ZOETIS
Zoetis discovers, develops, manufactures and commercializes veterinary medicines, vaccines and medicines and diagnostic products, which are complemented by biodevices, genetic tests and precision livestock farming.
ID: 564451610987-33
Lobbying Activity
16 Aug 2022
We welcome the objectives of this initiative with the goal to develop better access to chemicals data for safety assessments. We support to better streamline the flow of data on chemicals between different sector authorities/agencies (EU and national). We are however concerned about (unintended) consequences and impact which will not have been investigated in a proper impact assessment.
The key points we would like to emphasise in this consultation are:
1. The need to support investment in R&D and innovation in the EU, to avoid disincentives to investment through by allowing lower market entry costs to commercial competitors free-riders. The EFSA Transparency Regulation is not a model to follow in its entirety because the application data file is disclosed to the wider public prior to product approval, deterring companies from launching products in the EU first. Re-use of data should be limited to authorities, not to private enterprises.
2. The need to support investment in R&D and innovation in the EU by not undermining trade secret protection law, intellectual property rights and regulatory data protection and recognise the important monetary value of both new data and legacy data.
3. The transparency of data is important, but it is critical that the information contain appropriate context to avoid misinterpretation and misuse of data, and that confidential data is not made public which could negatively impact innovation.
4. The need to rigorously pursue the EC objectives through better regulation initiatives to reduce the administrative burden on EU business and agencies. This initiative appears to propose additional reporting and notification requirements while claiming not increase admin burden.
5. The need to bring efficiencies through harmonisation of rules, while respecting better regulation principles (meeting regulatory aims through measures that least impact commercial enterprise) and not taking the path of least resistance by adopting the highest common denominator without solid justification.
6. The need to respect better regulation principles through impact assessments; this initiative potentially will have significant impacts on business in the EU, and the statements to the contrary in the ‘Call for evidence’ need to be fully substantiated with evidence.
Consequently, we urge the Commission to invest more time to evaluate the impact and long term consequences of this horizontal legislative initiative on access to data together with stakeholders. We would also appreciate to be involved in the targeted stakeholder consultation, as we would like to constructively contribute to this initiative.
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