Last week US supported the move of India & South Africa at WTO for waiver of certain provisions of TRIPS agreement during covid-19 period. Many scholars, pundits, researchers expressed their views regarding the IP waiver & covid-19. Opponents argued that IP is never a barrier to the effective management of covid-19. Proponents argued that easing the IP provisions would certainly help to produce medicines, vaccines quickly to tackle this pandemic. But, I found many people have not read between the lines & expressed or interpreted it shallowly.
Let’s start with the proposal made by India & South Africa on Oct 02, 2020 at WTO. It states –
“It is important for WTO Members to work together to ensure that intellectual property rights such as patents (Section 5), industrial designs (Section 4), copyright (Section 1) and protection of undisclosed information (Section 7) do not create barriers to the timely access to affordable medical products including vaccines and medicines or to scaling-up of research, development, manufacturing and supply of medical products essential to combat COVID-19.”
First of all, I find that the patent is a talk of the town everywhere. But, this waiver is also sought for industrial designs, copyright and protection of undisclosed information. Second, many argued about the “vaccine” & how patent act as barrier. Again, this waiver is also sought for “medicines” which are used for treatment & not for vaccines only, which are used as preventive. Also, affordable medical products also include “diagnostic kits, medical masks, other personal protective equipment and ventilators”. Obviously, these things are missing from the discussion & hence, it was half baked discussion.
So, the question comes – how these IP provisions act as barrier to access affordable medicinal products? Many of you know that IP is a right granted to applicant to prevent others from making, selling, using the goods & services for certain period of time. Therefore, monopoly lies with the applicant who holds the IP.
Proponents argued that covid-19 pandemic is now widespread. The outbreak has led to increase in global demand with many countries facing acute shortages of affordable medicinal products. Shortages of these products has put the lives of health workers at risk and led to many avoidable deaths. Therefore, it imperative and urgent to collaborate internationally to rapidly contain the outbreak & “IP waiver” is an arsenal WTO should use to combat this pandemic. Opponents asked for the specific data about how IP act as a barrier to affordable medicinal products. According to opponent, there are other challenges & not IP which act as a barrier. These are – capacity constraint, supply chain challenges, complex know-how process etc. Moreover, there are already provisions in TRIPS such as compulsory licensing (Article 31) to tackle this kind of problem. Lastly, weakening IP protection would have devastating effects on the R&D capabilities of the research-based industry.
Let’s consider some examples:
1. The Rwanda-Canada Case Study (Article 31bis of TRIPS – Compulsory licensing):
Rwandans had been hit hard by AIDS that left nearly million dead. Therefore, Rwanda in July 2007 notified the WTO to import 260,000 packs of TriAvir® (zidovudine/lamivudine/nevirapine) for the treatment of HIV/AIDS over the course of two years. This TriAvir® was manufactured in Canada by Apotex. Apotex applied for the compulsory license in Canada, seeking permission to export to Rwanda & CL was approved subsequently. Apotex provided appropriate information required by paragraph 2(b) of the Annex to Article 31bis, including the labeling and listing requirements. But, unfortunately it took nearly three years for Rwanda to receive the full shipment of drugs that it had requested under the framework. This fiasco happened because of complex procedural/licensing requirements which were needed to be fulfilled – in short “red tape”.
Moreover, using CL as a tool for affordable medicines in a particular country may bring adverse consequences such as political & economic pressures. The country may be seen as IP violator, trade benefits may be cut, trade sanctions may be put in place or the country may be put under “Watch list”.
2. 3M suit regarding Mask: Amid the covid-19 pandemic, government agencies scramble to procure personal protective equipment (PPE), masks & other equipment as these are protected by IP. In one instance, 3M filed suit against one company for trademark infringement, unfair competition, false association, false endorsement, and deceptive acts and practices. Personally, I am of the opinion that unauthorised usage should be strongly prohibited but at the same time IP holder companies should try to provide adequate supply through various mechanisms such as licensing/sharing know-hows/open access & should not focus on monopoly, at least during this crucial time.
3. 3D printed ventilator: During exchange of information at WTO, the South African delegate pointed out that industrial designs and copyright protection can become barriers to reproduction of products, as witnessed in Italy, where “two local engineers 3D printed ventilator valves to supply a local hospital as the regular supplier could not supply the valves, and had faced IP barriers.”
4. Remdesivir – Voluntary licensing: Opponents argued that “voluntary licensing” mechanism can be invoked to meet the demand. But, this mechanism is not proven adequate in such global disaster. For example, Gilead has licensed Remdesivir to few Indian companies so that demand can be made in low/middle income countries (127 countries!). But we have seen recently that even India is facing critical shortage of medicine for itself; forget about the other countries which are dependent on India. Had it been open (IP waiver) to all generic companies, the situation would have been different.
These are above some examples where IP seemed to be a barrier for access to affordable medicine. Opponents obviously do not seem to be on same page with proponents on this. This is evident because devil lies in the details. Every country has its own agenda & its home industry to cater. Point to remember, the USA in its official statement mentioned only about “vaccine” IP waiver. Below are certain facts where one can see the differences.
- The medicine access programmes at international level are not working, such as COVAX / Access to COVID-19 Tools Accelerator (ACT-A) / covid-19 Technology Access Pool (C-TAP). Big pharmaceutical companies refused to join participation in the C-TAP, an initiative that encourages voluntary contribution of IP, technology and data to support global sharing and scale-up of manufacturing and supply of covid-19 medical and pharmaceutical products.
- Covid-19 vaccines and treatment technologies owe much to public investment. Many Governments have funded the covid-19 research programmes & it is not totally from Big pharma’s pocket. Given the demand volumes, pharma companies will anyway make profits. No need to take shelter of IP.
- Paradoxically, early in the pandemic, some developed country members amended laws to enable quicker and easier procedures for the grant of compulsory licenses to overcome possible IP barriers to COVID-19 technologies, without any specific instance of IP barriers necessitating the actual use of such a measure.
- Some companies have waived their IP rights, but it is for short period of time. It is perfectly fine. These waivers should be there till the covid-19 situation. Even, draft proposal shared by India & South Africa states that – “This waiver shall be reviewed by the General Council every year until the waiver terminates when widespread vaccination is in place globally, and the majority of the world’s population has developed immunity”.
Finally, opponents also argued that it would not help India or South Africa, if any IP waiver is granted because these countries do not have capabilities/resources to produce complex products such as vaccines. Point to note that, India or South Africa is not asking for IP waivers for 2 countries only. Once waiver is given, it would be applicable to all the members of WTO. So, for example, if any Indian company is having subsidiary in developed countries such as US, EU, or Canada, these waivers would also apply to them. Hence, these foreign subsidiaries may produce vaccines, because now waiver is in place in developed countries also. Many companies would do that given the chance. And, importantly, it can export to other countries, which would not have been possible, in absence of IP waiver. It would not solve global problem at large but it would be the small step in right direction. And, that is what we want in this situation.
By waiving IP rights (temporary) for say 2 to 3 years would not make IP holders poorer & would not harm innovation. In this grave situation, humanitarian approach should prevail. Law will take back seat for a while. And, no need to worry – “Sky is not going to fall!” Have faith & patience!