Countries with the right public policy frameworks in place can create an ecosystem where innovation can thrive.
Free market frameworks, underpinned by effective intellectual property protection, have fostered life sciences innovation in key global markets. For that innovation to continue, countries must continue to allow marketplace competition to support the development of lifesaving treatments and cures.
The imposition of price controls creates a fundamental market access barrier that deters future innovation. Research published by the Chamber in 2019 highlighted how a country’s legal and regulatory framework can hinder the creation of and access to innovative goods and services in key global markets.
Legal and regulatory frameworks have changed in many countries since the onset of the COVID-19 pandemic. The 2023 Patient Access Report ("Report") examines the national biopharmaceutical market for nine Organisation for Economic Co-operation and Development (OECD) economies and assesses the impact of their policies on access to innovative medicines. The updated report illustrates how countries that impose price controls have less access to lifesaving treatments and cures.
Key findings:
Strict price controls and other cost-cutting tools are widely used in most OECD economies: Before the passage of the Inflation Reduction Act, the U.S. was the sole economy included in the Report that did not impose direct national price controls or other policies adopted in the name of biopharmaceutical cost containment. Consequently, the U.S. achieves an overall score of 94.95%, as indicated by Figure 1 above. However, following the implementation of the IRA, the U.S. score will fall dramatically and be more in line with OECD economies where the government intervenes to set the price of medicines.
Countries that use price controls see the following:
- Fewer overall biopharmaceutical product launches: Canada, Japan, South Korea, Australia, and European Union (EU) member states have seen significantly fewer overall biopharmaceutical product launches than the United States has over the past 20 years.
- Fewer biologics: Countries with the most severe price controls in place, including South Korea and Australia, have seen fewer than half of new biologics launched in the same period. Only 49% of new biologics launched in the U.S. over the last 20 years were available in South Korea, while only 38% of those biologics were launched in Australia.
- Fewer oncology products: Out of 104 new oncology products launched globally since 2017, 80% were launched in the U.S., but only 56% were launched in Europe.
- Delayed access to treatments: The long lag time between market authorization and inclusion for government reimbursement delays access to the newest innovative medicines. In Germany, patients wait an average of 133 days to access new treatments; in Spain, the delay is as long as 500 days.
The price controls included in the Inflation Reduction Act will have a detrimental impact on biopharmaceutical innovation. Government intervention in price setting undermines the innovation ecosystem that empowered the U.S. to become one of the most innovative countries in the world. The price control provisions could lead to fewer new products and medicines developed and introduced in the United States.
Government officials must carefully consider the implications of price controls for patients, as well as litigation risk and other practical considerations, before proceeding with the implementation of a legally problematic framework that would jeopardize U.S. leadership on biopharmaceutical innovation and patient access to treatments.
