[Ip-health] Pharma Anti-Counterfeiting Conference, 30th June-2nd July, London

[mko]

A long extract from my journal article.  Kevin Outterson


The Database on Counterfeit Medicines is Unreliable
(full article (free):  http://ssrn.com/abstract=3D926985)

Statistics about counterfeit medicines are everywhere: press reports,[1]
WHO fact sheets,[2]  FDA press releases,[3]  U.S. government task forces,[4=
]
law review articles,[5]  medical journals,[6] and international trade
associations.[7]

Statistics are one thing; useful statistics are quite another.  Empirical,
reliable and transparent statistics about drug counterfeiting are virtually
non-existent.  In an excellent article, Robert Cockburn and his co-authors
examined the paucity of transparent data and called for mandatory public
reporting.[8]  Drug companies are reluctant to release information that
might harm the marketing efforts for their branded products.[9]  The only
comprehensive global collection point for counterfeit drug information is
the Pharmaceutical Security Institute (PSI), a trade organization
established by the security directors of 14 major global drug companies.[10=
]
In October 2004, one of us (KO) asked PSI for access to their database as a
researcher, but was told they do not release information to the public.
Instead, I was directed to the FDA, WHO or news reports.[11]  The =B3data=
=B2
begins to resemble a house of mirrors as each group cites the other as the
source of the information.

For example, one widely-cited =B3fact=B2 attributed to the WHO is the claim=
 that
=B3[c]ounterfeit medicines make up more than 10% of the global medicines
available in the market=B2[12] and =B3WHO estimates that one in ten medicin=
es
sold worldwide is fake, with no medical effect whatsoever.  In developing
countries, up to 25% of the medicines used are counterfeit or substandard.
Some estimates place the annual earnings from counterfeit medicines at over
$32 billion globally.=B2[13]   Another example is the often-repeated claim
that =B3[t]he World Health Organization (WHO) figures suggest that developi=
ng
countries account for around 60% of all reported cases of counterfeit and
substandard drugs.=B2[14]   But the WHO doesn=B9t really defend this figure=
 when
pressed, and generally cites figures from the US FDA.

In the U.S., the FDA cites the WHO figures for global counterfeiting
estimates. Domestically, the FDA estimates that less than 1% of U.S. drugs
are counterfeit, but =B3officials admit that this figure is not based on an=
y
scientific studies.=B2[15]   European officials also rely on the WHO
estimates.  The Deputy Secretary General of the Council of Europe said =B3W=
HO
estimates that counterfeit medicines make up for 8% to 10% of the European
pharmaceutical market and in some countries even as much as 12%.=B2[16]

The pharmaceutical industry historically was reticent to discuss
counterfeiting, for obvious reasons.  With the advent of consumer drug
purchasing over the internet, suddenly the industry was faced with
cross-border arbitrage pressure.[17]   After consumer focus groups
identified safety as a primary concern with internet drug purchases, the
industry and the FDA began to publicly discuss the problem.  Publicly
discussing counterfeiting is an important tool to enforce the industry=B9s
price discrimination structures across borders, enhancing overall industry
profits.[18]

To remedy this insufficient data, the federal government should fund
independent market surveillance to identify and describe problems with the
U.S. drug supply chain. Randomized purchases should be made across the U.S.
market, in various channels, and the purchased drugs should be tested in al=
l
regards for compliance with U.S. law.  When non-compliance is found,
investigators should track the problems back to the source.  The full
results must then be transparently available to all researchers and the
public.  Similar undertakings could occur in other countries on a recurring
basis. Market surveillance on this level would provide the basic facts
necessary to truly understand the threat to our drug supply, and to separat=
e
public relations campaigns from genuine threats to public health.


[1]  Associated Press, FDA:  Al-Qaida could poison medicines, Aug. 12, 2004=
,
available at http://msnbe.msn.com/id/5682351
<http://msnbe.msn.com/id/5682351> (last visited Mar. 19, 2006).

[2]   World Health Organization. Fact Sheet No. 275:  Substandard and
Counterfeit Medicines (November 2003), available at
http://www.who.int/mediacentre/factsheets/2003/fs
<http://www.who.int/mediacentre/factsheets/2003/fs> 275/en.

[3]   U.S. Food and Drug Administration, FY 2003 Performance Report to the
President and the Congress, available at
http://www.fda.gov/oc/pdufa/report2003/default.htm
<http://www.fda.gov/oc/pdufa/report2003/default.htm> (last visited March 19=
,
2006).

[4]   US Department of Health and Human Services, HHS Task Force on Drug
Importation: Report on Prescription Drug Importation 37-38 (December 2004).

[5]   Benjamin A. Drabiak, Reimportation of prescription drugs: Long-lastin=
g
relief or a short-term analgesic? 4 Wash. U. Global Stud. L. Rev. 135,
143-144 (2005).

[6]   L. Gibson, Drug regulators study global treaty to tackle counterfeit
drugs, 328 Brit. Med. J. 486 (2004).

[7]   See, e.g., International Council of Nurses, Counterfeits Kill (May 12=
,
2005),  available at www.icn.ch <http://www.icn.ch/> .

[8]   Robert Cockburn, Paul N. Newton, E. Kyeremateng Agyarko, Dora Akunyil=
i
& Nicholas J. White, The Global Threat of Counterfeit Drugs:  Why Industry
and Governments Must Communicate the Dangers, 2 PLoS Medicine 0302-0308
(April 2005), available at www.plosmedicine.org
<http://www.plosmedicine.org/> .

[9]   Id. at 0303-0304.

[10]   Pharmaceutical Security Institute, www.psi-inc.org
<http://www.psi-inc.org/> (last visited March 19, 2006).

[11]   Personal correspondence with the author, October 4, 2004.

[12]  International Council of Nurses, Counterfeits Kill at 5 (May 12, 2005=
)
available at www.icn.ch <http://www.icn.ch/> .

[13]   Id. at 38 (citing World Health Organization (2003).  Fact Sheet no.
275, Substandard and Counterfeit Medicines).

[14]   Id. at 11 (citing World Health Organization (2004) Essential Drugs
and Medicines Policy, Overview).

[15]   Elizabeth Cady Brown, Pharmaceutical Fakery, Long Island Press, June
9, 2005, available at
http://www.longislandpress.com/?cp=3D188&show=3Darticle&a_id=3D4250 (last v=
isited
March 19, 2006).

[16]   Maud de Boer-Buquicchio, Deputy Secretary General of the Council of
Europe, Opening speech on the occasion of the seminar =B3Counteract the
counterfeiters!=B2, Limiting the risks of counterfeit medicines to public
health in Europe by adequate measures and mechanisms (Sept. 21, 2005),
available at
http://www.coe.int/T/E/Com/press/News/2005/20050921_disc_sga.asp
<http://www.coe.int/T/E/Com/press/News/2005/20050921_disc_sga.asp> .

[17]   Kevin Outterson, Pharmaceutical Arbitrage, supra note    , at    .

[18]   Id. at    .



On 6/5/08 4:44 AM, "James Love" <james.love@keionline.org> wrote:

>
> Does anyone know who at the WHO has made this claim?
>
> * "The WHO estimates that 10% of global pharmaceutical commerce involves
> counterfeits."
>
>