Annexes to COM(2021)355 - EU strategy on covid-19 therapeutics - Main contents

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This page contains a limited version of this dossier in the EU Monitor.

dossier	COM(2021)355 - EU strategy on covid-19 therapeutics.
document	COM(2021)355
date	May 6, 2021

Agreement for medical countermeasures²⁹ provides for a voluntary mechanism enabling participating countries and EU institutions to jointly purchase medical countermeasures for different categories of cross-border health threat, including vaccines, antivirals and other therapeutics. It aims to improve preparedness to mitigate serious cross-border threats to health and secure more equitable access to specific medical countermeasures, greater security of supply and more balanced prices for the participating countries.

On 8 October 2020, the Commission signed a joint procurement framework contract with the pharmaceutical company Gilead for the supply of up to 500 000 treatment courses of remdesivir. All participating countries were able to place their orders to procure remdesivir directly. It also directly purchased doses under the Emergency Support Instrument, for a total of €70 million, and distributed these to Member States. Since late October 2020, it has signed over 70 joint procurement contracts for 19 medicines (analgesics, antibiotics, muscle relaxers, anaesthetics, resuscitation, including dexamethasone, etc.) to treat more severe COVID-19 cases in ICUs.

The Commission is ready to conclude further joint procurement contracts to facilitate the equitable availability of, and access to, new COVID-19 therapeutics across the EU. Currently, discussions are ongoing on three new joint procurements for COVID-19 therapeutics awaiting marketing authorisations from the Commission on the EMA’s recommendation.

However, while joint procurement agreements have proved successful in securing equitable access to medicines for all interested Member States, the instrument has also shown its limitations. The Commission will consider streamlined solutions in this context to maximise the strategic role of joint procurement in achieving key preparedness goals – emphasising fair access, choice, quality, sustainability and value for public spending, while enabling adaptation to national conditions.

²⁹ As of April 2020, the Joint Procurement Agreement had been signed by 37 signatories, including all EU and EEA countries, the UK, Albania, Montenegro, North Macedonia, Serbia, and Bosnia and Herzegovina, as well as Kosovo* (* This designation is without prejudice to positions on status, and is in line with UNSCR 1244/1999 and the ICJ Opinion on the Kosovo declaration of independence).

Further account needs to be taken of the special requirements of procuring in emergency contexts. To achieve greater speed and flexibility in the current legal framework, participating Member States and other joint procurement agreement signatories would need to:

i) adhere to shorter administrative deadlines;

ii) use a distribution key where the resources being procured prove to be scarce;

iii) place a certain percentage of orders in the first few months of the contract; and

iv) refrain from engaging in parallel procurement processes for the same products or services.

Finally, the Commission is also ready to make use of other EU mechanisms and mobilise all necessary funding to procure COVID-19 therapeutics, including where appropriate by means of advance purchase agreements or the ‘innovation partnership’ procurement procedure³⁰, allowing the development and purchase of therapeutics that are not yet available on the market, or direct purchasing and donation. This may also include the emergency stockpiling of therapeutics under rescEU, as part of the Union Civil Protection Mechanism, bearing in mind the need to ensure complementarity with other EU programmes.

By engaging EU funds while pooling negotiating power at EU level, advance purchase agreements put the EU and its Member States in a position to leverage scale in discussions with the industry and ensure equity of access, in a way that cannot be achieved with multiple and sometimes competing national and European channels.

ACTIONS

>* Launch new joint procurements of COVID-19 authorised therapeutics in the EU on

behalf of Member States - by end 2021. >* Explore the possibility of engaging with Member States in advance purchase

agreements or innovation partnerships with producers of promising new therapeutics. >* Review options for a fast-track pathway for joint procurement of medical

countermeasures. > Stockpiling of therapeutics under rescEU/Union Civil Protection Mechanism.

7. International cooperation

Collaboration on therapeutics is also crucial at global level. The Commission is committed to working together with international partners on COVID-19 therapeutics. The EU will intensify its cooperation with lower- and middle-income countries to strengthen their health systems and healthcare workforce, so as to ensure equitable and timely access to high-quality and affordable medicines. In the spirit of European solidarity, the Union Civil Protection Mechanism allows the Commission to support (financially and/or logistically) Member States willing to donate therapeutics to countries impacted by the crisis and in need of assistance as

Innovation partnership is a relatively new type of public procurement procedure provided for in Directive 2014/24/EU. It can be used only in cases where no solution for a public buyer’s needs is available on the market. The main feature of the innovation partnership is that the innovation occurs during the performance of the contract. In most other procedures, the public buyer knows what type of solution it is buying: innovation occurs in the pre-contracting phase and usually ends with the conclusion of the contract, when the solutions’ exact features are agreed.

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demonstrated most recently in responding to the request for assistance from India³¹. Furthermore, the Commission is exploring how to support the enabling environment for manufacturing health products, while strengthening research capacity and public health institutes in partner countries around the globe (including their capacity to generate evidence), through the EU’s external relations instruments and the international cooperation component of Horizon Europe.

As the current chair of the International Coalition of Medicines Regulatory Authorities, the EMA (together with the Commission) is working with international partners to expedite and streamline the development, assessment and availability of COVID-19 therapeutics worldwide. In particular, in December 2020, it started piloting a new ‘OPEN’ initiative³² to increase international collaboration with the Committee for Medicinal Products for Human Use on its evaluation of COVID-19 vaccines and therapeutics. Through the confidentiality arrangements that they have concluded with third parties (including the EMA’s ad hoc COVID-19 confidentiality arrangements) and through the EU’s mutual recognition agreements, the Commission and the EMA are able to use information produced by international regulators, avoid duplication and focus efforts on at-risk areas. The EMA collaborates and actively exchanges information with other non-EU national medicines agencies and the World Health Organization (WHO) to speed up the development of therapeutics and vaccines, including for virus variants.

The Commission is actively engaged in the Access to COVID-19 Tools Accelerator, a global collaborative project to accelerate the development and production of, and equitable access to, COVID-19 tests, therapeutics and vaccines. Set up in response to a call from G20 leaders in March 2020 and launched by the WHO, the Commission, France and the Bill & Melinda Gates Foundation in April 2020³³, it brings together governments, scientists, civil society, foundations, charities and global health organisations.

Equitable access to therapeutics means equitable supply by governments and companies. The Commission is promoting cooperation between the EU-funded European platform trials and the Access to COVID-19 Tools Accelerator partnerships, in particular to ensure the rapid sharing of clinical evidence for the assessment of therapeutics and candidate vaccines, and to facilitate the global roll-out and uptake of therapeutics that successfully exit research and development. It will also continue to promote a ‘trade and health’ initiative in the World Trade Organization with a view to facilitating trade in essential goods in the context of health emergencies.

At the Global Health Summit in Rome, co-hosted by Italy and the EU on 21 May 2021, G20 leaders, international and regional organisation heads and representatives of global health bodies will share lessons learned from the pandemic and, following consultation of the scientific community and civil society organisations, agree on principles for further cooperation and joint action to prevent future global health crises, in a spirit of global solidarity.

Responding to India’s request for assistance under the Union Civil Protection Mechanism, submitted on 23 April 2021, many Member States offered needed medical supplies (including oxygen and remdesivir). For more details see: https://ec.europa.eu/echo/news/india-eu-civil-protection-mechanism-continues-coordinate-emergency-supplies_en

https://www.ema.europa.eu/en/news/ema-covid-19-assessments-open-non-eu-regulators https://www.who.int/news/item/10-09-2020-coronavirus-global-response-access-to-covid-19-tools-accelerator-facilitation-council-holds-inaugural-meeting

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ACTIONS

^ Engage with international partners to develop COVID-19 therapeutics and ensure

their fair distributi on. >* Reinforce, together with Member States, engagement in the therapeutics pillar of the

Access to COVID-19 Tools Accelerator. > Step up EU support for affected countries through the Union Civil Protection

Mechanism.

Conclusions and next steps

While safe and effective vaccines against COVID-19 are increasingly available, the development and deployment of therapeutics and diagnostics also remain a priority when it comes to saving lives. Joint EU action, within a common strategic framework on therapeutics is urgently needed to enhance and accelerate significantly the return to normality for economic and social life in the EU and across the world. The Commission will implement this EU strategy for COVID-19 therapeutics together with the Member States and the European Parliament, thus contributing to equitable and affordable access to the most appropriate and effective therapeutics in the shortest possible timeframe.

These actions are 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.

This framework will be further strengthened by the establishment of the HERA, due to be proposed by the European Commission in 2021, which will ensure that the EU can anticipate and respond effectively to serious cross-border health threats, and builds on the pharmaceutical strategy for Europe³⁴, which will create a future-proof regulatory framework, supporting research and technologies resulting in safe and effective therapeutics that reach patients.

³⁴ COM(2020) 761

final.