LENACAPAVIR, an injectable antiretroviral drug developed by Gilead Sciences, recently made headlines after a Phase 3 clinical trial in South Africa and Uganda showed it to be 100 per cent effective in preventing HIV among women and adolescent girls.

Though hailed as a breakthrough in HIV prevention, lenacapavir serves as a stark reminder of the problems with the pricing of life-saving medicines.

While further data from this study and results from studies involving other populations are needed, lenacapavir could be considered the most durable HIV prevention method to show efficacy among women — a population for who biomedical HIV prevention evidence has been severely limited.

Yet, this case highlights a broader, systemic problem within the pharmaceutical industry, which is dominated by large transnational corporations, commonly referred to as Big Pharma.

The private pharmaceutical sector is plagued by severe dysfunctions. No honest observer can deny that the current system is characterised by a lack of innovation, the privatisation of public resources (also known as “double taxation”), a disconnect between research and development efforts and public health needs, shortages of essential health technologies, evidence-based clinical trials, distortions in drug prescriptions, and clandestine market.

However, one of the most glaring indicators of this model’s failure is the exorbitant prices charged for medicines, vaccines, and other health technologies.

The closest we got to an HIV vaccine — but not for everyone

Although lenacapavir may not be the best option for everyone or in all settings, along with other long-acting pre-exposure prophylaxis (PrEP) formulations it could be crucial for people who face barriers to daily pill-taking.

As a twice-annual injection, it could significantly improve the feasibility of PrEP for many people who could benefit from this new regimen. That is why it has been described as “the closest we have ever been to an HIV vaccine.” However, as history has shown time and again, scientific breakthroughs alone are not enough — medical innovations are usually inaccessible to those who most need them.

Gilead claims it is too early to price lenacapavir for prevention. However, given the company’s history and current practices, we can anticipate the worst. While the production cost of this medicine could be estimated at $40 per patient per year — including a 30 per cent profit margin — lenacapavir is currently marketed at $42,250 per patient per year to treat HIV infection.

This means Gilead is charging over a thousand times the estimated production cost, a clear example of abusive pricing that is entirely disconnected from actual production expenses.

False solutions

When we are confronted with this concrete problem, several false solutions commonly emerge. Bureaucrats from various sectors of society — multilateral organisations, national governments, the private sector, academia and NGOs — often resort to the same ineffective and dangerously irresponsible formulas.

The most extremists among them suggest we should simply wait and trust Gilead’s promise to formulate “a strategy to enable broad, sustainable access globally.” Others, slightly more grounded in reality, propose that national governments should “negotiate” discounts with the producer or, if necessary, pay the exorbitant prices imposed.

In this scenario, patients would have free access to their medicines, and governments could fulfil their constitutional duty. However, if a government cannot afford even the “negotiated” prices, the only remaining option is to wait for charitable donations, either from the originator company itself or benevolent billionaires.

Others advocate for waiting, “imploring” or, at best, pressuring for comprehensive voluntary licenses for lenacapavir’s patents. This means relying on the hope that the originator company will allow generic manufacturers to produce and sell the medicine at a lower price across all low — and middle-income countries (LMICs), including upper-middle-income nations like Brazil.

Although this approach is often portrayed as a more realistic or refined solution to the challenges posed by the private pharmaceutical sector, it remains a false and dangerous path. Cloaked in misleading propaganda and an unimaginative vision of the future, this narrative strategically ignores the negative consequences of voluntary licenses.

These include geographic segmentation (which excludes countries with a high incidence of the disease), control over competition, the imposition of abusive conditions on generic companies and communities (eg unethical anti-diversion requirements), and regulatory delays or blockages often orchestrated by the originator company.

They also overlook the emergence of de facto monopolies regardless of patent protection in each country, disincentives to patent opposition (especially from local generic companies and public laboratories), obstacles to compulsory licences, legitimisation of high prices in excluded countries, the reinforcement of the patent system, and the enhancement of the originator company’s public image. Above all, they overlook the immoral hierarchisation of human life.

All these false solutions share a common logic: they offer superficial and topical proposals to address systemic and structural problems, lacking the urgency, courage and imagination required for meaningful change.

These approaches conveniently ignore the dynamics of power and politics, favouring a purely “technical” rationale while anxiously avoiding conflict with Big Pharma. This leads to a detachment from people’s suffering and an excessive dependence on the will of the pharmaceutical industry.

Continuing down this same worn path will only lead us back to the same outcomes. Have we already forgotten what happened with sofosbuvir, dolutegravir, cabotegravir, remdesivir, and many other life-saving medicines that remained arbitrarily inaccessible to millions of people?

Have we already forgotten how the old strategies have failed, even as they were sold to us as grandiose victories? Can we afford the same outcomes in the case of lenacapavir? As the saying goes, “Insanity is doing the same thing over and over again and expecting different results.”

Public pharma

With this in mind, the first step is to recognise the urgent need to abandon simplistic formulas and begin discussing real solutions to the dysfunctions caused by transnational corporations.

In this context, and without oversimplifying the problem or being compromised by conflicts of interest, many stakeholders — including networks, social movements, civil society organisations, patients, scientists, activists and academics — indicate that the establishment, protection and expansion of public pharma is, at the very least, a crucial component of a real solution.

In contrast to Big Pharma, public pharma can be understood as state-owned infrastructure dedicated to the research, development, manufacturing and/or distribution of pharmaceutical products and other health technologies.

It encompasses all institutional arrangements where the state holds genuine decision-making power and can establish governance driven by public health needs. This does not include, for example, public-private partnerships (PPPs) or any arrangement in which states merely use public resources to derisk commercial enterprises.

An excellent example of creating new public pharma infrastructure could be the proposed European Salk Institute, envisioned by the Belgian organisation Medics for the People.

Protecting existing public pharma could take many ways, such as shielding public laboratories from austerity policies, as seen with Fiocruz and other public laboratories in Brazil. Similarly, opportunities for expanding public pharma could involve a diverse range of public institutions worldwide that currently focus on specific health technologies, production stages, or diseases.

In practice, public pharma has the potential to enable the public production of specific medicines (eg, lenacapavir), while significantly enhancing the state’s capacity to produce a broad range of essential health technologies.

It can facilitate the research, development, manufacturing, and distribution of health technologies driven exclusively by public health needs, ensuring high-quality, sustainability, transparency, and affordability. Public pharma can also promote international co-operation and reinforce health sovereignty by reducing dependency on transnational corporations.

Finally, it can empower states to engage in meaningful price negotiations with the private sector, effectively enforce TRIPS safeguards (especially through compulsory licenses), and ethically honour the contributions of populations participating in clinical trials.

Public pharma, of course, is not a panacea, but it is a bold step towards reclaiming our health systems from the grip of corporate greed. To truly address the crisis, we must do more than merely tinker with a broken system — we must challenge the neoliberal orthodoxy that enshrines patents as sacrosanct, dismantle Big Pharma’s stranglehold, and reclaim the power to determine our own futures.

This is the beginning of a necessary and urgent transformation. For the sake of current and future generations, we must have the courage to forge a new path, one that prioritises human lives over profit. The time to act is now, and we cannot afford to fail.
 
Alan Rossi Silva holds a PhD in law and serves as the European co-ordinator of the public pharma project at the People’s Health Movement. He writes in a personal capacity.

People’s Health Dispatch is a fortnightly bulletin published by the People’s Health Movement and Peoples Dispatch (www.peoplesdispatch.org).