How To Fix The Drug Pricing Crisis — And The Patent Problem Fueling It

Millions of Americans cannot afford the prescription drugs they need, and are forced to make difficult, even devastating, trade-offs as a result. Leading access-to-medicines changemaker Priti Krishtel, cofounder of I-MAK, shares more about the scope of the issue, the critical link to our patent system, and what corrective action can be taken at this juncture.

Ashoka: We’re hearing a lot these days about Americans not being able to afford drugs for their kids, parents, themselves – give us a sense for the scope of the problem and the difficult choices people are having to make.

Priti Krishtel: Drug prices are not just an economic issue, they are literally a matter of life and death: seniors put in the dangerous position of rationing their medication to make it stretch until their next Social Security check, parents having to crowdfund their child’s chemo co-pays .

Research from 2019 found that in the past five years, 1 in 8 of Americans have lost a loved one because they could not afford the cost of their medication. That figure is double for people of color. A Kaiser Family Foundation poll (Dec 2021) found that paying for out-of-pocket costs for medical care was difficult for a higher share of American adults (46%) than other expenses including rent or mortgage, gas or transport, utilities and food . The pandemic has only added to the pressure, with one-tenth of Black and Latino families and one-sixth of Indigenous families reporting the inability to afford prescriptions for a major health issue. Polling reflects that this is an issue that crosses party lines, with a bipartisan majority of Americans wanting to see Congressional action to lower the US’s exorbitant prescription drug prices.

Ashoka: What has happened specifically with patents in the past 20-30 years and how does this play in?

Krishtel: To put this issue in perspective, consider these stats – it took until 1991 for the US Patent and Trademark Office to issue its first five million patents. That’s 155 years from when the first patent was issued. Contrast that with the fact that in less than one fifth of that time, the PTO issued its next 6 million patents. It’s implausible that over half of all inventions in the history of the US patent system occurred in the last 30 years. In the last three decades, the largest private actors have become better at securing patents because our patent system is no longer stringent enough.

My organization, I-MAK, has done extensive research on how this plays out with pharmaceuticals. We evaluated the 10 top best selling drugs in 2019, and found companies file an average of 131 patents per medication, 2.5x more than filed on the same drugs in Europe and Japan. Over half of these patents are granted. This gives companies longer periods of patent protection and enables prices to rise exorbitantly. On the cancer drug Keytruda alone, we estimate Americans will pay $ 137 billion during the eight extra years of exclusivity granted through additional patents.

But all is not lost. There are many reasons to be optimistic that our leaders are taking these issues seriously. We rise at a Congressional hearing and saw our work on how patent gaming by pharmaceutical companies drives up drug prices cited extensively in the December 2021 House Committee for Oversight and Reform’s investigative report. We expect that drug pricing will be a key issue in the upcoming midterm elections, and are hopeful that we are on the cusp of meaningful reforms in the patent space.

Ashoka: Your organization has drawn attention to the need for the Administration to pick a USPTO head who will prioritize equity. The nominee has just been named, now what?

Krishtel: After several months of delaying a choice and at least one false start, President Biden recently named attorney Kathi Vidal as his nominee to head the PTO, and the Senate Judiciary Committee confirmed her. She will now go to the Senate for a full vote. This role is pivotal in influencing everything from global vaccine equity to our country’s drug pricing crisis. The latter is an issue that touches the lives of the two-thirds of Americans who rely on pharmaceuticals for everything from controlling blood pressure to battling cancer. Most Americans do not recognize that, as PTO head, Vidal will oversee a patent system that is being gamed at the expense of patients.

She is now presented with the choice to uphold the status quo of protecting business over consumers, or she could drive meaningful progress toward transparency and public participation in one of our most important – but often overlooked – government agencies.

My organization has put forward a 10-point list of recommendations to increase equity in the patent system based on our decades of work in this space that we are hopeful she will adopt.

Ashoka: Your organization also launched a new process to bring more transparency to the patent system. What are you hoping to achieve and how will you do it?

Krishtel: Given our decades of work in the patent world, we’ve developed a new system to reform the system called Participatory Changemaking. It will serve as a “360” assessment of the patent system, engaging stakeholders from several categories from patent judges to patients to business leaders. The process is grounded in the values ​​of robust public participation and the inherent dignity of every individual.

We just launched our Strengthening Competition Blueprint, which outlines several recommendations for how to strengthen a competitive market through patent and drug regulatory reforms. Making challenges to weak patents less cumbersome, amending outdated legislation to spur earlier generic drug entry into the market, and information sharing between the agencies are some of our key recommendations.

This latest set of reforms follows our initial Public Participation Blueprint, which focused on how to integrate public voices into the patent system. We were thrilled that shortly after that release, the PTO took up the recommendation that we and many others in the space have been requesting for years in appointing the first representative of the broader public to the agency’s Patent Public Advisory Committee.

Through our participatory changemaking efforts, we hope to drive forward democratization of the patent system by bringing together different stakeholders in the process with the ultimate goal of shifting the power dynamics of the patent system, including ensuring the PTO is not just an exclusive club for the few – but a true public agency.

Ashoka: You and the access to medicines movement have been working on this for some time – why are you hopeful that now is a turning point?

Krishtel: The pandemic presented the biggest challenge to protecting global health in a lifetime, but it is also forcing a long-overdue conversation on how we improve our systems and the need to interrogate why a market-based approach to health is never going to provide the same equity outcomes as a human-centered approach to health. We’re also seeing bipartisan leaders in Congress taking on the issue of high drug pricing, and making the connection to how this relates to the work of the PTO. And given we are about to have a new PTO leader, that means we have a chance at a new PTO vision.

Ashoka: And lastly, as someone who has been doing this work for so long, how are you feeling personally in this moment?

Krishtel: I’m extremely energized about what comes next! The work we do at I-MAK is often incremental in its wins, given we’re challenging such established systems of power and influence. But the past year has really given me hope that we’re at a true turning point, that people are realizing that we can’t think of health as a country-by-country and drug-by-drug issue. We are all connected, and we need a global health system that reflects that. From the remarkable move of the US supporting the WTO TRIPS waiver (which we now need the Biden-Harris administration to support for tests and treatments, not just vaccines) to everyone from Chelsea Clinton to Meghan Markle speaking out about the importance of lifting vaccine- related IP to end global vaccine inequity, global health has become a movement beyond just those directly tied to the field – it feels like a moment of historic opportunity.

Priti Krishtel is an Ashoka Fellow and cofounder of I-MAK. This interview was condensed for length and clarity.

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