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The conceptualization of a proper approach to patent law, as it relates to drug patents and access to medicines, remains contested. This article joins the discourse by positing that an application of the communitarian approach of ubuntu to the might of human rights is a useful framing for normalizing equity-based interventions and would help tilt the balance of power from a narrow profit-seeking imperative to one that prioritizes the public good. It contends that, while private entity ubuntu, corporate social responsibility or charity yield some positive results, they are inadequate and must be buttressed by the right to health, which entails access to the necessary diagnostics, therapeutics and medicine for all. The article argues against the predominant hegemony of current thought, which has so far not yielded meaningful and timely access, and advocates for a rethink of the possibilities of more just outcomes through more just processes.
The global impacts of COVID-19 have been calamitous, unleashing widespread human suffering and exacerbating health crises, all while worsening pre-existing inequalities and transgressing fundamental human rights. Despite earnest pleas from the United Nations and developing nations for an equitable distribution of COVID-19 vaccines, these appeals were largely unheeded. Instead, major pharmaceutical manufacturers and high-income countries (HICs) had maintained a stranglehold on vaccine technology through the safeguarding of intellectual property rights (IPRs), leading to exorbitant pricing and preferential distribution to affluent regions. This vaccine hoarding has left low- and middle-income countries (LMICs) with delayed and insufficient supplies, endangering the lives of the most vulnerable. The stringent enforcement of IPRs mechanisms, rather than aligning with international human rights obligations, has further marginalised the right to life, health, and access to vaccines and medicines, particularly in LMICs. This study ardently advocates for a policy shift that promotes the decolonisation of human rights in the context of IPRs and global health law.
Many treatment and vaccine candidates for COVID-19 will receive some form of exclusivity rights that protect against domestic and international competition. The COVID-19 pandemic has magnified the need to expediently develop vaccines and therapeutics, and exclusivities exist to incentivize research and development. However, we have seen in the past that exclusivities have unintended consequences – increased costs to patients and payers, shortages due to limited manufacturing capabilities, and efforts to forestall competition, particularly for lucrative products. Three forms of exclusivities are relevant in the context of COVID-19, which are cumulative but can also exist separately: data, patent, and regulatory exclusivity. This article compares each of these exclusivities in Europe and in the United States, focusing on implications for pricing, production and global access of therapeutics and vaccines for COVID-19. Given the need to develop, rigorously test, mass produce, and widely disseminate treatments and vaccines once available, exclusivity rights may be used as nationalistic shields, favoring provision to certain nations over others and posing an impediment to global treatment for and eradication of COVID-19. We suggest system improvements for COVID-19 and future emerging infectious disease outbreaks that balance the need to incentivize research and development without sacrificing cost, availability, or access. In public health emergencies such as pandemics, policies should be in place to optimize provision of essential products across the globe. We also explore potential reforms of the patent, regulatory, and antitrust systems that will help broaden access to essential treatments and vaccines in response to extraordinary situations such as COVID-19.
In a context of rapid technological innovation and expensive new products, the paper calls for the generation of real-world data to inform decision-making and an international discussion on the affordability of new medicines, particularly for low- and middle-income countries. Without these, the challenges of health judicialization will continue to grow.
High pharmaceutical pricing practices in Europe have been increasingly on the radar of the European Union, academia and civil society as a risk to Member State health budgets. It is therefore hardly surprising that, in recent years, competition authorities have resuscitated the excessive pricing prohibition contained in Article 102(a) TFEU. Focusing on this phenomenon, this piece highlights the diverse ways in which the United Brands test has been applied in pharmaceuticals by conducting a comparative study of the decisional practice of national competition authorities. Several observations and arguments are then derived therefrom, demonstrating that, while difficult (most notably in respect to patent-protected products), competition authorities and courts have established sophisticated ways of determining whether a pharmaceutical price is excessive in the sense of Article 102(a) TFEU. These findings should encourage hesitant competition authorities and private plaintiffs to at least carry out preliminary investigations when they suspect excessive pricing in pharmaceuticals is taking place.
Value-based agreements (VBAs) link access, reimbursement, or price to the real-world usage and impact of a medicine, thereby enabling patient access while reducing clinical or financial uncertainty for the payer. VBAs have the potential to support improved patient outcomes, given the value-oriented approach to care, and lead to overall savings, while enabling payers to share risk and reduce uncertainty.
Methods
This commentary outlines the key challenges, enablers, and a framework for successful implementation by comparing the experience of two VBAs for AstraZeneca medicines, aiming to increase confidence in their future use.
Results
Engagement by payers, manufacturers, physicians, and provider institutions, and robust data collection systems that are accessible, simple to use, and add little burden to physicians were key to successfully negotiating a VBA that worked for all stakeholders. In both country systems, a legal/policy framework enabled innovative contracting.
Conclusions
These examples demonstrate proof of concept for VBA implementation in different settings, and may inform future VBAs.
Equity is a foundational concept for the new World Health Organization (WHO) Pandemic Treaty. WHO Member States are currently negotiating to turn this undefined concept into tangible outcomes by borrowing a policy mechanism from international environmental law: “access and benefit-sharing” (ABS).
The paper surveys the intellectual property (IP) laws of seven Southern African Development Community countries to better understand the nature, scope, and depth of their patent laws with particular focus on their utilisation of TRIPS flexibilities to facilitate pharmaceutical access. The selected countries – Botswana, Malawi, Namibia, South Africa, Tanzania, Zambia, and Zimbabwe – represent a mix of both major and modest economies. While the current literature contains widespread assertions on the impact and effect of TRIPS on access to medicines in these countries and less-developed countries in general, this paper finds that the countries lack explicit and workable provisions implementing key TRIPS flexibilities. Hence, available TRIPS flexibilities have not been well utilised and it is often the complicated and unworkable domestic framework – rather than TRIPS – which becomes the stumbling block to pharmaceutical access. Another major finding is that patents may not be a major impediment in the region given that few patents and even fewer pharmaceutical patents are filed. The paper argues that since the surveyed countries are mainly net IP importers with similar developmental contexts and aspirations, the best approach would be to fully take advantage of existing flexibilities and more aggressively leverage policy space to engender access to cheaper medicines.
A significant issue in combatting the Covid-19 pandemic is the need to enhance developing states’ access to Covid-19 vaccines. The present paper considers the request for a temporary waiver of intellectual property rights in relation to Covid-19 technologies and treatments submitted to the World Trade Organization and analyses a key argument against the proposed waiver: that the compulsory licensing provisions set out in the TRIPS Agreement are sufficiently flexible to help states get access to vaccines. The compulsory licensing flexibilities set out in TRIPS, including the amendment to TRIPS in Article 31bis, are evaluated, to explore whether compulsory licensing could be an effective tool in helping developing states to access Covid-19 vaccines. Key issues are explored from a human rights perspective to examine whether a rights-based approach to the compulsory licensing provisions could offer further insights as to how the provisions could be more workable, to enhance access to medicines and vaccines for developing states.
The current debate over the global distribution of COVID-19 vaccines once again highlights the many shortcomings of the modern intellectual property (IP) system, especially when it comes to equitable access to medicines. This essay argues that the (unspoken) conceptual center of struggles over access to new pharmaceuticals rests in the IP system's colonial legacy, which perceives the world as uncharted territory that is ripe for discovery and ownership. This vision of the world as a blank canvas, or terra nullius, sets aside any other models of ownership and devalues other traditional modes of relating to territory and nature. Several examples show the long-lasting exclusionary effects of this hidden legacy of colonial conquest in the field of public health, ranging from the spiraling price of insulin to the distribution of COVID-19 vaccines to the negotiation of sharing mechanisms for virus samples. In all of these cases, the continuing marginalization of other interests by the IP system can lead to exploitation, without either the “sources” of materials, such as those from whom the samples were taken, or the recipients of the eventual product having any say in matters of price and access. This legacy of fundamental exclusion needs to be recognized and addressed in order to arrive at more equitable solutions to public health emergencies such as the current pandemic.
This chapter provides a summary of the key arguments made in this book. Crucially, the regulatory theory of patent law, which adopts a socio-centric approach to patent law, permits the incorporation of a model of human rights into a country’s patent law system. The model of human rights demands that any regulatory instrument implemented by a state must not constitute a breach of its international human rights obligations. The incorporation of a model of human rights into the design, implementation, interpretation, and enforcement of their national patent laws will help developing countries to preserve their patent policy space and secure access to affordable medicines for poor patients in their countries.
This chapter begins by introducing the problem of access to affordable medicines in developing countries. It describes the patent policy space available to states prior to the adoption of the TRIPS Agreement and the attempts made by developing countries to reclaim their patent policy space after the adoption of the TRIPS Agreement via the Doha Declaration on the TRIPS Agreement and Public Health. It notes that the Doha Declaration only yielded marginal gains in the form of the confirmation of the flexibilities that are already contained in the TRIPS Agreement and the introduction of a waiver system that is more burdensome and less beneficial. Nevertheless, the chapter contends that paragraph 4 of the Doha Declaration provides a linchpin that developing countries can use to preserve their patent policy space as it sanctions the incorporation of a right to health perspective, and invariably the incorporation of a model of human rights, into the design, implementation, interpretation, and enforcement of their national patent laws. The chapter also presents a roadmap for the rest of the book.
Patent rights on pharmaceutical products are one of the factors responsible for the lack of access to affordable medicines in developing countries. In this work, Emmanuel Kolawole Oke provides a systematic analysis of the tension between patent rights and human rights law, contending that, in order to preserve their patent policy space and secure access to affordable medicines for their citizens, developing countries should incorporate a model of human rights into the design, implementation, interpretation, and enforcement of their national patent laws. Through a comprehensive analysis of court decisions from three key developing countries (India, Kenya, and South Africa), Oke assesses the effectiveness of national courts in resolving conflicts between patent rights and the right to health, and demonstrates how a model of human rights can be incorporated into the adjudication of patent rights.
Access and benefit sharing (ABS) is a transactional mechanism designed to allow countries to trade access to their sovereign genetic resources for monetary and non-monetary benefits, with the ultimate goal of channelling those benefits into sustainable development and environmental conservation. Arguments about how pathogens are not the sort of genetic resources the world ought to conserve eventually gave way to a recognition that pathogens are indeed sovereign genetic resources under the Convention on Biological Diversity and its Nagoya Protocol, and that the ABS transaction may be an effective way to deliver scarce vaccines to developing nations as benefits received in exchange for shared pathogen samples. This article argues that categorising vaccines as benefits given in exchange for access to pathogen samples creates opposing incentives for providers and users of virus samples and undermines the human right to health because it makes that right a commodity to be bought. The provision of pathogen samples to the global research commons and the fair and equitable distribution of medicines should be two parallel public goods to be pursued as goals in and of themselves. We conclude that the linking of these goals through the ABS transaction should be reassessed.
This paper focuses on the drivers steering companies’ behaviour over uses of patented health technologies, taking Covid-19 as a case study. Global equitable access to health technologies is vital to bringing the pandemic under control. Reflecting this, global mechanisms for rightsholders to share intellectual property rights, data and know-how over such health technologies have been developed. Yet, to date, there is limited support from corporate rightsholders for such mechanisms. Instead, health technologies have been licensed largely based on bilateral deals, with vast global inequalities emerging. Given the traditional focus within company law on prioritising shareholders' short-term financial value, we argue that it is unsurprising that many corporate rightsholders adopt a protectionist approach to patents, even in the face of health crises. However, we argue that the tide may now be starting to shift, catalysed by an emergence of engaged shareholders petitioning for socially responsible corporate behaviour, including for uses of intellectual property over health technologies in a manner that more clearly aligns with public interests. If harnessed and encouraged, such engaged shareholder behaviour could present an opportunity to reframe the conception of shareholder value towards one that considers a long-term sustainable approach and ultimately to shift corporate behaviour around uses of intellectual property over health technologies to take public interests into account.
Turkey's health reforms started in 2003 with providing changes in regulatory, financing, and healthcare services. Access to health care and pharmaceuticals increased rapidly, and this resulted with an increase in public pharmaceutical expenditures. Our study aims to quantify and to evaluate the impact of a specific process within the Turkish system called “Medicines Brought From Abroad" (MBFA).
Methods
We reviewed the general reimbursement legislations of Social Security Institution (SSI), the guideline on MBFA, the SSI reimbursement list, the list of MBFA published by the Ministry of Health to describe the current supply mechanism of medicines and, in particular, the role of MBFA.
Results
Total costs of the of MBFA medicines over the period 2011–17 went up to more than $520 million, which takes 7.5 percent of total public pharmaceutical expenditure for 2017. Our results showed that MBFA provides access to many orphan drugs and in total, forty-two orphan drugs listed in MBFA accounted for 83 percent of all MBFA budget in the year 2017. Nine of the top ten MBFA medicines were orphan drugs and total costs were $408 million. The highest budget impact was for eculizumab for “paroxysmal nocturnal hemoglobinuria” (PNH), covering 31 percent of total MBFA costs and 2.3 percent of overall drug costs in 2017.
Conclusions
Turkey faced significant challenges for creating an access pathway for innovative medicines while continuing the sustainability of the public pharmaceutical budget like many other countries. Therefore, it may be argued that Turkey needs to create an independent health technology assessment organization to provide sustainable access to medicines in the future.
Chapter 7 analyzes the human right to the highest attainable standard of health, as the World Health Organization Constitution articulates it, as requiring both that scientific sharing for biomedical advances take place but also that the benefits of research must be distributed so as to ensure that humans have access to essential medicines. The right to science also seeks to ensure access to the benefits that arise from scientific research and its applications. These discussions are contextualized within the broader colonial histories of both global health and international law and recommends contextualizing both access to pathogens and the sharing of benefits within human rights obligations of states in a manner that is cohesive, and non-fragmented, with other international agreements, including the International Health Regulations and the Nagoya Protocol.
This chapter examines the debate over the right and ability of countries to grant compulsory licenses on patented pharmaceutical products, including biologic drugs produced in living organisms, as a means of ensuring access to medicines. Opponents of such measures sometimes label them as “theft.” This chapter contemplates the validity of such theft rhetoric from an unconventional perspective: that of biblical teachings on what it means to steal. After an introduction to the issue, Part II describes the use of theft rhetoric in relation to intellectual property infringement broadly and drug patent compulsory licenses in particular. Part III challenges the contention, suggested by theft rhetoric, that compulsory licenses are morally wrong as a form of stealing, by considering the meaning of theft in the context of its Judeo-Christian origins. Part IV considers the cogency of the accusation that the issuance of compulsory licenses in developing countries destroys pharmaceutical company innovation incentives. Part V concludes that expanding the definition of theft to include, as the Bible does, the possibility that a property owner may be stealing from the poor, can help us to properly evaluate the morality of drug patent compulsory licenses.
Life patents are a form of intellectual property protection being enshrined and strengthened in bi-lateral and multi–lateral trade agreements. The Church’s teaching and societal engagement to protect human rights has grown in response to the expanded use of patents on living matter, including human genes, DNA and stem cells, as well as microorganisms, plants and animals. This analysis is based on three assets of the work of the Church in the United States: 1) the teaching of the Church; 2) relationships with the Church in other nations; and 3) on–the–ground experience in developing nations, especially through the Conference’s relief and development agency, Catholic Relief Services (CRS). The paper explores two questions: What lessons can be learned from the Church’s engagement with life patents as they touch the rights of persons who are poor, indigenous or marginalized? How can the Church appropriately defend the rights of persons at the margins of the global economy, insuring their just and fair treatment, and their access to the life–saving benefits of life patents?