New EU custom regulation might allow wrongful seizures of generic drugs in transit, NGOs say

Regulation N° 608/2013 [pdf] of the European Parliament and of the Council of Europe, of 12 June 2013, repeals Council Regulation N°1383/2003 [pdf ].

In 2008, shipments of legitimate generic medicines transiting through Europe were detained by customs authorities on allegation of intellectual property rights infringement. Some 17 shipments were detained, 16 from India and 1 from China (IPW, Public Health, 5 June 2009). The medicines were not patented in the source or destination countries, and were supposed to be just passing through Europe.

In response, India requested dispute settlement consultations on 11 May 2010 at the World Trade Organization with the European Union and the Netherlands, where the shipments were detained. Brazil, Canada and Ecuador joined the consultation on 28 May 2010, and China, Japan and Turkey on 31 May 2010. The dispute remains to this day at the consultation level.

At issue was Regulation N° 1383/2003 which, according to Act-Up Paris, “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.” The updated version of the EU regulation was expected to solve the issue, but a number of civil society actors say it might not be the case.

New Regulation Still a Problem?

Act-Up Paris, in a July column said the new regulation does not solve the problem. The regulation, they said, “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.”

The group deplores that the EU did not take into account the December 2011 Court of Justice of the European Communities’ decision which 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,” they said.

“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,” they added.

“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,” according to Act Up-Paris. The group urged “the European Parliament and the Council of the European Union to make Regulation 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.” TRIPS refers to the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights.

For Prof. Book Baker from the Northeastern University school of law (US), who is a senior policy analyst for Health GAP (Global Access project, the EU regulation continues to cover alleged patent and also civil trademark disputes, ”where the name of a medicine, its packaging or its trade dress might be confusingly similar to a rightholder’s.”

“Assessment of the likelihood of these infringements … is virtually impossible for customs officials. Indeed, they are extraordinarily difficult even for highly trained judges,” he told Intellectual Property Watch.

Furthermore, he said, the new regulation permits seizure of any good subject to customs supervision or control, including goods in transit. “However, goods-in-transit, by definition, are goods intended for trans-shipment to another country. The patent or trademark status of such good in the EU is essentially irrelevant to their legality,” he said.

“The in-transit medicines are not intended for commercialization in EU territory and thus IP-status according to the national law of EU countries should be irrelevant, but it is not.”

Introductory Paragraph 11 of Particular Concern

The introductory paragraph 11 of the new regulation refers to the 2001 Doha Declaration on TRIPS and Public Health, he said, but the regulatory language of the directive does not, he said.

The language of paragraph 11 “is woefully inadequate,” according to Brooks, “to satisfy the rules set forth by the European Court of Justice (Philips and Nokia cases, 1 December 2011, joined cases C-446/09 and C495/09″.

In those cases, he said, the ECJ “provided explicit and clear rules on the scope of enforcement of EU IPRs by customs authorities on goods passing in transit: seizure or suspension is not allowed without a preliminary finding based on ‘clear and convincing evidence of a substantial risk of diversion’.” The burden is on the right holder to provide clear and convincing evidence of a substantial risk of diversion, he said.

The risk of diversion means that there is a risk that some of the shipments may be destined to other countries than the country of destination, in this case Europe. Paragraph 11 falls short of codifying “the full rule set forth by the ECJ,” he said. The regulation, he said, “fails to give customs officials proper guidance on the legal rules set forth by the ECJ.”

Paragraph 11 states: “Under the ‘Declaration on the TRIPS Agreement and Public Health’ adopted by the Doha WTO Ministerial Conference on 14 November 2001, the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all. Consequently, in line with the Union’s international commitments and its development cooperation policy, with regard to medicines, the passage of which across the customs territory of the Union, with or without transhipment, warehousing, breaking bulk, or changes in the mode or means of transport, is only a portion of a complete journey beginning and terminating beyond the territory of the Union, customs authorities should, when assessing a risk of infringement of intellectual property rights, take account of any substantial likelihood of diversion of such medicines onto the market of the Union.”

Tessel Mellema, policy advisor for Health Action International, shared the concerns. “The earlier Customs Regulation lacked clarity on the circumstances under which customs authorities were allowed to seize medicines in-transit. This lack of clarity led to several seizures of generics passing in-transit,” she told Intellectual Property Watch.

Paragraph 11 “seems to imply that this ‘risk of diversion’ is only one but not necessarily a key factor, where instead it should be a precondition before any decision about detention of medicines in-transit can be made,” she said.

That pre-condition should have been included clearly in the body of the new regulation, she said, “and not merely in a Recital [introductory paragraph] because without it, the regulation fails to adequately deal with the risk of illegitimate seizure of generic medicines at the EU borders,” she said.

“Most border measures are far-reaching, such as the so-called simplified procedure in Article 23 of the new Regulation,” Mellema said. “This allows for the destruction of goods detained at the border without having established whether they are infringing, and without explicit consent of the right holder.”

“This waiver of procedural guarantees should only, and even then arguably, be applicable in cases of counterfeit trademarked goods where there is a health and safety rationale for such waiver, and where risk of misuse and misjudgement by customs authorities is more limited as the analysis involves a less complex legal assessment,” she said.

EU Says New Regulation Meets the Needs

The EU is standing by its new regulation. “The EU fully respects its international commitments on access to medicines. Every effort has been made through the new legislation to ensure that generic medicines in transit to travel smoothly on to their final destination,” an EU official said.

“When developing and agreeing the new Regulation, particular attention was given to addressing the concerns of developing countries with regard to generic medicines in transit. Provisions which had previously created uncertainty and led to detentions of generic medicines in transit, have been removed from the EU rules and new provisions have been included to allow medicines in transit to flow smoothly to their final destination and to identify, and report on, any unexpected adverse effect that those rules might have on transit of legitimate medicines across the EU territory,” he told Intellectual Property Watch.

“Over the past 4 years, no cases of EU customs detaining generic medicines in transit have been reported,” he said.

A Brazilian official told Intellectual Property Watch that the country had acknowledged the new regulation and was waiting and watching to see how it would be implemented.

Source: Intellectual Property Watch