Advice on Data Access Negotiations
Advice on Data Access Negotiations
Kerona Scientific recently hosted their third virtual Biocides Symposium in March 2023, featuring Gerard McElwee, Partner at Fieldfisher in Brussels, as a guest speaker. Gerard’s presentation provided insights into the various aspects involved in data access negotiations under the BPR, including the types of data which may be accessed, where to source this data, general data protection timelines under the BPR, the general process of data access negotiations, and other considerations/legislative amendments set to have an impact on data access under the BPR.
During his presentation, Gerard touched on one of the very pressing topics currently facing the biocides industry, the expiration of the Review Programme hard stop date of the BPR on 31st December 2025. This expiration implies that post-2025, any company will be able to refer to the unprotected data in Article 95 applications under the BPR to ECHA or in support of their own active substance dossier. Applicants may also potentially rely on this data in applications for biocidal product authorisations (provided technical equivalence has been established).
Gerard also highlighted that at present, there are a growing number of active substances/products whose data protection under the BPR is beginning to expire, with a maximum of 15 years data protection being granted for data submitted with the approval of new active substances/products and 10 years in the case of existing active substances/products. In combination with the potential loss of data protection with the expiry of the Review Programme hard stop date, there is now the potential for a significantly larger amount of data to be available to access on the market. Historically, many applicants have not paid a great deal of attention to the data protection available for their active substances as under the early days of the BPR much of the generated data was under protection, and efforts were focused on organising data access negotiations with data holders. However, Gerard advised that applicants should now consider the potential for their required data to no longer be under data protection, allowing for the avoidance of lengthy negotiations with the data holders and the corresponding compensation costs. It should be noted that all data expiry is for citation access only and if applicants wish to obtain hard copies of unprotected data negotiations with the data holder may still be required.
Towards the end of Gerard’s presentation, he made note that there is currently an expectation that the Review Programme will be extended beyond this hard stop date of 31st December 2025. However, there is yet to be any clarification as to whether the period for data protection of all associated information under the Review programme will also be extended, thus leading to an ever-growing amount of uncertainty within the industry. In an attempt to address this uncertainty, data protection is to be discussed at CA meetings in the following months, with updates to follow.
If you missed the biocides symposium, a copy of all presentations is available on the Kerona website at the following link : https://kerona.ie/product/dublin-biocides-symposium-2021-speakers-presentations/
Our regulatory team can assist with your biocides applications in the European Member States and in GB. Please contact us at info@kerona.ie