{"id":5016,"date":"2025-11-04T20:04:51","date_gmt":"2025-11-04T20:04:51","guid":{"rendered":"https:\/\/blogs.luc.edu\/ipbytes\/?p=5016"},"modified":"2025-11-24T20:21:37","modified_gmt":"2025-11-24T20:21:37","slug":"no-one-should-wait-for-permission-to-stay-alive-in-the-next-pandemic","status":"publish","type":"post","link":"https:\/\/blogs.luc.edu\/ipbytes\/no-one-should-wait-for-permission-to-stay-alive-in-the-next-pandemic\/","title":{"rendered":"No One Should Wait for Permission to Stay Alive in the Next Pandemic"},"content":{"rendered":"

If your house was on fire, would you waste time asking for permission to borrow your neighbor\u2019s hose? Or would you grab it with no questions asked to save your home? To me, it felt like the house was burning down during the COVID-19 pandemic. Yet, when it came to life-saving vaccines, countries were stuck waiting for permission from patent holders, delaying access to care around the world. In fact, as recently as August of 2025, one article<\/a> suggests that intellectual property<\/a> (IP) laws were a contributing factor in the inequitable distribution of vaccines around the world which cost an estimated one million lives.<\/p>\n

To fix this, the European Union<\/a> has proposed<\/a> changes to the current system. This proposal hopes to establish robust compulsory licensing laws that apply to all 27 member countries and are quick to activate in times of crisis. The EU proposal is a great foundation. However, it misses the mark on a few features important to vaccine access.<\/p>\n

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Image by cromaconceptovisual from Pixabay<\/i><\/figcaption><\/figure>\n

But what is a compulsory license?<\/strong><\/p>\n

Let\u2019s return to the example of asking for permission before borrowing your neighbor\u2019s hose when your house is on fire. Would you want to be required to ask permission anytime a fire occurs? Or would you rather have an agreement in place that says: if flames break out, get the hose, no questions asked<\/em>? That is how a compulsory license works, with a couple of tweaks.<\/p>\n

A compulsory license<\/a> is when a government allows someone, other than the patent owner, to make a patented product or process without the patent owner’s consent. Patents<\/a> are some of the most powerful forms of IP<\/a>. Patents grant the patent owner exclusive rights over the invention. This allows them to prevent others from using, making, or selling their invention. This exclusivity lasts around 17 years on average<\/a>!<\/p>\n

Patent exclusivity is often justified by encouraging innovation<\/a>. However, in the middle of a crisis like the COVID-19 pandemic, patent exclusivity can leave many without access to critical medical treatments<\/a>. This is where compulsory licenses come in. They empower a government to authorize another manufacturer to make the patented invention (such as a critical vaccine), bypassing the need to get the patent owner\u2019s consent during the crisis. The patent owners are compensated, but the government determines<\/a> the amount, and it is usually less than what companies want. Compulsory licenses ensure that when things are burning down and people need vaccines, a country is prepared to borrow the hose without waiting for permission.<\/p>\n

The EU\u2019s Plan with Compulsory Licenses<\/strong><\/p>\n

As mentioned, the compulsory license proposal is a Union-wide plan applying to all member countries. In a pandemic or crisis, there is no time for 27 different governments to negotiate IP licenses with patent owners of key medical treatments. The EU\u2019s plan creates a pathway to obtain compulsory licenses in officially declared emergencies, such as global pandemics. These licenses would remain active only for the duration of the crisis. And patent owners would receive some compensation in exchange for using their IP. With the proposal, everyone can share and borrow the hose rather than make separate agreements with every neighbor.<\/p>\n

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Image by mufidpwt from Pixabay<\/i><\/figcaption><\/figure>\n

Is the EU\u2019s proposal foolproof?<\/strong><\/p>\n

Although a major step forward, the likely final<\/a> version of the EU proposal lacks several key provisions. Inapplicability to trade secrets<\/a>, exceptions to regulatory approval hurdles, and bans on exporting products made under these licenses are all remaining barriers.<\/p>\n

Let\u2019s start with trade secrets<\/u><\/p>\n

Even with compulsory licenses available for patents, trade secrets can pose an additional hurdle to accessing vaccines. Some medical treatments require specific manufacturing processes often protected as trade secrets. A trade secret<\/a> is information that has actual or potential value by virtue of being generally unknown, not readily ascertainable to others, and subject to reasonable secrecy measures. Although trade secrets can last indefinitely, if they lose their value or are no longer secret, the trade secret ceases to exist. Some famous trade secrets<\/a> include Coca-Cola\u2019s secret recipe and Hershey\u2019s chocolate-making process.<\/p>\n

In the context of healthcare, vaccines are hard to make<\/a>. They require specialized and technical know-how<\/a>. For example, the COVID vaccine is a biologic<\/a>. This means the vaccine must be prepared in a specific way, and the complicated process is often protected as a trade secret. Not all vaccines involve trade secrets. But for those that do, when someone gets a compulsory license to use the patent, they still <\/em>wouldn\u2019t be able to make a vaccine without the additional secret information. The current EU proposal<\/a> does not include a requirement for trade secrets to be disclosed, even though a prior proposal did. This barrier will remain.<\/p>\n

Next, what is regulatory approval and why is it a problem? <\/u><\/p>\n

A big hurdle after you get permission to make a medicine under the compulsory license is that you still need to get regulatory approval to sell it. <\/em>Similar to the US with the FDA<\/a>, the EU has a regulatory agency in charge of the safety of drugs: the European Medicines Agency (EMA<\/a>). Normally, this is a good thing. These agencies ensure drugs are tested and safe. However, in the middle of the pandemic, some of the laws that regulatory agencies apply can unintentionally slow down access to life-saving treatments.<\/p>\n

In the EU, this happens through something called data exclusivity<\/a>. When the original patent owner creates a new drug, they must submit clinical data to the EMA to prove their medicine is safe and effective to legally sell the drug. Creating this data takes time, research, and a lot of financial resources. Data exclusivity \u201clocks down\u201d the clinical information for 8 years. Nobody except the original patent owner can use the information to show safety and efficacy, even if they are making the exact same drug!<\/p>\n

This means that even when companies are allowed to make an invention under the EU\u2019s compulsory license, it would not be available to the public promptly without the ability to rely on that clinical data. Companies either have to run an expensive trial or wait until the 8-year period ends.<\/p>\n

However, the EU has not accounted for a data exclusivity waiver because patent owners have argued<\/a> that it isn\u2019t fair for outside companies to rely on expensive clinical information. The EU could create a flexible exception<\/a> that only applies in a public health crisis to deal with increased need, but not be permanent. This approach would allow companies to rely on already existing safety and efficacy data for faster market entry when it is most essential.<\/p>\n

Now, let\u2019s move on to the EU\u2019s failure to consider other countries. <\/u><\/p>\n

Another problem with the EU plan is that it bans exporting any inventions made under a compulsory license. This can be a big problem during a pandemic. COVID-19 didn\u2019t stop at the border. Neither should medical treatments. A lot of countries around the globe struggle with manufacturing capacity to produce drugs or vaccines on their own, so they rely on imports. The EU\u2019s ban on exports leaves these countries vulnerable without access to the medical treatments the EU knows they need.<\/p>\n

Some groups and organizations have recognized this gap in the EU proposal. Doctors Without Borders has asked<\/a> the EU to allow for exporting inventions made under a compulsory license. They also recognize that some international agreements concerning IP have been amended to allow for exports. One significant trade agreement that applies to all World Trade Organization (WTO<\/a>) countries, including the EU and US, already allows for exports to countries that lack manufacturing capacity to use compulsory licenses to make drugs themselves: TRIPS 31bis<\/a>.\u00a0 \u00a0However, not all countries have domestic laws implementing TRIPS 31bis. The latest EU proposal fails to address this. Why should one home burn down because they don\u2019t have a garden hose when the rest of the other neighbors could easily lend a helping hand? <\/em><\/p>\n

What Should Other Countries Do? <\/strong><\/p>\n

As of today, over 7 million people<\/a> around the world have died from COVID-19. The EU proposal is a step forward to have compulsory licenses on the table as a solution in a future crisis. However, while the EU proposal is a blueprint, it fails to account for multiple remaining barriers. Other countries should learn from the EU proposal \u2013 including its omissions.<\/p>\n

In the future, other countries should be sure to not only have compulsory license provisions for pandemics but also include exceptions for trade secrets and data exclusivity. Also, for countries that can effectively make treatments, they should have compulsory licenses that allow vaccines to be exported. The combination of reduced barriers and ability to export means that, in a future pandemic, lifesaving care can be shared exponentially sooner. With a faster response time, more of the public can be protected in the future. If these steps are taken, we might actually be in a position where we can put out fires at each other\u2019s homes.<\/p>\n

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Emily Miller<\/em>
\nAssistant Blogger<\/em>
\nLoyola University Chicago School of Law, J.D. 2027<\/em>
\n[With thanks to Iris Gomez for her collaboration on an earlier draft completed for Global Access to Medicine<\/em> class.<\/em>]<\/p>\n","protected":false},"excerpt":{"rendered":"

If your house was on fire, would you waste time asking for permission to borrow your neighbor\u2019s hose? Or would you grab it with no questions asked to save your home? To me, it felt like the house was burning down during the COVID-19 pandemic. Yet, when it came to life-saving vaccines, countries were stuck waiting for permission from patent holders, delaying access to care … Continue reading No One Should Wait for Permission to Stay Alive in the Next Pandemic<\/span><\/a><\/p>\n","protected":false},"author":106,"featured_media":5018,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[428],"tags":[],"class_list":["post-5016","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-ip-health"],"_links":{"self":[{"href":"https:\/\/blogs.luc.edu\/ipbytes\/wp-json\/wp\/v2\/posts\/5016","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.luc.edu\/ipbytes\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.luc.edu\/ipbytes\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.luc.edu\/ipbytes\/wp-json\/wp\/v2\/users\/106"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.luc.edu\/ipbytes\/wp-json\/wp\/v2\/comments?post=5016"}],"version-history":[{"count":6,"href":"https:\/\/blogs.luc.edu\/ipbytes\/wp-json\/wp\/v2\/posts\/5016\/revisions"}],"predecessor-version":[{"id":5045,"href":"https:\/\/blogs.luc.edu\/ipbytes\/wp-json\/wp\/v2\/posts\/5016\/revisions\/5045"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/blogs.luc.edu\/ipbytes\/wp-json\/wp\/v2\/media\/5018"}],"wp:attachment":[{"href":"https:\/\/blogs.luc.edu\/ipbytes\/wp-json\/wp\/v2\/media?parent=5016"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.luc.edu\/ipbytes\/wp-json\/wp\/v2\/categories?post=5016"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.luc.edu\/ipbytes\/wp-json\/wp\/v2\/tags?post=5016"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}