Initiative for Medicines, Access & Knowledge (I-MAK)
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The Initiative for Medicines, Access & Knowledge (I-MAK) is grateful for the opportunity to respond to the request for comments by the Department of Health and Human Services (HHS) for the Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs. I-MAK was established in 2006 with the mission to increase global access to affordable, lifesaving medicines. I-MAK is a team of lawyers, pharmaceutical scientists and health experts who are working to ensure people get the lifesaving medicine they need to survive and lead healthy lives. Today, people worldwide – including in the United States – are not receiving the lifesaving treatment they need due to skyrocketing prices.
Introduction
I-MAK welcomes the Administration’s intention to address the epidemic of high drug prices that is keeping affordable health care out of reach of millions of Americans. As an organization working to ensure affordable access to medicines in the United States and around the world, we believe only by taking far-reaching measures that generate sustainable drug development across the biomedical sciences will relief be provided to households and payers in the public and private sector. One-in-four Americans report difficulty filling a prescription for themselves or family members,[1] and a majority of Americans believe that taking action to lower prescription drug prices should be a top priority for Congress.[2] Since 2008, the cost index for branded drug prices has nearly tripled,[3] and by 2025 prescription drug spending nationally is poised to double again.[4]
Today, our policy makers and news outlets focus their attention on the exorbitant prices set by pharmaceutical manufacturers. Yet, insufficient attention is paid to how drug manufacturers are able to set prices at levels that are unaffordable to most, and how they are able to increase the prices of medicines as a means to increase revenues, even after a particular product has been on the market for many years. For example, just this month (July 2018), Pfizer made international headlines when it chose to arbitrarily raise the price of one hundred of its medicines in the United States[5], after having acted in a similar fashion in 2017.[6] Thus, even with the glare of the media, public and now the Administration, drug manufacturers continue to set high prices with impunity and indifference.
I-MAK’s years of research and successful legal challenges show that all too often, drug manufacturers hold unmerited patents on old science. This enables a few manufacturers to corner the market on entire diseases, artificially inflating the price of treatment, and blocking access to affordable generic drugs for decades. We believe America is facing two inter-related challenges: a drug pricing crisis and a patent system that is excessively tilted in favor of pharmaceutical manufacturers over patients. Pharmaceutical manufacturers secure scores of patents to protect and extend their market monopolies, far in excess of what is needed to incentivize drug development. Abuse of the patent system is directly linked to skyrocketing drug prices: by gaming the patent system with tactics such as ever-greening[7] and settlement agreements, pharmaceutical manufacturers delay generic competition and keep affordable medicines out of reach for many Americans. We believe that policy makers will only be able to curb the epidemic of runaway drug prices in the United States if they address the root cause: the underlying abuse and misuse of the patent system by pharmaceutical manufacturers.
Our response is divided into three sections:
- Seek to respond to the framework outlined by HHS in the Blueprint, and to some of the recommendations and questions;
- Provide evidence of how pharmaceutical manufacturers are abusing the patent system; and its impact on drug prices, and recommendations for how the Administration and the federal government can curb such patent abuse;
- Respond in particular to the Administration’s concerns with ‘foreign freeloading’ as both a cause and consequence of high drug prices in the United States.
