Updated: May 26
India and South Africa have jointly approached the WTO to ask for a waiver of certain WTO Trade Regulations relating to Intellectual Property so as to facilitate effective and fast-tracked availability potential vaccines for the COVID-19. The countries, in a joint submission to the Council for Trade-Related Aspects of Intellectual Property Rights, asserted that developing countries will be ‘disproportionally impacted’ by these IP safeguards and prevent the vaccine from reaching the third world quickly.
Experts around the world have started speculating that in the race for a vaccine for the virus, rich countries will start hoarding the vaccine, prioritizing their citizens, while the third world will suffer. Countries like the US, Britain, France etc. have already started ordering millions of unites of potential vaccines even before clinical trials have begun. India and South Africa are of the opinion that till the vaccine is commonplace worldwide, these IP regulations should be relaxed.
In the submission, the countries argue that the existing flexibilities in the safeguards would not provide sufficient relaxation in IP restrictions to promote prompt availability to meet the global demand and are thus looking for a waiver of certain safeguards. The countries urge a ‘global solidarity’ in the wake of this unprecedented pandemic and thus seek this radical departure from the existing regulation regime.
An African Union Communique in June stood united to fight the pandemic and asserted that there must be an equality of access for every nation as and when the vaccine becomes available, and there was a global responsibility to eliminate monopolies on the vaccine as it is a worldwide concern. It also cited that as per the Doha Declaration of 2001 of the WTO, compulsory licenses can be procured without the consent of the patent holder in matters of public health concern, and the COVID-19 pandemic met this threshold.
The Law and its Linkages
The WTO’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), negotiated during the 1986-94 Uruguay Round, essentially linked Intellectual Property Rights with International Trade and addressed growing concerns with respect to IP violations in the international sphere. The agreement has rules concerning copyright, trademark, Geographical Indications, industrial designs, patents, layout designs, licensing etc.
The WTO’s TRIPS Agreement is an attempt to bridge the differences in the way these rights are protected and enforced globally, and to bring them under a consolidated international regime. It establishes minimum standards of protection and enforcement that each government has to afford the intellectual property held by nationals of fellow WTO members. According to the jurisprudence surrounding the TRIPS agreement, the member states essentially have to strike a balance between incentivizing innovation and limiting access to protect IP rights.
Key Flexibilities and The Doha Declaration
Article 31 of the Doha Declaration provides that in cases of National emergency and extreme urgency, compulsory licences can be invoked which would not require governments to seek prior consent from the patent holder to utilize and distribute a certain product. Article 5 of the Declaration lays out the situations which constitute these emergencies.
These include public health crises ‘including those linked to epidemics’ like HIV, Malaria and other diseases which cross the threshold. Compulsory licenses have in the past been invoked in the past for diseases like HIV, flu, cancer, erectile dysfunction, anthrax etc. These diseases are fairly common and present throughout, yet IP relaxations and compulsory licenses have been provided for them. It logically follows that medicine or vaccine for an unprecedented pandemic like the coronavirus can be provided.
Some of these cases resulted in merely a price reduction, but for more serious diseases, announcements of full compulsory licenses were made, which must be the step taken in the case of the coronavirus.
Earlier, Article 31(f) of the TRIPS Agreement prohibited granting of compulsory licences to member states which cannot undertake manufacturing of the medicine for domestic use. This was immensely problematic legislation as it afforded the opportunity to rich member states to withhold medicines and vaccines from developing states, creating a monopoly and defeating the purpose of the Doha Declaration.
Eventually, an Implementation Decision was reached at along with an amendment protocol which invalidated this provision and allowed for free trade regardless of manufacturing capacity. However, even this decision was flawed as it could not materialize into the effective provision of medicines to developing and poor countries, as the terms were complex and the conditions stringent. To date, there is the scarce justification that the Implementation Decision and the Protocol can meaningfully contribute to overturning the lacuna of the industrialized world to supply much-needed vaccines and medications to third world countries which need it the most. Nor does there appear to be widespread enthusiasm for using Implementation Decision and Protocol mechanisms to facilitate the provision of low-cost or no-cost pharmaceuticals to those most in need.
Although this waiver remains in place, it does not translate into real-world change, as two-thirds of member states have not signed the Protocol yet and such grant of compulsory license has very little precedent. There is a need to radically overhaul the license granting regime and ensure effective transfer of potential vaccines and form global solidarity against the coronavirus. Only one case under the Implementation Decision of granting compulsory license has successfully been executed, which was between Canada and Rwanda, but was also riddled with hurdles and the medicines in question never reached on time.
Therefore, in the existing WTO regime, the relaxations and flexibilities seem too stringent and ineffective in the face of this imminent need the global community is going to have. There are still numerous legal hurdles in the way of achieving an equitable market and free trade of essential medicines and vaccines regardless of the status of the country in question.
The rich resourceful countries have till now shown least interest in seriously committing to providing new and existing medicines and vaccines in a timely manner and have remained apathetic to the new legal regime under the Implementation Decision and Protocol.
There are legitimate concerns of serious monopolies being created as a result of this attitude, and it is indeed WTO which must rally the rich affluent states to work towards global solidarity and further relaxations of these stringent IP regulations. India and South Africa’s legitimate concerns encapsulate increasing anxiety among the developing countries who have serious doubts about the availability and efficiency of the distribution of the imminent vaccine to this global pandemic.
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