Steering intellectual property rights and EU action towards a bolder approach to achieving global immunisation
By Giuseppe Mazziotti (Trinity College Dublin)
In the past few months, the World Health Organization (WHO) has been claiming that the only effective solution to immunize the world’s population from the SARS-CoV-2 virus is a vaccine intended as a common or public good, accessible to everyone without geographical and economic discriminations. However, it has been hard to achieve such an ambitious goal at a time global intellectual property law, as defined under the TRIPS (Trade Related Aspects of Intellectual Property Rights) Agreement administered by the World Trade Organization (WTO), conceives drugs mostly as a form of private property subject to patent protection.
Unfortunately, none of the limitations of pharmaceutical patent protection embodied in the TRIPS Agreement applies to a health emergency with no geographical boundaries, such as the current pandemic. A specific solution to this problem might derive from the adoption of a pandemic treaty, an idea that the WHO will start discussing in an assembly in May 2021. Such an unprecedented instrument could pave the way for international obligations enabling free access to life-saving drugs, such as vaccines, and effective standards of supranational sharing of scientific knowledge on a free or at least sustainable basis for all the world’s countries.
At government level, the disruptive effects the Covid-19 pandemic has had even within the most-developed countries have spurred a predominantly nationalist approach to public health protection, to the detriment of an international cooperation and solidarity. This approach has made the wealthiest countries compete in securing the largest supplies from each of the vaccine manufacturers for their own peoples, to reach a long-awaited (although purely territorial) herd immunity. In this scenario, least developed countries and other poor economies have been benefiting from initiatives that public-private institutions and consortia such as Medicines Patent Pool (United Nations), the WHO’s Technology Access Pool (TAP) and the Global Alliance for Vaccines and Immunisation’s (GAVI) Covax initiative are currently putting in place to broaden distribution of available vaccines.
Compulsory licensing in international law
In this unprecedented situation – at least in the past century – it is hard to understand why the European Union and its Member States have not tried to implement powerful legal instruments that are expressly contemplated under the TRIPS Agreement, such as compulsory licences of pharmaceutical patents. The sole fact of openly taking them into consideration or threatening their use within their own borders, while negotiating with pharmaceutical companies, would have allowed EU members to obtain better prices and conditions for their vaccine supplies.
According to the original version of the TRIPS Agreement (1994), each WTO member was entitled to allow uses of a patented drug without the right-holder’s consent in cases contemplating national emergencies or circumstances of extreme urgency, predominantly for the supply of the domestic market. This exception entailed that countries without domestic manufacturing capacity in the pharmaceutical sector could never have used this tool to enable access to generics. It was South Africa that, in 1997, amended its patent law to allow its Minister of Health to provide affordable generic forms of essential drugs, including anti-HIV therapies,triggering a harsh reaction from pharmaceutical groups and the US government, which claimed a violation of WTO law. It was in that historical context that the 2001 Doha Declaration on the TRIPS Agreement and Public Health amended the Agreement to allow WTO members not only to locally manufacture but also to import (and export) generic versions of patented medicines. The EU strongly supported this amendment by passing Regulation 816/2006, which enables EU Member States to readily respond to help requests coming from third countries having no manufacturing capacity and legalize production and export of generics within the limits justified by each health emergency.
The approach of the EU
What should the EU have done, and what it could still do, to make access to available Covid-19 vaccines faster, fairer, and wider, even in least developed and developing countries that, for obvious historical reasons, look at Europe in situations of health and humanitarian crises?
Serious delays in the current vaccine rollouts are not entirely the European Union’s fault. The Commission and other EU bodies have found themselves facing the Covid-19 pandemic emergency without having the competence to control two essential areas which are fundamental to the development and distribution of vaccines, namely: (i) health systems, which are strictly state-owned, and (ii) the European patent system, whose organization, the European Patent Organisation (which includes the European Patent Office) is not a EU institution and does not pursue full harmonization (or unification) of national patent laws, especially in the domain of patent exceptions and compulsory licences.
The purely contractual path the EU Commission has decided to take, with the support of its complex bureaucracy, by centralizing all acquisitions and supplies of vaccines for the EU population, proved to be much less effective and timely than vaccination campaigns in the United States and the United Kingdom.
The restrictions EU Member States took, in an uncoordinated and very often anti-European fashion, established unprecedented exceptions to the principles of free movement of people and unity of the Single Market, which are authentic cornerstones of the European Union. This nationalist approach has resulted in immeasurable damages to European economies and the sacrifice of European citizens’ fundamental rights that national authorities have imposed without adequate justification and a reasonable time limit. The fact that the Commission intends to re-establish free movement of tourists and other travellers through a Digital Green Certificate without seeking to ensure a significant acceleration of vaccine rollouts is a further blow to citizens’ fundamental rights and to the Schengen agreement (for more on the Digital Green Certificate, see here).
If vaccination campaigns are being so heavily delayed and widely unpredictable, causing so much economic harm, why has not the European Union discussed and tabled intergovernmental or legislative initiatives that could have significantly increased production and supplies of Covid-19 vaccines on an EU-wide basis? Why has not it encouraged Member States to plan a concerted application of Regulation 816/2006, to help third countries produce and import life-saving vaccines? Even more importantly, why has not the EU immediately endorsed the proposal for a temporary waiver of Covid-related pharmaceutical patents that India, South Africa and dozens of other countries made before the WTO Council, from October 2020 onwards? Having expressly acknowledged the relevance and desirability of a relaxation of patent rights and having advocated, one year ago, the idea of vaccines as public goods through its President Von der Leyen, the EU should have taken the lead in supporting compulsory licences or temporary waivers at international level. A lead that is now being taken by the US trade representative before the WTO following a statement of President Biden on May 5th, 2021.
The position of EU Member States
Given this inaction at the EU level, and lack of uniformity under national patent laws, national governments found themselves in very different situations. Most EU countries (including Austria, Belgium, Czech Republic, Denmark, Spain, Finland, Greece, Croatia, Netherlands, Poland, Portugal, Romania, Sweden) already had provisions in their legislation allowing compulsory licences to enable access to essential drugs on public health grounds or, through a broader definition, in the public interest. Other EU members (such as France, Germany, and Hungary) took a step further by reforming their patent laws to be able to broaden and streamline use of this powerful tool for specific purposes related to the Covid-19 pandemic. Other EU countries, instead, did not take any measures in this field, buying the argument of the pharmaceutical industry that vaccine manufacturers could have coped with the ongoing emergency doing their business as they usually do, i.e., through voluntary licences. The fact that countries like Ireland and Italy are part of the latter group should not come as a surprise if one considers how strong and influential the lobbying of large pharmaceutical companies headquartered in both countries can be on governments, political parties, and the media.
A policy agenda under the control of the EU
Within the policy areas entirely under the control of the European Union, two of them could play a greater role in improving and broadening access to vaccines in the current pandemic. The first is the pharmaceutical law concerning quality and safety controls, as well as market authorizations, based on the federal regulatory power of the European Medicines Agency (EMA), whose acts are uniformly valid throughout the EU. The second one is competition (or antitrust) law.
As regards pharmaceutical regulations, one can only imagine the administrative and public health chaos the EU would have faced if a pandemic like Covid-19 had broken out before the establishment of a centralised procedure for market authorisations in 2004. Twenty-seven national pharmaceutical agencies would have made potentially conflicting decisions, making the actual harm even bigger than it has been. In this context, the authority of EMA ensured not only uniformity but also availability of ad hoc and fast-track procedures, where all the relevant data and clinical trials related to Covid-19 vaccines have been examined as soon as their manufacturers submitted them (rolling review). What could be done at this stage is a reform of the EU regime of market exclusivity, which currently grants pharmaceutical companies a proprietary right to control access to their drugs’ clinical trials and data and to prevent third parties from producing generic versions. In a context such as a pandemic, these exclusive rights should be limited or suspended to make compulsory licences immediately effective.
As far as antitrust is concerned, the EU Commission has extensive powers of investigation, inspection, and sanction against companies to verify whether serious delays and failures in the supply of Covid-19 vaccines to EU countries are in any way linked to any refusal to grant licences or to agreements (which would clearly be illegal) aimed to slow down the sale on the market of much larger amounts of vaccines. A thorough investigation on this front would be much more effective than any lawsuits like those that the EU Commission and some national governments (including Italy) have threatened against manufacturers because of their delays and failures to provide contractually agreed supplies.
Exceptional circumstances such as a pandemic justify limitations of the scope of intellectual property rights, whose strict enforcement has harmful consequences on people’s right to health and other fundamental rights. It is time for EU institutions and national governments to act in a much more coordinated way and to use exceptional powers they have at their disposal or whose availability depends on reforms and policy changes that, especially at international level, would greatly help face global health emergencies in the future.
 Article 14(11) Regulation no 726/2004/EC of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, O.J. L 136/1.
Giuseppe Mazziotti is a Fellow and Professor of intellectual property law at Trinity College Dublin. He specialises in intellectual property, EU law, information technology law, and cultural policies. Born in Cosenza, he holds a Ph.D. in law from the European University Institute in Florence, a cum laude law degree from the University of Perugia and master’s degrees in clarinet performance and chamber music from the Perugia Music Conservatory.