Guest Editor Perspectives on Pharmaceutical Intellectual Property and Health Equity
Published in Sustainability and Law, Politics & International Studies
Pharmaceutical intellectual property refers to the legal rights a company has over a specific drug, manufacturing process, or branding. It gives companies the opportunity to exclusively manufacture and profit from a new pharmaceutical product for a short period of time, typically to cover the high costs that research incurs. The intellectual property (IP) system is vital to incentivise companies to keep developing new products. Research into a new drug can take many years of investment, and without the protection that IP offers there is little motivation to put money into such a high-risk area. Competitors can copy a drug in a much shorter timeframe, and without IP protections the commercial return on a new product would be extremely limited.
Pharmaceutical intellectual property can be a controversial topic when discussing health equity. Although it is generally understood that this model is the foundation upon which innovation is built, IP is also seen to be restricting access to valuable drugs for vulnerable populations. This contrast creates tension between pharmaceutical IP and health equity, and a fine balance must be maintained.
Technically, IP protection offers companies a ‘reward’ for their work developing a new drug, in the form of increased profits due to the protected period where only they can sell the drug. However, even with Competition watchdogs, there could still be pricing issues with serious effect. A 2017 South African Competition Authority investigation against Pfizer, Roche and other pharmaceutical companies alleged that drug prices were risking patients’ lives. The investigation focused on suspected excessive pricing of cancer medicines, but no final finding of wrongdoing was issued; the companies reached various settlements or the cases were withdrawn. Allegations stated that ‘most breast cancer patients’ were ‘unable to get treatment’, with lung cancer treatment described as ‘unaffordable’. These statements reflected the Commission’s concerns during the investigation, not confirmed outcomes.
These issues are even more pressing for diseases that primarily affect lower economically developed populations. Neglected tropical diseases (NTDs) are a collection of 20 tropical diseases, which affect one sixth of the world's population. NTDs affect a tiny number of patients in high income countries, meaning the market for drug sales is very small. Despite the huge number of NTD patients, commercially it is unattractive for a company to invest in drugs to treat them. In some cases, it would be almost impossible to recover the costs associated with researching a potential treatment. Despite the clear impact on research motivation that IP has in high-income countries, this same system compounds access issues for vulnerable populations, that already experience lower standards of healthcare.
SDG3 goal 3.8 calls for access to safe, effective, quality and affordable essential medicines and vaccines for all. It is impossible to consider increasing access to medicines without thinking about pharmaceutical IP. The tension created by the innovation-access argument calls for a nuanced and evidence-based approach to be taken if true health equity can be reached.
I spoke with the Guest Editors of Humanities and Social Sciences Communications’ Collection on Pharmaceutical Intellectual Property, to explore their perspectives on these issues.
How do you see pharmaceutical IP affecting health equity today?
“Pharmaceutical IP affects health equity not just by making medicines expensive, but by shaping the whole innovation pathway. The dominant model rewards innovation through monopoly rights, regulatory exclusivities and market power, while much of the scientific risk and enabling infrastructure is publicly or collectively supported. That model can produce important medicines, but it tends to prioritise commercially attractive markets and therapeutic areas, leaving lower-income populations, neglected diseases and weaker health systems structurally disadvantaged.” – Dr. Gabriela Lenarczyk
“Pharmaceutical IP continues to shape health equity in dynamic and sometimes unclear ways. On the one hand, patents remain central to the incentive framework for developing new medicines, particularly in areas of high technical uncertainty. On the other, exclusivity regimes can entrench disparities in access, especially where pricing strategies or limited manufacturing impede diffusion.” – Dr. John Liddicoat
“The COVID-19 pandemic demonstrated that IP can create barriers to access vaccines and treatments- especially if IP holders choose not to issue voluntary licences- this can lead to supply issues and high prices. Intellectual property and benefit-sharing obligations have become key points of contention in negotiations over the PABS annex of the WHO Pandemic Agreement. These disagreements have contributed to delays in finalising the annex - the May 2026 deadline has been pushed to May 2027. This could be problematic for equal access to medicines in future pandemics and we risk repeating the inequities of the past if an agreement cannot be reached.” – Dr. Brigitte Tenni
“Research-based pharmaceutical companies rationally target areas likely to generate the highest returns during the exclusivity period, especially chronic conditions affecting populations in wealthy countries because these patients (or their health insurers/governments) will pay large amounts over long periods. You can see this in the recent frenzy over weight-loss drugs. Meanwhile, diseases that mostly affect people in lower-income countries receive a fraction of the investment. That's not to say medications such as weight-loss drugs aren't good, but the way that research money is allocated could certainly be more equitable.” – Dr. Adam Buick
“The COVID-19 pandemic exposed inequalities in medicine and vaccine access, particularly in developing countries, and demonstrated that IP rights are a focal point during global health emergencies. This explains the COVID-19 WTO 2022 IPR waiver for COVID 19 vaccines, despite the argument that a patent is not a barrier for equitable medicine. The current Ebola outbreak highlights the importance of ensuring timely, equitable access to medical technologies in low-income regions that are the most vulnerable to infectious disease outbreaks. While patents continue to play a critical role in incentivising pharmaceutical innovation, future discussions are likely to move beyond patents alone to encompass broader issues such as manufacturing capacity, technology transfer, regulatory cooperation, data exclusivity and trade secret protection of pharmaceuticals. In this evolving landscape, the challenge is no longer whether patents matter, but how intellectual property systems can better balance innovation incentives with the urgent need for accessible medicines.” – Dr. Ezinne Igbokwe
What misconceptions exist about patents and access to medicines?
“A common misconception is that patents are either the whole problem or not a problem at all. In reality, patents are only one element in a wider exclusivity architecture that includes regulatory data protection, market exclusivity, secondary patents, trade secrets, manufacturing know-how and licensing practices. Conversely, removing a formal patent barrier may still not create access unless producers have the tacit knowledge, regulatory pathways, manufacturing capacity, procurement systems and financing needed to get a medicine to patients.” – Dr. Gabriela Lenarczyk
“A persistent misconception is that patents are always the primary cause of access problems. While patents can contribute to high prices, the relationship is more complex: patient demand, market structure, procurement systems (including HTA-based negotiations), and health system capacity all play significant roles. Conversely, the counter-misconception (i.e., that patents are always necessary for innovation) overlooks the diversity of funding models and the importance of publicly supported research.” – Dr. John Liddicoat
“One pervasive myth is that greater patent protection and more stringent IP provisions lead to greater pharmaceutical innovation. The converse can often be true: longer data protection periods can constrain innovation, and nondisclosure of test data can stifle follow-on innovation. Greater IP protection for pharmaceuticals can prolong monopoly periods and prevent generic competition-thereby maintaining high prices for longer. This can disincentive innovation, as originators can maximise their investment (especially for very commercially successful products) by using multiple IP clauses to prolong the patent life as long as possible without having to innovate.” – Dr. Brigitte Tenni
“As my co-editors have already mentioned, patents are not the only barriers to access. What I'd like to add here is that this doesn't just mean that there are non-IP barriers to access, there are also lots of barriers to access within the IP system in addition to patents. There's a range of non-patent exclusivities that operate alongside the patent framework, and these mean that even is a patent is invalidated, revoked, expired or subject to a compulsory license, IP barriers can remain in place. The most significant here is test data exclusivity, which prevents generic manufacturers from relying on originator clinical trial data for regulatory approval, but there are others as well, like paediatric exclusivity in the US. There's also trade secret protection of know-how, which can be extremely important as we saw during the pandemic, and even trademarks can have a role since brand name recognition is so important in medicine.” – Dr. Adam Buick
“One of the misconceptions is the fact that patents are often portrayed the sole or most significant obstacle to equitable access to medicines and medical technologies. For pharmaceutical innovation, this may be true to some extent because the industry is largely patent reliant. Consequently, without some form of protection, pharmaceutical companies have reduced incentives to invest in costly/risky drug development. While patents are important, they are not the only drivers of innovation. Public funding, university research, government grants, prizes, and collaborative research initiatives also contribute significantly to the development of medicines and vaccines.” – Dr. Ezinne Igbokwe
Where do you see the biggest access challenges globally?
“The biggest access challenges globally are where legal, technical and health-system barriers overlap. We see this especially in high-cost biologics, oncology, rare disease treatments, vaccines and platform technologies, where know-how and manufacturing capacity matter as much as formal IP. Low- and middle-income countries are also often late to be included in clinical trials, registration strategies, reimbursement plans and voluntary licensing arrangements, while many middle-income countries are squeezed: too “rich” for concessional access, but not financially able to absorb monopoly prices. The main question, in my view, is not whether innovation should be rewarded, but whether those rewards are (or could be) conditioned on equitable access from the start.” – Dr. Gabriela Lenarczyk
“Middle-income countries face significant and distinct challenges in accessing essential medicines. Many MICs (Egypt, Pakistan, Ukraine) bear a disproportionate burden of diseases that require costly treatments (the most cited is hepatitis C) while simultaneously being ineligible for donor support and being excluded from many voluntary and MPP licences. As a result, substantial gaps in access to medicines persist despite their economic classification as middle-income countries.” – Dr. Brigitte Tenni
“One thing COVID made clear (although in many ways HIV/AIDS had already shown this) is that the system of international agreements underpinning pharmaceutical IP protection is poorly equipped for major global health emergencies. Flexibilities like compulsory licensing exist on paper but are difficult to make effective use of in practice. There was some hope post-COVID that we'd get substantive reform here before the next pandemic, especially through the WHO Pandemic Treaty negotiations. However, as Brigitte notes, the PBAS annex has proven a sticking point and the deadline for the annex has now been pushed back to May 2027.” – Dr. Adam Buick
“The most pressing future challenge is not patents in isolation but the broader issue of global preparedness and equitable access during health emergencies. The COVID-19 pandemic and the current Ebola (the new variant largely differs from the previous variant) outbreaks in Africa remind us that when a public health crisis emerges, the critical question is not simply whether a medicine exists, but whether countries can obtain it quickly, affordably, and in sufficient quantities. The future access debate will therefore likely focus less on patents alone and more on building resilient systems that combine innovation incentives with rapid and equitable global access” – Dr. Ezinne Igbokwe
Thank you to the following Guest Editors for their contributions to this post:
- Adam Buick, PhD, Ulster University School of Law, UK
- Ezinne Igbokwe, PhD, University of Sheffield, UK
- Gabriela Lenarczyk, PhD, Inter-CeBIL, University of Copenhagen, Denmark
- John Liddicoat, PhD, King’s College London, UK and Inter-CeBIL, University of Copenhagen, Denmark
- Brigitte Tenni, PhD, University of Melbourne, Australia
Humanities and Social Sciences Communications is calling for papers on Pharmaceutical intellectual property as part of a Collection. We invite submissions addressing the multifaceted legal, economic, ethical, and policy dimensions of pharmaceutical IP from diverse disciplinary perspectives and geographical contexts. Submissions are welcome until 24th November 2026. Collection manuscripts typically see higher citations, downloads, and Altmetric scores and provide a one-stop-shop on a cutting-edge topic of interest.
To submit an article, please visit https://www.nature.com/collections/bffjbiagge
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