The Egualia association represents over 60 pharmaceutical companies that produce for both the national market and foreign markets and likewise companies that operate in the contract production of drugs for the entire pharmaceutical industry. We spoke to Adriano Pietrosanto, Director of the Technical and Scientific Area, Industrial Manufacturing and Quality, about sustainability and projects under development.
1. How important is participating in a fair like Pharmintech for your association?
Pharmintech has been a key event in the calendar for the chemicals and pharmaceuticals world for years now. An event that focuses on all the various stages of the supply chain, from production to technologies, to packaging materials and high value-added services.
These are all crucial issues for our member companies, which are constantly seeking technological advances in production and manufacturing in order to comply with the increasingly stringent GMP guidelines and cope with the major changes that the supply chain has experienced during recent years. On this matter, it is worth noting that EGUALIA represents an industry with approximately €3.2 billion turnover and annual investments totalling €200 million, with approximately 10,000 people under direct employment agreements working daily in the almost 40 production sites spread throughout Italy. It is one of the greatest drivers of the economy and industry not only nationally (as Italy ranks second among the countries that manufacture generic drugs in Europe with exports accounting for over 50% of its output), but also within Europe, where 67% of medicines dispensed every day are generic.
2. What is your mission and what are the issues and new projects you are focusing on?
When it comes to striking a balance between providing proper healthcare for all and making good use of the financial resources available, EGUALIA member companies are vital allies of the Italian national health service.
That is because the association's mission is to create value linked to patients' health by guaranteeing greater access to medicines in all the main areas of treatment, reducing inequality, optimising use of the national health service's resources, and improving patient compliance.
EGUALIA also plays an important advisory role in the Italian healthcare industry, working closely with Italian and European institutions to develop sustainable solutions for pharmaceutical care and to boost Italy's competitive strength in the global pharmaceutical market. The number of manufacturers joining EGUALIA is growing steadily and already today over 50% of the equivalent/generic medicines on the market in our country are produced by production facilities located throughout Italy. Thanks to the supply generated by the generic drugs market, many small and medium-sized businesses within the Italian economy have found new opportunities for growth and development and achieved globally recognised excellence with many pharmaceutical products.
EGUALIA aims to further develop the industry with a view to safeguarding the business community in Italy and creating new employment, both in manufacturing and related industries, and in areas of technological development.
To achieve this goal, we believe it is essential to diversify the sources of supply of raw materials and finished pharmaceutical products, increasing pharmaceutical production in Italy and Europe through reshoring policies, which has been one of the association's main objectives over recent years.
The pandemic first and the recent war in Ukraine have now highlighted the need to entirely rethink the value chain in terms of the pharmaceutical manufacturing supply chain. The difficulty in sourcing products that have been off-patent for some time now and are now highly necessary for intensive care highlights how the deeper causes of shortages must be addressed from a long-term prospective and not simply with respect to current circumstances.
Precisely on the topic of production, Egualia - in conjunction with European association Medicines for Europe - is engaged in dialogue with the European Commission with a view to strengthening the complex supply chain behind medicines. We hope to encourage the presence of multiple geographically distributed manufacturing hubs to ensure rapid supply and distribution of medicines in the event of an emergency. It is not a question of privileging the European market over Asia, but we must give European companies the tools to increase their production, which can be achieved through reshoring. The Italian manufacturing plants have numerous investment projects ready, but certain significant issues need to be resolved first, such as the difficulties in accessing funds and lengthy authorisation times. Addressing these issues, the Ministry for Enterprise and Made in Italy recently launched a call for tenders ("Development Contracts" area, for a total of approximately €392 million) to support the business plans of vital production chains in northern and central Italy. The projects, which encompass the chemical and pharmaceutical industry, could intensify the increase in production, the success of which is dependant on the granting of fast-track regulatory initiatives to speed up authorisation processes.
3. Sustainability and digitalisation: What contribution can your association make and, in your opinion, how is the life science market moving in relation to these issues?
The omnipresence of new technologies and the exponential increase in data production have both contributed to making all things digital an integral part of our lives. And the world of healthcare is also affected by this transformation.
Today, health systems - especially those most widely developed as pillars of social welfare, such as the Italian national health service - play a leading role in the data economy through the use of enabling technologies in an increasingly interconnected and dynamic world. In recent years, the World Health Organisation has also been focussing on the importance of digital technology to make health systems more efficient and sustainable and to help ensure fairer access and more effective care to improve people's health and quality of life.
The experiences of other leading countries in the digitalisation of healthcare (such as Finland, Estonia, and Israel) highlight the importance of having a nationwide digital strategy and a digital healthcare ecosystem that involves the entire supply chain, with investments in infrastructure and the digital skills of healthcare workers and users. This is why EGUALIA strives to support Europe in the drive towards sustainability and digitalisation.
Indeed, the European Commission's objectives include the promotion of digitalisation within the pharmaceutical industry starting from 2030. The businesses in our sector are overwhelmingly in favour of this push for digitalisation and feel that, mostly urgently, the paper product information leaflet in medicine packets needs to be replaced with an electronic version (known as "ePI" leaflets).
This solution would allow us to reduce paper use in medicine packaging (in line with the Green Deal goals) but above all the digital format would allow greater accessibility to information for all patients and therefore greater distribution of medicines within Europe, eliminating the need to print leaflets in different languages depending on the target country. It would also be an additional asset for managing shortages, by enabling distribution to be diverted to where it is most needed without undue difficulty.
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