On Friday, 10 July 2020, the European Parliament adopted a resolution entitled, The EU’s public health strategy post-COVID-19, by 526 votes to 105 and 50 abstentions. This resolution paves the way for the creation of a European Health Union and the establishment of a European Health Response Mechanism; the resolution contains strong language in support of WHO’s COVID-19 Technology Access Pool (C-TAP), de-linkage mechanisms, transparency, and compulsory licensing.
Operative paragraph 6 of the resolution calls on the European Commission and EU member states to “formally support the COVID-19 Technology Access Pool (C-TAP), allowing maximum sharing of COVID-19 health technology-related knowledge, intellectual property and data to the benefit of all countries and citizens”. The European Parliament’s unequivocal support for WHO’s Technology Access Pool (C-TAP) provides a strong mandate for the European Union’s engagement and support for the pool.
In relation to ensuring public return on public investment, operative paragraph 7 of the resolution calls on the European Commission and EU member states to “incorporate collective safeguards in favour of the public regarding public funding, such as transparency, accessibility and affordability clauses and non-exclusive licences for the exploitation of the final products, in all current and future calls for funding and investment”.
The resolution envisages the use of compulsory licensing in the event that third countries (non-EU member states) do not share COVID-19 vaccines, therapeutics and know-how:
8. Calls for dialogue and cooperation with third countries; urges Member States to issue compulsory licences, in the event that third countries do not share the vaccine and/or therapy or the respective knowledge;
In an effort to avert EU member states pursuing a beggar thy neighbor approach to procuring vaccines and treatments, the resolution states:
17. Calls for EU joint procurement to be used for the purchase of COVID-19 vaccines and treatments, and for it to be used more systematically to avoid Member States competing against each other and to ensure equal and affordable access to important medicines and medical devices, in particular for new innovative antibiotics, new vaccines and curative medicines, and medicines for rare diseases;
In relation to the transparency of prices, R&D costs, and clinical trial results, the resolution proposes the following:
20. Calls on the Commission and the Member States to present a new proposal to revise Directive 89/105/EEC on the transparency of prices, ensuring transparency of the R&D costs and putting Member States on an equal footing when negotiating with manufacturers for treatments that are not jointly procured;
21. Insists on the swift implementation of the heavily delayed Clinical Trials Regulation to ensure transparency of clinical trial results, regardless of the outcome, and facilitate larger, cross-border clinical trials; underlines that negative or inconclusive outcomes from clinical trials represent important knowledge that can help improve future research;
On intellectual property, the resolution proposed the following:
23. Encourages all countries to join the WTO’s Pharmaceutical Tariff Elimination Agreement and urges that the scope be extended to all pharmaceutical and medicinal products and supports that the EU must maintain a robust European intellectual property (IP) system to encourage R&D and manufacturing in Europe, to ensure that Europe remains an innovator and a world leader;
In relation to exploring “credible and effective alternatives” to monopoly-based protection for the financing of medical R&D, the resolution calls on the Commission to examine delinkage mechanisms.
44. Calls on the Commission to assess the impact of intellectual property incentives on biomedical innovation in general and to explore credible and effective alternatives to exclusive protections for the financing of medical R&D, such as the numerous tools based on delinkage mechanisms;
Jaume Vidal, Senior Policy Advisor, European Projects from Health Action International (HAI) provided the following insights.
“The approval of the 10 July 2020 European Parliament resolution, on the EU’s public health strategy post-COVID-19, by a wide margin in the plenary of the European Parliament is highly relevant not only for the wide margins of support but also because it puts pressure onto the European Commission (and Member States) to effectively support the WHO C-TAP initiative while leaving explicitly open the possibility of taking legislative action on easing the use of compulsory license in the EU and stating explicitly that access to COVID-19 vaccines or therapeutic response will not be a EU-first or US-only affair but a global, universal one.”
Viviana Galli, Coordinator, European Alliance for Responsible R&D and Affordable Medicines provided these comments on the passage of the resolution:
“A cross-party resolution calling for global equitable and affordable access, the inclusion of pro-public safeguards attached to public funds, more transparency and a review of the impact of IP incentives is a strong signal to the European Commission and Member States to prioritize public health across policies. The next fundamental step is to translate the guiding principles outlined in the resolution into policy action.”
The text of the resolution can be found here: https://www.europarl.europa.eu/doceo/document/TA-9-2020-0205_EN.html