U.S. SUPPORTS INDIA'S VACCINE PATENT WAIVER PROPOSAL
THE BIG PICTURE : U.S. SUPPORTS INDIA'S VACCINE PATENT WAIVER PROPOSAL
- US President’s administration announced its support for a temporary global waiver on patent protections for Covid-19 vaccines.
- Accepting a key element of a joint proposal by India and South Africa at the WTO, the administration said it will now actively participate in negotiating the terms.
- The announcement by the US was immediately welcomed by the World Health Organisation, with its chief calling it a monumental moment in the fight against Covid 19.
- For months, the WTO has been facing calls led by India and South Africa to temporarily remove the intellectual property protections on Covid-19 vaccines, so as to help boost production in developing countries.
- That proposal had, however, called for a waiver on all Covid interventions, including testing diagnostics and novel therapeutics.
- The proposal had garnered significant support from the developing world.
- US, UK and the European Union (EU), among other richer countries, have been vocal opponents of the IP waiver proposal.
- The pharmaceutical industry fiercely opposed it and vigorously lobbied many governments.
- Right-wing political groups in the high-income countries sided with the industry.
- Since the WTO operates on consensus rather than by voting, the proposal did not advance despite drawing support from over 60 countries.
- All 164 WTO members must agree on the draft, and any one member can veto it. The European Union, which had earlier opposed the waiver, has now stated its intent to discuss the US-backed proposal.
WHAT DOES THE INTELLECTUAL PROPERTY WAIVER FOR COVID-19 VACCINES MEAN?
- The IP waiver might open up space for production of Covid vaccines with emergency use authorisations — such as those developed by Pfizer, Moderna, AstraZeneca, Novavax, Johnson & Johnson and Bharat Biotech — on a larger scale in middle-income countries.
- This will lead to cheaper and more generic versions of Covid vaccines and will be a big step in overcoming vaccine shortage.
- It would lead to equitable distribution of vaccines and making more affordable vaccines readily accessible could be the best way to prepare for the surge once again
- Most production is currently concentrated in high-income countries; production by middle-income countries has been happening through licensing or technology transfer agreements.
WHAT IS INTELLECTUAL PROPERTY?
- It refers to creations of mind such as inventions, literary and artistic works, designs and symbols, names and images in commerce.
- IPR are the rights which allow creators of patents, trademarks or copyrighted work to benefit them for their own work or investment. These rights have been outlined in Article 27 of Universal Declaration of Human Rights.
- The importance of IPR was first recognized in the Paris Convention for the protection of Industrial Property (1883) and Berne Convention for the Protection of Literary and Artistic Works (1886) (both administered by WIPO).
- The Nice Agreement (1957) establishes a classification of goods and services for the purposes of registering trademarks and service marks.
- The Locarno Agreement (1968) establishes a classification for industrial designs.
- The Vienna Agreement (1973) establishes a classification for marks that consist of, or contain, figurative elements.
- The International Patent Classification (1971) is used to classify patents and utility models according to the different areas of technology to which they pertain. It was established by the Strasbourg Agreement.
- Section 3(d) of Indian Patent Act prevents the “ever-greening” of patents. It means that the following inventions are not patentable:
- mere discovery of a new form of a known substance and which does not result in increased efficacy of that substance.
- mere discovery of any new property.
- new use for a known substance.
- mere use of a known process, machine or apparatus unless such process results in a new product.
- Compulsory Licensing allows governments to license third parties (that is, parties other than the patent holders) to produce and market a patented product or process without the consent of patent owners. Any time after three years from date of sealing of a patent, application for compulsory license can be made, provided:
- reasonable requirements of public have not been satisfied;
- patented invention is not available to public at a reasonably affordable price;
- Patented invention is not worked in India.
Types of IPR
· Patent is granted for an invention which is a new product or process that meets conditions of novelty, non-obviousness and industrial use.
· Trademark means a mark capable of being represented graphically and which is capable of distinguishing the goods or services of one undertaking from those of other undertakings
· Geographical Indications is a sign used on agricultural or natural or manufactured goods as originating or manufactured in a particular region of a country.
· Copyright is a right given by the law to creators of literary, dramatic, musical and artistic works and producers of cinematograph films and sound recordings.
· An industrial design consists of the creation of a shape, configuration or composition of pattern or color, or combination of pattern and color in three-dimensional form containing aesthetic value.
· Plant Variety Protection refers to the protection granted for plant varieties.
CAN A WAIVER RESOLVE THE VACCINE SHORTAGE?
- This is a complex question to which there is, so far, no clear answer.
- First, there may be serious issues associated with manufacturing vaccines, for example, with those based on mRNA technology, if there is just an easing of the associated intellectual property rights rules but no further support to generic pharmaceutical firms in countries such as India and South Africa. To illustrate, Pfizer has pointed out that its vaccine requires the use of 280 components from 86 suppliers and highly specialised manufacturing equipment.
- Second, there is a strong likelihood that it will take a considerable amount of time, even several years, for generic producers’ plants to become operational at optimal capacity.
- Thirdly, other roadblocks to scaling up production: These include trade barriers, bottlenecks in supply chains, scarcity of raw materials and ingredients in the supply chain, and the unwillingness of rich countries to share doses with poorer nations.
- Finally, there is the classic counter-argument to calls for patent relaxations, that such policies could discourage pharmaceutical companies from investing in producing next-generation vaccines.
- While a TRIPS waiver would enable countries to escape WTO obligations, it will not change the nature of domestic IP regulations.
ARGUMENTS AGAINST WAIVER
- The pharmaceutical companies of the developed world feel the low and middle-income countries would not be in a position to assure quality vaccines as they do not have sophisticated laboratories and are limited in number.
- Ramping up production capacities will be a lengthy process — a reason being cited by pharmaceutical companies against the move.
- Pharma companies including Pfizer and AstraZeneca had opposed the proposed waiver — saying eliminating IP protections would “undermine the global response to the pandemic”, including the ongoing efforts to tackle new variants.
- It could also create confusion that could potentially undermine public confidence in vaccine safety and create a barrier to information sharing.
- Microsoft founder Bill Gates justification for not sharing vaccine tech with developing countries is “that it would not be feasible for a company to move vaccines to a developing nation”.
ARGUMENTS IN SUPPORT OF WAIVER
- The low labour costs in developing countries are attractive for the pharmaceutical companies which allows them to outsource their products for production. This shows they don’t mind as long as their patents and profits are protected.
- The counter to patent waiver is an offer to license manufacturers in developing countries while retaining patent rights. This restricts the opportunity for production to a chosen few. The terms of those agreements are opaque and offer no assurance of equity.
- It was also stated that developing countries could be supplied vaccines through the COVAX facility, set up by several international agencies and donors. While well-intended, it has fallen far short of promised delivery. Some S. states have received more vaccines than entire Africa has from COVAX.
- An argument put forth by multinational pharmaceutical firms is that a breach in the patent will allow China to steal their technologies, now and in the future. The original genomic sequence was openly shared by China, which gave these firms a head start in developing vaccines.
- The broader context for emergency action aimed at rapidly increasing vaccine availability across the world is the sharp surge in COVID-19 cases in India and Brazil. Indian variant, could potentially fuel second or third waves across the world. Additionally, the Brazil and South African variants still pose a threat in some pockets.
- The argument that these countries do not have the capacity to speedily produce vaccines goes against earlier moves towards a patents regime for generic drugs. Between 1972 and 2005, India had adopted process patenting rather than product patenting, and built up a huge generic industry.
- No significant steps forward will be possible until other major member nations of the WTO sign on, including the EU.
- The speed of potential action will also be dampened by the fact that in parallel to the waivers, a transfer of personnel, raw materials and equipment to developing nations will be necessary.
- The World Trade Organization resolves debates by consensus and not by voting. The process may drag on, despite U.S. intervention.
- Developing countries must start issuing compulsory licences. The Doha Declaration on TRIPS permits their use in a public health emergency.
- National governments must be trusted to promote credible companies and not permit businessmen who want to make money very quickly, without caring about the quality.
- High-income countries and multilateral agencies should provide financial and technical support to enable the expansion of global production capacity. That will reflect both altruism and enlightened self-interest.
- Countries should start working towards making suitable changes in their domestic legal framework to operationalise and enforce the TRIPS waiver.
- TRIPS waiver, it is not a magic pill. It would work well only if countries simultaneously address the non-IP bottlenecks such as technology transfer, production constraints, and other logistical challenges such as inadequacy of supply chains and unavailability of raw materials to manufacture vaccines and medicines.