Pharmaceutical Barriers Could Stop New Revolution in Fighting AIDS | Planet of the Future

The HIV Strategy, approved in 2023, set a target of reducing new HIV infections to fewer than 335,000 by 2030. However, according to UNAIDS, between 1 million and 1.7 million people will become infected with HIV in 2022. While new infections have declined by 38% since 2010, reaching the 2030 target would mean a reduction of almost 80% in just six years, tripling the current rate of decline. Prioritising prevention strategies such as pre-exposure prophylaxis (PrEP) is therefore a priority.

HIV prevention has advanced significantly in recent years with the introduction of long-acting injectables that improve adherence to treatment by reducing the frequency of dosing. Since the launch of PrEP with cabotegravir (CAB-LA), it has gone from taking daily pills to injecting every two months. Now, a new treatment could revolutionize PrEP: lenacapavir (LEN), which has shown promise in clinical trials to prevent infection with just two injections per year. Lenacapavir has demonstrated 100% efficacy in preventing new HIV infections in cisgender women (who identify with the gender they were born with) in South Africa and Uganda, with superiority over oral and daily drugs. Additionally, it does not require cold chain storage, making it easier to manage and integrate into supply chains in countries with high temperatures.

Lenacapavir, which has shown promising results in clinical trials, can prevent infection with just two injections a year.

Despite all these benefits, access to these fundamental public health tools faces numerous barriers, which are partly shared by the entire model of pharmaceutical innovation and development. And as more and more evidence shows, the practices of the for-profit sector, especially multinational corporations, are responsible for poor health outcomes and health equity (the so-called commercial determinants of health).

What can we learn from past experiences with this type of product that will help us avoid making the same mistakes in the future? The case of cabotegravir This can give us insight into the type of complex and interrelated issues that prevent the people who need them most from accessing these treatments: issues arising from monopoly and pricing, regulation, or production.

ViiV Healthcare’s monopoly is the main factor responsible for the high price of CAB-LA, as it prevents other companies from entering the market that could produce generic versions of the drug. Although the price for low-income countries (around €180 per person per year) is significantly lower than in other countries, it is still out of reach for many national health programs and is estimated to need to be at least four times lower to be viable. Independent studies have shown that the price of generics, if they exist, could fall to €13 per person per year, lower than current oral PrEP.

At the regulatory level, the tests needed to bring generic versions to market, called bioequivalence studies, will further delay the entry of competitors. In 2022, ViiV Healthcare and the Medicines Patent Pool (MPP) — a patent pool founded by global health organization Unitaid to improve access to medicines — signed a licensing agreement under which the company allowed MPP to manage and use CAB-LA’s intellectual property for generic manufacturers to sell the treatment at affordable prices in many middle-income countries. However, these bioequivalence studies are expected to prevent generic companies from selling their products for three years.

As of 2022, CAB-LA had been approved for prophylactic use in only four countries, and for marketing use in a further 12. By 2024, it had been approved in 20 countries and was being used in a further nine, largely due to pressure from civil society. The application for marketing authorisation is a key preliminary step to ensure access to a medicine, and therefore a key element of access in monopoly situations.

Transparency is an essential element of sustainable supply chains that improve public health. Unfortunately, transparency does not define the current pharmaceutical ecosystem, which is based on great opacity in research and development (R&D) costs, clinical trial results, or the actual price to the public payer. In the case of CAB-LA, the lack of transparency in manufacturing capacity and supply chain limits the ability to respond to growing global demand. And as we have seen in the response to Covid-19, fulminant monkeypox, or Ebola, in situations of increasing demand, middle- and low-income countries are the last to have access to treatment.

Transparency is an essential element of sustainable supply chains that improve public health.

These lessons from CAB-LA provide some clarity about the uncertain future of access to lenacapavir. Gilead, which owns the latter’s intellectual property, does not yet have a clear global access strategy. The web of patents surrounding the product will prevent any generic competitor from emerging until its last patent expires in August 2038 (a date that can be extended under laws governing various types of protection and exclusivity for drugs on the market). Given this prospect, it is essential that the company provide voluntary licenses to expand access to generics. To this end, the agreement negotiated with the Medicines Patent Pool should include as many countries as possible, following public health criteria and not just maximizing profits.

Ideally, these licensing agreements would be embedded in a broader global access strategy: rapid global registration of products, transparency across the supply chain, and affordable pricing for the various health systems and organizations that want to adopt these products. However, voluntary measures have very limited impact, as we have seen during Covid-19. So, looking ahead, what else can we do?

There are very interesting initiatives being promoted by UNITAID, which are developing long-acting drugs not only for HIV, but also for malaria, tuberculosis or hepatitis C, so that the innovations that are being produced are affordable. They are also implementing projects to fund the implementation of CAB-LA in Brazil and South Africa to stimulate global scaling.

Besides these actions, there are other tools for change status quo original. One of them is legally included in the section “Trade-Related Aspects of Intellectual Property”: compulsory licenses. These force companies to grant patent licenses for the production of generics. This is what Colombia did when it issued a compulsory license for access to generic versions of dolutegravir, an HIV drug. In the case of long-acting drugs, even if such a situation were to arise, it is most likely that we will not see the results materialize in the short or medium term, as these are usually very slow processes. Despite this, governments should take these measures into account in order to guarantee public health, since sometimes the threat of compulsory licensing itself leads to lower prices.

These are the solutions a posteriori, but they do not offer an alternative to rethinking the model whereby innovations are globally available by default and are an integral part of policy, acting as early and as quickly as possible to have the greatest impact. Beyond the necessary reform of the current intellectual property system, there are opportunities to influence the regulatory framework for pharmaceuticals to improve transparency and global access.

One possibility for this is the ongoing revision of European pharmaceutical legislation, in which these principles should become cornerstones rather than exceptions. For example, by conditioning the huge incentives currently provided to pharmaceutical companies through public funding (without the expectation of any public return in return) on mandatory commitments to develop and implement global access plans such as those mentioned above.

This vision of regional policy as a political determinant of global health is still rare among policymakers, who limit their analysis to a national or European framework. However, it is essential that we act on all fronts to achieve the goals that the international community has set for 2030. As we recently reported to the EU Council, “ensuring adequate access and supply of medicines is a standard by which a pharmaceutical company should be assessed, not a behaviour to be rewarded.”

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