Artificial Intelligence and Copyright — An Unavoidable Debate in the Digital Age
April 3, 2025Creativity, Commerce & Copyright: How IP Powers the Creative Economy
June 28, 2025Artificial Intelligence and Copyright — An Unavoidable Debate in the Digital Age
April 3, 2025Creativity, Commerce & Copyright: How IP Powers the Creative Economy
June 28, 2025Balancing Innovation & Access: Intellectual Property and Public Health
- Why talk about IP and health?
When a life-saving drug, vaccine or diagnostic test appears, two opposite needs collide. Governments and patients want fast, low-cost access everywhere, yet inventors and investors want to recoup the billions spent on R &D. Intellectual-property (IP) rules sit at the centre of that tension, determining who can make the product, where, how soon and at what price. Getting the balance wrong has real-world consequences: in 2022, for example, the World Health Organization (WHO) still recorded primary COVID-19 vaccination rates below 25 % in many low-income countries while high-income states considered fourth boosters. apps.who.int
- Patents: incentives and obstacles
A patent grants a 20-year legal monopoly on a new medical technology. That exclusivity attracts investment (few venture-capital firms back projects they cannot own), but it also means the patent holder can set prices and limit supply. In pandemics, that high-price, low-volume model becomes a bottleneck when billions need doses at once.
- TRIPS: the global rule-book
Most countries follow the WTO’s Agreement on Trade-Related Aspects of IP Rights (TRIPS). TRIPS set minimum patent standards worldwide, so a drug that is patented in Paris will likely also be patented in Pretoria or Phnom Penh. The treaty, however, includes “flexibilities” that let governments override patents in emergencies.
- Flexibilities you should know
- Compulsory licensing (CL) – a government issues a licence so a local company can make the product without the patent holder’s consent, paying a royalty. The EU is currently drafting a CL-for-crises regulation to streamline this option. apps.who.int
- Government use – the state itself manufactures or imports a product purely for public programmes.
- Parallel import – a country buys the same patented drug from a market where it is sold cheaper.
These safeguards are legal, yet they attract political pressure. A 2024 study shows developing countries often face backlash from trading partners when they merely threaten to use CL. medicineslawandpolicy.org
- COVID-19 and the TRIPS-waiver debate
In October 2020 India and South Africa asked the WTO to waive certain TRIPS rules for COVID-19 vaccines, treatments and diagnostics. The idea was simple: suspend patents temporarily so every manufacturer that could legally copy the technology and scale up supply. After two years of negotiation, members agreed in 2022 to a partial waiver covering vaccines; by early 2025 discussions about extending it to therapeutics and tests were still ongoing. aippi.orgughj.unicamillus.org
- Did other mechanisms help?
While governments argued, voluntary efforts reduced, but did not eliminate, the access gap:
Initiative | What it did | Limitation |
COVAX | Shipped 74 % of all COVID-19 doses delivered to low-income countries | Relied on donations; deliveries slowed after interest waned in 2023 who.int |
Medicines Patent Pool (MPP) | Negotiated licences so 27 generic firms could copy antivirals like paxlovid | Deals exclude several middle-income countries |
WHO mRNA Technology-Transfer Hub | Teaching companies in South Africa, Argentina and elsewhere to make mRNA vaccines from scratch | First locally made clinical batches expected only in 2025-26 who.intiol.co.za |
These schemes show that voluntary sharing is possible but often slow and selective.
- Compulsory licensing in real life
During the HIV crisis in the early 2000s and again in the COVID-19 pandemic, countries such as Canada, Brazil and Malaysia passed laws enabling quick compulsory licences when public health was at risk. Civil-society groups are now urging governments to consider the same tool so that a promising long-acting HIV-prevention injection (lenacapavir) can reach every region, not just a favoured list of 120 countries. apnews.com
- Beyond patents: know-how and data
Even when a patent is waived, manufacturers still need the “recipe”: cell lines, production protocols, clinical-trial data. New proposals for open science clauses would oblige companies that accept public R &D funding to share such know-how during declared health emergencies. The draft WHO Pandemic Accord, due for negotiation in late 2025, contains language pointing in that direction.
- The path forward
- Smarter incentives – “delinkage” models (e.g., prize funds or advance market commitments) reward innovation without a monopoly.
- Regional production hubs – the mRNA network shows how capacity-building can reduce dependency on charity.
- Automatic waivers or fast-track CL – clear triggers (a WHO Public-Health Emergency of International Concern, for instance) could activate IP flexibilities instantly, avoiding years of negotiation.
- Key take-aways for readers
- Patents are not the enemy; they are a policy tool. The challenge is designing rules that incentivise breakthrough science yet do not price patients out.
- The COVID-19 era exposed both the power and the limits of voluntary licensing. Mechanisms that are mandatory, automatic and transparent are gaining traction.
- As future pandemics loom, expect a more prominent role for regional manufacturing, patent pools and tougher clauses on technology sharing.
This article is a brief commentary on legal developments; it is not intended to be an exhaustive analysis or to provide legal advice. For more information, please contact us at info@ellipseip.com