MAQUINARIA PARA EL MOVIMIENTO DE TIERRAS.

Page 13 - Paragraphs 3.17, 3.20 and 3.21

Questions:

51. In FTAs between the EU and developing countries, does the EU seek to establish intellectual property provisions that limit in any way the flexibilities contained in the TRIPs Agreement, such as compulsory licenses?

EU reply: No, the EU does not introduce IP provisions in its FTAs with developing countries that limit the flexibilities in the TRIPS Agreement including as regards compulsory licenses.

52. If so, how does the EU explain the compatibility of such provisions and the Doha Declaration on TRIPs and Public Health?

Irrelevant given that the reply to the above question 51 is negative

53. In FTAs between the EU and developing countries, does the EU seek to establish intellectual property provisions that restrict in any way the flexibilities in the TRIPs Agreement regarding data exclusivity protection for pharmaceutical products?

EU reply: In several FTA's, the EU and its Partners have agreed to implement the TRIPS data protection obligation through the definition of a period of exclusivity during which third parties cannot rely on the data submitted by the originator. This is, for instance, in line with the way Brazil implemented this obligation for agro-chemical products.

54. If so, how does the EU explain the compatibility of such provisions and the Doha Declaration on TRIPs and Public Health, as such measures would delay the registration of generic drugs?

EU reply: The European Union specifically addresses the respect of the Doha Declaration on the TRIPS Agreement and Public Health in the IP Chapters of its FTAs with developing countries, which include a provision ensuring the consistency of its IPR provisions with such Declaration. Regarding an alleged delay in the registration of generic drugs, the EU points out that, in the overwhelming majority of cases, the data exclusivity protection expires before the patent protection and therefore has no effect on the entry into the market of generics.

55. In FTAs between the EU and developing countries, does the EU seek to establish intellectual property provisions that allow for patentability of modifications and "new use" of pharmaceutical inventions (also know as "evergreening" of patents)?

EU reply: No, in its FTAs with developing countries, the EU does not seek to establish IP provisions that allow for the "new use" of pharmaceutical inventions.

56. If so, does the EU recognize the impact of such provisions on the price of medicines (as established in paragraph 3 of the Doha Declaration on TRIPs and Public Health?

EU reply: Irrelevant as answer to Q 55 is negative

57. In FTAs between the EU and developing countries, does the EU seek to establish intellectual property provisions that allow for extension of the patent term of protection? EU reply: In a number of FTAs, the EU and its Partners agreed on the possibility of an optional mechanism, in accordance with the domestic legislation of the Parties, to compensate the patent owner of a product that is subject to a marketing approval for the unreasonable curtailment of the effective patent term resulting from the marketing approval of that product.

58. If so, how does the EU explain their compatibility with the Doha Declaration on TRIPs and Public Healh and, in particular, the impact of such provisions on the price of medicines (as established in paragraph 3 of the Doha Declaration on TRIPs and Public Health)?

EU reply: The European Union specifically addresses the respect of the Doha Declaration on the TRIPS Agreement and Public Health in the IP Chapters of its FTAs with developing countries, which include a provision ensuring the consistency of its IPR provisions with such Declaration. Furthermore, the European Union considers that such supplementary protection provides an important encouragement to pharmaceutical research, thus playing a decisive role in the continuing improvement to public health

59. In FTAs between the EU and developing countries, does the EU seek to establish intellectual property provisions establishing stricter rules for enforcement of patent products?

EU reply: No, the enforcement rules in FTAs apply to all IPR in the same manner.

60. Do such rules allow for customs officers to apprehend pharmaceutical products in transit? EU reply: In a certain number of FTA's, the parties agreed that customs authorities must be empowered to temporarily detain goods, including when goods are claimed to be in transit, when they have grounds for suspecting that there is an infringement of trademarks or copyrights. These measures also exist in Brazil. There are no specific references to the case where the product suspected of such infringements would be a pharmaceutical.

61. If so, how does the EU explain the compatibility of such provisions with the Doha Declaration on TRIPs and Public Health, as they would affect the access to drugs?

EU reply: The European Union specifically addresses the respect of the Doha Declaration on the TRIPS Agreement and Public Health in the IP Chapters of its FTAs with developing countries, which include a provision ensuring the consistency of its IPR provisions with such Declaration. The EU does not envisage the possible detention of a pharmaceutical product suspected of trademark counterfeiting as being incompatible with the Doha Declaration.

Page 16 - Paragraph 3.41

Regulation (EU) No 978/2012, which establishes a revised General System of Preferences, eliminates the benefits of the System for Members classified by the World Bank as "High Income" or "Medium High Income" countries. In doing so, the EU adopted criteria based on income as a proxy for level of development.

Question:

62. Could the EU explain how such criteria conform to the requirements of the Enabling Clause?

EU reply: The criterion conforms to the requirements of the Enabling Clause as it responds to the 'development, financial and trade needs' of developing countries.

GSP shall respond to the needs of developing countries, to enhance exports and, as a result, economic growth—which is typically measured by income. Different levels of income signal different needs by partners and elicit a differentiated response by GSP.

The income criterion used by the EU's revised GSP is based on the World Bank's GNI per capita, Atlas method. In line with the principles of the Enabling Clause, this is an objective, internationally accepted and widely used indicator which every year defines categories of countries and reflects different needs to which GSP responds.

The EU claims that with the revised GSP "preferences have been focused on 89 countries in greatest need".

Question:

63. Could the EU explain how such claim can be reconciled with the results of the impact assessment for the revised GSP, which anticipate a reduction in exports from LDCs? EU reply: Actually, the impact assessment forecasts a significant improvement of the situation of LDCs and countries most in need. The results of the impact assessment imply that the impacts of preference erosion are reduced. In addition, dynamic effects will cause the exports figures to increase further as additional opportunities arise given the deferral of preferences for key competitors.

Page 17 - Paragraph 3.43

Regulation (EU) No 978/2012 modifies the graduation mechanism of the GSP. Question:

64. Could the EU inform whether the new mechanism results in more or less countries and sections being graduated, in comparison with the previous version of the system?

EU reply: A quantitative comparison between the two systems is hardly significant, since the current one defines 21 'GSP Product Sections' while the revised system defines 32 of them, in order to ensure more objectivity. Plus, the two systems rely on a set of import data that cover two different periods (current: 2006-08; revised: 2009-11). For information, the current system graduates 18 sections from 6 different countries. The revised one graduates 43 sections from 8 different countries.