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SOUTHNEWS

 
No. 319,  8 May 2020

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The Covid-19 Pandemic:  Intellectual Property Management for Access to Diagnostics, Medicines and Vaccines


The South Centre held an open webinar with Dr. Carlos Correa, Executive Director, and Dr. Viviana Munoz Tellez, Coordinator of the Health, Intellectual Property and Biodiversity (HIPB) Program, on 30 April 2020 to discuss access to diagnostics, medicines and vaccines for addressing the Covid-19 pandemic.  There is an urgent need to ensure that innovations in medical technologies for Covid-19 go hand in hand with affordable access to these, for all. The main principle to move forward is recognition of these technologies and know how as global public goods.

The South Centre held an open webinar with Dr. Carlos Correa, Executive Director, and Dr. Viviana Munoz Tellez, Coordinator of the Health, Intellectual Property and Biodiversity (HIPB) Program, on 30 April 2020 to discuss access to diagnostics, medicines and vaccines for addressing the Covid-19 pandemic. Approximately 100 participants joined the webinar.  
 

 
The webinar was part of the effort of the South Centre to share information and its recent publications to support informed, evidence-based policy making. These publications are available on the South Centre website (www.southcentre.int) and in the dedicated website (https://ipaccessmeds.southcentre.int/covid-19-pandemic/).
 
The main message of the webinar was the urgent need to ensure that innovations in medical technologies for Covid-19 go hand in hand with affordable access to these, for all. The main principle to move forward is recognition of these technologies and know how as global public goods.  Business as usual is not an option.
 
The protection of intellectual property (IP) rights such as patents, can come into tension with the goal of affordable access to medical technologies for all people.  Dr. Correa discussed how IP can create barriers to affordable access and the various instruments that governments can use legitimately to overcome these, including through the non-grant of secondary medical use patents and application of rigorous standards of examination of patent applications. Other instruments also include compulsory licensing and the use of the security exception under Article 73(b) of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Dr. Correa also discussed proposals for a moratorium on TRIPS obligations and the pooling of IP-protected technologies, know-how and data. These instruments are not mutually exclusive and all should be on the table. Dr. Munoz presented her recently published policy brief on research and development (R&D) and the management of IP for access to diagnostics, treatment and vaccines.

 
Dr. Carlos Correa opened the webinar noting the tension between the protection of intellectual property and access to medicines. The literature in this area is extensive, including by organizations of the United Nations. The HIV/AIDS crisis sadly brought to bear this tension. Many people died for lack of access to treatments which were available, which was unacceptable. This avoidable situation led to the approval of the World Trade Organization (WTO) Doha Declaration on TRIPS and Public Health. Now, the Covid-19 crisis may be another example where this tension between IP and access to medicines is a major issue to be addressed at the national and international level. Billions of people need to have access to supplies, devices, diagnostic kits and equipment, as well as treatments, medicines and vaccines. Only through international cooperation will we achieve this, requiring bold action, so that all people at the same time can have affordable access. This will require access to technologies and products. It is unthinkable that only a group of companies will be able to supply all medicines, equipment and diagnostic kits to address this global pandemic.  Sharing technologies is a key component. Products must be made affordable, and the only way of achieving this is to allow a significant number of producers to get access to the technologies and to lend the know-how which will lead to affordable prices. In the case of HIV/AIDS, the main issue was about the enforcement of patents, including on repurposing of products, which was the case of zidovudine (AZT).

There are two visions in relation to intellectual property in this context: one vision has been presented by the Secretary-General of the United Nations (UN), who stated that “these new tools (to address Covid-19) must be a very clear and essential example of a global public good”. This is a concept the South Centre has also used in a letter to the World Health Organization (WHO), World Intellectual Property Organization (WIPO) and WTO arguing that this concept of global public goods should be the base for any further action in this area. Another vision, however, was expressed by the WIPO Director-General: “there does not appear to be any evidence that IP is a barrier to access... Focusing on access…may not only represent a misunderstanding of the sequencing of innovation and access, but also create a disincentive to investment in needed innovation.” These are very different visions. WIPO is paradoxically a UN specialized agency in the area of IP, but seems to keep relying on the old concept that IP is an end in itself and that access is a secondary issue. However, innovation without access does not make any sense.
 
In Covid-19, IP comes into the picture not only with regards to patents but other areas in the field of IP may be concerned. We need a broad understanding of the barriers IP may create. In the case of HIV/AIDS, the main issue was about patents. In Covid-19, again patents are relevant, but not only these. There are two aspects in relation to patents. The first aspect is the protection of second medical use of an existing medicine. Many medicines have been tested recently to see whether they could provide some treatment for Covid-19. For sure there will be attempts by companies to get new patents on the new use of an existing medicine. In some countries these kinds of claims in patent applications are allowed, but this is not required by the TRIPS Agreement. There is no reason under the basic principles of patent law to grant these claims, as they do not comply with the key requirement of novelty. They also do not comply with industrial applicability as in essence they are methods of treatment. Therefore, there is no reason whatsoever to grant these claims.
 
The second aspect is the application for patents over new medicines and new vaccines. Patents may create barriers, but there are also issues of data exclusivity (particularly those who signed free trade agreements that contain such rights), there might be issues related to know-how of devices, and also designs.
 
What actions can governments take?
 
Many actions can be taken at the national level. Governments can make use of the instruments known as TRIPS flexibilities. First, governments can instruct their patent offices not to grant secondary medical use patents. Secondly, governments should apply rigorous standards for examination of patent application. There is a lot of diversity at the global level on examination. Some countries apply rigorous requirements while others apply very lax requirements. In this latter situation, it creates patent thickets, which may prevent access to technologies and then the availability of products at affordable prices.
 
Governments have various tools, and they can act fast and introduce changes, as necessary, to promote access where IP may become a barrier. These instruments include compulsory licensing. The South Centre has published a guide on compulsory licensing and government use that can be used as a tool to designing reforms to their laws or to apply existing laws (available at https://www.southcentre.int/research-paper-107-april-2020/).
 
Another instrument that governments have, which is provided under Article 73(b) of the TRIPS Agreement, is the national security exception. This is also in the General Agreement on Tariffs and Trade (GATT). Under this clause, that was not very much looked at, every WTO member can suspend any obligation related to the granting and enforcement of intellectual property rights (IPRs) for security issues, and one of the cases that Article 73(b) refers to is an international emergency. If this is not an international emergency, then what is it? There is no need to demand authorization from WTO, it can be used without further procedures. In the case of Covid-19 it could be used in a very legitimate manner by WTO members.
 
A third alternative is to negotiate at the WTO a moratorium, a “peace clause”. Governments would agree not to submit complaints related to IP protection or enforcement in accordance to the TRIPS Agreement. But unlike Article 73(b), there would be a need to negotiate this moratorium with all WTO members. We can expect that some members would oppose. The decision-making at WTO is by consensus. In WTO there is always a quid pro quo. To get this moratorium, developing countries would need to pay a price – for instance, on the e-commerce moratorium that may deprive governments from very needed income through taxation. Moreover, since the WTO Ministerial Conference will not take place this year, the moratorium negotiation may not take place in a timely manner.
 
A fourth alternative is the proposal by Costa Rica for a pool of information of IP-protected technologies, data, know-how, etc. The proposal is based on the idea of putting into practice a memorandum of understanding that will establish the commitments by governments, eventually by companies. It has not been implemented yet, however the idea has received significant support. For example, the Director-General of WHO, Unitaid, as well as a large number of non-governmental organizations (NGOs) have supported this initiative. One important element is that if this pool is established, it should have a global reach. The Medicines Patent Pool (MPP) has done very effective work to get licenses from a significant number of companies. In some cases companies retain the most profitable markets for them, and therefore the issue of getting access to medicines for all has also been a challenge in the context of the MPP. So the question now is how can this idea be implemented effectively, as will be discussed during the forthcoming World Health Assembly (WHA). It will be important for developing countries and all seeking a global solution to the problem to make their own submissions and participate so that this and other initiatives can succeed. Again, the underlying principle should be the supply of global public goods, and that proposal should be seen as one of the possible instruments to achieve that objective without prejudice to the other alternatives mentioned before, such as compulsory licensing, government use and the security exception.
 
The pool proposal and the others instruments discussed before can be used and are not mutually exclusive. All of them need to be on the table, also in order for companies to realize that governments can use instruments, whether voluntary and non-voluntary, to address their public health needs.

Business as usual is not possible anymore. There is a need to take action at the global scale. There is a need for real international cooperation. Public health should prevail over commercial interest.  This crisis is also an opportunity to change, even to rethink the R&D model that is not responding to public health needs. There is a recently published South Centre Policy Brief by Dr. Germán Velásquez that addresses this issue (see https://www.southcentre.int/policy-brief-75-april-2020/ (English) or https://www.southcentre.int/informe-sobre-politicas-75-mayo-2020/ (Spanish)).  

 
Dr. Viviana Muñoz Tellez presented the policy brief she recently authored on the topic of R&D and IP management for access to diagnostics, treatments and vaccines for Covid-19 (available at https://www.southcentre.int/policy-brief-73-april-2020/).
 
She highlighted the urgency of the response to Covid-19 and noted the many challenges related to the Covid-19 pandemic.  Covid-19 is both a health and economic crisis. On the one hand, there is urgent need to address the health response, including by making widely available diagnostics and testing kits, general equipment for health workers, ventilators in hospitals and more. There is also urgent need for a safe and effective vaccine to prevent Covid-19 infection, as well as treatments.  On the other hand, countries are suffering a huge economic impact from the Covid-19 pandemic. Containment measures such as isolation have brought the working population into pause, which is debilitating the livelihoods of billions of people around the world. In developing countries, it will be very difficult to sustain these measures. Having no income can endanger livelihoods as much as the Covid-19 infection. Therefore people in developing countries must receive the vaccine and treatments as soon as these are available. Removing potential IP obstacles and increasing manufacturing capacity worldwide are part of the necessary response.
 
The pandemic has also changed the context for innovation. Firstly, there is an enormous demand. Secondly, there is vast financing available. This is very different from the conditions observed in traditional innovation theory and market failures for new vaccines and medicines. While theoretically IP is considered an important incentive to stimulate private R&D for medicines and vaccines, in this context it is less so the case. This is a very different setting.
 
The IP challenge is very real. Response to Covid-19 is urgent and it is necessary to already consider the existing problems regarding the assertion of IP rights and foresee potential future obstacles to broad and affordable access. Manufacturers are already concerned about potential infringement of existing IP rights, such as in the case of 3D manufacturing of ventilators in Italy and making N95 respirator masks. Increasing manufacturing capacity for diagnostics, treatments and vaccines is a pressing priority.
 
How to deal with the IP challenge? Voluntary initiatives can be promoted, asking all potential IP holders to share knowledge including data on clinical trials and technologies in the public domain. The idea of a pool to bring these together is important. We also need to know what technologies are there and what is useful. This should include open technologies available. There is a lag in patent information from the moment the patent application is filed to when it is published. At the same time, countries should be aware of what they can proactively do to broaden access to technologies and to increase manufacturing capacity. Technology transfer and know-how will be critical to scale up production of treatments and vaccines when these become available.
 
In addition to voluntary initiatives, governments can make use of TRIPS flexibilities to scale up production and increase procurement options to facilitate affordable access to IP-protected technologies. These include non-voluntary licenses known as compulsory licensing, to allow the use of a patent-protected product without the authorization of the patent holder, subject to remuneration. Most countries already have in their national legislations provisions for authorizing compulsory licensing and government non-commercial use. In the Covid-19 context, various countries are preparing to use these provisions as necessary. For example, Canada has issued a new bill to simplify the procedures for the issuance of a compulsory license.
 
Another important flexibility is parallel importation. Many countries will not be able to manufacture locally, and thus parallel importation is a mechanism to procure patented products at more affordable prices. Other important flexibilities include the research exemption so that scientists can undertake work using patented technology, and similarly generic manufacturers can rely on the Bolar exception to use patented technology for the purpose of obtaining regulatory approval for generics.
 
Finally, TRIPS plus provisions such as data exclusivity that can delay access to generics should be avoided. During the Covid-19 pandemic, parties involved in negotiations of free trade agreements should halt inclusion of TRIPS plus provisions. 
 
The presentations were followed by 30 minutes of Q&A.
 
The video recording of the webinar is available at https://www.youtube.com/watch?v=3GFuiF3mF4U&feature=youtu.be.
 
For details on the webinar, please go to https://ipaccessmeds.southcentre.int/event/the-covid-19-pandemic-intellectual-property-management-for-access-to-diagnostics-medicines-and-vaccines-webinar/.
 

Authors: Viviana Munoz Tellez, Coordinator, and Vitor Ido, Programme Officer, of the Health, Intellectual Property and Biodiversity (HIPB) Programme of the South Centre.
SOUTHNEWS is an e-newsletter service of the South Centre providing information and news on topical issues from a South perspective.

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For more information, please contact Anna Bernardo of the South Centre: Email bernardo@southcentre.int, or telephone +41 22 791 80 50.
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