Strategy for the development of biotechnology and biomanufacturing in the context of public health challenges in the EU

Subject: Strategy for the development of biotechnology and biomanufacturing in the context of public health challenges in the EU

In a communication published on 20 March 2024 entitled ‘Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU’, the Commission highlights biotechnology as one of the fastest growing innovative industries in the European Union. The communication follows on from the earlier Commission Recommendation (EU) 2023/2113 on critical technology areas, and makes reference to the proposal for a Parliament and Council regulation establishing the Strategic Technologies for Europe Platform (STEP).

Taking into account that, on the one hand, the EU already has a wide range of financial instruments at its disposal to support biotechnology and biomanufacturing – Horizon Europe (along with the CBE JU and IHI JU initiatives), the EU4Health Programme, the Innovation Fund – and, on the other hand, given the context of the proposed priorities for the development of biotechnology and biomanufacturing and their overarching role, as confirmed by communications and previous recommendations:

Does the Commission intend to present a roadmap of new initiatives that would specifically identify those branches of biotechnology and biomanufacturing that could be used strategically to make practical improvements in the quality of public health through targeted prevention and treatment of chronic diseases, drug production, development of regenerative and personalised medicine, and countering antimicrobial resistance?

Submitted:3.4.2024

Answer given by Ms Kyriakides on behalf of the European Commission (4 June 2024)

The Commission Communication on ‘Building the future with nature: Boosting Biotechnology and Biomanufacturing in the EU’ (1) summarises the current challenges and barriers for biotechnology and biomanufacturing, and it proposes a list of concrete actions to help address these challenges in a timely manner.

These actions include measures on the use of public investments to encourage private investments in the sector. In this regard, the Commission announced in the communication that it will continue to follow up and strengthen the EU level framework.

Health and health-related matters are at the forefront of the political agenda of the Commission, reflecting its unwavering commitment to safeguarding the well-being of EU citizens and fostering a resilient, innovative, and competitive healthcare sector.

In addition, the Commission would like to draw the attention of the Honourable Member to the fact that on 26 April 2023, it has adopted a comprehensive reform of the EU pharmaceutical legislation (2).

The reform has introduced a number of measures to ensure that the EU regulatory system can keep pace with scientific and technological progress and create an enabling regulatory environment for promising new therapies and breakthrough innovation.

These measures would directly benefit biotechnological products. In parallel, the Council Recommendation on antimicrobial resistance (3) (AMR) together with the related measures proposed under the reform of the EU pharmaceutical legislation, complement and extend actions under the 2017 EU One Health Action Plan against AMR.

1 ∙ ⸱ https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52024DC0137R(01)

2 ∙ ⸱ https://health.ec.europa.eu/medicinal-products/pharmaceutical-strategy-europe/reform-eu-pharmaceutical-legislation_en

3 ∙ ⸱ https://data.consilium.europa.eu/doc/document/ST-9581-2023-INIT/en/pdf