[e-drug] Regulation of Complementary Medicines in Australia

e-drug
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E-DRUG: Regulation of Complementary Medicines in Australia
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[In Australia, the term Complementary Medicines covers 'traditional' medicines from indigenous cultures all over the world and includes herbal products and homeopathic medicines as well as dietary supplements, vitamins etc.... BS]

An article on deficiencies in the regulation of complementary medicines
in Australia has been published in the Medical Journal of Australia:

Harvey KJ, Korczak VS, Marron LJ, Newgreen DB. Commercialism, choice and
consumer protection: regulation of complementary medicines in Australia.
MJA 2008; 188 (1): 21-25. See:

http://www.mja.com.au/public/issues/188_01_070108/har10522_fm.html

Some media coverage is also available. See:

http://www.theage.com.au/news/national/regulator-lists-1000-diet-drugs-despite-lack-of-testing/2008/01/06/1199554486493.html

&

http://www.news.com.au/heraldsun/story/0,21985,23015042-2862,00.html

The abstract of the article is appended for those without www access.

Cheers
Ken
--
Dr. Ken Harvey
Adjunct Senior Research Fellow
School of Public Health, La Trobe University
http://www.medreach.com.au
VOIP: +61 3 9029 0634; Mobile +61 4 1918 1910
Ken Harvey <k.harvey@medreach.com.au>

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Harvey KJ, Korczak VS, Marron LJ, Newgreen DB. Commercialism, choice and
consumer protection: regulation of complementary medicines in Australia.
MJA 2008; 188 (1): 21-25.

Abstract

     * Controls on the supply and promotion of complementary medicines
in Australia are weak.

     * We used weight-loss products as an example to compare the
regulation in Australia of listed complementary medicines and registered
pharmaceutical products.

     * Complementary medicines are listed without evaluation for
efficacy, while conventional pharmaceutical products are registered
after evaluation for quality, safety and efficacy.

     * From 1996 to 2006, over 1000 “weight-loss” products were listed
on the Australian Register of Therapeutic Goods; most contained multiple
unevaluated ingredients (herbs, vitamins, minerals) of dubious efficacy.
Over the same period, 10 conventional medicines were registered; each
contained one evaluated ingredient of proven efficacy.

     * The number of listed weight-loss products (and complaints about
their promotion) is increasing. These appear to be a direct consequence
of the decision not to evaluate listed products for efficacy and the
lower fees for listing a product, compared with registration.

     * Complaint procedures (now overloaded) are no substitute for
adequate regulation at the time of market entry.

     * Regulatory reform of listed and homoeopathic products is required.

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E-DRUG: Innovator Pharma companies with Generic manufacturing business
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Dear colleagues,

I would like to know if there is a record / database out there of Innovator pharma companies that have diversified into the manufacture and sale of generic drugs. These drugs will either be their own products whose patent protection is over, or are manufacturing a wide range of other drugs in generic form.

I was at a meeting towards the end of 2007, where the point was disucssed in passing of innovator companies diversifying into generic market. The inference made at that meeting was that innovator companies where 'not welcome' (my quotes) in the generic sector, as their participation would 'distort' the generics market, etc. Therefore, I would like to establish how many of the innovator companies do have established generic manufacturing activities, for us to see what the true picture on the ground is.

I will value your support.

Bonface Fundafunda PhD., MBA., B.Pharm
Manager, Drug Supply Budget Line
Ministry of Health,
P.O. Box 30205,
Ndeke House,
Lusaka,
Zambia
Tel: +260 1 25 59 11
Mobile: + 260 979 25 29 00
Email: bcfunda@hotmail.com

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E-DRUG: Innovator Pharma companies with Generic manufacturing business (2)
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Dear Bonface,
Most innovator companies have some sort of arrangement to produce generic
drugs - either the ones they developed or those of others. There is no
complete data base of this information, though it can be organized on a
country by country basis. Some donor funded activities such as the MeTa
project are aiming to collect and organize such information, but to date
this has not been done. Your question is but one that could be answered by
such a database.

The status of a drug in a particular country in terms of
  1. whether it is on patent or available in generic form, AND
  2. whether a particular dose, formulation and strength of a drug is
registered in the country are two pieces of critical information necessary to know before a drug can be imported. I refer to imported drugs as most countries do not produce
sufficient quantities of drugs to be free from having to import.

Regrettably this information is not readily available even at the country
level never mind at any other. It is considered good pharmaceutical
practice to make this information available easily, but in practice
countries do not maintain an electronic searchable list.

This state of affairs makes the process of any global drug program such as
the Global Fund, SCMS, DNDI, TB Alliance and all the others more difficult
than it has to be, yet for some reason no funding has been made available to
organize this information along with the legal and regulatory information
one must be able to access as well. There has been a call for this
information too. As the project director of database that is designed to
collect the legal and regulatory material, I certainly hope this situation
can be addressed soon. I wish you luck in your search and if you find
something, please let me know.

Yours,
Michele Forzley, JD, MPH
Director IPHLIP
Forzley & Associates - Global Public Health Lawyers and Consultants
301-565-0680
Silver Spring, MD USA
"Michele Forzley" <mforzley@comcast.net>

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E-DRUG: Innovator Pharma companies with Generic manufacturing business (5)
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Dear Bonface,

I presume the meeting that you are talking about below is the UNDP meeting
in Pretoria during which we were discussing the issue of "authorized"
generics? We had raised this issue not as a blanket condemnation of
originator companies entering into the generics market, but only in the
context of the possible anticompetitive effects that may arise when
originator companies "game" the system to discourage "true" generic
competition by launching an "authorized" generic version (e.g., through its
generic subsidiary).

Such a practice can be harmful particularly within the context of the
legislative scheme in the U.S., where the law provides for a 6-month market
exclusivity to the first generic entrant. This exclusivity period was
designed to provide an incentive for generic companies quickly to enter the
market with lower cost versions, and in the process to challenge any
questionable patents pertaining to the drug. Now, when the originator
company allows an "authorized" generic to be launched during this
exclusivity period, the incentive for "true" generic companies to face the
risk of protracted patent litigation is substantially diminished, with
possible anticompetitive effects. Although this particular use of
authorized generics is somewhat peculiar to the U.S. legislative framework,
it is nevertheless possible that this strategy could be adapted to other
situations with similar effect.

For a more detailed account of the potential harmful effects of authorized
generics, see the US Generic Pharmaceutical Association's submission to the
Federal Trade Commission on this topic. It is available at:

http://www.ftc.gov/os/comments/genericdrugstudy3/062806gpha.pdf

Warm regards,

Chan
"Chan Park" <chan.park@lawyerscollective.org>