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Towards a new structural approach to pharmaceutical innovation, intellectual property and public health: If not now, when?

Towards a new structural approach to pharmaceutical innovation, intellectual property and public health: If not now, when?

By Raffaella Ravinetto
on January 14, 2021

In 1994, the General Agreement on Tariffs and Trade  (GATT), a provisional organization that had been providing the rules for world trade since 1948, was replaced by the World Trade Organization (WTO). The Marrakesh Agreement  formally established the WTO. Under normal circumstances, only specialists would be familiar with this document. However, its Article IX recently gained some popularity, as it allows, in exceptional circumstances, waivers from certain obligations of the WTO member countries. On 2 October 2020, India and South Africa referred to this article when they formulated the proposal of a temporary waiver  on the provisions of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) related to copyright, industrial design, patents and protection of undisclosed information. Given the pandemic we’re facing, for Covid-19 related technologies, obviously.

Article IX of the Marrakesh Agreement states that “in exceptional circumstances, the Ministerial Conference may decide to waive an obligation imposed on a Member by this Agreement or any of the Multilateral Trade Agreements, provided that any such decision shall be taken by three fourths of the Members …”; and that a decision granting a waiver shall state “the exceptional circumstances justifying the decision, the terms and conditions governing the application of the waiver…”.   The first pandemic since 1918 surely qualifies as “exceptional circumstances”, so the waiver proposal from India and South Africa seems more than justified.

The importance of access to (essential) medicines for all, already explicitly acknowledged by the WTO Member States in the midst of the HIV epidemic in the 2001 Doha Declaration  (on the TRIPS agreement and public health), became even more evident during the ongoing Covid-19 pandemic, wreaking havoc in a highly globalized and interconnected world. As Dr. Tedros  put it“No one is safe until everybody is safe”. The waiver proposed by India and South Africa would remove many barriers, and accelerate the deployment of vaccines and other medical products at global level, addressing the individual right to health, and the global urgency to end the pandemic. Unfortunately, WTO member states don’t have the same interpretation of this urgency, it seems, as they remain divided on the waiver proposal. Some welcomed, supported or co-sponsored it, but many high-income countries are still (fiercely) opposing it. Their choice perpetuates an old habit of systematically backing the interests of pharmaceutical corporations, but is largely based on misinformation and oversimplifications, as well as on a dangerous tendency not to learn from previous experiences.

For instance, it is (conveniently?) “forgotten” that in the ‘90s and ‘2000s, the TRIPS rules delayed access to antiretrovirals for millions of people; that compulsory licenses did not play a key role in securing access to first-line antiretrovirals in low- and middle-income countries (generic competition did); and that the focus on patents diverted the R&D agenda from the most urgent needs of vulnerable groups, to the priorities of the most profitable markets. Furthermore, scant consideration is being given to the fact that the ongoing COVID19 R&D efforts result from global collaborations rather than from private investments only. If all these elements were taken into account, perhaps more delegations would agree to urgently pursue innovative policies for the fair pricing of essential medicines; and perhaps they wouldn’t be afraid of putting their signature under a proposal that asks for exceptional measures to face exceptional public health circumstances.

Unfortunately, policy-making around access to medicines tends to be fragmented, and the Covid-19 pandemic is no exception. While some stakeholders are opposing the TRIPS waiver proposal in order to protect the economic interests of private companies, others  are struggling to secure sufficient availability of Covid-19 related medical products. To be meaningful, policy decisions should be coordinated. All concerned stakeholders should sit at the same national (or international) concertation table, and weigh together the protection of  private economic interests versus public health. No doubt, if stakeholders acted in an informed and coordinated way, the pandemic could be put more rapidly under control.

One day the pandemic will be over, we all hope, but (particularly in low- and middle-income countries), people will keep on suffering and dying from preventable or treatable diseases, such as some cancers, hepatitis, diabetes, rabies, multi-resistant infections etc. Put differently, “access to medicines” is not the zillionth “vertical issue”, and a society that survived the pandemic, will have an even stronger moral obligation to protect those with other diseases. Shouldn’t we thus seize upon the pandemic to (re-)build solidarity in global health?  

Indeed, the Covid pandemic should act as a window of opportunity to make transformative progress on access to medicines.  The early access advocates worked by disease, or focusing on specific medicines, to untangle the complex links between innovation, intellectual property and access . In the year 2021, however, we know all too well that monopolies are barriers to access, that there will be no Universal Health Coverage (UHC) without universal access to all essential medical products, and that structural reconciliation is needed between rewards to innovation and the protection of public health. The current system, which rewards R&D investments through the market only, has come of age. It is time to thoroughly rethink it, and to achieve transparency on the costs of pharmaceutical R&D.

Even if global solidarity has been fairly disappointing so far, this pandemic, with its strong sense that “nobody is safe until everybody is safe”, can still become the perfect opportunity to take a quantum leap forward on access to medicines. Indeed, it would be tragic if future pandemics saw our children, or grand-children, again discussing a TRIPS waiver, in the midst of the pharmaceutical nationalisms of their times. Let’s bring all stakeholders together now, to build a truly innovative model of pharmaceutical R&D, which does not impede fair profit, and has the ultimate aim of addressing unmet needs while building  access to all essential medicines, for all.

The long journey to access…
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