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Vol 28- Apr 2010
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RMI outlines its take on clinical trials in New Zealand
New Zealand could be missing out on earning over NZ$200
million per year by not having developed a comprehensive strategy to
support clinical trials in this country.
That’s the basis of the RMI submission to the
Government Inquiry into Improving New Zealand's
environment to support innovation through clinical trials. The submission
represented the views of member companies and followed consultation with
clinicians involved in running clinical trials in New Zealand, as well as a
number of patient advocacy groups
In February, the Health Select Committee called for
submissions to the Inquiry, which was charged with considering:
‘ ... ways to ensure:
coordinated, nationwide approaches to clinical trials and performance
measures; streamlined ethics approvals systems; national patient referral
networks, and better ways to approve, establish and conduct clinical
trials; removal of unnecessary barriers; and benefit to New Zealand
patients through clinical trials, as well as the New Zealand innovation
system, health system, and economy.'
In its submission, the RMI argued many countries
recognised the economic, health and scientific benefits of clinical trials,
and actively competed to attract this research. For New Zealand to figure
in this competitive environment a clear strategy was needed, including
tackling the numerous difficulties faced by the New Zealand research
community, before the country could become a destination for the not
inconsiderable international clinical research investment available.
For example, in 2008 the top ten multinational
companies (by R&D spend) contributed US$58.5 billion, while the
Australian spend between 2006-07 was A$860 million.
The RMI submission argued that although containing
only a fraction of the world’s population, Australia contributed
3% of global medical research. With a similarly well trained health
workforce, similar patient-to-doctor ratios, and an efficient clinical
trials infrastructure, New Zealand should aspire to producing a similarly
scaled body of research.
A level of research in New Zealand similar to that in
Australia in 2007 (adjusted for population size) would result in an annual
spend of NZ$ 223.6 million at current exchange rates.
The RMI recommendations included:
1. improving the speed of application processes
to allow rapid start to trials
2. developing a critical mass of experienced
clinical trials staff
3. establishing a trials infrastructure
4. formulating sustainable tax incentives
5. developing improved relationships with the
pharmaceuticals industry.
The
RMI submission on clinical trials can be accessed here.
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What are clinical trials?
Clinical trials of medicines, medical devices, and
other therapies are intended primarily to benefit those suffering ill
health. They are also beneficial to clinicians, medical scientists,
innovators, and health standards in the country in which they are carried
out.
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TPP talks kick off
in Melbourne
The first round of Trans Pacific Strategic Economic Partnership
(TPP) negotiations finished in Melbourne on 19 March, following a week of
‘officials only’ talks which included around 15 New Zealand
representatives.
Currently including New Zealand, Chile, Singapore and Brunei,
expansion of the TPP to include the US, Australia, Peru and Vietnam could
have significant impact on New Zealand’s economy and also the
pharmaceutical industry here.
Some New Zealand commentators have voiced concern that
US lobbyists, including the pharmaceutical industry, would use free
trade agreement talks to block New Zealand exports to America, distort New
Zealand import opportunities to advantage American firms, and attack the
PHARMAC funding model.
Already negotiations have faced opposition from several US Senators,
including former Democratic Presidential nominee John Kerry. However,
claims that losses to US dairy producers could total up to US$20 billion
during the first decade of the agreement have
been dismissed as "palpable nonsense" by New Zealand Trade
Minister, Tim Groser, (pictured right), who has described the TPP as a
"highly complex new generation agreement".
From the New Zealand pharmaceutical industry’s point of view, the
RMI would expect a TPP to usher in changes by way of reform of the PHARMAC
model, rather than its removal, in order to align practices in New Zealand
with other trade agreements.
These could include independent clinical assessments of the benefits
of medicines separated from financial considerations, application processes
subject to specific timeframes to avoid arbitrary delays, greater public
access to criteria underpinning decisions on listing and reimbursement of
medicines, and publication of the threshold - based on disease burden and patient
numbers - when determining which medicines are considered cost effective
and affordable.
Also in line with overseas practice, applicants could gain the
opportunity to respond to judgements made during PHARMAC’s approvals
process, with scientific assessments on both sides subject to review.
The second round of talks is currently scheduled to take place in
June 2010, with officials expected to further consult with stakeholders in
the lead up to the round.
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First Zachary Gravatt Memorial Scholarship awarded
The inaugural Zachary Gravatt Memorial Scholarship has been awarded to
sixth year medical student, Tim Hopgood.
The annual Scholarship was established by Lance and Jenny Gravatt in memory
of their son, Zachary.  A promising
student at Auckland University Medical School, Zac (pictured left) passed
away in 2009 after contracting meningococcal C septicaemia. He was aged 22.
The
Scholarship funds $5000 of professional development and training for a Year
IV to VI medical student in the MBChB course at Auckland University. The
award is based on clinical skills and achievement, rather than purely
academic merit.
Announcing the award, Lance and Jenny said the Selection Committee had
unanimously resolved Tim Hopgood should receive the award to assist him in
his Year VI elective of researching areas of paediatric medicine and
Pacific Island health.
Tim had achieved Distinction in his Year V clinical assessment, as well as
admirable overall grades, in the face of demanding family and financial
circumstances.
These had included looking after a family member requiring frequent
hospitalisations over the past 3 ½ years.
“In our opinion Tim is a very worthy inaugural recipient of this
award and we have no doubt he will make the finest of doctors,” Lance and
Jenny said.
“On a personal note, it gives us pleasure to know that in a small way Zac's
spirit continues through fine young people like Tim, who have shown great
strength of character while achieving excellence in their clinical work.”
Support for the Scholarship from around 80 individual donors, including the
RMI, had meant approximately $75,000 was now in the bank and the goal of
establishing a sustainable fund into the future was within reach.
“This is an amazing response and we sincerely thank you all,” Lance and
Jenny said.
The fund remains open for donations. To support the scholarship online, see
www.givingtoauckland.org.nz/zacgravatt.aspx
The next closing date for applications for the Zachary Gravatt Memorial
Scholarship is November 2010 (to be awarded 2011).
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RMI
elects four new Board members
Four new members
were elected to the RMI Board at the RMI AGM held in Auckland on 24 March.
The new members are:
• Sean Evans (General Manager, Novartis New Zealand Limited)
• Chris Hourigan (Business Unit Director, Janssen-Cilag (New Zealand)
Ltd)
• Stuart Knight (Managing Director, Roche Products (NZ) Ltd)
• Nicholas Leach (Commercial Director, Abbott Laboratories NZ
Limited).
They join current Board members Lex Henry (non-executive Chairman); Alan
Carter (Vice Chairman) Country Manager, sanofi-aventis new zealand limited;
Darcy Downey, Managing Director, Boehringer Ingelheim NZ Limited; Geoff
McDonald, General Manager, GlaxoSmithKline NZ Limited; and Frances Benge,
Country Lead, Pfizer New Zealand Limited.
The RMI is governed by an eight-member Board of Directors elected annually
from senior representatives of member companies.
RMI
CEO, Denise Wood, said the new Board represented a pleasing blend of
experience.
“I’m delighted that the skills and continuity provided by the returning
members fit so well with the fresh input the new members will bring to the
table,” Ms Wood said.
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The new RMI Board (L-R, front)
Denise Wood (CEO), Lex Henry (Board Chair), Geoff McDonald, Alan Carter
(Vice Chair), Frances Benge, Nicholas Leach. (L-R, back) Chris Hourigan,
Darcy Downey, Sean Evans, Stuart Knight.
NOTE: photographs of individual members
and the group shot of the RMI Board are available from the Photo Gallery on
www.rmianz.co.nz
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This newsletter is
published on behalf of the
Researched Medicines Industry Association of New Zealand. The views and
opinions expressed in this publication are not necessarily those of the
RMI.
For further information:
Researched Medicines Industry Association
PO Box 10447 Wellington
Phone 04 499 4277
http://www.rmianz.co.nz
info@rmianz.co.nz
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RMI hosts meeting after Marevan recall
The group responsible for regulating
therapeutic products in this country – the New Zealand Medicines and
Medical Devices Safety Authority (Medsafe) - has not often had to invoke
its recall procedure to consumer level.
However, in
consultation with GlaxoSmithKline (GSK), Medsafe's recent recall of 3mg
tablets (blue) tablets of Marevan (Warfarin) dispensed to patients since 23
November 2009, gave the procedure a thorough testing.
The recall was due to
a manufacturing problem which could have meant a limited number of tablets
contained more medicine than the labelled amount.
This highlighted an
interesting perspective probably not considered an issue during the
original consultation for the procedure, that is compensation for time
spent on recalls by Pharmacists.
In the days following
the 28 January recall, the Pharmacy Guild decided to issue legal
proceedings against GSK and encouraged a flood of widely variable claims
for compensation from Pharmacists.
Whether or not the claim is legitimate, it is clear the
procedure as it stands does not offer clear guidance on the matter.
In order to support
GSK and to obtain clear guidelines for this and any future recalls, the RMI
hosted a meeting of those involved in the consultation for the original
document to discuss the issue. Those present agreed the procedure was in
need of a review, and resolved to go back to their respective organisations
to agree a way forward.
The RMI is hopeful
Medsafe will conduct a full review of the procedure, including a wide
consultation involving interested parties.
New RMI office space
The recently refurbished RMI
offices now offer a convenient, centrally sited venue for individuals from
member companies to use when in the Capital.
Complete with
meeting room, the offices are situated on the eight floor of Primeproperty
Tower in the heart of Wellington’s CBD.
The office is adjacent to Bowen House and the Beehive, opposite the
new Supreme Court, and backs onto The Terrace. It is a short walk
from the Railway Station, the gateway to Westpac Stadium,
Wellington’s waterfront, and key Government and other agencies.
Upcoming events
- Renal Society of
Australasia Conference. Cairns Convention Centre, 2 - 5 June 2010. http://www.rsa2010.org.au/
- GP CME 2010.
Energy Events Centre,
Rotorua, 10-13 June 2010. http://www.gpcme.co.nz/
- GP CME South. Christchurch, 5-8 August 2010 (Details
YTC). http://www.gpcme.co.nz/
- BIO Asia Pacific 2010. International Conference and
Exhibition. Brisbane Convention and Exhibition Centre, August 17th -
19th 2010.
- 17th World Congress of the International Society for the
Study of Hypertension in Pregnancy. Melbourne Convention and
Exhibition Centre, 3 - 6 October 2010.
http://www.isshp2010-melbourne.org/
- International Society of Obstetric Medicine (ISOM) Meeting,
Melbourne Australia. 1 - 3 October 2010.
Want
to highlight your upcoming conference in the RMI E-zine? Send the details
to info@rmianz.co.nz
www.rmianz.co.nz
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