By Marcelo Figueiras*
The Argentine government’s recent decision to revoke the pharmaceutical patentability guidelines in force since 2012 has reopened a key debate: how to balance innovation with access to medicines. In this context, a piece by Rachel Soeiro and Nancy Guerrero Castillo — directors of Médecins Sans Frontières (MSF) for the Americas and Latin America — offers a relevant perspective on the potential consequences of this change.
MSF has no commercial interests in Argentina. Its concern is strictly public health: in crisis contexts, access to medicines depends on price and availability. And Argentina plays a relevant role: it exports medicines to more than 120 countries, and in 2025 alone those sales reached USD 1.2 billion, the highest level in the historical series. That flow includes generics and biosimilars that are critical for the health systems of developing countries.
What did the 2012 guidelines do? The repealed rules defined which modifications to an existing drug are insufficient to justify a new patent: minor changes such as new salts, polymorphs, formulations, or secondary indications. These types of patents — known as evergreening — extend commercial exclusivity without providing any real therapeutic benefit, a phenomenon widely documented in the industry.
The debate, then, is not about whether genuine innovations are protected — which have always been patentable — but whether minor modifications that prolong monopolies will be allowed to be patented.
A system that lowered prices and improved access
Changing patentability criteria directly alters the level of competition in the market. Evidence shows that drug prices depend not only on production costs, but on the degree of competition. When there is a single patent-protected supplier, that laboratory has the power to set prices well above marginal cost. In contrast, when generics or biosimilars enter the market, prices fall.
Sofosbuvir, the standard treatment for hepatitis C, was launched at USD 84,000 per treatment in the United States by Gilead. In Argentina, the entry of generic versions — such as Probirase, by Richmond — significantly reduced costs, generating savings in public procurement estimated at over USD 20 million over five years, according to data cited by MSF.
The same occurred with other high-impact active ingredients, such as biosimilars of pembrolizumab, bevacizumab, and adalimumab, whose local availability expanded access for social health insurance funds, hospitals, and the state, all of which depend on competition to negotiate prices. Ultimately, rising prices translate directly into reduced access. This is particularly critical in high-cost diseases — such as cancer or hepatitis — where small price differences have massive impacts on coverage.
The official argument is that the repeal simplifies procedures. But a patent is not a procedure: it is a temporary legal monopoly. Broadening patentability criteria tends to increase these monopolies, which may delay competition from generics and biosimilars and drive up prices.
The question that remains open is what mechanism will prevent evergreening under the new framework. INPI will need to clearly define the technical criteria for evaluating applications, in a context where economic incentives are high.
The debate is not between innovation and access, but about what kind of innovation is promoted and at what cost. And on this point, actors as different as the domestic industry and MSF agree: the goal is for medicines to reach those who need them, at prices that health systems can sustain.
*President, Laboratorios Richmond
Published in lanacion.com.ar on 07/04/2026