[Ip-health] Act Up-Paris - Threat on generic medications, the European Union ignores it

Céline Grillon international at actupparis.org
Wed Aug 21 02:55:46 PDT 2013


Threat on generic medications, the European Union ignores it

EU has just modified its legislation on the customs control concerning  
the enforcement of “intellectual property” rights, not considering  
that it impedes the legitimate trade of generic medicines in  
Developing countries.

Generic medicines in transit seized

These past few years, several shipments of generic medicines routing  
through the EU have been seized under the pretext of infringing  
“intellectual property”, even though these medicines were not under  
patents in the source or destination countries. For example, a  
shipment of Losartan (medication used to treat high blood pressure),  
coming from India and headed to Brazil, was seized in Rotterdam. India  
and Brazil had then protested to the EU and World Trade Organization  
(WTO), denouncing repeated, abusive practices. As a matter of fact, in  
2008 alone, 17 shipments containing generic medicines were seized by  
Dutch authorities [1].

These seizures were carried out upon the European regulation CE No  
1383/2003 [2], initially meant to fight counterfeiting. This  
regulation allowed the customs from the EU member States to seize  
goods in transit suspected to infringe “intellectual property” rights,  
especially patents registered in Europe, without taking into account  
the fact that these rights may not exist without EU’s borders.

A new legislation that does not solve the problem

Last June, this regulation was abrogated and replaced with the  
regulation No 608/2013 [3]. Although EU should have taken this  
opportunity to exclude medicines in transit from the span of controls,  
the problem still remains in the new legislation. In fact, the new  
regulation continues to allow the seizing of goods over a simple  
suspicion of “intellectual property” infringement, without checking  
beforehand whether these goods are headed to the European territory or  
just in transit. At the most, the regulation is accompanied by an  
introductory paragraph explaining that, when customs estimate a  
potential patent infringement in a shipment of medicines, they must  
take into account the possibility for the shipment to be rerouted  
toward the European market [4]. Far from solving the problem, this  
paragraph only plants seeds of doubt, for any shipment of medicines in  
transit may be suspected of illegal rerouting.

The CJEC showed the way

In December 2011, the Court of Justice of the European Communities  
clearly stated that goods coming from a third-party State and harming  
a trademark or an author’s right protected within the EU, could not be  
described as “counterfeit goods” or “pirated goods” just by entering  
the customs territory of the EU [5]. This jurisprudence clearly shows  
that customs should first verify whether a  shipment is not simply in  
transit before checking that any “intellectual property” rights might  
have been infringed. It is a logical solution when considering that  
laws are not the same everywhere. The EU would have had a great idea  
if it had put this jurisprudence in the new regulation and if it had  
established a control of the goods’ destination beforehand.

The EU chooses to look away

The height of hypocrisy being that, in the article 37 of this  
regulation, it is provided for the Commission to present, by December  
31st 2016, a report concerning the putting in place of this regulation  
and notifying any “significant incident” regarding medicines in  
transit. This report will also estimate the potential impact of these  
incidents on the EU’s commitments on access to medication, as stated  
in the Doha Declaration on the TRIPS Agreement and Public Health [6].  
These incidents have already occurred, why wait three more years? By  
postponing the examination of difficulties encountered by generic  
medicines in transit on its territory, the EU shows that, if the  
matter is known, they do not consider finding a solution.

Yet, every seizure of generic medicines headed to South countries  
means treatments that will not reach the people who need them. In the  
case of HIV, if the medicines are not taken regularly at set times, it  
increases the chances to become resistant to the medicines and, thus,  
to resort to second- and third-line treatments, which are much more  
expensive and not always available in South countries. In the name of  
fighting counterfeiting and to protect its pharmaceutical industry,  
the EU puts the lives of million ill people at risk.

The EU does not fulfill its commitments towards access to treatments

In 2001, the Doha Declaration, signed by the EU, reminded the  
necessity to use the flexibilities that were provided for in the TRIPS  
Agreement (Agreement on Trade Related Aspects of Intellectual Property  
Rights), in order to grant universal access to medicines. The new  
regulation goes against the EU’s commitments by introducing provisions  
called TRIPS+, provisions that grant more rights and guarantees to  
patent holders.
   Goods contravening a patent may be controlled and seized, whereas  
in the TRIPS Agreement, only counterfeited goods (relating to  
trademarks) and pirated ones (relating to author’s right) can be  
   Customs intervention can occur on goods in transit, whereas the  
TRIPS Agreement states that only imported goods can be controlled.  
This point is particularly criticized by countries exporting generic  
medications such as India.

By allowing the checking and seizing of medicines in transit, and  
widening the span of controls to patent-related medicines, the EU is  
not only going further than what the TRIPS Agreement provides for, but  
also impedes the use of the flexibilities the South countries were  
granted. This legislation goes against the commitments taken by the EU  
regarding access to treatments.

Act Up-Paris demands that the European Parliament and the Council of  
the European Union make the regulation EU No 608/2013 consistent with  
the commitments taken by the EU regarding access to treatments, and  
this, by excluding medicines in transit from its scope of application.


[1] http://www.evb.ch/fr/p25016127.html

[2] COUNCIL REGULATION (EC) No 1383/2003 of 22 July 2003 concerning  
customs action against goods suspected of infringing certain  
intellectual property rights and the measures to be taken against  
goods found to have infringed such right http://eur-lex.europa.eu/LexUriServ 

COUNCIL of 12 June 2013 concerning customs enforcement of intellectual  
property rights and repealing Council Regulation (EC) No 1383/2003 http://eur-lex.europa.eu/LexUriServ 

[4] Regulation (EU) No 608/2013 §11

[5] CJEC, Nokia and Philips cases, December 1st 2011, cf. http://eurlex.europa.eu/LexUriServ/ 

[6] Declaration on the TRIPS agreement and public health adopted on 14  
November 2001 at Doha by the WTO Ministerial conferences http://www.wto.org/english/thewto_e 

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