Regulation (EU) No 528/2012 of the European Parliament and of the CouncilShow full title

Article 63 U.K. Compensation for data sharing

1. Where a request has been made in accordance with Article 62(2), the prospective applicant and the data owner shall make every effort to reach an agreement on the sharing of the results of the tests or studies requested by the prospective applicant. Such an agreement may be replaced by submission of the matter to an arbitration body and a commitment to accept the arbitration order.

2. Where such agreement is reached, the data owner shall make all the scientific and technical data related to the tests and studies concerned available to the prospective applicant or shall give the prospective applicant permission to refer to the data owner’s tests or studies when submitting applications under this Regulation.

3. Where no agreement is reached with respect to data involving tests or studies on vertebrates, the prospective applicant shall inform the [F1 competent authority] and the data owner thereof, at the earliest one month after the prospective applicant receives the name and address of the data submitter from the [F1 competent authority].

Within 60 days of being informed, the [F1 competent authority] shall give the prospective applicant permission to refer to the requested tests or studies on vertebrates, provided that the prospective applicant demonstrates that every effort has been made to reach an agreement and that the prospective applicant has paid the data owner a share of the costs incurred. Where the prospective applicant and data owner cannot agree, national courts shall decide on the proportionate share of the cost that the prospective applicant is to pay to the data owner.

The data owner shall not refuse to accept any payment offered pursuant to the second subparagraph. Any acceptance is without prejudice, however, to his right to have the proportionate share of the cost determined by a national court, in accordance with the second subparagraph.

4. Compensation for data sharing shall be determined in a fair, transparent and non-discriminatory manner, having regard to the guidance [F2 either specified or referred to by the competent authority]. The prospective applicant shall be required to share only in the costs of information that it is required to submit for the purposes of this Regulation.

5. An appeal may be brought, in accordance with Article 77, against decisions of the [F3 competent authority] under paragraph 3 of this Article.

Textual Amendments

F1 Words in Art. 63(3) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 109(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 63(4) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 109(b); 2020 c. 1, Sch. 5 para. 1(1)

F3 Words in Art. 63(5) substituted (31.12.2020) by The Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/720), reg. 1(2), Sch. 2 para. 109(c); 2020 c. 1, Sch. 5 para. 1(1)