Richard Bruton (Dublin North Central, Fine Gael)
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To allow a product to be approved to a standard, one needs a body to vet that this standard is being achieved. However, I will revert to the Deputy on whether there are cases in which Ireland has different standards from the European Union. In general, however, if an organisation comes to Ireland to produce a medical device, it will seek to get approval in Ireland but will want that approval to carry to the other 27 member states. It will not wish to have approval just in Ireland and to be unable to go any further with the product. While what regulators do is to approve to a standard, the hope is that if both the European Union and the US have certain expectations of a product and have a certain way of measuring the extent to which those expectations are being met, we will accept each other's measurements of where the product is on the spectrum.

It is not that we would seek to reduce the cut-off point but that we would not require a measurement that has already been done through, say, clinical trials, to be repeated at significant cost. It would also mean that regulators would have similar vetting procedures over time. Having similar procedures in place allows for more opportunity for mutual recognition and reduced costs. There is no intention to dilute public policy in this regard.

The reason food is not included in these negotiations is because it is one of the most contentious areas. It was very contentious in the negotiations of the EU-Canadian partnership but agreement was reached in the end with greater access for European dairy products to the Canadian market and Canadian beef products to European markets. This will be a hotly contested area and the stakeholders include those in primary production.

The European Commissioner for Trade, Karel De Gucht, will conduct the negotiations along with his directorate-general and the Directorate-General for Agriculture and Rural Development. Their staff are drawn from across the European Union, not from one nationality - the trade Commissioner is Belgian - and they report weekly to the trade policy committee which is made up of officials from member states. Mr. Gerard Monks is our representative on that committee. The negotiators work on a mandate from the Council and report back to it. Under European treaties, it is the Commission which negotiates trade agreements, not member states. Every country, accordingly, ensures its interests are represented in negotiations. When we negotiated the mandate, the specific issue around the recognition of cultural exceptions and diversity, a point which one would want to protect in any trade negotiations, was raised which caused disagreement across member states and had to be brokered.

The general European view is that we struggle for growth in the Union while up to 90% of future growth in the world economy will be outside of it. Accordingly, we need trade agreements with growth economies such as the US, Japan, Korea, India and so forth. Long-term European economic growth will be boosted if we can negotiate trade agreements. Overall, it is reckoned that an additional 2% of gross domestic product could be obtained from such agreements with potential partners.

They have to be two-way agreements with mutual gains on both sides or else states will not sign up to them. They are about bringing down barriers on both sides to ensure equal benefit to both. There is a complaints mechanism if signatories feel the rules are not being applied.

Deputy Kyne asked why now. It is the growth issue and the need for Europe to rebuild its economy. Many European internal economies are going through fiscal correction and are not dynamic growth markets. Clearly, there is an interest in the EU to getting better access to trading in other parts of the world where there is greater growth.

There will be no change in European policy on GM, genetically modified food, while the complete ban on hormone-treated beef and other meat will remain.

Progress in world trade negotiations on multilateral trade agreements has been virtually non-existent for the past decade. In the Indonesian round last year, there were some modest changes. That is why there have been more of these bilateral trade agreements. If Europe starts to negotiate bilateral agreements, will it have an adverse effect on other trading partners, third countries? Research showed it did not and that there were more growth opportunities than a displacement effect for third countries.