Sovereignty and cooperation

Gulf funds have invested 12 billion in the EU’s healthcare and biomanufacturing sectors

Medicines, expertise and the Mediterranean: how the healthcare landscape is being reshaped, partly thanks to Italia. Meanwhile, Morocco has increased its generic medicines production capacity by 22 per cent, whilst Tunisia has boosted its production of sterile products. Egypt aims to double its vaccine production

by Piero Matica

Analisi di laboratorio Adobe Stock

4' min read

Translated by AI
Versione italiana

4' min read

Translated by AI
Versione italiana

When a consignment of active ingredients arrives at the factories in Tuscany and Lombardy, it speaks of a dependency that Europe wishes to reshape. Italia is at the centre not by chance but by virtue of its ‘industrial geometry’: a network of production sites, a tradition in fine chemicals, research hubs in Trieste, Rome, Naples and Milan, and the ability to absorb technologies, bring them into line with stringent regulatory standards and redistribute them to neighbouring markets.

The domestic pharmaceutical market has well exceeded 50 billion euros, with exports on the rise. However, around 70 per cent of active pharmaceutical ingredients come from abroad, often from concentrated geographical areas: this represents a vulnerability in terms of both quantity and quality, because producing active pharmaceutical ingredients requires specific expertise, modular facilities, lengthy validation processes and staff who cannot be trained overnight. Italy’s strategy aims to bridge the gap between basic research, process engineering and vocational training, transforming research hubs into technology transfer platforms.

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The transfer of know-how takes place through shared contracts and standards. Agreements are being established between biotechnology clusters and training centres in Morocco, Tunisia and Egypt to develop expertise in process engineering, validation and compliance. The aim is not to relocate research, but to increase the number of certified sites, bringing laboratories and manufacturing plants closer together. In 2023, Morocco increased its capacity for generics and biosimilars by 22 per cent; Tunisia saw an 18 per cent increase in sterile products; and Egypt aims to double its vaccine production by 2030. Italia can act as a bridge: operational protocols, training on pilot lines, and support for validation in accordance with EMA standards. On paper it is simple; in practice it is rigorous: transferred procedures, anonymised process data, operators trained on real-world scenarios, and independent audits.

I FONDI DEL GOLFO E LE PIATTAFORME NEL MEDITERRANEO

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Leverage

Between 2022 and 2024, Gulf sovereign wealth funds committed around 12 billion euros to the European healthcare and biomanufacturing sectors, with a significant proportion going towards joint ventures, applied research platforms and logistics in the Mediterranean. They are not merely seeking returns: strategic security, diversification and access to innovative ecosystems are also key objectives. Tech transfer clauses, mandatory local training, minimum production thresholds and dispute resolution mechanisms provide stability. The impact is clear: new filling and freeze-drying lines, centres for the characterisation of biomolecules, viral vectors and mRNA, and public-private co-funding. The multiplier effect extends beyond individual sites: it stimulates supply chains, reduces validation times and bridges the gap between prototyping and production.

The EMA has introduced fast-track procedures for essential medicines and vaccines of public interest, whilst maintaining the same standards of safety and efficacy: rolling reviews, updated guidelines for biosimilars, and greater post-marketing flexibility. AIFA has followed suit by setting up dedicated helpdesks for projects involving the transfer of know-how and monitoring platforms. On the intellectual property front, Europe and multilateral organisations are experimenting with patent pools, non-exclusive licences and transparency regarding preclinical data; the EU has launched an emergency framework allowing for temporary derogations, balancing needs with compensation. Italia is adopting a pragmatic approach: protecting investments, whilst recognising that resilience depends on the ability to produce, not just to patent.

Rules and logistics

The third pillar is logistics. Just-in-time has shown its limitations: whilst it optimises warehousing costs, it leaves the system vulnerable to stock-outs and disruptions to treatment. The move to a ‘just-in-case’ approach would involve calibrating buffers according to risk, diversifying suppliers, creating regional hubs and enhancing digital traceability. The data indicate that logistics costs are on average 15–20% higher, offset by a 60% reduction in the risk of stock-outs and a 40% reduction in emergency response times. Italia is investing in intermodal platforms linking ports, railways and refrigerated storage facilities, with a focus on the cold chain for biologics and vaccines.

The figures set the course: growth in exports of generic medicines, co-funding with Gulf countries, upskilling programmes, a 90-day logistics buffer, and 15,000 certified technical professionals in the region.

This is where training comes into play, as the true glue that holds the system together. Without operators who understand validation, contamination limits and the management of deviations, the plants remain empty shells. Italia is strengthening its training programmes in process engineering, applied biotechnology and regulatory quality; whilst North African partners are adopting shared modules, simulators and work placements on pilot lines. Skills are being standardised, start-up times are being reduced and reliability is increasing. Professional mobility is becoming strategic.

Intellectual property

Patents drive innovation, but they must not hinder access to essential medicines. Non-exclusive licences and technology pools, together with patent expiry dates and mapping of critical patents, reduce fragmentation. Systems that integrate technology transfer and advanced regulatory standards are already demonstrating shorter validation times for generics and biosimilars, a higher proportion of local production and more stable prices.

The macroeconomic picture suggests that Italia is not seeking an impossible form of self-sufficiency, but rather a ‘controlled connection’: patient foreign capital, local expertise, European standards and adaptable logistics. Gulf funds act as long-term partners; North African centres serve as local production hubs; and European regulation provides a framework for security and competitiveness. Projections for 2030 point to a 35 per cent increase in exports of generics and biosimilars, a reduction in dependence on foreign active pharmaceutical ingredients to 40 per cent, and twelve new biomanufacturing sites. Execution will make all the difference: validated facilities, trained operators, traceable logistics and regulatory oversight.

The line between health sovereignty and cooperation is becoming increasingly blurred. No one can produce everything, but no one can relinquish control over critical segments of the supply chain. Italia has chosen an approach that combines safety, accessibility and sustainability. The success of this approach will be measured not so much by plans as by the batches released, validation times, the availability of medicines and the continuity of care.

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