Canada is a good option for Americans seeking to access their medications at a lower cost through personal drug importation, but even I agree with the pharmaceutical industry when they say that wholesale drug importation on a large scale is not workable with Canada. Why? Simply because Canada is too small a nation to supply the U.S. market. I have written that there is much more promise if importation is expanded to the European Union. We already rely on the EU to assess U.S. drug safety, and current events have only brought that into greater focus.
Due to the world’s efforts to quell Covid-19, Regulatory Focus reported on increased cooperation between the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). These drug regulators have engaged in regular consultations since 2003 in order to share insights and best practices. In 2014, that same cooperation led to the creation of Mutual Recognition Agreements (MRA). Due to an MRA between the FDA and EMA, the U.S. can rely on EU inspections of drug manufacturing establishments in any EU country. That means we have a lot of faith in EU pharmaceutical safety standards.
In fact, according to the EMA, “the two agencies work together on a near-daily basis with the aim to better align, and advance scientific and regulatory excellence worldwide.” The new cooperation on Covid-19 is carried out under the auspices of International Coalition of Medicines Regulatory Authorities (ICMRA). As reported by Regulatory Focus:
“The regulators went over challenges each are facing in the race to develop vaccines for COVID-19 and make them available. The regulators, through ICMRA, are collaborating on other aspects of COVID-19 research, including using observational research to build out real-world evidence on vaccine surveillance, increasing collaboration and reducing hurdles to conduct research with international cohorts, and investigating the use of medicines for COVID-19 in pregnant women.”
With all the nationalist rhetoric about competing for earliest access to treatments and vaccines, and which countries lay claim to the pharmaceutical companies manufacturing of the future products to fight Covid-19, I love to hear about deepening and worthwhile cooperation among drug regulators.
Since many of our drugs are made in the European Union and their regulators are counted on to inspect the plants making these drugs, Americans are now more reliant than ever on Europe’s drug safety oversight. That is a good thing. Why should taxpayers in the U.S. or in the EU pay to have a drug establishment inspected, which has already – recently – received a certification of Good Manufacturing Practices.
On the issue of drug importation, the EU allows countries to sell to each other in a system called parallel importation. Spain can export pharmaceuticals to Germany; France can import from Italy; etc. What is required is proper labeling for the different languages.
Current U.S. law allows for importation of medication from Canada to lower drug costs for Americans. It’s noteworthy that the law permitting importation, Section 804 of the Food, Drug and Cosmetic Act, replaced the statute of the Medicines Equity and Drug Safety Act of 2000 (MEDS Act). The MEDS Act allowed for much wider importation, from “a country, union, or economic area that is listed in subparagraph (A) of section 802(b)(1) or designated by the Secretary, subject to such limitations as the Secretary determines to be appropriate to protect the public health.” Section 802(b)(1) included Australia, Canada, Israel, Japan, New Zealand, Switzerland, or South Africa or the European Union. That was before the incredibly close regulatory ties we witness today. It is time for legislation to expand Section 804 to include the EU, which consists of over half a billion people, and make this transatlantic cooperation mean lower drug prices in the U.S.
