Canada/EU draft agreement on Data Protection on Plant Protection Products and Rules on Avoidance of Duplicative Testing

From the March 23, 2010 version of the leaked chapter on Intellectual Property in the proposed Canada – EU Comprehensive Economic Trade Agreement.

While the entire Canada/EU agreement is important, there is particular interest in the EU proposals in Article 11, concerning “Data Protection on Plant Protection Products and Rules on Avoidance of Duplicative Testing.” Following lobbying by animal rights groups, the European Union is essentially ending data exclusivity in areas where the tests are duplicative, and violate ethics standards involving tests involving vertebrate animals. This agreement has been emulated also in legislation proposed by Senator Sanders in the U.S. Congress (S. 3921, 111th Congress), concerning ethical pathways for the registration of new drugs and vaccines.

The rules on the Avoidance of Duplicative Testing are paragraphs 7 to 11.

[EC: Article 11
Data Protection on Plant Protection Products and Rules on Avoidance of Duplicative Testing

1. The Parties shall determine safety and efficacy requirements before authorising the placing on the market of plant protection products.

2. The Parties shall recognise a temporary right to the owner of a test or study report submitted for the first time to achieve a marketing authorisation for a plant protection product.

During such period, the test or study report will not be used for the benefit of any other person aiming to achieve a marketing authorisation for plant protection product, except when the explicit consent of the first owner is proved. This right will be hereinafter referred as data protection.

3. The test or study report should fulfil the following conditions:
(a) be necessary for the authorisation or for an amendment of an authorisation in order to allow the use on other crops, and
(b) be certified as compliant with the principles of good laboratory practice or of good experimental practice.

4. The period of data protection should be ten years starting at the date of the first authorisation in that Party. In case of low risk plant protection products the period can be extended to 13 years.

5. Those periods shall be extended by three months for each extension of authorisation for minor uses/fn7/ if the applications for such authorisations are made by the authorisation holder at the latest five years after the date of the first authorisation. The total period of data protection may in no case exceed 13 years. For low risk plant protection products the total period of data protection may in no case exceed 15 years.

6. A test or study shall also be protected if it was necessary for the renewal or review of an authorisation. In those cases, the period for data protection shall be 30 months.

7. Rules to avoid duplicative testing on vertebrate animals will be laid down by the Parties. Any applicant intending to perform tests and studies involving vertebrate animals shall take the necessary measures to verify that those tests and studies have not already been performed or initiated.

8. The new applicant and the holder or holders of the relevant authorisations shall make every effort to ensure that they share tests and studies involving vertebrate animals. The costs of sharing the test and study reports shall be determined in a fair, transparent and non-discriminatory way. The prospective applicant is only required to share in the costs of information he is required to submit to meet the authorisation requirements.

9. Where the new applicant and the holder or holders of the relevant authorisations of plant protection products cannot reach agreement on the sharing of test and study reports involving vertebrate animals, the new applicant shall inform the Party.

10. The failure to reach agreement shall not prevent the Party from using the test and study reports involving vertebrate animals for the purpose of the application of the new applicant.]

11. The holder or holders of the relevant authorisation shall have a claim on the prospective applicant for a fair share of the costs incurred by him. The Party may direct the parties involved to resolve the matter by formal and binding arbitration administered under national law.

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fn7 Minor use: use of a plant protection product in a particular Party on plants or plant products which are not widely grown in that particular Party or widely grown to meet an exceptional plant protection need.

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