ince at least the birth of ICH in 1990, regulatory harmonization and trade globalization have followed parallel trajectories, synergizing successfully, exceeding expectations, and surprising those who may have initially been skeptical of its prospects. These trajectories are now diverging. This is not good news for patients.

The notion that globalization is broadly beneficial in most areas of trade and human activity took hold in the early 21st century and has found expression on many fronts, including for example in the World Trade Organization. Even before that, regulatory harmonization was initially devised in the European Union, driven by centuries-old national disparities and by the desire to eliminate barriers to trade, including barriers that hamper access to life-saving medicines. The European Medicines Agency is one of the many positive outcomes of this effort. From Europe, the concept of harmonizing regulatory requirements for the development and approval of medicines spread to every continent, largely as a result of ICH and the expanding number of its members, partners, and interested observers around the world.

On the heels of harmonization, regulatory convergence and mutual reliance have evolved and expanded steadily in the past decade, driven by the recognition that the development and registration of new medicines are now urgent global imperatives to benefit patients, and that regulators ought to cooperate as closely as possible to that end. Several well-attended sessions at last month’s 2024 DIA Global Annual Meeting in San Diego made it clear that ICH and ICMRA regulators within and beyond Europe have learned to collaborate transparently, constructively, and efficiently across national and even continental borders to speed the development and approval of novel therapeutics, and that they intend to continue doing so. As a result of this stance, and with cloud technology support, it will soon be possible to submit the same medicines registration application to dozens of national regulatory agencies and at the same time. Years ago, this was laughable fantasy; soon it will be reality.

That’s the good news.

The worry is the global countertrajectory of declining interest in globalization, increased trade fragmentation, sanctions, tariffs, nationalism, protectionism, short-sighted competition, and deliberate misinformation (“fake news”) that threatens to unravel globalization as we have come to know it, perhaps with collateral damage to regulatory harmonization and reliance.

In his 2024 book The Age of Revolutions, the renowned and discerning global observer Fareed Zakaria argues persuasively that the era of globalization is coming to an end, likely the result of a global economic downturn. He suggests that the previous decades of globalization, characterized by increasing economic interdependence, free trade, and open borders, are being replaced by a period of deglobalization and fragmentation. Openness is giving way to insularity and isolation. Zakaria attributes this shift to several factors:

1. Nationalism and Populism: A rise in nationalist and populist movements across the world has led to a pushback against global institutions and agreements, favoring more protectionist and isolationist policies.
2. Economic Disparities: The benefits of globalization have not been evenly distributed, leading to significant economic inequalities both within and between countries. This has fueled discontent and skepticism about the merits of globalization.
3. Geopolitical Tensions: Increasing geopolitical rivalries, particularly between major powers, have strained international cooperation and led to a more fragmented global landscape.
4. Technological Changes: Advances in technology are reshaping economies and societies, often exacerbating job displacement and economic uncertainty, which in turn fuels antiglobalization sentiments.
5. Environmental Concerns: Climate change and environmental degradation are forcing nations to reconsider the impacts of global trade and industry on the planet, prompting moves towards more localized and sustainable practices.

Zakaria posits that these trends collectively signal the end of the globalization era as we have known it, leading to a world that is more divided and less cooperative on a global scale.

Will this countertrajectory be harmful to patients and their prospects for better health? It very well may be.

Even as regulators strive to find ways to allow more and better innovation to enter multiple markets and reach patients rapidly and near-simultaneously, geopolitical and economic countertrends ironically may make this more difficult and, in some cases, even impossible.

One factor may be the imposition of trade barriers to the entry of medicines and other health products into specific economies. This is not happening on a large scale yet, but it might if nations tighten their trade restrictions further. Patients may be unable to secure the medicines they need.

Another factor is the cost of healthcare and the highly fragmented roles of payers and insurers: the final gateway to patient access to affordable healthcare and medicines. Healthcare inequities and disparities may be further exacerbated, both within and across nations.

Regulators say publicly, as they did repeatedly in San Diego last week, that their focus is on science and the best interests of patients, and that they expect both will prevail despite these existential challenges. This generally turned out to be the case during the pandemic, although even then we saw emerging signs of national protectionism with respect to COVID vaccines and treatments.

Privately and off the record, however, some regulators express grave concern about the growing divergence of these trajectories and its future impact on medicines and patients. They fear that these new headwinds will hinder progress.

DIA and Global Forum will continue to advocate for patients around the world, for affordable access to healthcare and medicines, for science-based policies and decisions, and for regulatory harmonization, convergence, and reliance. The remarkable progress achieved to date must not be slowed or arrested, much less reversed; on the contrary, it must be leveraged for even greater health benefits. The world’s millions of suffering patients require nothing less.

Alberto Grignolo
DIA Global Forum Editor-in-Chief