On Friday, 16 October 2020, the European Union provided the following perspectives during a three hour debate on the proposed waiver from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of COVID-19 co-sponsored by Eswatini, Kenya, India, and South Africa.
The European Union asserted that “[t]here is no indication that IPR issues have been a genuine barrier in relation to COVID-19-related medicines and technologies.”
In relation to public funding, the European Union cited the recent Manifesto for EU COVID-19 Research.
We note that public financing of research and development of the innovative treatments and vaccines can be subject to certain conditions. For example, the European Commission has published a Manifesto for EU COVID-19 research to encourage recipients of EU funding to make research results accessible to all. Recent Horizon 2020 COVID-19 calls have also included a temporary obligation to license results on a non-exclusive basis and at fair and reasonable conditions.
The European Union’s full statement can be found below.
15. PROPOSAL FOR A WAIVER FROM CERTAIN PROVISIONS OF THE TRIPS AGREEMENT FOR THE PREVENTION, CONTAINMENT AND TREATMENT OF COVID-19
The European Union fully shares concerns expressed by various Members about pandemic caused by COVID-19 and its devastating impact on people’s health and wellbeing as well as on economic prosperity.
Safe and effective diagnostics, treatments and vaccines are crucial in the fight against COVID-19. In a global pandemic only broad and equitable access to vaccines across the globe will ensure that the public health crisis can be tackled effectively, including in developing countries that have no production capacities or more limited financial resources.
We need to find solutions for everyone, whether in the developed or developing countries, because it is a challenge we face together and because no one is safe until everyone is safe. The European Union stands committed to work with all Members on this global challenge.
Researchers and pharmaceutical industry, supported by public funding, have put extraordinary efforts into the development of future treatments and vaccines against COVID-19. A well-functioning intellectual property rights system is crucial to ensure that these efforts are adequately incentivised and rewarded.
There is no indication that IPR issues have been a genuine barrier in relation to COVID-19-related medicines and technologies. While we agree that maintaining continued supply of such medicines and technologies is a difficult task we all face, non-efficient and underfunded healthcare and procurement systems, spike in demand and lack of manufacturing capacity or materials are much more likely to have an impact on the access to those medicines and technologies.
A well-functioning IPR system, including its wide range of exceptions and flexibilities, is part of the solution rather than an obstacle. It is our view that we should concentrate on the key current challenges:
- rapidly developing safe and effective treatment or vaccine against COVID-19;
increasing manufacturing capacity;
-
keeping global supply chains open;
- ensuring broad and equitable global distribution of treatments and vaccines once they become available.
We would like to present in more detail how the European Union tackles these challenges.
The absolute priority and a major challenge at the moment is the rapid development and rolling out of safe and effective treatments and vaccines against COVID-19. Vaccine development is a complex and lengthy process, which normally takes around 10 years. The public funding and support is contributing significantly to the development of the future vaccines, potentially within a timeframe between 12 and 18 months. However, it is the researchers and the industry with their know-how, previous and current investment that will be delivering these new vaccines, including the running of clinical trials in parallel with investing in production capacity to be able to produce millions, or even billions, of doses of a successful vaccine. This work must be incentivised and adequately rewarded and the IPR system is one the main economic incentives.
We note that public financing of research and development of the innovative treatments and vaccines can be subject to certain conditions. For example, the European Commission has published a Manifesto for EU COVID-19 research to encourage recipients of EU funding to make research results accessible to all. Recent Horizon 2020 COVID-19 calls have also included a temporary obligation to license results on a non-exclusive basis and at fair and reasonable conditions.
Once the treatment or the vaccine is available, the manufacturing of these treatments and vaccines at such an unprecedented scale and within an unprecedented timeline is likely to be the most problematic issue to be tackled. We should collaborate and assist the pharmaceutical sector in ramping up the manufacturing capacity. To tackle current and future supply side shortages, the European Commission signed and continues discussing further pre-purchase agreements that incentivise and enable the pharmaceutical sector to build and prepare large-scale production facilities once effective treatments and vaccines become available.
Being aware of the importance of the global supply chains in the pharmaceutical sector, the EU is discussing with some WTO partners a possible WTO ‘trade and health’ initiative with the aim to facilitate global access to affordable healthcare products, including for vulnerable countries without appropriate manufacturing capacities. The goal is to make supply chains more resilient and diversified and to support efforts to build strategic reserves of critical equipment. This initiative would cover issues such as establishing a scheme of global cooperation in times of health crisis in order to remove unnecessary barriers to trade, abolishing tariffs on pharmaceutical and medical goods, enhanced transparency and trade facilitating measures.
Finally, global collaboration is the only way to overcome a global pandemic. At present, international efforts are being made to ensure equitable distribution of affordable vaccines, in particular to the most vulnerable populations. To enable broad and equitable global distribution of treatments and vaccines, the EU has taken a leading role in the Global Coronavirus Response where so far nearly EUR 16 billion have been pledged for universal access to tests, treatments and vaccines against COVID-19 for the global recovery.
In collaboration with the WHO, the European Commission is actively supporting the Access to COVID-19 Tools Accelerator (ACT-A) and its vaccine pillar – the COVAX Facility. In September, the European Commission announced that it would fully participate in the COVAX Facility for equitable access to affordable COVID-19 vaccines everywhere, for everyone who needs them. As part of a Team Europe effort, the Commission contributes EUR 400 million in guarantees to support COVAX and its objectives in the context of the Coronavirus Global Response.
The EU considers that on the basis of the global innovation system, with the necessary IP tools such as patent pools and procurement arrangements as the COVAX Facility in place, existing and new treatments, and ultimately vaccines, can be made available and effectively deployed rapidly across the globe.
The TRIPS Agreement together with the principles endorsed in the Doha Declaration, is fit for purpose and allows for the necessary flexibilities in relation to IPR protection, including in the case of a health emergency, such as the COVID-19 pandemic.
If all voluntary solutions failed and IP became a barrier to treatments or vaccines against COVID-19, mechanisms to overcome it are already available. The EU has consistently supported the use, where necessary and justified, of the flexibilities provided under the TRIPS Agreement and the Doha Declaration with the objective of ensuring effective access to medicines.
In particular, the TRIPS Agreement provides for the possibility, under certain conditions, of issuing a compulsory licence for local consumption of medicines and provides for fast-track procedures in health emergencies. The TRIPS Council Secretariat has, regularly and consistently, offered its services to any WTO Member that sees itself in the need of getting help to manage the process of Article 31bis. This was confirmed in the presentation we saw yesterday.
This system is accompanied by other inbuilt TRIPS flexibilities, applying to the various IP rights. In addition, we note that the Least Developed Countries are exempt from the application of the TRIPS Agreement and, in particular, its pharmaceutical-related provisions.
Public health in light of the pandemic is a clear and undisputed priority. No effort must be spared to obtain safe, effective and affordable treatments, vaccines, tests and medical devices necessary to fight this pandemic and to ensure that these products are equitably distributed on a global scale. However, all these efforts must be geared towards addressing genuine challenges in this pandemic with appropriate solutions.