229. The representative of the European Union said that access to essential medicines for developing countries was of utmost importance to his delegation. This explained why it had taken an active part in the negotiations that had led to the 2003 waiver decision and to the TRIPS amendment. Subsequently, it had taken the necessary steps to implement the Paragraph 6 System at the EU level and to accept the amendment. He stressed the need to make the System work, as well as the fact that his delegation was committed to do so. Rather than reopening a debate on the System as a whole, it was important to have a focused discussion within the framework of the Council's annual review. To that extent, the list of issues for discussion which the Chairman had circulated was helpful. However, his delegation was disappointed about the debate, as it had hoped to learn more about the reasons why the developing countries for whom the System had been designed, apart from Rwanda, had not used it. He disagreed with those Members that claimed that the operation of the System would be hindered by legal, procedural, commercial and other obstacles. There were few conditions required for the System to work properly.
230. Several reasons could explain why the System had not been used more often. These included the fact that 90 per cent of essential medicines were in the public domain. Least developed countries were also not obliged to implement any TRIPS obligations with respect to patents and test data protection in the area of pharmaceuticals until 1 January 2016. Moreover, there were other channels developing countries could use to get access to cheap medicines, including, for instance, through the use of existing TRIPS flexibilities and direct negotiation with pharmaceutical companies. The Paragraph 6 System was equally effective when it was used as when it was not used due to its effect as both a negotiating chip and a strong deterrent. It would be interesting to hear more about the System's impact on negotiations and on pricing since it had been put in place.
231. In his delegation's view, those who criticized the System as being too burdensome without real life experience of the matter were discouraging developing countries from using an instrument which could help them secure access to affordable medicines. Positions taken by some countries like Ecuador who had said that they would not accept the System were unfair, since those countries had domestic manufacturing capacities that other countries that really needed the System lacked.
232. In response to the questions which the delegation of Ecuador had addressed to his delegation, he said that it was not clear whether those were meant to demonstrate how the System had been put in place or whether they were addressing an unrelated matter, such as the use of compulsory licences under normal circumstances. He clarified that, in any event, European countries were not using the System as importers. Addressing those issues would require some research, but his delegation would be prepared to do so under the relevant agenda item.
