40 payment for each
script dispensed under PBS Online and a $1.53 payment (indexed
annually) for the dispensing of ‘premium free’
medicine.[34] The
wholesaler Community Service Obligation (CSO) pool was increased to
$69 million over three years from 1 July 2008.[35] Although the PBS Online
incentive has been scrapped, the $1.53 payment is likely to
generate significant income to pharmacists. This payment generated
$112 million (over 75 million scripts) for pharmacists from 1
August 2008 to 31 July 2009.[36] Given the indexation arrangements, this amount
will continue to increase during the 5CPA. This payment essentially
provides pharmacists additional income for a task which is already
remunerated by the dispensing fee. Furthermore, it is not
contingent on the supply of a generic medicine or activities
associated with the quality use of medicines, raising questions
about the ‘value for money’ to government and consumers
in this additional payment. Similar arguments could be made about
the continuation of the wholesaler CSO payment as it provides
additional funding to eligible wholesalers to ensure the timely
supply of the full range of PBS medicines. The pricing of PBS
medicines includes specific provision for a wholesaler margin which
remunerates wholesalers for the supply of PBS medicines.
The introduction of a $0.15 payment for each transaction to
pharmacists for dispensing RPBS prescriptions and for co-payment
prescriptions is designed to offset some of the costs charged to
pharmacists by electronic prescription providers.[37] This electronic prescribing
program is owned by the Guild and therefore uptake among Guild
members is likely to be high, potentially increasing costs to the
Government. Currently, pharmacists are charged $0.25 for each
transaction.[38]
This program is expected to generate income of $30 million per
annum to the Guild and, under the 5CPA, the Government will pay $18
million.[39] Other
online initiatives, such as PBS Online, have had a much higher
uptake than expected, at a considerable additional cost to the
Government.[40]
This arrangement has also been criticised on the grounds that, as
the Government has abandoned its electronic prescribing project,
the Guild will have an advantage in the current market and any
future policy considerations.[41]
The 5CPA reinforces the fee-for-service model for community
pharmacy. This is in direct contrast to many of the reforms
announced as part of the National Health and Hospitals Network
which signal a shift from fee-for-service to block funding for the
provision of services. Pharmacists are essential to the timely
provision of PBS medicines, yet this does come at a cost to
Government. It remains to be seen whether the projected savings
will be realised, if consumers will benefit from the proposed
changes to existing programs and how pharmacy will be integrated
into the proposed Medicare Locals, the National Health and
Hospitals Network and the new payment arrangements.
Concluding comments
Both the MOU and the 5CPA are expected to deliver considerable
savings to the Government, but there is no requirement in either
agreement that these savings be delivered, or any indication what
the consequences might be if the projected savings are not
realised. Both agreements limit the action of the Government for
the next five years, creating certainty for the branded
pharmaceutical industry and pharmacists, but potentially limiting
the capacity of Government to respond to new and emerging policy
challenges.
The overarching policy framework for the PBS is the National
Medicines Policy and the objectives of access, equity and
affordability. It remains to be seen whether the MOU and the 5CPA
advance these objectives.
[1]. The budget figures and policy
details in this brief have been taken from the following document
unless otherwise sourced: Australian Government, Portfolio budget statements 20010–11: budget
related paper no. 1.11: Health and Ageing Portfolio,
Commonwealth of Australia, Canberra, 2010.
[2]. Medicines Australia, Australia’s
pharmaceutical industry signs historic agreement with Commonwealth
Government, media release, 11 May 2010, viewed 12 May 2010,
http://www.medicinesaustralia.com.au/pages/view_news.asp?id=191
[3]. Ibid.
[4].
Department of Health and Ageing, Strengthening your PBS –
preparing for the future, media release, 16 November 2007,
viewed 13 May 2010,
http://www.health.gov.au/internet/main/publishing.nsf/Content/Strengthening-your-PBS.htm
[5].
Commonwealth of Australia, The impact of PBS reform: report to
the Parliament on the National Health Amendment (Pharmaceutical
Benefits Scheme) Act 2007, Commonwealth of Australia,
Canberra, February 2010, pp. 8–9,
http://www.health.gov.au/internet/main/publishing.nsf/Content/pbs-reform-report
[6]. Australian Government, Budget
measures: budget paper no.2: 2010–11, Commonwealth of
Australia, Canberra, 2010, pp. 248–9.
[7].
Department of Health and Ageing (DoHA) and Medicines Australia,
Memorandum of Understanding, 11 May 2010, viewed 12 May
2010,
http://www.medicinesaustralia.com.au/pages/images/APLHGR14@health.gov.au_20100507_154458.pdf
[8]. Under current price disclosure
arrangements, suppliers provide the price at which the drug is sold
to wholesalers and/or pharmacies. DoHA then invites other supplies
of the same medicines to disclose their pricing arrangements. This
information is then used to calculate the weighted average price.
If the price reduction is less than 10 per cent of the ex-supplier
price, the price reduction will not apply. If the reduction is
greater than 10 per cent, the weighted average disclosed price will
be the subsidised price, rather than the disclosed price.
[9]. Presumably this clause does not allow the
Government to revisit the therapeutic groups that were announced as
part of the 2009–10 Budget. The three new Therapeutic Groups
announced in the 2009–10 Mid-Year Economic and Fiscal
Outlook are exempted from the MOU.
[10]. K Mercer and N Ahmed, ‘The drug wars’,
Australian Financial Review, 14 May 2010, p. 65.
[11]. Pharmacy Guild of Australia, Federal Budget and
Fifth Agreement deliver certainty, media release, 11 May 2010,
viewed 12 May 2010, http://www.guild.org.au/content.asp?id=2810
[12]. K Mercer and
N Ahmed, ‘The drug wars’, Australian Financial
Review, 14 May 2010, p. 65, viewed 14 May 2010,
http://parlinfo/parlInfo/search/display/display.w3p;adv=yes;db=;group=;holdingType=;id=;orderBy=customrank;page=0;query=Author%3AMercer%20Date%3A14%2F05%2F2010%20Dataset%3Apressclp;querytype=;rec=0;resCount=Default
[13]. P Clarke, ‘Drug deal costing billions: Medicines
Australia’, The Australian, 15 May 2010, viewed 15
May 2010,
http://www.theaustralian.com.au/news/health-science/drug-deal-costing-billions-medicines-australia/story-e6frg8y6-1225866384337
[14]. The impact of PBS reform: report to the Parliament
on the National Health Amendment (Pharmaceutical Benefits Scheme)
Act 2007, op. cit., p. 6.
[15]. Senate Community Affairs References Committee,
‘Reference: Consumer Access to Pharmaceutical
Benefits’, Committee Hansard, 7 May 2010,
pp. CA 56–7, viewed date, http://www.aph.gov.au/hansard/senate/commttee/S12998.pdf
[16]. See, for example, S Kwon, ‘Pharmaceutical reform
and physician strikes in Korea: separation of drug prescribing and
dispensing. Social Science and Medicine, vol. 57, 2003,
pp. 529–38.
[17]. The impact of PBS reform: report to the Parliament
on the National Health Amendment (Pharmaceutical Benefits Scheme)
Act 2007, op. cit., p. 36.
[18]. DoHA, Pharmaceutical Benefits Scheme (PBS)
reform, media release, 2 February 2007,
http://www.health.gov.au/internet/main/publishing.nsf/Content/pbs_reform_02feb07.htm
[19]. N Lush, ‘Exclusive interview: MA CEO, Brendan
Shaw, explains the MOU’, Pharmainfocus, 17–23
May 2010, viewed 17 May 2010, http://www.pharmainfocus.com.au/feature.asp?id=364
[20]. The Therapeutic Group arrangements ensure that the
Government pays the same price for products that offer the same
therapeutic outcome; and the price paid by the Government is the
lowest price of the group.
[21]. See, for example, N Roxon (Minister for Health and
Ageing), Agreement to deliver certainty for community pharmacy
and government, media release, 24 December 2009, viewed 13
March 2010,
http://www.health.gov.au/internet/ministers/publishing.nsf/Content/BFBA048EF82E6841CA2576960007A261/$File/nr243.pdf
[22]. Pharmacy Guild of Australia, New agreement to
deliver certainty for community pharmacy, media release, 24
December 2009, viewed 13 March 2010,
http://www.guild.org.au/uploadedfiles/National/Public/News_and_Events/Media_Release_Archive/NR_5th_%20Agreement_media%20release.pdf
[23]. N Roxon (Minister for Health and Ageing),
Agreement to deliver certainty for community pharmacy and
government, op. cit.
[24]. N Roxon
(Minister for Health and Ageing), Better pharmacy
services, media release, 3 May 2010, viewed 13 May 2010,
http://www.health.gov.au/internet/ministers/publishing.nsf/Content/mr-yr10-nr-nr079.htm?OpenDocument&yr=2010&mth=5
[25]. Pharmacy Guild of Australia, New agreement:
quality care for consumers, certainty for community pharmacy,
expanded role for pharmacists, media release, 3 May 2010,
viewed 13 May 2010, http://www.guild.org.au/content.asp?id=2800
[26]. Ibid.
[27]. Australian Medical Association (AMA), Community
pharmacy agreement – government puts patients at risk,
media release, 3 May 2010, viewed 13 May 2010, http://www.ama.com.au/node/5539
[28]. L Mulligan,
‘Prescriptions still apply: Fifth Community Pharmacy
Agreements Continuance Program, The Australian, 15 May
2010, viewed 15 May 2010,
http://www.theaustralian.com.au/news/health-science/prescriptions-still-apply-fifth-community-pharmacy-agreements-continuance-program/story-e6frg8y6-1225866384285
[29]. Portfolio budget statements 2010–11: budget
related paper no. 1.11: Health and Ageing Portfolio, p.
107
[30]. L Buckmaster,
Fourth Community Pharmacy Agreement, Background note, no.
SP008, 2005, Parliamentary Library, Canberra, 2005, viewed 13 May
2010, http://libiis1/Library_Services/BN/health/sp008.doc
[31]. The median price for a pharmacy is estimated to be
$1.89 million. See E Connors, ‘Calls to ease limits on new
pharmacies’, Australian Financial Review, 10 August
2009, p. 5,
http://parlinfo/parlInfo/search/display/display.w3p;adv=yes;db=;group=;holdingType=;id=;orderBy=customrank;page=0;query=Author%3A%22connors%20%22%20Date%3A01%2F08%2F2009%20%3E%3E%2030%2F08%2F2009%20Dataset%3Apressclp;querytype=;rec=6;resCount=Default
[32]. E Connors,
‘Calls to ease limits on new pharmacies’,
Australian Financial Review, 10 August 2009, p. 5,
http://parlinfo/parlInfo/search/display/display.w3p;adv=yes;db=;group=;holdingType=;id=;orderBy=customrank;page=0;query=Author%3A%22connors%20%22%20Date%3A01%2F08%2F2009%20%3E%3E%2030%2F08%2F2009%20Dataset%3Apressclp;querytype=;rec=6;resCount=Default
[33]. Ibid.; and E
Connors and N Ahmed, ‘Roxon puts squeeze on chemists’,
Australian Financial Review, 29 June 2009, p. 1,
http://parlinfo/parlInfo/search/display/display.w3p;adv=yes;db=;group=;holdingType=;id=;orderBy=customrank;page=0;query=Author%3A%22connors%20%22%20Date%3A01%2F06%2F2009%20%3E%3E%2030%2F06%2F2009%20Dataset%3Apressclp;querytype=;rec=1;resCount=Default
[34]. It should be noted that this is not necessarily a
generic medicine. It is a medicine that does not have a brand
premium or special patient contribution.
[35]. The impact of PBS reform: report to the Parliament
on the National Health Amendment (Pharmaceutical Benefits Scheme)
Act 2007, op. cit., p. 6.
[36]. Ibid.
[37]. Portfolio budget statements 2010–11: budget
related paper no. 1.11: Health and Ageing Portfolio, p.
107
[38]. Portfolio budget statements 2010–11: budget
related paper no. 1.11: Health and Ageing Portfolio, p.
107
[39]. K Mercer, ‘Pharmacy Guild gets electronic leg
up’, Australian Financial Review, 8 February 2010,
p. 3,
http://parlinfo/parlInfo/search/display/display.w3p;adv=yes;db=;group=;holdingType=;id=;orderBy=customrank;page=0;query=Author%3Amercer%20Date%3A01%2F02%2F2010%20%3E%3E%2028%2F02%2F2010%20Dataset%3Apressclp;querytype=;rec=7;resCount=Default
[40]. The impact of PBS reform: report to the Parliament
on the National Health Amendment (Pharmaceutical Benefits Scheme)
Act 2007, op. cit., p. 8.
[41]. K Mercer, op. cit.
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