Delinkage as a Solution for Access to Pharmaceuticals

By: Fred Jankilevich

Lawyer / Consultant

December 6th 2017


Our health care system has an unwanted reputation for exorbitant medical bills. A few years ago, producer Michael Moore made it a point that most Canadians don’t cross the border without traveller’s insurance because of the exorbitant American cost of getting sick.


The Health Care reform has been one of the key issues between Democrats and Republicans for decades. Obama’s Obamacare was landmark, specially in terms of Medicare and Medicaid, but policymakers in the present still struggle with the production cost of and access to pharmaceuticals among the several other matters that the healthcare reform has ensued over the subsequent years after Obamacare. As a result, this week at Harvard visiting scholars discussed Delinkage as a viable alternative to further reduce costs and improve the efficacy of the system to healthcare service receivers.


Delinkage is extrapolated from the European model in the sense that European countries have a disconnect between EMA approval and insurance coverage. These technologies can be produced to the extent that there can be a reduction to access, pricing and production of information.


The traditional view between the FDA and CMS is that CMS has the purpose of providing access to drugs. American Policymakers have implemented a nationalized version of this European model recently. The policy reform was executed under this Commonwealth by utilizing limited evidence of clinical efficacy as a foundation for the model. The procedure accelerates the approval pathway for instances where insufficient evidence and/or surrogate endpoints exist. Thus, Delinkage on the basis of evidence instead of cost is prioritized.

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