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Balancing Innovation & Access: Intellectual Property and Public Health

  1. 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

  1. 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.

  1. 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.

  1. 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

  1. 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

  1. 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.

  1. 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

  1. 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.

  1. The path forward
  1. Smarter incentives – “delinkage” models (e.g., prize funds or advance market commitments) reward innovation without a monopoly.
  2. Regional production hubs – the mRNA network shows how capacity-building can reduce dependency on charity.
  3. 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.
  1. 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

Balancing Innovation & Access: Intellectual Property and Public Health
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