[Ip-health] EP question tabled on access to medicine and ACTA by MEP Michelle Rivasi

david at davidhammerstein.org david at davidhammerstein.org
Tue Oct 26 02:02:17 PDT 2010


The current wording on damages and other remedies in the the proposed  
ACTA (Anti-counterfeiting Trade Agreement) text could allow for  
excessive damages for infringement that go beyond current  
international legal standards, and which could have a strong  
dissuasive effect on generic medicine competition and on access to  
life-saving drugs. By increasing the damages to this extent the  
agreement effectively expands the rights of the IP right-holders,  
increasing the risks and the viability for generic competitors seeking  
to enter the market. This could dampen innovation and the production  
and trade of generic medicines. These proposed high levels for damages  
and penalties will force changes in the laws in some EU Member States  
and also clearly contradicts present US law

ACTA could still constitute barriers to medicines going to developing  
countries. The border measures section no longer includes patents but  
patents remains in the rest of the agreement  that includes civil  
trademark infringement with greatly increased penalties. This means a  
customs official could initiate a seizure and even destruction of an  
allegedly infringing good without judicial review or even notification  
to the rights holder— simply on the basis of an assertion by a rights  
holder of a commercial trademark dispute.

Third parties are at risk of injunctions, provisional measures, and  
even criminal penalties, including imprisonment and severe economic  
losses. This could imply, for example, that suppliers of active  
pharmaceutical ingredients used for producing generic medicines;  
distributors and retailers who stock generic medicines; NGOs who  
provide treatment; funders who support health programs; and drug  
regulatory authorities who examine medicines. This could act as a  
significant deterrent to anyone involved in the production, sale and  
distribution of affordable generic medicines.

Given the possible impacts of the inclusion of patents the agreement  
on access to medicines and on innovation,  would the Commission  
consider accepting the exclusion of patents from the agreement as  
proposed by a number of  ACTA negotiating parties?  Will the  
Commission consider carrying out an impact evaluation of ACTA on its  
impact on access to medicine, generic competition and technological  

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