[A2k] PhRMA comments on ACTA: ISP Liability, Parallel Trade and Generic APIs

James Love james.love@keionline.org
Wed Jul 9 21:51:02 2008


http://www.keionline.org/index.php?option=3Dcom_jd-wp&Itemid=3D39

PhRMA comments on ACTA:  ISP Liability, Parallel Trade and Generic APIs

July 10th, 2008 by James Love

PhRMA=E2=80=99s comments to USTR on ACTA are here:
http://www.keionline.org/index.php?option=3Dcom_content&task=3Dview&id=3D19=
3

These are a few quick comments about the PhRMA submission:

1. PhRMA asks that ACTA =E2=80=9CEstablish liability for Internet Service
Providers and Other Operators that Facilitate Trade in Counterfeit
Medical Products.=E2=80=9D

This is potentially quite an important and controversial recommendation.
PhRMA wants to make telecommunications companies liable if one of their
customers sells counterfeit products.

--------PhRMA Recommendation: Establish liability for Internet Service
Providers and Other Operators that Facilitate Trade in Counterfeit
Medical Products.=E2=80=9D Expressly prohibit online activities that direct=
ly or
indirectly facilitate trade in counterfeit medical products and provide
legal incentives for ISPs and online intermediaries to cooperate with
legitimate manufacturers in combating counterfeiting activities. . . We
note that Korea recently implemented a system for taking down web sites
selling counterfeits, and recommend examination of that system for
possible adaptation and use in other countries to combat online
counterfeit medicines.---------

2. PhRMA wants curbs on parallel trade, and to define products diverted
from distribution channels as criminal counterfeit offenses. Most
legitimate parallel trade falls into this category today.

----------PhRMA Recommendation. Provide Effective Border Enforcement
against the Importation and=C2=B7 Exportation of Counterfeit Medical
Products. . . without effective controls against diversion, parallel
trade in pharmaceuticals becomes a potential pathway for the
introduction of counterfeit medical products. ACTA members should also
be required to prohibit the distribution of medical products diverted
from legitimate distribution channels and such distribution of diverted
products should be treated as a counterfeiting offense.-----------

3. PhRMA is targeting the market for bulk chemicals used for generic
pharmaceutical drugs.

----------PhRMA Recommendation: Ensure that criminal and administrative
remedies extend to all upstream and downstream links in the drug
counterfeiting channel, including the supply of unauthorized bulk
chemicals and the distribution of finished counterfeit products. . . .
Effective anti-counterfeiting enforcement depends critically upon law
enforcement=E2=80=99s ability to block so-called chokepoints in the
counterfeiting manufacture and distribution channel, from the upstream
supply of raw materials to the downstream distribution of finished
products. In the case of counterfeit medical products, this holistic
approach to enforcement necessitates effective enforcement tools and
remedies to stop the unauthorized manufacture and supply (both domestic
and international) of the bulk chemicals used to produce counterfeit
medical products, as well as measures to prevent the unauthorized
wholesale and retail distribution of counterfeit products.

--
James Love, Director, Knowledge Ecology International
http://www.keionline.org | mailto:james.love at keionline.org
Wk: +1.202.332.2671 | US Mobile +1.202.361.3040 | Geneva Mobile +41.76.413.=
6584