Design a fit-for-purpose regulatory framework for Value Added Medicines

VAMs are based on existing, approved molecules, whose efficacy and safety have already been thoroughly evaluated. Existing regulatory frameworks don’t offer a clear way to build on existing evidence, and developers may waste resources and face additional complexity by using a suboptimal pathway. A fit-for-purpose pathway would cut down on costs and hurdles for continuous innovation.

Recognize VAM as a category of innovation with proportionate incentives

Currently, developers of new, innovative medicines as well as manufacturers of off-patent medicines are offered certain IP protections as an incentive to bring products to market. Since the current framework does not recognize VAMs, there is no equivalent IP protection that serves as an incentive proportionate to the costs of bringing a VAM product to market. To enable developers to invest in VAM, we support recognition of VAM as a separate category of innovation with proportionate incentives.

Recognize and define the value of VAM for healthcare systems

Systems for medicine pricing and reimbursement vary across Europe, but generally incorporate an assessment of a medicine’s value. Many health systems do not differentiate between VAM and generics, since they are both based on existing molecules. The lack of any process to recognize the additional value of VAM and acknowledge the additional development costs compared to a generic leads to the undervaluation of VAM. Without any mechanism to price VAMs differently than generics, it may not be viable for manufactures to invest in their development.