These are a few quick points about the PhRMA submission.
1. PhRMA asks that ACTA “Establish liability for Internet Service Providers and Other Operators that Facilitate Trade in Counterfeit Medical Products.”
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. Expressly prohibit online activities that directly 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· 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’s 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.