Halifax Aug 6 /2002
Mr Greg Monsour
Policy and Promotion Division
Centre for Policy and Regulatory affairs
Biologic and Genetic Therpies Directorate
Health Canada
Address locator 3104A2
1600 Scott St
Ottawa, Ontario
K1A 1B6
Dear Mr Monsour
Following receipt of your letter (subject: regulatory
policy for the positron emission radiopharmaceuticals – drafts posted
on the net last month), I have provided you with a list of names and CVs
for the committee of experts on PET radiopharmaceuticals. I would also
like to take the opportunity to comment on the draft, to reiterate
previous statements on the issues and to echo the discussions that have
taken place within the Nuclear medicine community.
Those issues are mostly the establishment of a safe
framework that will allow reasonable access to PET technology by all
Canadians regardless of where they live. Unlike most European and
American demographics our population is spread over a large area - and
while we must not sacrifice consistent quality of the test and of the
radiopharmaceuticals, provisions should be made to ensure access both to
the existing agents to the developments of this rapidly expanding
technology. In Canada, this will most likely be achieved through larger
centers being equipped for radiopharmaceutical production with satellite
centres dedicated to scanning within a 2 hour drive - 4 hours at the
most).
As you know, PET radiopharmaceuticals differ
significantly from the many agents for which the existing framework has
been developed:
- PET agents are tracers by definition and have a
very short lifespan,
- They have been extensively studied in the
literature and accepted for clinical use in many countries without
passing through the usual regulatory framework. The large classical
phase one –two –three trials do not exist in the usual format
for any of the indications for PET.
- More importantly, since PET benefits are now
clinically recognized, it is not considered ethical to repeat
studies just because Canadians did not have access to the technology
previously. The indications for PET agents and their mode of
production are well defined in the classical literature and
recognized pharmacopias. Indeed, PET has become accepted as a
standard of care.
I was glad to see that in your introduction
(background section) that you took the opportunity to state that all the
main short lived radioisotopes are produced a cyclotron and that you
recognized the time constraint associated with their use. I would like
to further comment, that many of those isotopes are used in research and
soon will be used clinically to label agents to study receptor sites as
well, specific activity will coumpound the issue of short half life. The
short half life of the isotopes is certainly a key issue to be addressed
in planning the diffusion of this technology throughout the Canadian
health care system – finding ways to ensure access to PET for both
research and clinical use while not compromising standards and quality
in the process. The federal agency must ensure that the legislative
process is put in place in a near future will be flexible enough to
allow research and clinical use of PET that supports both objectives.
As you commented, the time restriction leads to a lack
of stock piling is an issue and limits both the distribution and the
cost effectiveness per dose associated with the production of PET
radiopharmaceuticals. The legislative process should keep in mind again
that while no one will contest the need for safe agents with consistent
quality, but that the resources associated with production of PET
radiopharmaceutical are limited and their intrinsic qualities differ
from anything that your agency has previously experienced. The emphasis
given to the manufacturing process should be reviewed and reminded the
“tracer”aspect of PET drugs and a fine balance between test on
process and test on final product will be needed to insure that the safe
product could be obtained without unrealistic cost.
In your “analysis of the key issues related to the
framework” you identified the lack of status of the PET agents. Since
they haven been “approved” in Canada, they can’t be provided to
our patients by other means than a formal IND or special access program.
This limits pharmacists and physicians to use existing facilities and
provide service under the practice of Medicine and Pharmacy until the
formal legislative framework is put in place. This issue should be
quickly addressed and I reiterate that an approach similar to the FDA
and both European and Australian legislative agencies should be quickly
adopted. If this can help you, I would be glad to request my MLA to
consider the preparation of an Act similar to the USA’s Modernisation
act.
As far as the discussion on Compounding by non profit
institution ( page 8 section b and c ) , it is a topic that seems to
come back regularly in discussion between the Nuclear Medicine community
and the federal agency. This is an area that I though was finalized:
approved drugs that are not commercially available can be dispensed
under the practice of Medicine and Pharmacy. The intent remains to
permit reasonable access of the radiopharmaceuticals to our population
if commercial venture does not justify the cost of production. The real
issue is to define “commercially available” taking into account the
time factor and production of lower specific activity agents, a concept
that might not have been previously raised within the existing
legislative framework.
In response to your comment, on page 9-10, regarding
the acquisition of data for market authorization,. generating data to
confirm the already existing literature describing the safety and
efficacy of PET is a very unfortunate way to reinvent the wheel. It just
delays establishment of the technology in spite of patient needs. I will
reiterate the recommendations of the CSNM paper. I am suggesting again,
a way similar to the American approach, that special arrangements be put
in place at least to limit the number of patients to substantiate the
acceptance of PET agents and that the existing body of literature be
taken in consideration. I can understand the safe approach that the
federal agency takes, however, in the case of PET the question is to
rapidly establish reasonable standard of safety that takes into
considerations what has been already documented for those agents that
are injected in TRACER amounts.
I definitely applauded the formation of a committee of
experts that was recommended. I would again suggested a permanent
committee not only restricted to PET but also to any of the Nuclear
Medicine modalities since they significantly differ from any current non
radioactive therapies. Reading the document, I realized that it will be
a learning experience for both the federal agency and our medical
community to understand the potential and the limitations of the PET
technology (Nuclear medicine technology for that matter), the commercial
aspects and restriction of producing radiopharmaceuticals and the
existing legislative framework. I wish we had more time but already our
Canadians patients are unfairly disadvantaged compared to patients of
other “industrial “ countries.
It is apparent by the document that the federal agency
is willing to look at PET agents in a new light. This to me and a great
many others this is a welcomed step to permitting access of this
technology by the Canadian population. However I must take great
exception to one major assumption that appears to be made.
I will not argue that fact that PET is one of the best
functional imaging modalities, and that Canadians should have access to
this technology, but I will strongly argue that PET centres presently
scattered across the country provide reasonable accessibility. Who ever
wrote this does not obviously have cancer and does not live in either
Alberta, most of BC, Saskatchewan, Manitoba, most of Ontario, the
Maritimes or Newfoundland, where clinical access to PET is most
certainly not available. If you are lucky and live in Quebec, we can
discuss the issue of the 4 months waiting time.
I will close by requesting that actions should be
taken efficiently and as soon as possible to minimize delay and to give
the Medical community some workable indication of how new diagnostic
technology can develop within a recognized legal frame.
If you have any questions please contact me.
Dr Gilbert Matte B.Pharm.PhD |
