Public Comment: Demand Equitable Contribution to Biomedical Innovation
June 27, 2025 — No Patient Left Behind (NPLB) wrote to the Office of the United States Trade Representative to address unfair trade practices that let wealthy countries free-ride on American biomedical innovation.
Dear Ambassador Greer:
Thank you for the opportunity to comment on how the US Trade Representative (USTR) can take action to reduce non-tariff market access barriers that wealthy foreign countries use to freeload off U.S. biomedical innovation.
These countries use outdated and flawed health technology assessments (HTAs) to arbitrarily set below private-sector negotiated competitive market prices on U.S.-developed medicines. Foreign government value estimates from these assessments often omit quantifiable patient and societal benefits, such as improved productivity, reduced caregiver burden, and long-term cost savings through genericization. As a result, they not only underpay for innovation but also delay or deny their own citizens access to the best available life-saving treatments.
I am writing on behalf of No Patient Left Behind (NPLB), a coalition of biotech investors, innovators, researchers, physicians, and patient advocates committed to lowering patient out-of-pocket costs while preserving incentives for US biomedical innovation. We support the Trump administration’s initiative- taking approach to use trade-centered solutions to address the significant and growing problem of foreign free-riding on U.S.-led biomedical innovation.
American patients and taxpayers disproportionately fund the global R&D ecosystem that enables life- saving medical advances, while wealthy countries impose price controls that underpay by as much as 60% relative to their economic capacity. The below points outline how adopting the Most Favored Nation (MFN) approach for price setting undermines U.S. leadership in medical innovation, hurts patients at home and abroad, and also impairs global progress against disease.
U.S. market-based pricing delivers great value to employers, taxpayers, and consumers: U.S. prices for innovative medicines reflect remarkable value, with analyses showing that market-based prices are, on average, 70% below the full societal benefit these medicines deliver through improved outcomes, increased productivity, and reduced healthcare costs.1 While innovative medicines comprise just 8% of total U.S. healthcare spending, they drive long-term savings by replacing costlier hospital- based care with inexpensive generic drugs after patent expiration.
“Middlemen” are the true pricing problem in the US and abroad: Patients often do not see the benefits of negotiated discounts because of intermediaries like pharmacy benefit managers (PBMs), who retain more than 50% of brand drug expenditures. Internationally, foreign government-run HTA bodies systematically set prices based on outdated, narrow, and flawed health economic models that significantly undervalued innovative medicines that address critical unmet needs. Recent research found Canadian and German HTA assessments undervalued novel treatments by 90% and 94%, respectively.2
These models, known as the traditional cost-effectiveness analysis (TCEA) models, introduce significant bias into the HTA processes. TCEA models routinely omit critical quantifiable elements of value, including productivity gains, caregiver burden reduction, and price drops due to generic entry.
A recent expert consensus led by twelve leading health economists highlights the Generalized Cost- Effectiveness Analysis (GCEA) framework as a superior alternative.3 GCEA integrates market dynamics and societal value and found that U.S. market prices are, on average, 69% below a treatment’s full societal value. In contrast, TCEA-based HTAs used by countries like Canada and Germany led to systematic undervaluation and patient access delays.
The Trump administration and its trade negotiators and policymakers should reject the use of outdated TCEA-based HTA recommendations as the basis for price-setting, particularly during the patent- protected period when innovators are being rewarded for taking on lengthy, costly, and risky R&D endeavors in the fight against diseases.
Quantifying our trade competitors “free ride”: The "Freeriding Index" developed from RAND, CIA, and RA Capital data shows that wealthy countries pay just 30% of U.S. net prices for branded drugs, when a GDP-adjusted benchmark would be closer to 74%. That 44-point gap—roughly 60% freeriding—means that U.S. patients and taxpayers are unfairly subsidizing the world. Australia, France, and Germany are the top three offenders, with other wealthy countries similarly underpaying.4
The consequences of inaction: Foreign freeriding weakens the global incentive system for innovation, resulting in fewer drug launches abroad, delayed access for patients, and suppressed global R&D investment. If five major trade partners (e.g., Germany, France, UK, Japan, and Italy) paid fair prices, economists estimate at least twelve additional new drugs could reach the market annually, benefiting patients everywhere and reducing costs through increased competition.
Importing foreign price controls guts U.S. market competition: The proposed "Most Favored Nation" (MFN) policy would import foreign price controls into U.S. markets, resulting in slashing return to pharmaceutical R&D by at least 50%. This will backfire by undermining investment in R&D, delaying drug launches, harming U.S. patients, and validating the same flawed HTA systems used to justify underpayment abroad. Under MFN, innovators will have no choice but to launch only in the US, or to launch outside of the US with US prices to sustain the innovative engine. MFN will not force foreign countries to pay more. It will only result in fewer treatments, higher long-term costs, and weakened U.S. global leadership.
The right solution is trade deals that open foreign markets: USTR should lead bilateral and multilateral efforts to:
Require high-income countries to align spending on innovative medicines with their GDP- adjusted capacity (e.g., pay ~74% of U.S. net prices).
Eliminate discriminatory price controls, reference pricing based on poorer nations, and long reimbursement delays.
Enforce timely access and fair pricing commitments via binding trade agreements and robust implementation mechanisms.
Apply reciprocal trade pressure on unrelated exports (e.g., autos, wine, dairy) if nations continue to freeride on U.S. scientific investment.
Healthcare innovation as shared global defense: Biomedical innovation is a shared mission to protect humanity from disease. Just as the Trump administration successfully encouraged NATO allies to commit to spending 5% of GDP on common defense,5 wealthy nations must do their part in sustaining medical progress. America should not have to carry this burden alone.
USTR prioritization is essential to continued U.S. biomedical competitiveness and leadership:
The U.S. must preserve, defend, and improve its market-based pricing system—the foundation of global medical progress. But to ensure a sustainable future, USTR must hold our trade partners accountable for contributing their fair share. Now is the time to flex American trade leverage to stop foreign freeriding and secure a stronger, more equitable global innovation ecosystem.
We appreciate USTR's dedication to advancing fair trade policies that benefit American innovators and patients worldwide. We urge USTR to take strong action to address these unfair trade practices and ensure that all wealthy nations share in the cost of biomedical progress.
Please feel free to contact me if I can provide more information.
Thank you for your consideration.
Sincerely,
Peter Rubin
No Patient Left Behind
References
1 Valuing Healthcare Innovation: What Generalized Cost-Effectiveness Analysis (GCEA) reveals about market- based pricing of innovative drugs and whether foreign countries standards objectively reward value or subjectively cut costs. https://www.nopatientleftbehind.org/long-ex-us-report
2 New Analysis Reveals Foreign Countries’ Flawed Value Assessments Undervalue Innovative Medicines by up to 94% https://www.nopatientleftbehind.org/press-releases-1/new-study-highlights-challenges-in-medicare-part-d- access-sn433
3 Valuing the Societal Impact of Medicines and Other Health Technologies: A User Guide to Current Best Practices. https://www.degruyterbrill.com/document/doi/10.1515/fhep-2024-0014/html
4 No More Freeriding on the Great American Drug Deal:
Making wealthy countries pay their fair share for novel medicines without sacrificing America’s current bargainhttps://rapport.racap.com/all-stories/no-more-freeriding-great-american-drug-deal.
5 A Note from America’s Innovators and Investors on adopting the ‘Most Favored Nation’ Policy for US Drug Pricing https://www.nopatientleftbehind.org/protect-american-competitiveness-from-price-controls.