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The European single market strategy

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On 21 May, the European Commission published its proposal for a Single Market Strategy, aimed at supporting companies in developing their businesses while providing greater protection for consumers.

More specifically, the Commission aims to remove ten barriers that still exist to trade between EU countries, which are considered “terrible” because of their impact on the overall competitiveness of the European bloc in an increasingly complex global environment. The proposal also plans to modernise rules in certain key sectors, including construction, postal services and parcel delivery, and to simplify regulations for many services. A new definition of small and medium-sized enterprises (SMEs) should enable them to enjoy certain benefits typically available to SMEs.

Furthermore, the digitisation of processes should make digital filing the norm for companies required to comply with European regulations.

The ten key actions to break down barriers

The European single market currently has 26 million businesses and 450 million consumers, generating 18% of the global economy and €18 trillion in value for European gross domestic product. However, the single market is characterised by low productivity (around 1%), which impacts European competitiveness. According to the European Commission, completing the single market would double its benefits. In particular, the services sector alone contributes 75% of the European Union’s GDP, but 60% of the barriers are the same as they were 20 years ago.

In this regard, one of the ten priorities identified by the legislation is the definition of the 28th company regime. Furthermore, the sharing of objectiveswith individual Member States should see each of them appoint a high-level representative for the single market, known as a “sherpa”, responsible for promoting the application of the new rules and ensuring that national legislation does not hinder the completion of the single market.

Other simplification measures should impact public procurement rules and speed up the recognition of professional qualifications. The standardisation regulation should also be reviewed, with the possibility for the Commission to establish common specifications where necessary. The digital product passport is one of the measures planned for the packaging and labelling of goods on the market, with the extension and harmonisation of extended producer responsibility schemes for the end-of-life management of products.

A European market surveillance authority could also be created and authorisations and certifications for cross-border services could be harmonised. Cross-border mobility of workers could be facilitated by the adoption of an electronic declaration for posted workers and the coordination of social security. Finally, the strategy plans to develop new tools against unjustified territorial restrictions on supply, beyond the situations prohibited under competition law.

Latest EFPIA data on access to innovative medicines in Europe

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Only 46% of innovative medicines approved centrally in the period 2020-2023 (173 in total) were found to be available to European patients in 2024, according to data from the latest Patients W.A.I.T. Indicator report published by EFPIA. This figure is slightly lower than the previous survey (48%), which dates back to 2019. Much more pronounced than the same comparison period is the gap in medicines fully available under public reimbursement, which stood at 29% in 2004 vs 42% in 2019. On the other hand, the number of medicines available with restrictions increased from 6% in 2019 to 17% last year.

‘The EFPIA W.A.I.T. indicators have been published for more than two decades, and during this period there has been a collective failure across Europe to tip the balance for millions of patients,’said Nathalie Moll, Director General of EFPIA. It has long been recognised that there is no one-size-fits-all solution and that no single actor can solve the problem: strong will, country-specific solutions and a true alliance between EU policymakers, Member States and the pharmaceutical industry are needed to streamline bureaucracy, reduce duplication and ensure swift and pragmatic decisions on pricing and reimbursement that truly value and reward innovation‘.

Some more data on access to innovative medicines

The Patients W.A.I.T. Indicator study, conducted by Iqvia on behalf of EFPIA, was first published in 2004 and this year examined 36 different European countries.

The data showed an increase of about one month in the time needed to make innovative medicines available to European patients, from 531 days in the 2023 report to 578 in the latest release. High disparities in access (87%) between different European countries were also confirmed. From this point of view, Germany has the shortest time (128 days), while at the other end of the scale is Portugal (840 days). Significantly, the waiting time for access to cancer treatments also continues to increase, rising by 33 days since the last edition of the report.

The causes of unavailability

EFPIA has also published a second report, prepared by Charles River Associates, which explores the causes of the unavailability of innovative medicines in European countries, complementing the Patients W.A.I.T. Indicator.

There is no single cause at the root of the problem, but rather a mix of factors that can come into play at different points in the authorisation process. These include, for example, possible regulatory issues that slow down the MA granting process, delays in health technology assessment decisions or in price and reimbursement negotiations. Duplicate requests for evidence and the need to include products in different local formularies are other possible factors causing delays. These factors are particularly relevant in Italy, given the fragmentation of regional healthcare systems, which, according to the report, results in an average delay in access of 65 days (min 1 day – max 773 days) compared to the timing of decisions at national level.

Other points raised by the EFPIA document concern possible infrastructural difficulties in accessing new medicines, for example due to insufficient diagnostic capacity or staff specialisation, particularly for more complex products such as orphan medicines or advanced therapies.

HERA’s first three years of activity

Three years have passed since the creation of the Health Emergency Preparedness and Response Authority (HERA), one of the first initiatives born in response to the Covid-19 pandemic. The results obtained so far by HERA are summarised in a report published by the European Commission at the end of March 2025.

The Authority plays a central role in coordinating activities to improve preparedness and response capacities at the EU-level, including issues with the supply chains of critical medicines shortages. According to the report, the availability of a structure dedicated to medical countermeasures for pandemic preparedness and response helps to improve policy coherence and provides a clear EU added value in the area of health security, e.g. for joint procurement and stockpiling of medical countermeasures.

Recommended areas for future improvement of HERA’s activities should include synergies between HERA and other European institutions (e.g. ECDC, EMA, the Health Security Committee and the Advisory Committee on Public Health Emergencies), as well as an enhanced coordination and cooperation with Member States. Flexibility, optimisation of funding and effective communication of HERA’s activities are other key recommendations for the future.

Mediterranean Nutrition Science: pioneering the future of nutraceuticals

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The pharmaceutical and nutraceutical industries are rapidly evolving, with growing demand for science-backed, sustainable solutions. Professionals in clinical research, regulatory affairs, quality control, and supply chain management seek innovative formulations that align with both patient needs and market trends. At the forefront of this transformation is Esserre, a leader in Mediterranean Nutrition Science, committed to developing clinically validated nutraceuticals. Thanks to its R&D center in Formello, Italy, and an open research network, Esserre creates solutions that blend Mediterranean extracts with pharmaceutical-grade ingredients. Recognized as the most effective strategy to prevent chronic diseases, the Mediterranean diet promotes longevity, holistic wellness and sustainability. Esserre enhances this approach by integrating advanced extraction techniques, phytocomplex characterization and a green supply chain, ensuring high-quality and science-backed formulations. Esserre’s nutraceutical portfolio addresses key health concerns with ready-to-market products, including:

  • Cardiometabolic Health: based on Brumex, a bergamot-derived extract clinically proven to support cholesterol and triglyceride reduction, backed by one clinical trial.
  • Immune & Energy Support: formulated with PunicaPLUS™, a pomegranate-derived extract with antioxidant activity.
  • Gut Health & Microbiota Balance: soluble fibers to support intestinal health.
  • Mental Wellness & Stress Reduction: a formula inspired by the principles of the Mediterranean diet, designed to support stress relief and cognitive function.

Esserre follows a pharma-inspired development model, ensuring scientific validation, regulatory compliance and market-readiness:

  • In-House R&D & Open Research Network – Proprietary scientific studies with leading universities.
  • Advanced Extraction & Formulation – Optimizing bioavailability.
  • Regulatory & Clinical Validation – Conducting preclinical and clinical trials under EU standards.
  • Sustainable Supply Chain – Traceable, clean-label production from botanical sourcing to final product.

As longevity and preventive healthcare gain global relevance, Esserre bridges the gap between pharma and nutraceuticals, delivering trusted, science-backed solutions.

AUDA-NEPAD is the new PIC/S associated partner

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The ongoing initiative to strengthen regulatory capacity across the African continent took a significant step forward with the formal integration of the African Union Development Agency–New Partnership for Africa’s Development (AUDA-NEPAD) into the Pharmaceutical Inspection Co-operation Scheme (PIC/S). This milestone reflects a broader commitment to enhancing the quality and safety standards of pharmaceuticals manufactured and distributed across Africa.

In January 2025, the PIC/S Committee officially granted AUDA-NEPAD the status of Associated Partner Organisation, recognizing its strategic role in supporting the development of the African Medicines Agency (AMA). The newly established partnership is underpinned by a cooperation agreement focused on aligning GMP (Good Manufacturing Practice) standards and quality systems for both finished pharmaceutical products and active pharmaceutical ingredients (APIs).

This agreement is designed to streamline the pre-accession and accession pathways to PIC/S for National Regulatory Authorities (NRAs) that are part of the AMA framework. It also aims to provide structured training programs for GMP inspectors, fostering the technical competence and regulatory oversight capabilities of national agencies across the continent.

Moreover, the collaboration is expected to serve as a catalyst for confidence-building measures among African NRAs, reinforcing their capacity to ultimately become full PIC/S Participating Authorities. In the long term, this alignment with international GMP standards will not only improve the regulatory harmonization across Africa but also bolster the global competitiveness and safety of medicines produced within the region.

This development marks a pivotal moment in Africa’s pharmaceutical sovereignty journey, signaling a deeper integration into the international regulatory community and a renewed focus on building resilient, quality-focused supply chains across the continent.

The Warsaw Declaration on the future of framework programmes

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The Warsaw Declaration, released during the informal meeting of research ministers held on 10 and 11 March 2025 under the Polish presidency of the Council, contains the recommendations for the negotiations of the post-2027 Multiannual Financial Framework. Key points include the recognition of the long-standing importance of framework programmes as tools for fostering excellent science, technological development and innovation in the EU. The last two programmes also worked to expand transnational science and innovation cooperation within Europe and with like-minded countries.

The new FP10 should be designed so to provide long-term orientation to address the Union’s key challenges, secure a stable and predictable framework for the R&I community and strengthen the European Research Area. The Declaration recalls the pivotal role played by the European Research Council (ERC) and the European Innovation Council (EIC) and calls upon the Commission to preserve their independence and expand their role. EU research ministries also recall the provisions of the Treaty on the Functioning of the European Union, highlighting that the FP shall establish the scientific and technological objectives to be achieved, fix the maximum overall amount, and establish the detailed rules for Union financial participation.

The Declaration also underlines that the future FP should support excellent and impactful R&I in an open and fair competition. The request to the Commission is for an adequate budget matching the programme’s strategic role. In particular, none of the future programmes or instruments should be funded at the expense of the FP. Furthermore, funds should be allocated solely to research and innovation to maintain programme continuity and efficiency.

EU Commission, how to design a monitoring framework of the EU One Health Action Plans against AMR

The One Health approach, which integrates human, animal, and environmental health, plays a fundamental role in shaping numerous initiatives aimed at combating Antimicrobial Resistance (AMR). Recognizing the importance of a coordinated strategy, the European Commission has recently released a report detailing the design of a monitoring framework for the EU’s 2017 One Health Action Plan against AMR, as well as the 2023 Council Recommendation on strengthening EU efforts to tackle antimicrobial resistance through a One Health perspective.

The primary objective of this framework is to systematically track the implementation, progress, and overall impact of One Health initiatives, ensuring that EU actions addressing AMR are approached in a comprehensive and integrated manner. It encompasses a wide range of legislative and non-legislative measures that span across all 27 EU member states, along with Iceland and Norway. The study underpinning this framework was developed through extensive consultations with relevant stakeholders, the identification of key indicators from pre-existing data collection initiatives, and the proposal of additional indicators where necessary to fill gaps in monitoring efforts.

Given the evolving nature of policies and actions in the fight against AMR, the framework is expected to be adaptable over time. Future updates and refinements may be introduced to ensure its continued relevance and effectiveness as new challenges and developments emerge in the field of antimicrobial resistance.

(Source: European Commission)

The new European Biotech and Biomanufacturing Hub

The new Biotech and Biomanufacturing Hub, a key milestone in the European Commission’s Strategy to boost biotechnology and biomanufacturing in the EU, was officially launched on 30 January 2025. Designed as a central reference point, the Hub is accessible through the Your Europe web portal and aims to streamline the scale-up process while making it easier for businesses – particularly startups and SMEs – to navigate complex regulatory frameworks.

Companies looking to bring innovative biotech products to the EU market and enhance their competitiveness can access a comprehensive set of resources within the Hub. The platform provides essential information on regulatory pathways for human and veterinary medicines, biologicals, advanced therapy medicinal products (ATMPs), and feed and food ingredients. Additionally, it offers guidance on the authorisation process for different biotech products, intellectual property protection, and health technology assessments—all of which are crucial for ensuring market access and compliance.

Beyond regulatory insights, the Hub also serves as a gateway to EU funding opportunities, helping biotech and biomanufacturing companies identify financial support mechanisms tailored to their needs. A dedicated section highlights available research infrastructures, including pilot and testing facilities, networks, and collaborations that can support R&D and innovation activities. Moreover, companies can leverage market insights provided through the platform to make informed strategic decisions.

By consolidating all these resources into a single access point, the new Biotech and Biomanufacturing Hub represents a significant step toward fostering a more dynamic, competitive, and innovation-driven biotech sector in Europe.

Source: European Commission

A €200 billion initiative to fund AI gigafactories

On 11 February 2025, European Commission President Ursula von der Leyen unveiled the new InvestAI initiative at the Artificial Intelligence (AI) Action Summit in Paris. This ambitious program aims to mobilize €200 billion in investments dedicated to advancing artificial intelligence across the European Union. A key component of the initiative is the EU’s InvestAI fund, which will allocate €20 billion to finance the construction of four new AI gigafactories across the continent. Each of these cutting-edge facilities will house around 100,000 next-generation AI chips and will be specialized in training the most advanced, large-scale AI models.

According to the European Commission, these gigafactories will constitute the world’s most significant public-private partnership in the AI sector, positioning Europe as a leader in the development of trustworthy artificial intelligence. The initiative aligns with the EU’s cooperative and open innovation model, prioritizing complex industrial and mission-critical applications. This announcement follows the initial plan for seven AI factories, which was unveiled in December 2024, with an additional five expected to be introduced in the near future.

InvestAI will also establish a layered investment fund, offering different risk and return profiles to attract a diverse range of investors. The European Commission’s initial financial contributions will be drawn from existing EU funding programs that include a digital component, such as the Digital Europe Programme, Horizon Europe, and InvestEU.

In addition to these efforts, the Commission will launch a European AI Research Council to consolidate resources and explore innovative ways to leverage data for AI and other emerging technologies. Furthermore, 2025 will see the introduction of the “Apply AI” initiative, designed to accelerate the adoption of artificial intelligence across key industrial sectors, reinforcing Europe’s competitive position in the global AI landscape.

Switzerland to join EU’s research and innovation programmes

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After years of negotiations, Switzerland and the European Union have reached a long-awaited agreement that will see the country participate in key EU research and innovation (R&I) initiatives. The discussions, which aimed to update trade relations across twelve different sectors, concluded on 20 December 2024. The formal signing of the agreements is expected in 2025, followed by a national consultation phase in Switzerland, with the Swiss Parliament set to express its opinion by 2026.

One of the most significant outcomes of this deal is the reintegration of Swiss researchers into EU R&D programmes, including Horizon Europe (all Pillars), Euratom Research & Training, and Digital Europe. Swiss institutions and researchers will be eligible to apply for most funding calls as early as 1 January 2025, thanks to a transitional arrangement established between the two parties. This development restores Switzerland’s role as a key player in European scientific collaboration, strengthening partnerships with institutions across the EU. Beyond research, the agreement also includes a financial contribution from Switzerland to the EU’s cohesion fund, amounting to CHF 130 million per year from 2025 to 2029. These funds will be directly allocated to programmes and projects in EU partner countries, reinforcing Switzerland’s commitment to European economic and scientific cooperation.

Additionally, the negotiations have resulted in an updated health agreement, expanding Switzerland’s involvement in European health security frameworks. The country is now set to participate in the EU’s health security mechanisms and the European Centre for Disease Prevention and Control (ECDC), ensuring closer collaboration in areas such as pandemic preparedness, disease monitoring, and crisis response. With these agreements, Switzerland is taking a crucial step towards deeper integration with the EU’s research, digital, and health ecosystems, fostering stronger ties with European partners and reinforcing its position as a hub for scientific and technological excellence.

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