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THE KEYS TO ADDRESSING PHARMA SUPPLY CHAIN CHALLENGES – ESG, DIVERSIFICATION & GLOBAL HARMONIZATION

Since 2022, the global population of > 8 billion human beings have been consuming our natural renewal resources faster and faster, currently at a rate which is twice as much as our planet generates per year. Even commodities such as steel and wood are becoming scarce, as different industries and countries compete for the limited supply. We are also now experiencing the dramatic and often fatal effects of global warming on all continents.

Over the past 30 years, although the global economy has proven that collaboration and innovative technology can solve many problems, as was in the case of Hydrochlorofluorocarbons (HCFCs) becoming a greener alternative to the damaging effects of CFCs, the recent pandemic demonstrated how quickly those improvements can be undermined due to supply chain disruptions such as lock downs, transportation restrictions, and political conflicts. Through this process we have been forced to shine a collective light on the economic responsibilities connecting global warming, the need to consume fewer resources, and shifting supply chains.

Since all these events profoundly affect the pharmaceutical industry as well, we asked 23 CDMO panelists what they consider to be the greatest challenges in maintaining Pharma supply chain continuity. Among the responses, we identified common themes such as the increasing requirements for sustainability, the need for diversification of suppliers and regions, and the additional costs associated with them both as the major fields to be addressed for the Pharma supply chain of the future.

ENVIRONMENTAL, SOCIAL & CORPORATE GOVERNANCE (ESG) REQUIREMENT

The globalization of the world economy has made it very transparent that we all live on the same planet, where environmental pollution and global warming do not stop at national borders. Therefore, governments worldwide have implemented high standards for Environmental, Social, and corporate Governance (ESG) across all industries, including Pharma. Big Pharma companies expect that all companies in the supply chain adhere to the same principles, including their CDMO suppliers. As a result, Europe and the United States initiated several legislative activities from the Task Force on Climate-related Financial Disclosures (TCFD) and the Modern Slavery Act to the incoming US SEC Climate-Risk Disclosures rules.

Ingrid Vande Velde from PCSI points out that investors prefer companies that comply with ESG standards, since non-compliance can represent serious long-term business risks. However, all countries and companies involved in the global pharmaceutical industry should harmonize and develop these standards jointly. Otherwise, economics might drive pharmaceutical production to countries with laxer regulation and control by the authorities, as Paolo Tubertini from Olon Group comments, leading to further concentration of the production capacities in certain regions with lower standards.

Many panelists see the reduction of their carbon footprint as one of the major aspects of ESG. Most CDMOs have already joined an existing initiative such as Science-Based Targets initiative (SBTi) or EcoVadis. Some companies are developing their own programs. In general, ESG initiatives occur on different levels: 1) They start with energy efficiency projects in the existing plants to reduce energy consumption; 2) They switch to renewable energy sources by installing, for example, photovoltaic panels at the sites; 3) They explore and implement new, more energy-efficient technologies such as Flow Chemistry; and 4) They work with their suppliers to reduce the carbon footprint of the incoming goods.

 

The first two activities can be implemented quickly with limited investment and clear payback times. The latter two are more challenging, as they also affect the regulatory filing that increases cost and timelines. Many panelists mention the different requirements of the authorities for regulatory changes as a real obstacle for the fast implementation of improved processes or new starting materials. Specifically, greater regulatory scrutiny increases the hurdles for new material qualification, as Stefan Randl of Evonik points out. Herve Bedrou, from Piramal Pharma Solutions, hopes that the regulatory systems can be globally harmonized, leading to convergent international standards and mutual acceptance of data for regulatory filing.

To enforce the new ESG standards, the need for audits will increase. However, since some companies say they are already at the limit of hosting customer and authority audits, Jim Fries of Rx-360 proposes going for joint audits or licensing audit reports by globally accepted auditing companies.

DIVERSIFICATION OF SUPPLIERS & REGIONS

In the past few years, we saw different events that disrupted the pharmaceutical supply chain in unprecedented ways – shutdowns of facilities in China due to environmental problems, the blockage of the Suez channel, Covid-19, and the war in the Ukraine were completely unpredictable factors affecting the pharmaceutical industry as a whole. They not only led to problems and delays in pharmaceutical production, but also shortages of crucial, life-saving medicines, where some countries went so far as to restrict the export of medicines, which only compounded the situation. It’s safe to say we all hope governments will prepare better for such events in the future through closer collaboration and more sound science-based decision making, which takes into account that pandemics and the expected effects of global warming such as flooding, storms, and droughts will occur more often.

ENVIRONMENTAL, SOCIAL & CORPORATE GOVERNANCE (ESG) REQUIREMENT

In the past few years, we saw different events that disrupted the pharmaceutical supply chain in unprecedented ways – shutdowns of facilities in China due to environmental problems, the blockage of the Suez channel, Covid-19, and the war in the Ukraine were completely unpredictable factors affecting the pharmaceutical industry as a whole. They not only led to problems and delays in pharmaceutical production, but also shortages of crucial, life-saving medicines, where some countries went so far as to restrict the export of medicines, which only compounded the situation. It’s safe to say we all hope governments will prepare better for such events in the future through closer collaboration and more sound science-based decision making, which takes into account that pandemics and the expected effects of global warming such as flooding, storms, and droughts will occur more often.

Many companies act now by applying a multitude of approaches, depending on their expertise and position in the market. This includes diversifying their supplier region, stocking of critical raw materials, and identifying alternate reagent sources, as Michael W. Pennington of AmbioPharm comments. Procos (Chiara Rigotti and Paolo Paisoni) focuses on developing close relationships with carefully chosen preferred suppliers and having several backups for key raw materials in different regions.
Ed Roullard from Actylis, points out that a proper risk mitigation and thorough analysis of the supply chain is key for success. The back-up supply chain must be truly independent, and must not go back to the same intermediate suppliers.
Some companies like Uquita India (Kishore Reddy) consider backward integration and using closer suppliers as a good strategy to make the supply chain more resilient.

Anming Liu, WuXi STA, explains that insourcing could be an opportunity to open new business fields, such as WuXi STA did by developing its own amidite manufacturing capability for their oligo customers, which resulted in them now offering more than 300 types of catalog amidite products to the market.

Europe noticed the painful dependency on India and China for certain medicines during the Covid pandemic. Several panelists mentioned the governmental tender systems in Europe and the US with the sole focus on price as one cause for the concentration of the generics in India and China.

Many countries announced aims to strengthen their pharmaceutical industry, and Chris Neasham, Almac science, thinks that the manufacturing is shifting back to the west. France, for instance, initiated large programs. However, Elizabeth Stampa, President of Medicines for Europe, noticed that beyond these big announcements, so far the initiatives only received minimum support in most European countries. We will see if the European governments have a sincere and sustainable intention to support more robust and diversified pharma supply chains, and to also consider other aspects such as such as sustainability and supply chain security in their public tender systems for medicinal products.

Several panelists, including Matthieu Gobillot, Seqens, expect that India’s chemical industry will benefit from the situation, as there is a clear support by the government and a large pool of exquisite talents. However, Chiara Rigotti and Paolo Paisoni, of Procos point out that China will remain more competitive for certain raw materials, due to their lower environmental standards. Both India and China remain big players in the pharmaceutical industry.

INCREASING COSTS & INFLATION

Due to the financial pressures during Covid, coupled with increased energy prices, we now observe a worldwide inflation, which is very pronounced in the EU. Actions to mitigate the supply chain risk and implement ESG principles also increase the production cost in the long-term. Stefan Randl, Evonik Health Care, thinks that the backward integration of regulatory starting materials helps to stay competitive, while ensuring quality and supply security. Dr. Shijie Zhang, Dr. Jack Chen, and Celine Chen say Pharmablock is focusing on upgrading their chemistry – e.g. flow chemistry, micro-packed bad hydrogenation and bio catalysis – in order to reduce carbon footprint, while keeping the cost low.

Kenneth N. Drew, Flamma, comments that for generics, it is very difficult to transfer the additional cost from supply chain disruptions to customers, as in many cases the prices were negotiated before the crisis for very long-term contracts. Andrea Sentimenti of Bormioli points out that where the margins were low before inflation, the increase of energy and raw material cost has caused a dramatic erosion of margins for the generic market. Therefore, authorities should transform the system of public tenders so that buying decisions are not only made on price, but also consider supply security, social and environmental impacts (Ana Marti, Medichem).

Since innovative pharmaceutical companies are more open to accepting higher prices, the chances are better that a part of the inflation and ESG costs will be jointly covered by the CDMOs and their customers. Nevertheless, CDMOs remain under strong pressure to reduce cost and optimize their supply chain.

CONCLUSION

The Pharma industry faces big challenges, not the least of which is that we compete with different industries for the same limited resources. We must fight global warming and deal with its effect, all this in uncertain geo-political situations. As paradigms shift, we probably all agree with Timothy Woodcock of CordenPharma that “the biggest challenge is to adapt our mindset – the way we think and what we will accept – in Supply Chains of tomorrow.”

Pharmaceutical companies apply different approaches to cope with the future challenges – including Artificial Intelligence and block chain technology – that can help to make the supply chain more predictable and resilient.

Changing production processes are currently a lengthy and costly endeavour due to the filing of the regulatory changes to different authorities. The health care authorities could further support the transformation of the industry by implementing globally-harmonized procedures for changes and mutually accepted data.

 

Governments play the most decisive role in the transformation of the Pharma industry, as they can set the proper incentives by implementing the appropriate legislation. These incentives should reward companies that have implemented measures for environmental protection and CO2 reduction, as well as high ethical standards. The legislation must be globally harmonized; otherwise, companies complying with the higher ethical and environmental standards will be at a continual disadvantage against those that do not have obey the same strict standards. Here, it is crucial that governments and authorities demonstrate their willingness to collaborate openly and peacefully to solve the problems which not only affect the supply of life-saving medications for patients, but also the future of our global community and planet.

 

Over the last two decades, a broad spectrum of AI-driven solutions has appeared, catering to laboratories, pilot plants, and full-scale facilities across multiple industries. Many practitioners appreciate the versatility that arises from modular data architectures and flexible analytics platforms, which can be quickly repurposed for different product lines or global markets. Although smaller-scale tools initially received the most attention, the trend is shifting toward large, integrated systems capable of processing massive datasets and seamlessly interfacing with international networks. In some cases—especially with complex or proprietary workflows—fully customized frameworks are developed to address specific ESG mandates and reinforce responsible product stewardship.

A more recent development in AI-guided supply chains is the incorporation of process analytical technologies (PAT) and automated decision-making protocols. Panelists noted that AI-driven analytics, when combined with real-time data, can significantly accelerate R&D milestones—ranging from the design of greener packaging solutions to the reduction of harmful byproducts. Once these optimized processes are standardized, basic operational monitoring may suffice to preserve consistent quality. Nevertheless, the dynamic nature of AI allows continuous data streams to yield vital, up-to-date insights, enabling supply chain managers to fine-tune operations to minimize environmental and social impacts. In addition, automated feedback loops are particularly powerful in mitigating out-of-specification outputs by responding quickly to any fluctuations that might compromise safety, quality, or compliance.

Despite these advantages, many professionals still question why AI and ESG frameworks are not yet embedded in every aspect of manufacturing and supply chain operations. Their skepticism often reflects the cultural and financial obstacles that arise from longstanding corporate habits and infrastructures. Some experts argue that educational initiatives, beginning as
early as undergraduate curricula in life sciences, engineering, and supply chain management, are needed to cultivate a generation of professionals fully conversant in AI-based sustainability methods. Others note that cost barriers, especially for smaller organizations or academic labs, can be substantial. These hurdles, however, may be mitigated by growing awareness that forward- looking companies who invest in ESG and AI not only gain a competitive edge but also secure long-term risk mitigation. Indeed, industry-wide regulations appear to be heading in a direction that favours early adoption of responsible technologies.

Classical challenges associated with fragmented data systems and siloed legacy platforms are gradually resolving, thanks in part to the advent of cloud-based architectures capable of handling large and diverse datasets. A renewed focus on data interoperability is making it easier for organizations to adopt a holistic approach, in which information regarding climate impact, resource utilization, and fair labour practices all feed into the same AI-driven analytics engine. Moreover, many software vendors now provide user-friendly interfaces that allow supply chain operators to track ESG goals in real
time, bridging the gap between purely algorithmic models and the practical requirements of manufacturing facilities. Looking
ahead, it seems likely that AI and ESG considerations will become increasingly intertwined in many regulated industries.
Recent global disruptions—most visibly during the COVID-19 pandemic—have underscored both the vulnerabilities in multinational supply chains and the importance of local resilience. These events have spurred renewed emphasis on safe, resource- efficient, and socially responsible operations, including reshoring initiatives in multiple regions.

The potential for automation and advanced analytics to expedite process development is immense, especially when weighed against the pressing need to minimize waste and ensure ethical compliance. In response, emerging guidelines are
expected to offer clearer incentives for integrating AI and ESG within supply chains, helping to harmonize global standards
on safety, sustainability, and cost-effectiveness. Ultimately, the fusion of AI-driven analytics with ESG objectives signals
a transformation in manufacturing and service delivery that goes well beyond incremental improvements. From reducing
environmental footprints to ensuring transparent labour practices, and from enhancing patient outcomes to safeguarding
community well-being, these emerging strategies mark the start of a promising new era. As data scientists, engineers,
healthcare professionals, and policymakers converge, the goal is to forge a supply chain that is not only more efficient and
adaptable, but also respects the planet and the people who rely on essential products and services.

A total of 19 companies participated in the panel discussions. Their insights—detailing AI and ESG implementation strategies, case studies, and best practices—are featured in the sections that follow this commentary. These contributions provide a wide-ranging view of how organizations are adapting to new AI capabilities and sustainability demands across multiple industries.

1-1

MAGGIE SAYKALI

Director, EFCG

The current state of affairs

For the last three decades, the European pharmaceutical supply chain has been increasingly offshoring the production of some of its most widely used medicines to Asia. Nowadays, taking into account key raw materials and intermediates, this dependency is critical as the EU relies for 74% (1) on other world regions for the manufacturing of its APIs. This worrying decline is exacerbated by the offshoring to these regions of key technologies and processes.

The global production share of EU-produced APIs tumbled down from 53% in 2000 to 25% in 2020, causing Europe’s dependency on other regions for its APIs, of which 56% currently originate from India and China (2). Many critical APIs are no longer produced in Europe as illustrated by the striking example of Metoprolol, used for high blood pressure. Formerly produced in the EU, it is currently produced mainly in China and India as 16 EU sites have stopped producing it. Similarly, Gabapentin, a treatment for epilepsy, now comes mainly from India after 10 EU producers stopped its production. These are just two examples of the many molecules for which Europe is dependent on other regions, putting at risk the security of supply to patients.

The perils of this model have been clearly demonstrated during the initial stages of the Covid-19 pandemic, when China was hit by its first wave: some of its production plants ground to a halt, restricting the quantity of medicines available for Europe. The successive crises that Europe went through since 2020 further highlighted the vulnerability of the EU pharma supply chain and the need for a clear strategy to strengthen its autonomy.

European API producers are currently faced with a double challenge: securing critical raw materials and producing at competitive cost. They have been hit by a doubling of their utility bills in 2022 compared to 2019 and severe price increases for their essential raw materials (3), with some of these reaching 150% up to 300%. Meanwhile, other world regions were not affected by the same increases and their API manufacturers continue to benefit from a production cost advantage linked to economies of scale, a lower cost of labour, lower regulatory and environmental standards and lighter administrative burdens.

Tensions in the supply chain are once again aggravated by the current wave of Covid in China that is crippling production units of precursors, intermediates and APIs. Other issues further contribute to disrupt the smooth supply of everyday essential medicines in Europe: the increase in demand from internal markets in Asia, combined with the unexpectedly high seasonal demand for some medicines such as antibiotics, and the lure of more attractively-priced markets, all negatively impact the supply chain. Several EU member states are currently dealing with drug shortages such as antibiotics, antiepileptics, pain killers and cancer drugs and as much as 500 medicines are currently reported missing from pharmacy shelves and hospitals.

Turning the tide

APIs are the key components of pharmaceuticals and a strong European API industrial capacity must be at the centre of the EU’s plan for the strategic autonomy of its pharmaceutical supply chain.

Financial, policy and administrative support mechanisms are necessary to bolster API production in Europe and to drive relocation of critical supply chains. To be successful, proposed measures must be pan-European and address vulnerabilities at every point of the supply chain.

EFCG recommends a set of essential measures to achieve a strong, innovative, globally competitive and sustainable EU-based pharmaceutical supply chain.

1. Investments

The EU must support investments that stimulate the construction or modernisation of production facilities and cutting-edge manufacturing technologies. API production involves bespoke technology and dedicated production lines with investments ranging from €50 to 180 million per infrastructure and a completion time frame of three to six years. A framework for API investments in Europe would accelerate the relocation of existing production and prevent the extinction of current activities.

2. Support for competitive pricing

EU Public funding schemes should be available to foster a competitive environment as well as the hiring and training of staff in the skills needed for high-quality API production.

3. Environmental protection

Financial incentives for expenditure on environmentally-friendly manufacturing will encourage and accelerate investments in Europe and facilitate the EU’s plan for a Green Transition. The EU should also ensure that all world regions cooperate to minimise the environmental impact of the production of pharmaceuticals.

4. Lighter and faster administrative procedures

Administrative procedures should include fast-tracking the approval for sustainable processing technologies such as innovative and environmentally-friendly synthesis routes and the digitalisation of regulatory processes.

5. Levelling the playing field

Authorities in reimbursement and procurement policy should move towards non-price related criteria, such as backward integration of raw materials and intermediates, process innovation and social and environmental factors to reward the production of APIs in Europe. They should recognise that the continuous price pressure on mature molecules have their limitations and that price erosion should not go beyond the point where production is no longer sustainable or financially viable. Pricing of mature drugs should be adapted to reflect their industrial, environmental and social benefits and their role in maintaining security of supply and improving access to medicines.

The time for action is now

n the past three years, our industry relentlessly strove to alert EU authorities and inform them of the need to address the situation head-on. We provided several sets of solid data to document the root causes of the supply tensions and shortages that are affecting Europe and put forward several practical recommendations to reverse the trend. However, time is now quickly running out and the EU authorities must urgently move forward and implement the necessary measures. Only then can we turn the tide and ensure that Europe can depend on a robust, innovative, sustainable and forward-looking API industry that will guarantee citizens a safe, reliable and available access to their needed medicines.

2

ELIZABETH STAMPA

President of Medicines for Europe

2

ELIZABETH STAMPA

President of Medicines for Europe

Pharma supply chains face significant challenges and are looking for innovative solutions and incentives to deal with rising costs

What are in your view the biggest upcoming challenges in supply chain?

The Pharma supply chain is confronted with very diverse challenges at the same time: high inflation rates which affect solvents and key starting materials for the Active Pharmaceutical Ingredients (API) manufacturers to the increased cost of these APIs for the Pharma producers, increased salaries, higher prices of services to the industry,… Besides inflation, the increase in energy prices is also adding more difficulties, as the cost has doubled in the best-case scenario, and in some countries, the risk of rationalization is high due to the dependency on certain supply countries. Transport costs and availability have now stabilized, however, there has been a significant increase in prices compared to pre-pandemic months.

Which strategies do you consider as suitable to mitigate the risks in supply chain management? E.g. re-shoring, back integration, diversifications of suppliers and regions? What are the benefits and risks?

During the worst pandemic months there were many talks about increasing European autonomy and bringing back production to Europe. However, so far this initiative has had minimum support from the authorities and without incentives, it is unlikely there will be partners willing to bring back production to Europe. In certain cases, like for some specific key starting materials, the European environmental regulations do not allow these products to be produced in the European territory, or the investment to counter-balance the environmental impact is simply too high to be done at a private level. It would be not realistic to talk about re-shoring of every pharma component we bring from outside Europe, however, having some internal production of certain essential APIs or pharmaceuticals would be highly desirable: one of the biggest challenges, in this case, would be to define what is considered “essential”. There is already a high degree of diversification, as most pharma producers tend to favor having more than one supplier of API, excipient, or components, and API producers use more than one qualified source for their intermediates or key starting materials (KSM). And back integration would, as mentioned earlier, not be possible for environmental or cost reasons.
 

What initiatives or programs do you consider as appropriate to improve the robustness and resilience of your supply chains in the current environment of increasing political uncertainty and transportation problems due to lockdowns and closed borders? Do you expect to transfer some of the cost to your customers? What initiatives or programs have you initiated in the past 6 months?

Most individual players have opted to include and validate a variety of suppliers to increase the robustness of their supply chains. In fact, in India a specific incentive line was developed to increase production of intermediates and KSM for the API industry. Seeing this, similar instruments would be also desirable for the European producers. Relating the transfer of increased costs to customers, this is extremely difficult as in most European countries prices of medicines are fixed at commercial launch and never reviewed after that. This reality affects even stronger the off-patent industry, as most of the generic and biosimilars are subject to tender procurement initiatives in different countries, and prices spiral downwards once the tender system is in place: while it is certainly an effective short-term cost containment measure, it does not cover the long-term consequences of products being discontinued due to extremely low prices (both APIs and finished dosage forms) and then sourced outside Europe, increasing again the dependency of products produced in foreign countries.
 

How could / should governments support the reorganization of the chemical and pharmaceutical industry to help improve the supply security? What technologies should they support?

Governments should support two critical aspects: the first would be adopting procurement strategies based not only on price but also on quality aspects (i.e. recall track record, official inspections quality observations,…), environmentally friendly production systems, or pricing review schemes (i.e. linkage to inflation). The second would be incentives for the local European industry, to preserve the current manufacturing capacities, the European R&D and innovation, and the employment the chemical and pharma industry provide and strengthen the adoption of greener technologies and capabilities for a positive environmental impact.

How would you suggest implementing the Regulatory system and making it more homogeneous?

The first and more urgent request would be to harmonize and digitalize the Regulatory system within Europe. After so many years the requests still vary among the different regulatory bodies and processes to file and obtain approval of variation are burdensome and lengthy both for the industry and the regulators.

What are in your view the biggest upcoming challenges in supply chain?

Pharma supply chains face significant challenges and are looking for innovative solutions and incentives to deal with rising costs

The Pharma supply chain is confronted with very diverse challenges at the same time: high inflation rates which affect solvents and key starting materials for the Active Pharmaceutical Ingredients (API) manufacturers to the increased cost of these APIs for the Pharma producers, increased salaries, higher prices of services to the industry,… Besides inflation, the increase in energy prices is also adding more difficulties, as the cost has doubled in the best-case scenario, and in some countries, the risk of rationalization is high due to the dependency on certain supply countries. Transport costs and availability have now stabilized, however, there has been a significant increase in prices compared to pre-pandemic months.

Which strategies do you consider as suitable to mitigate the risks in supply chain management? E.g. re-shoring, back integration, diversifications of suppliers and regions? What are the benefits and risks?

During the worst pandemic months there were many talks about increasing European autonomy and bringing back production to Europe. However, so far this initiative has had minimum support from the authorities and without incentives, it is unlikely there will be partners willing to bring back production to Europe. In certain cases, like for some specific key starting materials, the European environmental regulations do not allow these products to be produced in the European territory, or the investment to counter-balance the environmental impact is simply too high to be done at a private level. It would be not realistic to talk about re-shoring of every pharma component we bring from outside Europe, however, having some internal production of certain essential APIs or pharmaceuticals would be highly desirable: one of the biggest challenges, in this case, would be to define what is considered “essential”. There is already a high degree of diversification, as most pharma producers tend to favor having more than one supplier of API, excipient, or components, and API producers use more than one qualified source for their intermediates or key starting materials (KSM). And back integration would, as mentioned earlier, not be possible for environmental or cost reasons.
 

What initiatives or programs do you consider as appropriate to improve the robustness and resilience of your supply chains in the current environment of increasing political uncertainty and transportation problems due to lockdowns and closed borders? Do you expect to transfer some of the cost to your customers? What initiatives or programs have you initiated in the past 6 months?

Most individual players have opted to include and validate a variety of suppliers to increase the robustness of their supply chains. In fact, in India a specific incentive line was developed to increase production of intermediates and KSM for the API industry. Seeing this, similar instruments would be also desirable for the European producers. Relating the transfer of increased costs to customers, this is extremely difficult as in most European countries prices of medicines are fixed at commercial launch and never reviewed after that. This reality affects even stronger the off-patent industry, as most of the generic and biosimilars are subject to tender procurement initiatives in different countries, and prices spiral downwards once the tender system is in place: while it is certainly an effective short-term cost containment measure, it does not cover the long-term consequences of products being discontinued due to extremely low prices (both APIs and finished dosage forms) and then sourced outside Europe, increasing again the dependency of products produced in foreign countries.
 

How could / should governments support the reorganization of the chemical and pharmaceutical industry to help improve the supply security? What technologies should they support?

Governments should support two critical aspects: the first would be adopting procurement strategies based not only on price but also on quality aspects (i.e. recall track record, official inspections quality observations,…), environmentally friendly production systems, or pricing review schemes (i.e. linkage to inflation). The second would be incentives for the local European industry, to preserve the current manufacturing capacities, the European R&D and innovation, and the employment the chemical and pharma industry provide and strengthen the adoption of greener technologies and capabilities for a positive environmental impact.

How would you suggest implementing the Regulatory system and making it more homogeneous?

The first and more urgent request would be to harmonize and digitalize the Regulatory system within Europe. After so many years the requests still vary among the different regulatory bodies and processes to file and obtain approval of variation are burdensome and lengthy both for the industry and the regulators.

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