The International Intellectual Property Rights Regime and its impact on responding to the global pandemic
It has been heralded all over the world, that the end to these “unprecedented times” will come either in the form of a vaccine or a cure for COVID-19. However, that is just step one of our return back to normal, after the discovery of a vaccine, the question still remains, will the governments of the world facilitate its access so that everyone may be protected? It is at this point that we reach the barrier of the international intellectual property rights (IPR) regime. COVID-19 has highlighted the interconnectedness between the international trade regime and global health. The international IPR regime has been enshrined through the Agreement on Trade-Related Aspects of Intellectual Property (TRIPs) during the 1994 Uruguay Round of the World Trade Organisation (WTO). The TRIPs Agreement has had a profound impact on the way in which the international trade regime could dictate domestic policy. It placed restrictions placed upon countries (especially developing ones) which has meant that they have been severely hindered in their ability to adequately provide affordable access to health, particularly regarding life-saving medication (Coriat et al., 2006, Stiglitz, 2009, Chang, 2001). The current pandemic has brought these issues to the fore and the barriers placed by TRIPs may lead to developing countries (in particular) being unable to protect the lives of its citizens despite the fact that a COVID-19 vaccine may exist.
By signing TRIPs, member-states agreed to create new enforceable minimum standards regarding IPR which included national treatment, a mandatory minimum of 20 years for patents, stricter conditions for compulsory licensing and forced patentability of certain products such as active pharmaceutical ingredients (Coriat et al., 2006, Lee et al., 2009). Although they were some concessions made to developing countries in the form of grace periods and the non-patentability “diagnostic, therapeutic, and surgical methods of human or animal treatment and of plants, animals and their biological processes (Chang, 2001)”. Beyond this, expanding the existing IPR regime remains a key objective of both the European Union and the United States of America (two members of the powerful WTO Quad), which in recent years has been undertaken through the pursuit of “TRIPs-plus” agreements with emerging economies (Stavinoha, 2016, Conley, 2020). For countries with a competitive pharmaceutical industry, favourable market access for exports has trumped public health priorities. This is true even in cases where the benefits are likely to be fleeting, for example, “the Peruvian and Columbian Governments agreed to a free trade agreement with the USA that contained various TRIPs-plus standards, despite warnings by public-health authorities of potentially disastrous effects from increased drug costs (Lee et al., 2009)”. In this regard, the IPR regime has become a barrier for accessing achievable public health outcomes by building upon pre-existing power imbalances to further limit the flexibilities offered to emerging economies.
In the wake of the COVID-19 Pandemic, some countries have taken pre-emptive measures regarding the government’s ability to circumvent the international IPR regime as enforced by the WTO, namely through easing access to compulsory licensing (World Trade, 2020). Compulsory licensing according to trade advocates are flexibilities that allow for affordable and accessible access to life-saving medications. Compulsory licensing entitles governments to arrange for a good to be produced by another firm in cases where the patent-holding firm does not go into production, produces an insufficient amount of the good or at an excessive price, and when the good is in the public interest. The other firm can use the information contained within the patent to produce a previously agreed upon amount, with a fee being paid to the patent owner. For example, Canada on the 27th of March passed emergency legislation that empowers the Canadian Health Minister to authorise the government or a third party to manufacture patented innovations to respond to a public health emergency (Madar, 2020). The Chilean Parliament on the 17th of March, and the Ecuadorian National Assembly on the 20th of March, passed through legislation which deemed the COVID-19 pandemic as a justified reason for compulsory licencing, in order to secure the procurement of key medical products necessary to uphold the right to health, including but not limited to ventilators, medicines and vaccines. Israel has gone even further by already issuing compulsory licences for the importation of generic versions for Kaletra, antiviral medication for HIV, which is currently being tested by the WHO (Brown, 2020, Hay, 2020). In Australia, current legislation, i.e. last year’s Amendments to the Patents Act (1990) allows for compulsory licenses to be issued for “crown use”, and furthermore Shadow Industry Minister Brendan O’Connor articulated that “The government will need to detail how Crown use of patents may be invoked, […] to address shortages of essential goods impacted by disrupted supply chains,” (Hay, 2020). Thereby showcasing a willingness from Australia’s government to use compulsory licensing to resolve challenges brought forth by the current COVID-19 Pandemic. The above examples demonstrate how governments from around the globe are willing to use the inherent flexibility of compulsory licensing regarding the TRIPs agreement to uphold the right to health for citizens during a pandemic. It highlights how in the case of a global health emergency; governments were able to mobilise themselves to use their authority to facilitate positive health outcomes for their citizens.
Looking at the current actions taken by the international community to try and circumvent the barriers placed by the TRIPs Agreement have been moves that include an Open COVID Pledge, where in the event that a vaccine is created it will not be patented, and instead be open-sourced so that manufacturing is not limited to certain firms, or third parties (Stolanoff, 2020). This is also in line with the initiative championed by the World Health Organisation, SOLIDARITY, which is a multinational mega-trial of four well-known antiviral medications involving at least ten different countries (Brown, 2020). The mega trial brings together large pharmaceutical companies like Gilead and Pfizer, with the institutional support of the WHO. These steps of international cooperation are commendable. It is important that in times of such international distress we are able to stretch out across borders.
However, these initiatives are outside of the norm for the trajectory of pharmaceutical research and development and this fact should not be forgotten. It pays to remember that although companies like Gilead have joined the WHO’s SOLIDARITY initiative, the United States based pharmaceutical multinational initially received an orphan drug designation for a potential COVID-19 medicine, Remdesvir. Remdesvir is not a cure for COVID-19, but rather a failed Ebola cure, which in clinical tests demonstrates a lessening of symptoms related to COVID-19 such that it can shorten hospital stays by 4 days. The company intended to enjoy a monopoly over the use of the drug and only backtracked following criticisms from activists. Orphan drug status applies to diseases that affect up to two hundred thousand people within the US, but at the time the designation was granted over four hundred thousand people globally were diagnosed with COVID-19. After criticism, Gilead acknowledged the urgent public health needs posed by the pandemic and committed to advancing the development of Remdesvir as soon as possible (Madar, 2020, Brown, 2020). Even within developed countries, Gilead is ready to sell Remdesvir at approximately USD$2340 per patient. This is in spite of the fact that the manufacturing cost of the drug is rough USD$10, including costs for research and development. Talking about research and development, it also is vital to mention that Gilead received 70.5 million from the US Government as a grant for the development of the aforementioned drug.
It is concerning to consider that a US-based pharmaceutical firm was ready to enjoy a monopoly and related tax benefits relating to a drug that could treat a pandemic disease affecting hundreds of thousands. It is clear to see a difference between the priorities for pharmaceutical firms versus the priorities for the wider international community, where one favours corporate profits over the lives of people. It is even more disconcerting to acknowledge that it took a global pandemic threatening the lives of millions for these priorities to finally match up. In defence of Gilead, those exorbitant prices are for developed countries only, for the developing world Gilead has tasked generic drug makers like Cipla and Hetero Labs to make a supply of Remdesvir for 127 developing countries, resulting in a generic price of USD$66. The COVID-19 pandemic has swiftly demonstrated that international cooperation relating to the research and development of essential medicines is possible but unfortunately is not the norm (United, 2020).
As stressed by the United Nations, “international cooperation, as well as flexible policies on intellectual property, to access the latest technology and research on potential treatments, including any future vaccine, are necessary to defeat this threat on a global scale. (United, 2020)”. In the past, the international IPR regime has acted as a hindrance especially for developing countries in accessing and facilitating a right to health, as enforced through the multilateral trading system. In our current crisis, COVID-19 Pandemic, there needs to be a concerted push, not just domestically but internationally to push through these barriers. Here it is important again to underline that although in the past the health community has focused limitedly on how trade affects health, the importance of protecting health for trade reasons has been crystallised by the current situation (Coriat et al., 2006). There is an opportunity to create new precedents of using compulsory licensing to ensure generic medication can be manufactured which may extend beyond the current crisis.
References
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