Q&A on pooling patents, know-how and technology

We need to do everything within our power to end the corona pandemic as quickly as possible. Now that a number of pharmaceutical companies have developed safe and effective vaccines, the next step is to make them available to everyone in the world without further delay. The longer we wait, the more damage it will inflict on our health, societies and economies. Moreover, new mutations of the virus might make current vaccines less effective.

To protect everyone in the world rapidly, it is vital to maximize the production capacity of vaccines. All available factories of qualified pharmaceutical companies worldwide should be running right now to make enough vaccines for all of us. The few pharmaceutical companies that currently produce approved vaccines, should share their patents, know-how and technology, enabling other pharmaceutical companies to produce these vaccines as well.

Sharing only patents would be insufficient. Patents give manufacturers the right to make the vaccine, but do not tell them how to make them. Therefore, it is also essential that companies share all knowledge necessary to produce vaccines. This includes, for example, the recipe, test data and technical instructions.

Thus, in order to curb the pandemic, an optimal manufacturing capacity is crucial. Making both patents and knowledge accessible for others to contribute to this, is key.

In 2020, the World Health Organization (WHO) set up a platform to facilitate the voluntary sharing of Covid-19 related patents, know-how and technology: the Covid-19 Technology Access Pool (C-TAP). This pool provides pharmaceutical companies the opportunity to share their patents and knowledge in return for a fair remuneration. As such, they allow and enable other qualified pharmaceutical companies to produce vaccines as well, without fear of prosecution for breaching patents.

Unfortunately, no pharmaceutical company has shared information through C-TAP yet.

Pooling of patents and knowledge for treatments against infectious diseases, is not new. In 2010, Unitaid established the Medicines Patent Pool (MPP) to increase the production, availability and affordability of HIV medicines. This caused a revolution in the fight against the AIDS epidemic, making these treatments accessible to people in 141 countries who otherwise would have had to do without. As a pooling mechanism for patents and knowledge, the MPP has saved millions of lives. This approach has proven to be highly effective in curbing epidemics.

The MPP works in a very similar fashion as the Covid-19 Technology Access Pool (C-TAP): inventors of authorized technologies share their patents and knowledge voluntarily with generic manufacturers. Subsequently, the patent holding inventors receive royalties from the sale of the medicines.

COVAX is an international initiative to support low- and middle-income countries in obtaining Covid-19 vaccines. Originally, COVAX was meant to be a big money jar to equally distribute vaccines over the 190 participating countries (both high- and low- and middle-income countries), regardless the amount of money each country puts in the jar. As high-income countries decided to stock up vaccines for themselves, COVAX is now being used as a tool to donate money to purchase vaccines for 92 low- and middle-income countries.

To date, COVAX aims to provide only 20% of the population of the participating countries with vaccines. To be able to purchase these vaccines, they have to be available first. In addition, we also need vaccines for the remaining 80%. The sharing of patents, know-how and technology by pharmaceutical companies will increase the production of vaccines, which would help COVAX to go beyond its original goal. In fact, sharing patents and knowledge could enable some of the low- and middle-income countries to produce vaccines themselves, reducing their dependency on other countries and increasing their resilience to future epidemics and pandemics.

Yes. We do not have exact numbers on the total amount of manufacturers that can help increase the production capacity for Covid-19 vaccines, but we have clear indications that a lot of potential is still unused. Several certified companies have offered their help to vaccine producers, but were refused. 21 generic manufacturers of medicines have pledged to help produce treatments against Covid-19. In low- and middle-income countries, at least 41 manufacturers are available for production. Only a few of them have yet been licensed by patent holding pharmaceutical companies to utilize their capacity to assist in the production of vaccines.

The only way we can be sure to maximize global manufacturing capacity, is by taking away all barriers for generic production. Therefore, sharing patents, know-how and technology is key.

Companies, governments and global actors like the World Health Organization (WHO) should do everything possible to map all available manufacturers to help tackle the corona crisis. It is important that all these actors cooperate in order to find efficient ways to expand the production capacity.

In order to answer this question, we can look at the evidence provided by the Medicines Patent Pool (MPP). The annual costs of the MPP amount to about 7 million US dollars. The costs of a pooling mechanism for Covid-19 treatments will probably be somewhat higher, as these products are slightly more complex, which requires more attention to transferring knowledge on how to produce them. Obviously, these costs are insignificant compared to the economic damage of the corona pandemic.

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is an international legal agreement between all member states of the World Trade Organization (WTO). It requires member states to respect and protect the intellectual property rights of patent holders.

In October 2020, India and South Africa proposed a ‘TRIPS waiver’. This entails that the protection of certain intellectual property rights on Covid-19 technologies would be temporarily suspended in order to enable other qualified manufacturers to produce these technologies too. High-income countries have been blocking this proposal for a long time. However, since May 2021, the tide seems to turn. The US proposed a limited version of the TRIPS waiver, seeking applicability only to vaccines (excluding other medical products, such as medicines and diagnostics). France announced its support to the ‘full’ TRIPS waiver, proposed by India and South-Africa.

Temporarily lifting the legal barriers to produce patent protected vaccines, would be an important step to bring the world out of this crisis. Though, waiving rights for a certain amount of time would not yet be enough. To be able to make vaccines, manufacturers do not only need the rights to do so, but also all specific knowledge on how to do it (recipe, test data, technical instructions, etc.)

In the Covid-19 Technology Access Pool (C-TAP), pharmaceutical companies do not only share their patents but also their knowledge regarding the production of Covid-19 related technologies, therefore taking away both barriers that block generic production of Covid-19 vaccines. Another difference is that the TRIPS waiver would force patent holders to release their rights, while participation in C-TAP is voluntarily.

Pharmaceutical companies are holding on tightly to their patents, know-how and technology regarding Covid-19 vaccines. This is highly questionable as governments put billions of dollars of taxpayer’s money in the development of these vaccines. When the vaccines are ready for use in the end, governments are again paying billions to purchase them.

Governmental investments in medicines and vaccines is common practice. For instance, medicines and vaccines that have been approved by the FDA (the US Food and Drug Administration) between 2010 and 2016 contain at least 100 billion US dollars of taxpayer’s money. The same applies to Covid-19 vaccines. For example, the development of the Moderna vaccine was almost completely paid by the American government (2,5 billion US dollars), and the development of the Pfizer/BioNTech vaccine was heavily sponsored by the German government (345 million euros).

According to research done by Bloomberg, the government of the United States has already funded research into Covid-19 treatments and vaccines for more than 12 billion US dollars. Governments should leverage this public funding to make sure that patents, know-how and technology are shared through the Covid-19 Technology Access Pool (C-TAP).

No pharmaceutical company has yet shared their patents and knowledge in the Covid-19 Technology Access Pool (C-TAP). Seven developers of Covid-19 treatments have declared to have no intention to do so. It is clear that without political and/or public pressure on pharmaceutical companies, C-TAP will stay unutilized and many parts of the world will be lacking vaccine access for years to come.

It is now up to governments and international institutions like the World Health Organization (WHO) and the European Commission to promote and actively support the pooling of patents, know-how and technology. Together, they have to urge pharmaceutical companies to do whatever is necessary to end the corona crisis as soon as possible.