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A new member within EIPG


The European Industrial Pharmacists Group (EIPG) is pleased to announce the Romanian Association (AFFI) as its newest member following the annual General Assembly of EIPG in Rome (20th-21st April 2024). Commenting on the continued growth of EIPG’s membership, EIPG President Read more

The EU Parliament voted its position on the Unitary SPC


by Giuliana Miglierini The intersecting pathways of revision of the pharmaceutical and intellectual property legislations recently marked the adoption of the EU Parliament’s position on the new unitary Supplementary Protection Certificate (SPC) system, parallel to the recast of the current Read more

Reform of pharma legislation: the debate on regulatory data protection


by Giuliana Miglierini As the definition of the final contents of many new pieces of the overall revision of the pharmaceutical legislation is approaching, many voices commented the possible impact the new scheme for regulatory data protection (RDP) may have Read more

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EU’s Industrial Forum, the future of advanced manufacturing technologies

October 6, 2023 , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

by Giuliana Miglierini

The expert group “Industrial Forum” is a multistakeholder body created by the European Commission to support the implementation of the Industrial Strategy launched in March 2020 and its following update of May 2021. Its members include Member States authorities, NGOs, industrial representations, research institutions and social partners representing different industrial ecosystems.

Its recently published report is the result of the structured dialogue among members on how to accelerate the deployment of advanced manufacturing technologies (AMTs) across the European industry. Among members which participated in the drafting of the document is also EuropaBio on behalf of the biomanufacturing industry.

Europe is leader in advanced manufacturing

Advanced manufacturing is based on the integration and convergence of the most advanced industrial technologies, i.e. automation, robotics, artificial intelligence and digitally connected solutions. New processes, new products as well as new business models based on this new approach are deemed to represent a fundamental competitive factor in the next few years.

Europe is currently well position in the ranking on “future of production” readiness, with 18 out of 25 countries considered by the World Economic Forum to be leading the change in manufacturing. Despite this, according to the report many efforts are still needed to accelerate the implementation of advanced manufacturing technologies in the EU, so not to be superseded by other fast-evolving competitors.

In order to achieve this challenging goal, the Industrial Forum identified seven different areas of attention, each of which is addressed by specific recommendations based on a SWOT analysis.

The seven areas of recommendation

The transition to new manufacturing models should, first of all, meet the EU sustainability goals established by the European Green Deal: the “net-zero industry” plan for renewables and industrial efficiency technologies is confirmed as a priority action, together with the expansion of the use of REPowerEU. The Commission is working on new energy savings directives, which should be timely implemented. Circularity of manufacturing processes and products is another main goal of EU’s industrial policies, to be supported by a set of new fit-for-purpose rules. A more rapid uptake of advanced manufacturing technologies should also be supported by both the availability of specific public procurement guidance and a targeted communication of the environmental benefits of European clean technologies.

The second area of action addresses how to improve access to capital, a key factor in ensuring the timely implementation of advanced manufacturing technologies. This may include a better use of public investment, as well as a cautious application of state aid instruments specifically targeted at later stages in the innovation and deployment process. The potential of these new technologies for sustainability should also be recognised within the upcoming EU Taxonomy de-legated acts.

The resilience of supply chains could be tackled by the rapid implementation of AMTs. In order to achieve this goal, the Industrial Forum highlighted the need for workable and proportionate rules on Due Diligence. No less important is the negotiation and activation of new Free Trade Agreements with third countries (such as the EU-Mercosur FTA). A critical area refers to the improvement of EU semiconductor capacity. According to the report, incentives and funding aimed to increase the supply chain resilience should be exempt from directing specific outcomes. The European institutions should also better support the local and regional industrial supply chains. Secure access to critical raw materials should be pursued by leveraging the trade policy.

The building of an EU Single Market is a main goal of the European Commission, also in the pharmaceutical field. Its freedoms should be safeguarded by narrowing down the scope of the Single Market Emergency Instrument, while promoting mitigation measures for advanced manufacturing. The Industrial Forum also recommends the availability of a single platform to provide companies with all the needed information to expand and/or export. Furthermore, a Single Market test should be included in the impact assessments of national laws to minimise the occurrence of gold-plating phenomena. New standards for AMTs would also be needed, an area which according to the Industrial Forum should conjugate an enhanced flexibility in standardisation requests and timely delivery in standard setting. Digital product standardisation should also be promoted, and adhesion to the New Legislative Framework should be ensured.

Data is a fundamental asset of the new economy. Recommendations in this area include supporting existing initiatives to create a strong European manufacturing data space, as well as ad-dressing the protection of both personal data and intellectual property rights and trade secrets. As artificial intelligence (AI) will assume an increasingly relevant role in future advanced manufacturing processes, the Forum recommends the development of clear, focused criteria on high-risk AI, while avoiding unnecessary regulation of industrial AI.

The availability of data should be pursued through the identification of a method for data collection in the advanced manufacturing category. It would also be important to generate trusted data sets at the European level for advanced manufacturing deployment, global competitive position, and economic / environmental / societal gains.

Many new skills will be needed in the next few years to handle the expansion of AMTs. To this instance, the Industrial Forum highlighted the importance to promote the harmonisation of Vocational Education and Training (VET) practices and qualification systems and to encourage women and girls to study STEM subjects and working in manufacturing. Other recommendations re-fer to the possibility of developing a Pact for Skills partnership and the proposal of a Blueprint Alliance for Advanced Manufacturing. A better entrepreneurial culture in Europe should also be promoted, as well as capitalisation on European creative industries.

Examples of biomanufacturing

Weaknesses to biomanufacturing identified by the Industrial Forum include the fact that it is still an emerging production process compared to chemical manufacturing. The report also mentions existing regulatory barriers, mainly linked to a process rather than product approvals pathway. Furthermore, significant investments in biomanufacturing are primarily located outside Europe. Possible risks identified by the report also refer to biomanufacturing being excluded or overlooked in key policymaking e.g. taxonomy supporting biomanufacture and sustainable financing.

The report includes two examples of AMTs linked to the health and agrifood sector. Chimeric antigen receptor T cells (CAR-T) represent one of the main areas of innovation in cancer treatment over the past two decades, in which the patient’s immune cells are engineered to produce the final immunotherapy. Many pharmaceutical companies are building specialised manufacturing facilities for CAR-T therapies within Europe, a biomanufacturing process which is highly complex and patient-specific, and requires long term investments, skills development, and integration into the European Union industrial base.

Biomanufacturing may also be applied to the production of vitamin B2 (riboflavin), that multi-step chemical synthesis is complex, requires hazardous agents and has low yields (~60%). Biotechnologies allow for the one-step production of vitamin B2, starting from vegetables as carbon sources and using a genetically modified bacterium (Bacillus subtilis) or fungus (Ashbya gossypii).


The Made in Europe partnership for manufacturing

March 18, 2022 , , , , , , , , , , , , , , , , , , , , , , , , ,

by Giuliana Miglierini

The availability of a robust framework to support a sustainable European manufacturing system is undoubtedly a priority in the challenging times we are experiencing. In the pharmaceutical sector, the reshoring of productions of both active ingredients and finished medicinal products is already a key point of the new EU Pharmaceutical Strategy and of the consequent ongoing revision of the legislation governing the sector.

A broader action addressed to the entire European industrial system was launched in 2019 within the framework programme Horizon Europe (HE) 2021-2027: the Made in Europe manufacturing partnership aims to become the main driver for sustainable manufacturing in Europe. The partnership was modelled with the contribution of the European Commission, member states and the European Factories of the Future Research Association (EFFRA); the latter is also the leading entity in charge of coordinating the initiative, which include all actors taking part to the manufacturing ecosystem (i.e. academia, industry, non-governmental organisations and the public sector).

The main goals of the Made in Europe partnership

The two themes of ecological and digital transitions central to the policies of the von der Leyen Commission are the main source of inspiration for the Made in Europe partnership. The availability of a European manufacturing environment able to compete on global scenarios thanks to its technological leadership is the main objective of the initiative. Many challenges need to be faced to reach it, especially in the field of the integration of technologies based on artificial intelligence to fully exploit the potential of industrial data, the reshaping of a circular economy and a high flexibility in response to emerging trends and issues.

The Made in Europe partnership represents a common platform for national and regional manufacturing technology initiatives, including the required disciplines and technologies. The principles governing its actions are described in a guidance document available at the EFFRA website; a Strategic Research and Innovation Agenda (SRIA) is also available.

According to the guidance document, manufactured goods represented in 2018 83% of EU exports, and accounted for a annual trade surplus of 286 billion euro. Despite this very high surplus, the document warns it may be not sufficient to cover deficits arising from the purchase of non-manufactured goods and services. Also considering these factors, the balance moved from a surplus of € 22 billion in 2017 to a deficit of € 25 billion in 2018. This situation may now dramatically evolve further, due to the high increase of costs of energy and raw materials experienced in the last month, as a consequence of the war occurring at the Eastern boundaries of the EU. A situation that might make harder for the EU to also face the competition of Asiatic economies.

The guidance document identifies twelve challenges to be faced by the European manufacturing industry, starting from the need to strongly reduce to the minimal level its environmental impact. To this instance, optimisation of resource efficiency and the carbon intensity of the entire supply chains are among the main factors to be addressed, leading to the opportunity for European-made environmental-friendly but high-priced products. This switch also supports the development of circular models for the economy, and the use of next-generation sustainable materials and products, requiring to manage profound changes if the manufacturing systems and related supply chains. Recycling and re-manufacturing may play in the future an important role in redefining products’ life cycle. The resilience and agility of the European manufacturing industry shall be also tackled, in order to limit the impact of sudden crisis, as occurred with the Covid-19 pandemic or now with the Ukraine war. This goal calls for the availability of flexible and reconfigurable production lines within a country or region, suggests the document. The pharmaceutical sector already experienced criticalities during the Covid-19 arising from the dependence from extra-EU supplies; the same applies to all European industrial sectors, and according to the Made in Europe partnership it should be faced through achieving manufacturing sovereignty and technological leadership in key areas and critical value chains. A very challenging objective, that requires a coordinated European effort on manufacturing.

As for competition from other economies, the document warns that big public-private manufacturing partnerships are being launched also in Asia and America (i.e. Made in China). Environmental and social aspects should be jointly considered in the location/relocation of manufacturing companies, to account for the environmental sustainability of the businesses coupled to the requirements arising from a EU’s population mainly living in urban areas.

The challenges of digitalisation

Many of the above-mentioned targets identified by the Made in Europe partnership may benefit from the potential offered by the implementation of digital technologies to accelerate innovation and industrial transformation, thus leading to the improvement of the overall efficiency of manufacturing. Data are becoming a central driver for the creation of value, but companies are called to better understand the data economy also from a non-technological point of view. Cybersecurity should be also carefully addressed, as digitalisation is reflected by a higher vulnerability to cyber attacks.

Digitalisation also impacts on the availability of new business models, such as “manufacturing-as-a-service” and “collaborative product-service engineering”. Automated systems governed by artificial intelligence are now widely available in many industrial plants, and attention should be paid to modes of interactions between collaborative robots and human operators. Nevertheless, the availability of trained and skilled human staff is considered as a major barrier and threat by the Made in Europe partnership, particularly for SMEs.

The planned actions

Six different calls for actions in the field of green and digital transitions were launched by the Made in Europe manufacturing partnership within the Horizon Europe work programme 2021-2022. The total available budget is around € 1 billion. Topics of interest included AI enhanced robotic systems for smart manufacturing, zero-defect manufacturing towards zero-waste, laser-based technologies for green manufacturing, manufacturing technologies for bio-based materials, advanced digital technologies for manufacturing, and data-driven distributed industrial environments.

The Made in Europe partnership was also involved in calls about reconfigurable production process chains, products with complex functional surfaces, excellence in distributed control and modular manufacturing, intelligent work piece handling in a full production line, ICT Innovation for manufacturing sustainability in SMEs, and digital tools to support the engineering of a circular economy.

A consultation on possible topics to be included in the HE work programme 2023-2024 is still open to comments and can be accessed by the dedicated webpage at the EFFRA website. A summary document is also available presenting potential recommendations and discussion topics received up to now. New possible lines of actions may address the availability of “excellent, responsive and smart factories & supply chains” , how to achieve a circular products and climate- neutral manufacturing, new use models referred to new integrated business, product-service and production approaches, and models for a human-centered and human-driven manufacturing innovation.