Lenacapavir: The race to democratize HIV prevention.

The accelerated approval of a generic drug in the US for HIV prevention shows that it is possible to shorten the path between pharmaceutical innovation and public health. But it also exposes the contradictions of a system capable of developing extraordinary technologies without ensuring that they reach those who need them most.

On November 2, 2026, the Indian pharmaceutical company Dr. Reddy's Laboratories announced that it had received provisional approval from the US regulatory agency, the FDA , for a generic version of lenacapavir , a drug developed by Gilead Sciences for HIV prevention with only two applications per year.

The news could be treated as yet another advance in the history of antiretroviral drugs. But there's a detail that changes its significance: the generic drug received regulatory approval only 16 months after the original medication was approved for HIV prevention. In an industry where the arrival of generic competitors usually depends on long periods of commercial exclusivity, we are facing a rather unconventional trajectory.

The product is expected to be supplied for US$40 per person per year in the 120 countries covered by Gilead's voluntary licensing agreement. In the United States, the annual list price of the original drug exceeds US$28,000. These are different markets and commercial conditions, therefore this is not a direct comparison of costs or margins. Even so, the difference between these values reveals the influence that intellectual property , competition, bargaining power, and access policies exert on drug prices.

The most interesting issue lies elsewhere. An innovation of this magnitude reached the stage of regulatory approval for its first generic version because preparations for its production began even before the original product was approved for preventive use. It wasn't necessary to wait for the market to mature in order to organize some of the access conditions.

Perhaps this is the main innovation of this story. And perhaps it is also where its greatest contradictions lie.

Lenacapavir: A revolution we already knew about

In January of this year, IBIS Insights published an analysis of the dilemma between innovation, price, and access to lenacapavir , when Anvisa authorized its preventive use in Brazil. At that time, the clinical results already justified the enthusiasm.

In the PURPOSE 1 study, published in the New England Journal of Medicine , none of the 2,134 participants who received lenacapavir acquired HIV during the study period. In PURPOSE 2 , which involved cisgender men, transgender people, and participants of different gender identities, two infections occurred among 2,183 people who received the medication.

The results supported the World Health Organization 's recommendation, published in July 2025, to offer lenacapavir as an additional pre-exposure prophylaxis (PrEP) option.

The difference compared to existing alternatives is not limited to pharmacological potency. Oral PrEP already offers extremely high protection when used correctly. The problem is that the effectiveness demonstrated under controlled conditions is not always replicated in everyday life.

Taking a pill every day may seem like a simple requirement. For those facing stigma, violence, discrimination, housing instability, or difficulties accessing healthcare services, this routine can represent a considerable barrier. Long-lasting technology can reduce some of this effort and expand the possibilities for choice.

However, reducing the frequency of administration does not eliminate the need for clinical follow-up, HIV testing, and organization of services. The medication also does not replace other prevention strategies, especially those aimed at sexually transmitted infections against which it offers no protection.

Lenacapavir had already demonstrated that science could offer an extraordinarily effective solution. The November announcement adds something new: the possibility of rapidly transforming this discovery into a lower-cost product .

What has changed in the way the market is developed?

The path of generic drugs deserves examination because it contradicts the more well-known sequence of pharmaceutical innovation. Traditionally, a company develops the drug, obtains regulatory approval, and begins its commercial exploitation under patent protection and other exclusive rights. The entry of generic drugs happens later, depending on negotiations, licenses, patent disputes, or the expiration of applicable protection periods.

In the case of lenacapavir, some of these steps occurred in parallel. In October 2024, before the approval of the original PrEP drug, Gilead announced voluntary, royalty-free licensing agreements with six generic manufacturers. According to the company, the technology transfer to these partners was completed in December of that year.

In September 2025, Unitaid , Clinton Health Access Initiative (CHAI) , and Wits Reproductive Health and HIV Institute announced an agreement with Dr. Reddy’s , combining financial, technical, and regulatory support with an upfront commitment to supply $40 annually.

Fourteen months later, provisional FDA approval arrived . The regulatory strategy also played a significant role. The partners combined the treatment and prevention indications in a single submission, using the 505(b)(2) regulatory pathway and obtaining priority review from the agency. The result was one of the shortest intervals between the approval of an innovative HIV prevention drug and the positive regulatory assessment of a generic alternative.

What happened wasn't just a price reduction. There was a redistribution of risks among different players. Gilead took over the development and clinical demonstration of the original technology and authorized selected manufacturers to work ahead on generic versions. Dr. Reddy's mobilized its industrial and regulatory capacity to develop a long-acting injectable drug, whose manufacture and quality control require more complex expertise than that needed for many conventional oral medications.

Global health institutions have contributed to reducing development risks, anticipating commercial conditions, and preparing acquisition pathways. International organizations have begun planning for demand before availability at scale. This is a form of coordination that brings together technological development , regulation , access policy , and market formation .

There is a relevant lesson here for other segments of healthcare, especially those that rely on complex technologies and face significant commercial uncertainties.

The ability to develop an innovation does not need to remain concentrated in the same organization responsible for ensuring its dissemination. Different institutions can assume complementary risks, provided that the economic incentives, responsibilities, and expected results are defined.

This does not eliminate the role of intellectual property . On the contrary, it shows that it can also be used as an instrument of productive coordination, in addition to being a mechanism of exclusivity. The difference lies in the architecture of the agreement, especially in who participates, who can produce, and which markets remain protected.

An approval that does not mean immediate access.

The FDA announcement calls for a regulatory distinction. Dr. Reddy's received tentative approval , a type of provisional approval used, among other contexts, in the US PEPFAR program. This indicates that the product meets the relevant regulatory requirements, but cannot yet be marketed in the United States due to patent or exclusivity restrictions.

This assessment can facilitate its acquisition by international programs and recognition by other regulatory authorities. However, it does not mean automatic authorization for commercialization in the 120 countries covered by the licensing. Each country may require its own procedures. Manufacturers need to guarantee capacity and regularity of supply. Governments and funding institutions must contract the product. Healthcare services need to prepare professionals, protocols, and monitoring systems.

According to CHAI , the first supplies are expected as early as 2026, with wider availability in 2027. The Global Fund to Fight AIDS, Tuberculosis and Malaria reported in September that it was preparing to expand its purchases of quality-assured generics, recognizing the need to combine different suppliers to meet demand.

Demand had already been growing before the generic drug was approved. According to the partnership led by Unitaid, CHAI, and Wits RHI, more than 125,000 people in ten African countries had started using lenacapavir supplied by Gilead by the time of the November announcement.

The Global Fund and the United States have set a joint ambition to reach three million people with lenacapavir by the end of 2028. This is a significant commitment. But it doesn't guarantee access for everyone who could benefit from the technology. Nor does it guarantee its continuity after the initial funding commitments end.

Therefore, November 2026 marks a regulatory breakthrough , not the completion of the access process. The distinction matters because the performance of an innovation policy cannot be measured solely by the speed at which a product goes through regulatory evaluation. The true outcome depends on the time elapsed until its effective use, with quality, continuity, and coverage compatible with the epidemiological need.

The geography of innovation remains uneven.

The licensing for 120 countries represents a significant initiative. It includes several nations with high HIV incidence and limited capacity to finance prevention, especially in Sub-Saharan Africa.

It is reasonable for a global access strategy to prioritize populations at higher risk and healthcare systems with fewer resources. Gilead argues that its agreements seek to reconcile speed, scale, and sustainability of supply. While generics are not yet available in sufficient volume, the company has committed to making the product available at no profit in priority markets through programs coordinated with international partners.

These commitments should not be ignored. They demonstrate that the industry can participate in more flexible access models without necessarily giving up the protection of its assets in all markets.

There is also a legitimate economic dimension. Drug development involves significant investments, risk of failure, and a long period before the invested capital is recovered. Models that disregard these incentives may compromise future investments, including in diseases that do not yet have adequate therapeutic alternatives.

But recognizing this reality does not mean accepting any pricing and licensing architecture as inevitable. Geographic selection remains a source of controversy.

Doctors Without Borders has questioned the restrictions of the agreements, especially the exclusion of middle-income countries that concentrate vulnerable populations and face significant budgetary difficulties. Brazil , Argentina , Mexico , and Peru , which participated in clinical studies on lenacapavir, are not included in the license to supply low-cost generics. The organization also criticized the supply restrictions for its own programs and the dependence on centralized distribution mechanisms.

The critique introduces a problem that extends beyond HIV. A country's economic classification does not adequately describe the accessibility of its different population groups. A middle-income nation may be home to millions of people for whom an innovative technology remains economically inaccessible . And universal public systems need to negotiate prices that are compatible not only with the individual benefit of the product, but also with its budgetary sustainability .

The choice of eligible countries may be defensible as a strategy for prioritizing scarce resources, but it also produces distributional consequences . By preserving more profitable markets outside of licenses, the company maintains room for differentiated commercial negotiations. For excluded governments, the only options are to negotiate directly, seek collective procurement mechanisms, or resort to other available legal instruments.

There is also the dimension of scientific reciprocity . When populations in a given country participate in generating evidence that supports the approval of a drug, what access commitments should be associated with that participation?

There is no simple answer . Clinical trials involve investments, regulatory responsibilities, and agreements distinct from the instruments of sanitary incorporation. Participating in a research study does not, in itself, create an automatic right to a specific commercial price. This does not prevent post-study access conditions from being discussed in advance.

On the contrary, the lenacapavir case itself shows that some of these negotiations can occur before the product is approved.

The funding paradox: more technology, less prevention.

There is another problem, possibly more serious than industrial availability. According to data released by UNAIDS for 2025, approximately 1.2 million people acquired HIV that year. Although this represents a 42% reduction compared to 2010, the result remains far from the trajectory needed to end AIDS as a public health threat by 2030.

The most worrying data comes from funding. Preliminary information from 62 countries indicates that the number of people who received PrEP at least once fell by 38% between 2024 and 2025. UNAIDS attributes this decline to disruptions in international funding, insufficient domestic resources, and the vulnerability of preventive programs in the face of reduced external aid.

It is necessary to interpret the indicator correctly: it refers to a specific group of countries, not a 38% drop in global coverage. Even so, the signal is worrying. The pharmaceutical industry and its partners are managing to accelerate the availability of a highly effective technology while health systems struggle to maintain existing preventive services.

The contradiction puts the meaning of the $40 price into perspective. This value refers to the supply of the medication in the markets covered by the agreement. It does not necessarily represent the full cost of a prevention program. Testing, professionals, infrastructure, logistics, community mobilization, clinical follow-up, and continuity of care also need to be funded. The start of the regimen may require additional oral doses, while periodic testing remains essential to prevent inappropriate use in people with undiagnosed infection.

An innovation capable of preventing infections can generate significant future savings, including by avoiding lifelong antiretroviral treatments. For this benefit to materialize, however, someone needs to fund prevention now . This is a well-known asymmetry in public health: the economic benefits of preventing a disease accumulate over many years, while the costs of prevention must fit within the current budget.

No single price reduction solves this problem . Sustainability also depends on how long people remain protected. A semi-annual intervention reduces the frequency of administration, but does not eliminate the risk of dropout. People who do not return for the next dose may no longer be adequately protected, even if they initially adhered to the treatment.

The challenge for public programs is not just to initiate thousands of people into a new PrEP modality. It is to ensure continuity , follow-up capacity , and safe transitions between different preventive alternatives. Therefore, the population effectiveness of lenacapavir will depend on issues that do not appear in clinical efficacy studies or licensing agreements: organization of services, recurring funding, community trust, and reduction of social barriers that hinder access to prevention.

Brazil between scientific advancement and trade negotiations.

Since the analysis published by IBIS in January, the Brazilian scenario has gained new elements. ANVISA approved the preventive indication of lenacapavir on January 12, 2026. In October, a maximum consumer price of R$ 20,914.22 per six-month application was announced, according to the table regulated by the Chamber for the Regulation of the Medicines Market (CMED) . This value is a regulatory ceiling for retail trade, not a purchase price negotiated by the SUS (Brazilian Public Health System). It would not be correct to use it directly to calculate the cost of a potential public policy.

Federal negotiations, however, had already encountered obstacles. In an interview published by Agência Aids in July, the director of the Department of HIV, AIDS, Tuberculosis, Viral Hepatitis and STIs at the Ministry of Health, Draurio Barreira , stated that the government had proposed a price of US$400 per person per year to Gilead, without reaching an agreement at that time.

The Brazilian offer was equivalent to ten times the price projected for the generic version in licensed countries. This comparison does not demonstrate that the company could supply the product to the SUS (Brazilian public health system) under the same economic conditions, but it does illustrate the negotiating effort of a country excluded from the international low-cost mechanism.

In September, an institutional alternative emerged. The Pan American Health Organization announced an agreement with Gilead to facilitate the acquisition of the drug through its Regional Revolving Funds , involving 14 countries in Latin America and the Caribbean, including Brazil. The initiative includes countries that were left out of the voluntary licensing of generic drugs. It also foresees advancing discussions on technology transfer for future production in Brazil, although specific deadlines, conditions, and mechanisms have not yet been defined. This is a significant step forward, but it does not equate to a decision to incorporate the drug into the SUS (Brazilian Unified Health System) nor does it, by itself, resolve the price issue.

Brazil is also participating in generating evidence for implementation. The ImPrEP LEN Brasil study, coordinated by researchers from Fiocruz , seeks to evaluate the feasibility of using lenacapavir in the public healthcare system. The preliminary results presented at the 2026 International AIDS Conference offer important information about the demand for this type of prevention. Among 571 participants included from February to the beginning of July, 98% opted for lenacapavir when given the choice between injectable and oral PrEP.

The result is significant, but it needs to be interpreted within the context of the study design. These are individuals selected from those who sought preventive services or were reached through specific recruitment strategies. The observed preference cannot be automatically extrapolated to the entire eligible population of the Brazilian Unified Health System (SUS), nor does it equate to demonstrating persistence in use over the years. Even so, the data contradicts a hypothesis that could limit implementation: that injectable administration would be unattractive to people who already have oral alternatives.

The study may produce evidence on acceptability, continuity, access, safety, and actual delivery conditions. Its strategy includes digital support tools, reminders integrated into monitoring systems, and initiatives to reach populations underserved by traditional services. But there is a difference between knowing how to implement a technology and having the resources to fund it permanently.

The Brazilian risk is not just falling behind in the arrival of a new drug. It's investing in regulatory capacity, clinical research, and implementation studies without simultaneously building an economically viable access pathway. This concern becomes even more relevant in light of a recent change in the SUS (Brazilian Public Health System) negotiation rules.

The Brazilian public health system (SUS) is beginning to change its negotiation rules.

On July 23, 2026, Ordinance GM/MS No. 12,011 was published, establishing the Committee for Negotiation of Prices and Economic Conditions of Health Technologies . The new structure was designed to negotiate prices and commercial conditions of technologies, especially in situations involving patented medicines, exclusive suppliers, and products with a high budgetary impact.

The most significant change is in the timing of when the negotiation can take place.

Historically, technical-scientific evaluation and commercial negotiation have not always progressed in a coordinated manner. A technology could receive a favorable recommendation for incorporation and subsequently face difficulties in obtaining supply conditions compatible with the public budget.

This mismatch created a governance problem: the health decision preceded the resolution of commercial issues that could compromise its implementation. With the new model, the Committee can be called upon during the evaluation conducted by Conitec , when there is a need to negotiate economic conditions compatible with the technical parameters of incorporation.

The regulation also allows for more flexible instruments, including risk-sharing agreements, conditional discounts, installment purchases, portfolio negotiation, and, under certain circumstances, confidentiality regarding prices actually negotiated. This is a potentially important change for medications like lenacapavir.

The possibility of linking commercial negotiations to cost-effectiveness and budget impact assessments can expand the SUS 's ( Brazilian Public Health System) capacity to establish defensible economic parameters. Instead of treating the price presented by the company as a variable practically external to the evaluation, the Ministry of Health could use clinical and economic evidence to guide the acquisition conditions.

International experience offers valuable insights . In September, representatives from the Ministry of Health and the National Institute for Health and Care Excellence (NICE) in the United Kingdom held technical workshops to discuss negotiation models associated with health technology assessment. In the British system, NICE assessments provide clinical and economic parameters that can guide commercial agreements with the industry. This coordination allows certain technologies to be made available under price conditions different from those publicly announced by manufacturers.

Brazil is seeking to develop a similar institutional capacity, adapted to the characteristics of the SUS (Unified Health System) and its legal framework. However, there are significant differences between creating a committee and consolidating a negotiation policy.

The effectiveness of the model will depend on the technical competence of its teams, the capacity for economic analysis, coordination with Conitec and the purchasing areas, the legal consistency of the contracts and, above all, the willingness of suppliers to accept the proposed conditions. The ordinance does not oblige a company to practice a certain price. Nor does it eliminate the need for incorporation evaluation or guarantee that a negotiation will result in an agreement.

There is no public confirmation to date that the new Committee has specifically taken over the negotiation of lenacapavir. This distinction is crucial to avoid confusing an institutional innovation with a health outcome already achieved.

The confidential price and its limits.

Among the instruments foreseen, the possibility of confidentiality regarding trade discounts is particularly sensitive. Pharmaceutical companies often resist granting significant price reductions in markets where the price actually paid can be used as a reference in international negotiations. Disclosing a significant discount in a particular country can influence the manufacturer's trade policy in other markets.

In this context, preserving certain commercial conditions can facilitate agreements that would not be viable with full disclosure of net prices. The argument has economic merit. But it also presents risks. The acquisition of medicines with public funds requires transparency, control, and accountability. If the amounts actually paid remain unavailable for independent analysis, it becomes more difficult to assess the cost-effectiveness of purchases, compare contracts, and identify any negotiation asymmetries.

The issue cannot be resolved simply by choosing between disclosing all prices or keeping negotiations entirely confidential. A consistent model needs to distinguish between legitimately protected commercial information and data essential for monitoring public spending.

The ordinance and model announced by the Ministry of Health establish specific conditions for the use of confidentiality, while preserving oversight by control bodies such as the Federal Court of Accounts . Even so, the quality of this governance can only be assessed as the agreements are actually implemented.

There is also a methodological challenge in using outcome-based contracts. In the case of a therapy for a rare disease, it may be possible to track certain individual clinical indicators and link part of the payment to the response to treatment. The Ministry of Health itself cites the Zolgensma negotiation as an example of risk sharing.

In HIV prevention, the logic is different . The absence of infection in a person who received lenacapavir does not, individually, demonstrate that the infection would have occurred without the intervention. Measuring the benefit requires epidemiological comparisons, counterfactual models, and longitudinal follow-up. This does not preclude risk-sharing agreements, but it makes their modeling more complex.

Volume-related discounts, supply commitments, periodic review rules, and implementation monitoring can be more manageable alternatives, depending on the negotiation structure. The key point is that sophisticated contracts are not necessarily better contracts. Their usefulness must be demonstrated by their ability to reduce costs, ensure supply, and produce measurable results.

The distance between incorporating and offering

Another recent change complements this movement. Ministerial Decree GM/MS No. 11,981, of July 20, 2026 , established a monitoring flow for the availability of technologies incorporated into the SUS (Brazilian Unified Health System) whose financing is the responsibility of the Federal Government. It seeks to address a known problem: the gap between the formal decision to incorporate a technology and its actual provision to patients.

After incorporation, adjustments to clinical protocols, budget forecasting, definition of responsibilities, logistical organization, and procurement procedures may still be necessary. The new standard establishes mechanisms to coordinate and monitor these steps, identifying responsibilities and risks of non-compliance with deadlines.

The two regulations therefore address complementary bottlenecks. The first seeks to bring economic negotiation closer to technology assessment. The second aims to improve coordination between incorporation and effective deployment. For lenacapavir, this new architecture can be relevant, provided that the technology progresses through the necessary stages for its eventual incorporation.

Brazil now has a combination of possibilities that did not exist when IBIS examined the topic in January: a regional procurement mechanism by PAHO, prospects for negotiation on technology transfer, an ongoing national implementation study, and institutional instruments to integrate evaluation and trade negotiation.

None of them, in isolation, solves the problem . Together, however, they can broaden negotiation alternatives and reduce dependence on a single access model. The challenge will be to coordinate them without transforming institutional complexity into yet another source of delay.

What should we be measuring?

Lenacapavir offers an opportunity to reconsider how we evaluate the success of innovation in healthcare. The industry typically tracks development indicators such as time to approval, research investment, patent generation, and commercial performance. Health authorities assess quality, safety, and efficacy. Public managers analyze cost-effectiveness and budgetary impact.

They are all necessary. None, in isolation, describes the social impact of a technology.

In the case of PrEP, we also need to look at how many people are able to start using it, how many remain protected over time, which groups remain excluded, how much it costs to deliver complete prevention, and finally, what reduction in new infections is attributable to the intervention.

Evaluation needs to consider equity in a concrete way . An innovative technology can improve the average results of a program and, simultaneously, widen inequalities if its provision is concentrated on people with easier access to services. On the other hand, a well-designed strategy can use the flexibility of semi-annual administration to reach populations underserved by traditional models.

This requires community involvement from the planning stage, not just outreach campaigns after decisions have already been made. There are also legitimate clinical choices. Some people will prefer the convenience of semi-annual injections. Others may prefer oral PrEP, whether for autonomy, the ability to discontinue its use more easily, or due to restrictions related to monitoring and local reactions. The WHO recommends expanding prevention options, not indiscriminately replacing one technology with another.

In Brazil, the new negotiation model offers the opportunity to incorporate economic and healthcare indicators from the formulation of agreements. It will not be enough to report how many contracts were signed or what percentage discount was obtained. It will be necessary to monitor the time between registration, incorporation and availability, the population coverage, the regularity of supply, the total cost of the intervention and its health outcomes.

For commercial agreements involving confidentiality, this assessment becomes even more important. The protection of sensitive information should not prevent society from knowing the performance of policies funded with public resources. In this sense, the most relevant innovation is not necessarily the one that achieves the largest market share. It is the one that allows offering the right choice to the greatest number of people possible, with security and continuity.

What this case teaches us about innovation in global health.

The trajectory of lenacapavir deserves to be recognized as a breakthrough on two fronts. The first is scientific . Gilead developed a technology with extraordinary clinical results, capable of substantially altering the possibilities for HIV prevention. The second is institutional . The collaborative work between an originator company, generic manufacturers, funders, academic institutions, multilateral organizations, and regulatory authorities demonstrated that the interval between the approval of an innovation and the development of affordable alternatives can be significantly shortened.

These are not competing achievements. One depends, to some extent, on the other. Without companies willing to invest in high-risk research, many of these technologies simply would not exist. Without dissemination and funding mechanisms, a significant portion of the social value of these discoveries would remain unrealized. The problem begins when we treat these two processes as completely separate responsibilities. Access ceases to be a verifiable commitment and becomes dependent on subsequent negotiations, commercial decisions, budgetary availability, and philanthropic initiatives that are not always permanent.

The lenacapavir case demonstrates that part of this process can be anticipated. It also demonstrates the limitations of doing so only for specific markets. For those who formulate innovation policies, the experience suggests a change of perspective. Access planning should enter earlier into development decisions, involving licensing, production capacity, economic evaluation, regulation, and implementation strategies.

The new Brazilian negotiation model points in the same direction, although it operates at a different stage of the chain. While international experience has anticipated the development of generic drugs, the Ministry of Health seeks to anticipate commercial negotiations and better organize the transition between incorporation and supply. These are different institutional responses to a similar problem: the fragmentation of decisions that determine access.

The discussion also touches on industrial policy . The announcement of a possible technology transfer for the production of lenacapavir in Brazil could open opportunities for the Health Economic-Industrial Complex , but requires careful evaluation.

Domestic production does not automatically guarantee lower prices. Viability will depend on scale, industrial costs, technological expertise, intellectual property rights, regulatory capacity, and specific transfer conditions. There are legitimate reasons to develop national productive capacity, including security of supply, training of industrial skills, and reduction of strategic vulnerabilities. But these objectives should not dispense with demonstrating the cost-effectiveness and health impact of the initiative.

Industrial policy can reinforce access policy. It should not be confused with it. This caution is especially relevant for technologies whose international price can fall rapidly with the entry of new manufacturers. Long-term industrial investments need to consider not only the current price of the original product, but also the likely evolution of competition and demand.

It also doesn't mean imposing the same solution on all medications. Technologies for rare diseases, treatments for chronic conditions, and large-scale preventive interventions present distinct risks, cost structures, and economic models. It means recognizing that the value of a health innovation also depends on the institutional architecture that allows its use.

Innovation still needs to reach its destination.

Just a few years ago, it seemed unlikely that a technology with this level of effectiveness could become available for tens of dollars annually so quickly. Lenacavir shows that some of the barriers we considered inherent to pharmaceutical development are, in fact, the result of organizational, contractual, and political choices that can be redesigned. This deserves recognition.

But it would be premature to declare the access problem solved. Dr. Reddy's generic drug still needs to reach the target countries, achieve scale, and be integrated into sustainable prevention programs. The funding crisis continues. Middle-income countries, like Brazil, remain dependent on specific negotiations. And experience shows that approving medications is much simpler than ensuring their equitable use.

In the Brazilian case, the discussion has taken on an additional dimension. The creation of the Committee for Negotiating Prices and Economic Conditions could expand the SUS 's (Brazilian Unified Health System) capacity to negotiate innovative technologies under conditions compatible with its budgetary reality. The new mechanisms for monitoring incorporation could reduce delays and improve coordination between decision-making and implementation. But the results of these changes still need to be demonstrated.

The performance of the new model will not be measured by the publication of regulations or the complexity of the contracts it manages to produce. It will depend on effectively negotiated prices, evidence-based decisions, fulfilled supply conditions, and expanded access without compromising the system's sustainability.

The next major measure of lenacapavir's success will not be a patent, regulatory approval, or a new licensing agreement. It will be its ability to reduce infections among people who currently remain outside of preventative care .

The industry has managed to develop an extraordinary drug. International partners have shown that access can begin to be planned before approval. Brazil is beginning to organize instruments to negotiate the economic value of these technologies in a more structured way. Now, governments, funders, companies, and civil society organizations need to demonstrate that this coordination can work on a large scale and last beyond the initial commitments.

Because, in the end, the impact of innovation in healthcare isn't measured solely by what science has made possible. It's also measured by what our institutions have managed to bring to people's lives.

by Marcio de Paula

Founder of the Brazilian Health Innovation Institute - IBIS , with over 25 years of experience in life sciences, he has held strategy and innovation positions in companies such as Biolab and Ferring Pharmaceuticals , founded the Brazilian Pharmaceutical Innovation Network , and is a member of health innovation boards in Brazil. He writes about the paths to radical innovation in health and how to connect science, industry, and public policy.