In accordance with the common registration principle, companies that register the same substance must share data. However, disputes can arise over data access and cost sharing.
Solution approach: based on fair, transparent and non-discriminatory cost sharing principles; documenting the true cost and scope of data; keeping records of negotiations; to consider alternative strategies, such as temporary registration, if necessary.
ONAY Mühendislik represents your company in data sharing negotiations and provides the most appropriate solution.
Typical Sources of Disputes
Data sharing disputes generally fall under three headings: how to share the cost of existing studies, what data is actually needed, and what the scope of access permission will be. In addition, how to carry past testing expenses to today's value is a frequently discussed issue. Most disputes arise from not having the rules written down at the initial stage of the forum.
Fair and Transparent Cost Sharing Principle
Legislation requires data owners to share on fair, transparent and non-discriminatory terms. This requires that the price requested must be justifiable. A lump sum price offer that is not broken down by item is an offer open to objection. The requesting party is also expected to clearly demonstrate which data they need and why.
Recording Correspondence
When the dispute is brought to the institution, the basis for evaluation is the correspondence between the parties. Therefore, all requests, offers and reasoned objections must be made through dated written communication. It is not possible to prove that the processes are carried out in good faith and are not written down in writing.
Procedure When No Solution Found
If an agreement cannot be reached despite the parties making reasonable efforts, the requesting party may report the situation to the competent authority. If the institution is satisfied that the necessary care has been taken, it may allow reference to relevant studies. This way prevents the recording from being blocked indefinitely; However, the notification must be supported by complete documentation.
Avoiding Conflict in the First Place
The most effective method is to have the cost sharing model, decision-making procedure and scope of access permission linked to a written memorandum of understanding as soon as the forum is established. Defining the retroactive calculation method for newly joined members in the same text eliminates the debate on the bargaining power of the subsequent parties.
Rewriting Data Sharing Rules
Most disputes arise from Data Sharing rules not being written down when the forum is established. The cost sharing model, decision-making procedure, calculation method for subsequent participants and scope of access permission should be defined in the initial memorandum. It is equally important that Data Sharing discussions are conducted via dated correspondence.
Related pages
Contact ONAY Mühendislik for your process.
Official full text of the regulation: KKDIK Regulation - Official Gazette.