Giuliana Miglierini, Autore a NCF International

The role of patents from from public research organisations

Research

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27 November 2025

The role of patents from from public research organisations

The latest study by the European Patent Office (EPO) Observatory on Patents and Technology reveals that patent applications from public research organisations (PROs) nearly doubled between 2001 and 2020. European PROs generated almost 63,000 European patent applications during this period, while the number of annual European patent applications increased from around 2,000 to over 3,500 by 2020.

The study identified 250 PROs that had each filed at least 20 academic patent applications with the EPO between 2001 and 2020. Over two-thirds of all PRO filings came from the top 16 organisations alone. Two French PROs are leading the ranking, the National Centre for Scientific Research (CNRS) and the Alternative Energies and Atomic Energy Commission (CEA), followed by Germany’s Fraunhofer-Gesellschaft.

Europe’s research hospitals increased their patenting activity by almost 50% between 2001 and 2020, filing around 17,400 European patent applications in the fields of pharmaceuticals, biotechnology, medical technologies and diagnostics. France’s Assistance Publique – Hôpitaux de Paris (AP-HP) was the most active research hospital.

The EU strategy for AI in science and healthcare

Giuliana Miglierini

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20 November 2025

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<strong>The EU strategy for AI in science and healthcare</strong>

The new European framework for the deployment of AI in science and healthcare has become clearer in October. The European Commission firstly launched its Apply AI strategy, targeting key industries and the public sector. At the same time, it launched the AI in Science Strategy, which is intended to make the EU a leader in AI-driven research and scientific innovation. A key measure included in the strategy is the Resource for AI Science in Europe (RAISE), a virtual European institute that pools and coordinates AI resources for developing AI and applying it in science.

Other strategic actions include measures to attract global scientific talent and highly skilled professionals, a €600 million budget from Horizon Europe to enhance access to computational power for science, and plans to double HE’s annual investments in AI to over €3 billion, including doubling of funding for AI in science. The Commission is also establishing the Apply AI Alliance, a forum that will bring together industry, the public sector, academia, social partners and civil society. In October, the Commission also launched the COMPASS-AI initiative, which includes establishing a community of experts to promote the safe and effective use of AI in healthcare.

Updates to the Q&A’s on the EU-US mutual recognition agreement

Regulatory

Giuliana Miglierini

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13 November 2025

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Updates to the Q&A’s on the EU-US mutual recognition agreement

The document published on 1 October 2025 by the EMA Inspections Office updates the Questions & Answers on the impact of the Mutual Recognition Agreement (MRA) between the European Union and the United States.

Question 1 has been updated with regard to GMP inspections of veterinary products. Specifically, between June 2023 and September 2025 the FDA confirmed the capability of Sweden, Latvia, Lithuania, Germany, Cyprus, Czech Republic, Slovakia, Italy and Romania. Assessments of Malta and Croatia for inspections of manufacturers of veterinary products are ongoing.

Q3 now states that, on the basis of a pilot programme, the EU GMP/GDP Inspectors Working Group has agreed to enable the voluntary provision of the EU-US MRA, as set out in Article 3(1) of the agreement to rely on the outcome of US FDA inspections conducted outside the US as of 1 October 2025.

According to the new Q11, the batch testing provision for veterinary products will be implemented once the FDA has recognised all the EU National Competent Authorities responsible for veterinary medicinal products. This is expected to be completed by Q1/2025. Further guidance on this topic will be published in due cours

Bern and Brussels seal new research partnership

R&D

Giuliana Miglierini

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6 November 2025

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<strong>Bern and Brussels seal new research partnership</strong>

As part of a broader package of bilateral agreements negotiated between the EU and the Swiss Confederation in 2024, Switzerland will join several R&I Union programmes, including Horizon Europe, Digital Europe, and EU4Health. The agreement on the participation to EU’s research programmes should be implemented retroactively as of 1 January 2025. Following its formal adoption by the European Council on 21 October 2025, the Commission and the Swiss authorities are due to sign the agreement in Bern on 10 November 2025 (we write at the end of October).

The complex procedure will then include the Council’s request for the EU Parliament consent and the completion of all procedures by the Swiss party necessary for the package to entry into force by the end of 2028. Only at this stage will the Council complete the process concluding the broad package of agreements, allowing them to enter into force. The package also includes updates of five agreements that give Switzerland access to the EU internal market, three new agreements on food safety, health and electricity, and a new agreement on Switzerland’s permanent and fair financial contribution to the EU’s economic and social cohesion.

The European strategy on research and technology infrastructures

Giuliana Miglierini

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23 October 2025

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<strong>The European strategy on research and technology infrastructures</strong>

On 15 September 2025, the EU Commission launched a new European strategy on research and technology (R&T) infrastructures, aiming to boost Europe’s leadership in scientific excellence and technological innovation. The new framework will give scientists, researchers, innovators, and industry easy access to Europe’s cutting-edge facilities, high-quality data and tailored services. The strategy identifies five areas of action, beginning with the strengthening the ecosystem of European research and technology infrastructures. This should include increased capacity, investment mobilisation, and better alignment of available facilities and services with user needs.

Simpler and better access to R&T infrastructures is expected to provide researchers and innovative companies with a continuum of complementary services. Great attention has also been paid to making Europe more attractive to talents, in line with the “Choose Europe” approach. R&T infrastructures should also support the “fifth freedom”, namely the free movement of research, innovation and knowledge. The governance framework for R&T infrastructures should better support long-term investment decisions and align priorities among the EU member states and stakeholders.

EU-US Framework Agreement, 15% tariff on innovative pharmaceuticals

Giuliana Miglierini

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4 September 2025

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<strong>EU-US Framework Agreement, 15% tariff on innovative pharmaceuticals</strong>

The Joint Statement issued on 21 August by the EU and the US sheds light on the tariffs announced by President Donald Trump. Building on the political agreement reached by by the parties on 27 July, the Joint Statement aims to restore stability and predictability in EU-US trade and investment. In terms of the pharmaceutical sectors, a 15% tariff will be applied to innovative medicinal products exported from the EU to the US. This is the same tariff that has been announced for most European industrial goods.

According to the Joint Statement, generic medicines, their ingredients and chemical precursors will only be subject to the Most Favoured Nation (MFN) tariff from 1 September 2025. The Statement makes no mention of tariffs applied to the medtech sector, which will therefore be subject to the standard 15% tariff. The Commission is now expected to swiftly implement the key elements of the agreement. The EU will also negotiate a fair, balanced and mutually beneficial trade agreement with the US.

The Commission’s proposal for the EU Life Sciences Strategy

Giuliana Miglierini

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28 August 2025

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The Commission’s proposal for the EU Life Sciences Strategy

On 1 July 2025, the Commission launched its proposal for a European Life Sciences Strategy. The initiative aims to significantly enhance the sector’s attractiveness and competitiveness by 2030. Life sciences encompass medicine, food and sustainable agriculture, and represent a key area for driving innovation and adding nearly €1,5 trillion in value to the life sciences value chain. The deployment of the Strategy should be supported by an annual budget of €10 billion.

The proposed Strategy would focus on three areas, the first of which is optimising the EU’s research and innovation ecosystem. This should include an EU investment plan as well as the development and deployment of microbiome-based solutions and cross-sectorial life sciences technologies. The EU Biotech Act and a new matchmaking interface connecting startups, industry and investors should support rapid market access for innovation. Procurement of life sciences innovation in key areas should receive €300 million in funding. A new Life Sciences Coordination Group is expected to facilitate the alignment of policies and funding across sectors.

EMA’s public consultation on the use of RWD in non-interventional studies

Research

Giuliana Miglierini

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31 July 2025

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EMA’s public consultation on the use of RWD in non-interventional studies

A total of 695 comments were collected from 39 different stakeholders during the public consultation on EMA’s revised reflection paper on the use of real-world data (RWD) in non-interventional studies to generate real-world evidence (RWE). The final version of the reflection paper was published on 3 April 2025. The EMA has now released a summary of the comments received and the decisions made on their basis.

The majority of comments supported the initiative, although some specific topics were of concerns. The main decisions include maintaining the original proposal for the definitions of RWD and RWE. The suggestion that non-interventional studies using RWD should focus on assessing effectiveness rather than efficacy was adopted, as well as the request of additional considerations in cases where RWD is collected through primary data collection, and recommendations on the use of AI, machine learning and natural language processing technologies.

The European Council adopted its position on the Pharmaceutical package

Giuliana Miglierini

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24 July 2025

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The European Council adopted its position on the Pharmaceutical package

The European Council adopted on 4 June 2025 its position on the new rules for the EU’s pharmaceutical sector. The mandate will allow the negotiation phase to begin in order to reach a final agreement on the reform. According to the approved text, regulatory data protection should last eight years, while regulatory market protection will add a further year (extendable to two years upon achieving pre-defined key objectives). The Council also introduced an obligation to supply, giving member states the power to require the marketing authorisation holder make a medicinal product available in sufficient quantities to cover the needs of patients in the member state.

As for the transferrable exclusivity vouchers, the Council’s position states that they can only be used in the fifth year of the regulatory data protection period, if the MA holder can demonstrate that the annual gross EU sales of the product were not greater than €490 million in any of the preceding four years. The Council has addresses access to market for generics and biosimilars by clarifying the scope of the Bolar exemption and expanding it to include submissions for procurement tenders.

The AESGP report on the 2024 of the self-care industry

Giuliana Miglierini

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16 July 2025

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The AESGP report on the 2024 of the self-care industry

2024 marked the 60th anniversary of the Association of the European Self-Care Industry (AESGP), which has spent the last six decades providing patients with the sustainable, safe and effective self-care products to help them self-manage a wide variety of ailments and everyday health issues.

According to the AESGP’s 2024 annual report, the sector manages over 4,000 non-prescription medicines, based on more than 200 different active pharmaceutical ingredients and their combinations. At least thirteen switches took place in ten different European countries in 2024.

Last year, 4.7 billion packs of non-prescription medicines were sold for the self-management of 1.2 billion minor health issues per year (e.g. allergies, gastrointestinal disorders, cough and cold, etc).

The self-care industry comprised in 2024 more than 2,000 companies operating in Europe, half of which were small- and medium-sized enterprises. The sector includes also producers of food supplements (1.3 billion of packs of minerals and vitamins sold in 2024) and self-care medical devices (2.2 billion packs purchased in Europe every year). The AESGP report mentions overall savings of €34 billion resulting from the use of non-prescription medicines.

Giuliana Miglierini

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