On vaccine patent waivers, why they won't help and a few proposed solutions

The U.S. administration proposed a patent waiver for the Coronavirus vaccine. In this post, I give insights into their reasoning^[1]. I realised that many people support this proposal by sharing signing requests for online petitions to suspend vaccine patents. While it is an understandable gesture and a beautiful Robin Hood idea, it is also essential to know why it won't help in the short term. In this post, I am trying to bring light to the debate.

FIRST, the U.S. administration's effort is more of a political theatre than an act of substance since they attempt to recover from the egoistic and arrogant decisions of the last six months. In addition, strong advocates for the decision were Bernie Sanders and Alexandria Ocasio-Cortez, who have been aiming more to lower drug prices in the U.S.^[2]. I deeply respect them for their efforts to create a fairer society, but in regards to this, they are wrong. Drug prices in the U.S. are not necessarily high because of intellectual property royalties but more because of their entire healthcare system. The TIME Magazine wrote an article comparing insulin prices in the U.S. with Germany^[3].

It is also worth mentioning that the U.S. government owns a patent relating to how the spike protein is stabilised in vaccines, but European companies hold nearly half of the mRNA vaccine patent application^[4]. Because of this, it is also easy to recognise the egoistic self-interest of why the U.S. government is promoting a patent waiver, especially if we consider the perspective of mRNA-based drugs and their promising perspective for cancer immunotherapy^[5]. Pfizer's decision to develop mRNA-based drugs on their own, without BioNTech, brings a negative connotation into the situation, too. Their CEO Albert Bourla said, "we have our expertise developed" when he openly did not extend the collaboration with BioNTech^[6], but do they hold the required intellectual property? Remember, BioNTech actually made it and NOT Pfizer. Another aspect is that Fosun Pharma, a Chinese-based pharmaceutical company, submitted the clinical trial data of a COVID-19 mRNA vaccine co-developed with BioNTech^[7] so that prices will drop, and volume will increase anyway.

SECOND, patent waivers or patent suspension won't fix the problem. In the following, you will read why.

— The most significant problem is that the U.S and U.K. are not exporting vaccines or raw materials. Europe produced >400 million doses and shipped>200 outside the European Union. The U.S. made ~321.5 million doses and exported 2.5 million. Adding to this, the U.K produce 22 million doses and exported 0.7 million. These production and export figures clearly show that global supply chains are not working. Patent waivers won't help here.

— Another big challenge is the complicated manufacturing process. BioNTech needed three months to build a manufacturing site in Germany and three months to reach mass-production volumes. Please note that they did not start from scratch and bought this site from Novartis, which manufactured proteins at this location^[8]. Patent waivers won't speed up the establishment of new manufacturing sides.

— A patent describes only a single embodiment and its claims. It is not giving you the company secrets and the know-how of pharmaceutical companies; providing access to a patent for mRNA-based vaccines will not show how to manufacture it.

— Patents are currently not the limiting factor. For example, BioNTech's manufacturing process involves more than 15.000 steps and around 200 ingredients. The entire manufacturing process needs to be executed accurately to ensure the effectiveness and safety of the vaccine. In addition, you need specialised equipment and facilities. Patent waivers will not address this, too^[9].

— The manufacturing process of mRNA-based drugs is challenging and complicated^[10]. One of the most significant challenges is the scalability and cost-effectiveness in mRNA manufacturing, mainly since the development of the vaccine relies on expensive and limited materials. The biggest problem is the production: Emergent BioSolutions vaccine factory in Baltimore had to destroy 15 million vaccine doses due to technical issues and contamination^[11].

— Many international companies are holding patents to produce mRNA-based vaccines. For example: To deliver the encapsulated mRNA to the interior cells, Pfizer depends on a lipid nanoparticle (NLP) system made in Canada^[12]. Indeed, under Article 27(2)^[13] of the TRIPS Agreement, WTO member countries may exclude the patentability of inventions necessary to protect public health. Still, a patent release would be negotiated in this framework, and all 164 signatory states would have to agree. This agreement is unrealistic and consumes valuable time. Bird & Bird shows questions and answers on the use of patented products and processes without authorisation of patent holder according to National compulsory license laws^[14].

— Out of more than 70 vaccine projects, only 14 have been approved so far. More than 50 have been wasted money for the companies. Imagine how pharmaceutical companies worldwide will feel once a patent waiver comes, mainly after working hard to ramp up new manufacturing capabilities. It is unfair and unresponsible of the Biden Administration to pass the bucket to the pharmacy companies, especially after they partly created the problem.

— Getting a vaccine reviewed and certified by any medical agency is time-consuming and cumbersome. Just look at the guidelines for vaccine antigens of the European Agency to evaluate medical products. If just one tiny piece of the >200 ingredients will change, even the glass vial packaging, the whole certification process has to restart to some levels. This certification process also is required for the vaccine manufacturing sites.

— The waiver of intellectual property regulations and TRIPS has unknown consequences to an already crumbled and heavily challenged global supply chain—thanks to the U.S. and U.K. It would cause supply chain chaos for raw materials, quality issues, counterfeit issues. Patent waivers sound humanitarian but would be a nightmare. It also will hinder and slow down innovation.

THIRD, what emerging countries need are vaccines, not patents. The intellectual discussion is just politics. The debate should be how can emerging countries receive the vaccine the fastest way.

NOW, since we learned why patent waivers would not solve the problem, what does solve the problem?

The answer is:

• COMPULSORY LICENSES

• COLLABORATION ON GLOBAL SUPPLY CHAINS

• INCREASE THE SUPPORT FOR THE LIKES OF COVAX

• WESTERN NATIONS SHOULD STOP HOARDING

(1) Compulsory licensing is when a government can allow others to make the product, usually with a reasonable royalty or fee, paid to the patent owner. It is the middle way and is sustainable for both the governments and the pharmaceutical companies^[15][16].

(2) Global supply chains need to be reactivated. The U.S. should eliminate its embargo of raw material so that vaccine production can ramp up. Adar Poonawalla, the CEO of the most prominent vaccine manufacturer globally based in India, humbly requested this April 16.

(3) All countries capable of manufacturing vaccines, especially the G20 states, should work together and support alliances like COVAX. Europe delivers 50% (>200 million doses), manufactured in the European Union to the world and did not keep it in Europe as the U.S. and U.K. did. The Biden administration is bluffing and wants to improve its image. They should start exporting vaccines.

(4) Western nations should stop hoarding vaccines. For example, The U.K. ordered five doses per capita, the same as the U.S. (including potential expansion). The European Union ordered two per capita and three with possible additions^[17]. This vaccine hoarding has to stop, especially after it is clear which vaccines will work and which not.