American healthcare consumers should have access to medicines and…

Reprinted from Cato Institute

Swiss Medtech, the trade association representing the medical technology industry, has released Press release On Nov. 28, praised the Swiss Parliament for passing legislation to allow Swiss healthcare providers and patients to access FDA-approved medical devices. Until now, the Swiss government has only allowed patients and doctors access to devices that have CE marking, indicating that the device complies with European Union standards and the EU approves its sale among member states. Action by the Swiss Parliament should expand access and increase price competition for medical devices.

Australia began giving patients and doctors access to FDA-approved medical devices in 2018 and allowed them to use EU-approved devices for several years. Israel allows devices approved in USA, EU, Australia and Canada.

US lawmakers have proposed legislation to allow US consumers and healthcare providers to access drugs and/or devices approved in other developed countries. Politicians inappropriately refer to the proposal as “reciprocity,” but the reform does not depend on other countries allowing their residents to use FDA-approved drugs or devices instead.

AT testimony before the Joint Economic Committee in September 2020, I stated:

Congress must pass a law giving mutual approval for medicines and medical devices (including tests) in similar countries. Mutual approval already exists among European Union states plus Iceland, Liechtenstein and Norway. In July 2019, Senator Ted Cruz (R‑TX) introduced S.2161The Reciprocity Act provides a streamlined use of lifesaving treatment (RESULT) that will allow drugs that are approved in certain countries but not yet approved by the FDA to be sold if “there is an unmet need.” While this is indeed a step in the right direction, in the interest of promoting competition and consumer choice, mutual acceptance should not depend on an unmet need.

AT drug reformationpublished later that year, Michael F. Cannon and I wrote:

… at a minimum, Congress should remove the ability of the FDA to restrict manufacturers’ truthful information about their products and allow American consumers to purchase drugs that have received approval from designated certifying agencies, including foreign regulators. According to one study, recognition of drugs approved by regulators in Canada and Europe between 2000 and 2010 would give U.S. consumers faster access to 37 “new” drugs for which “no other FDA-approved prescription drug did not have the same mechanism of action. including 10 drugs for the treatment of mostly orphan diseases “for which no alternative therapy was available in the US”. Such recognition would enable US consumers to access these drugs an average of 13.6 months earlier.

If members of the new Congress are serious about expanding access to healthcare and cutting healthcare costs, they should, at a minimum, pass legislation to allow drugs and devices to be “reciprocated” with other developed countries.

Jeffrey A. Singer

Jeffrey Singer

Jeffrey A. Singer is a senior fellow at the Cato Institute in the Department of Health Policy Research. He is the director and founder of Valley Surgical Clinics, Ltd., the largest and oldest private surgical practice in Arizona.

He received his bachelor’s degree from Brooklyn College (CUNY) and his MD from New York Medical College. He is a member of the American College of Surgeons.

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