Swiss Medtech, a trade association representing the medical technology industry, issued a press release on November 28 praising the Swiss Parliament for enacting legislation allowing Swiss health care providers and patients to access medical devices approved by the U.S. Food and Drug Administration. Until now, the Swiss government only permitted patients and doctors to access devices that have a CE Marking, which indicates the device meets European Union standards, and the E.U. approves it for marketing among member states. The Swiss Parliament’s action should expand access and increase price competition for medical devices.
Australia began permitting patients and doctors to access FDA‐approved medical devices in 2018 and has been allowing them to use E.U.-approved devices for several years. Israel allows devices approved in the U.S., E.U., Australia, and Canada.
U.S. lawmakers have proposed legislation permitting American health care consumers and providers to access drugs and/or devices approved in other developed countries. Policymakers inaptly refer to the proposal as “reciprocity,” but the reform is not contingent upon the other countries permitting their residents to use FDA‐approved drugs or devices in return.
In testimony before the Joint Economic Committee in September 2020, I stated:
Congress should pass legislation giving reciprocal approval to drugs and medical devices (which includes tests) in similar countries. Reciprocal approval already exists among the European Union states plus Iceland, Liechtenstein, and Norway. In July 2019 Senator Ted Cruz (R‑TX) introduced S.2161, the Reciprocity Ensures Streamlined Use of Lifesaving Treatment (RESULT) Act, which would allow for the marketing of drugs approved in certain countries, but not yet approved by the FDA, 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, reciprocal approval should not be contingent on an unmet need.
…at a minimum Congress should eliminate the FDA’s ability to restrict truthful speech by manufacturers about their products and allow American consumers to purchase drugs that have won approval from designated certification agencies, including foreign regulatory bodies. According to one study, recognizing drug approvals by regulatory bodies in Canada and Europe between 2000 and 2010 would have given U.S. consumers quicker access to 37 “novel” drugs for which “no other FDA‐approved prescription medicine had the same mechanism of action,” including 10 drugs treating mostly orphan diseases “for which no alternative therapy was available in the USA.” Such recognition would have allowed U.S. consumers to access those drugs a median of 13.6 months earlier.
If members of the incoming Congress are serious about increasing access to health care and reducing health care costs, they should, at a minimum, pass a law that allows for drug and device “reciprocity” with other developed nations.