International
Patients across the world deserve fast access to the latest medicines, but for too long, many wealthy countries have devalued biopharmaceutical innovation. Foreign government policies that deny fair market value and access to innovative medicines:
PhRMA works to ensure that new treatments and vaccines reach patients wherever they are, through international trade and global health agreements, fair market access policies, strong intellectual property protections and efficient regulatory systems.
International Trade
Strong trade agreements benefit patients in the United States and abroad through better health, jobs and economic growth. Ambitious, pro-innovation trade policies that defend American workers and intellectual property rights, strengthen supply chains and ensure other countries pay their fair share for innovative medicines help maintain America’s leadership in biopharmaceutical innovation. The industry, and the more than one million Americans it employs, depend on these important trade policies to develop, manufacture and distribute innovative medicines to health systems and patients worldwide.
International Trade
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Market Access
Timely and fair access to innovative medicines helps patients live longer, healthier and more productive lives and prevents more costly medical care. However, many countries devalue innovative treatments and cures by delaying or denying patient access to safe and effective medicines and setting prices below fair market value. These harmful policies reduce investment in research and development of future treatments and cures and allow other wealthy nations to free-ride off U.S.-financed innovation.
Market Access
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Intellectual Property Protections
Strong intellectual property protection and enforcement is a key component of America’s global competitiveness and incentivizes the investment necessary to bring new medicines to market. Intellectual property systems differ from country to country. Many countries delay or prevent biopharmaceutical innovators from securing patents, maintaining and effectively enforcing patents, and protecting regulatory test data. These policies compromise access to new medicines and innovation and often violate international obligations.
IP Protections
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Science and Regulatory
The United States is a leading contributor to the development and advancement of regulatory sciences that support the R&D of innovative medicines. International standards, including those set through the International Council for Harmonisation, support advances in regulatory science to facilitate access to innovative medicines for patients. When regional regulatory requirements differ, manufacturers face additional barriers to obtaining marketing authorization that can delay or prevent patients from accessing new treatments and vaccines.
Science and Regulatory
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Global Health
The biopharmaceutical industry supports global health policies and agreements that protect the innovation ecosystem, including through public-private collaboration, and expand access to lifesaving treatments and vaccines for patients worldwide. Global health agreements should support the development, manufacturing and distribution of these critically important technologies needed to prevent, prepare for and respond to global health challenges.
Global Health
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Related Resources
Report
2026 National Trade Estimate Report on Foreign Trade Barriers (NTE) Submission
High-income Country Spending on Innovative Medicines
Tariffs on medicines would harm American competitiveness, industry and patients
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International
New medicines covered by public insurance: 23% Patient access delay: 49 months Harmful policies: Reference pricing, Biased HTA, Unreasonable delays
Patient access barriers all too common for cancer patient
New medicines covered by public insurance: 88% Patient access delay: 3 months
New medicines covered by public insurance: 25% Patient access delay: 32 months Harmful policies: Reference pricing, Biased HTA, Unreasonable delays
Patient denied long-term access to pericarditis treatment
New medicines covered by public insurance: 40% Patient access delay: 25 months Harmful policies: Biased assessment, Excessive rebates, Clawbacks
Patient sues government for refusing to cover her cancer treatment
New medicines covered by public insurance: 58% Patient access delay: 14 months Harmful policies: Restrictive requirements, Reference pricing, unreasonable price regulations
New medicines covered by insurance: 45% Patient access delay: 29 months Harmful policies: Clawbacks, unreasonable access delays
Cystic Fibrosis League criticizes failure to approve new treatment
New medicines covered by public insurance: 53% Patient access delays: 17 months Harmful policies: Repeated price cuts, Biased HTA
Parents of pediatric cancer patient find treatments not available in Japan
New medicines covered by public insurance: 47% Patient access delay: 30 months Harmful policies: Reference pricing, Unreasonable access delays, Clawbacks
Region took almost twice as long to provide coverage of a therapy for multiple myeloma patients
New medicines covered by public insurance: 20% Patient access delay: 47 months Harmful policies: Unreasonable access delays, Reference pricing, Biased HTA
Patients denied coverage for the only treatment for their disease
New medicines covered by public insurance: 46% Patient access delay: 30 months Harmful policies: Biased HTA, Clawbacks
Long wait times for patients caused worse conditions and cost the government billions
Related Resources
2026 National Trade Estimate Report on Foreign Trade Barriers Submission
2026 National Trade Estimate Report on Foreign Trade Barriers (NTE) Submission
PhRMA submitted comments to the Office of the U.S. Trade Representative identifying significant foreign trade barriers for inclusion in the 2026 National Trade Estimate Report (NTE).
2026 National Trade Estimate Report on Foreign Trade Barriers (NTE) Submission.png
Trade
Comment
PhRMA submission calls for USTR to correct course on trade policy, enforcement
On October 17, PhRMA submitted comments to the Office of the United States Trade Representative (USTR) to inform USTR’s 2025 National Trade Estimate (NTE) Report on Foreign Trade Barriers. PhRMA’s submission identifies intellectual property (IP) challenges and market access barriers in more than two dozen foreign markets that threaten American jobs and exports of innovative medicines. The submission also details how USTR’s current trade policies are failing to address these barriers and illustrates the need for the next U.S. Administration to more aggressively defend American innovation abroad.
The U.S. biopharmaceutical industry leads the world in the research and development of valuable new medicines, supports over 4.9 million jobs across the U.S. economy and is the largest exporter of goods among the United States’ R&D intensive industries. American workers in this vital industry depend on fair access to overseas markets, and robust IP protections in those markets, to remain globally competitive and deliver life-saving medicines to patients.
Unfortunately, many foreign governments continue to deny basic market access and IP protections to U.S. innovators. For example:
- Government price controls in markets such as Canada and Japan are non-tariff barriers to trade that deny American inventors and workers the ability to compete on fair and equitable terms;
- Korea has failed to adopt market access policies that are transparent and appropriately value American-made innovative medicines as required by the U.S.-Korea Free Trade Agreement;
- Mexico has yet to implement key IP provisions in the United States-Mexico-Canada Agreement; and
- Pending EU proposals to condition IP incentives on product launches in all EU member states would discourage R&D and harm patient access to new medicines.
These and similar policies around the world undermine U.S. global competitiveness and restrict patient access to innovative medicines. Despite this, the Biden Administration has not adequately enforced our trading partners’ commitments to protect American innovation and has declined to negotiate new trade agreements that promote IP protection and fair market access abroad.
To safeguard American jobs and global leadership in the biopharmaceutical sector, the next Administration must correct course by aggressively pursuing trade agreements and enforcement actions that protect IP and provide fair access to foreign markets.
Brian Picone
"PhRMA submission calls for USTR to correct course on trade policy, enforcement "
Global Access to New Medicines Report
PhRMA’s Global Access to New Medicines Report analyzes what share of new medicines are available in over 70 countries and how long patients wait to receive them. The Global Access to New Medicines Report includes comprehensive comparisons across countries in the G20, OECD and several geographic regions. Policymakers can enable timely patient access to new medicines by having strong intellectual property rights and enforcement, science-based and globally-harmonized regulatory review, and transparent pricing and reimbursement policies that value innovation.
Global Access to New Medicines Report image
Access to Medicines
Report
World IP Day 2024: Supporting an innovative and sustainable future
Today, PhRMA joins innovators from across the globe in celebrating World Intellectual Property Day. This year’s theme recognizes the importance of intellectual Property (IP) in supporting progress on the United Nation’s Sustainable Development Goals (SDGs) by “building our common future with innovation and creativity.” The SDG’s are a call to action for global partnership toward peace and prosperity for people and the planet. With individual goals spanning health and well-being, equality, economic growth, innovation, sustainable communities and climate action, progress towards the SDG’s is dependent on innovative solutions to complex, intertwined problems.
Innovative medicines and vaccines are a crucial part of the solution to our most pressing health care challenges. They dramatically reduce the disease burden on patients and help people avoid hospital stays, physician office visits and other costly health care services. And unlike other parts of the health care system, innovative medicines become low-cost generics and biosimilars that provide long-term value to individuals and society. None of this is possible without strong IP protections to encourage medical breakthroughs.
PhRMA is committed to helping patients across the globe live longer, healthier, more productive lives. The industry’s works in achieving the SDGs includes:
- Health and well-being: A record number of new medicines launched globally in 2021 and more than 8,000 medicines are in the pipeline today. For example, we are improving survival rates for breast cancer and pediatric leukemia with cell and gene therapies, and advances in sickle-cell treatments are helping address health equity concerns.
- Economic growth: The biopharmaceutical industry is a key component of the U.S. innovation economy, supporting more than 4.4 million high-skill jobs and contributing more than $1.4 trillion in economic output.
- Fostering innovation: Our scientists are now able to deliver medicines that are more personalized and convenient for patients, meaning more time with loved ones. Biopharmaceutical companies are transforming medicine development using new technology, including AI, and collaborating with partners to identify promising ideas, improve R&D and clinical trials, and safely deliver medicines faster.
Biopharmaceutical research, development and manufacturing relies on the global IP and innovation ecosystem to enable risk-taking and collaboration on a massive scale. As the world continues to work towards a common future with innovation and creativity, IP must continue to be valued and celebrated.
Ernest Kawka
World IP Day 2024: Supporting an innovative and sustainable future