3.10 Efficient regulatory data protection neccesary
Licensing by the authorities of new medicinal products, new administration forms and new indications requires the production of very comprehensive documentation establishing a product’s efficacy and safety. Efficient documentation protection is essential for protecting this research.
The new legislation, which generally provides a 10-year protection, creates new possibilities for data protection. Thus, it is now possible to obtain one year’s data protection for new indications, both in relation to new medicinal products and for well-known medicinal products. It is also possible to obtain one year’s data protection for switch to OTC.
However, the new rules create a need for transparency and explicit definitions as well as a need for the rights obtained by the companies being efficiently enforced.
Lif believes:
- that clear rules should be established for how the enterprises are to be informed of the new data protection legislation,
- that there should be transparent and explicit definitions with respect to the criteria for obtaining the new data protection,
- that the new scope provided by the act for data protection should be enforced in such a way that it is clear at all points when the possibility for substitution is limited and when full reimbursement is feasible.
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