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SOUTHNEWS

 
No. 329,  12 August 2020

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EU Parliament adopts resolution on public health strategy post-COVID-19 based on use of TRIPS flexibilities to ensure access to health technologies

The European Parliament has adopted a Resolution on the post-COVID-19 European Union (EU) health strategy that calls upon the European Commission (EC) and EU member States to make use of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) flexibilities, including granting compulsory licenses, ensure joint procurement and transparency of research and development (R&D) costs and pricing, as well as explore alternatives to the existing intellectual property based model of incentivizing biomedical research and development.

On 10 July 2020, the European Parliament adopted a resolution on the European Union’s (EU) public health strategy post-COVID-19.[1] Significantly, this resolution calls upon the EU member States to take measures to ensure access to health technologies for responding to COVID-19 by making use of the flexibilities available under the World Trade Organization (WTO) Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), ensure joint procurement for equitable distribution of health technologies among EU member States, and enhance transparency of research and development (R&D) costs and pricing of medical products.

The Resolution recognizes that COVID-19 has highlighted the fact that the European Union does not have strong enough tools to deal with a health emergency such as the spread of a novel infectious disease. In particular, it notes the supply chain limitations and dependence of the EU for active pharmaceutical ingredients and generic medicines on a few third countries, and also the failure of the EU Vaccine Strategy to address the issue of availability of vaccines at cost while relying on advance purchase agreements.

In this context, the Resolution notes that the TRIPS flexibilities can be used for issuing compulsory licenses in public health crises situations, and calls upon the European Commission (EC), the EU member States and global partners to ensure rapid, equal and affordable access for all people worldwide to future COVID-19 vaccines and treatments as soon as they are available. It also calls upon the EC and the 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. It also calls for 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. Most significantly, the Resolution calls for for dialogue and cooperation with third countries and urges EU member States to issue compulsory licences, if third countries do not share the vaccine and/or therapy or the respective knowledge.

The Resolution also 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.

With regard to transparency in pricing and cost of R&D the Resolution calls on the EC and the EU 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.

Reflecting a long-term and systemic view of biomedical R&D in the context of the shortages evident in the current pandemic, the Resolution calls on the EC to assess the impact of intellectual property-related incentives on biomedical innovation in general, to explore credible and effective alternatives to exclusive protections for the financing of medical R&D such as the numerous tools based on de-linkage mechanisms.

Though the European Parliament Resolution is non-binding, it provides important guidance to the EC and the EU member States on the measures that should be taken to ensure affordable and equitable access to medicines, vaccines, diagnostics, personal protective equipment, and other medical devices such as ventilators, etc. Indeed, a number of EU member States have already adopted legislation enabling the issuance of compulsory licenses to ensure access to health technologies for COVID-19. Italy has recently adopted a decree to ensure transparency of prices and R&D costs for pharmaceutical products.[2] This makes it clear that other countries, particularly developing countries, can and should consider the need for similar measures. The commented Resolution shows that the TRIPS flexibilities, particularly compulsory licenses, are legitimate tools that all members of the World Trade Organization (including developed countries) can and should use in order to overcome obstacles that intellectual property rights may pose to the timely access to pharmaceuticals at affordable prices. Some of the relevant sections of the Resolution are the following:

AK.  whereas flexibilities provided for in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), further reaffirmed by the Doha Declaration, can be used for the issuing of compulsory licences in public health crises;

5. Calls on the Commission, the Member States and global partners to ensure rapid, equal and affordable access for all people worldwide to future COVID-19 vaccines and treatments as soon as they are available;

6. Calls on the Commission and the 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;

7. Calls on the Commission and the 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;

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;

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;

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;

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 RD, such as the numerous tools based on delinkage mechanisms.
 
[1] European Parliament resolution of 10 July 2020 on the EU’s public health strategy post-COVID-19 (2020/2691(RSP)). Available from https://www.europarl.europa.eu/doceo/document/TA-9-2020-0205_EN.html.
[2] Mirza Alas and Vitor Ido, “Governments adopt new measures to increase transparency on prices in the pharmaceutical sector”, SouthNews, 10 August 2020. Available from https://us5.campaign-archive.com/?u=fa9cf38799136b5660f367ba6&id=4b438bf9bd.


Author: Nirmalya Syam is Senior Programme Officer of the Health, Intellectual Property and Biodiversity Programme (HIPB) of the South Centre. 
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For more information, please contact Anna Bernardo of the South Centre: Email bernardo@southcentre.int, or telephone +41 22 791 80 50.
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