Translation of "Accord d'exclusivité " (French → English) :

In the absence of prior informed consent having been obtained in a timely manner and mutually agreed terms having been established, and until an agreement is reached with the provider country concerned, no exclusive rights of any kind will be claimed by such a user to any developments made via the use of such pathogens.

2. However, where an exclusive right is necessary for the provision of a service in the public interest, the validity of the exclusive rights arrangement shall be subject to regular review by the authority referred to in Article. 4(4), and shall, in any event, be reviewed every three years.

For many years, bilateral agreements have had an exclusivity clause to prevent private agreements in countries where the EU has a bilateral one, though the exact terms of these clauses vary with the agreement.

16. Calls on the Commission to exclude language providing for data exclusivity from the Agreement; neither party should be required to change existing regimes to provide protection of clinical trial data generated by pharmaceutical companies to gain market approval for new medicines; India in particular should not have to introduce any term of data exclusivity, given the impact this would have on access to generic medicines in India and across the developing world;

Your Rapporteur encourages South Africa to use the so-called flexibilities built into the TRIPS Agreement in order to be able to provide essential medicines at affordable prices, such as compulsory licences and the mechanism provided by Article 30 thereof, and insists that the EU should not negotiate pharmaceutical-related TRIPS-plus provisions affecting public health and access to medicines, such as data exclusivity, patent extensions and limitation of grounds of compulsory licences.

He has called upon the Commission to provide a comprehensive annual report on the implementation of the Agreement - together with the Protocol and the Annexes, which form an integral part thereof - in order to enable Parliament to assess more effectively and with greater transparency whether or not the various objectives stated in the Agreement have been achieved, whether or not the Agreement is fully operational, whether or not it acts in the interests of the parties involved and whether or not it is cost-effective for the Community and its fisheries sector. This will afford the sector greater legal security, including monitoring of the applicati ...[+++]on of the exclusivity clause laid down in the Agreement (Article 6) in order to ensure that other parties are not offered (by means of private agreements) opportunities to fish for high-commercial-value species which are withheld from the Community under the public Agreement on the pretext that resources have to be conserved.