A global necessity

Vaccine IPRWaiver

By DrS.Saraswathi
(Former Director, ICSSR, New Delhi)

It is reported that the chief of World Trade Organisation (WTO) is persuading member-nations to reach an agreement on waiver of Intellectual Property Rights (IPR) for Covid-19 vaccines as the pandemic is developing second and third waves and showing no indication of leaving even after that. The WTO Director-Generalemphasisedthe urgency for arriving at an international trade agreement to relax IPR for Covid-related products so as to allow more manufacturers to enter this field to meet growing worldwide demands and save human lives. Next meetingof the WTO to discuss IPR is scheduled to take place in June.
The proposal for a 3-year patent waiver for Covid-19 related health products and technologies including drugs and vaccines,along with their “material or components and their methods and means to manufacture” originated from India and South Africa in October 2020as necessary to fight fast spreading Coronavirus.Their latest submission, a few days back,specifies inclusion in the waiver list besides vaccines and medicines, diagnostics, therapeutics, medical devices, and personal protective equipment to cover “prevention, treatment, or containment of Covid-19”. Somereportsmentionthat about 120 member countries, including China are in support of the proposal.
USA, Britain, EU, and Switzerland were initially notinfavour of the proposition,but US is changing its position. American President Joe Biden promised waiver of IPR for Covidvaccine during his election campaigns in the late 2020s and there are hopes of getting the support of EU, Japan, Switzerland, and Brazil also.The EU is batting forrevisingits stand.
An Open Covid Coalition is promoting the Open Covid Pledge, which calls on organisations around the world to make their patents and copyrights fully available in the fight against Covid-19 pandemic. Germany, the home of BioNTech, the firm that produced an effective vaccine for Covid-19 was not in favour of IP waiver. It believesthat the protection of IP is a “source of innovation and must remain so”.Ascommercialimpact of IP waiver will be enormous, India may have to overcome many practical hurdles in establishing and running its own plant.
SouthAfricamooted the idea of IP waiver two decades agowith regard to AIDS drugs. India managed to build support for it that led to insertion of compulsory licensing provisions for all countries under TRIPS (Trade Related Intellectual Property Rights).
WTO Agreement allows waiving obligations in “exceptional circumstances”. But, existence of such circumstancesis not enough to obtain waiver. Political will andconcurrence of concerned commercial interests are needed. Many countries arenow busy negotiating forloosening IPR to enable countries that possess the requisite capacities to produce Covid-19 vaccines. Countries like India willbeable to produce forself-use and alsoto meet the demands of other developing countries at a price they can afford.
It’s in the interest of the entire world to make this possible by removing restrictions. Commercialinterests arenot bigger than the survival of humans. Apandemiclike Covid-19cannot be fought successfully without pooling global resources – human and material.
Licensing is midway between IPR regime and totalIP waiver. Normally, in case of IPR,licence is given only with the consent of holders of the right.Under Indian Patent Act,government may resolve to license the innovation to anyone three years after the grant of the patent without the consent of the owner of the patentunder three conditions – if reasonable requirementof the public is not fulfilled; if the product is not available at affordable prices to the public; andif the patented invention is not used in India. Compulsory licensing was notgranted for manufacture for purposes of exports. This condition was removed in 2003 to enable export of AIDS medicine to countries that were not in a position to manufacture them. Rules restrict manufacture of more than the required quantity of the medicine for use and export.
As demand for drugs, vaccine, and other equipment used for diagnosis, treatment, and prevention of Covid-19 and related diseases isincreasing enormously and has tobe met immediately in many countries, there is an urgent need for removing obstructions in the way of production, transportation, and distribution of the goods in utmost speed. Shortageof or delay in the supplyof required goods can be removed byadministrative corrections and promoting cooperation and coordination between concerned agencies unlike lack of required medicalgoods which in addition need intellectual resources which are not available everywhere.
Flexibility in patents for vaccines and free movement of medical material between nations are sine qua non at the present juncture to fight Covid-19. The proposal sponsored by India and South Africa is exactly meant for that freedom presently restricted by production and trade rules betweennations.
WTO’s decisions are taken by consensus. Hence, the waiver will take time to be formulated andapproved. The speed of the pandemic will not allow slow progress of talks for agreement. India and South Africa want the waiver not only to Covid-19 vaccine, but to related medicines, other therapeutics and technologies, whereas the US wants to restrict it to vaccine.
IP waiver is only part of the project of vaccine manufacture. India has also to acquire technical knowledge, raw materials, supply chains, necessary infrastructureand so on, which are not protected by patent laws, but must be in place tomakeuse ofIPwaiver. Therefore, our struggle will not end with crossing the IPR hurdle at the WTO.The nation must understand the situation.
IPRis,no doubt, avaluable reward that encourages invention of cures and medicines by granting exclusive rights over the products to their creators. Such aresource should not become an impediment in reaching medicines and medical equipment to patients on time and in sufficient quantity. Public health is a humanright where research and innovations should benefit the public and commercial gains should be secondary.
IPR itself is a questionable right especially in the case oflife-saving vaccines, medicine, and medical and other equipment needed during epidemics, war, and natural calamities. Can there be any intellectual resourcethat can be claimed as the creation exclusively from one identifiable source? It is doubtful. Knowledgeisbuilt and does not appear suddenly.The conflict is between individual right and mass survival.
However, in matters like medicine, we have to guard against spurious drugs and duplicates resembling he originals but lacking its properties.
IPR waiver for Covid-19 medicines will be needed until the majority of world population develop immunity and until enough vaccine and drugs become available throughout the world. No country, including those that have won the battle against Corona and also having required products far in excess of local demand can remain in peace if the virus is active in another part of the world. Immunity has to come to the whole world in cases of pandemic. IPR waiver is as much in the interest of countries that seem to be winning the Covid-19 battle as in the interest of those living under fear of the invisible enemy. — INFA