Threat on generic medications, the European Union ignores it

Source: Act up Paris

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 checked.
-  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.

Notes

[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…

[3] REGULATION (EU) No 608/2013 OF THE EUROPEAN PARLIAMENT AND OF THE 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…

This entry was posted in Generics, IP Rights, Patents, TRIPS, TRIPS plus and tagged , . Bookmark the permalink.

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