The European Union and China held a Leaders’ Meeting via videoconference on 14 September 2020. An EU-China Leaders’ meeting with the participation of leaders of all EU member states was initially scheduled to take place on this date. President of the European Council, Charles Michel, President of the European Commission, Ursula von der Leyen, and the Federal Chancellor of Germany, Angela Merkel, for the Council Presidency, conducted the videoconference with Chinese President Xi Jinping. The meeting provided an opportunity to follow up on discussions at the 22nd EU-China Summit (22 June). The meeting was important to maintain the momentum of EU-China high-level exchanges in order to achieve concrete results in line with EU interests and values.
The comprehensive agenda of the Leaders’ meeting covered trade and investment, climate change and biodiversity, the response to the COVID-19 pandemic, as well as international affairs and other issues.
With regard to the negotiations for an ambitious EU-China Comprehensive Investment Agreement (CAI), while both sides registered progress on the rules regulating the behaviour of State-owned-enterprises, on forced technology transfer and on transparency of subsidies, the EU emphasised that more work was urgently needed on the issues of rebalancing market access and on sustainable development. The EU called on China to step up its ambition on these issues. The two sides reaffirmed their objective of closing the remaining gaps before the end of the year. The EU side emphasised that high-level political engagement would be required within the Chinese system to achieve a meaningful agreement.
On other trade and economic issues, the EU reiterated its call on China to engage in future negotiations on industrial subsidies in the WTO. The EU stressed that, in line with China’s stated commitment to open up and ensure that EU producers are fairly treated on the Chinese market, more needed to be done to improve market access in the agri-food trade, financial services and the digital sector. The EU also again made clear its concerns on overcapacity, both in traditional sectors such as steel and aluminium as well as in high tech.
The two sides welcomed the signature of the EU-China Agreement on Geographical Indications which will improve access to the Chinese market especially for high-quality European agricultural products.
The EU underlined the need for reciprocity and a level playing field in the area of science and technology, underpinned by high ethical and integrity standards. Leaders welcomed and agreed to continue the high level digital dialogue. They looked forward to concrete progress on ICT standards, product safety and research and innovation.
On climate change and biodiversity, the EU encouraged China to strengthen its climate commitments in terms of peaking carbon dioxide emissions and setting the goal of climate neutrality domestically. The EU also stressed the importance of a moratorium in China of building coal-fired power plants and financing their construction abroad, at least as part of a global initiative. The EU also encouraged China to launch its national emission trading system soon. The two sides agreed to establish a High-Level Environment and Climate Dialogue to pursue ambitious joint commitments on these issues.
The EU noted that joint commitments by both sides on biodiversity could be a game-changer at global level and China has a key role to play as host of the Conference of the Parties next year. An ambitious global agreement would be a major achievement.
On the COVID-19 response, the EU emphasised the shared responsibility to participate in global efforts to stop the spread of the virus, boost research on treatments and vaccines, and strengthen the role of the World Health Organisation, including through the full implementation of the World Health Assembly resolution of May 2020. The EU also underlined that the recovery measures should support the transition to a greener and more sustainable economy. China’s full engagement in G20 efforts to support low-income countries and effectively implement the G20 – Paris Club Debt Service Suspension Initiative will also be essential.
With regard to Hong Kong, EU Leaders voiced their grave concerns about the erosion of the fundamental rights and freedoms following the imposition of the national security law on Hong Kong on 30 June, which is contrary to China’s international commitments. They also reiterated the EU’s concerns at the postponement of the Legislative Council election and the disqualification of candidates.
The EU reiterated its serious concerns about the treatment of ethnic and religious minorities, the situation of human rights defenders, as well as the limitations to freedom of expression and access to information. The two sides agreed that the Human Rights Dialogue will take place as a physical meeting in China later this year.
On regional and international issues, the EU referred to the escalating tensions in the South China Sea, urging for self-restraint and a peaceful resolution of disputes in accordance with international law. Leaders welcomed the start of the intra-Afghan negotiations in Doha. They also confirmed their commitment to upholding the Joint Comprehensive Plan of Action (the Iran nuclear deal).
The EU also expressed readiness to continue to discuss the Strategic Agenda for Cooperation 2025, which can only be concluded once significant progress has been made in the negotiations on the Comprehensive Investment Agreement.
An EU-China Leaders’ Meeting with the participation of the Heads of State and Government of the EU member states and President Xi is foreseen to be held in 2021.
EU proposes a strong multilateral trade response to the COVID-19 pandemic
EU has submitted its proposal seeking the commitment of World Trade Organization (WTO) members for a multilateral trade action plan to expand the production of COVID-19 vaccines and treatments, and ensure universal and fair access. With this proposal to the WTO, divided in two communications, the EU underlines the WTO’s central role in the response to the COVID-19 pandemic and urges fellow WTO members to agree on a set of commitments, including on intellectual property rights.
President von der Leyen said: “The EU has actively shown solidarity with the world since the beginning of the pandemic. The European Union authorized exports of around half of the total amount of vaccines produced in Europe. Our immediate, urgent goal is to ensure equitable access for low – and middle-income countries, to share vaccines wider and faster. And we continue to help ramping up production. The EU proposes concrete short and medium term solutions to ensure universal access at affordable prices. I am looking forward to discuss with the G7 leaders next week how to achieve this goal. Beyond the current crisis, it is important to ensure global preparedness for future pandemics: diversifying manufacturing so that it is not centralised only in a handful of countries and strengthening the resilience of the healthcare infrastructure in least developed countries”.
Executive Vice-President and Commissioner for Trade Valdis Dombrovskis said: “The pandemic is still with us and there can be no room for complacency. We need to urgently concentrate on proposals that accelerate the equitable distribution of COVID-19 vaccines worldwide. In this respect, a strong multilateral trade response could deliver a huge boost in the fight against COVID-19. In reality, the main problem at this moment relates to the lack of sufficient manufacturing capacity to rapidly produce the required quantities. The objective must be to ensure that any available and adequate manufacturing capacity anywhere in the world is used for the COVID-19 vaccines production.”
More on the EU’s proposal
The EU calls on governments to:
- Ensure that COVID-19 vaccines, treatments and their components can cross borders freely;
- encourage producers to expand their production, while ensuring that those countries most in need of vaccines receive them at an affordable price, and;
- facilitate the use of compulsory licensing within the WTO’s existing Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The TRIPS Agreement already provides this flexibility, which is a legitimate tool during the pandemic that can be used swiftly where needed
The first element aims to limit the use of export restrictions and keep supply chains open. Vaccine-producing countries should be ready to export a fair share of their domestic production. Supply chains are highly interconnected and should not be disrupted. In addition, the EU considers that supplies to the COVAX Facility should never be restricted, and no measures should limit trade in inputs necessary for the production of COVID-19 vaccines and treatments.
The second element calls on governments to strongly encourage and support vaccine manufacturers and developers to expand production and ensure the affordable supply of vaccines to low- and middle-income countries. Such actions could include licensing agreements, the sharing of expertise, tiered pricing including non-profit sales to low-income countries, contract manufacturing and new investments in manufacturing facilities in developing countries. The EU expects all vaccine producers and developers to make concrete pledges that increase supplies to vulnerable developing countries. In this regard, the EU welcomes the commitment of companies such as BioNTech and Pfizer, Johnson & Johnson and Moderna, which have already committed to delivering 1.3 billion doses this year to low-income countries at no profit and to middle-income countries at lower cost.
The third element, on intellectual property, sets out that voluntary licences are the most effective instrument to facilitate the expansion of production and sharing of expertise. Where voluntary cooperation fails, compulsory licences, whereby a government grants a targeted licence allowing a willing producer to make a vaccine without the consent of a patent holder, are a legitimate tool in the context of a pandemic. The EU considers that all WTO members should be ready to:
- agree that the COVID-19 pandemic is an exceptional circumstance of national emergency, and that the requirement to negotiate with the rights’ holder may be legitimately waived where needed;
- support manufacturers that are ready to produce vaccines and/or treatments at affordable prices under a compulsory licence so that the level of remuneration paid by the manufacturer to the patent holder reflects such affordable prices;
- agree that the compulsory licence could cover any exports destined to countries that lack manufacturing capacity, including via the COVAX facility.
The EU is also tabling a dedicated communication on intellectual property to the WTO body in charge of implementing the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Council). Here, the EU provides more detail and clarity on each of the three points on intellectual property and links them with the specific provisions in the TRIPS Agreement. As regards the broad waiver proposed by a number of WTO members, the European Commission, while ready to discuss any option that helps end the pandemic as soon as possible, is not convinced that this would provide the best immediate response to reach the objective of the widest and timely distribution of COVID-19 vaccines that the world urgently needs. Today’s proposals aim at achieving that objective in a swift and effective manner.
EU Digital COVID Certificate: Parliament and Council reach agreement
The Commission welcomes today’s provisional political agreement between the European Parliament and the Council on the Regulation governing the EU Digital COVID Certificate. This means that the certificate (previously called the Digital Green Certificate) is well on track to be ready end of June, as planned. Today’s agreement has been reached in record time just two months after the Commission’s proposal. The negotiations on the certificate for the Commission have been led by Commissioner Didier Reynders in close cooperation with Vice-Presidents Vera Jourová and Margaritis Schinas and Commissioners Thierry Breton, Stella Kyriakides, and Ylva Johansson.
Welcoming this swift progress, President Ursula von der Leyen said:
“We are delivering on our commitment to have the EU Digital COVID Certificate up and running before the summer. European citizens are looking forward to travelling again, and today’s agreement means they will be able to do so safely very soon.
The EU Digital COVID Certificate is free of charge, secure and accessible to all. It will cover vaccination, test and recovery offering different options to the citizens. It fully respects citizens’ fundamental rights, including protection of personal data.
All EU citizens have a fundamental right to free movement in the EU. The EU Digital COVID Certificate, available in paper or digital format, will make it easier for Europeans to travel – whether to see their families and loved ones or to get some well-deserved rest.
We would like to thank the European Parliament and the Portuguese Presidency for their dedication, perseverance and immense work at record speed to find an agreement on the proposal we presented.
Work still remains. At EU level, the system will be ready in the next few days. It is now crucial that all Member States press ahead with the roll-out of their national systems to ensure that the system can be up and running as soon as possible. This is what EU citizens rightly expect.
Today’s agreement has demonstrated that with the commitment and cooperation of all, the EU Digital COVID Certificate will be available on time.”
The EU Digital COVID Certificate – key features
Following the agreement reached by the European Parliament and the Council, the EU Digital COVID Certificate:
- will cover vaccination, test and recovery;
- will be available in a digital and paper-based format, depending on the choice of the recipients, and contain a digitally signed QR code;
- will be free of charge, be obtained easily and also available to persons vaccinated before the EU Digital COVID Certificate Regulation has entered into force;
- may also be used by Member States for national purposes, if this is provided for in national law.
- Member States shall refrain from imposing additional travel restrictions on the holders of an EU Digital COVID Certificate, unless they are necessary and proportionate to safeguard public health.
- The Commission will also mobilise €100 million to support Member States in providing affordable tests.
The political agreement will now have to be formally adopted by the European Parliament and the Council. The Regulation will enter into force on 1 July, with a phasing-in period of six weeks for the issuance of certificates for those Member States that need additional time.
In parallel, the Commission will continue to support the Member States in finalising their national solutions for the issuance and verification of EU Digital COVID Certificate, and to provide technical and financial support to Member States to on-board the gateway.
On 17 March 2021, the European Commission presented a proposal to create an EU COVID certificate to facilitate the safe free movement of citizens within the EU during the COVID-19 pandemic. At the Commission’s request, the Parliament voted in favour of the activation of the urgent procedure for the two proposals on 25 March. The Council adopted its negotiating position on 14 April, and the Parliament did so on 29 April. On 20 May co-legislators reached provisional agreement on this file.
In parallel to the legislative process, important progress was already made on the technical side. The EU Gateway, which allows to verify certificates across borders, is ready and will go live as of June. Successful pilot tests took place with 17 Member States and Iceland during the last two weeks, further five Member States will test next week.
The Commission also provide open source reference software to support Member States to develop their national solution to issue certificates, to scan and check the QR codes, and a reference wallet for storage.
Previously, on 21 April, technical specification guidelines were adopted by Member States representatives in the eHealth Network, a voluntary network connecting national authorities responsible for eHealth. They are building on the close work of the Commission with the Member States, having resulted in first guidelines adopted in January and updated on 12 March, and a trust framework outline agreed on 12 March 2021. In addition, a common design template was developed in the eHealth network.
Coronavirus: EU Strategy for the development and availability of therapeutics
The European Commission is today complementing the successful EU Vaccines Strategy with a strategy on COVID-19 therapeutics to support the development and availability of much-needed COVID-19 therapeutics, including for the treatment of ‘long COVID’. Today’s Strategy covers the full lifecycle of medicines: from research, development and manufacturing to procurement and deployment.
It is part of the strong European Health Union, in which all EU countries prepare and respond together to health crises and ensure the availability of affordable and innovative medical supplies – including the therapeutics needed to treat COVID-19.
The Strategy includes clear actions and targets, including authorising three new therapeutics to treat COVID-19 by October 2021 and possibly two more by end of the year. Concretely:
- Research, development and innovation
- Invest €90 million in population studies and clinical trials to establish links between risk factors and health outcomes to further inform public health policy and clinical management, including for long-COVID patients.
- Set up a ‘therapeutics innovation booster’ by July 2021 to support the most promising therapeutics from preclinical research to market authorisation. It will build on current initiatives and investments in therapeutic development, working in a close cooperation with the European Health Emergency Preparedness and Response Authority (HERA) preparatory action on mapping therapeutics. It will therefore ensure the coordination of all research projects on COVID-19 therapeutics, stimulating innovation and boosting therapeutic development.
- Access to and swift approval of clinical trials
- Invest €5 million under the EU4Health programme to generate better, high-quality safety data in clinical trials, which will help produce robust results in a timely manner.
- Provide EU countries with financial support of €2 million under the EU4Health 2021 work programme for expedited and coordinated assessments to facilitate approval of clinical trials.
- Explore how to support developers of therapeutics to build capacity to produce high-grade material for clinical trials.
- Scanning for candidate therapeutics
- Invest €5 million to map therapeutics and diagnostics to analyse development phases, production capacities and supply chains, including possible bottlenecks.
- Establish a broader portfolio of 10 potential COVID-19 therapeutics and identify five of the most promising ones by June 2021.
- Supply chains and delivery of medicines
- Fund a €40 million preparatory action to support flexible manufacturing and access for COVID-19 therapeutics under the EU Fab project, which in turn will become over time an important asset for the future the European Health Emergency Preparedness and Response Authority (HERA).
- Regulatory flexibility
- Authorise at least three new therapeutics by October and possibly two more by the end of the year and develop flexible regulatory approaches to speed up the assessment of promising and safe COVID-19 therapeutics.
- Start seven rolling reviews of promising therapeutics by end-2021, subject to research and development outcomes.
- Joint procurement and financing
- Launch new contracts for the purchase of authorised therapeutics by the end of the year.
- Secure faster access to medicines with shorter administrative deadlines.
- International cooperation to make medicines available to all
- Reinforce engagement for the therapeutics pillar of the Access to COVID-19 Tools Accelerator.
- Boost ‘OPEN’ initiative for international collaboration.
The Commission will draw up a portfolio of 10 potential COVID-19 therapeutics and by June 2021, identify the five most promising ones. It will organise matchmaking events for industrial actors involved in therapeutics to ensure enough production capacity and swift manufacturing. New authorisations, rolling reviews and joint procurement contracts will be up and running before the end of the year.
The therapeutics innovation booster, matchmaking events and preparatory action to support flexible manufacturing and access for COVID-19 therapeutics under the EU Fab project, will feed into the HERA, for which a proposal is due later in the year. The pilot project on access to health data will feed into the European Health Data Space proposal expected later this year.
Members of the College said:
Vice-President for Promoting our European Way of Life, Margaritis Schinas, said: “The situation in many intensive care units across the continent remains critical. We need to focus both on vaccines and therapeutics, as two powerful and complementary ways to combat COVID-19. But currently we have only one authorised medicine to treat COVID-19. By acting on better availability of medicines today, we are making sure patients receive the treatments they need while also preparing our future biomedical preparedness. A coordinated strategy on quick access to therapeutics will boost our strategic autonomy and contribute to a strong Health Union.”
Commissioner for Health and Food Safety, Stella Kyriakides, said: “Vaccinations save lives, but they cannot yet eradicate COVID-19. We need a strong push on treatments to limit the need for hospitalisation, speed up recovery times, and reduce mortality. Patients in Europe and across the world should have access to world-class COVID-19 medicines. This is why we have set a very clear goal: by October, we will develop and authorise three new effective COVID-19 therapeutics that can have the potential to change the course of the disease. We will do so by investing in research and innovation, the identification of new promising medicines, ramping up production capacity and supporting equitable access. Our Therapeutics Strategy is a strong European Health Union in action.”
Commissioner for Innovation, Research, Culture, Education and Youth, Mariya Gabriel, said: “By increasing vaccine availability across Europe, more and more Europeans are now protected against COVID-19. In the meantime, the development of innovative medicines to treat coronavirus patients remains a priority when it comes to saving lives. Research and innovation is the first step to finding effective and safe therapeutics, which is why we are proposing to establish a new COVID-19 ‘therapeutics innovation booster’ and will invest € 90 million in population studies and clinical trials.”
The Strategy on COVID-19 therapeutics complements the EU strategy for COVID-19 vaccines from June 2020 and builds on ongoing work by the European Medicines Agency and the Commission to support research, development, manufacturing and deployment of therapeutics.
The Strategy forms part of a strong European Health Union, using a coordinated EU approach to better protect the health of our citizens, equip the EU and its Member States to better prevent and address future pandemics, and improve the resilience of Europe’s health systems.
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