MOTION FOR A RESOLUTION on meeting the global COVID-19 challenge: effects of the waiver of the WTO TRIPS Agreement on COVID-19 vaccines, treatment, equipment and increasing production and manufacturing capacity in developing countries

B9‑0306/2021

European Parliament resolution on meeting the global COVID-19 challenge: effects of the waiver of the WTO TRIPS Agreement on COVID-19 vaccines, treatment, equipment and increasing production and manufacturing capacity in developing countries

(2021/2692(RSP))

The European Parliament,

– having regard to the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), notably Article 31(a) thereof,

– having regard to the Doha Declaration of 14 November 2001 on the TRIPS Agreement and Public Health,

– having regard to the decision of the WTO’s Council for Trade-Related Aspects of Intellectual Property Rights of 6 November 2015 on the extension of the exemption for least developed country (LDC) WTO members to implement provisions of the TRIPS Agreement related to pharmaceutical products,

– having regard to the communication from India and South Africa of 2 October 2020 requesting a waiver from certain provisions of the TRIPS Agreement for the prevention, containment and treatment of COVID-19, co-sponsored by Eswatini, Kenya, Mozambique and Pakistan, and supported by 100 other countries,

– having regard to the current International Health Regulations,

– having regard to the Pharmaceutical Strategy for Europe published by the Commission on 25 November 2020,

– having regard to the Commission communication of 11 November 2020 entitled ‘Building a European Health Union: Reinforcing the EU’s resilience for cross-border health threats’ (COM(2020)0724) and its accompanying proposals,

– having regard to the open letter from 243 civil society organisations to the WTO Director-General of 13 April 2021 on addressing the global challenges of inadequate supply and inequitable access to COVID-19 medical products, especially vaccines,

– having regard to the joint statement on transparency and data integrity of the International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) of 7 May 2021,

– having regard to the statement of US Trade Representative of 5 May 2021 on the COVID-19 TRIPS waiver,

– having regard to the open letter of the President of the Republic of Costa Rica and the Director-General of the WHO of 27 May 2021, to call once again on all WHO Member States to actively support the COVID-19 Technology Access Pool (C-TAP),

– having regard to the statement by the President of the Commission following the informal EU-India leaders’ meeting of 8 May 2021 in Porto,

– having regard to the Rome Declaration adopted at the Global Health Summit on 21 May 2021,

– having regard to the letter of 31 May 2021 by the Director-General of the WHO, the Director-General of the WTO, the Managing Director of the International Monetary Fund (IMF) and the President of the World Bank Group calling for a new commitment for vaccine equity and defeating the pandemic,

– having regard to the UN 2030 Agenda for Sustainable Development and to the Sustainable Development Goals (SDGs),

– having regard to the Universal Declaration of Human Rights,

– having regard to Rule 132(2) of its Rules of Procedure,

A. whereas there have been approximately 170 000 000 cases of COVID-19, resulting in over 3 500 000 deaths worldwide, bringing unprecedented suffering, distress and the destruction of their livelihoods to millions of people; whereas the true extent and the long-term effects of the pandemic remain unknown;

B. whereas an effective response to COVID-19 requires rapid access to affordable medical products, vaccines and medicines; whereas shortages of these products have led to many avoidable deaths; whereas mRNA-based vaccines have proven to be the most effective, but also the most expensive vaccines on the market; whereas none of the companies currently producing mRNA vaccines have made a commitment to sell them at production cost prices for the duration of the pandemic;

C. whereas as of May 2021, approximately 1.5 billion vaccine doses have been administered worldwide, the vast majority of which have been in industrialised and vaccine-producing countries; whereas low- and middle-income countries have received only a fraction of the global commitment and, if current trends continue, may have to wait until 2024 for mass immunisation; whereas the EU has announced that it will purchase 1.8 billion doses of second-generation vaccines using mRNA technology;

D. whereas worrying new COVID-19 variants are emerging, which are more transmissible, deadly and less susceptible to vaccines, and may require additional vaccine shots, pushing demand far beyond the 11 billion necessary doses originally estimated; whereas as long as COVID-19 remains prevalent, it may continue to mutate, cost lives and undermine the efficacy of vaccines as a whole, requiring the swift acquisition and administration of updated vaccines;

E. whereas huge amounts of public funds and resources have been invested in research and development, clinical trials and procurement in order to develop vaccines and COVID-19 treatments in an open and accessible way; whereas public sector research, health institutions, frontline workers, scientists, researchers and patients have all gathered information on the virus, which pharmaceutical companies have utilised;

F. whereas the COVID-19 pandemic has caused unprecedented disruption to the global economy and a breakdown in global supply chains, coupled with growing shortages of critical medical equipment and pharmaceuticals where they are most needed; whereas vaccines could prevent the loss of USD 375 billion every month to the global economy and address social inequalities resulting from the pandemic;

G. whereas the WHO has launched the COVID-19 C-TAP initiative, calling on pharmaceutical companies to commit to transparent, non-exclusive global voluntary licensing; whereas a majority of pharmaceutical companies has, however, favoured a voluntary bilateral contracting approach, thereby withholding technology and know-how in order to control production, supply and prices;

H. whereas numerous offers have been made to large pharmaceutical companies by generic and smaller producers with significant production capacities to assist in the manufacture of vaccines or their components, but none of these offers have been accepted; whereas Pakistan, Bangladesh, Indonesia, South Africa and Senegal have stated that they have facilities ready and available to produce COVID-19 vaccines;

I. whereas on 11 May 2021, Bolivia announced that it will seek to import 15 million vaccines produced under a compulsory license from Canada, a decision which was welcomed by the head of the WTO IPR division; whereas Canada has not yet approved compulsory licensing for any of the COVID-19 vaccines; whereas Article 31(a) of the TRIPS Agreement has only once been successfully used, and several countries have criticised the system for being too slow and burdensome for dealing with public health emergencies;

J. whereas the Commission has previously supported the LDCs’ call for easier access to cheaper medicines by means of an indefinite exemption from WTO intellectual property rules for pharmaceuticals;

K. whereas the Doha Declaration on Public Health outlines the flexibilities contained in the TRIPS Agreement to address public health; whereas, however, many developing countries with insufficient or no manufacturing capacity still face significant political pressure and legal difficulties preventing their use of TRIPS flexibilities, notably Article 31(a) and the cumbersome and lengthy process for the import and export of pharmaceutical products;

L. whereas COVAX is expected to have distributed only 20 % of its target of approximately 187 million vaccine doses by the end of May 2021, with concerns that doses could run critically low, emphasising the need for well-supplied countries to start donating some of their doses immediately; whereas a worrying funding shortfall of USD 18.5 billion remains for the Access to COVID-19 Tools (ACT) Accelerator;

M. whereas thus far 400 million doses of vaccines have been produced in the EU, half of which have been exported; whereas the EU, under Team Europe, has committed to donate a further 100 million doses for use in lower- and middle-income countries by the end of 2021; whereas some of the EU’s trading partners have regrettably placed export bans on vaccines and their ingredients, preventing an increase in global production and causing bottlenecks in supply chains;

N. whereas UN SDG 3 aims to provide universal access to affordable essential medicines and vaccines; whereas the right to physical and mental health is a fundamental human right; whereas every person, without discrimination, has the right to access modern and comprehensive healthcare; whereas universal health coverage is an SDG that all signatories have committed to achieve by 2030;

1. Reaffirms that access to healthcare is a fundamental human right and that governments have a duty to fulfil their obligations by providing a public health service to all; stresses that humanity must do whatever it takes to end the pandemic, and that the affordability of COVID-19-related health products, the scaling-up of COVID-19 vaccine production and the global geographical distribution of manufacturing capacity for COVID-19-related health technologies are of the utmost priority; calls, therefore, for a temporary TRIPS waiver for COVID-19 vaccines and related health technologies, and for the EU to actively participate in text-based negotiations at the WTO to achieve this;

2. Underlines that global equitable access to affordable vaccines, diagnostics and treatments is the only way to mitigate the global public health and economic impact of the pandemic, and that the temporary waiving of international intellectual property protection obligations for COVID-19-related medicinal products, medical devices and other health technologies is one of the important contributions to this goal;

3. Stresses that one of the main priorities should be the urgent increase of global production capacities, particularly in low- and middle-income countries; underlines the need for the active transfer of technology and know-how to make this happen; reaffirms its support for the WHO COVID-19 C-TAP initiative and the mRNA vaccine technology transfer hub, and calls on the Commission to ensure that vaccine manufactures engage in this initiative through future advance purchase agreements and other vaccine contracts; insists that vaccine manufacturers actively engage in technology transfers to boost vaccine production and to ensure better geographical distribution of manufacturing capacities, including in emerging and developing countries; calls on the Commission to work with manufacturers to enable them to mobilise already existing manufacturing capacity which is lying idle in, for example, Pakistan, Bangladesh, India, South Africa, Indonesia and Senegal, while complying with good manufacturing practice (GMP); calls for C-TAP and the technology transfer hub to actively map companies, including sub-contractors, with the necessary know-how to transfer technology and to pair them with companies with idle production facilities; supports the Commission’s announcement of a Team Europe initiative on manufacturing and access to vaccines, medicines and health technologies in Africa, in particular the development of regional manufacturing hubs; expects the Commission to set these up as soon as possible and complement them with support for logistics and skills development;

4. Underlines that the health systems connector pillar of the ACT-Accelerator must be reinforced to increase processing, storage, distribution and delivery capacities worldwide, particularly in vulnerable countries; calls for the EU and its Member States to increase engagement at the WHO, prioritising the ACT-Accelerator as part of the EU’s global response in all of its pillars of diagnostics, therapeutics, vaccine and the strengthening of health systems;

5. Recognises that the EU and its Member States have contributed to the COVAX facility; points out, however, that this still falls far short of global demand; urges the Commission to pursue effective vaccine and medical supply diplomacy to strengthen the EU’s credibility and diplomatic visibility; welcomes, therefore, the announcement by the EU that it will donate 100 million doses to COVAX by the end of 2021, and calls for doses to be shared immediately; welcomes the pledge by certain manufacturers to supply 1.3 billion vaccine doses at production or low cost, and reiterates its calls to step up efforts to make vaccines globally accessible; calls for the EU and its partners to significantly increase financial and non-financial contributions to COVAX, recalling that, according to estimates, the EU Member States will receive a surplus of at least 400 million vaccine doses in 2021; underlines the need to prioritise supplying COVAX over bilateral deals; regrets moves by the UK and the US to develop a secondary re-sale market to sell surplus vaccines to other industrialised countries;

6. Calls on the Commission to prioritise negotiations with partner countries in order to remove obstacles to trade, remove export bans and increase the supply of critical materials, minerals, active pharmaceutical ingredients, medicines and medical equipment along the manufacturing value chain, covering both vaccines and the components necessary to produce them; calls for an international investment mechanism for solving bottlenecks and scaling up production across the vaccine supply chain; reiterates that the EU export authorisation scheme must be replaced by a transparency mechanism to monitor imports and exports;

7. Reiterates the need for a greater number of licensing agreements in order to maximise global manufacturing capacity for vaccine production; insists that the Commission include commitments on technology transfer partnerships with third parties, particularly developing countries, in the EU’s second-generation advance purchase agreements;

8. Calls for the EU and its Member States to work towards a holistic WTO-WHO initiative with developing countries, including on investments in local production sites, and establishing a system of non-exclusive licensing for COVID-19-related products; underlines that recipient partner countries should retain the full regulatory space needed to develop health strategies during the pandemic; points out that a gender-sensitive and intersectional approach is crucial to achieving equality and at every stage of vaccination process, from development through to roll-out;

9. Expects the Commission to increase its engagement to conclude the WTO Trade and Health initiative by the 12th WTO Ministerial Conference in November 2021; notes, in this context, the new proposal for an EU Health Initiative; encourages the Commission to continue pursuing as a matter of urgency tangible WTO commitments related to export restrictions, trade facilitation, the expansion of production and resolving bottlenecks across the value chain; underlines that the current TRIPS rules significantly limit exports and imports of compulsory licensed products and that this can hinder the scaling up of production and access to affordable health products; calls for a revision of the rules for compulsory licensing in order to enhance affordable access to health products; calls on the Commission to assess the TRIPS+ commitments in EU trade agreements in order to ensure that they are in line with the 2001 Doha Declaration; calls on the Commission to come forward with a legislative proposal to harmonise compulsory licensing at EU level;

10. Calls, furthermore, for the establishment of a Trade and Health Committee at the 12th WTO Ministerial Conference in order to draw lessons from the pandemic, make proposals to increase the effectiveness of the WTO response during international health crises and to prepare a trade pillar for an international pandemic treaty in order to address supply chain disruptions, increase production capacities, take action against price speculation and revisit the WTO law framework in light of lessons learned (including for IPRs);

11. Deplores the lack of transparency in the voluntary bilateral licensing approach between pharmaceutical companies and producers, especially with regard to conditions for the duration of licenses, limits on outputs, royalties on sales and production know-how, and the locations where a licensee can offer the companies’ products; underlines that such conditions must be eliminated in order to effectively defeat the pandemic and increase global vaccine production;

12. Insists that vaccine research and development funded through public money must remain in the public domain, including through public-private contracts, which should include commitments on licensing, the sharing of research, gender-sensitive and intersectional research, technology transfers, transparency on profits, and contracts with third party manufacturers; expects full compliance with the contractual commitments made by pharmaceutical companies and welcomes the launch of legal proceedings against AstraZeneca;

13. Calls for the EU to ensure that future advance purchase agreements are fully disclosed, particularly for next-generation vaccines; calls for the EU to integrate commitments with regard to trade secrets, proprietary data and technology transfers, and insist on the necessary transparency from suppliers, including a cost-profit analysis per product;

14. Reiterates the need for the utmost transparency in the negotiation of COVID-19 vaccine contracts, including through directly involving Members of the European Parliament through the vaccine contact group in the contractual decision-making processes; expects the European Parliament to regularly receive a comprehensive and detailed analysis of the production, imports, exports and forecasts of vaccines, including information on the country of destination of EU exports, as well as the origin of vaccine and vaccine component imports;

14. Calls on the Commission to examine the bilateral and regional trade agreements that include provisions which go beyond the WTO TRIPS Agreement and hinder the safeguards established by the Doha Declaration, for example parallel imports, which assert the primacy of human health over commercial interests; calls on the WTO to renegotiate the existing flexibilities in the TRIPS agreement, in order to reduce barriers to trade in generic products;

15. Underlines that the EU must continue to lead multilateral and global efforts in vaccine distribution, coordination and multiannual planning at the upcoming TRIPS Council meetings of 8 June and 14 October 2021, the G7 Summit of 11 to 13 June 2021, the 2021 G20 Summit, the 2021 EU-US summit, the 2021 UN General Assembly, the 2021 World Health Assembly, and at the WTO 12th Ministerial Conference and beyond;

16. Instructs its President to forward this resolution to the European Commission, the European External Action Service, the EU Member States, the Director-General of the World Health Organization, the Director-General of the World Trade Organization, the governments of the G20, the International Monetary Fund, the World Bank, the Secretary-General of the United Nations, and the members of the UN General Assembly.